2106.07    Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility [R-10.2019]

Eligibility rejections must be based on failure to comply with the substantive law under 35 U.S.C. 101  as interpreted by judicial precedent. The substantive law on eligibility is discussed in MPEP §§ 2106.03 through 2106.06. Examination guidance, training, and explanatory examples discuss the substantive law and establish the policies and procedures to be followed by examiners in evaluating patent applications for compliance with the substantive law, but do not serve as a basis for a rejection. Accordingly, while it would be acceptable for applicants to cite training materials or examples in support of an argument for finding eligibility in an appropriate factual situation, applicants should not be required to model their claims or responses after the training materials or examples to attain eligibility.

When evaluating a claimed invention for compliance with the substantive law on eligibility, examiners should review the record as a whole (e.g., the specification, claims, the prosecution history, and any relevant case law precedent or prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. The evaluation of whether the claimed invention qualifies as patent-eligible subject matter should be made on a claim-by-claim basis, because claims do not automatically rise or fall with similar claims in an application. For example, even if an independent claim is determined to be ineligible, the dependent claims may be eligible because they add limitations that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception recited in the independent claim. And conversely, even if an independent claim is determined to be eligible, a dependent claim may be ineligible because it adds a judicial exception without also adding limitations that integrate the judicial exception or provide significantly more. Thus, each claim in an application should be considered separately based on the particular elements recited therein.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claim as a whole does not satisfy both criteria for eligibility (Step 1: NO and/or Step 2B: NO), then examiners should formulate an appropriate rejection of that claim under Step 1 and/or Step 2B. The rejection should set forth a prima facie case of ineligibility under the substantive law. The concept of the prima facie case is a procedural tool of patent examination, which allocates the burdens going forward between the examiner and applicant. In particular, the initial burden is on the examiner to explain why a claim or claims are ineligible for patenting clearly and specifically, so that applicant has sufficient notice and is able to effectively respond.

When an examiner determines a claim does not fall within a statutory category (Step 1: NO), the rejection should provide an explanation of why the claim does not fall within one of the four statutory categories of invention. See MPEP § 2106.03 for a discussion of Step 1 and the statutory categories of invention.

When an examiner determines that a claim is directed to a judicial exception (Step 2A: YES) and does not provide an inventive concept (Step 2B: NO), the rejection should provide an explanation for each part of the Step 2 analysis. For example, the rejection should identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception, identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception, and explain the reason(s) that the additional elements taken individually, and also taken as a combination, 1) do not integrate the judicial exception into a practical application and 2) do not result in the claim as a whole amounting to significantly more than the judicial exception. See MPEP § 2106.04 et seq. for a discussion of Step 2A and the judicial exceptions, MPEP § 2106.05 et seq. for a discussion of Step 2B and the search for an inventive concept, and MPEP § 2106.07(a) for more information on formulating an ineligibility rejection.

If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claimed invention falls within a statutory category (Step 1: YES) and is either not directed to a judicial exception (Step 2A: NO) or is directed to a judicial exception and amounts to significantly more than the judicial exception (Step 2B: YES), then the examiner should not reject the claim. When evaluating a response by applicant to a subject matter eligibility rejection, examiners must carefully consider all of applicant’s arguments and evidence presented to rebut the rejection. If applicant properly challenges the examiner’s findings, the rejection should be withdrawn or, if the examiner deems it appropriate to maintain the rejection, a rebuttal must be provided in the next Office action. This is discussed in greater detail in MPEP § 2106.07(b).

2106.07(a)    Formulating a Rejection For Lack of Subject Matter Eligibility [R-10.2019]

After determining what the applicant invented and establishing the broadest reasonable interpretation of the claimed invention (see MPEP § 2111), the eligibility of each claim should be evaluated as a whole using the analysis detailed in MPEP § 2106. If it is determined that the claim does not recite eligible subject matter, a rejection under 35 U.S.C. 101  is appropriate. When making the rejection, the Office action must provide an explanation as to why each claim is unpatentable, which must be sufficiently clear and specific to provide applicant sufficient notice of the reasons for ineligibility and enable the applicant to effectively respond.

Subject matter eligibility rejections under Step 1 are discussed in MPEP § 2106.03.

A subject matter eligibility rejection under Step 2 should provide an explanation for each part of the Step 2 analysis:

  • • For Step 2A Prong One, the rejection should identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception. For example, if the claim is directed to an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim and explain why it is an abstract idea. Similarly, if the claim is directed to a law of nature or a natural phenomenon, the rejection should identify the law of nature or natural phenomenon as it is recited (i.e., set forth or described) in the claim and explain using a reasoned rationale why it is considered a law of nature or natural phenomenon.
  • • For Step 2A Prong Two, the rejection should identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception; and evaluate the integration of the judicial exception into a practical application by explaining that 1) there are no additional elements in the claim; or 2) the claim as a whole, looking at the additional elements individually and in combination, does not integrate the judicial exception into a practical application using the considerations set forth in MPEP §§ 2106.04(d), 2106.05(a)- (c) and (e)- (h). Examiners should give weight to all of the claimed additional elements in Prong Two, even if those elements represent well-understood, routine, conventional activity.
  • • For Step 2B, the rejection should explain why the additional elements, taken individually and in combination, do not result in the claim, as a whole, amounting to significantly more than the identified judicial exception. For instance, when the examiner has concluded that certain claim elements recite well understood, routine, conventional activities in the relevant field, the examiner must expressly support the rejection in writing with one of the four options specified in Subsection III.

Under the principles of compact prosecution, regardless of whether a rejection under 35 U.S.C. 101  is made based on lack of subject matter eligibility, 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. Thus, examiners should state all non-cumulative reasons and bases for rejecting claims in the first Office action.

I.    WHEN MAKING A REJECTION, IDENTIFY AND EXPLAIN THE JUDICIAL EXCEPTION RECITED IN THE CLAIM (STEP 2A PRONG ONE)

A subject matter eligibility rejection should point to the specific claim limitation(s) that recites (i.e., sets forth or describes) the judicial exception. The rejection must explain why those claim limitations set forth or describe a judicial exception (e.g., a law of nature). Where the claim describes, but does not expressly set forth, the judicial exception, the rejection must also explain what subject matter those limitations describe, and why the described subject matter is a judicial exception. See MPEP § 2106.04 for more information about Step 2A of the eligibility analysis.

When the examiner has determined the claim recites an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim, and explain why it falls within one of the groupings of abstract ideas (i.e., mathematical concepts, mental processes, or certain methods of organizing human activity) enumerated in MPEP § 2106.04(a)(2). Alternatively, the examiner should provide justification for why a specific limitation(s) recited in the claim is being treated as an abstract idea if it does not fall within the groupings of abstract ideas in accordance with the "tentative abstract idea" procedure (see MPEP § 2106.04, subsection (IV)). While not required, this explanation or justification may include citing to an appropriate court decision that supports the identification of the subject matter recited in the claim language as an abstract idea within one of the groupings. Examiners should be familiar with any cited decision relied upon in making or maintaining a rejection to ensure that the rejection is reasonably tied to the facts of the case and to avoid relying upon language taken out of context. Examiners should not go beyond those concepts that are enumerated as abstract ideas in MPEP § 2106.04, unless they are identifying a tentative abstract idea in the claim, and should avoid relying upon or citing non-precedential decisions unless the facts of the application under examination uniquely match the facts at issue in the non-precedential decisions. Examiners are reminded that a chart of court decisions is available on the USPTO’s Internet website (www.uspto.gov/ PatentEligibility ).

Sample explanation: The claim recites the step of comparing collected information to a predefined threshold, which is an act of evaluating information that can be practically performed in the human mind. Thus, this step is an abstract idea in the "mental process" grouping.

When the examiner has determined the claim recites a law of nature or a natural phenomenon, the rejection should identify the law of nature or natural phenomenon as it is recited (i.e., set forth or described) in the claim and explain using a reasoned rationale why it is considered a law of nature or natural phenomenon. See MPEP § 2106.04(b) for more information about laws of nature and natural phenomena.

Sample explanation: The claim recites the correlation of X, and X is a law of nature because it describes a consequence of natural processes in the human body, e.g., the naturally-occurring relationship between the presence of Y and the manifestation of Z.

Sample explanation: The claim recites X, which is a natural phenomenon because it occurs in nature and exists in principle apart from any human action.

When the examiner has determined the claim recites a product of nature, the rejection should identify the exception as it is recited (i.e., set forth or described) in the claim, and explain using a reasoned rationale why the product does not have markedly different characteristics from its naturally occurring counterpart in its natural state. See MPEP § 2106.04(b) for more information about products of nature, and MPEP § 2106.04(c) for more information about the markedly different characteristics analysis.

Sample explanation: The claim recites X, which as explained in the specification was isolated from naturally occurring Y. X is a nature-based product, so it is compared to its closest naturally occurring counterpart (X in its natural state) to determine if it has markedly different characteristics. Because there is no indication in the record that isolation of X has resulted in a marked difference in structure, function, or other properties as compared to its counterpart, X is a product of nature exception.

II.    WHEN MAKING A REJECTION, EXPLAIN WHY THE ADDITIONAL CLAIM ELEMENTS DO NOT RESULT IN THE CLAIM AS A WHOLE INTEGRATING THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION OR AMOUNTING TO SIGNIFICANTLY MORE THAN THE JUDICIAL EXCEPTION (STEP 2A PRONG TWO AND STEP 2B)

After identifying the judicial exception in the rejection, identify any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception and explain why they do not integrate the judicial exception into a practical application and do not add significantly more to the exception. The explanation should address the additional elements both individually and as a combination when determining whether the claim as whole recites eligible subject matter. It is important to remember that a new combination of steps in a process may be patent eligible even though all the steps of the combination were individually well known and in common use before the combination was made. Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ 1, 9 (1981). Thus, it is particularly critical to address the combination of additional elements, because while individually-viewed elements may not appear to integrate an exception into a practical application or add significantly more, those additional elements when viewed in combination may amount to significantly more than the exception by meaningfully limiting the judicial exception. See MPEP § 2106.05 for more information about Step 2B of the eligibility analysis.

A rejection should be made only if it is readily apparent to an examiner relying on the examiner's expertise in the art in the Step 2A Prong Two inquiry and Step 2B inquiry that the additional elements do not integrate the exception into a practical application and do not amount to claiming significantly more than the recited judicial exception. When making a rejection, it is important for the examiner to explain the rationale underlying the conclusion so that applicant can effectively respond. On the other hand, when appropriate, the examiner should explain why the additional elements integrate an exception into a practical application or provide an inventive concept by adding a meaningful limitation to the claimed exception. See MPEP §§ 2106.04(d) and 2106.05 for a listing of considerations that qualify, and to not qualify, as integrating an exception or providing significantly more than an exception , and MPEP § 2106.07(c) for more information on clarifying the record when a claim is found eligible.

In the Step 2B inquiry, if the examiner has concluded that particular claim limitations are well understood, routine, conventional activities (or elements) to those in the relevant field, the rejection should support this conclusion in writing with a factual determination in accordance with Subsection III below. See MPEP § 2106.05(d) for more information about well understood, routine, conventional activities and elements, and Subsection III below for more information about how to support a conclusion that a claim limitation is well understood, routine, conventional activity.

For claim limitations that recite a generic computer component performing generic computer functions at a high level of generality, such as using the Internet to gather data, examiners can explain why these generic computing functions do not meaningfully limit the claim. Examiners should keep in mind that the courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic. DDR Holdings, LLC v. Hotels.com, LP, 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See MPEP § 2106.05(f) for more information about generic computing functions that the courts have found to be mere instructions to implement a judicial exception on a computer, and MPEP § 2106.05(d) for more information about well understood, routine, conventional activities and elements (a relevant consideration only in Step 2B).

For claim limitations that add insignificant extra-solution activity to the judicial exception (e.g., mere data gathering in conjunction with a law of nature or abstract idea), or that generally link the use of the judicial exception to a particular technological environment or field of use, examiners should explain why they do not meaningfully limit the claim. For example, adding a final step of storing data to a process that only recites computing the area of a two dimensional space (a mathematical relationship) does not add a meaningful limitation to the process of computing the area. As another example, employing well-known computer functions to execute an abstract idea, even when limiting the use of the idea to one particular environment, does not integrate the exception into a practical application or add significantly more, similar to how limiting the computer implemented abstract idea in Flook to petrochemical and oil-refining industries was insufficient. See e.g., Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (limiting use of mathematical formula to use in particular industries did not amount to an inventive concept). See MPEP § 2106.05(g) for more information about insignificant extra-solution activity, and MPEP § 2106.05(h) for more information about generally linking use of a judicial exception to a particular technological environment or field of use.

In the event a rejection is made, it is a best practice for the examiner to consult the specification to determine if there are elements that could be added to the claim to make it eligible. If so, the examiner should identify those elements in the Office action and suggest them as a way to overcome the rejection.

