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 .
Claim Status
Claims 1, 4-7, 35, 40, 44-54 are pending.
Claims 2-3, 8-34, 36-39, and 41- 43 are cancelled.
Claims 1, 4-7, 35, 40, and 44-54 have been examined.
Priority
This application is a 371 of PCT /US2016/054455 filed on 09/29/2016, which claims the priority of provisional application filed on 09/30/2015.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/18/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Objection and Rejection
The objection to claim 42 is withdrawn because claim 42 has been cancelled.
The rejection of claim 32 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn because claim 32 has been cancelled.
Maintained Rejection
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-7, 35, 40, and 44-54 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (WO 2014/144842 A2, previously cited 4/2/2019).
Claim 1 is drawn to a compound as follows.
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Sharma et al. teach polypeptides possessing higher selectivity and potency for the melanocortin-4 receptor (MC4R)[0004-0005]. Sharma et al. teach the use of cAMP assays to determine EC-50 and selectivity ratio of different polypeptides known to one of ordinary skill in the art [00159, Table 2]. Sharma et al. teach a selected cyclic peptide consisting of Ac-Arg-cyclo [hCys-Gln-D-Phe-Arg-Trp-Cys ]-NH2 (SEQ ID NO: 29).reading on all SEQ ID Nos: 1-4.
With respect to claim 4, Sharma et al. teach the peptide pharmaceutical composition further comprising a pharmaceutically acceptable carrier [Abstract, 0079, claim 40].
With respect to claims 5-6 and 44, Sharma et al. suggest the peptide has unit dose from about 1 mg/ml to about 50 mg/ml (claim 44) in a unit dosage such as tablet or capsule [00133].
With respect to claim 7, Sharma et al. suggest the unit dosage suitable for injection [0082], preferred to be subcutaneous administration [00132].
With respect to claim 35, Sharma et al. teach the peptide pharmaceutical composition further comprising an anionic excipient of anionic phospholipid [Abstract; 0018 Anionic excipients].
With respect to claim 45, Sharma et al. teach the composition can be administered hourly, four times daily, three time daily, twice daily, once daily [00131] in a unit dosage such as tablet or capsule [00133].
With respect to claims 47 and 50-51, Sharma et al. suggest a cyclic peptide comprising Gln (Q) can be optimized by conserved substitution by Asn (p14, 2nd last para of A3), reading on Xxx is Asn of SEQ ID NO: 1.
With respect to claims 47, 49, and 53, Sharma et al. suggest a cyclic peptide comprising Gln can be optimized by being replaced with Ser or Asn (p14, 2nd last para of A3), reading on Xxx is Ser of SEQ ID NO: 3.
One of ordinary skill in the art before the effective filing date of this invention would have been found it obvious to use amino acid substitution in Sharma’s cyclic peptide formula because (a) Sharma et al. teach natural amino acids of Ala, Ser, Thr, Asn, or Gln can be substituted by each other at A3 position immediately after the residue of hCys (p14, 2nd last para of A3) to optimized Melanocortin agonist compounds [claims 1, 16, and 38; 0048] and (b) Sharma et al. teach the cyclization of peptide formula via Cys, hCys, or Pen side chains to form a disulfide bond [0016]. The substitution would have reasonable expectation of success as suggested by Sharma et al. described above.
Applicant’s Arguments
Sharma discloses over 85 individual peptide sequences that vary in length from 6-10 amino acid residues, but only 31 are heptapeptide (35% of the total peptides) and only 2 of the 31 heptapeptides are linked through a disulfide moiety between the amino acid residues hCys and Pen. Thus, a person of ordinary skill in the art would find no motivation in Sharma to select SEQ ID NO: 31 out of the over 85 total peptides disclosed as a starting point for further experimentation (Remarks, p6, para 3).
The Office also does not clarify why a skilled artisan would choose to replace Ala with
the amino acids Xxx in instant claim 1, namely Asn, Gln, Ser, or Thr. A person with expertise in
biochemistry and/or peptide chemistry understands Ala has different physicochemical properties
compared with the Xxx amino acids in claim 1. In contrast, the side chain methyl group of Ala is nonpolar and does not engage in hydrogen bond interactions as a matter of course. For at least these reasons, Applicant submits that the instant claims are not obvious in view of Sharma and the rejection should be withdrawn (Remarks, p6, last para to p7, para 1).
Applicant further submits that the unexpected and surprising results provided in the
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application as filed and the declaration under 37 C.F.R. §1.132 with data shown in Table 1 would rebut any finding of prima facie obviousness presented by the Examiner. The strong agonist activity of the instantly claimed peptides are exemplified by the calculated EC50 values for SEQ ID NOs: 1-4 in the Table on pg. 46. The selectivity ratio of the instant peptides of SEQ ID NOs: 1-4 demonstrated superior selectivity against at least one sub-type of MCR receptor and exemplified comparable increased selectivity to other MCRs relative to the Sharma peptide.
