DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 9/11/25 is acknowledged.
Claims 10-12 and 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/11/25.
Claims 1-9, 13-15 and 19-21 are examined on the merits. Claims 20 and 21 are newly presented.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Response to Amendment
The declaration under 37 CFR 1.132 filed 2/3/26 is sufficient to overcome the rejection of claims 1, 3-7, 9, 13-15 and 19-21 based upon 35 USC 103a. Applicant’s amendment to the claims and the information provided in this specification has overcome the obviousness rejection previously raised.
Claim Objections
(Prior Objection Maintained and extended to claim 2) Claims 2 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New Rejection Necessitated by Amendments) Claims 1, 3-7, 9, 13-15 and 19-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice .... reduction to drawings .... or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 1, 3-7, 9, 13-15 and 19-21 are rejected as lacking adequate descriptive support for a generating a peptide having at least 70% sequence identity to the amino acid of SEQ ID NO: 1, wherein the peptide is a F1-ATPase activator.
The peptide can have N-terminal acetylation and/or C-terminal amidation; the peptide can be modified by attaching long-lasting molecule, such as at the C-terminus and the long-lasting molecule can be a fatty acid, PEG or Fc portion of immunoglobulin.
Additionally, the peptide is modified by attaching a palmitic acid to the C-terminus. The invention also requires a nucleotide sequence encoding the peptide, a vector comprising the peptide and an isolated host cell that comprises the nucleotide sequence or the vector.
SEQ ID NO: 1 is 31 amino acids in length. Therefore, the 70% sequence identity limitation permits 9 amino acids to be altered/mutated/deleted/inserted within SEQ ID NO: 1.
In support of the claimed genus (a peptide having at least 70% sequence identity to the amino acid of SEQ ID NO: 1, wherein the peptide is a F1-ATPase activator), the application discloses one example in which the peptide of SEQ ID NO: 1 and also exhibits a F1-ATPase activator function. This peptide can be found in formulas I and II in claim 8 and in working example 1 of the instant specification. No derivatives or variants or mutants thereof are disclosed that can achieve this function. Thus, the application fails to provide examples of any species within the claimed genus.
Further, while the claims provide both a structure and a function, other than the peptide of SEQ ID NO:1, the application fails to draw any correlation between the two. I.e., there is no evidence that any mutant of SEQ ID NO: 1 within the 70% sequence identity can still retain F1-ATPase activator function. Moreover, no correlation has been made to which portion of the 70% sequence identity to SEQ ID NO: 1 is required to be retained (i.e., unmutated) in the peptide in order to achieve the claimed F1-ATPase activator function. Lastly, the specification does not establish any additionally guidance that resolves this issue.
The teachings of the art also fail to indicate that, without such evidence, those in the art would have expected the full scope of the claimed peptide having at least 70% sequence identity to the amino acid of SEQ ID NO: 1, would confer the claimed F1-ATPase activator function. For example, a search of the art indicates that modifications to biological molecules such as proteins are unpredictable, and require experimentation regarding the relationships between alterations in sequence bases/side chains and the function and structure of the protein in order to determine the actual effects of the modifications as discussed by Bowie et al. (Science 247: 1306-10 at page 1306). Bowie et al. teach that amino acid substitutions of a protein are largely unpredictable based on research conducted with a lac repressor protein, wherein half of the mutations altered the repressor’s phenotype or function [see page 1306, right column, first full paragraph]. In addition, a small amino acid portion of the lambda repressor was subjected to amino acid substitutions, which were unpredictable with regard to maintaining protein functions. As shown in figure 1 of Bowie et al., while some amino acid positions could be highly mutated, such as positions 79, 85, 86 and 89, others could not, such as positions 76 and 84. Therefore, mutating amino acid sequences of a protein is not predictable with regard to interfering with the function of that protein.
Thus, in view of the above, there would have been significant uncertainty as to which 30% of SEQ ID NO: 1 can be mutated and be able confer the claimed a peptide having F1-ATPase activator function. In view of this uncertainty and the lack of any examples of the claimed genus, the claims are rejected for lack of adequate written description support.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(Prior Rejections Withdrawn in view of Applicant’s Amendments) Claims 2, 4, 5 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(Prior Rejection Withdrawn in view of Applicant’s Amendments) Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim Rejections - 35 USC § 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.
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.
(Prior Rejection Withdrawn in view of Applicant’s Amendments) Claims 15 and 19 are 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).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(Prior Rejection Withdrawn in view of Applicant’s Amendments) Claim(s) 1 and 2 are rejected under 35 U.S.C. 102al as being anticipated by GenBank Accession NP_001124626 (published 11/11/18).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
(Prior Rejection Withdrawn in view of Applicant’s Amendments) Claim(s) 1, 2, 4, 5, 9, 13-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Birsoy et al. (US PGPub 2015/0065556) and GenBank Accession NP_001124626 (supra).
(Prior Rejection Withdrawn in view of Applicant’s Amendments) Claim(s) 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Birsoy et al. GenBank Accession NP_001124626 as applied to claims 1, 2, 4, 5, 9, 13-15 and 19 above, and further in view of Du et al. (US PGPub 2022/0347113).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671