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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/17/2025 has been entered.
Claim Status
Claims 1, 4-7, 32, 35, 40, 42, 44-54 are pending.
Claims 2-3, 8-31, 33-34, 36-39, 41, and 43 are cancelled.
Claims 1, 4-7, 32, 35, 40, 42, 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 10/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
New Ground of Objection and Rejection
Claim Objections
Claim 42 is objected to because of claim 42 is substantially the same as claim 4.
Applicant is advised that should claim 4 be found allowable, claim 42 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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.
Claim 32 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 32 is drawn to SEQ ID Nos: 1-4 or a pharmaceutically acceptable salt thereof, but fails to further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 32, 35, 40, 42, 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. further show 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. suggest the amino acid next to hCys can be Ala, Asn, Gln, Ser, Thr, or other amino acids to optimized Melanocortin agonist compounds (p14, 2nd last para of A3; claims 1, 16, and 38). Sharma et al. show a specific Melanocortin analog peptide SEQ ID NO: 31 [0052] in comparison to the elected peptide species SEQ ID NO: 4 as follows, reading on the elected species SEQ ID No: 4 in claims 1, 32, 40, 48, 50, and 54.
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In addition, Sharma et al. teach the cyclization of peptides via Cys, hCys, or Pen side chains to form a disulfide bond [0016]. Thus, one of ordinary skill in the art would have been taught/suggested to substitute Cys with Pen or hCys to form a cyclic peptide (e.g., SEQ ID No: 29) via a disulfide shown as follows, further reading on the instant SEQ ID NO: 2 in claims 1, 32, 46, 48-49, and 52. Sharma et al. further suggest the amino acid next to hCys can be substituted among Ala, Asn, Gln, Ser, Thr, or other amino acids (p14, 2nd last para of A3), reading on all SEQ ID Nos: 1-4.
With respect to claims 4 and 42, 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 Ala can be optimized by being replaced with Ser (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
The Office has failed to meet these requirements and thus the claims are not obvious in view of Sharma.
Sharma discloses over 85 individual peptide sequences that vary in length from 6-10 amino acid residues, only 31 are heptapeptides. The Office fails to make clear why a skilled person would select SEQ ID NO: 31 over the other 85 peptides to further develop, particularly those peptides for which there is compelling efficacy and selectivity data (Remarks p6, 2nd last para).
Sharma’s heptapeptide comprising hCys and Pen, which she would not, the artisan would certainly not be motivated to select Ala from the seven amino acid residues in the Sharma peptide as a point of substation. The side chain of Ala is a single methyl group (-CH3), which is several atoms smaller than the side chains of the amino acids as claimed Remarks p6, last para to p7, para 1).
Applicant further submits that the unexpected and surprising results that the instant peptides have both strong agonist activity for the melanocortin 4 receptor (MC4R) as well as increased selectivity for the MC4R compared with the other melanocortin receptors tested provided in the application as filed and the declaration under 37 C.F.R. §1.132 from Dr. Sharma (Remarks p7, last two para to p8, para 1).
Declaration from Dr. Sharma. I strongly believe that the pending claims are not obvious in view of Sharma or any other reference because (a) Sharma contains no efficacy or selectivity data for SEQ ID NO: 31 (Remarks, Declaration #6), (b) Surprisingly and unexpectedly, the peptides recited by the instant claims all exhibited improved selectivity for MC4R over one or more MCRs, particularly MC5R, compared with SEQ ID NO: 31 (Remarks, Declaration #7) and (c) nothing in Sharma specifically direct a person of skill in the art to select SEQ ID NO: 31 out of all the peptides disclosed in Sharma, then to select the Ala residue from all the possible positions in SEQ ID NO: 31, and to further substitute this Ala with one of Ser, Thr, Gln, or Asn. This would require impermissible hindsight.
Response to Arguments
Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s argument (i) is not persuasive because (a) Sharma et al. teach a desired polypeptide having higher selectivity and potency for the melanocortin-4 receptor (MC4R) compared to melanocortin-1 receptor (MC4R) to reduce or eliminate such undesirable side effects [0005] and explicitly show a lead compound of Ac-Arg-cyclo [ hCys-Ala-D-Phe-Arg-Trp-Pen ]-NH2 (SEQ ID NO: 31) and other peptides [0052], (b) Sharma et al. suggest the amino acid next to hCys can be Ala, Asn, Gln, Ser, Thr, or other amino acids to optimized Melanocortin agonist compounds (claims 1, 16, and 38) (p14, 2nd last para of A3) for EC50 with respect to MC4R ranged from 0.01 nM to about 10 nM [0048], and (c) Sharma et al. further show the use of cAMP assays to determine EC-50 and selectivity ratio known to one of ordinary skill in the art [00159, Table 2]. Thus, it would be obvious to optimize MC4R agonist polypeptide by amino acid substitution as taught by Sharma et al. Furthermore, the rejection also includes substitution of Cys with Pen or hCys to form a cyclic peptide of SEQ ID No: 29 via a disulfide bond, not limited to SEQ ID NO: 31 as argued by applicant. It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. See MPEP 2144.05(II).
Applicant’s argument (ii) is not persuasive because Sharma et al. clearly 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] even though Ala’s side chain of a methyl group (-CH3) smaller than the side chains of other amino acids in replacement of Ala.