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Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s argument (i) is not persuasive because 35% of hexapeptide in a total of 85 peptides is a representative number and statistically significant for one of ordinary skill to consider and optimize the bioactivity of a hexapeptide according to Sharma’s teachings and suggestion to optimize the peptide design.
Applicant’s argument (ii) is not persuasive because Sharma et al. teach the amino acid next to hCys can be Ala, Asn, Gln, Ser, Thr, or other amino acids with diverse side chains to optimized Melanocortin agonist compound design (p14, 2nd last para of A3; claims 1, 16, and 38). Based on these substitutions, a compound formula I can possess higher selectivity and potency for the MC4R and melanocortin-3 receptor/MC3R when compared to melanocortin-1 receptor/MC1R [0096] and a compound formula I, as a modulator of MC4R [0095], can be a full agonist, partial agonist, neutralist, or an inverse agonist [0097-0098]. In contrast to applicant’s argument, Sharma et al. explicitly teach to beneficially substitute Ala of position 3 with other amino acids comprising diverse side chains to optimized Melanocortin agonist compound design to generate a full agonist, partial agonist, neutralist, or an inverse agonist to treat any disorder that can be treated by activation (agonizing) or inhibition of MC4R. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). See MPEP 2123 (I).
Applicant’s argument (iii) is not persuasive because the data are not commensurate in scope of the claims. The rejection is based on substitution of an amino acid in SEQ ID NO 31 and SEQ ID NO: 29 [0052]. Neither Table 1 nor Example of EC50 shows data comparison to SEQ ID NO: 29. Sharma et al. teach explicitly teach the peptides are cyclic peptides using Cys, hCys, or Pen side chains to form a disulfide bond [0016]. Thus, substitution of amino acids among Cys, hCys, or Pen to form a disulfide bond would be obvious with expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
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Claims 1, 4, 40, and 46-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 8, and 17-20 of U.S. Patent No. 10,196,425 B2 (the ‘425 patent, previously cited 3/3/2021). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 4-5, 8, and 17-20 the ‘435 patent disclosed peptide sequences obvious to all SEQ ID NOs: 1-4 shown as follows, satisfying the instant claims 1, 4, 40, and 46-54.
Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive because the single ‘425 patent claims various polypeptides reading on all of the instant SEQ ID NOs: 1-4 shown in the table above. Applicant needs to file terminal disclaimer to overcomes this ODP rejection.
Claims 1, 4, 40, and 46-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,858,399 B2 (the ‘399 patent, previously cited 3/3/2021). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant peptide formula (I) in claims 1, 4, 40, and 46-54 are obvious to claim 1-8 of the ‘399 patent shown as follows.
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Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive because the single ‘399 patent claims various polypeptides reading on all of the instant SEQ ID NOs: 1-4 shown in the table above. Applicant needs to file terminal disclaimer to overcomes this ODP rejection.
Claims 1, 5-7, 32, 35, 40, and 51-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 34-35, 38, 43, and 49-52 of copending Application No. 17/712,752 (the ‘752 application dated 6/3/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘752 application is a method of using the instant cyclic peptides as claimed.
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Claim 9 of the ‘752 application disclosed a method of administering a cyclic peptide from the compound formula I shown as follows to treat a metabolic disease or obesity, stratifying the instant claim 1.
Claim 34 of the ‘752 application disclosed unit dosage suitable for injection, satisfying the instant claim 7.
Claim 35 of the ‘752 application disclosed the unit dosage comprises between 0.1 and 100 mg of the MC4R agonist, satisfying the instant claims 5-6 and 44.
Claim 38 of the ‘752 application disclosed the MC4R agonist is administered to the subject daily, satisfying the instant claim 45.
Claim 43 of the ‘752 application disclosed Xxx is Ser or Thr, satisfying the instant claim
40.
Claim 49-52 of the ‘752 application disclosed the instant SEQ ID Nos: 1, 2, 3, and 4 respectively, satisfying the instant claims 51-54.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant did not argue this rejection.
Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive because the single ‘399 patent claims various polypeptides reading on all of the instant SEQ ID NOs: 1-4. Applicant needs to file terminal disclaimer to overcomes this ODP rejection.
Claims 1, 40, and 46-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/782,986 (the ‘986 application filed on 2/28/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘986 application encompasses this instant application.
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Claim 1 of the ‘986 application disclosed a cyclic peptide formula (I).
In search for the definition of amino acid, the specification of ‘986 defines amino acid residues can be either in L- or in D-configuration (p4, line 13-18). Thus, the cyclic peptide formula in claim 1 the ‘986 application reads on all of the instant SEQ IDs NO: 1-4 and satisfied the instant claims 1, 40, and 46-54.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant did not argue this rejection.
Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive because the single ‘986 patent claim 1 teaches various polypeptides reading on all of the instant SEQ ID NOs: 1-4 shown above. Applicant needs to file terminal disclaimer to overcomes this ODP rejection.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.L/Examiner, Art Unit 1658
03-June-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights