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 .
Claims 1-20, (4/7/2023,) are pending and under consideration by the Examiner.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 9/10/2024, 8/16/2023, and 4/7/2023, are in compliance with the provisions of 37 CFR 1.97 and have been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
Claim Rejections - 35 USC § 101
There is no rejection under 35 USC 101 for the instant set of claims because the specification, on page 61, defines the term “pharmaceutically acceptable salt” as “a derivative of the disclosed peptides wherein the peptide is modified by making acid or base salts of the agent.” Thus, this specific definition makes the claimed peptide different from the natural peptide and, thus, the claimed peptide is NOT directed to a natural product.
Claim Rejections - 35 U.S.C. § 112 second paragraph
5. 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.
5a. Claims 5-13 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 pre-AIA the applicant regards as the invention.
Claim 5 is vague and indefinite because it is confusing and should correctly recite “a composition of claim 1 and a pharmaceutically acceptable carrier”.
Claim 8 is vague and indefinite because it is confusing and should correctly recite “the composition of claim 5 further comprising an adjuvant selected from the group consisting of….”.
Claims 6-7, and 9-13 are rejected as vague and indefinite insofar as they depend on rejected claims 5 and 8 for their limitations.
Claim rejections-Provisional Double Patenting
Non-statutory double patenting rejection (obviousness-type)
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 claims at issue 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); and 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
6a. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,836,806 (‘806) in view of Stevanovic et al WO 2009/138236.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of the ‘806 patent (having five common inventors with the instant application), claims a method of eliciting an immune response in a patient who has cancer, comprising administering to said patient a population of activated T cells that express a peptide, wherein said peptide consists of the amino acid sequence of SEQ ID NO: 296 (which is identical to Applicant’s SEQ ID NO: 296), wherein the peptide is in a complex with a MHC molecule. The method claims also use the peptide in a composition with adjuvants (including those listed in Applicant’s claims 8-13). The only difference between the patent claims and the claims in the instant application is the formulation of the peptide as pharmaceutically acceptable salts (chloride salt, acetate sale), the compositions comprising buffer and water, saline, Ringer’s solution, dextrose solution, sustained release preparations, and the peptide being pegylated.
Stevanovic et al discloses a method of treating a patient who has cancer or a method of eliciting an immune response in a cancer patient, comprising administering to said patient a composition comprising a population of activated T cells that selectively recognize cells in the patient that aberrantly express a peptide wherein the peptide is in a complex with MHC (see summary, page 56 and entire reference). The reference also discloses that the peptides can be modified by making acids or base salts of the peptide and these salts include acetate salts and chloride salts (page 24-25). The reference also discloses that the peptides can be pegylated to extend circulatory half-life. The peptides can be also be in compositions containing, buffers and water (page 59), saline, Ringer’s solution, dextrose solution, sustained release preparations (page 36-39) and adjuvants, including those listed in applicant’s claims 9-13 (pages 56-58).
Thus, since both the patent claims and the reference disclose a method of eliciting an immune response in a cancer patient, comprising administering to said patient a composition comprising a population of activated T cells that express a peptide wherein the peptide is in a complex with MHC and since the peptides in the reference can be in pharmaceutically acceptable salt forms such as acetate salts, chloride salts, and in buffers, adjuvants and water, saline, Ringer’s solution, dextrose solution, sustained release preparations and since the peptide can be pegylated to extend circulatory half-life, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the peptide in the salts and formulations as disclosed in the reference.
With respect to claim 19, this is a product-by-process claim. MPEP 2113(I) states ““[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Thus, claim 19 is being examined as a product claim.
The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
Claims Free from Prior Art
The closest prior art is US Patent No. 11,419,925 (‘295). Amino acids 235-242 of SEQ ID NO:18 (526 amino acids) in ‘295 is identical to Applicant’s SEQ ID NO: 296 (8 amino acids). Since the peptide in the instant set of claims is claimed using closed language, the claimed peptide is limited to a length of 8 amino acids. Since the length of the peptide in ‘295 is 526 amino acids and the instantly claimed peptide is limited to 8 amino acids, the patent is not prior art.
Conclusion
No claim is allowable.
Claims 1-20 are rejected.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1646