III.    EVIDENTIARY REQUIREMENTS IN MAKING A § 101 REJECTION

The courts consider the determination of whether a claim is eligible (which involves identifying whether an exception such as an abstract idea is being claimed) to be a question of law. Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1047, 119 USPQ2d 1370, 1372 (Fed. Cir. 2016); OIP Techs. v. Amazon.com, 788 F.3d 1359, 1362, 115 USPQ2d 1090, 1092 (Fed. Cir. 2015); DDR Holdings v. Hotels.com, 773 F.3d 1245, 1255, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014); In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335, 110 USPQ2d 1668, 1670 (Fed. Cir. 2014); 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). Thus, the court does not require "evidence" that a claimed concept is a judicial exception, and generally decides the legal conclusion of eligibility without resolving any factual issues. FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1097, 120 USPQ2d 1293, 1298 (Fed. Cir. 2016) (citing Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1373, 118 USPQ2d 1541, 1544 (Fed. Cir. 2016)); OIP Techs., 788 F.3d at 1362, 115 USPQ2d at 1092; Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1349, 113 USPQ2d 1354, 1359 (Fed. Cir. 2014). In some cases, however, the courts have characterized the issue of whether additional elements are well-understood, routine, conventional activity as an underlying factual issue upon which the legal conclusion of eligibility may be based. See, e.g., Interval Licensing LLC v. AOL, Inc., 896 F.3d. 1335, 1342, 127 USPQ2d 1553, 1557 (Fed. Cir. 2018) (patent eligibility is a question of law that may contain underlying issues of fact), Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018) (issue of whether additional elements are well-understood, routine, conventional activity is factual).

When performing the analysis at Step 2A Prong One, it is sufficient for the examiner to provide a reasoned rationale that identifies the judicial exception recited in the claim and explains why it is considered a judicial exception (e.g., that the claim limitation(s) falls within one of the abstract idea groupings). Therefore, there is no requirement for the examiner to rely on evidence, such as publications or an affidavit or declaration under 37 CFR 1.104(d)(2), to find that a claim recites a judicial exception. Cf. Affinity Labs of Tex., LLC v. Amazon.com Inc., 838 F.3d 1266, 1271-72, 120 USPQ2d 1210, 1214-15 (Fed. Cir. 2016) (affirming district court decision that identified an abstract idea in the claims without relying on evidence); OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362-64, 115 USPQ2d 1090, 1092-94 (Fed. Cir. 2015) (same); Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357-58 (Fed. Cir. 2014) (same).

At Step 2A Prong Two or Step 2B, there is no requirement for evidence to support a finding that the exception is not integrated into a practical application or that the additional elements do not amount to significantly more than the exception unless the examiner asserts that additional limitations are well-understood, routine, conventional activities in Step 2B.

Examiners should not assert that an additional element (or combination of elements) is well-understood, routine, or conventional unless the examiner finds, and expressly supports the rejection in writing with one or more of the following:

  • (A) A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s). A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element.
  • (B) A citation to one or more of the court decisions discussed in MPEP § 2106.05(d), subsection II, as noting the well-understood, routine, conventional nature of the additional element(s). Examiners should be careful to ensure the claim limitations before the examiner are the same as those found to be well-understood, routine, conventional by the courts. The additional elements under examination should be recited in the same manner, meaning they should be recited at the same high level of generality as in those court decisions. It is not enough that the additional elements are similar to the elements at issue in those cases. In addition, the court decisions discussed in MPEP § 2106.05(d), subsection II, are not meant to imply that all computer functions are well-understood, routine, conventional functions, or that a claim reciting a generic computer component performing a generic computer function is necessarily ineligible. Examiners should keep in mind that the courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic. DDR Holdings, LLC v. Hotels.com, LP, 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See MPEP § 2106.05(f) for more information about generic computing functions that the courts have found to be mere instructions to implement a judicial exception on a computer.
  • (C) A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s). An appropriate publication could include a book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. It does not include all items that might otherwise qualify as a "printed publication" as used in 35 U.S.C. 102. Whether something is disclosed in a document that is considered a "printed publication" under 35 U.S.C. 102  is a distinct inquiry from whether something is well-known, routine, conventional activity. A document may be a printed publication but still fail to establish that something it describes is well-understood, routine, conventional activity. See Exergen Corp. v. Kaz USA, 725 Fed. App’x. at 959, 966 (Fed. Cir. 2018) (the single copy of a thesis, written in German and located in a German university library, considered to be a "printed publication" in In re Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986) "would not suffice to establish that something is 'well-understood, routine, and conventional activity previously engaged in by scientists who work in the field'"). The nature of the publication and the description of the additional elements in the publication would need to demonstrate that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a). For example, while U.S. patents and published applications are publications, merely finding the additional element in a single patent or published application would not be sufficient to demonstrate that the additional element is well-understood, routine, conventional, unless the patent or published application demonstrates that the additional element is widely prevalent or in common use in the relevant field.
  • (D) A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). This option should be used only when examiners are certain, based upon their personal knowledge, that the additional element(s) represents well-understood, routine, conventional activity engaged in by those in the relevant art, in that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a). For example, the examiner could take official notice that a generic computer component performing generic computer functions at a high level of generality, such as using the Internet to gather data, is well-understood, routine, conventional. Procedures for taking official notice and addressing an applicant’s challenge to official notice are discussed in MPEP § 2144.03.

2106.07(a)(1)    Form Paragraphs for use in Lack of Subject Matter Eligibility Rejections [R-10.2019]

Use form paragraphs 7.04.01, 7.05, and 7.05.01 for rejections based on a failure to claim an invention that falls within the statutory categories of invention (i.e., the claim is not to one of the four statutory categories of invention and is thus rejected at Step 1 of the eligibility analysis).

Use form paragraphs 7.04.01, 7.05, and 7.05.016 for rejections based on a failure to claim an invention that is directed to patent-eligible subject matter, i.e., the claim is directed to a judicial exception without providing an inventive concept/significantly more, and is thus rejected at Step 2B of the eligibility analysis. If the judicial exception to which the claim is directed is a "tentative abstract idea," i.e., an abstract idea that does not fall within any of the groupings of abstract ideas discussed in MPEP § 2106.04(a)(2), then the Step 2B rejection must also use form paragraph 7.05.017 (in addition to form paragraphs 7.04.01, 7.05, and 7.05.016) and include the TC Director's signature.

¶ 7.04.01    Statement of Statutory Basis, 35 U.S.C. 101

35 U.S.C. 101 reads as follows:

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.

Examiner Note:

This form paragraph must precede the first use of 35 U.S.C. 101  in all first actions on the merits and final rejections.  

¶ 7.05    Rejection, 35 U.S.C. 101, -Heading Only- (Utility, Nonstatutory, Inoperative)

Claim [1] rejected under 35 U.S.C. 101  because

Examiner Note:

1. This form paragraph must be preceded by form paragraph 7.04.01 in first actions and final rejections.

2. This form paragraph must be followed by a detailed explanation of the grounds of rejection using one or more of form paragraphs 7.05.01, 7.05.016, 7.05.017, 7.05.02, 7.05.03, or another appropriate reason.

3. See MPEP §§ 2105 - 2107.03 for additional guidance.

¶ 7.05.01    Rejection, 35 U.S.C. 101, Nonstatutory (Not One of the Four Statutory Categories)

the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because [1]

Examiner Note:

1. This form paragraph should be preceded by form paragraph 7.05.

2. In bracket 1, explain why the claimed invention is not patent eligible subject matter by identifying what the claim(s) is/are directed to and explain why it does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101  (process, machine, manufacture, or composition of matter), e.g., the claim(s) is/are directed to a signal per se, mere information in the form of data, a contract between two parties, or a human being (see MPEP § 2106, subsection I).

3. For a claim that is directed to a judicial exception and is nonstatutory, use form paragraph 7.05.016.

¶ 7.05.016    Rejection, 35 U.S.C. 101, Nonstatutory (Directed to a Judicial Exception without an Inventive Concept/Significantly More)

the claimed invention is directed to [1] without significantly more. The claim(s) recite(s) [2]. This judicial exception is not integrated into a practical application because [3]. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because [4].

Examiner Note:

1. This form paragraph should be preceded by form paragraph 7.05. For claims that recite a tentative abstract idea (i.e., a limitation identified as an abstract idea even though it does not fall within the groupings of abstract ideas discussed in MPEP § 2106.04(a)(2)), this form paragraph should be accompanied by form paragraph 7.05.017.

2. This form paragraph is for use with all product (machine, manufacture, and composition of matter) and process claims, and for all claims directed to a law of nature, natural phenomenon (including a product of nature), or abstract idea.

3. In bracket 1, identify whether the claim(s) are directed to a law of nature, a natural phenomenon (including a product of nature), or an abstract idea.

4. In bracket 2, identify the exception by referring to how it is recited in the claim and explain why it is considered an exception (e.g., for an abstract idea, identify the abstract idea grouping in MPEP § 2106.04(a)(2) into which the recited exception falls). For example, "the Arrhenius equation, which is a law of nature and a mathematical concept which describes the relationship between temperature and reaction rate" or "the series of steps instructing how to hedge risk, which is a fundamental economic practice and thus grouped as a certain method of organizing human interactions." For a product of nature exception, refer to how it is recited in the claim and explain why its characteristics are not markedly different from the product’s naturally occurring counterpart in its natural state. For example, "the naturally occurring DNA segment, which is not markedly different from its naturally occurring counterpart because it conveys the same genetic information." Provide additional explanation regarding the exception and how it has been identified when appropriate.

5. In bracket 3, explain why the combination of additional elements fails to integrate the judicial exception into a practical application. For example, if the claim is directed to an abstract idea with additional generic computer elements, explain that the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer; or, if the claim is directed to a method of using a naturally occurring correlation, explain that data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity. Similarly, if the claim recites a "naturally occurring DNA segment" with an additional element of a test tube, explain that merely placing the product of nature into a generic container such as a test tube does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment.

6. In bracket 4, identify the additional elements and explain why, when considered separately and in combination, they do not add significantly more (also known as an "inventive concept") to the exception. For example, if the additional limitations only store and retrieve information in memory, explain that these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d).

¶ 7.05.017    Rejection, 35 U.S.C. 101, TC Director Approval for "Tentative Abstract Idea"

The identified claim limitation(s) that recite(s) an abstract idea do/does not fall within the groupings of abstract ideas discussed in MPEP § 2106.04(a)(2), i.e., mathematical concepts, mental processes, or certain methods of organizing human activity. Nonetheless, the claim limitation(s) is/are being treated as reciting an abstract idea because [1].

This rejection has been approved by the Technology Center Director signing below.

[2]

Examiner Note:

1. This form paragraph should be preceded by form paragraph 7.05.016.

2. Approval from the TC Director is required to treat a tentative abstract idea (i.e., a claim limitation(s) that does not fall within the groupings of abstract ideas discussed in MPEP § 2106.04(a)(2)) as an abstract idea. This form paragraph should be used to demonstrate that this approval has been obtained.

3. In bracket 1, provide the justification for why the claim limitation(s) is/are being treated as an abstract idea. For example, provide an explanation of why the claim limitation is among the "basic tools of scientific and technological work."

4. In bracket 2, insert the TC Director's signature. Approval of the TC Director is required to treat a claim limitation that does not fall within the groupings of abstract ideas discussed in MPEP § 2106.04(a)(2) as reciting an abstract idea. See MPEP § 2106.04(a)(3).

2106.07(b)    Evaluating Applicant's Response [R-10.2019]

After examiners identify and explain in the record the reasons why a claim is directed to an abstract idea, natural phenomenon, or law of nature without significantly more, then the burden shifts to the applicant to either amend the claim or make a showing of why the claim is eligible for patent protection.

In response to a rejection based on failure to claim patent-eligible subject matter, applicant may: (i) amend the claim, e.g., to add additional elements or modify existing elements so that the claim as a whole amounts to significantly more than the judicial exception, (or integrates the judicial exception into a practical application), (ii) present persuasive arguments based on a good faith belief as to why the rejection is in error and/or (iii) submit evidence traversing a subject matter eligibility rejection according to the procedures set forth in MPEP § 716.01 and 37 CFR 1.132. When evaluating a response, examiners must carefully consider all of applicant's arguments and evidence rebutting the subject matter eligibility rejection. If applicant has amended the claim, examiners should determine the amended claim’s broadest reasonable interpretation and again perform the subject matter eligibility analysis.

If applicant's claim amendment(s), evidence, and/or argument(s) persuasively establish that the claim is not directed to a judicial exception or is directed to significantly more than a judicial exception, the rejection should be withdrawn. Applicant may argue that a claim is eligible because the claim as a whole integrates the judicial exception into a practical application or amounts to significantly more than the judicial exception when the additional elements are considered both individually and in combination. When an additional element is considered individually by the examiner, the additional element may be enough to integrate the judicial exception into a practical application or to qualify as "significantly more" if it meaningfully limits the judicial exception, e.g., it improves another technology or technical field, improves the functioning of a computer itself.

