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 without traverse of Group I, claims 1-11 and 27-30 in the reply filed on 6/30/2026 is acknowledged.
Claims 31-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/30/2026.
Applicant’s response to species election of a peptide consisting of SEQ ID NO: 28 is shown as follows.
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The selected species reads on claims 1, 4-6. 11, 27-28, and 30; thus, claims 2-3, 7-10 and 29 are further withdrawn as directed to non-elected species.
Claim Status
Claims 1-11 and 27-33 are pending.
Claims 12-26 are cancelled.
Claims 2-3, 7-10, 29, and 31-33 are withdrawn as being directed to a non-elected invention, the election having been made on 6/30/2026.
Claims 1, 4 -6, 11, 27-28, and 30 have been examined.
Priority
This application is a DIV of 17/686,748 03/04/2022 ABN
17/686,748 is a DIV of 16/329,062 02/27/2019 ABN
16/329,062 is a 371 of PCT/JP2017/032079 09/06/2017
PCT/JP2017/032079 has PRO 62/384,333 09/07/2016
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/17/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 11, 27-28, and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 11 contain a peptide formula of LSSTQAQQSX1 (SEQ ID NO:34) without definition of X1, rendering the claims indefinite. Claims 2-6, 27-28, and 30 are further rejected as depending on claim
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 –
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.
Claims 1, 11, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peled et al. (US 2013/0130996 A1).
Claim 1 is drawn to a peptide comprising at least 5 consecutive amino acids from LSSTQAQQSXl (SEQ ID NO:34) and 8-12 amino acid in length.
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Peled et al. show a chemokine modulator peptide of SEQ ID NO: 110 comprising the underlined SSTQA with 12 amino acids in length (claims 1) as shown follows, reading on claim 1.
With respect to claim 11, Peled et al. teach the peptide further conjugated to an immunogenic agent [0111].
With respect to claim 27, Peled et al. teach the peptide is formulated with conventional pharmaceutical carriers [0101].
Claims 1, 11, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Faure et al. (US 2005/0267020 A1, cited in IDS).
Claim 1 is drawn to a peptide comprising at least 5 consecutive amino acids from LSSTQAQQSXl (SEQ ID NO:34) and 8-12 amino acid in length.
Faure et al. show a peptide sequence of TLSSSTQASL (SEQ ID NO: 14 in claim 11) consisting of 10 amino acid residues and comprising 5 consecutive amino acid of underlined SSTQA in claim 11), reading on the limitation of claim 34.
With respect to claim 11, Faure et al. teach the peptide linked to a carrier of a compound or a polypeptide [0046, claim 17].
With respect to claim 27, Faure et al. teach a pharmaceutical composition comprising the peptide and a pharmaceutical acceptable carrier of a natural or synthetic microparticle [0046].
Claims 1, 4-6, 11, 27-28 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2010-222300A (referred as JP-2010, English Translation attached).
Claim 1 is drawn to a peptide comprising at least 5 consecutive amino acids from LSSTQAQQSXl (SEQ ID NO:34) and 8-12 amino acid in length.
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JP-2010 shows a functional peptide sequence consisting of SSTQAQQS with 8 amino acid residues in length with 100% homology to the elected peptide species of SEQ ID NO: 28 as shown follows (Fig 23), reading on the limitations of claims 1 and 4-6.
With respect to claim 11, JP-2010 teaches the functional peptide of SSTQAQQS conjugated to carboxyacylchitosan (p61, DESCRIPTION OF EMBODIMENTS, para 2) or conjugated/immobilized to a chip (p64, 2nd last para).
With respect to claim 27, JP-2010 teaches a composition comprising the functional peptide and a pharmaceutically acceptable excipient of food or drink or food additive (p74, para 2).
With respect to claims 28 and 30, JP-2010 teaches a polypeptide-containing food composition comprising the functional peptide, e.g., SSTQAQQS, (p54, last 4 lines; p61, DESCRIPTION OF EMBODIMENTS, para 2). JP-2010 further teaches the peptide in a food additive (p74, para 2).
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, 4-6, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 18/720, 588 (the ‘588 application, 6/9/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘588 application disclosed various peptide sequences obvious to the instant claim 1.
Claims 1 and 3 of the ‘588 application disclosed a peptide comprising at least 5 consecutive amino acids from the peptide of LSSTQAQQS[YWF] in length of 5 to 15 amino acids or a pharmaceutically acceptable salt, satisfying the instant claims 1, 4-6, and 27.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-6, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. PCT/US22/81558 (the ‘558 application, 12/14/20252). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘558 application disclosed various peptide sequences obvious to the instant claim 1.
Claims 1 and 3 of the ‘588 application disclosed a peptide comprising at least 5 consecutive amino acids from the peptide of LSSTQAQQS[YWF] in length of 5 to 15 amino acids or a pharmaceutically acceptable salt, satisfying the instant claims 1, 4-6, and 27.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.L/Examiner, Art Unit 1658
03-September-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights