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706.03(a) Rejections Under 35 U.S.C. 101 [R-08.2017]

Patents are not granted for all new and useful inventions and discoveries. 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."

I. DOUBLE PATENTING

35 U.S.C. 101 prevents two patents issuing on the same invention to the same applicant. The "same invention" means that identical subject matter is being claimed. 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 Chapter 800 , specifically MPEP § 804 for criteria relevant to the doctrine of "double patenting."

II. SUBJECT MATTER ELIGIBILITY

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 categories of invention recited 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 to 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. _, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013)). See also Bilski v. Kappos, 561 U.S. 593, 601, 130 S. Ct. 3218, 3225, 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 also MPEP § 2105 for more information about claiming living subject matter, as well as the prohibition against claiming human organisms.

Use form paragraphs 7.04.01 and 7.05.01 for rejections based on a failure to claim an invention that falls within the statutory categories of invention. Use form paragraphs 7.04.01 and 7.05.015 for rejections based on a failure to claim an invention that is directed to patent-eligible subject matter. Use form paragraph 7.04.03 for rejections based on a claim directed to or encompassing a human organism.

Eligible subject matter is further limited by the Atomic Energy Act explained in MPEP § 706.03(b), 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.

III. UTILITY

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.

Use form paragraphs 8.30, 8.31 and 8.32 for statutory double patenting rejections. Use form paragraphs 7.04.01 and 7.05.02 through 7.05.04 to reject under 35 U.S.C. 101 for failure to satisfy the utility requirement.

IV. IMPROPER NAMING OF INVENTOR

Although the AIA eliminated pre-AIA 35 U.S.C. 102(f), the patent laws still require the naming of the actual inventor or joint inventors of the claimed subject matter. See 35 U.S.C. 115(a). The Office presumes that the named inventor or joint inventors in the application are the actual inventor or joint inventors of the claimed invention. See MPEP § 2137.01. Where an application has an incorrect inventorship, the applicant should submit a request to correct inventorship under 37 CFR 1.48. In the rare situation 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 35 U.S.C. 115 (and pre-AIA 35 U.S.C. 102(f) for applications subject to pre-AIA 35 U.S.C. 102 ). Use Form Paragraph 7.04.02.aia to reject under 35 U.S.C. 101 and 115 for failing to set forth the correct inventorship.

¶ 7.04.101.aia Statement of Statutory Bases, 35 U.S.C. 101 and 35 U.S.C. 115— Improper Inventorship

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.

35 U.S.C. 115(a) reads as follows (in part):

An application for patent that is filed under section 111(a) or commences the national stage under section 371 shall include, or be amended to include, the name of the inventor for any invention claimed in the application.

The present application sets forth the incorrect inventorship because [1].

Examiner Note:

1. If form paragraph 7.04.01 is already being used for a rejection that is not based on improper inventorship, then in lieu of this form paragraph, use form paragraph 7.04.102.aia with form paragraph 7.04.01 for a rejection based on improper inventorship.

2. In bracket 1, insert the basis for concluding that the inventorship is incorrect.

3. This form paragraph must be followed by form paragraph 7.04.02.aia.

¶ 7.04.102.aia Statement of Statutory Basis, 35 U.S.C. 115— Improper Inventorship

35 U.S.C. 115(a) reads as follows (in part):

The present application sets forth the incorrect inventorship because [1].

Examiner Note:

1. This form paragraph is to be used ONLY when a rejection under 35 U.S.C. 101 on another basis has been made and the statutory text thereof is already present.

2. This form paragraph must be preceded by form paragraph 7.04.01 for a rejection based on improper inventorship.

3. In bracket 1, insert an explanation of the supporting evidence establishing that an improper inventor is named.

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

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

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.

¶ 7.04.02.aia Rejection, 35 U.S.C. 101/115

Claim [1] rejected under 35 U.S.C. 101 and 35 U.S.C. 115 for failing to set forth the correct inventorship for the reasons stated above.

Examiner Note:

1. In bracket 1, pluralize "Claim" if necessary, insert "is" or "are" as appropriate, and insert the claim number(s) which are under rejection.

2. This rejection must be preceded by either form paragraph 7.04.101.aia or 7.04.102.aia.

¶ 7.04.03 Human Organism

Section 33(a) of the America Invents Act reads as follows

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

Claim [1] rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101 ). [2]

Examiner Note:

1. This paragraph must be preceded by form paragraph 7.04.01 which quotes 35 U.S.C. 101.

2. In bracket 1, pluralize "Claim" if necessary, insert claim number(s), and insert "is" or "are" as appropriate.

3. In bracket 2, explain why the claim is interpreted to read on a human organism.

¶ 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, 7.05.015, 7.05.02, 7.05.03, or another appropriate reason.

3. See MPEP §§ 706.03(a) and 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 (i.e., a law of nature, a natural phenomenon, or an abstract idea) and is nonstatutory, use form paragraph 7.05.015.

¶ 7.05.015 Rejection, 35 U.S.C. 101, Nonstatutory (Directed to a Judicial Exception without Significantly More)

the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) [1] is/are directed to [2]. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because [3].

Examiner Note:

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

2. This form paragraph is for use with all claims, including product (machine, manufacture, and composition of matter) and process claims, and for any type of judicial exception.

3. In bracket 1, identify the claim or claims that recite the judicial exception.

4. In bracket 2, identify the exception by referring to how it is recited (set forth or described) in the claim and explain why it is considered an exception. For example, "the Arrhenius equation, which is a law of nature in the form of a mathematical algorithm" or "the series of steps instructing how to hedge risk, which is a fundamental economic practice and thus an abstract idea." For products of nature, explain how the 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, identify the additional elements and explain why, when considered separately and in combination, they do not add significantly more to the exception. 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 would be routine in any computer implementation, or if the claim is directed to a method of using a naturally occurring correlation explain that steps for routine data gathering in order to test for the correlation do not add a meaningful limitation to the method as they would be routinely used by those of ordinary skill in the art in order to apply the correlation.

¶ 7.05.02 Rejection, 35 U.S.C. 101, Utility Lacking

the claimed invention lacks patentable utility. [1]

Examiner Note:

In bracket 1, provide explanation of lack of utility. See MPEP §§ 706.03(a) and 2105 - 2107.03.

¶ 7.05.03 Rejection, 35 U.S.C. 101, Inoperative

the disclosed invention is inoperative and therefore lacks utility. [1]

Examiner Note:

In bracket 1, explain why invention is inoperative.

¶ 7.05.04 Utility Rejections Under 35 U.S.C. 101 and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), First Paragraph

Claim [1] rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a [2] asserted utility or a well established utility.

[3]

Claim [4] also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a [5] asserted utility or a well established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.

Examiner Note:

1. Where the specification would not enable one skilled in the art to make the claimed invention, or where alternative reasons support the enablement rejection, a separate rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, enablement should be made using the factors set forth in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) and an undue experimentation analysis. See MPEP §§ 2164 - 2164.08(c).

2. Use Format A, B, or C below as appropriate.

Format A:

(a) Insert the same claim numbers in brackets 1 and 4.
(b) Insert --specific and substantial-- in inserts 2 and 5.
(c) In bracket 3, insert the explanation as to why the claimed invention is not supported by either a specific and substantial asserted utility or a well established utility.
(d) Format A is to be used when there is no asserted utility and when there is an asserted utility but that utility is not specific and substantial.

Format B:

(a) Insert the same claim numbers in brackets 1 and 4.
(b) Insert --credible-- in inserts 2 and 5.
(c) In bracket 3, insert the explanation as to why the claimed invention is not supported by either a credible asserted utility or a well established utility.

Format C:

For claims that have multiple utilities, some of which are not specific and substantial, some of which are not credible, but none of which are specific, substantial and credible:
- (a) Insert the same claim numbers in brackets 1 and 4.
- (b) Insert --specific and substantial asserted utility, a credible-- in inserts 2 and 5.
- (c) In bracket 3, insert the explanation as to why the claimed invention is not supported by either a specific and substantial asserted utility, a credible asserted utility or a well established utility. Each utility should be addressed.