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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/29/2025 has been entered.
Claim Status
Claims 9, 12, 29, 31, and 33-52 are pending.
Claims 1-8, 10-11, 13-28, 30, 32, and 53-54 are cancelled.
Claim 41 is withdrawn as being directed to a non-elected species, the election having been made on 8/28/2023.
Claims 9, 12, 29, 31, 33-40, and 42-52 have been examined.
Priority
This application is a CON of 15/764,730 03/29/2018
15/764,730 is a 371 of PCT/US2016/054455 09/29/2016
PCT/US2016/054455 has PRO 62/235,003 09/30/2015
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/29/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Rejection
The provisional nonstatutory double patenting rejection of claims 9, 12, 29, 31, 33-35, 38-40, and 42-52 as being unpatentable over claim 1 of copending Application No. 17/080,293 in view of Sharma et al. is withdrawn because the amendment to 17/080,293 overcomes the rejection.
New Ground of Objection and Rejection
Claim Objections
Claims 43 and 48 are objected to because of the following informalities: A period “.” required at the end of claim 43 and 48 is missing. Appropriate correction is required.
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 48 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 48 is drawn to SEQ ID Nos: 1-4 failing to further limit the subject matter of the compound formula I in claim 9. 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.
1. Claims 9, 12, 29, 31, 33-35, 38-40, and 42-52 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (WO 2014/144842 A2, previously cited 11/16/2023).
Claim 1 is drawn to a method of treating a metabolic disease or obesity in a subject comprising administering a therapeutic effective amount of melanocortin-4 (MC4R) agonist of a compound formula I 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 administering to a subject an effective amount of an ionic complex comprising as the cationic polypeptide of melanocortin-4 receptor (MC4R) modulator to treat type 2 diabetes, obesity, insulin resistance (reading on insulin insensitivity), and metabolic syndrome [0004, line 6-10; 00111]. 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, Ac-Arg-(hCys-Thr-D-Phe-Arg-Trp-Pen)-NH2, in claims 9, 43, 47-48, and 52.
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:
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29) via a disulfide shown as follows, further reading on the instant SEQ ID NOs: 2-4 in claims 9, 43-46, and 48-51. 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 12, 29, 31, and 40, Sharma et al. teach the treated diseases comprising medical conditions accompanied by weight gain such as obesity, feeding disorders and Prader-Willi Syndrome [00109].
With respect to claims 33 and 39, Sharma et al. teach the MC4R agonist is administered sufficient to partially or totally reduce the body weight (as measured, for example, by a body mass index, BMI) [00108].
With respect to claim 34, Sharma et al. suggest the peptide is formulated in a liquid isotonic formulation or liquid reconstituted from a solid form [0086] such as a single dosage form of injectable liquid [00133], reading on a unit dosage suitable for injection.
With respect to claim 35, Sharma et al. suggest the unit dosage is more preferably from about 1 to 200 mg/day in single or 2-4 divided doses [00135].
With respect to claim 38, Sharma et al. suggest the MC4R modulator peptide can be administered daily for the entire treatment period in need up to 6 months [00131].
With respect to claim 42, Sharma et al. suggest administering the peptide variants of formula [0037] to treat obesity [00108], reading on disease of body weight, of a subject having a body mass index (BMI) of about 30 kg/m2 or higher, e.g., a BMI of 25, 26, 27, 28, 29, 30-37 kg/m2, or more [00112].
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to substitute alanine among amino acids comprising Asn, Gln, Ser, Thr, and other (p14, [0037] 2nd last para of A3) because Sharma et al. suggest such amino acid substitution at a particular position in a MC4R agonist peptide (e.g., SEQ ID NO: 29 and/or 31) to optimize selectivity and potency for the melanocortin-4 receptor (MC4R)[0004-0005] using cAMP assays to determine EC-50 and selectivity ratio of different polypeptides known to one of ordinary skill in the art [00159, Table 2]. The substitution would have reasonable expectation in light of Sharma’s teaching and suggestion.
Applicant’s Arguments
Sharma discloses over 85 individual peptide sequences that vary in length from 6-10 amino acid residues, only 31 are heptapeptides. No experimental data at all is provided in Sharma for SEQ ID NO: 31. As such, a person of ordinary skill in the art would not read Sharma and find any information described therein to motivate her to select SEQ ID NO: 31 among all of the peptides disclosed as a starting point for further experimentation (Remarks p9, para 2).
A person in the art would not select a heptapeptide comprising hCys and Pen or replace Ala with asparagine, glutamine, serine, or threonine. 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 p9, para 3 to p710, 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 Table on page 46 (Remarks p10, para 2-3).
