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 .
ETAILED ACTION
Claims 1-20 are pending in the instant application.
Priority
This application is a Divisional of 17489557, filed on 9/29/2021 which claims priority to the provisional application 63084963 filed on 9/29/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 12/5/2023 complies with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Interpretation
The term “sustained release preparation” in claims 16-17 was interpreted as “semipermeable matrices of solid hydrophobic polymers” and “matrices are in the form of shaped articles, e.g., films, liposomes or microparticles” as described in the instant specification (pg 75, para 3).
Objections to the Claims
Claim 18 contains a nested list that is not delineated. Please add a comma after “synthesis”.
Claim Rejections – 35 USC § 112(b)
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 2-3 and 13-14 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.
Claim 2-3, 13-14
Claims 2-3 and 13-14 are drawn to “wherein the pharmaceutically acceptable salt is chloride/acetate salt”. The lack of an article after “is” generates confusion, as does the difference in language when compared to claims 5-6 which recite “wherein the peptide is in the form of a chloride salt”. It is unclear in claims 2-3 and 13-14 whether applicant is invoking an additional pharmaceutically acceptable salt that is not ionically bonded to the peptide (e.g. sodium chloride) to the composition or whether applicant is claiming the salt of the peptide (e.g. the chloride as described in claim 5). Because of these multiple interpretations, these claims are rendered indefinite.
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.
US1197716
Claims 12-15 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11957716. Although the claims at issue are not identical, they are not patentably distinct from each other as described in the claim-by-claim analysis.
Regarding instant claim 12, the reference claims a pegylated peptide consisting of the amino acid sequence of VFLLLPYPRF (SEQ ID NO: 31) (claim 24).
Regarding instant claim 13, the reference claims the chloride salt of said peptide (claim 25).
Regarding instant claim 14, the reference claims the acetate salt of said peptide (claim 26).
Regarding instant claim 15, the reference claims a composition comprising the pegylated peptide and a pharmaceutically acceptable carrier (claim 27).
Regarding instant claim 17, the reference claims the pharmaceutically acceptable carrier is saline, Ringer's solution, dextrose solution, and sustained release preparation (claim 13).
No Non-Statutory Double Patenting Rejection Made on Claims 1-11, 16, and 18-20
The instant application is a Divisional of parent application 17/489557, now U.S. Patent No. 11833195 (issued on 12/5/2023) that was made in response to a restriction requirement mailed on 2/21/2023. The instant application was filed on 12/5/2023 and is drawn to a composition comprising the same peptide as the method in co-pending patent application 18/543993 (filed on 12/18/2023). The instant application is afforded protection under 35 U.S.C. 121 because:
The instant application is drawn to a composition comprising the peptide GVDDTSLLY and the reference application (18/543993) is drawn to a method of using the peptide GVDDTSLLY, wherein both applications are divisionals of parent application 17/489557, which recognized the peptides and the methods of using the peptides as distinct and separate inventions according to the restriction requirement.
As a result of meeting these criteria, claims 1-11, 16, 18-20 of the instant application are prohibited from Nonstatutory Double Patenting rejections. For further details, please see MPEP § 804.01.
Allowable Subject Matter
Claims 1-20 are considered allowable over the prior art. The following is an examiner’s statement of reasons for allowance:
claim 1, 12, 20
Base claims 1 and 20 are drawn to composition comprising a pharmaceutically acceptable salt of a peptide that consists of instant SEQ ID NO: 91, GVDDTSLLY. Base claim 12 is drawn to a composition comprising a PEGylated peptide that consists of instant SEQ ID NO: 31, VFLLLPYPRF. These two peptides were not found in the prior art.
The closest prior art to SEQ ID NO: 91 is that of Nguyen et al. (US11421016; SEQ ID NO: 645498) who teaches the cancer neoepitope, shown below.
instant_91 GVDDTSLLY 9
Nguyen_645498 LGGGTSLLY 9
..*****
The closest prior art to SEQ ID NO: 31 is that of Nguyen et al. (US11421016; SEQ ID NO: 163099) who teaches the cancer neoepitope, shown below.
instant_31 ---VFLLLPYPRF 10
Nguyen_163099 PPQSFLLLP---- 9
*****
No where does Nguyen suggest modifying the disclosed peptides to generate the instantly claimed sequences. Nguyen et al. (US11421016, SEQ ID NOs: 1-1,408,729) teaches small cancer neoepitopes which are able to be presented by major histocompatibility complex class I (MHC-I) molecules(col 4, para 2) in order to elicit an immune response toward cancer cells of a subject; however the sequences of Nguyen, at best, match 55% of the residues contained within instant SEQ ID NOs: 91 and 31. Importantly, Nguyen teaches that not every peptide elicits an immune response (col 3, para 1), thus to arrive at effective neoantigen peptides, several screens were performed to select peptides with sufficient binding affinity, sufficient strength of expression, and proper sub-cellular location (col 2, para 5).
Given the substantial number of functional neoepitopes disclosed by Nguyen, one of skill in the art would not have been motivated to mutate a given sequence taught by this reference and have any reasonable expectation of success that it would function as a cancer neoepitope, given the unpredictability of the immune response generated by a given peptide. In essence, Nguyen teaches such amino acid changes are unpredictable, thus there was no guidance to arrive at the specific peptide recited, given the art of record.
Claims 2-20
The remaining claims, claims 2-11 and 13-19, are all dependent on either claim 1 or 12, which requires the inclusion of one of the novel peptides mentioned previously. Thus are also rendered allowable over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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