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
Applicant’s election of Group I (claims 1-6,9,14,21 and 26) and species SEQ ID NO:229 comprising (GLP-1 SEQ ID NO:57; linker1 SEQ ID NO: 66, Hinge Fc SEQ ID NO: 84, Linker 2 SEQ ID NO:93; and cyclic PYY SEQ ID NO: 27) in the reply filed on 12/18/2025 is acknowledged. 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)).
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-6, 9, 14 and 18-27 are pending.
Claims 18-20, 22-25 and 27 are withdrawn for being drawn to non-elected inventions (i.e., Groups II-III).
Claims 1-6, 9, 14, 21 and 26 are consideration to the extent they read on the elected species.
Priority
The instant application is a CON of US 15/733,776 filed on 10/22/2020.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 is objected for the use of an abbreviated phrase (PYY), which should be described for the first time followed by an abbreviated form placed in a bracket.
Appropriate correction is required.
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 1-6, 9, 14, 21 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,780,900. Although the claims at issue are not identical, they are not patentably distinct from each other because a conjugate comprising a glucagon-like peptide 1 (GLP-1) fusion peptide coupled to a cyclic PYY peptide, wherein the GLP-1 fusion peptide comprises a GLP-1 peptide having an amino acid sequence selected from the group consisting of SEQ ID NOs:56-59,an optional first linker peptide, if present, comprising an amino acid sequence selected from the group consisting of SEQ ID NOs:60-83, a hinge-Fc region peptide having an amino acid sequence selected from the group consisting of SEQ ID NOs:84-90, and a second linker peptide having an amino acid sequence selected from the group consisting of SEQ ID NOs:93-11, wherein the cyclic PYY peptide is represented by Formula I or a derivative or pharmaceutically acceptable salt thereof are taught in claims 1-13 of US U.S. Patent No. 11,780,900.
Claims 1-6, 9, 14, 21 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim claims 1-11 and 13-16 of U.S. Patent No. 10,875,902. Although the claims at issue are not identical, they are not patentably distinct from each other because a conjugate comprising a glucagon-like peptide 1 (GLP-1) fusion peptide coupled to a cyclic PYY peptide, wherein the GLP-1 fusion peptide comprises a GLP-1 peptide having an amino acid sequence selected from the group consisting of SEQ ID NOs:56-59,an optional first linker peptide, if present, comprising an amino acid sequence selected from the group consisting of SEQ ID NOs:60-83, a hinge-Fc region peptide having an amino acid sequence selected from the group consisting of SEQ ID NOs:84-90, and a second linker peptide having an amino acid sequence selected from the group consisting of SEQ ID NOs:93-11, wherein the cyclic PYY peptide is represented by Formula I or a derivative or pharmaceutically acceptable salt thereof, wherein the cyclic PYY is selected from SEQ ID NO: 24, 25, 27, 28,29,30, 33 or 34 are taught in claims 1-11 and 13-16 of U.S. Patent No. 10,875,902.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674