Applicant cancels claim 32. Applicant further submits that nothing in Adan, when combined with Sharma, would render the claims obvious (Remarks, p10, last para).
Response to Arguments
Applicant's arguments filed 9/29/2025 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]. 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]. 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) is 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).
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The Table on page 46 for argument of unexpected result is shown as follows. Each peptide sequence of SEQ ID Nos: 1-4 has higher selectivity and potency for melanocortin-4 receptor (MC4R) to reduce or eliminate such undesirable side effects as taught and/or suggested by Sharma et al. [0004-0005]. Even though Sharma et al. did not explicitly show EC50 or selectivity of all peptides or their variants, 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]. Merely performing cAMP assays and comparison of selectivity ratio for MC4R agonist homolog and analog variants taught by Sharma et al. shown in the Table below is insufficient to support arguments of unexpected result. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b).
Applicant’s argument (iv) is not persuasive because Adan is no long cited for the rejection. See the new ground of rejection based on Sharma et al. in view of Chu below.
New Ground of Rejection
2. Claims 9, 12, 29, 31, 33-40, and 42-52 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. as applied to claims 9, 12, 29, 31, 33-35, 38-40, 42-52 and further in view of Chu (MIT NEWS. https://news. mit.edu/2012/needleless-injections-0524, May 24, 2012).
Claim 36 is drawn to Claim 36 is drawn to the unit dosage is disposed within a delivery device.
Sharma et al. suggest the peptide is formulated in a single dosage form of injectable liquid [00133], but do not specify the use of a deliver device to deliver the liquid MC4R agonist peptide.
Chu shows a medical device to inject drugs without needles as follows (p1). Chu teaches
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the injection device that delivers a tiny, high pressure jet of medicine through the skin without the use of a hypodermic needle. The device can be programmed to deliver a range of doses to various depths and beneficially reduce the potential for needle-stick injuries (p2, para 2-3), reading on a needleless hypodermic injection device in claims 36-37.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Sharma’s injectable liquid MC4R agonist peptide formulation [00133] with Chu’s injection device because Chu teaches a injection device can be programmed to deliver a range of doses to various depths without the use of a hypodermic needle and beneficially reduce the potential for needle-stick injuries (p2, para 2-3). The combination would have reasonable expectation of success because both references teach injection of a drug in a liquid formulation.
New Ground of Rejection
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.
Claims 9, 12, 29, 31, 33-40, and 42-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 32, 40, and 46-54 of copending Application No. 15/764,730 (the ‘730 application dated 10/17/2025) in view of Sharma et al. (WO 2014/144842 A2) and Chu (MIT NEWS. https://news. mit.edu/2012/ needleless-injections-0524, May 24, 2012).
Claim 1 of the ‘730 application disclosed a peptide formula identical to the instant MC4R agonist peptide formula I as follows.
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Claim 5-6 of the ‘730 application disclosed a unit dosage comprises between 0.1 and 100 mg of the compound, satisfying the instant claim 35.
Claim 7 of the ‘730 application disclosed the unit dosage suitable for injection, satisfying the instant claim 34.
Claim 32 of the ‘730 application disclosed the instant peptide SEQ ID Nos: 1-4, satisfying the claim 48.
Claims 40, 47 and 50 of the ‘730 application disclosed Xxx is Ser or Thr, satisfying the instant claim 43.
Claims 46-47 and 50 of the ‘730 application disclosed Xxx is Asn, satisfying the instant claim 44.
Claims 46 and 48 of the ‘730 application disclosed Xxx is Gln, satisfying the instant claim 45.
Claims 47 and 49 of the ‘730 application disclosed Xxx is Ser, satisfying the instant claim 46.
Claims 48 and 50 of the ‘730 application disclosed Xxx is Thr, satisfying the instant claim 47.
Claims 51-54 of the ‘730 application disclosed the instant SEQ ID Nos: 1-4, satisfying the instant claims 49-52 respectively.
Claims 1, 5-7, 32, 40, and 46-54 of the ‘730 application does not disclosed administration of the peptide formula to treat a metabolic disease or obesity in a subject.
The relevancy of Sharma et al. in view of Chu as applied to claims 9, 12, 29, 31, 33-40, and 42-52 described above not repeated here.
Because Sharma et al. in view of Chu teach beneficial administration the cyclic peptides taught by claims 1, 5-7, 32, 40, and 46-54 of the ‘730 application to treat various disease, one of ordinary skill in the art would have found it obvious to combine claims 1, 5-7, 32, 40, and 46-54 of the ‘730 application and Sharma et al. in view of Chu to treat various diseases.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 9/29/2025 have been fully considered but they are not persuasive.
Claims 9, 12, 29, 31, 33-40, and 42-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12/285,460 (the ‘460 patent) in view of Sharma et al. (WO 2014/144842 A2) and Chu (MIT NEWS. https://news. mit.edu/2012/ needleless-injections-0524, May 24, 2012).
Claim 1 of the ‘460 patent disclosed a melanocortin-4 receptor agonist cyclic peptide of SEQ ID NO: 1 as follows.
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Claim 1 of the ‘460 patent did not disclose administer a modified melanocortin-4 receptor agonist peptide as claimed to treat a disease such as obesity.
Sharma et al. show a specific Melanocortin agonist peptide SEQ ID NO: 31 [0052] homologous to the SEQ ID NO: 1 disclosed by the ‘460 patent. Sharma et al. teach the cyclization of peptides via functionally equivalent Cys, hCys, or Pen side chains to form a disulfide bond [0016]. 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) via cAMP assays to determine EC-50 and selectivity ratio of different polypeptides known to one of ordinary skill in the art [00159, Table 2]. The same reasons to modify the SEQ ID NO: 1 of ‘‘460 patent as taught by Sharma et al. to produce various MC4R homolog/analog peptides for selection by cAMP assays are descried above not repeated here. The relevancy of Sharma et al. in view of Chu as applied to claims 9, 12, 29, 31, 33-40, and 42-52 also described above not repeated here.
Because Sharma et al. in view of Chu teach beneficial administration the cyclic peptides modified from SEQ ID NO: 1 of ‘460 patent to treat various disease, one of ordinary skill in the art would have found it obvious to combine claim 1 of the ‘460 patent in view of Sharma et al. and Chu to treat various diseases.
Thus, claim 1 of the ‘460 patent in view of Sharma et al. and Chu. Are obvious to the instant claims 9, 12, 29, 31, 33-40, and 42-52.
Claims 9, 12, 29, 31, 33-40, and 42-52 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 dated 2/28/2025) in view of Sharma et al. (WO 2014/144842 A2) and Chu (MIT NEWS. https://news. mit.edu/2012/ needleless-injections-0524, May 24, 2012).
Claim 1 of the ‘986 application disclosed a cyclic peptide formula I of MC4R agonist as follows:
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Claim 1 of the 986 application disclosed A1 can be Arg; A2 can be hCys; A3 can be Ala, Asn, Gln, Ser, Thr; A4 can be absent; A5 can be Phe or modified Phe; A6=Arg; A7=Trp, and A8 can be Pen reading on the instant SEQ ID Nos: 1-4. Claim 1 of the 986 application further defined any amino acid residue of MC4R agonist is either L- or D- configuration.
Claim 1 of the 986 application did not disclosed administration of a cyclic peptide of formula I to treat a disease.
The relevancy of Sharma et al. in view of Chu as applied to claims 9, 12, 29, 31, 33-40, and 42-52 described above not repeated here.
Because Sharma et al. in view of Chu teach beneficial administration the cyclic peptides taught by claim 1 of the 986 application to treat various disease, one of ordinary skill in the art would have found it obvious to combine claim 1 of the 986 application and Sharma et al. in view of Chu to treat various diseases.
This is a provisional nonstatutory double patenting rejection.
Claims 9, 12, 29, 31, 33-40, and 42-52 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 dated 11/10/2025) in view of Sharma et al. (WO 2014/144842 A2) and Chu (MIT NEWS. https://news. mit.edu/2012/ needleless-injections-0524, May 24, 2012).
Claim 1 of the ‘163 application disclosed a cyclic peptide formula I of MC4R agonist as follows:
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Claim 1 of the 163 application disclosed A1 can be Arg; A2 can be hCys; A3 can be Ala, Asn, Gln, Ser, Thr; A4 can be absent; A5 can be Phe or modified Phe; A6=Arg; A7=Trp, and A8 can be Pen reading on the instant SEQ ID Nos: 1-4. Claim 1 of the 163 application further defined any amino acid residue of MC4R agonist is either L- or D- configuration.
Claim 1 of the 163 application did not disclosed administration of a cyclic peptide of formula I to treat a disease.
The relevancy of Sharma et al. in view of Chu as applied to claims 9, 12, 29, 31, 33-40, and 42-52 described above not repeated here.
Because Sharma et al. in view of Chu teach beneficial administration the cyclic peptides taught by claim 1 of the 986 application to treat various disease, one of ordinary skill in the art would have found it obvious to combine claim 1 of the 163 application and Sharma et al. in view of Chu to treat various diseases.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
29-November-2025
/LI N KOMATSU/ Primary Examiner, Art Unit 1658