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706.03(a) Rejections Under 35 U.S.C. 101 [R-9]

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 prohibition of "double patenting."

II. SUBJECT MATTER ELIGIBILITY

A claimed invention must fall within one of the four categories of invention recited in 35 U.S.C. 101: process, machine, manufacture, or composition of matter, as these categories have been interpreted by the courts. Additionally, a claimed invention must not be directed to one of the judicially recognized exceptions, which have been specifically excluded from patent eligibility by the courts. These judicially recognized exceptions include scientific truths, abstract principles, abstract intellectual concepts, laws of nature, natural phenomena, abstract ideas, mental processes, processes of human thinking, and systems that depend for their operation on human intelligence alone. These have been collectively referred to as laws of nature, natural phenomena, or abstract ideas, but encompass the basic tools of scientific and technological work.

See MPEP § 2105 for patent eligibility of living subject matter and MPEP § 2106 for guidelines pertaining to subject matter eligibility in general.

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 through 7.05.03 to reject under 35 U.S.C. 101 for failure to claim eligible subject matter and for failure to satisfy the utility requirement.

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

¶ 7.04.01 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 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, Non-Statutory, Inoperative)

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

Examiner Note:

1. This form paragraph must be followed by one or more of form paragraphs - 7.05.01, 7.05.011, 7.05.012, 7.05.013, 7.05.02, 7.05.03, or another appropriate reason.

2. Explain the rejection following the recitation of the statute and the use of form paragraph(s) or other reason.

3. See MPEP §§ 706.03(a) and 2105- 2107.03 for other situations.

4. This form paragraph must be preceded by form paragraph 7.04 in first actions and final rejections.

¶ 7.05.01 Rejection, 35 U.S.C. 101, Non-Statutory

the claimed invention is directed to non-statutory subject matter because [1]

Examiner Note:

1. In bracket 1, explain why the claimed invention is not patent eligible subject matter, e.g.,

(a) why the claimed invention 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 is directed to a signal per se, a contract between two parties, or a human being; or

(b) why the claimed invention, although nominally falling within at least one of the four eligible categories, is directed to a judicial exception to 35 U.S.C. 101 (i.e., an abstract idea, natural phenomenon, or law of nature); or

(c) why the claimed invention would impermissibly cover every substantial practical application of, and thereby preempt all use of, an abstract idea, natural phenomenon, or law of nature.

2. For a claim that is directed to an abstract idea and is non-statutory, use form paragraph 7.05.011.

¶ 7.05.011 Rejection, 35 U.S.C. 101, Non-Statutory Method (Abstract Idea)

the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, claim(s) [1] is/are determined to be directed to an abstract idea. The rationale for this determination is explained below: [2]

Examiner Note:

1. This form paragraph should only be used when rejecting method claim(s) directed to an abstract idea.

2. In bracket 2, identify the decisive factors weighing against patent eligibility under 35 U.S.C. 101, and explain the manner in which these factors support a conclusion of patent ineligibility under 35 U.S.C. 101. For instance, that additional limitations are no more than a field of use or merely involve insignificant extrasolution activity; e.g., data gathering. The explanation needs to be sufficient to establish a prima facie case of patent ineligibility under 35 U.S.C. 101.

¶ 7.05.012 Dependent Claim(s) - Rejection, 35 U.S.C. 101, Non-Statutory Method (Abstract Idea)

Dependent claim(s) [1] when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea, as detailed below: [2]

Examiner Note:

1. This form paragraph should only be used when rejecting dependent method claim(s) directed to an abstract idea.

2. In bracket 2, provide an explanation as to why the claim(s) is/are directed to an abstract idea; for instance, that the additional limitations are no more than a field of use or merely involve insignificant extrasolution activity; e.g., data gathering. The explanation needs to be sufficient to establish a prima facie case of patent ineligibility under 35 U.S.C. 101.

¶ 7.05.013 Rejection, 35 U.S.C. 101, Non-Statutory Method (Law of Nature)

the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) [1] is/are determined to be directed to a law of nature/natural principle. The rationale for this determination is explained below: [2]

Examiner Note:

1. This form paragraph should only be used when rejecting method claim(s) that have a law of nature/natural principle as a claim limitation.

2. In bracket 2, identify the natural principle that is the limiting feature in the claim, and explain why the additional elements or steps in the claim do not integrate the natural principle into the method and/or why the additional elements or steps in the claim are not sufficient to ensure that the claim amounts to significantly more than the natural principle itself. For instance, the additional elements or steps can be shown to be extrasolution activity or mere field of use that impose no meaningful limit on the performance of the method or can be shown to be no more than well-understood, purely conventional, and routinely taken by others in order to apply the natural principle. The explanation needs to be sufficient to establish a prima facie case of patent ineligibility under 35 U.S.C. 101.

¶ 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, 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, first paragraph. Specifically, since 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, 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:

(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.