2101-2102    [Reserved]

2103    Patent Examination Process [R-10.2019]

It is essential that patent applicants obtain a prompt yet complete examination of their applications. Under the principles of compact prosecution, each claim should be reviewed for compliance with every statutory requirement for patentability in the initial review of the application, even if one or more claims are found to be deficient with respect to some statutory requirement. Thus, examiners should state all reasons and bases for rejecting claims in the first Office action. Deficiencies should be explained clearly, particularly when they serve as a basis for a rejection. Whenever practicable, examiners and patent reexamination specialists should indicate how rejections may be overcome and how problems may be resolved. Where a rejection not based on prior art is proper (lack of adequate written description, enablement, or utility, etc.) such rejection should be stated with a full development of the reasons rather than by a mere conclusion. A failure to follow this approach can lead to unnecessary delays in the prosecution of the application.

The examination of reissue applications is covered in MPEP Chapter 1400, reexamination proceedings are covered in MPEP Chapters 2200 (ex parte) and 2600 (inter partes), and supplemental examination is covered in MPEP Chapter 2800.

Prior to focusing on specific statutory requirements, examiners must begin examination by determining what, precisely, the inventor or joint inventor has invented and is seeking to patent, and how the claims relate to and define that invention. Examiners will review the complete specification, including the detailed description of the invention, any specific embodiments that have been disclosed, the claims and any specific, substantial, and credible utilities that have been asserted for the invention.

After obtaining an understanding of what applicant invented, the examiner will conduct a search of the prior art and determine whether the invention as claimed complies with all statutory requirements.

The claimed invention as a whole must be useful. The purpose of this requirement is to limit patent protection to inventions that possess a certain level of "real world" value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research (Brenner v. Manson, 383 U.S. 519, 528-36, 148 USPQ 689, 693-96 (1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)).

Examiners should review the application to identify any asserted utility. The applicant is in the best position to explain why an invention is believed useful. Accordingly, a complete disclosure should contain some indication of the practical application for the claimed invention, i.e., why the applicant believes the claimed invention is useful. Such a statement will usually explain the purpose of the invention or how the invention may be used (e.g., a compound is believed to be useful in the treatment of a particular disorder). Note that the concept of a "practical application" in the evaluation of utility is different from the concept of whether a judicial exception is integrated into a "practical application" in the evaluation of subject matter eligibility. Regardless of the form of statement of utility, it must enable one ordinarily skilled in the art to understand why the applicant believes the claimed invention is useful. See MPEP § 2106 for subject matter eligibility guidelines and MPEP § 2107 for utility examination guidelines. An applicant may assert more than one utility and practical application, but only one is necessary. Alternatively, an applicant may rely on the contemporaneous art to provide that the claimed invention has a well-established utility.

The written description will provide the clearest explanation of the applicant’s invention, by exemplifying the invention, explaining how it relates to the prior art and explaining the relative significance of various features of the invention. Accordingly, examiners should continue their evaluation by

• (A) determining the function of the invention, that is, what the invention does when used as disclosed (e.g., the functionality of a programmed computer); and
• (B) determining the features necessary to accomplish at least one asserted practical application.

Patent applicants can assist the USPTO by preparing applications that clearly set forth these aspects of an invention.

The claims define the property rights provided by a patent, and thus require careful scrutiny. The goal of claim analysis is to identify the boundaries of the protection sought by the applicant and to understand how the claims relate to and define what the applicant has indicated is the invention. Examiners must first determine the scope of a claim by thoroughly analyzing the language of the claim before determining if the claim complies with each statutory requirement for patentability. See In re Hiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998) ("[T]he name of the game is the claim.").

Examiners should begin claim analysis by identifying and evaluating each claim limitation. For processes, the claim limitations will define steps or acts to be performed. For products, the claim limitations will define discrete physical structures or materials. Product claims are claims that are directed to either machines, manufactures or compositions of matter.

Examiners should then correlate each claim limitation to all portions of the disclosure that describe the claim limitation. This is to be done in all cases, regardless of whether the claimed invention is defined using means- (or step-) plus- function language. The correlation step will ensure that examiners correctly interpret each claim limitation in light of the specification.

The subject matter of a properly construed claim is defined by the terms that limit the scope of the claim when given their broadest reasonable interpretation. It is this subject matter that must be examined. As a general matter, grammar and the plain meaning of terms as understood by one having ordinary skill in the art used in a claim will dictate whether, and to what extent, the language limits the claim scope. See MPEP § 2111.01 for more information on the plain meaning of claim language. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect:

• (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble,
• (B) "adapted to" or "adapted for" clauses,
• (C) "wherein" or "whereby" clauses,
• (D) contingent limitations,
• (E) printed matter, or
• (F) terms with associated functional language.

This list of examples is not intended to be exhaustive. The determination of whether particular language is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002)(finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). For more information about these types of claim language and how to determine whether they have a limiting effect on claim scope, see MPEP §§ 2111.02 through 2111.05.

Examiners are to give claims their broadest reasonable interpretation in light of the supporting disclosure. See MPEP § 2111. Disclosure may be express, implicit, or inherent. Examiners are to give claimed means- (or step-) plus- function limitations their broadest reasonable interpretation consistent with all corresponding structures (or materials or acts) described in the specification and their equivalents. See In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011). Further guidance in interpreting the scope of equivalents is provided in MPEP §§ 2181 through 2186.

While it is appropriate to use the specification to determine what applicant intends a term to mean, a positive limitation from the specification cannot be read into a claim that does not itself impose that limitation. See MPEP § 2111.01, subsection II. As explained in MPEP § 2111, giving a claim its broadest reasonable interpretation during prosecution will reduce the possibility that the claim, when issued, will be interpreted more broadly than is justified.

Finally, when evaluating the scope of a claim, every limitation in the claim must be considered. Examiners may not dissect a claimed invention into discrete elements and then evaluate the elements in isolation. Instead, the claim as a whole must be considered. See, e.g., Diamond v. Diehr, 450 U.S. 175, 188-89, 209 USPQ 1, 9 (1981) ("In determining the eligibility of respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.").

Prior to evaluating the claimed invention for patentability, examiners are expected to conduct a thorough search of the prior art. See MPEP §§ 904 through 904.03 for more information about how to conduct a search. In many cases, the result of such a search will contribute to examiners understanding of the invention. Both claimed and unclaimed aspects of the invention described in the specification should be searched if there is a reasonable expectation that the unclaimed aspects may be later claimed. A search must take into account any structure or material described in the specification and its equivalents which correspond to the claimed means- (or step-) plus- function limitation, in accordance with 35 U.S.C. 112(f)  and MPEP § 2181 through MPEP § 2186.

Section 101  of title 35, United States Code, provides:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

35 U.S.C. 101  has been interpreted as imposing four requirements: (i) only one patent may be obtained for an invention; (ii) the inventor(s) must be identified in an application filed on or after September 16, 2012 or must be the applicant in applications filed before September 16, 2012; (iii) the claimed invention must be eligible for patenting; and, (iv) the claimed invention must be useful (have utility).

See MPEP § 2104 for a discussion of the four requirements, MPEP § 2106 for a discussion of eligibility, and MPEP § 2107 for the utility examination guidelines.

The patent eligibility inquiry under 35 U.S.C. 101  is a threshold inquiry. Even if a claimed invention qualifies as eligible subject matter under 35 U.S.C. 101, it must also satisfy the other conditions and requirements of the patent laws, including the requirements for novelty (35 U.S.C. 102 ), nonobviousness (35 U.S.C. 103 ), and adequate description and definite claiming (35 U.S.C. 112 ). Bilski v. Kappos, 561 U.S. 593, 602, 95 USPQ2d 1001, 1006 (2010). Therefore, examiners should avoid focusing on only issues of patent-eligibility under 35 U.S.C. 101  to the detriment of considering an application for compliance with the requirements of 35 U.S.C. 102, 35 U.S.C. 103, and 35 U.S.C. 112, and should avoid treating an application solely on the basis of patent-eligibility under 35 U.S.C. 101  except in the most extreme cases.

35 U.S.C. 112(b)  contains two separate and distinct requirements: (A) that the claim(s) set forth the subject matter the inventor or a joint inventor regards as the invention, and (B) that the claim(s) particularly point out and distinctly claim the invention. An application will be deficient under the first requirement of 35 U.S.C. 112(b)  when evidence outside the application as filed, e.g., admissions, shows that the inventor or a joint inventor regards the invention to be different from what is claimed (see MPEP § 2171 - MPEP § 2172.01).

An application fails to comply with the second requirement of 35 U.S.C. 112(b)  when the claims do not set out and define the invention with a reasonable degree of precision and particularity. In this regard, the definiteness of the language must be analyzed, not in a vacuum, but always in light of the teachings of the disclosure as it would be interpreted by one of ordinary skill in the art. Applicant’s claims, interpreted in light of the disclosure, must reasonably apprise a person of ordinary skill in the art of the invention.

The scope of a limitation that invokes 35 U.S.C. 112(f)  is defined as the corresponding structure or material set forth by the inventor in the written description and equivalents thereof that perform the claimed function. See MPEP § 2181 through MPEP § 2186. See MPEP § 2173 et seq. for a discussion of a variety of issues pertaining to the 35 U.S.C. 112(b)  requirement that the claims particularly point out and distinctly claim the invention.

35 U.S.C. 112(a)  contains three separate and distinct requirements:

• (A) adequate written description,
• (B) enablement, and
• (C) best mode.

For the written description requirement, an applicant’s specification must reasonably convey to those skilled in the art that the applicant was in possession of the claimed invention as of the date of invention. See MPEP § 2163 for further guidance with respect to the evaluation of a patent application for compliance with the written description requirement.

An applicant’s specification must enable a person skilled in the art to make and use the claimed invention without undue experimentation. The fact that experimentation is complex, however, will not make it undue if a person of skill in the art routinely engages in such experimentation.

See MPEP § 2164 et seq. for detailed guidance with regard to the enablement requirement of 35 U.S.C. 112(a).

Determining compliance with the best mode requirement requires a two-prong inquiry:

• (1) at the time the application was filed, did the inventor possess a best mode for practicing the invention; and
• (2) if the inventor did possess a best mode, does the written description disclose the best mode in such a manner that a person of ordinary skill in the art could practice the best mode.

See MPEP § 2165 et seq. for additional guidance. Deficiencies related to disclosure of the best mode for carrying out the claimed invention are not usually encountered during examination of an application because evidence to support such a deficiency is seldom in the record. Fonar Corp. v. General Elec. Co., 107 F.3d 1543, 1548-49, 41 USPQ2d 1801, 1804-05 (Fed. Cir. 1997).

Reviewing a claimed invention for compliance with 35 U.S.C. 102  and 35 U.S.C.103  begins with a comparison of the claimed subject matter to what is known in the prior art. See MPEP §§ 2131 - 2146 and MPEP §§ 2150 - 2159 for specific guidance on patentability determinations under 35 U.S.C. 102  and 35 U.S.C. 103. If no differences are found between the claimed invention and the prior art, then the claimed invention lacks novelty and is to be rejected by USPTO personnel under 35 U.S.C. 102. Once differences are identified between the claimed invention and the prior art, those differences must be assessed and resolved in light of the knowledge possessed by a person of ordinary skill in the art. Against this backdrop, one must determine whether the invention would have been obvious to one of ordinary skill in the art. If not, the claimed invention satisfies 35 U.S.C. 103.

Once examiners have completed the above analyses of the claimed invention under all the statutory provisions, including 35 U.S.C. 101, 35 U.S.C. 112, 35 U.S.C. 102, and 35 U.S.C. 103, they should review all the proposed rejections and their bases to confirm that a prima facie case of unpatentability exists. Only then should any rejection be imposed in an Office action. The Office action should clearly communicate the findings, conclusions and reasons which support them.

EXAMINERS SHOULD USE THE APPLICABLE FORM PARAGRAPHS IN OFFICE ACTIONS TO STATE THE BASIS FOR ANY OBJECTIONS OR REJECTIONS TO REDUCE THE CHANCE OF A MISUNDERSTANDING AS TO THE GROUNDS OF OBJECTION OR REJECTION.

2104    Requirements of 35 U.S.C. 101 [R-10.2019]

Patents are not granted for all new and useful inventions and discoveries. For example, the subject matter of the invention or discovery must come within the boundaries set forth by 35 U.S.C. 101, which permits a patent to be granted only for "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."

35 U.S.C. 101  has been interpreted as imposing four requirements, which are described below.

35 U.S.C. 101  requires that whoever invents or discovers an eligible invention may obtain only ONE patent therefor. Thus it prevents two patents issuing on the same invention to the same applicant. The "same invention" means that identical subject matter is being claimed. This requirement forms the basis for statutory double patenting rejections. If more than one patent is sought, a patent applicant will receive a statutory double patenting rejection for claims included in more than one application that are directed to the same invention.

See MPEP § 804 for a full discussion of the prohibition against double patenting. Use form paragraphs 8.30, 8.31 and 8.32 for statutory double patenting rejections.

The inventor(s) must be the applicant in an application filed before September 16, 2012, (except as otherwise provided in pre-AIA 37 CFR 1.41(b) ) and the inventor or each joint inventor must be identified in an application filed on or after September 16, 2012. See MPEP § 2109 for a detailed discussion of inventorship and MPEP § 602.01(c) et seq. for details regarding correction of inventorship.

In the rare situation where it is clear the application does not name the correct inventorship and the applicant has not filed a request to correct inventorship under 37 CFR 1.48, the examiner should reject the claims under 35 U.S.C. 101  and 115  for applications subject to AIA 35 U.S.C. 102  (see MPEP § 2157) or under pre-AIA 35 U.S.C. 102(f)  for applications subject to pre-AIA 35 U.S.C. 102  (see MPEP § 2137).

A claimed invention must be eligible for patenting. As explained in MPEP § 2106, there are two criteria for determining subject matter eligibility: (a) first, a claimed invention must fall within one of the four statutory categories of invention set forth in 35 U.S.C. 101, i.e., process, machine, manufacture, or composition of matter; and (b) second, a claimed invention must be directed to patent-eligible subject matter and not a judicial exception (unless the claim as a whole includes additional limitations amounting to significantly more than the exception). The judicial exceptions are subject matter which courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013)). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)).

See MPEP § 2106 for a discussion of subject matter eligibility in general, and the analytical framework that is to be used during examination for evaluating whether a claim is drawn to patent-eligible subject matter, MPEP § 2106.03 for a discussion of the statutory categories of invention, MPEP § 2106.04 for a discussion of the judicial exceptions, and MPEP § 2106.05 for a discussion of how to evaluate claims directed to a judicial exception for eligibility. See MPEP § 2106.07(a)(1) for form paragraphs for use in rejections under 35 U.S.C. 101  based on a lack of subject matter eligibility. See also MPEP § 2105 for more information about claiming living subject matter, as well as the Leahy-Smith America Invents Act (AIA)'s prohibition against claiming human organisms.

Eligible subject matter is further limited by the Atomic Energy Act explained in MPEP § 2104.01, which prohibits patents granted on any invention or discovery that is useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon.

A claimed invention must be useful or have a utility that is specific, substantial and credible.

A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is "useful" because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101  for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy. See Juicy Whip Inc. v. Orange Bang Inc., 185 F.3d 1364, 1367-68, 51 USPQ2d 1700, 1702-03 (Fed. Cir. 1999) ("[Y]ears ago courts invalidated patents on gambling devices on the ground that they were immoral…, but that is no longer the law…Congress never intended that the patent laws should displace the police powers of the States, meaning by that term those powers by which the health, good order, peace and general welfare of the community are promoted…we find no basis in section 101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool some members of the public.").

The statutory basis for this rejection is 35 U.S.C. 101. See MPEP § 2107 for guidelines governing rejections for lack of utility. See MPEP §§ 2107.01 - 2107.03 for legal precedent governing the utility requirement. See MPEP § 2107.02, subsection IV, for form paragraphs to be used to reject claims under 35 U.S.C. 101  for failure to satisfy the utility requirement.

2104.01    Barred by Atomic Energy Act [R-10.2019]

A limitation on what can be patented is imposed by the Atomic Energy Act of 1954. Section 151(a) (42 U.S.C. 2181(a)) thereof reads in part as follows:

No patent shall hereafter be granted for any invention or discovery which is useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon.

The terms "atomic energy" and "special nuclear material" are defined in Section 11 of the Act (42 U.S.C. 2014).

Sections 151(c) and 151(d) (42 U.S.C. 2181(c) and (d)) set up categories of pending applications relating to atomic energy that must be brought to the attention of the Department of Energy. Under 37 CFR 1.14(d), applications for patents which disclose or which appear to disclose, or which purport to disclose, inventions or discoveries relating to atomic energy are reported to the Department of Energy and the Department will be given access to such applications, but such reporting does not constitute a determination that the subject matter of each application so reported is in fact useful or an invention or discovery or that such application in fact discloses subject matter in categories specified by the Atomic Energy Act.

All applications received in the U.S. Patent and Trademark Office are screened by Technology Center (TC) work group 3640 personnel, under 37 CFR 1.14(d), in order for the Director to fulfill his or her responsibilities under section 151(d) (42 U.S.C. 2181(d)) of the Atomic Energy Act. Papers subsequently added must be inspected promptly by the examiner when received to determine whether the application has been amended to relate to atomic energy and those so related must be promptly forwarded to Licensing and Review in TC work group 3640.

All rejections based upon sections 151(a) (42 U.S.C. 2181(a)), 152 (42 U.S.C. 2182), and 155 (42 U.S.C. 2185) of the Atomic Energy Act must be made only by TC work group 3640 personnel.

2105    Patent Eligible Subject Matter — Living Subject Matter [R-10.2019]

Prior to 1980, it was widely believed that living subject matter was not eligible for patenting, either because such subject matter did not fall within a statutory category, or because it was a judicial exception to patent eligibility. However, the decision of the Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), made it clear that the question of whether an invention embraces living matter is irrelevant to the issue of patent eligibility. Note, however, that Congress has excluded claims directed to or encompassing a human organism from eligibility. See The Leahy-Smith America Invents Act (AIA), Pub. L. 112-29, sec. 33(a), 125 Stat. 284 (September 16, 2011).

In Chakrabarty, the Supreme Court held that a claim to a genetically engineered bacterium was directed to at least one of the four statutory categories, because the bacterium was a "manufacture" and/or a "composition of matter." In its opinion, the Court stated that "Congress plainly contemplated that the patent laws would be given wide scope" because it chose to draft 35 U.S.C. 101  using "such expansive terms as ‘manufacture’ and ‘composition of matter,’ modified by the comprehensive ‘any.’" 447 U.S. at 308, 206 USPQ at 197. The Court also determined that the distinction between living and inanimate things was not relevant for subject matter eligibility. 447 U.S. at 313, 206 USPQ at 199. Thus, the Court held that living subject matter with markedly different characteristics from any found in nature, such as the claimed bacterium produced by genetic engineering, is not excluded from patent protection by 35 U.S.C. 101. 447 U.S. at 310, 206 USPQ at 197.

Following the reasoning in Chakrabarty, the Board of Patent Appeals and Interferences determined that animals are patentable subject matter under 35 U.S.C. 101. In Ex parte Allen, 2 USPQ2d 1425 (Bd. Pat. App. & Inter. 1987), the Board decided that a non-naturally occurring polyploid Pacific coast oyster could have been the proper subject of a patent under 35 U.S.C. 101  if all the criteria for patentability were satisfied. Shortly after the Allen decision, the Commissioner of Patents and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) stating that the Patent and Trademark Office "now considers nonnaturally occurring, non-human multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.

With respect to plant subject matter, the Supreme Court held that patentable subject matter under 35 U.S.C. 101  includes newly developed plant breeds, even though plant protection is also available under the Plant Patent Act (35 U.S.C. 161  - 164 ) and the Plant Variety Protection Act (7 U.S.C. 2321 et. seq.). J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’ l, Inc., 534 U.S. 124, 143-46, 60 USPQ2d 1865, 1874 (2001) (The scope of coverage of 35 U.S.C. 101  is not limited by the Plant Patent Act or the Plant Variety Protection Act; each statute can be regarded as effective because of its different requirements and protections).

See MPEP § 2106.03 for a discussion of the categories of statutory subject matter.

The Supreme Court in Chakrabarty held a claim to a genetically engineered bacterium eligible, because the claimed bacterium was not a "product of nature" exception. As the Court explained, the modified bacterium was patentable because the patent claim was not to a "hitherto unknown natural phenomenon," but instead had "markedly different characteristics from any found in nature," due to the additional plasmids and resultant capacity for degrading oil. 447 U.S. at 309-10, 206 USPQ at 197.

Subsequent judicial decisions have made clear that the Supreme Court’s decision in Chakrabarty is "central" to the eligibility inquiry with respect to nature-based products. See, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 590, 106 USPQ2d 1972, 1979 (2013). For example, the Federal Circuit has indicated that "discoveries that possess ‘markedly different characteristics from any found in nature,’ … are eligible for patent protection." In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1336, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ2d at 197). In Roslin, the claimed invention was a live-born clone of a pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and goats. An embodiment of the claimed invention was the famous Dolly the Sheep, which the court stated was "the first mammal ever cloned from an adult somatic cell." Despite acknowledging that the method used to create the claimed clones "constituted a breakthrough in scientific discovery", the court relied on Chakrabarty in holding the claims ineligible because "Dolly herself is an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature.’" Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671.

See MPEP § 2106.04 for a discussion of the judicial exceptions in general, MPEP § 2106.04(b), subsection II, for a discussion of products of nature, and MPEP § 2106.04(c) for a discussion of the markedly different characteristics analysis that examiners should use to determine whether a nature-based product such as living subject matter is eligible for patent protection.

Congress has excluded claims directed to or encompassing a human organism from patentability. The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33(a), 125 Stat. 284, states:

Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.

The legislative history of the AIA includes the following statement, which sheds light on the meaning of this provision:

[T]he U.S. Patent Office has already issued patents on genes, stems cells, animals with human genes, and a host of non-biologic products used by humans, but it has not issued patents on claims directed to human organisms, including human embryos and fetuses. My amendment would not affect the former, but would simply affirm the latter.

157 Cong. Rec. E1177-04 (testimony of Representative Dave Weldon previously presented in connection with the Consolidated Appropriations Act, 2004, Public Law 108-199, 634, 118 Stat. 3, 101, and later resubmitted with regard to the AIA; see 149 Cong. Rec. E2417-01). Thus, section 33(a) of the AIA  codifies existing Office policy that human organisms are not patent-eligible subject matter.

If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human organism, then a rejection under 35 U.S.C. 101  and AIA sec. 33(a)  must be made indicating that the claimed invention is directed to a human organism and is therefore nonstatutory subject matter. Furthermore, the claimed invention must be examined with regard to all issues pertinent to patentability, and any applicable rejections under 35 U.S.C. 102, 103, or 112  must also be made.

Use form paragraph 7.04.03 to reject a claim under 35 U.S.C. 101  and AIA sec. 33(a).

2106    Patent Subject Matter Eligibility [R-10.2019]

First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101  defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b)  ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.

Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.

Because abstract ideas, laws of nature, and natural phenomenon "are the basic tools of scientific and technological work", the Supreme Court has expressed concern that monopolizing these tools by granting patent rights may impede innovation rather than promote it. See Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). However, the Court has also emphasized that an invention is not considered to be ineligible for patenting simply because it involves a judicial exception. Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1980-81 (citing Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)). See also Thales Visionix Inc. v. United States, 850 F.3d. 1343, 1349, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017) ("That a mathematical equation is required to complete the claimed method and system does not doom the claims to abstraction."). Accordingly, the Court has said that integration of an abstract idea, law of nature or natural phenomenon into a practical application may be eligible for patent protection. See, e.g., Alice, 573 U.S. at 217, 110 USPQ2d at 1981 (explaining that "in applying the §101  exception, we must distinguish between patents that claim the ‘buildin[g] block[s]’ of human ingenuity and those that integrate the building blocks into something more" (quoting Mayo, 566 U.S. at 89, 110 USPQ2d at 1971) and stating that Mayo "set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts"); Mayo, 566 U.S. at 80, 84, 101 USPQ2d at 1969, 1971 (noting that the Court in Diamond v. Diehr found "the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole," but the Court in Gottschalk v. Benson "held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle"); Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) ("Diehr explained that while an abstract idea, law of nature, or mathematical formula could not be patented, ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.’" (quoting Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)) (emphasis in original)); Diehr, 450 U.S. at 187, 192 n.14, 209 USPQ at 10 n.14 (explaining that the process in Parker v. Flook was ineligible not because it contained a mathematical formula, but because it did not provide an application of the formula). See Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972); Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978).

The Supreme Court in Mayo laid out a framework for determining whether an applicant is seeking to patent a judicial exception itself, or a patent-eligible application of the judicial exception. See Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961). This framework, which is referred to as the Mayo test or the Alice/Mayo test, is discussed in further detail in subsection III, below. The first part of the Mayo test is to determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon (i.e., a judicial exception). Id. If the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). The Supreme Court has described the second part of the test as the "search for an 'inventive concept'". Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).

The Alice/Mayo two-part test is the only test that should be used to evaluate the eligibility of claims under examination. While the machine-or-transformation test is an important clue to eligibility, it should not be used as a separate test for eligibility. Instead it should be considered as part of the "integration" determination or "significantly more" determination articulated in the Alice/Mayo test. Bilski v. Kappos, 561 U.S. 593, 605, 95 USPQ2d 1001, 1007 (2010). See MPEP § 2106.04(d) for more information about evaluating whether a claim reciting a judicial exception is integrated into a practical application and MPEP § 2106.05(b) and MPEP § 2106.05(c) for more information about how the machine-or-transformation test fits into the Alice/Mayo two-part framework. Likewise, eligibility should not be evaluated based on whether the claim recites a "useful, concrete, and tangible result," State Street Bank, 149 F.3d 1368, 1374, 47 USPQ2d 1596, 1602 (Fed. Cir. 1998) (quoting In re Alappat, 33 F.3d 1526, 1544, 31 USPQ2d 1545, 1557 (Fed. Cir. 1994)), as this test has been superseded. In re Bilski, 545 F.3d 943, 959-60, 88 USPQ2d 1385, 1394-95 (Fed. Cir. 2008) (en banc), aff'd by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) ("It is well-settled that mere recitation of concrete, tangible components is insufficient to confer patent eligibility to an otherwise abstract idea"). The programmed computer or "special purpose computer" test of In re Alappat, 33 F.3d 1526, 31 USPQ2d 1545 (Fed. Cir. 1994) (i.e., the rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim for the "special purpose" of executing the algorithm or software) was also superseded by the Supreme Court’s Bilski and Alice Corp. decisions. Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) ("[W]e note that Alappat has been superseded by Bilski, 561 U.S. at 605–06, and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 110 USPQ2d 1976 (2014)"); Intellectual Ventures I LLC v. Capital One Bank (USA), N.A., 792 F.3d 1363, 1366, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015) ("An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment, such as the Internet [or] a computer"). Lastly, eligibility should not be evaluated based on whether the claimed invention has utility, because "[u]tility is not the test for patent-eligible subject matter." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1380, 118 USPQ2d 1541, 1548 (Fed. Cir. 2016).

Examiners are reminded that 35 U.S.C. 101  is not the sole tool for determining patentability; 35 U.S.C. 112  , 35 U.S.C. 102, and 35 U.S.C. 103  will provide additional tools for ensuring that the claim meets the conditions for patentability. As the Supreme Court made clear in Bilski, 561 U.S. at 602, 95 USPQ2d at 1006:

The § 101  patent-eligibility inquiry is only a threshold test. Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act’s protection the claimed invention must also satisfy ‘‘the conditions and requirements of this title.’’ § 101. Those requirements include that the invention be novel, see § 102, nonobvious, see § 103, and fully and particularly described, see § 112.

It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility. The BRI sets the boundaries of the coverage sought by the claim and will influence whether the claim seeks to cover subject matter that is beyond the four statutory categories or encompasses subject matter that falls within the exceptions. See MyMail, Ltd. v. ooVoo, LLC, 934 F.3d 1373, 1379, 2019 USPQ2d 305789 (Fed. Cir. 2019) ("Determining patent eligibility requires a full understanding of the basic character of the claimed subject matter"), citing Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1273-74, 103 USPQ2d 1425, 1430 (Fed. Cir. 2012); In re Bilski, 545 F.3d 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (en banc ), aff'd by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010) ("claim construction … is an important first step in a § 101  analysis"). Evaluating eligibility based on the BRI also ensures that patent eligibility under 35 U.S.C. 101  does not depend simply on the draftsman’s art. Alice, 573 U.S. 208, 224, 110 USPQ2d at 1984, 1985 (citing Parker v. Flook, 437 U.S. 584, 593, 198 USPQ 193, 198 (1978) and Mayo, 566 U.S. at 72, 101 USPQ2d at 1966). See MPEP § 2111 for more information about determining the BRI.

Claim interpretation affects the evaluation of both criteria for eligibility. For example, in Mentor Graphics v. EVE-USA, Inc., 851 F.3d 1275, 112 USPQ2d 1120 (Fed. Cir. 2017), claim interpretation was crucial to the court’s determination that claims to a "machine-readable medium" were not to a statutory category. In Mentor Graphics, the court interpreted the claims in light of the specification, which expressly defined the medium as encompassing "any data storage device" including random-access memory and carrier waves. Although random-access memory and magnetic tape are statutory media, carrier waves are not because they are signals similar to the transitory, propagating signals held to be non-statutory in Nuijten. 851 F.3d at 1294, 112 USPQ2d at 1133 (citing In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007)). Accordingly, because the BRI of the claims covered both subject matter that falls within a statutory category (the random-access memory), as well as subject matter that does not (the carrier waves), the claims as a whole were not to a statutory category and thus failed the first criterion for eligibility.

With regard to the second criterion for eligibility, the Alice/Mayo test, claim interpretation can affect the first part of the test (whether the claims are directed to a judicial exception). For example, the patentee in Synopsys argued that the claimed methods of logic circuit design were intended to be used in conjunction with computer-based design tools, and were thus not mental processes. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1147-49, 120 USPQ2d 1473, 1480-81 (Fed. Cir. 2016). The court disagreed, because it interpreted the claims as encompassing nothing other than pure mental steps (and thus falling within an abstract idea grouping) because the claims did not include any limitations requiring computer implementation. In contrast, the patentee in Enfish argued that its claimed self-referential table for a computer database was an improvement in an existing technology and thus not directed to an abstract idea. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336-37, 118 USPQ2d 1684, 1689-90 (Fed. Cir. 2016). The court agreed with the patentee, based on its interpretation of the claimed "means for configuring" under 35 U.S.C. 112(f)  as requiring a four-step algorithm that achieved the improvements, as opposed to merely any form of storing tabular data. See also McRO, Inc. v. Bandai Namco Games America, Inc. 837 F.3d 1299, 1314, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) (the claim’s construction incorporated rules of a particular type that improved an existing technological process). Claim interpretation can also affect the second part of the Alice/Mayo test (whether the claim recites additional elements that amount to significantly more than the judicial exception). For example, in Amdocs (Israel) Ltd. v. Openet Telecom, Inc., where the court relied on the construction of the term "enhance" (to require application of a number of field enhancements in a distributed fashion) to determine that the claim entails an unconventional technical solution to a technological problem. 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016).

Examiners should determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance with the following flowchart. The flowchart illustrates the steps of the subject matter eligibility analysis for products and processes that are to be used during examination for evaluating whether a claim is drawn to patent-eligible subject matter. It is recognized that under the controlling legal precedent there may be variations in the precise contours of the analysis for subject matter eligibility that will still achieve the same end result. The analysis set forth herein promotes examination efficiency and consistency across all technologies.

As shown in the flowchart, Step 1 relates to the statutory categories and ensures that the first criterion is met by confirming that the claim falls within one of the four statutory categories of invention. See MPEP § 2106.03 for more information on Step 1. Step 2, which is the Supreme Court’s Alice/Mayo test, is a two-part test to identify claims that are directed to a judicial exception (Step 2A) and to then evaluate if additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception). See MPEP § 2106.04 for more information on Step 2A and MPEP § 2106.05 for more information on Step 2B.

The flowchart also shows three pathways (A, B, and C) to eligibility:

• Pathway A: Claims taken as a whole that fall within a statutory category (Step 1: YES) and, which may or may not recite a judicial exception, but whose eligibility is self-evident can be found eligible at Pathway A using a streamlined analysis. See MPEP § 2106.06 for more information on this pathway and on self-evident eligibility.
• Pathway B: Claims taken as a whole that fall within a statutory category (Step 1: YES) and are not directed to a judicial exception (Step 2A: NO) are eligible at Pathway B. These claims do not need to go to Step 2B. See MPEP § 2106.04 for more information about this pathway and Step 2A.
• Pathway C: Claims taken as a whole that fall within a statutory category (Step 1: YES), are directed to a judicial exception (Step 2A: YES), and recite additional elements either individually or in an ordered combination that amount to significantly more than the judicial exception (Step 2B: YES) are eligible at Pathway C. See MPEP § 2106.05 for more information about this pathway and Step 2B.

Claims that could have been found eligible at Pathway A (streamlined analysis), but are subjected to further analysis at Steps 2A or Step 2B, will ultimately be found eligible at Pathways B or C. Thus, if the examiner is uncertain about whether a streamlined analysis is appropriate, the examiner is encouraged to conduct a full eligibility analysis. However, if the claim is not found eligible at any of Pathways A, B or C, the claim is patent ineligible and should be rejected under 35 U.S.C. 101.

Regardless of whether a rejection under 35 U.S.C. 101  is made, a complete examination should be made for every claim under each of the other patentability requirements: 35 U.S.C. 102, 103, 112, and 101  (utility, inventorship and double patenting) and non-statutory double patenting. MPEP § 2103.

2106.01    [Reserved]

2106.02    [Reserved]

2106.03    Eligibility Step 1: The Four Categories of Statutory Subject Matter [R-10.2019]

35 U.S.C. 101  enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these "four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of § 101  even if the subject matter is otherwise new and useful." In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007).

A process defines "actions", i.e., an invention that is claimed as an act or step, or a series of acts or steps. As explained by the Supreme Court, a "process" is "a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing." Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) (italics added) (quoting Cochrane v. Deener, 94 U.S. 780, 788, 24 L. Ed. 139, 141 (1876)). See also Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501 ("The Supreme Court and this court have consistently interpreted the statutory term ‘process’ to require action"); NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) ("[A] process is a series of acts.") (quoting Minton v. Natl. Ass’n. of Securities Dealers, 336 F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003)). As defined in 35 U.S.C. 100(b), the term "process" is synonymous with "method."

The other three categories (machines, manufactures and compositions of matter) define the types of physical or tangible "things" or "products" that Congress deemed appropriate to patent. Digitech Image Techs. v. Electronics for Imaging, 758 F.3d 1344, 1348, 111 USPQ2d 1717, 1719 (Fed. Cir. 2014) ("For all categories except process claims, the eligible subject matter must exist in some physical or tangible form."). Thus, when determining whether a claimed invention falls within one of these three categories, examiners should verify that the invention is to at least one of the following categories and is claimed in a physical or tangible form.

• • A machine is a "concrete thing, consisting of parts, or of certain devices and combination of devices." Digitech, 758 F.3d at 1348-49, 111 USPQ2d at 1719 (quoting Burr v. Duryee, 68 U.S. 531, 570, 17 L. Ed. 650, 657 (1863)). This category "includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result." Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501 (quoting Corning v. Burden, 56 U.S. 252, 267, 14 L. Ed. 683, 690 (1854)).
• • A manufacture is "a tangible article that is given a new form, quality, property, or combination through man-made or artificial means." Digitech, 758 F.3d at 1349, 111 USPQ2d at 1719-20 (citing Diamond v. Chakrabarty, 447 U.S. 303, 308, 206 USPQ 193, 197 (1980)). As the courts have explained, manufactures are articles that result from the process of manufacturing, i.e., they were produced "from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery." Samsung Electronics Co. v. Apple Inc., 580 U.S. __, 120 USPQ2d 1749, 1752-3 (2016) (quoting Diamond v. Chakrabarty, 447 U. S. 303, 308, 206 USPQ 193, 196-97 (1980)); Nuijten, 500 F.3d at 1356-57, 84 USPQ2d at 1502. Manufactures also include "the parts of a machine considered separately from the machine itself." Samsung Electronics, 137 S. Ct. at 435, 120 USPQ2d at 1753 (quoting 1 W. Robinson, The Law of Patents for Useful Inventions §183, p. 270 (1890)).
• • A composition of matter is a "combination of two or more substances and includes all composite articles." Digitech, 758 F.3d at 1348-49, 111 USPQ2d at 1719 (citation omitted). This category includes all compositions of two or more substances and all composite articles, "'whether they be the results of chemical union or of mechanical mixture, or whether they be gases, fluids, powders or solids.'" Chakrabarty, 447 U.S. at 308, 206 USPQ at 197 (quoting Shell Dev. Co. v. Watson, 149 F. Supp. 279, 280 (D.D.C. 1957); id. at 310 holding genetically modified microorganism to be a manufacture or composition of matter).

It is not necessary to identify a single category into which a claim falls, so long as it is clear that the claim falls into at least one category. For example, because a microprocessor is generally understood to be a manufacture, a product claim to the microprocessor or a system comprising the microprocessor satisfies Step 1 regardless of whether the claim falls within any other statutory category (such as a machine). It is also not necessary to identify a "correct" category into which the claim falls, because although in many instances it is clear within which category a claimed invention falls, a claim may satisfy the requirements of more than one category. For example, a bicycle satisfies both the machine and manufacture categories, because it is a tangible product that is concrete and consists of parts such as a frame and wheels (thus satisfying the machine category), and it is an article that was produced from raw materials such as aluminum ore and liquid rubber by giving them a new form (thus satisfying the manufacture category). Similarly, a genetically modified bacterium satisfies both the composition of matter and manufacture categories, because it is a tangible product that is a combination of two or more substances such as proteins, carbohydrates and other chemicals (thus satisfying the composition of matter category), and it is an article that was genetically modified by humans to have new properties such as the ability to digest multiple types of hydrocarbons (thus satisfying the manufacture category).

Non-limiting examples of claims that are not directed to any of the statutory categories include:

• • Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations;
• • Transitory forms of signal transmission (often referred to as "signals per se"), such as a propagating electrical or electromagnetic signal or carrier wave; and
• • Subject matter that the statute expressly prohibits from being patented, such as humans per se, which are excluded under The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 Stat. 284 (September 16, 2011).

As the courts' definitions of machines, manufactures and compositions of matter indicate, a product must have a physical or tangible form in order to fall within one of these statutory categories. Digitech, 758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the Federal Circuit has held that a product claim to an intangible collection of information, even if created by human effort, does not fall within any statutory category. Digitech, 758 F.3d at 1350, 111 USPQ2d at 1720 (claimed "device profile" comprising two sets of data did not meet any of the categories because it was neither a process nor a tangible product). Similarly, software expressed as code or a set of instructions detached from any medium is an idea without physical embodiment. See Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible). Thus, a product claim to a software program that does not also contain at least one structural limitation (such as a "means plus function" limitation) has no physical or tangible form, and thus does not fall within any statutory category. Another example of an intangible product that does not fall within a statutory category is a paradigm or business model for a marketing company. In re Ferguson, 558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009).

Even when a product has a physical or tangible form, it may not fall within a statutory category. For instance, a transitory signal, while physical and real, does not possess concrete structure that would qualify as a device or part under the definition of a machine, is not a tangible article or commodity under the definition of a manufacture (even though it is man-made and physical in that it exists in the real world and has tangible causes and effects), and is not composed of matter such that it would qualify as a composition of matter. Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. As such, a transitory, propagating signal does not fall within any statutory category. Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, 1294, 112 USPQ2d 1120, 1133 (Fed. Cir. 2017); Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03.

As described in MPEP § 2106, subsection III, Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Like the other steps in the eligibility analysis, evaluation of this step should be made after determining what applicant has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation (BRI). See MPEP § 2106, subsection II, for more information about the importance of understanding what the applicant has invented, and MPEP § 2111 for more information about the BRI.

In the context of the flowchart in MPEP § 2106, subsection III, Step 1 determines whether:

• • The claim as a whole does not fall within any statutory category (Step 1: NO) and thus is non-statutory, warranting a rejection for failure to claim statutory subject matter; or
• • The claim as a whole falls within one or more statutory categories (Step 1: YES), and thus must be further analyzed to determine whether it qualifies as eligible at Pathway A or requires further analysis at Step 2A to determine if the claim is directed to a judicial exception.

A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step (Step 1: NO) and should be rejected under 35 U.S.C. 101, for at least this reason. In such a case, it is a best practice for the examiner to point out the BRI and recommend an amendment, if possible, that would narrow the claim to those embodiments that fall within a statutory category.

For example, the BRI of machine readable media can encompass non-statutory transitory forms of signal transmission, such as a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the BRI encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101  as failing to claim statutory subject matter would be appropriate. Thus, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under 35 U.S.C. 101  as being directed to non-statutory subject matter. See, e.g., Mentor Graphics v. EVE-USA, Inc., 851 F.3d at 1294-95, 112 USPQ2d at 1134 (claims to a "machine-readable medium" were non-statutory, because their scope encompassed both statutory random-access memory and non-statutory carrier waves).

If a claim is clearly not within one of the four categories (Step 1: NO), then a rejection under 35 U.S.C. 101  must be made indicating that the claim is directed to non-statutory subject matter. Form paragraphs 7.05 and 7.05.01 should be used; see MPEP § 2106.07(a)(1). However, as shown in the flowchart in MPEP § 2106 subsection III, when a claim fails under Step 1 (Step 1: NO), but it appears from applicant’s disclosure that the claim could be amended to fall within a statutory category (Step 1: YES), the analysis should proceed to determine whether such an amended claim would qualify as eligible at Pathway A, B or C. In such a case, it is a best practice for the examiner to recommend an amendment, if possible, that would resolve eligibility of the claim.

2106.04    Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception [R-10.2019]

Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101  (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not end the eligibility analysis, because claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185, 209 USPQ 1, 7 (1981). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013)); Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978); Gottschalk v. Benson, 409 U.S. 63, 67-68, 175 USPQ 673, 675 (1972). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) ("The Court’s precedents provide three specific exceptions to § 101's  broad patent-eligibility principles: ‘laws of nature, physical phenomena, and abstract ideas’") (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)).

In addition to the terms "laws of nature," "natural phenomena," and "abstract ideas," judicially recognized exceptions have been described using various other terms, including "physical phenomena," "products of nature," "scientific principles," "systems that depend on human intelligence alone," "disembodied concepts," "mental processes," and "disembodied mathematical algorithms and formulas." It should be noted that there are no bright lines between the types of exceptions, and that many of the concepts identified by the courts as exceptions can fall under several exceptions. For example, mathematical formulas are considered to be a judicial exception as they express a scientific truth, but have been labelled by the courts as both abstract ideas and laws of nature. Likewise, "products of nature" are considered to be an exception because they tie up the use of naturally occurring things, but have been labelled as both laws of nature and natural phenomena. Thus, it is sufficient for this analysis for the examiner to identify that the claimed concept (the specific claim limitation(s) that the examiner believes may recite an exception) aligns with at least one judicial exception.

The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena, even if the judicial exception is narrow (e.g., a particular mathematical formula such as the Arrhenius equation). See, e.g., Mayo, 566 U.S. at 79-80, 86-87, 101 USPQ2d at 1968-69, 1971 (claims directed to "narrow laws that may have limited applications" held ineligible); Flook, 437 U.S. at 589-90, 198 USPQ at 197 (claims that did not "wholly preempt the mathematical formula" held ineligible). This is because such a patent would "in practical effect [] be a patent on the [abstract idea, law of nature or natural phenomenon] itself." Benson, 409 U.S. at 71- 72, 175 USPQ at 676. The concern over preemption was expressed as early as 1852. See Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852) ("A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right.").

While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible. Diamond v. Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1, 10-11 n.14 (1981) ("We rejected in Flook the argument that because all possible uses of the mathematical formula were not pre-empted, the claim should be eligible for patent protection"). See also Synopsys v. Mentor Graphics, 839 F.3d at 1150, 120 USPQ2d at 1483; FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1098, 120 USPQ2d 1293, 1299 (Fed. Cir. 2016); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); Sequenom, 788 F.3d at 1379, 115 USPQ2d at 1158. Several Federal Circuit decisions, however, have noted the absence of preemption when finding claims eligible under the Alice/Mayo test. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016); BASCOM Global Internet v. AT&T Mobility, LLC, 827 F.3d 1341, 1350-52, 119 USPQ2d 1236, 1243-44 (Fed. Cir. 2016).

The Supreme Court’s decisions make it clear that judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions. For example, the mathematical formula in Flook, the laws of nature in Mayo, and the isolated DNA in Myriad were all novel or newly discovered, but nonetheless were considered by the Supreme Court to be judicial exceptions because they were "‘basic tools of scientific and technological work’ that lie beyond the domain of patent protection." Myriad, 569 U.S. 576, 589, 106 USPQ2d at 1976, 1978 (noting that Myriad discovered the BRCA1 and BRCA1 genes and quoting Mayo, 566 U.S. 71, 101 USPQ2d at 1965); Flook, 437 U.S. at 591-92, 198 USPQ2d at 198 ("the novelty of the mathematical algorithm is not a determining factor at all"); Mayo, 566 U.S. 73-74, 78, 101 USPQ2d 1966, 1968 (noting that the claims embody the researcher's discoveries of laws of nature). The Supreme Court’s cited rationale for considering even "just discovered" judicial exceptions as exceptions stems from the concern that "without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’" Myriad, 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting Mayo, 566 U.S. at 86, 101 USPQ2d at 1971). See also Myriad, 569 U.S. at 591, 106 USPQ2d at 1979 ("Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101  inquiry."). The Federal Circuit has also applied this principle, for example, when holding a concept of using advertising as an exchange or currency to be an abstract idea, despite the patentee’s arguments that the concept was "new". Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). Cf. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a new abstract idea is still an abstract idea") (emphasis in original).

For a detailed discussion of abstract ideas, see MPEP § 2106.04(a); for a detailed discussion of laws of nature, natural phenomena and products of nature, see MPEP § 2106.04(b).

As described in MPEP § 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217-18, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68). Like the other steps in the eligibility analysis, evaluation of this step should be made after determining what applicant has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation. See MPEP § 2106, subsection II for more information about the importance of understanding what the applicant has invented, and MPEP § 2111 for more information about the broadest reasonable interpretation.

Step 2A asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? In the context of the flowchart in MPEP § 2106, subsection III, Step 2A determines whether:

• • The claim as a whole is not directed to a judicial exception (Step 2A: NO) and thus is eligible at Pathway B, thereby concluding the eligibility analysis; or
• • The claim as a whole is directed to a judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B to determine if the claim as a whole amounts to significantly more than the exception itself.

Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception. Together, these prongs represent the first part of the Alice/Mayo test, which determines whether a claim is directed to a judicial exception.

The flowchart below depicts the two-prong analysis that is performed in order to answer the Step 2A inquiry.

Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims "set forth" an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words "intermediated" or "settlement."

The Supreme Court has held that Section 101 contains an implicit exception for ‘‘[l]aws of nature, natural phenomena, and abstract ideas,’’ which are ‘‘the basic tools of scientific and technological work.’’ Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (citing Mayo, 566 US at 71, 101 USPQ2d at 1965). Yet, the Court has explained that ‘‘[a]t some level, all inventions embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,’’ and has cautioned ‘‘to tread carefully in construing this exclusionary principle lest it swallow all of patent law.’’ Id. See also Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335, 118 USPQ2d 1684, 1688 (Fed. Cir. 2016) ("The ‘directed to’ inquiry, therefore, cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon"). Examiners should accordingly be careful to distinguish claims that recite an exception (which require further eligibility analysis) and claims that merely involve an exception (which are eligible and do not require further eligibility analysis).

An example of a claim that recites a judicial exception is "A machine comprising elements that operate in accordance with F=ma." This claim sets forth the principle that force equals mass times acceleration (F=ma) and therefore recites a law of nature exception. Because F=ma represents a mathematical formula, the claim could alternatively be considered as reciting an abstract idea. Because this claim recites a judicial exception, it requires further analysis in Prong Two in order to answer the Step 2A inquiry. An example of a claim that merely involves, or is based on, an exception is a claim to "A teeter-totter comprising an elongated member pivotably attached to a base member, having seats and handles attached at opposing sides of the elongated member." This claim is based on the concept of a lever pivoting on a fulcrum, which involves the natural principles of mechanical advantage and the law of the lever. However, this claim does not recite these natural principles and therefore is not directed to a judicial exception (Step 2A: NO). Thus, the claim is eligible at Pathway B without further analysis.

If the claim recites a judicial exception (i.e., an abstract idea enumerated in MPEP § 2106.04(a), a law of nature, or a natural phenomenon), the claim requires further analysis in Prong Two. If the claim does not recite a judicial exception (a law of nature, natural phenomenon, or abstract idea), then the claim cannot be directed to a judicial exception (Step 2A: NO), and thus the claim is eligible at Pathway B without further analysis.

For more information how to determine if a claim recites an abstract idea, see MPEP § 2106.04(a). For more information on how to determine if a claim recites a law of nature or natural phenomenon, see MPEP § 2106.04(b). For more information on how to determine if a claim recites a product of nature, see MPEP § 2106.04(c).

Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole integrates the exception into a practical application of that exception. If the additional elements in the claim integrate the recited exception into a practical application of the exception, then the claim is not directed to the judicial exception (Step 2A: NO) and thus is eligible at Pathway B. This concludes the eligibility analysis. If, however, the additional elements do not integrate the exception into a practical application, then the claim is directed to the recited judicial exception (Step 2A: YES), and requires further analysis under Step 2B (where it may still be eligible if it amounts to an ‘‘inventive concept’’). For more information on how to evaluate whether a judicial exception is integrated into a practical application, see MPEP § 2106.04(d)(2).

The mere inclusion of a judicial exception such as a mathematical formula (which is one of the mathematical concepts identified as an abstract idea in MPEP § 2106.04(a)) in a claim means that the claim "recites" a judicial exception under Step 2A Prong One. However, mere recitation of a judicial exception does not mean that the claim is "directed to" that judicial exception under Step 2A Prong Two. Instead, under Prong Two, a claim that recites a judicial exception is not directed to that judicial exception, if the claim as a whole integrates the recited judicial exception into a practical application of that exception. Prong Two thus distinguishes claims that are "directed to" the recited judicial exception from claims that are not "directed to" the recited judicial exception.

Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B. If there are no additional elements in the claim, then it cannot be eligible. In such a case, after making the appropriate rejection (see MPEP § 2106.07 for more information on formulating a rejection for lack of eligibility), it is a best practice for the examiner to recommend an amendment, if possible, that would resolve eligibility of the claim.

A claim may recite multiple judicial exceptions. For example, claim 4 at issue in Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010) recited two abstract ideas, and the claims at issue in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012) recited two laws of nature. However, these claims were analyzed by the Supreme Court in the same manner as claims reciting a single judicial exception, such as those in Alice Corp., 573 U.S. 208, 110 USPQ2d 1976.

During examination, examiners should apply the same eligibility analysis to all claims regardless of the number of exceptions recited therein. Unless it is clear that a claim recites distinct exceptions, such as a law of nature and an abstract idea, care should be taken not to parse the claim into multiple exceptions, particularly in claims involving abstract ideas. Accordingly, if possible examiners should treat the claim for Prong Two and Step 2B purposes as containing a single judicial exception.

In some claims, the multiple exceptions are distinct from each other, e.g., a first limitation describes a law of nature, and a second limitation elsewhere in the claim recites an abstract idea. In these cases, for purposes of examination efficiency, examiners should select one of the exceptions and conduct the eligibility analysis for that selected exception. If the analysis indicates that the claim recites an additional element or combination of elements that integrate the selected exception into a practical application or that amount to significantly more than the selected exception, then the claim should be considered patent eligible. On the other hand, if the claim does not recite any additional element or combination of elements that integrate the selected exception into a practical application, and also does not recite any additional element or combination of elements that amounts to significantly more than the selected exception, then the claim should be considered ineligible. University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 762, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014) (because claims did not amount to significantly more than the recited abstract idea, court "need not decide" if claims also recited a law of nature).

In other claims, multiple abstract ideas, which may fall in the same or different groupings, or multiple laws of nature may be recited. In these cases, examiners should not parse the claim. For example, in a claim that includes a series of steps that recite mental steps as well as a mathematical calculation, an examiner should identify the claim as reciting both a mental process and a mathematical concept for Step 2A Prong One to make the analysis clear on the record. However, if possible, the examiner should consider the limitations together as a single abstract idea for Step 2A Prong Two and Step 2B (if necessary) rather than as a plurality of separate abstract ideas to be analyzed individually.

2106.04(a)    Abstract Ideas [R-10.2019]

The abstract idea exception has deep roots in the Supreme Court’s jurisprudence. See Bilski v. Kappos, 561 U.S. 593, 601-602, 95 USPQ2d 1001, 1006 (2010) (citing Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–175 (1853)). Despite this long history, the courts have declined to define abstract ideas. However, it is clear from the body of judicial precedent that software and business methods are not excluded categories of subject matter. For example, the Supreme Court concluded that business methods are not "categorically outside of § 101's  scope," stating that "a business method is simply one kind of ‘method’ that is, at least in some circumstances, eligible for patenting under § 101." Bilski, 561 U.S. at 607, 95 USPQ2d at 1008 (2010). See also Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357 (Fed. Cir. 2014) ("there is no categorical business-method exception"). Likewise, software is not automatically an abstract idea, even if performance of a software task involves an underlying mathematical calculation or relationship. See, e.g., Thales Visionix, Inc. v. United States, 850 F.3d 1343, 121 USPQ2d 1898, 1902 ("That a mathematical equation is required to complete the claimed method and system does not doom the claims to abstraction."); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1316, 120 USPQ2d 1091, 1103 (Fed. Cir. 2016) (methods of automatic lip synchronization and facial expression animation using computer-implemented rules were not directed to an abstract idea); Enfish, 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016) (claims to self-referential table for a computer database were not directed to an abstract idea).

To facilitate examination, the Office has set forth an approach to identifying abstract ideas that distills the relevant case law into enumerated groupings of abstract ideas. The enumerated groupings are firmly rooted in Supreme Court precedent as well as Federal Circuit decisions interpreting that precedent, as is explained in MPEP § 2106.04(a)(2). This approach represents a shift from the former case-comparison approach that required examiners to rely on individual judicial cases when determining whether a claim recites an abstract idea. By grouping the abstract ideas, the examiners’ focus has been shifted from relying on individual cases to generally applying the wide body of case law spanning all technologies and claim types.

The enumerated groupings of abstract ideas are defined as:

• 1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I);
• 2) Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II); and
• 3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).

Examiners should determine whether a claim recites an abstract idea by (1) identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea, and (2) determining whether the identified limitations(s) fall within at least one of the groupings of abstract ideas listed above. The groupings of abstract ideas, and their relationship to the body of judicial precedent, are further discussed in MPEP § 2106.04(a)(2).

If the identified limitation(s) falls within at least one of the groupings of abstract ideas, it is reasonable to conclude that the claim recites an abstract idea in Step 2A Prong One. The claim then requires further analysis in Step 2A Prong Two, to determine whether any additional elements in the claim integrate the abstract idea into a practical application, see MPEP § 2106.04(d).

If the identified limitation(s) do not fall within any of the groupings of abstract ideas, it is reasonable to find that the claim does not recite an abstract idea. This concludes the abstract idea judicial exception eligibility analysis, except in the rare circumstance discussed in 2106.04(a)(3), below. The claim is thus eligible at Pathway B unless the claim recites, and is directed to, another exception (such as a law of nature or natural phenomenon).

If the claims recites another judicial exception (i.e. law of nature or natural phenomenon), see MPEP §§ 2106.04(b) and 2106.04(c) for more information on Step 2A analysis.

MPEP § 2106.04(a)(1) provides examples of claims that do not recite abstract ideas (or other judicial exceptions) and thus are eligible at Step 2A Prong One.

MPEP § 2106.04(a)(2) provides further explanation on the abstract idea groupings. It should be noted that these groupings are not mutually exclusive, i.e., some claims recite limitations that fall within more than one grouping or sub-grouping. For example, a claim reciting performing mathematical calculations using a formula that could be practically performed in the human mind may be considered to fall within the mathematical concepts grouping and the mental process grouping. Accordingly, examiners should identify at least one abstract idea grouping, but preferably identify all groupings to the extent possible, if a claim limitation(s) is determined to fall within multiple groupings and proceed with the analysis in Step 2A Prong Two.

2106.04(a)(1)    Examples of Claims That Do Not Recite Abstract Ideas [R-10.2019]

When evaluating a claim to determine whether it recites an abstract idea, examiners should keep in mind that while "all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomenon, or abstract ideas", not all claims recite an abstract idea. See Alice Corp. Pty. Ltd. v. CLS Bank, Int’l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1980-81 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 US 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Step 2A Prong One analysis articulated in MPEP § 2106.04 accounts for this cautionary principle by requiring a claim to recite (i.e., set forth or describe) an abstract idea in Prong One before proceeding to the Prong Two inquiry about whether the claim is directed to that idea, thereby separating claims reciting abstract ideas from those that are merely based on or involve an abstract idea.

Some claims are not directed to an abstract idea because they do not recite an abstract idea, although it may be apparent that at some level they are based on or involve an abstract idea. Because these claims do not recite an abstract idea (or other judicial exception), they are eligible at Step 2A Prong One (Pathway B).

Non-limiting hypothetical examples of claims that do not recite (set forth or describe) an abstract idea include:

• i. a printer comprising a belt, a roller, a printhead and at least one ink cartridge;
• ii. a washing machine comprising a tub, a drive motor operatively connected to the tub, a controller for controlling the drive motor, and a housing for containing the tub, drive motor, and controller;
• iii. an earring comprising a sensor for taking periodic blood glucose measurements and a memory for storing measurement data from the sensor;
• iv. a method for sequencing BRCA1 gene sequences comprising: amplifying by a polymerization chain reaction technique all or part of a BRCA1 gene from a tissue sample from a human subject using a set of primers to produce amplified nucleic acids; and sequencing the amplified nucleic acids; and
• v. a method for loading BIOS into a local computer system which has a system processor and volatile memory and non-volatile memory, the method comprising the steps of: responding to powering up of the local computer system by requesting from a memory location remote from the local computer system the transfer to and storage in the volatile memory of the local computer system of BIOS configured for effective use of the local computer system, transferring and storing such BIOS, and transferring control of the local computer system to such BIOS;
• vi. a method of rearranging icons on a graphical user interface (GUI) comprising the steps of: receiving a user selection to organize each icon based on the amount of use of each icon, determining the amount of use of each icon by using a processor to track the amount of memory allocated to the application associated with the icon over a period of time, and automatically moving the most used icons to a position in the GUI closest to the start icon of the computer system based on the determined amount of use; and
• vii. a method of training a neural network for facial detection comprising: collecting a set of digital facial images, applying one or more transformations to the digital images, creating a first training set including the modified set of digital facial images; training the neural network in a first stage using the first training set, creating a second training set including digital non-facial images that are incorrectly detected as facial images in the first stage of training; and training the neural network in a second stage using the second training set.

2106.04(a)(2)    Abstract Idea Groupings [R-10.2019]

The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Supreme Court has identified a number of concepts falling within this grouping as abstract ideas including: a procedure for converting binary-coded decimal numerals into pure binary form, Gottschalk v. Benson, 409 U.S. 63, 65, 175 USPQ2d 673, 674 (1972); a mathematical formula for calculating an alarm limit, Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ2d 193, 195 (1978); the Arrhenius equation, Diamond v. Diehr, 450 U.S. 175, 191, 209 USPQ 1, 15 (1981); and a mathematical formula for hedging, Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ 2d 1001, 1004 (2010).

The Court’s rationale for identifying these "mathematical concepts" as judicial exceptions is that a ‘‘mathematical formula as such is not accorded the protection of our patent laws,’’ Diehr, 450 U.S. at 191, 209 USPQ at 15 (citing Benson, 409 U.S. 63, 175 USPQ 673), and thus ‘‘the discovery of [a mathematical formula] cannot support a patent unless there is some other inventive concept in its application.’’ Flook, 437 U.S. at 594, 198 USPQ at 199. In the past, the Supreme Court sometimes described mathematical concepts as laws of nature, and at other times described these concepts as judicial exceptions without specifying a particular type of exception. See, e.g., Benson, 409 U.S. at 65, 175 USPQ2d at 674; Flook, 437 U.S. at 589, 198 USPQ2d at 197; Mackay Radio & Telegraph Co. v. Radio Corp. of Am., 306 U.S. 86, 94, 40 USPQ 199, 202 (1939) (‘‘[A] scientific truth, or the mathematical expression of it, is not patentable invention[.]’’). More recent opinions of the Supreme Court, however, have affirmatively characterized mathematical relationships and formulas as abstract ideas. See, e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 218, 110 USPQ2d 1976, 1981 (describing Flook as holding "that a mathematical formula for computing ‘alarm limits’ in a catalytic conversion process was also a patent-ineligible abstract idea."); Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (noting that the claimed "concept of hedging, described in claim 1 and reduced to a mathematical formula in claim 4, is an unpatentable abstract idea,").

When determining whether a claim recites a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations), examiners should consider whether the claim recites a mathematical concept or merely limitations that are based on or involve a mathematical concept. A claim does not recite a mathematical concept (i.e., the claim limitations do not fall within the mathematical concept grouping), if it is only based on or involves a mathematical concept. See, e.g., Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902-03 (Fed. Cir. 2017) (determining that the claims to a particular configuration of inertial sensors and a particular method of using the raw data from the sensors in order to more accurately calculate the position and orientation of an object on a moving platform did not merely recite "the abstract idea of using ‘mathematical equations for determining the relative position of a moving object to a moving reference frame’."). For example, a limitation that is merely based on or involves a mathematical concept described in the specification may not be sufficient to fall into this grouping, provided the mathematical concept itself is not recited in the claim.

It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea); and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a stable value protected life insurance policy by performing calculations and manipulating the results’’ as an abstract idea).

A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words or using mathematical symbols. For example, pressure (p) can be described as the ratio between the magnitude of the normal force (F) and area of the surface on contact (A), or it can be set forth in the form of an equation such as p = F/A.

Examples of mathematical relationships recited in a claim include:

• i. a relationship between reaction rate and temperature, which relationship can be expressed in the form of a formula called the Arrhenius equation, Diamond v. Diehr; 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981);
• ii. a conversion between binary coded decimal and pure binary, Benson, 409 U.S. at 64, 175 USPQ at 674;
• iii. a mathematical relationship between enhanced directional radio activity and antenna conductor arrangement (i.e., the length of the conductors with respect to the operating wave length and the angle between the conductors), Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 91, 40 USPQ 199, 201 (1939) (while the litigated claims 15 and 16 of U.S. Patent No. 1,974,387 expressed this mathematical relationship using a formula that described the angle between the conductors, other claims in the patent (e.g., claim 1) expressed the mathematical relationship in words); and
• iv. organizing information and manipulating information through mathematical correlations, Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). The patentee in Digitech claimed methods of generating first and second data by taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form. The court explained that such claims were directed to an abstract idea because they described a process of organizing information through mathematical correlations, like Flook's method of calculating using a mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721.

A claim that recites a numerical formula or equation will be considered as falling within the "mathematical concepts" grouping. In addition, there are instances where a formula or equation is written in text format that should also be considered as falling within this grouping. For example, the phrase "determining a ratio of A to B" is merely using a textual replacement for the particular equation (ratio = A/B). Additionally, the phrase "calculating the force of the object by multiplying its mass by its acceleration" is using a textual replacement for the particular equation (F= ma).

Examples of mathematical equations or formulas recited in a claim include:

• i. a formula describing certain electromagnetic standing wave phenomena, Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 91, 40 USPQ 199, 201 (1939) (50.9(l/lambda<-0.513>);
• ii. the Arrhenius equation, Diamond v. Diehr; 450 U.S. 175, 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981) (ln v = CZ + x);
• iii. a formula for computing an alarm limit, Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978) (B1=B0 (1.0–F) + PVL(F)); and
• iv. a mathematical formula for hedging (claim 4), Bilski v. Kappos, 561 U.S. 593, 599, 95 USPQ2d 1001, 1004 (2010) (Fixed Bill Price = Fi + [(Ci + Ti + LDi) x (α + βE(Wi))]).

A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.

Examples of mathematical calculations recited in a claim include:

• i. performing a resampled statistical analysis to generate a resampled distribution, SAP America, Inc. v. Investpic, LLC, 898 F.3d 1161, 1163-65, 127 USPQ2d 1597, 1598-1600 (Fed. Cir. 2018), modifying SAP America, Inc. v. Investpic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed. Cir. 2018);
• ii. calculating a number representing an alarm limit value using the mathematical formula ‘‘B₁=B₀ (1.0–F) + PVL(F)’’, Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978);
• iii. using a formula to convert geospatial coordinates into natural numbers, Burnett v. Panasonic Corp., 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) (non-precedential);
• iv. managing a stable value protected life insurance policy via performing calculations, Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012);
• v. using an algorithm for determining the optimal number of visits by a business representative to a client, In re Maucorps, 609 F.2d 481, 482, 203 USPQ 812, 813 (CCPA 1979); and
• vi. calculating the difference between local and average data values, In re Abele, 684 F.2d 902, 903, 214 USPQ 682, 683-84 (CCPA 1982).

The phrase "methods of organizing human activity" is used to describe concepts relating to:

• • fundamental economic principles or practices (including hedging, insurance, mitigating risk);
• • commercial or legal interactions (including agreements in the form of contracts, legal obligations, advertising, marketing or sales activities or behaviors, and business relations); and
• • managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions).

The Supreme Court has identified a number of concepts falling within the "certain methods of organizing human activity" grouping as abstract ideas. In particular, in Alice, the Court concluded that the use of a third party to mediate settlement risk is a ‘‘fundamental economic practice’’ and thus an abstract idea. 573 U.S. at 219–20, 110 USPQ2d at 1982. In addition, the Court in Alice described the concept of risk hedging identified as an abstract idea in Bilski as ‘‘a method of organizing human activity’’. Id. Previously, in Bilski, the Court concluded that hedging is a ‘‘fundamental economic practice’’ and therefore an abstract idea. 561 U.S. at 611–612, 95 USPQ2d at 1010.

The term "certain" qualifies the "certain methods of organizing human activity" grouping as a reminder of several important points. First, not all methods of organizing human activity are abstract ideas (e.g., "a defined set of steps for combining particular ingredients to create a drug formulation" is not a certain "method of organizing human activity"), In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1160-61, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018). Second, this grouping is limited to activity that falls within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people, and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances as explained in MPEP § 2106.04(a)(3). Finally, the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the "certain methods of organizing human activity" grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings.

The courts have used the phrases "fundamental economic practices" or "fundamental economic principles" to describe concepts relating to the economy and commerce. Fundamental economic principles or practices include hedging, insurance, and mitigating risks.

The term "fundamental" is not used in the sense of necessarily being "old" or "well-known." See, e.g., OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1364, 115 U.S.P.Q.2d 1090, 1092 (Fed Cir. 2015) (a new method of price optimization was found to be a fundamental economic concept); In re Smith, 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. 2016) (describing a new set of rules for conducting a wagering game as a "fundamental economic practice"); In re Greenstein, 774 Fed. Appx. 661, 664, 2019 USPQ2d 212400 (Fed Cir. 2019) (non-precedential) (claims to a new method of allocating returns to different investors in an investment fund was a fundamental economic concept). However, being old or well-known may indicate that the practice is fundamental. See, e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 219-20, 110 USPQ2d 1981-82 (2014) (describing the concept of intermediated settlement, like the risk hedging in Bilski, to be a "‘fundamental economic practice long prevalent in our system of commerce’" and also as "a building block of the modern economy") (citation omitted); Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (claims to the concept of hedging are a "fundamental economic practice long prevalent in our system of commerce and taught in any introductory finance class.") (citation omitted); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1313, 120 USPQ2d 1353, 1356 (2016) ("The category of abstract ideas embraces ‘fundamental economic practice[s] long prevalent in our system of commerce,’ … including ‘longstanding commercial practice[s]’").

An example of a case identifying a claim as reciting a fundamental economic practice is Bilski v. Kappos, 561 U.S. 593, 609, 95 USPQ2d 1001, 1009 (2010). The fundamental economic practice at issue was hedging or protecting against risk. The applicant in Bilski claimed "a series of steps instructing how to hedge risk," i.e., how to protect against risk. 561 U.S. at 599, 95 USPQ2d at 1005. The method allowed energy suppliers and consumers to minimize the risks resulting from fluctuations in market demand for energy. The Supreme Court determined that hedging is "fundamental economic practice" and therefore is an "unpatentable abstract idea." 561 U.S. at 611-12, 95 USPQ2d at 1010.

Another example of a case identifying a claim as reciting a fundamental economic practice is Bancorp Services., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Cir. 2012). The fundamental economic practice at issue in Bancorp pertained to insurance. The patentee in Bancorp claimed methods and systems for managing a life insurance policy on behalf of a policy holder, which comprised steps including generating a life insurance policy including a stable value protected investment with an initial value based on a value of underlying securities, calculating surrender value protected investment credits for the life insurance policy; determining an investment value and a value of the underlying securities for the current day; and calculating a policy value and a policy unit value for the current day. 687 F.3d at 1270-71, 103 USPQ2d at 1427. The court described the claims as an "attempt to patent the use of the abstract idea of [managing a stable value protected life insurance policy] and then instruct the use of well-known [calculations] to help establish some of the inputs into the equation." 687 F.3d at 1278, 103 USPQ2d at 1433 (alterations in original) (citing Bilski).

Other examples of "fundamental economic principles or practices" include:

• i. mitigating settlement risk, Alice Corp. v. CLS Bank,573 U.S. 208, 218, 110 USPQ2d 1976, 1982 (2014);
• ii. rules for conducting a wagering game, In re Smith, 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. 2016);
• iii. financial instruments that are designed to protect against the risk of investing in financial instruments, In re Chorna, 656 Fed. App'x 1016, 1021 (Fed. Cir. 2016) (non-precedential);
• iv. offer-based price optimization, OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362–63, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015);
• v. local processing of payments for remotely purchased goods, Inventor Holdings, LLC v. Bed Bath Beyond, 876 F.3d 1372, 1378-79, 125 USPQ2d 1019, 1023 (Fed. Cir. 2017);
• vi. using a marking affixed to the outside of a mail object to communicate information about the mail object, i.e., the sender, recipient, and contents of the mail object, Secured Mail Solutions LLC v. Universal Wilde, Inc., 873 F.3d 905, 911, 124 USPQ2d 1502, 1506 (Fed. Cir. 2017); and
• vii. placing an order based on displayed market information, Trading Technologies Int’l, Inc. v. IBG LLC, 921 F.3d 1084, 1092, 2019 USPQ2d 138290 (Fed. Cir. 2019).

"Commercial interactions" or "legal interactions" include agreements in the form of contracts, legal obligations, advertising, marketing or sales activities or behaviors, and business relations.

An example of a claim reciting a commercial or legal interaction, where the interaction is an agreement in the form of contracts, is found in buySAFE, Inc. v. Google, Inc., 765 F.3d. 1350, 112 USPQ2d 1093 (Fed. Cir. 2014). The agreement at issue in buySAFE was a transaction performance guaranty, which is a contractual relationship. 765 F.3d at 1355, 112 USPQ2d at 1096. The patentee claimed a method in which a computer operated by the provider of a safe transaction service receives a request for a performance guarantee for an online commercial transaction, the computer processes the request by underwriting the requesting party in order to provide the transaction guarantee service, and the computer offers, via a computer network, a transaction guaranty that binds to the transaction upon the closing of the transaction. 765 F.3d at 1351-52, 112 USPQ2d at 1094. The Federal Circuit described the claims as directed to an abstract idea because they were "squarely about creating a contractual relationship--a ‘transaction performance guaranty’." 765 F.3d at 1355, 112 USPQ2d at 1096.

Other examples of subject matter where the commercial or legal interaction is an agreement in the form of contracts include:

• i. managing a stable value protected life insurance policy via performing calculations, Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); and
• ii. processing insurance claims for a covered loss or policy event under an insurance policy (i.e., an agreement in the form of a contract), Accenture Global Services v. Guidewire Software, Inc., 728 F.3d 1336, 1338-39, 108 USPQ2d 1173, 1175-76 (Fed. Cir. 2013).

An example of a claim reciting a commercial or legal interaction in the form of a legal obligation is found in Fort Properties, Inc. v. American Master Lease, LLC, 671 F.3d 1317, 101 USPQ2d 1785 (Fed Cir. 2012). The patentee claimed a method of "aggregating real property into a real estate portfolio, dividing the interests in the portfolio into a number of deedshares, and subjecting those shares to a master agreement." 671 F.3d at 1322, 101 USPQ2d at 1788. The legal obligation at issue was the tax-free exchanges of real estate. The Federal Circuit concluded that the real estate investment tool designed to enable tax-free exchanges was an abstract concept. 671 F.3d at 1323, 101 USPQ2d at 1789.

Other examples of subject matter where the commercial or legal interaction is a legal obligation include:

• i. hedging, Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1004 (2010);
• ii. mitigating settlement risk, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 218, 110 USPQ2d 1976, 1979 (2014); and
• iii. arbitration, In re Comiskey, 554 F.3d 967, 981, 89 USPQ2d 1655, 1665 (Fed. Cir. 2009).

An example of a claim reciting advertising is found in Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). The patentee in Ultramercial claimed an eleven-step method for displaying an advertisement (ad) in exchange for access to copyrighted media, comprising steps of receiving copyrighted media, selecting an ad, offering the media in exchange for watching the selected ad, displaying the ad, allowing the consumer access to the media, and receiving payment from the sponsor of the ad. 772 F.3d. at 715, 112 USPQ2d at 1754. The Federal Circuit determined that the "combination of steps recites an abstraction—an idea, having no particular concrete or tangible form" and thus was directed to an abstract idea, which the court described as "using advertising as an exchange or currency." Id.

Other examples of subject matter where the commercial or legal interaction is advertising, marketing or sales activities or behaviors include :

• i. structuring a sales force or marketing company, which pertains to marketing or sales activities or behaviors, In re Ferguson, 558 F.3d 1359, 1364, 90 USPQ2d 1035, 1038 (Fed. Cir. 2009);
• ii. using an algorithm for determining the optimal number of visits by a business representative to a client, In re Maucorps, 609 F.2d 481, 485, 203 USPQ 812, 816 (CCPA 1979); and
• iii. offer-based price optimization, which pertains to marketing, OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362-63, 115 USPQ2d 1090, 1092 (Fed. Cir. 2015).

An example of a claim reciting business relations is found in Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 123 USPQ2d 1100 (Fed. Cir. 2017). The business relation at issue in Credit Acceptance is the relationship between a customer and dealer when processing a credit application to purchase a vehicle. The patentee claimed a "system for maintaining a database of information about the items in a dealer’s inventory, obtaining financial information about a customer from a user, combining these two sources of information to create a financing package for each of the inventoried items, and presenting the financing packages to the user." 859 F.3d at 1054, 123 USPQ2d at 1108. The Federal Circuit described the claims as directed to the abstract idea of "processing an application for financing a loan" and found "no meaningful distinction between this type of financial industry practice" and the concept of intermediated settlement in Alice or the hedging concept in Bilski. 859 F.3d at 1054, 123 USPQ2d at 1108.

Another example of subject matter where the commercial or legal interaction is business relations includes:

• i. processing information through a clearing-house, where the business relation is the relationship between a party submitted a credit application (e.g., a car dealer) and funding sources (e.g., banks) when processing credit applications, Dealertrack v. Huber, 674 F.3d 1315, 1331, 101 USPQ2d 1325, 1339 (Fed. Cir. 2012).

The sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions.

An example of a claim reciting managing personal behavior is Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir. 2015). The patentee in this case claimed methods comprising storing user-selected pre-set limits on spending in a database, and when one of the limits is reached, communicating a notification to the user via a device. 792 F.3d. at 1367, 115 USPQ2d at 1639-40. The Federal Circuit determined that the claims were directed to the abstract idea of "tracking financial transactions to determine whether they exceed a pre-set spending limit (i.e., budgeting)", which "is not meaningfully different from the ideas found to be abstract in other cases before the Supreme Court and our court involving methods of organizing human activity." 792 F.3d. at 1367-68, 115 USPQ2d at 1640.

Other examples of managing personal behavior recited in a claim include:

• i. filtering content, BASCOM Global Internet v. AT&T Mobility, LLC, 827 F.3d 1341, 1345-46, 119 USPQ2d 1236, 1239 (Fed. Cir. 2016) (finding that filtering content was an abstract idea under step 2A, but reversing an invalidity judgment of ineligibility due to an inadequate step 2B analysis);
• ii. considering historical usage information while inputting data, BSG Tech. LLC v. Buyseasons, Inc., 899 F.3d 1281, 1286, 127 USPQ2d 1688, 1691; and
• iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982).

An example of a claim reciting social activities is Voter Verified, Inc. v. Election Systems & Software, LLC, 887 F.3d 1376, 126 USPQ2d 1498 (Fed. Cir. 2018). The social activity at issue in Voter Verified was voting. The patentee claimed "[a] method for voting providing for self-verification of a ballot comprising the steps of" presenting an election ballot for voting, accepting input of the votes, storing the votes, printing out the votes, comparing the printed votes to votes stored in the computer, and determining whether the printed ballot is acceptable. 887 F.3d at 1384-85, 126 USPQ2d at 1503-04. The Federal Circuit found that the claims were directed to the abstract idea of "voting, verifying the vote, and submitting the vote for tabulation", which is a "fundamental activity that forms the basis of our democracy" and has been performed by humans for hundreds of years. 887 F.3d at 1385-86, 126 USPQ2d at 1504-05.

Another example of a claim reciting social activities is Interval Licensing LLC, v. AOL, Inc., 896 F.3d 1335, 127 USPQ2d 1553 (Fed. Cir. 2018). The social activity at issue was the social activity of "’providing information to a person without interfering with the person’s primary activity.’" 896 F.3d at 1344, 127 USPQ2d 1553 (citing Interval Licensing LLC v. AOL, Inc., 193 F. Supp.3d 1184, 1188 (W.D. 2014)). The patentee claimed an attention manager for acquiring content from an information source, controlling the timing of the display of acquired content, displaying the content, and acquiring an updated version of the previously-acquired content when the information source updates its content. 896 F.3d at 1339-40, 127 USPQ2d at 1555. The Federal Circuit concluded that "[s]tanding alone, the act of providing someone an additional set of information without disrupting the ongoing provision of an initial set of information is an abstract idea," observing that the district court "pointed to the nontechnical human activity of passing a note to a person who is in the middle of a meeting or conversation as further illustrating the basic, longstanding practice that is the focus of the [patent ineligible] claimed invention." 896 F.3d at 1344-45, 127 USPQ2d at 1559.

An example of a claim reciting following rules or instructions is In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018). The patentee claimed a method of playing a dice game including placing wagers on whether certain die faces will appear face up. 911 F.3d at 1160; 129 USPQ2d at 1011. The Federal Circuit determined that the claims were directed to the abstract idea of "rules for playing games", which the court characterized as a certain method of organizing human activity. 911 F.3d at 1160-61; 129 USPQ2d at 1011.

Other examples of following rules or instructions recited in a claim include:

• i. assigning hair designs to balance head shape, In re Brown, 645 Fed. Appx. 1014, 1015-16 (Fed. Cir. 2016) (non-precedential); and
• ii. a series of instructions of how to hedge risk, Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1004 (2010).

The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).

Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. A discussion of concepts performed in the human mind, as well as concepts that cannot practically be performed in the human mind and thus are not "mental processes", is provided below with respect to point A.

The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Mental processes performed by humans with the assistance of physical aids such as pens or paper are explained further below with respect to point B.

Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). Mental processes recited in claims that require computers are explained further below with respect to point C.

Because both product and process claims may recite a "mental process", the phrase "mental processes" should be understood as referring to the type of abstract idea, and not to the statutory category of the claim. The courts have identified numerous product claims as reciting mental process-type abstract ideas, for instance the product claims to computer systems and computer-readable media in Versata Dev. Group. v. SAP Am., Inc., 793 F.3d 1306, 115 USPQ2d 1681 (Fed. Cir. 2015). This concept is explained further below with respect to point D.

The following discussion is meant to guide examiners and provide more information on how to determine whether a claim recites a mental process. Examiners should keep in mind the following points A, B, C, and D when performing this evaluation.

Claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, for instance when the human mind is not equipped to perform the claim limitations. See SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1304 (Fed. Cir. 2019) (declining to identify the claimed collection and analysis of network data as abstract because "the human mind is not equipped to detect suspicious activity by using network monitors and analyzing network packets as recited by the claims"); CyberSource, 654 F.3d at 1376, 99 USPQ2d at 1699 (distinguishing Research Corp. Techs. v. Microsoft Corp., 627 F.3d 859, 97 USPQ2d 1274 (Fed. Cir. 2010), and SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 94 USPQ2d 1607 (Fed. Cir. 2010), as directed to inventions that ‘‘could not, as a practical matter, be performed entirely in a human’s mind’’).

Examples of claims that do not recite mental processes because they cannot be practically performed in the human mind include:

• • a claim to a method for calculating an absolute position of a GPS receiver and an absolute time of reception of satellite signals, where the claimed GPS receiver calculated pseudoranges that estimated the distance from the GPS receiver to a plurality of satellites, SiRF Tech., 601 F.3d at 1331-33, 94 USPQ2d at 1616-17;
• • a claim to detecting suspicious activity by using network monitors and analyzing network packets, SRI Int’l, 930 F.3d at 1304;
• • a claim to a specific data encryption method for computer communication involving a several-step manipulation of data, Synopsys., 839 F.3d at 1148, 120 USPQ2d at 1481 (distinguishing the claims in TQP Development, LLC v. Intuit Inc., 2014 WL 651935 (E.D. Tex. Feb. 19, 2014)); and
• • a claim to a method for rendering a halftone image of a digital image by comparing, pixel by pixel, the digital image against a blue noise mask, where the method required the manipulation of computer data structures (e.g., the pixels of a digital image and a two-dimensional array known as a mask) and the output of a modified computer data structure (a halftoned digital image), Research Corp. Techs., 627 F.3d at 868, 97 USPQ2d at 1280.

In contrast, claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. Examples of claims that recite mental processes include:

• • a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);
• • claims to "comparing BRCA sequences and determining the existence of alterations," where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014);
• • a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011); and
• • a claim to identifying head shape and applying hair designs, which is a process that can be practically performed in the human mind, In re Brown, 645 Fed. App'x 1014, 1016-17 (Fed. Cir. 2016) (non-precedential).

If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, 839 F.3d at 1139, 120 USPQ2d at 1474 (holding that claims to the mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper").

The use of a physical aid (e.g., pencil and paper or a slide rule) to help perform a mental step (e.g., a mathematical calculation) does not negate the mental nature of the limitation, but simply accounts for variations in memory capacity from one person to another. For instance, in CyberSource, the court determined that the step of "constructing a map of credit card numbers" was a limitation that was able to be performed "by writing down a list of credit card transactions made from a particular IP address." In making this determination, the court looked to the specification, which explained that the claimed map was nothing more than a listing of several (e.g., four) credit card transactions. The court concluded that this step was able to be performed mentally with a pen and paper, and therefore, it qualified as a mental process. 654 F.3d at 1372-73, 99 USPQ2d at 1695. See also Flook, 437 U.S. at 586, 198 USPQ at 196 (claimed "computations can be made by pencil and paper calculations"); University of Florida Research Foundation, Inc. v. General Electric Co., 916 F.3d 1363, 1367, 129 USPQ2d 1409, 1411-12 (Fed. Cir. 2019) (relying on specification’s description of the claimed analysis and manipulation of data as being performed mentally "‘using pen and paper methodologies, such as flowsheets and patient charts’"); Symantec, 838 F.3d at 1318, 120 USPQ2d at 1360 (although claimed as computer-implemented, steps of screening messages can be "performed by a human, mentally or with pen and paper").

Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675. See also Mortgage Grader, 811 F.3d at 1324, 117 USPQ2d at 1699 (concluding that concept of "anonymous loan shopping" recited in a computer system claim is an abstract idea because it could be "performed by humans without a computer").

In evaluating whether a claim that requires a computer recites a mental process, examiners should carefully consider the broadest reasonable interpretation of the claim in light of the specification. For instance, examiners should review the specification to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept. In these situations, the claim is considered to recite a mental process.

• 1. Performing a mental process on a generic computer. An example of a case identifying a mental process performed on a generic computer as an abstract idea is Voter Verified, Inc. v. Election Systems & Software, LLC, 887 F.3d 1376, 1385, 126 USPQ2d 1498, 1504 (Fed. Cir. 2018). In this case, the Federal Circuit relied upon the specification in explaining that the claimed steps of voting, verifying the vote, and submitting the vote for tabulation are "human cognitive actions" that humans have performed for hundreds of years. The claims therefore recited an abstract idea, despite the fact that the claimed voting steps were performed on a computer. 887 F.3d at 1385, 126 USPQ2d at 1504. Another example is Versata, in which the patentee claimed a system and method for determining a price of a product offered to a purchasing organization that was implemented using general purpose computer hardware. 793 F.3d at 1312-13, 1331, 115 USPQ2d at 1685, 1699. The Federal Circuit acknowledged that the claims were performed on a generic computer, but still described the claims as "directed to the abstract idea of determining a price, using organizational and product group hierarchies, in the same way that the claims in Alice were directed to the abstract idea of intermediated settlement, and the claims in Bilski were directed to the abstract idea of risk hedging." 793 F.3d at 1333; 115 USPQ2d at 1700-01.
• 2. Performing a mental process in a computer environment. An example of a case identifying a mental process performed in a computer environment as an abstract idea is Symantec Corp., 838 F.3d at 1316-18, 120 USPQ2d at 1360. In this case, the Federal Circuit relied upon the specification when explaining that the claimed electronic post office, which recited limitations describing how the system would receive, screen and distribute email on a computer network, was analogous to how a person decides whether to read or dispose of a particular piece of mail and that "with the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper". 838 F.3d at 1318, 120 USPQ2d at 1360. Another example is FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 120 USPQ2d 1293 (Fed. Cir. 2016). The patentee in FairWarning claimed a system and method of detecting fraud and/or misuse in a computer environment, in which information regarding accesses of a patient’s personal health information was analyzed according to one of several rules (i.e., related to accesses in excess of a specific volume, accesses during a pre-determined time interval, or accesses by a specific user) to determine if the activity indicates improper access. 839 F.3d. at 1092, 120 USPQ2d at 1294. The court determined that these claims were directed to a mental process of detecting misuse, and that the claimed rules here were "the same questions (though perhaps phrased with different words) that humans in analogous situations detecting fraud have asked for decades, if not centuries." 839 F.3d. at 1094-95, 120 USPQ2d at 1296.
• 3. Using a computer as a tool to perform a mental process. An example of a case in which a computer was used as a tool to perform a mental process is Mortgage Grader, 811 F.3d. at 1324, 117 USPQ2d at 1699. The patentee in Mortgage Grader claimed a computer-implemented system for enabling borrowers to anonymously shop for loan packages offered by a plurality of lenders, comprising a database that stores loan package data from the lenders, and a computer system providing an interface and a grading module. The interface prompts a borrower to enter personal information, which the grading module uses to calculate the borrower’s credit grading, and allows the borrower to identify and compare loan packages in the database using the credit grading. 811 F.3d. at 1318, 117 USPQ2d at 1695. The Federal Circuit determined that these claims were directed to the concept of "anonymous loan shopping", which was a concept that could be "performed by humans without a computer." 811 F.3d. at 1324, 117 USPQ2d at 1699. Another example is Berkheimer v. HP, Inc., 881 F.3d 1360, 125 USPQ2d 1649 (Fed. Cir. 2018), in which the patentee claimed methods for parsing and evaluating data using a computer processing system. The Federal Circuit determined that these claims were directed to mental processes of parsing and comparing data, because the steps were recited at a high level of generality and merely used computers as a tool to perform the processes. 881 F.3d at 1366, 125 USPQ2d at 1652-53.

Examiners should keep in mind that both product claims (e.g., computer system, computer-readable medium, etc.) and process claims may recite mental processes. For example, in Mortgage Grader, the patentee claimed a computer-implemented system and a method for enabling borrowers to anonymously shop for loan packages offered by a plurality of lenders, comprising a database that stores loan package data from the lenders, and a computer system providing an interface and a grading module. The Federal Circuit determined that both the computer-implemented system and method claims were directed to "anonymous loan shopping", which was an abstract idea because it could be "performed by humans without a computer." 811 F.3d. at 1318, 1324-25, 117 USPQ2d at 1695, 1699-1700. See also FairWarning IP, 839 F.3d at 1092, 120 USPQ2d at 1294 (identifying both system and process claims for detecting improper access of a patient's protected health information in a health-care system computer environment as directed to abstract idea of detecting fraud); Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1345, 113 USPQ2d 1354, 1356 (system and method claims of inputting information from a hard copy document into a computer program). Accordingly, the phrase "mental processes" should be understood as referring to the type of abstract idea, and not to the statutory category of the claim.

Examples of product claims reciting mental processes include:

• • An application program interface for extracting and processing information from a diversity of types of hard copy documents – Content Extraction, 776 F.3d at 1345, 113 USPQ2d at 1356;
• • A computer-implemented system for enabling anonymous loan shopping – Mortgage Grader, 811 F.3d at 1318, 117 USPQ2d at 1695;
• • A computer readable medium containing program instructions for detecting fraud – CyberSource, 654 F.3d at 1368 n. 1, 99 USPQ2d at 1692 n.1;
• • A post office for receiving and redistributing email messages on a computer network – Symantec, 838 F.3d at 1316, 120 USPQ2d at 1359;
• • A self-verifying voting system – Voter Verified, 887 F.3d at 1384-85, 126 USPQ2d at 1504;
• • A wide-area real-time performance monitoring system for monitoring and assessing dynamic stability of an electric power grid – Electric Power Group, 830 F.3d at 1351 and n.1, 119 USPQ2d at 1740 and n.1; and
• • Computer readable storage media comprising computer instructions to implement a method for determining a price of a product offered to a purchasing organization – Versata, 793 F.3d at 1312-13, 115 USPQ2d at 1685.

Examples of process claims reciting mental process-type abstract ideas are discussed in the preceding subsections (A) through (C). See, for example, the discussion of Flook, 437 U.S. 584, 198 USPQ 193; Benson, 409 U.S. 63, 175 USPQ 673; Berkheimer, 881 F.3d 1360, 125 USPQ2d 1649; Synopsys, 839 F.3d 1138, 120 USPQ2d 1473; and Ambry Genetics, 774 F.3d 755, 113 USPQ2d 1241, supra.

2106.04(a)(3)    Tentative Abstract Ideas

There may be rare circumstances in which an examiner believes a claim limitation should be treated as an abstract idea even though it does not fall within any of the groupings of abstract ideas discussed in MPEP § 2106.04(a)(2) (i.e., mathematical concepts, certain methods of organizing human activity, mental processes). This type of claim limitation is referred to as a "tentative abstract idea."

In such circumstances, the examiner should evaluate the claim under the subject matter eligibility framework:

• • If the claim as a whole integrates the tentative abstract idea into a practical application, the claim is not directed to a judicial exception (Step 2A; NO) and thus is eligible at Pathway B. This concludes the eligibility analysis.
• • If the claim as a whole does not integrate the tentative abstract idea into a practical application, then the claim is directed to a judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B. At Step 2B, if the claim as a whole provides an inventive concept (Step 2B: YES), the claim is eligible at Pathway C. This concludes the eligibility analysis.
• • If the claim as a whole does not provide an inventive concept (Step 2B: NO), the application should be brought to the attention of the Technology Center (TC) director. A rejection of a claim reciting a tentative abstract idea must be approved by the TC director (which approval will be indicated in the file record of the application) and must provide a justification for why such claim limitation is being treated as reciting an abstract idea.

The TC Director will give approval for a Step 2B subject matter eligibility rejection of a claim reciting a tentative abstract idea. The ensuing Office action will identify that the claim(s) are directed to a previously non-enumerated abstract idea via form paragraph 7.05.017 and include the TC Director’s signature. The TC Director will then inform Patents Management that this procedure has been used so that the public can be notified, for example, on USPTO.GOV at the Subject Matter Eligibility website.

In response to a Step 2B rejection of a claim reciting a tentative abstract idea, an interview with the examiner may be conducted, which may help advance prosecution and identify patent eligible subject matter. See MPEP § 713. For applications in which an abstract idea has been identified using the tentative abstract idea procedure, an interview with the TC Director that provided approval is not necessary because the examiner retains the authority to withdraw or maintain a rejection upon consideration of applicant’s reply. The examiner is not required to obtain TC Director approval to withdraw or maintain such a § 101  subject matter eligibility rejection.

2106.04(b)    Laws of Nature, Natural Phenomena & Products of Nature [R-10.2019]

Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including "physical phenomena," "scientific principles", "natural laws," and "products of nature."

The law of nature and natural phenomenon exceptions reflect the Supreme Court's view that the basic tools of scientific and technological work are not patentable, because the "manifestations of laws of nature" are "part of the storehouse of knowledge," "free to all men and reserved exclusively to none." Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter" under Section 101. Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980). "Likewise, Einstein could not patent his celebrated law that E=mc²; nor could Newton have patented the law of gravity." Id. Nor can one patent "a novel and useful mathematical formula," Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or "[t]he qualities of ... bacteria, ... the heat of the sun, electricity, or the qualities of metals," Funk, 333 U.S. at 130, 76 USPQ at 281; see also Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1853).

The courts have identified the following concepts and products as examples of laws of nature or natural phenomena:

• i. isolated DNA, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013);
• ii. a cloned farm animal such as a sheep, In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014);
• iii. a correlation between variations in non-coding regions of DNA and allele presence in coding regions of DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1375, 118 USPQ2d 1541, 1545 (Fed. Cir. 2016);
• iv. a correlation that is the consequence of how a certain compound is metabolized by the body, Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012);
• v. a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017);
• vi. electromagnetism to transmit signals, O’Reilly v. Morse, 56 U.S. 62, 113 (1853);
• vii. qualities of bacteria such as their ability to create a state of inhibition or non-inhibition in other bacteria, Funk Bros., 333 U.S. at 130, 76 USPQ at 281;
• viii. single-stranded DNA fragments known as "primers", University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. 2014);
• ix. the chemical principle underlying the union between fatty elements and water, Tilghman v. Proctor, 102 U.S. 707, 729 (1880);
• x. the existence of cell-free fetal DNA (cffDNA) in maternal blood, Ariosa Diagnostics, Inc. v. Sequenom, 788 F.3d 1371, 1373, 115 USPQ2d 1152, 1153 (Fed. Cir. 2015); and
• xi. the natural relationship between a patient’s CYP2D6 metabolizer genotype and the risk that the patient will suffer QTc prolongation after administration of a medication called iloperidone, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117, 1135-36, 126 USPQ2d 1266, 1281 (Fed. Cir. 2018).

The courts have also noted, however, that not every claim describing a natural ability or quality of a product, or describing a natural process, necessarily recites a law of nature or natural phenomenon. See Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1048-49, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims reciting process steps of fractionating, recovering, and cryopreserving hepatocytes held to be eligible, because they are not focused on merely observing or detecting the ability of hepatocytes to survive multiple freeze-thaw cycles). Thus, in a claimed method of treating cancer with chemotherapy, the cancer cells’ inability to survive chemotherapy is not considered to be a law of nature. Similarly, in a claimed method of treating headaches with aspirin, the human body’s natural response to aspirin is not considered to be a law of nature. These claims are accordingly eligible at Prong One unless they recite another exception, in which case they require further analysis in Prong Two (and Step 2B, if needed) to determine their eligibility. Similarly, a method of producing a new compound is not directed to the individual components’ ability to combine to form the new compound. Id. See also Tilghman v. Proctor, 102 U.S. 707, 729 (1881) (claims reciting process steps for manufacturing fatty acids and glycerol by hydrolyzing fat at high temperature and pressure were held to be eligible, because they are not focused on the chemical principle that fat can be hydrolyzed into its components).

Even if a claim does recite a law of nature or natural phenomenon, it may still be eligible at any of Pathways A through C. For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not "directed to" that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype. Vanda Pharms., 887 F.3d at 1134-36, 126 USPQ2d at 1279-81. This particular treatment step applied the natural relationship in a manner that integrated it into a practical application. The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).

As explained in MPEP § 2106.04, a claim that recites a law of nature or a natural phenomenon requires further analysis in Step 2A Prong Two to determine whether the claim integrates the exception into a practical application.

A claim that does not recite a law of nature or natural phenomenon is eligible at Pathway B (Step 2A: NO) unless the claim recites, and is directed to, another exception (such as an abstract idea, or a product of nature).

When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".

It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g., In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.

When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions. Examples of nature-based products include the isolated gene and cDNA sequences of Myriad, the cloned farm animals of Roslin, and the bacterium of Chakrabarty. As is evident from these examples, and as further discussed in MPEP § 2105, a nature-based product that is a living organism (e.g., a plant, an animal, a bacterium, etc.) is not excluded from patent protection merely because it is alive, and such a product is eligible for patenting if it satisfies the markedly different characteristics analysis.

It is important to keep in mind that under the broadest reasonable interpretation (BRI) of the claims, a nature-based product limitation may encompass both eligible and ineligible products. For example, a claim to a "cloned giraffe" may have a BRI encompassing cloned giraffes with markedly different characteristics, as well as cloned giraffes that lack markedly different characteristics and thus are products of nature. Cf. Roslin, 750 F.3d at 1338-39, 110 USPQ2d at 1673 (applicant could not rely on unclaimed features to distinguish claimed mammals from donor mammals).

Such a claim recites a product of nature, and thus requires further analysis in Prong Two. If the claim is ultimately rejected as failing to encompass an inventive concept (Step 2B: NO), it is a best practice for the examiner to point out the broadest reasonable interpretation and recommend an amendment, if possible, that would narrow the claim to those embodiments that are not directed to products of nature, or that are otherwise eligible.

For claims that recite a nature-based product limitation (which may or may not be a product of nature exception) but which are directed to inventions that clearly do not seek to tie up any judicial exception, examiners should consider whether the streamlined eligibility analysis discussed in MPEP § 2106.06 is appropriate. In such cases, it would not be necessary to conduct a markedly different characteristics analysis.

2106.04(c)    The Markedly Different Characteristics Analysis [R-10.2019]

The markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions. For example, Chakrabarty relied on a comparison of the claimed bacterium to naturally occurring bacteria when determining that the claimed bacterium was not a product of nature because it had "markedly different characteristics from any found in nature". Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980). Similarly, Roslin relied on a comparison of the claimed sheep to naturally occurring sheep when determining that the claimed sheep was a product of nature because it "does not possess ‘markedly different characteristics from any [farm animals] found in nature.’" In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ at 197 (alterations in original)).

This section sets forth guidelines for performing the markedly different characteristics analysis, including information on when to perform the analysis, and how to perform the analysis. Examiners should consult these guidelines when performing an eligibility analysis of a claim that recites a nature-based product limitation. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.

If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites another exception (such as a law of nature or abstract idea, or a different natural phenomenon). For claims where the entire claim is a single nature-based product (e.g., a claim to "a Lactobacillus bacterium"), once a markedly different characteristic in that product is shown, no further analysis would be necessary for eligibility because no product of nature exception is recited (i.e., Step 2B is not necessary because the answer to Step 2A is NO). For claims including limitations in addition to the nature-based product, examiners should consider whether the claim recites another exception and thus requires further eligibility analysis.

If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.

Because a nature-based product can be claimed by itself (e.g., "a Lactobacillus bacterium") or as one or more limitations of a claim (e.g., "a probiotic composition comprising a mixture of Lactobacillus and milk in a container"), care should be taken not to overly extend the markedly different characteristics analysis to products that when viewed as a whole are not nature-based. Instead, the markedly different characteristics analysis should be applied only to the nature-based product limitations in the claim to determine whether the nature-based products are "product of nature" exceptions.

Examiners should keep in mind that if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception. However, if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception.

Where the claim is to a nature-based product by itself (e.g., a claim to "a Lactobacillus bacterium"), the markedly different characteristics analysis should be applied to the entire product. See, e.g., Chakrabarty, 447 U.S. at 305, 309-10, 206 USPQ at 195, 197-98 (applying analysis to entire claimed "bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway").

Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately. See subsection II, below, for further guidance on the markedly different characteristic analysis.

Where the claim is to a nature-based product in combination with non-nature based elements (e.g., a claim to "a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt"), the markedly different characteristics analysis should be applied only to the nature-based product limitation. For instance, for the yogurt starter kit example, the Lactobacillus would be analyzed for markedly different characteristics. The container and instructions would not be subject to the markedly different characteristics analysis as they are not nature-based products, but would be evaluated as additional elements in Prong Two (and Step 2B if needed) if it is determined that the Lactobacillus does not have markedly different characteristics from any naturally occurring counterpart and thus is a product of nature exception. See, e.g., Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (although claims 7, 8, 13 and 14 recited an inoculant comprising a bacterial mixture and a powder base, only the bacterial mixture was analyzed).

For a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart. See MPEP § 2113 for more information on product-by-process claims.

For a process claim, the general rule is that the claim is not subject to the markedly different analysis for nature-based products used in the process. This is because the analysis of a process claim should focus on the active steps of the process rather than the products used in those steps. For example, when evaluating a claimed process of cryopreserving hepatocyte cells comprising performing density gradient fractionation to separate viable and non-viable hepatocytes, recovering the viable hepatocytes, and cryopreserving the recovered viable hepatocytes, the court did not subject the claim to the markedly different characteristics analysis for the nature-based products (the hepatocytes) used in the process. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1049, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims are directed to a process of creating a preparation of multi-cryopreserved hepatocytes, not to the preparation itself).

However, in the limited situation where a process claim reciting a nature-based product is drafted in such a way that there is no difference in substance from a product claim, the claim is subject to the markedly different analysis for the recited nature-based product. These types of claims are drafted in a way that focuses on the product rather than the process steps. For example, consider a claim that recites, in its entirety, "a method of providing an apple." Under the broadest reasonable interpretation, this claim is focused on the apple fruit itself, which is a nature-based product. Similarly, claims to detecting naturally occurring cell-free fetal DNA (cffDNA) in maternal blood were held to be directed to the cffDNA, because the "existence and location of cffDNA is a natural phenomenon [and thus] identifying its presence was merely claiming the natural phenomena itself." Rapid Litig. Mgmt., 827 F.3d at 1048, 119 USPQ2d at 1374, (explaining the holding in Ariosa Diagnostics, Inc. v. Sequenom, 788 F.3d 1371, 115 USPQ2d 1152 (Fed. Cir. 2015)).

The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.

This section sets forth guidelines for performing the markedly different characteristics analysis, including information on (a) selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation, (b) identifying appropriate characteristics for analysis, and (c) evaluating characteristics to determine whether they are "markedly different".

Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.

When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. For example, assume that applicant claims deoxyacid A, which is a chemical derivative of a naturally occurring chemical called acid A. Because applicant created the claimed nature-based product (deoxyacid A) by modifying the naturally occurring acid A, the closest natural counterpart for deoxyacid A would be the natural product from which it was derived, i.e., acid A. See, e.g., Chakrabarty, 447 U.S. at 305 and n.1, 206 USPQ at 195 and n.1 (counterpart to genetically modified Pseudomonas bacterium containing multiple plasmids is the naturally occurring unmodified Pseudomonas bacterium from which the claimed bacterium was created); Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671-72 (counterparts to cloned sheep are naturally occurring sheep such as the donor ewe from which the clone was created).

Although the selected counterpart should be in its natural state, examiners should take care not to confuse the counterpart with other material that may occur naturally with, or adjacent to, the counterpart. For example, assume that applicant claims a nucleic acid having a nucleotide sequence derived from naturally occurring gene B. Although gene B occurs in nature as part of a chromosome, the closest natural counterpart for the claimed nucleic acid is gene B, and not the whole chromosome. See, e.g., Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) (comparing isolated BRCA1 genes and BRCA1 cDNA molecules to naturally occurring BRCA1 gene); Roche Molecular System, Inc. v. CEPHEID, 905 F.3d 1363, 1371, 128 USPQ2d 1221, 1227 (Fed. Cir. 2018) (comparing claimed primers to "their corresponding nucleotide sequences on the naturally occurring DNA"). Similarly, assume that applicant claims a single-stranded piece of DNA (a primer) having a nucleotide sequence derived from the sense strand of naturally occurring nucleic acid C. Although nucleic acid C occurs in nature as a double-stranded molecule having a sense and an antisense strand, the closest natural counterpart for the claimed nucleic acid is the sense strand of C only. See, e.g., University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. 2014) (comparing single-stranded nucleic acid to the same strand found in nature, even though "single-stranded DNA cannot be found in the human body").

When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. For example, assume that applicant creates a cloned sheep D by transferring nuclear DNA from a Finn-Dorset sheep into an egg cell (which contains mitochondrial DNA) from a Scottish Blackface sheep. Applicant then claims sheep D. Here, because sheep D was created via combining DNA from two different naturally occurring sheep of different breeds, there is no single closest natural counterpart. The examiner should therefore select the counterpart most closely related to sheep D based on the examiner’s expertise in the particular art. For the example discussed here, the closest counterparts might be naturally occurring Finn-Dorset or Scottish Blackface sheep, as opposed to sheep of a different breed such as Bighorn sheep. Cf. Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671-72 (claimed sheep produced by nuclear transfer into an oocyte and subsequent manipulation of natural embryonic development processes was compared to naturally occurring sheep such as the donor ewe from which the nuclear material was obtained). When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil"). See subsection II. C.

If the claim is rejected as ineligible, it is a "best practice" for the examiner to identify the selected counterpart in the Office action if the record is not already clear. This practice assists the applicant in responding, and clarifies the record as to how the examiner is interpreting the claim.

Because the markedly different characteristics analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart, the second step in the analysis is to identify appropriate characteristics to compare.

Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility). Examiners can identify the characteristics possessed by the claimed product by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. In some claims, a characteristic may be explicitly recited. For example, in a claim to "deoxyribose", the recited chemical name informs those in the art of the structural characteristics of the product (i.e., the "deoxy" prefix indicates that a hydroxyl group has been removed as compared to ribose). In other claims, the characteristic may be apparent from the broadest reasonable interpretation even though it is not explicitly recited in the claim. For example, in a claim to "isolated gene B," the examiner would need to rely on the broadest reasonable interpretation of "isolated gene B" to determine what characteristics the isolated gene has, e.g., what its nucleotide sequence is, and what, if any, protein it encodes.

Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include:

• • Biological or pharmacological functions or activities;
• • Chemical and physical properties;
• • Phenotype, including functional and structural characteristics; and
• • Structure and form, whether chemical, genetic or physical.

Examples of biological or pharmacological functions or activities include, but are not limited to:

• i. the protein-encoding information of a nucleic acid, Myriad, 569 U.S. at 590-91, 106 USPQ2d at 1979;
• ii. the ability of complementary nucleotide sequences to bind to each other, Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244;
• iii. the properties and functions of bacteria such as the ability to infect certain leguminous plants, Funk Bros., 333 U.S. at 130-31, 76 USPQ2d at 281-82;
• iv. the ability to degrade certain hydrocarbons, Diamond v. Chakrabarty, 447 U.S. at 310, 206 USPQ2d at 195; and
• v. the ability of vitamin C to prevent and treat scurvy, In re King, 107 F.2d 618, 27 CCPA 754, 756-57, 43 USPQ 400, 401-402 (CCPA 1939).

Examples of chemical and physical properties include, but are not limited to:

• i. the alkalinity of a chemical compound, Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103-04 (S.D.N.Y. 1911); and
• ii. the ductility or malleability of metals, In re Marden, 47 F.2d 958, 959, 18 CCPA 1057, 1059, 8 USPQ 347, 349 (CCPA 1931).

Examples of phenotypic characteristics include, but are not limited to:

• i. functional and structural characteristics such as the shape, size, color, and behavior of an organism, Roslin, 750 F.3d at 1338, 110 USPQ2d at 1672.

Examples of structure and form include, but are not limited to:

• i. physical structure or form such as the physical presence of plasmids in a bacterial cell, Chakrabarty, 447 U.S. at 305 and n.1, 206 USPQ2d at 195 and n.1;
• ii. chemical structure and form such as a chemical being a "nonsalt" and a "crystalline substance", Parke-Davis, 189 F. at 100, 103;
• iii. genetic structure such as the nucleotide sequence of DNA, Myriad, 569 U.S. at 590, 594-95, 106 USPQ2d at 1979, 1981; and
• iv. the genetic makeup (genotype) of a cell or organism, Roslin, 750 F.3d at 1338-39, 110 USPQ2d at 1672-73.

The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.

If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by applicant’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.

In Chakrabarty, the Supreme Court identified a claimed bacterium as a nature-based product having markedly different characteristics. This bacterium had a changed functional characteristic, i.e., it was able to degrade at least two different hydrocarbons as compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. The claimed bacterium also had a different structural characteristic, i.e., it was genetically modified to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium. The Supreme Court considered these changed characteristics to be "markedly different characteristics from any found in nature" due to the additional plasmids and resultant capacity for degrading multiple hydrocarbon components of oil. Therefore, the bacterium was eligible. Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980).

In Myriad, the Supreme Court identified a claimed full-length complementary DNA (cDNA) of the BRCA1 gene as a nature-based product having markedly different characteristics. This claimed cDNA had the same functional characteristics (i.e., it encoded the same protein) as the naturally occurring gene, but had a changed structural characteristic, i.e., a different nucleotide sequence containing only exons, as compared to the naturally occurring sequence containing both exons and introns. The Supreme Court concluded that the "cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, [this] cDNA is not a ‘product of nature’" and is eligible. Myriad, 569 U.S. at 595, 106 USPQ2d at 1981.

In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. The patentee in Myriad had discovered the location of the BRCA1 and BRCA2 genes in the human genome, and isolated them, i.e., separated those specific genes from the rest of the chromosome on which they exist in nature. As a result of their isolation, the isolated genes had a different structural characteristic than the natural genes, i.e., the natural genes had covalent bonds on their ends that connected them to the rest of the chromosome, but the isolated genes lacked these bonds. However, the claimed genes were otherwise structurally identical to the natural genes, e.g., they had the same genetic structure and nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.

In Ambry Genetics, the court identified claimed DNA fragments known as "primers" as products of nature, because they lacked markedly different characteristics. University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The claimed primers were single-stranded pieces of DNA, each of which corresponded to a naturally occurring double-stranded DNA sequence in or near the BRCA genes. The patentee argued that these primers had markedly different structural characteristics from the natural DNA, because the primers were synthetically created and because "single-stranded DNA cannot be found in the human body". The court disagreed, concluding that the primers’ structural characteristics were not markedly different than the corresponding strands of DNA in nature, because the primers and their counterparts had the same genetic structure and nucleotide sequence. 774 F.3d at 760, 113 USPQ2d at 1243-44. The patentee also argued that the primers had a different function than when they are part of the DNA strand because when isolated as a primer, a primer can be used as a starting material for a DNA polymerization process. The court disagreed, because this ability to serve as a starting material is innate to DNA itself, and was not created or altered by the patentee:

In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction--a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here--the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.

Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244. In sum, because the characteristics of the claimed primers were innate to naturally occurring DNA, they lacked markedly different characteristics from nature and were thus product of nature exceptions. A similar result was reached in Marden, where the court held a claim to ductile vanadium ineligible, because the "ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics". In re Marden, 47 F.2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 (CCPA 1931).

In Roslin, the court concluded that claimed clones of farm animals were products of nature, because they lacked markedly different characteristics from the counterpart farm animals found in nature. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014). Applicant created its clones (which included the famous cloned sheep named Dolly) by transferring the genetic material of a donor into an oocyte (egg cell), letting the oocyte develop into an embryo, and then implanting the embryo into a surrogate animal where it developed into a baby animal. The applicant argued that the clones, including Dolly, were eligible because they were created via human ingenuity, and had phenotypic differences such as shape, size and behavior compared to their donors. The court was unpersuaded, explaining that the clones were exact genetic replicas of the donors and thus did not possess markedly different characteristics. 750 F.3d at 1337, 110 USPQ2d at 1671-72 ("Roslin’s chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection."). The court noted that the alleged phenotypic differences (e.g., the fact that Dolly may have been taller or heavier than her donor) could not make the clones markedly different because these differences were not claimed. 750 F.3d at 1338, 110 USPQ2d at 1672. See also Roche Molecular System, Inc. v. CEPHEID, 905 F.3d 1363, 1370, 128 USPQ2d 1221, 1226 (Fed. Cir. 2018) (alleged structural differences between linear primers and their counterparts on a circular chromosome were neither claimed nor relevant to the eligibility inquiry).

2106.04(d)    Integration of a Judicial Exception Into A Practical Application [R-10.2019]

The Supreme Court has long distinguished between principles themselves (which are not patent eligible) and the integration of those principles into practical applications (which are patent eligible). See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in Diamond v. Diehr found ‘‘the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,’’ but the Court in Gottschalk v. Benson ‘‘held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle’’). Similarly, in a growing body of decisions, the Federal Circuit has distinguished between claims that are ‘‘directed to’’ a judicial exception (which require further analysis to determine their eligibility) and those that are not (which are therefore patent eligible), e.g., claims that improve the functioning of a computer or other technology or technological field. See Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972). See, e.g., MPEP § 2106.06(b) (summarizing Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016), McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 120 USPQ2d 1091 (Fed. Cir. 2016), and other cases that were eligible as improvements to technology or computer functionality instead of being directed to abstract ideas).

Accordingly, after determining that a claim recites a judicial exception in Step 2A Prong One, examiners should evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception in Step 2A Prong Two. A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. Whether or not a claim integrates a judicial exception into a practical application is evaluated using the considerations set forth in subsection I below, in accordance with the procedure described below in subsection II.

In the context of the flowchart in MPEP § 2106, subsection III, Step 2A Prong Two determines whether:

• • The claim as a whole integrates the judicial exception into a practical application, in which case the claim is not directed to a judicial exception (Step 2A: NO) and is eligible at Pathway B. This concludes the eligibility analysis.
• • The claim as a whole does not integrate the exception into a practical application, in which case the claim is directed to the judicial exception (Step 2A: YES), and requires further analysis under Step 2B (where it may still be eligible if it amounts to an inventive concept). See MPEP § 2106.05 for discussion of Step 2B.

The Supreme Court and Federal Circuit have identified a number of considerations as relevant to the evaluation of whether the claimed additional elements demonstrate that a claim is directed to patent-eligible subject matter. The list of considerations here is not intended to be exclusive or limiting. Additional elements can often be analyzed based on more than one type of consideration and the type of consideration is of no import to the eligibility analysis. Additional discussion of these considerations, and how they were applied in particular judicial decisions, is provided in MPEP § 2106.05(a) through (c) and MPEP § 2106.05(e) through (h).

Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:

• • An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• • Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• • Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• • Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• • Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).

The courts have also identified limitations that did not integrate a judicial exception into a practical application:

• • Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• • Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• • Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).

Step 2A Prong Two is similar to Step 2B in that both analyses involve evaluating a set of judicial considerations to determine if the claim is eligible. See MPEP §§ 2106.05(a) through (h) for the list of considerations that are evaluated at Step 2B. Although most of these considerations overlap (i.e., they are evaluated in both Step 2A Prong Two and Step 2B), Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity. Accordingly, in Step 2A Prong Two, examiners should ensure that they give weight to all additional elements, whether or not they are conventional, when evaluating whether a judicial exception has been integrated into a practical application. Additional elements that represent well-understood, routine, conventional activity may integrate a recited judicial exception into a practical application.

It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2A Prong Two. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point"). See also Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis are not "sufficient" to render claim 1 patent eligible merely because they are physical steps). Conversely, the presence of a non-physical or intangible additional element does not doom the claims, because tangibility is not necessary for eligibility under the Alice/Mayo test. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the improvement is not defined by reference to ‘physical’ components does not doom the claims"). See also McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a process producing an intangible result (a sequence of synchronized, animated characters) was eligible because it improved an existing technological process).

In addition, a specific way of achieving a result is not a stand-alone consideration in Step 2A Prong Two. However, the specificity of the claim limitations is relevant to the evaluation of several considerations including the use of a particular machine, particular transformation and whether the limitations are mere instructions to apply an exception. See MPEP §§ 2106.05(b), 2106.05(c), and 2106.05(f). For example, in Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978), the Supreme Court noted that the "patent application does not purport to explain how to select the appropriate margin of safety, the weighting factor, or any of the other variables" in the claimed mathematical formula, "[n]or does it purport to contain any disclosure relating to the chemical processes at work, the monitoring of process variables, or the means of setting off an alarm or adjusting an alarm system." 437 U.S. at 586, 198 USPQ at 195. The Court found this failure to explain any specifics of how to use the claimed formula informative when deciding that the additional elements in the claim were insignificant post-solution activity and thus not meaningful enough to render the claim eligible. 437 U.S. at 589-90, 198 USPQ at 197.

The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).

Many of these considerations overlap, and often more than one consideration is relevant to analysis of an additional element. Not all considerations will be relevant to every element, or every claim. Because the evaluation in Prong Two is not a weighing test, it is not important how the elements are characterized or how many considerations apply from the list. It is important to evaluate the significance of the additional elements relative to applicant’s invention, and to keep in mind the ultimate question of whether the exception is integrated into a practical application. If the claim as a whole integrates the judicial exception into a practical application based upon evaluation of these considerations, the additional limitations impose a meaningful limit on the judicial exception and the claim is eligible at Step 2A.

Examiners should examine each claim for eligibility separately, based on the particular elements recited therein. Claims should not be judged to automatically stand or fall with similar claims in an application. For instance, one claim may be ineligible because it is directed to a judicial exception without amounting to significantly more, but another claim dependent on the first may be eligible because it recites additional elements that do amount to significantly more, or that integrate the exception into a practical application.

For more information on how to evaluate claims reciting multiple judicial exceptions, see MPEP § 2106.04, subsection II.B.

The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application. Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. However, the way in which the additional elements use or interact with the exception may integrate it into a practical application. Accordingly, the additional limitations should not be evaluated in a vacuum, completely separate from the recited judicial exception. Instead, the analysis should take into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application.

Two examples of how the Office evaluates whether the claim as a whole integrates the recited judicial exception into a practical application are provided. In Solutran, Inc. v. Elavon, Inc., 931 F.3d 1161, 2019 USPQ2d 281076 (Fed. Cir. 2019), the claims were to methods for electronically processing paper checks, all of which contained limitations setting forth receiving merchant transaction data from a merchant, crediting a merchant’s account, and receiving and scanning paper checks after the merchant’s account is credited. In part one of the Alice/Mayo test, the Federal Circuit determined that the claims were directed to the abstract idea of crediting the merchant’s account before the paper check is scanned. The court first determined that the recited limitations of "crediting a merchant’s account as early as possible while electronically processing a check" is a "long-standing commercial practice" like in Alice and Bilski. 931 F.3d at 1167, 2019 USPQ2d 281076, at *5 (Fed. Cir. 2019). The Federal Circuit then continued with its analysis under part one of the Alice/Mayo test finding that the claims are not directed to an improvement in the functioning of a computer or an improvement to another technology. In particular, the court determined that the claims "did not improve the technical capture of information from a check to create a digital file or the technical step of electronically crediting a bank account" nor did the claims "improve how a check is scanned." Id. This analysis is equivalent to the Office’s analysis of determining that the exception is not integrated into a practical application at Step 2A Prong Two, and thus that the claims are directed to the judicial exception (Step 2A: YES).

In Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018), the claimed invention was a method of virus scanning that scans an application program, generates a security profile identifying any potentially suspicious code in the program, and links the security profile to the application program. 879 F.3d at 1303-04, 125 USPQ2d at 1285-86. The Federal Circuit noted that the recited virus screening was an abstract idea, and that merely performing virus screening on a computer does not render the claim eligible. 879 F.3d at 1304, 125 USPQ2d at 1286. The court then continued with its analysis under part one of the Alice/Mayo test by reviewing the patent’s specification, which described the claimed security profile as identifying both hostile and potentially hostile operations. The court noted that the security profile thus enables the invention to protect the user against both previously unknown viruses and "obfuscated code," as compared to traditional virus scanning, which only recognized the presence of previously-identified viruses. The security profile also enables more flexible virus filtering and greater user customization. 879 F.3d at 1304, 125 USPQ2d at 1286. The court identified these benefits as improving computer functionality, and verified that the claims recite additional elements (e.g., specific steps of using the security profile in a particular way) that reflect this improvement. Accordingly, the court held the claims eligible as not being directed to the recited abstract idea. 879 F.3d at 1304-05, 125 USPQ2d at 1286-87. This analysis is equivalent to the Office’s analysis of determining that the additional elements integrate the judicial exception into a practical application at Step 2A Prong Two, and thus that the claims were not directed to the judicial exception (Step 2A: NO).

2106.04(d)(1)    Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in Step 2A Prong Two [R-10.2019]

A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the claimed invention improves the functioning of a computer or improves another technology or technical field. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A because they are not "directed to" the recited judicial exception.

The courts have not provided an explicit test for this consideration, but have instead illustrated how it is evaluated in numerous decisions. These decisions, and a detailed explanation of how examiners should evaluate this consideration are provided in MPEP § 2106.05(a). In short, first the specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. Second, if the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. That is, the claim includes the components or steps of the invention that provide the improvement described in the specification. The claim itself does not need to explicitly recite the improvement described in the specification (e.g., "thereby increasing the bandwidth of the channel").

While the courts usually evaluate "improvements" as part of the "directed to" inquiry in part one of the Alice/Mayo test (equivalent to Step 2A), they have also performed this evaluation in part two of the Alice/Mayo test (equivalent to Step 2B). See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349-50, 119 USPQ2d 1236, 1241-42 (Fed. Cir. 2016). However, the improvement analysis at Step 2A Prong Two differs in some respects from the improvements analysis at Step 2B. Specifically, the "improvements" analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity. That is, the claimed invention may integrate the judicial exception into a practical application by demonstrating that it improves the relevant existing technology although it may not be an improvement over well-understood, routine, conventional activity. It should be noted that while this consideration is often referred to in an abbreviated manner as the "improvements consideration," the word "improvements" in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.

Examples of claims that improve technology and are not directed to a judicial exception include: Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) (claims to a self-referential table for a computer database were directed to an improvement in computer capabilities and not directed to an abstract idea); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial expression animation were directed to an improvement in computer-related technology and not directed to an abstract idea); Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253,1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed to an improvement in computer capabilities and not an abstract idea); Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an improvement in computer technology and not directed to an abstract idea); SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1303 (Fed. Cir. 2019) (claims to detecting suspicious activity by using network monitors and analyzing network packets were found to be an improvement in computer network technology and not directed to an abstract idea). Additional examples are provided in MPEP § 2106.05(a).

2106.04(d)(2)    Particular Treatment and Prophylaxis in Step 2A Prong Two

A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional element(s) demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A, because they are not "directed to" the recited judicial exception.

The particular treatment or prophylaxis consideration originated as part of the other meaningful limitations consideration discussed in MPEP § 2106.05(e) and shares the same legal basis in Supreme Court jurisprudence as that consideration. However, recent jurisprudence has provided additional guidance that is especially relevant to only a subset of claims, thus warranting the elevation of the particular treatment or prophylaxis consideration to become a stand-alone consideration in the Step 2A Prong Two analysis. Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The claims in Vanda recited a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a disruption of the heart’s normal rhythm that can lead to serious health problems) in patients having a particular genotype associated with poor drug metabolism. 887 F.3d at 1121, 126 USPQ2d at 1269-70. In particular, the claims recited steps of: (1) performing a genotyping assay to determine if a patient has a genotype associated with poor drug metabolism; and (2) administering iloperidone to the patient in a dose range that depends on the patient’s genotype. Id. Although Vanda’s claims recited a law of nature (the naturally occurring relationship between the patient’s genotype and the risk of QTc prolongation) like the claims in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012), the Federal Circuit distinguished them from the Mayo claims based on the differences in the administration steps. In particular, the court explained that Mayo’s step of administering a drug to a patient was performed in order to gather data about the recited laws of nature, and this step was thus ancillary to the overall diagnostic focus of the claims. 887 F.3d at 1134-35, 126 USPQ2d at 1280. In contrast, Vanda’s claims used the recited law of nature to more safely treat the patients with the drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, 126 USPQ2d at 1280. Accordingly, the court held Vanda’s claims eligible at the first part of the Alice/Mayo test (Step 2A) because the claims were not "directed to" the recited judicial exception. 887 F.3d at 1136, 126 USPQ2d at 1281.

Examples of "treatment" and prophylaxis" limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. For example, an immunization step that integrates an abstract idea into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases is considered to be a particular prophylaxis limitation that practically applies the abstract idea. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011).

Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.

When determining whether a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant.

• a. The Particularity Or Generality Of The Treatment Or Prophylaxis
• The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.

  Examiners may find it helpful to evaluate other considerations such as the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether a treatment or prophylaxis limitation is particular or general.

  
• b. Whether The Limitation(s) Have More Than A Nominal Or Insignificant Relationship To The Exception(s)
• The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). For example, consider a claim that recites a natural correlation (law of nature) between blood glucose levels over 250 mg/dl and the risk of developing ketoacidosis (a life-threatening medical condition). The claim also recites "treating a patient having a blood glucose level over 250 mg/dl with insulin". Insulin acts to lower blood glucose levels, and administering insulin to a patient will reduce the patient’s blood glucose level, thereby lowering the risk that the patient will develop ketoacidosis. Thus, in the context of this claim, the administration step is significantly related to the recited correlation between high blood glucose levels and the risk of ketoacidosis. Because insulin is also a "particular" treatment, this administration step integrates the law of nature into a practical application. Alternatively, consider a claim that recites the same law of nature and also recites "treating a patient having a blood glucose level over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment for ketoacidosis or diabetes, although some patients with diabetes may be on aspirin therapy for other medical reasons (e.g., to control pain or inflammation, or to prevent blood clots). In the context of this claim and the recited correlation between high blood glucose levels and the risk of ketoacidosis, administration of aspirin has at best a nominal connection to the law of nature, because aspirin does not treat or prevent ketoacidosis. This step therefore does not apply or use the exception in any meaningful way. Thus, this step of administering aspirin does not integrate the law of nature into a practical application.

  Examiners may find it helpful to evaluate other considerations such as the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether a treatment or prophylaxis limitation has more than a nominal or insignificant relationship to the exception(s).

  
• c. Whether The Limitation(s) Are Merely Extra-Solution Activity Or A Field Of Use
• The treatment or prophylaxis limitation must impose meaningful limits on the judicial exception, and cannot be extra-solution activity or a field-of-use. For example, consider a claim that recites (a) administering rabies and feline leukemia vaccines to a first group of domestic cats in accordance with different vaccination schedules, and (b) analyzing information about the vaccination schedules and whether the cats later developed chronic immune-mediated disorders to determine a lowest-risk vaccination schedule. Step (b) falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). While step (a) administers vaccines to the cats, this administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited exception. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. Conversely, consider a claim reciting the same steps (a) and (b), but also reciting step (c) "vaccinating a second group of domestic cats in accordance with the lowest-risk vaccination schedule." Step (c) applies the exception, in that the information from the mental analysis in step (b) is used to alter the order and timing of the vaccinations so that the second group of cats has a lower risk of developing chronic immune-mediated disorders. Step (c) thus integrates the abstract idea into a practical application.

  Examiners may find it helpful to evaluate other considerations such as the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)), and the field of use and technological environment consideration (see MPEP § 2106.05(g)), when making a determination of whether a treatment or prophylaxis limitation is merely extra-solution activity or a field of use.

  

2106.05    Eligibility Step 2B: Whether a Claim Amounts to Significantly More [R-10.2019]

The second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)).

An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).

Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. Because this approach considers all claim elements, the Supreme Court has noted that "it is consistent with the general rule that patent claims ‘must be considered as a whole.’" Alice Corp., 573 U.S. at 218 n.3, 110 USPQ2d at 1981 (quoting Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ 1, 8-9 (1981)). Consideration of the elements in combination is particularly important, because even if an additional element does not amount to significantly more on its own, it can still amount to significantly more when considered in combination with the other elements of the claim. See, e.g., Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) (process reciting combination of individually well-known freezing and thawing steps was "far from routine and conventional" and thus eligible); BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (inventive concept may be found in the non-conventional and non-generic arrangement of components that are individually well-known and conventional).

Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting "the Government’s invitation to substitute §§ 102, 103, and 112  inquiries for the better established inquiry under § 101 "). As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101  categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a new abstract idea is still an abstract idea. The search for a § 101  inventive concept is thus distinct from demonstrating § 102  novelty."). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) ("The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces."). Specifically, lack of novelty under 35 U.S.C. 102  or obviousness under 35 U.S.C. 103  of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102  and 103  with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101 ) and patentability over the art (under 35 U.S.C. 102  and/or 103 ) is further discussed in MPEP § 2106.05(d).

The Supreme Court has identified a number of considerations as relevant to the evaluation of whether the claimed additional elements amount to an inventive concept. The list of considerations here is not intended to be exclusive or limiting. Additional elements can often be analyzed based on more than one type of consideration and the type of consideration is of no import to the eligibility analysis. Additional discussion of these considerations, and how they were applied in particular judicial decisions, is provided in in MPEP § 2106.05(a) through (h).

Limitations that the courts have found to qualify as "significantly more" when recited in a claim with a judicial exception include:

• i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
• ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
• iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
• iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
• v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
• vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).

Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include:

• i. Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
• ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
• iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
• iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).

It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2B. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception is not in itself an inventive concept and does not guarantee eligibility:

The fact that a computer "necessarily exist[s] in the physical, rather than purely conceptual, realm," is beside the point. There is no dispute that a computer is a tangible system (in § 101  terms, a "machine"), or that many computer-implemented claims are formally addressed to patent-eligible subject matter. But if that were the end of the § 101  inquiry, an applicant could claim any principle of the physical or social sciences by reciting a computer system configured to implement the relevant concept. Such a result would make the determination of patent eligibility "depend simply on the draftsman’s art," Flook, supra, at 593, 98 S. Ct. 2522, 57 L. Ed. 2d 451, thereby eviscerating the rule that "‘[l]aws of nature, natural phenomena, and abstract ideas are not patentable,’" Myriad, 133 S. Ct. 1289, 186 L. Ed. 2d 124, 133).

Alice Corp., 573 U.S. at 224, 110 USPQ2d at 1983-84 (alterations in original). See also Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis "do not, individually or in combination, provide sufficient inventive concept to render claim 1 patent eligible" merely because they are physical steps). Conversely, the presence of a non-physical or intangible additional element does not doom the claims, because tangibility is not necessary for eligibility under the Alice/Mayo test. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the improvement is not defined by reference to ‘physical’ components does not doom the claims"). See also McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a process producing an intangible result (a sequence of synchronized, animated characters) was eligible because it improved an existing technological process).

Alice Corp. provides an example of how courts conduct the significantly more analysis. In this case, the Supreme Court analyzed claims to computer systems, computer readable media, and computer-implemented methods, all of which described a scheme for mitigating "settlement risk," which is the risk that only one party to an agreed-upon financial exchange will satisfy its obligation. In part one of the Alice/Mayo test, the Court determined that the claims were directed to the abstract idea of mitigating settlement risk. Alice Corp., 573 U.S. at 221, 110 USPQ2d at 1982. The Court then walked through part two of the Alice/Mayo test, in which:

• • The Court identified the additional elements in the claim, e.g., by noting that the method claims recited steps of using a computer to "create electronic records, track multiple transactions, and issue simultaneous instructions", and that the product claims recited hardware such as a "data processing system" with a "communications controller" and a "data storage unit" (573 U.S. at 224-26, 110 USPQ2d at 1984-85);
• • The Court considered the additional elements individually, noting that all the computer functions were "‘well-understood, routine, conventional activit[ies]’ previously known to the industry," each step "does no more than require a generic computer to perform generic computer functions", and the recited hardware was "purely functional and generic" (573 U.S. at 225-26, 110 USPQ2d at 1984-85); and
• • The Court considered the additional elements "as an ordered combination," and determined that "the computer components … ‘[a]dd nothing … that is not already present when the steps are considered separately’" and simply recite intermediated settlement as performed by a generic computer." 573 U.S. at 225 (citing Mayo, 566 U.S. at 79, 101 USPQ2d at 1972).

Based on this analysis, the Court concluded that the claims amounted to "‘nothing significantly more’ than an instruction to apply the abstract idea of intermediated settlement using some unspecified, generic computer", and therefore held the claims ineligible because they were directed to a judicial exception and failed the second part of the Alice/Mayo test. Alice Corp., 573 U.S. at 225-27, 110 USPQ2d at 1984.

BASCOM provides another example of how courts conduct the significantly more analysis, and of the critical importance of considering the additional elements in combination. In this case, the Federal Circuit vacated a judgment of ineligibility because the district court failed to properly perform the second step of the Alice/Mayo test when analyzing a claimed system for filtering content retrieved from an Internet computer network. BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 119 USPQ2d 1236 (Fed. Cir. 2016). The Federal Circuit agreed with the district court that the claims were directed to the abstract idea of filtering Internet content, and then walked through the district court’s analysis in part two of the Alice/Mayo test, noting that:

• • The district court properly identified the additional elements in the claims, such as a "local client computer," "remote ISP server," "Internet computer network," and "controlled access network accounts" (827 F.3d at 1349, 119 USPQ2d at 1242);
• • The district court properly considered the additional elements individually, for example by consulting the specification, which described each of the additional elements as "well-known generic computer components" (827 F.3d at 1349, 119 USPQ2d at 1242); and
• • The district court should have considered the additional elements in combination, because the "inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art" (827 F.3d at 1350, 119 USPQ2d at 1242).

Based on this analysis, the Federal Circuit concluded that the district court erred by failing to recognize that when combined, an inventive concept may be found in the non-conventional and non-generic arrangement of the additional elements, i.e., the installation of a filtering tool at a specific location, remote from the end-users, with customizable filtering features specific to each end user. 827 F.3d at 1350, 119 USPQ2d at 1242.

As described in MPEP § 2106, subsection III, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Like the other steps in the eligibility analysis, evaluation of this step should be made after determining what applicant has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation. See MPEP § 2106, subsection II for more information about the importance of understanding what the applicant has invented, and MPEP § 2111 for more information about the broadest reasonable interpretation.

Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)).