Applicant’s argument (iii) of unexpected result is not persuasive because (a) Sharma et al. suggest optimized compounds (derived from a reference peptide sequence SEQ ID NO: 29 or 31 discussed above) possessing higher selectivity and potency for the melanocortin-4 receptor (MC4R) compared to melanocortin-1 receptor (MC4R) to reduce or eliminate such undesirable side effects [0004-0005], (b) Sharma et al. suggest the amino acid next to hCys can be Ala, Asn, Gln, Ser, Thr, or other amino acids to optimize Melanocortin agonist compounds (claims 1, 16, and 38) (p14, 2nd last para of A3) for EC50 of MC4R expected to be ranged from 0.01 nM to about 10 nM [0048], and (c) Sharma et al. further show the use of cAMP assays to determine EC-50 and selectivity ratio known to one of ordinary skill in the art [00159, Table 2]. Thus, one of ordinary skill in the art would expect to optimize a reference cyclic peptide derived from SEQ ID NO: 29 and/or 31 by amino acid substitution as discussed above would further improve EC50 and/or selectivity compared to SEQ ID NO: 29 or 31. See MPEP 2123(I). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Applicant’s argument (iv) of Declaration from Dr. Sharma for unexpected result is not persuasive for the reasons as follows.
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The argument (iv)(a) is not persuasive because (A) Sharma et al. show the use of cAMP assays to determine EC-50 and selectivity ratio known to one of ordinary skill in the art [00159, Table 2], (B) Sharma et al. teach a desired polypeptide having higher selectivity and potency for the melanocortin-4 receptor (MC4R) compared to melanocortin-1 receptor (MC4R) to reduce or eliminate such undesirable side effects [0005] and explicitly show a lead compound of Ac-Arg-cyclo [ hCys-Ala-D-Phe-Arg-Trp-Pen ]-NH2 (SEQ ID NO: 31) and other peptides [0052], (C) Sharma et al. suggest the amino acid next to hCys can be Ala, Asn, Gln, Ser, Thr, or other amino acids to optimized Melanocortin agonist compounds (claims 1, 16, and 38) (p14, 2nd last para of A3) for EC50 with respect to MC4R ranged from 0.01 nM to about 10 nM [0048]. Even though Sharma et al. did not explicitly show EC50 or selectivity of all peptides or their analogs, Sharma et al. have demonstrated the use of cAMP assays to determine EC-50 and selectivity ratio known to one of ordinary skill in the art [00159, Table 2]. Furthermore, the argument does not apply to the rejection based on substitution of Cys with Pen or hCys to form a cyclic peptide of SEQ ID No: 29 via a disulfide bond.
The argument (iv)(b) is not persuasive. SEQ ID NO: 31 is the second best of selectivity of MC4R:MC1R at 453 with better selectivity of MC4R:MC1R than SEQ IDS NO: 2 according cAMP assays (Table 1 in declaration), which actually further motivates one of ordinary skill in the art to optimize SEQ ID NO: 31 via amino acid substitution to reducing binding to other receptors as suggested by Sharma et al. Furthermore, the opinions of from Dr. Sharma do not establish the evidence "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance" according to MPEP 716.02(b).
The argument (iv)(c) is not persuasive because the rejection is based on Sharma et al. not hindsight as argued by applicant. Sharma et al. teach and/or suggest optimization of a reference peptide comprising SEQ ID NO: 29 or SEQ ID NO: 31 via cAMP assays to identify analog peptides with higher selectivity and potency for the melanocortin-4 receptor (MC4R) compared to melanocortin-1 receptor (MC4R) to reduce or eliminate such undesirable side effects [0005]. One of ordinary skill in the art would have found it obvious optimize a reference peptide comprising SEQ ID NO: 29 or SEQ ID NO: 31 via amino acid substitution to create the claimed peptide sequences for cAMP assays in light of Sharma et al. See response to arguments (i)-(iii) above. It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. SEE MPEP 2144.05 II.
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, 32, 40, 42, and 46-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 8, 17-20 and 27 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, 32, 40, and 46-54.
Claim 27 of the' 425 patent disclosed the peptide composition further comprising
pharmaceutically acceptable carrier, satisfying the instant claims 4 and 42.
Response to Arguments
Applicant's arguments filed 10/17/2025 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, 32, 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, 32, 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 10/17/2025 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.
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Claims 1, 4-7, 32, 35, 40, 42, and 44-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 34-35, 38, 43, and 48-54 of copending Application No. 17/712,752 (the ‘752 application dated 9/29/2025). 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.
Claim 9 of the ‘752 application disclosed a method of administering a cyclic peptide from the compound formula I shown above to treat a metabolic disease or obesity.
Claim 48 of the ‘752 application disclosed polypeptide sequences of SEQ ID NOs: 1-4 shown as follows
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Thus, claim 9 in view of claim 48 of the ‘752 application is obvious to the instant claims
1, 32, 40, and 46-54.
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.
Claim 53 of the ‘752 application disclosed a compound of claim 9 and a pharmaceutically acceptable carrier, satisfying the instant claims 4 and 42.
Claim 54 of the ‘752 application disclosed the composition further comprises an anionic excipient, satisfying the instant claim 35.
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.
Claims 1, 32, 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.
Thus, claim 1 of the ‘986 application satisfies the instant claims 1, 32, 40, and 46-54.
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.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
14-November-2025
/LI N KOMATSU/Primary Examiner, Art Unit 1658