DETAILED ACTION
Examiner acknowledges receipt of the reply filed 7/21/2026, in response to the restriction requirement mailed 6/03/2026.
Claims 1-9 are pending. Claims 2 and 6-9 have been withdrawn from further consideration for the reasons set forth herein.
Claims 1 and 3-5 are being examined on the merits in this office 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 .
Priority
The filing receipt dated 10/04/2024 provides the following information:
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Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The instant application claims benefit of priority to Appl No 17/873386 (hereinafter referred to as “the ‘386 application”). A notice of allowance was mailed in the ‘386 application on 11/29/2023. See file wrapper of the ‘386 application. Issue fees were paid by applicant on 1/31/2024. An issue notification was mailed out on 2/21/2024. The ‘386 application issued as Pat NO 11925674 (hereinafter referred to as “the ‘674 patent”) on 3/12/2024.
The instant application was filed 8/13/2024; five months after the ‘386 application had already issued as the ‘674 patent. Thus, the instant application and the ‘386 application were not co-pending at the time the instant application was filed 8/13/2024.
This application is claiming the benefit of prior-filed application No. 17/873386 under 35 U.S.C. 120, 121, 365(c), or 386(c). Copendency between the current application and the prior application is required. Since the applications are not copending, the benefit claim to the prior-filed application is improper. Applicant is required to delete the claim to the benefit of the prior-filed application, unless applicant can establish copendency between the applications.
Benefit of priority to the ‘386 application (and priority applications thereof) is denied for the reasons set forth herein.
The ‘386 application was also filed as a CIP of PCT/US2023/0620024 (filed 2/06/2023), with priority to Prov Appl 63/309881 (filed 2/14/2022).
The earliest effective filing date of the instant application is deemed to be 2/14/2022, filing date of Prov Appl 63/309881.
Election/Restrictions
Applicant’s election of Group 1 (claims 1-5) in the reply filed 7/21/2026. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-9 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 7/21/2026.
Applicant’s election of the following species is acknowledged:
FSP27 sequence: SEQ ID NO:2
Claims 1 and 3-5 read on the elected species.
Claim 2 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/21/2026.
Drawings
Examiner acknowledges receipt of the petition for color drawings filed 8/13/2024. The petition was dismissed on 10/11/2024. See file wrapper.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claim Objections
Claims 1, 4, and 5 are objected to because of the following informalities:
Claim 1 should be amended to recite “muscle cells and muscle tissues” at ll. 3 and 6.
Claim 4 should be amended to recite “wherein a [[the]] composition comprising the recombinant peptide is administered”.
Claim 5 should be amended to recite “than in [[is]] a subject”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1 and 3-5 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.
Regarding claim 1 and the words “improving” and “muscle performance” as used in “improving muscle performance”, the terms are relative terms which render the claim indefinite. The terms “improving” and “muscle performance” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, claim 1 is rejected as indefinite.
Regarding claim 1, the term “increase muscle function” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, claim 1 is rejected as indefinite.
Claim 1 recites the limitation "the need". There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, Applicant recommends that the claim be amended to recite “without [[the]] need for” or “without needing
Because claims 3-5 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
Claim 4 recites the limitation "the composition". There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the FSP27 medicament". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 and 3-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Puri et al (WO2020/023456).
Puri is a named inventor of the instant application.
Puri et al teach FSP27 compositions and methods for treating cardiovascular disease (abstract). Puri et al teach a method for inhibiting cardiovascular disease in a subject, comprising, administering an FSP27 medicament or a pharmaceutically acceptable composition thereof, in an amount to treat cardiovascular disease. Cardiovascular disease include cardiovascular conditions: ischemic heart disease, coronary artery disease (CAD), angina, infarction, coronary syndrome, peripheral artery disease (PAD), cerebrovascular disease, stroke, congestive heart failure, systolic or diastolic cardiomyopathy, insulin resistance, vascular spasm, vasospastic angina, cardiac arrhythmia, impaired angiogenesis, reduced vascular growth (claims 1-2). FSP27 medicament comprises full length FSP27 [SEQ ID NO: 12], or peptide fragments thereof (claim 3). SEQ ID NO:12 of Puri et al has 100% identity with instant SEQ ID NO:2 (claim 3, Fig 17).
The dosage amount of a composition administered to an animal or human patient can be determined by physical and physiological factors such as body weight, severity of condition, the type of disease being treated, previous or concurrent therapeutic interventions, idiopathy of the patient, and the route of administration. Depending upon the dosage and the route of administration, the number of administrations of a preferred dosage and/or an effective amount may vary according to the response of the subject. The compounds are generally effective over a wide dosage range. The practitioner responsible for administration can, in any event, determine the concentration of active ingredient(s) in a composition and appropriate dose(s) for the individual subject (para [00158]). FSP27 can be administered by injection (e.g, para [0150]-[0154]). Puri teach that treatment with rFSP27 significantly improved vasomotor function [reads on improving vascular muscle performance] (para [00100]). Accordingly, the limitations of claim 1 are satisfied.
Regarding claim 3, the subject is a human (e.g., para [0024], claim 19). Regarding claim 4, the peptide can be administered by injection (parenterally) (e.g, para [0150]-[0154]).
Regarding claim 5, FSP27 resulted in improved vasodilation, increased oxygen consumption, respiratory exchange ratio, and movement [construed as reading on higher endurance] (e.g., Figs 3, 20-25; paras [0032], [0095]-]0100], [0130]-[0133]).
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
Relevant Art Not Relied Upon
The amino acid sequence of instant SEQ ID NO:2 correlates with human FSP27 protein (specification at para. [0071]). Instant SEQ ID NO:2 has 100% sequence identity with UnitProt Accession No. Q96AQ7 (accessed 5/11/2023 at URL rest.uniprot.org/uniprotkb/Q96AQ7.txt). See SCORE for sequence comparison.
Conclusion
No claims are allowed.
Claims 1-9 are pending. Claims 2 and 6-9 have been withdrawn.
Claims 1 and 3-5 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
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