In addition, even if an element does not integrate a judicial exception into a practical application or amount to significantly more on its own (e.g., because it is merely a generic computer component performing generic computer functions), it can still integrate or amount to significantly more when considered in combination with the other elements of the claim. For example, generic computer components that individually perform merely generic computer functions (e.g., a CPU that performs mathematical calculations or a clock that produces time data) in some instances are able in combination to perform functions that are not generic computer functions and therefore integrate or amount to significantly more than an abstract idea (and are thus eligible).

If applicant properly challenges the examiner's findings but the examiner deems it appropriate to maintain the rejection, a rebuttal must be provided in the next Office action. Several examples of appropriate examiner responses are provided below.

  • (1) If applicant challenges the identification of a tentative abstract idea that was based on a court case and the challenge is not persuasive, an appropriate response would be an explanation as to why the abstract idea identified in the claim is similar to the concept in the cited case.
  • (2) If applicant responds to an examiner's assertion that something is well-known, routine, conventional activity with a specific argument or evidence that the additional elements in a claim are not well-understood, routine, conventional activities previously engaged in by those in the relevant art, the examiner should reevaluate whether the additional elements are in actuality well-known, routine, conventional activities to those who work in the relevant field. It is especially necessary for the examiner to fully reevaluate their position when such additional elements are not discussed in the specification as being known generic functions/components/activities or are not treated by the courts as well-understood, routine, conventional activities. If the rejection is to be maintained, the examiner should consider whether evidence should be provided to further support the rejection and clarify the record for appeal. See MPEP § 2106.05(d) for examples of elements that the courts have found to be well understood, routine and conventional activity. If the examiner has taken official notice per item (D) of subsection III above that an element(s) is well-understood, routine, conventional activity, and the applicant challenges the examiner's position, specifically stating that such element(s) is not well-understood, routine, conventional activity, the examiner must then provide one of the items discussed in paragraphs (A) through (C) of subsection III above, or an affidavit or declaration under 37 CFR 1.104(d)(2)  setting forth specific factual statements and explanation to support the examiner’s position. See also MPEP § 2106.07(b), item (2).
  • (3) If applicant amends a claim to add a generic computer or generic computer components and asserts that the claim is integrated into a practical application or 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 judicial 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, 224, 110 USPQ2d 1976, 1984 (2014). See also OIP Techs. v. Amazon.com, 788 F.3d 1359, 1364, 115 USPQ2d 1090, 1093-94 (Fed. Cir. 2015) ("Just as Diehr could not save the claims in Alice, which were directed to ‘implement[ing] the abstract idea of intermediated settlement on a generic computer’, it cannot save OIP's claims directed to implementing the abstract idea of price optimization on a generic computer.") (citations omitted).
  • (4) If applicant argues that the claim is specific and does not preempt all applications of the exception, the examiner should reconsider Step 2A of the eligibility analysis, e.g., to determine whether the claim is directed to an improvement to the functioning of a computer or to any other technology or technical field. If an examiner still determines that the claim is directed to a judicial exception, the examiner should then reconsider in Step 2B whether the additional elements in combination (as well as individually) amount to an inventive concept, e.g., because they are more than the non-conventional and non-generic arrangement of known, conventional elements. Such reconsideration is appropriate because, although preemption is not a standalone test for eligibility, it remains the underlying concern that drives the two-part framework from Alice Corp. and Mayo (Steps 2A and 2B). Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015).

2106.07(c)    Clarifying the Record [R-08.2017]

When the claims are deemed patent eligible, the examiner may make clarifying remarks on the record. For example, if a claim is found eligible because it improves upon existing technology, the examiner could reference the portion of the specification that describes the claimed improvement and note the claim elements that produce that improvement. The clarifying remarks may be made at any point during prosecution as well as with a notice of allowance.

Clarifying remarks may be useful in explaining the rationale for a rejection as well. For instance, explaining the broadest reasonable interpretation (BRI) of a claim will assist applicant in understanding and responding to a rejection. As an example, a rejection for failure to recite patent eligible subject matter in a claim to a computer readable medium could include an explanation that the broadest reasonable interpretation of the claim covers a carrier wave, which does not fall within one of the four categories of invention, and a suggestion to overcome the rejection by submitting a narrowing amendment to cover the statutory embodiments.