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 are pending and being examined on the merit.
Examiner attempted to reach the applicant for a terminal disclaimer, but was unsuccessful in connecting with the applicant. Thus, the following office action is issued.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11357797B2 in view of Stevanovioc et al. (WO2009/138236, IDS entered on 3/17/2023). Although the claims at issue are not identical, they are not patentably distinct from each other.
The patented claims are directed to a method treating cancer comprised of administering a peptide consisting of SEQ ID NO:85, which is the same as the instant claimed peptide. A claimed product is obvious over a patented method comprising the product. Therefore, the instant claims are not patentably distinct from the issued claims.
The only different between the patent claims and the instant application is the formulation of the peptide in pharmaceutically acceptable salts, chloride salt, acetate salt, the peptide being pegylated and the formation of the peptide in adjuvants. However these deficiencies are made up in Stevanovioc.
Stevanovioc discloses methods of treating a patient who has cancer or a methods 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 in formulations containing acetate salts, chloride salts (page 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 diluents (page 59), Ringer’s, saline and dextrose solution (page 36) and adjuvants (pages 56-58), wherein the adjuvants includes IL-2, IL-7, IL12, IL-15, and IL-21 (pages 57-58, bridging paragraph).
Thus, since both the patent claims and the reference disclose a method of treating a patient who has cancer or a methods 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 and since the peptides in the reference can be in formulations containing acetate salts, chloride salts, buffers and diluents, Ringer's, saline, dextrose solution and adjuvants, wherein the adjuvants includes IL-2, IL-7, IL12, IL-15, and IL-21, 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 formulations and with adjuvants, including IL-2, IL-7, IL12, IL-15, and IL-21, because Stevanovioc teaches that antigen peptides can be formulated in such a manner. Regarding claim 19, the peptide that is administered in the composition is the same as the peptide that is produced by a bacterial cell expression system. One of ordinary skill in the art before the effective filing date would have had a reasonable expectation of success for formulating a peptide comprising SEQ ID NO:85 with a pharmaceutically acceptable salt (including acetate salts or chloride salts), buffers and diluents, Ringer's, saline, dextrose solution and adjuvants, wherein the adjuvants includes IL-2, IL-7, IL12, IL-15, and IL-21, and since the peptide can be pegylated to extend circulatory half-life, and adjuvants, including IL-2, IL-7, IL12, IL-15, and IL-21, can be formulated with peptide antigens.
Allowable Subject Matter
The claims are free from the art of record because the prior art neither teaches nor suggests a peptide consisting of SEQ ID NO:85. The closest prior art is Mintz (US20070083334A1) discloses SEQ ID NO:985269, which is 63 amino acids which comprises a which residues 34-42 reads on instant SEQ ID NO:85. The instantly claimed peptide is claimed using closed language and therefore is limited to a length of 9 amino acids. Thus, peptide in the reference is does not anticipate nor is it obvious over the instant claimed peptide consisting of SEQ ID NO:85.
Further, the instant claimed composition is not a natural product because it is formulated in a pharmaceutically acceptable salt as read in light of the instant specification. Instant specification on page 52:
“a pharmaceutically acceptable salt” refers to a derivative of the disclosed peptides wherein the peptide is modified by making acid or base salts of the agent. For example, acid salts are prepared from the free base (typically wherein the neutral form of the drug has a neutral -NH2 group) involving reaction with a suitable acid. Suitable acids for preparing acid salts include both organic acids, e.g., acetic acid, propionic acid, glycolic acid, pyruvic acid, oxalic acid, malic acid, malonic acid, succinic acid, maleic acid, fumaric acid, tartaric acid, citric acid, benzoic acid, cinnamic acid, mandelic acid, methane sulfonic acid, ethane sulfonic acid, p-toluenesulfonic acid, salicylic acid, and the like, as well as inorganic acids, e.g., hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid phosphoric acid and the like. Conversely, preparation of basic salts of acid moieties which may be present on a peptide are prepared using a pharmaceutically acceptable base such as sodium hydroxide, potassium hydroxide, ammonium hydroxide, calcium hydroxide, trimethylamine or the like.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE WU whose telephone number is (571)272-5205. The examiner can normally be reached M-F 9-5PM.
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/JULIE WU/Supervisory Patent Examiner, Art Unit 1643