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
In response to the restriction requirement dated 17 February, 2026, Applicant elects, without
traverse: Group I, claims 1-20 for examination. In response to a species election, Applicant elects , without traverse, the compound MBX 1416 as disclosed in Fig. 7. Claims 1-4, 7-9, 11, 15 and 20 read on the elected species. Applicant’s election in the reply filed on 16 April 2026 is acknowledged.
Claims 1-4, 7-9, 11, 15 and 20 are hereby examined on the merits. Claims 5, 6, 10, 12-14, 16-19 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
This application filed 08/03/2023 claims priority from Provisional Application 63395783 , filed 08/05/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/20/2024, 08/22/2025 and 01/21/2026 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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 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.
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, 7-9, 11, 15 and 20 are rejected under 35 U.S.C. 103 as being obvious over James T. Patterson et al., hereinafter Patterson (James T. Patterson et al., A Novel Human-Based Receptor Antagonist of Sustained Action Reveals Body Weight Control by Endogenous GLP-1, ACS Chem. Biol. 2011, 6, 135-145; published October 2010; reference provided in IDS) in view of Defelippis et al., hereinafter Defelippis (Defilippis et al., WO 03/020201A2; published 13 March 2003) as evidenced by Jesper Mikkelsen et al., hereinafter Jesper (Jesper Mikkelsen et al., Selective N‑Terminal Acylation of Peptides and Proteins with Tunable Phenol Esters, Bioconjugate Chem. 2022, 33, 625−633); published 23 March 2022).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
For prior art purpose, the Examiner interprets “comprising the amino acid sequence of” in claim 1, as any sequence comprising the sequence of SEQ ID NO: 97, as elected by the Applicant.
Regarding claim 1, Patterson teaches GLP-1/Ex-4 hybrid peptides, to generate a pure GLP-1 based antagonist (see Abstract in the main article) comprising the sequence of DVSSYLEEQAVREFIAWLVKGGPSSGAPPPS-NH2 (peptide 28; Jant-4 (9-39)a) (see Supplementary information, page 5, Table 1). The sequence in Patterson, differs from the instant sequence SEQ ID NO: 97, at the underlined residue. As noted, in Table 1 of the main article, Patterson teaches that Jant-4(9-39)a has an IC50 (antagonism) of 70±10 nM and is superior to the well-established antagonist peptide 4 in Table 1 (page 138, first paragraph). Patterson teaches that Jant-4 antagonists acylated with palmitic acid is synthesized with the objective of extending serum half-life by binding to albumin. Patterson teaches that acylation of Jant-4 (9-40)a at Lys40 improves potency by approximately 3-fold. Notably, Patterson teaches that C8, C14 and C18 fatty acids (i.e. C18 diacid as recited in the claim) show similar improvements in potency (page 138, first paragraph, last two lines). Patterson teaches that acylated Jant-4, (peptide 28) has a 10-fold preferential activity at the GLP-1 receptor, demonstrating that the fatty acid increases inherent potency but lessens selectivity (page 139, last few lines of first paragraph).
Patterson does not teach that the C18 diacid is covalently linked to the N-terminal alpha amine. Patterson does not teach substituting position 34 with arginine. Position 34 is underlined in the sequence of Patterson, as set forth above.
Defilippis teaches GLP-1/Extendin-4 peptide analogs (see page 17, last paragraph). A preferred group of GLP-1 analogs represented in Formula III (SEQ ID NO: 3) is a 100 % match to SEQ ID NO: 97 in the instant application. Defilippis teaches, that Xaa at position 34 is Lys or Arg or Glu or Asp or Asn or His (page 20, line 10). Defilippis teaches a preferred group of Glp-1 analogs wherein the amino-terminal end of the peptides is alternated with the C-terminal ends (see pages 20-22 for a list).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to modify the teaching of Patterson, of a potent acylated GLP-1 receptor antagonist with the teachings of Defilippis, and alternate the -N and -C terminal ends of the peptide, substitute the ‘K’ with ‘R’ as suggested in Defilippis and modify Nα with fatty acid side chains as evidenced by Jesper (see Abstract).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
One motivated to do so would have a reasonable expectation of success, as all references are directed to GLP-1 peptide analogs. Patterson teaches that acylated Jant-4, (peptide 28) has a 10-fold preferential activity at the GLP-1 receptor, demonstrating that the fatty acid increases inherent potency. Therefore, one would have recognized that applying the teachings in Patterson with the teachings in Defilippis, would yield predictable results, as Defillippis discloses that a conservative substitution is a replacement of an amino acid with another that has the same net electronic charge and approximately the same size and shape (see page 16, first paragraph). (See MPEP § 2143 I(A)(B)).
Regarding claims 2-4, 7-9, 11, 15 the claim limitations, as elected by the Applicant, are met by the obviousness rationale set forth above.
Regarding claim 20, Defilippis teaches pharmaceutically acceptable buffer (page 3, line 23; page 8, line 6).
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 1-4, 7-9, 11, 15 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 34 of copending Application No. 18264157 (reference application) in view of Defilippis et al., WO 03/020201A2; published 13 March 2003. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1-4, 7-9, 11 and 15, reference application ‘157 teaches GLP-1 receptor antagonist comprising the sequence of SEQ ID NO: 97 which is identical to the sequence in the instant application and accompanying R10 and R20 modifications. The reference application ‘157 clearly anticipates the instant claims. The teachings of Defilippis, has been set forth above. It is noted that Defillippis teaches that a conservative substitution is a replacement of an amino acid with another that has the same net electronic charge and approximately the same size and shape (see SEQ ID NO: 3 in Defillippis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching of ‘157 with the teachings of Defillippis to generate the specific GLP-1 receptor antagonist (elected by the Applicant) in the instant claims (see page 16, first paragraph). (See MPEP § 2143 I(A)(B)).
Regarding claim 20, reference application ‘157 teaches pharmaceutically acceptable carrier, diluent or excipient (see claim 34).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARCHANA VARADARAJ/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights