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
Applicants’ election without traverse of Group I (i.e., claims 1-13 drawn to a synthetic peptide) in the reply filed on 01/23/2026 is acknowledged. Applicants’ election of SEQ ID NO: 6 (i.e., Species A), without traverse, in the reply filed on 01/23/2026 is also acknowledged.
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claims 3-4 and 6-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species; there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/23/2026.
Priority
The present application also claims status as a 371 (National Stage) of PCT/US2021/057495 filed November 1st 2021, and claims the benefit under 35 U.S.C 119 (e) to U.S. Provisional Application No. 63/108,762 filed November 2nd 2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C 119 (e) or under 35 U.S.C 120, 121, or 365 (c ) is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 05/06/2024 and 10/28/2024, have been considered by the Examiner.
Claim Objections
Claims 1-2 and 5 are objected to because of the following informalities: plural recitation of the sequences missing. The claims recite “SEQ ID NO: 6-13”, the claims should read “SEQ ID NOs: 6-13” Appropriate correction is required.
Sequence Interpretation
Regarding claim 1, the Examiner is interpreting the scope of a synthetic peptide as requiring at least 95% sequence identity to SEQ ID NO: 6 (Applicants’ elected species), with any N-/C-terminal additions. Since SEQ ID NO: 6 is 15 amino acids in length, a sequence that is at least about 95% identical would encompass up to 1 modification including any insertions, substitutions, deletions, etc.
Regarding claims 1 and 5, the Examiner is interpreting the scope of a synthetic peptide as requiring at least 95% sequence identity to SEQ ID NO: 6 (Applicants’ elected species), with any N-/C-terminal additions. Since SEQ ID NO: 6 is 15 amino acids in length, a sequence that is at least about 95% identical would encompass up to 1 modification including any insertions, substitutions, deletions, etc.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claims 1-2, 5 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 10,005,818 B2 Date of Patent Jun. 26, 2018 (cited in the IDS filed on 05/06/2024) (herein after “ Krishna et al.”), as evidenced by GenCore Sequence Alignment.
For claims 1-2 and 5, Krishna et al. disclose a synthetic peptide comprising at least about 90% sequence identity to the amino acid sequence of SEQ ID NO: 3-47 (see column 79, claim 1, lines 33-35). Kishna et al. also disclose SEQ ID NO: 11, which is 15 residues in length and includes sarcosine at position 8 (see pg. where the amino acid residue at position 8 is sarcosine (see column 61, last entry).
As evidenced by GenCore, instant SEQ ID NO:6 (i.e., Applicants’ elected species) is 98.6% identical to Krishna et al.’s SEQ ID NO: 11 (see GenCore Sequence Alignment). As such, the disclosure of Krishna et al. anticipates the instantly claimed synthetic peptide comprising at least about 95% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 6-13, as recited in instant claims 1; wherein the synthetic peptide of claim 1 comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 6-13, as recited in instant claim 2; and also anticipates the synthetic peptide of claim 1 consisting of an amino acid sequence comprising at least about 95% sequence identity to SEQ ID NO: 6, as recited in instant claim 5.
For claim 13, Krishna et al. claim a pharmaceutical composition comprising a therapeutically effective amount of the synthetic peptide of claim 1, and at least one pharmaceutically acceptable carrier, diluent, or excipient (see column 79, claim 5, lines 45-48). Therefore, Krishna et al.’s disclosure anticipate the claim limitations recited in instant claim 13.
Accordingly, instant claims 1-2, 5 and 13 are anticipated by the disclosure of Krishna et al.
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.
2. Claims 1-2, 5 and 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 10,005,818 B2 (here in after “Krishna et al.”).
Regarding instant claims 1-2 and 5, Krishna et al. claim:
A synthetic peptide comprising at least about 90% sequence identity to the amino acid sequence of SEQ ID NO: 3-47 (see Krishna et al., column 79, claim 1, lines 33-35).
Regarding instant claim 13, Krishna et al. claim:
A pharmaceutical composition comprising a therapeutically effective amount of the synthetic peptide of claim 1 and at least one pharmaceutically acceptable carrier, diluent, or excipient (see Krishna et al., column 79, claim 5, lines 45-48).
Although the claims are issue are not identical, they are not patentably distinct from each other.
3. Claims 1-2, 5 and 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of Copending Application No. 19/182,023, claim set filed on 04/17/2025 (here in after “023”), as evidenced by GenCore Sequence Alignment of instant SEQ ID NO: 6 v ‘023’s SEQ ID NO: 11.
Regarding instant claims 1-2 and 5, ‘023 claims:
A synthetic peptide comprising at least about 90% sequence identity to the amino acid sequence of SEQ ID NO: 3-47 (see ‘023, claim 1). As evidenced by the GenCore sequence alignment, instant SEQ ID NO: 6 is 98.6% percent identical to ‘023’s SEQ ID NO: 11.
Regarding instant claim 13, ‘023 claims:
A pharmaceutical composition comprising a therapeutically effective amount of the synthetic peptide of claim 1 and at least one pharmaceutically acceptable carrier, diluent, or excipient (see ‘023, claim 5).
Although the claims are issue are not identical, they are not patentably distinct from each other.
Conclusion
No claims are allowed.
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/CLAUDIA ESPINOSA/ Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654