This evaluation is made with respect to the considerations that the Supreme Court has identified as relevant to the eligibility analysis, which are introduced generally in Part I.A of this section, and discussed in detail in MPEP § 2106.05(a) through (h). Many of these considerations overlap, and often more than one consideration is relevant to analysis of an additional element. Not all considerations will be relevant to every element, or every claim. Because the evaluation in Step 2B is not a weighing test, it is not important how the elements are characterized or how many considerations apply from this list. It is important to evaluate the significance of the additional elements relative to applicant’s invention, and to keep in mind the ultimate question of whether the additional elements encompass an inventive concept.

Although the conclusion of whether a claim is eligible at Step 2B requires that all relevant considerations be evaluated, most of these considerations were already evaluated in Step 2A Prong Two. Thus, in Step 2B, examiners should:

• • Carry over their identification of the additional element(s) in the claim from Step 2A Prong Two;
• • Carry over their conclusions from Step 2A Prong Two on the considerations discussed in MPEP §§ 2106.05(a) - (c), (e) (f) and (h):
• • Re-evaluate any additional element or combination of elements that was considered to be insignificant extra-solution activity per MPEP § 2106.05(g), because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and
• • Evaluate whether any additional element or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP § 2106.05(d).

In the context of the flowchart in MPEP § 2106, subsection III, Step 2B determines whether:

• • The claim as a whole does not amount to significantly more than the exception itself (there is no inventive concept in the claim) (Step 2B: NO) and thus is not eligible, warranting a rejection for lack of subject matter eligibility and concluding the eligibility analysis; or
• • The claim as a whole does amount to significantly more than the exception (there is an inventive concept in the claim) (Step 2B: YES), and thus is eligible at Pathway C, thereby concluding the eligibility analysis.

Examiners should examine each claim for eligibility separately, based on the particular elements recited therein. Claims should not be judged to automatically stand or fall with similar claims in an application. For instance, one claim may be ineligible because it is directed to a judicial exception without amounting to significantly more, but another claim dependent on the first may be eligible because it recites additional elements that do amount to significantly more.

For more information on how to evaluate claims reciting multiple judicial exceptions, see MPEP § 2106.04, subsection II.B.

If the claim as a whole does recite significantly more than the exception itself, the claim is eligible (Step 2B: YES) at Pathway C, and the eligibility analysis is complete. If there are no meaningful limitations in the claim that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, the claim is not patent-eligible (Step 2B: NO) and should be rejected under 35 U.S.C. 101. See MPEP § 2106.07 for information on how to formulate an ineligibility rejection.

2106.05(a)    Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field [R-10.2019]

In determining patent eligibility, examiners should consider whether the claim "purport(s) to improve the functioning of the computer itself" or "any other technology or technical field." Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 225, 110 USPQ2d 1976, 1984 (2014). This consideration has also been referred to as the search for a technological solution to a technological problem. See e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1257, 113 USPQ2d 1097, 1105 (Fed. Cir. 2014); Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016).

While improvements were evaluated in Alice Corp. as relevant to the search for an inventive concept (Step 2B), several decisions of the Federal Circuit have also evaluated this consideration when determining whether a claim was directed to an abstract idea (Step 2A). See, e.g., Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-16, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); Visual Memory, LLC v. NVIDIA Corp., 867 F.3d 1253, 1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. 2017). Thus, an examiner should evaluate whether a claim contains an improvement to the functioning of a computer or to any other technology or technical field at Step 2A Prong Two and Step 2B, as well as when considering whether the claim has such self-evident eligibility that it qualifies for the streamlined analysis. See MPEP § 2106.04(d)(1) for more information about evaluating improvements in Step 2A Prong Two, and MPEP § 2106.07(b) for more information about improvements in the streamlined analysis context.

If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).

After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., "thereby increasing the bandwidth of the channel"). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim "as a whole," in other words, the claim should be evaluated "as an ordered combination, without ignoring the requirements of the individual steps." When performing this evaluation, examiners should be "careful to avoid oversimplifying the claims" by looking at them generally and failing to account for the specific requirements of the claims. McRO, 837 F.3d at 1313, 120 USPQ2d at 1100.

An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a claim satisfies the improvement consideration.

It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.

During examination, the examiner should analyze the "improvements" consideration by evaluating the specification and the claims to ensure that a technical explanation of the asserted improvement is present in the specification, and that the claim reflects the asserted improvement. Generally, examiners are not expected to make a qualitative judgement on the merits of the asserted improvement. If the examiner concludes the disclosed invention does not improve technology, the burden shifts to applicant to provide persuasive arguments supported by any necessary evidence to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology. Any such evidence submitted under 37 CFR 1.132  must establish what the specification would convey to one of ordinary skill in the art and cannot be used to supplement the specification. See, e.g. MPEP § 716.09 on 37 CFR 1.132  practice with respect to rejections under 35 U.S.C. 112(a). For example, in response to a rejection under 35 U.S.C. 101, an applicant could submit a declaration under § 1.132  providing testimony on how one of ordinary skill in the art would interpret the disclosed invention as improving technology and the underlying factual basis for that conclusion.

In computer-related technologies, the examiner should determine whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). In Enfish, the court evaluated the patent eligibility of claims related to a self-referential database. Id. The court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality. Id. It was the specification’s discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, 118 USPQ2d at 1691. The claim was not simply the addition of general purpose computers added post-hoc to an abstract idea, but a specific implementation of a solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at 1691.

Examples that the courts have indicated may show an improvement in computer-functionality:

• i. A modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, DDR Holdings, 773 F.3d at 1258-59, 113 USPQ2d at 1106-07;
• ii. Inventive distribution of functionality within a network to filter Internet content, BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016);
• iii. A method of rendering a halftone digital image, Research Corp. Techs. v. Microsoft Corp., 627 F.3d 859, 868-69, 97 USPQ2d 1274, 1380 (Fed. Cir. 2010);
• iv. A distributed network architecture operating in an unconventional fashion to reduce network congestion while generating networking accounting data records, Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1536-37 (Fed. Cir. 2016);
• v. A memory system having programmable operational characteristics that are configurable based on the type of processor, which can be used with different types of processors without a tradeoff in processor performance, Visual Memory, LLC v. NVIDIA Corp., 867 F.3d 1253, 1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. 2017);
• vi. Technical details as to how to transmit images over a cellular network or append classification information to digital image data, TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 614-15, 118 USPQ2d 1744, 1749-50 (Fed. Cir. 2016) (holding the claims ineligible because they fail to provide requisite technical details necessary to carry out the function);
• vii. Particular structure of a server that stores organized digital images, TLI Communications, 823 F.3d at 612, 118 USPQ2d at 1747 (finding the use of a generic server insufficient to add inventive concepts to an abstract idea);
• viii. A particular way of programming or designing software to create menus, Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1241, 120 USPQ2d 1844, 1854 (Fed. Cir. 2016);
• ix. A method that generates a security profile that identifies both hostile and potentially hostile operations, and can protect the user against both previously unknown viruses and "obfuscated code," which is an improvement over traditional virus scanning. Finjan Inc. v. Blue Coat Systems, 879 F.3d 1299, 1304, 125 USPQ2d 1282, 1286 (Fed. Cir. 2018);
• x. An improved user interface for electronic devices that displays an application summary of unlaunched applications, where the particular data in the summary is selectable by a user to launch the respective application. Core Wireless Licensing S.A.R.L., v. LG Electronics, Inc., 880 F.3d 1356, 1362-63, 125 USPQ2d 1436, 1440-41 (Fed. Cir. 2018);
• xi. Specific interface and implementation for navigating complex three-dimensional spreadsheets using techniques unique to computers; Data Engine Techs., LLC v. Google LLC, 906 F.3d 999, 1009, 128 USPQ2d 1381, 1387 (Fed. Cir. 2018); and
• xii. A specific method of restricting software operation within a license, Ancora Tech., Inc. v. HTC America, Inc., 908 F.3d 1343, 1345-46, 128 USPQ2d 1565, 1567 (Fed. Cir. 2018).

It is important to note that in order for a method claim to improve computer functionality, the broadest reasonable interpretation of the claim must be limited to computer implementation. That is, a claim whose entire scope can be performed mentally, cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit into a hardware component description of a logic circuit was found to be ineligible because the method did not employ a computer and a skilled artisan could perform all the steps mentally). Similarly, a claimed process covering embodiments that can be performed on a computer, as well as embodiments that can be practiced verbally or with a telephone, cannot improve computer technology. See RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1328, 122 USPQ2d 1377, 1381 (Fed. Cir. 2017) (process for encoding/decoding facial data using image codes assigned to particular facial features held ineligible because the process did not require a computer).

Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality:

• i. Generating restaurant menus with functionally claimed features, Ameranth, 842 F.3d at 1245, 120 USPQ2d at 1857;
• ii. Accelerating a process of analyzing audit log data when the increased speed comes solely from the capabilities of a general-purpose computer, FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016);
• iii. Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a loan-application process by enabling borrowers to avoid physically going to or calling each lender and filling out a loan application, LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential);
• iv. Recording, transmitting, and archiving digital images by use of conventional or generic technology in a nascent but well-known environment, without any assertion that the invention reflects an inventive solution to any problem presented by combining a camera and a cellular telephone, TLI Communications, 823 F.3d at 611-12, 118 USPQ2d at 1747;
• v. Affixing a barcode to a mail object in order to more reliably identify the sender and speed up mail processing, without any limitations specifying the technical details of the barcode or how it is generated or processed, Secured Mail Solutions, LLC v. Universal Wilde, Inc., 873 F.3d 905, 910-11, 124 USPQ2d 1502, 1505-06 (Fed. Cir. 2017);
• vi. Instructions to display two sets of information on a computer display in a non-interfering manner, without any limitations specifying how to achieve the desired result, Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1344-45, 127 USPQ2d 1553, 1559-60 (Fed. Cir. 2018);
• vii. Providing historical usage information to users while they are inputting data, in order to improve the quality and organization of information added to a database, because "an improvement to the information stored by a database is not equivalent to an improvement in the database’s functionality," BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281, 1287-88, 127 USPQ2d 1688, 1693-94 (Fed. Cir. 2018); and
• viii. Arranging transactional information on a graphical user interface in a manner that assists traders in processing information more quickly, Trading Technologies v. IBG LLC, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019).

The courts have also found that improvements in technology beyond computer functionality may demonstrate patent eligibility. In McRO, the Federal Circuit held claimed methods of automatic lip synchronization and facial expression animation using computer-implemented rules to be patent eligible under 35 U.S.C. 101, because they were not directed to an abstract idea. McRO, 837 F.3d at 1316, 120 USPQ2d at 1103. The basis for the McRO court's decision was that the claims were directed to an improvement in computer animation and thus did not recite a concept similar to previously identified abstract ideas. Id. The court relied on the specification's explanation of how the claimed rules enabled the automation of specific animation tasks that previously could not be automated. 837 F.3d at 1313, 120 USPQ2d at 1101. The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process. 837 F.3d at 1314, 120 USPQ2d at 1102. The McRO court also noted that the claims at issue described a specific way (use of particular rules to set morph weights and transitions through phonemes) to solve the problem of producing accurate and realistic lip synchronization and facial expressions in animated characters, rather than merely claiming the idea of a solution or outcome, and thus were not directed to an abstract idea. 837 F.3d at 1313, 120 USPQ2d at 1101.

Consideration of improvements is relevant to the eligibility analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management v. CellzDirect, Inc., 827 F.3d 1042, 119 USPQ2d 1370 (Fed. Cir. 2016), in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural. Notably, the court did not distinguish between the types of technology when determining the invention improved technology. However, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.

Examples that the courts have indicated may be sufficient to show an improvement in existing technology include:

• i. Particular computerized method of operating a rubber molding press, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 8 and 10 (1981);
• ii. New telephone, server, or combination thereof, TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 612, 118 USPQ2d 1744, 1747 (Fed. Cir. 2016);
• iii. An advance in the process of downloading content for streaming, Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d 1253, 1256, 120 USPQ2d 1201, 1202 (Fed. Cir. 2016);
• iv. Improved, particular method of digital data compression, DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259, 113 USPQ2d 1097, 1107 (Fed. Cir. 2014); Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016);
• v. Particular method of incorporating virus screening into the Internet, Symantec Corp., 838 F.3d at 1321-22, 120 USPQ2d at 1362-63;
• vi. Components or methods, such as measurement devices or techniques, that generate new data, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1355, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016);
• vii. Particular configuration of inertial sensors and a particular method of using the raw data from the sensors, Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017);
• viii. A specific, structured graphical user interface that improves the accuracy of trader transactions by displaying bid and asked prices in a particular manner that prevents order entry at a changed price, Trading Techs. Int’l, Inc. v. CQG, Inc., 675 Fed. App'x 1001 (Fed. Cir. 2017) (non-precedential); and
• ix. Improved process for preserving hepatocytes for later use, Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1050, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016).

To show that the involvement of a computer assists in improving the technology, the claims must recite the details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology. See MPEP § 2106.05(f) for more information about mere instructions to apply an exception.

Examples that the courts have indicated may not be sufficient to show an improvement to technology include:

• i. A commonplace business method being applied on a general purpose computer, Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1976; Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015);
• ii. Using well-known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017);
• iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;
• iv. Delivering broadcast content to a portable electronic device such as a cellular telephone, when claimed at a high level of generality, Affinity Labs of Tex. v. Amazon.com, 838 F.3d 1266, 1270, 120 USPQ2d 1210, 1213 (Fed. Cir. 2016); Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016);
• v. A general method of screening emails on a generic computer, Symantec, 838 F.3d at 1315-16, 120 USPQ2d at 1358-59;
• vi. An advance in the informational content of a download for streaming, Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d 1253, 1263, 120 USPQ2d 1201, 1208 (Fed. Cir. 2016); and
• vii. Selecting one type of content (e.g., FM radio content) from within a range of existing broadcast content types, or selecting a particular generic function for computer hardware to perform (e.g., buffering content) from within a range of well-known, routine, conventional functions performed by the hardware, Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d 1253, 1264, 120 USPQ2d 1201, 1208 (Fed. Cir. 2016).

2106.05(b)    Particular Machine [R-10.2019]

When determining whether a claim integrates a judicial exception, into a practical application in Step 2A Prong Two and whether a claim recites significantly more than a judicial exception in Step 2B, examiners should consider whether the judicial exception is applied with, or by use of, a particular machine. "The machine-or-transformation test is a useful and important clue, and investigative tool" for determining whether a claim is patent eligible under § 101. Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010).

It is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility. Id.

All claims must be evaluated for eligibility using the two-part test from Alice/Mayo. If a claim passes the Alice/Mayo test (i.e., is not directed to an exception at Step 2A, or amounts to significantly more than any recited exception in Step 2B), then the claim is eligible even if it fails the machine-or-transformation test ("M-or-T test"). Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010) (explaining that a claim may be eligible even if it does not satisfy the M-or-T test); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) ("[T]here is nothing that requires a method ‘be tied to a machine or transform an article’ to be patentable"). And if a claim fails the Alice/Mayo test (i.e., is directed to an exception at Step 2A and does not amount to significantly more than the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T test. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) ("[I]n Mayo, the Supreme Court emphasized that satisfying the machine-or-transformation test, by itself, is not sufficient to render a claim patent-eligible, as not all transformations or machine implementations infuse an otherwise ineligible claim with an 'inventive concept.'").

Examiners may find it helpful to evaluate other considerations such as the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether an element (or combination of elements) is a particular machine. For information on the definition of the term "machine," see MPEP § 2106.03.

When determining whether a machine recited in a claim provides significantly more, the following factors are relevant.

The particularity or generality of the elements of the machine or apparatus, i.e., the degree to which the machine in the claim can be specifically identified (not any and all machines). One example of applying a judicial exception with a particular machine is Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 40 USPQ 199 (1939). In this case, a mathematical formula was employed to use standing wave phenomena in an antenna system. The claim recited the particular type of antenna and included details as to the shape of the antenna and the conductors, particularly the length and angle at which they were arranged. 306 U.S. at 95-96; 40 USPQ at 203. Another example is Eibel Process, in which gravity (a law of nature or natural phenomenon) was applied by a Fourdrinier machine (which was understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web. Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923).

It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions). If applicant amends a claim to add a generic computer or generic computer components and asserts that the claim recites significantly more because the generic computer is 'specially programmed' (as in Alappat, now considered superseded) or is a 'particular machine' (as in Bilski), the examiner should look at whether the added elements integrate the exception into a practical application or provide significantly more than the judicial exception. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223-24, 110 USPQ2d 1976, 1983-84 (2014). See In re Alappat, 33 F.3d 1526, 1545 (Fed. Cir. 1994); In re Bilski, 545 F.3d 943 (Fed. Cir. 2008)

Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. See CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) ("We are not persuaded by the appellant's argument that the claimed method is tied to a particular machine because it ‘would not be necessary or possible without the Internet.’ . . . Regardless of whether "the Internet" can be viewed as a machine, it is clear that the Internet cannot perform the fraud detection steps of the claimed method"). For example, as described in MPEP § 2106.05(f), additional elements that invoke computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must "play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly").

Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) ("[N]othing in claim 3 requires an infringer to use the Internet to obtain that data. The Internet is merely described as the source of the data. We have held that mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted)). See MPEP § 2106.05(g) & (h) for more information on insignificant extra-solution activity and field of use, respectively.

2106.05(c)    Particular Transformation [R-10.2019]

Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two and whether a claim recites significantly more in Step 2B is whether the claim effects a transformation or reduction of a particular article to a different state or thing. "[T]ransformation and reduction of an article ‘to a different state or thing’ is the clue to patentability of a process claim that does not include particular machines." Bilski v. Kappos, 561 U.S. 593, 658, 95 USPQ2d 1001, 1007 (2010) (quoting Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972)). If such a transformation exists, the claims are likely to be significantly more than any recited judicial exception or to integrate any recited judicial exception into a practical application.

It is noted that while the transformation of an article is an important clue, it is not a stand-alone test for eligibility. Id.

All claims must be evaluated for eligibility using the two-part test from Alice/Mayo. If a claim passes the Alice/Mayo test (i.e., is not directed to an exception at Step 2A, or amounts to significantly more than any recited exception in Step 2B), then the claim is eligible even if it "fails" the M-or-T test. Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010) (explaining that a claim may be eligible even if it does not satisfy the M-or-T test); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) ("[T]here is nothing that requires a method ‘be tied to a machine or transform an article’ to be patentable"). And if a claim fails the Alice/Mayo test (i.e., is directed to an exception at Step 2A and does not amount to significantly more than the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T test. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) ("[I]n Mayo, the Supreme Court emphasized that satisfying the machine-or-transformation test, by itself, is not sufficient to render a claim patent-eligible, as not all transformations or machine implementations infuse an otherwise ineligible claim with an "inventive concept.").

Examiners may find it helpful to evaluate other considerations such as the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether a claim satisfies the particular transformation consideration.

An "article" includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. "Transformation" of an article means that the "article" has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Purely mental processes in which thoughts or human based actions are "changed" are not considered an eligible transformation. For data, mere "manipulation of basic mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been deemed a transformation. CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360 (Fed. Cir. 1994)).

Tilghman v. Proctor, 102 U.S. 707 (1881), provides an example of effecting a transformation of a particular article to a different state or thing. In that case, the claim was directed to a process of subjecting a mixture of fat and water to a high degree of heat and included additional parameters relating to the level of heat, the quantities of fat and water, and the strength of the mixing vessel. The claimed process, which used the natural principle that the elements of neutral fat require that they be severally united with an atomic equivalent of water in order to separate and become free, resulted in the transformation of the fatty bodies into fat acids and glycerine. Id. at 729.