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 .
DETAILED ACTION
Claims 1-20 are pending.
Claims 1-20 are under examination on the merits.
Priority
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, 365(c), or 386(c) is acknowledged. Claims 1-20 have an effective filing date of 03/27/2015, corresponding to GB1505305.1
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/10/2023 and 04/07/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Notes on the Prior Art
Following a review of the prior art, it has been determined that the prior art does not teach or suggest a peptide consisting of the amino acid sequence GLAEFQENV (SEQ ID NO: 243) in the form of a pharmaceutically acceptable salt, nor does the prior art teach or suggest a pegylated peptide consisting of the amino acid sequence of GLAEFQENV (SEQ ID NO: 243) or a pharmaceutically acceptable salt thereof.
Claim Rejections
Nonstatutory 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 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,059,755.
With respect to claim 1, although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims recite a composition comprising a peptide in the form of a pharmaceutically acceptable salt and an adjuvant, wherein said peptide consists of the amino acid sequence GLAEFQENV (SEQ ID NO: 243).
With respect to claim 2, given that both sets of claims recite identical peptides, specifically, a peptide in the form of a pharmaceutically acceptable salt, wherein said peptide consists of the amino acid sequence GLAEFQENV (SEQ ID NO: 243), the peptide in both claim sets would be expected to bind to an MHC class-I molecule, and wherein said peptide, when bound to said MHC, is capable of being recognized by CD8 T cells.
Claims 3-13, 19, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,059,755, as applied to claims 1 and 2, in view of Flohr et al. (AU 2009201589, publication date: 11/12/2009).
With respect to claim 1, although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims recite a composition comprising a peptide in the form of a pharmaceutically acceptable salt and an adjuvant, wherein said peptide consists of the amino acid sequence GLAEFQENV (SEQ ID NO: 243).
With respect to claim 2, given that both sets of claims recite identical peptides, specifically, a peptide in the form of a pharmaceutically acceptable salt, wherein said peptide consists of the amino acid sequence GLAEFQENV (SEQ ID NO: 243), the peptide in both claim sets would be expected to bind to an MHC class-I molecule, and wherein said peptide, when bound to said MHC, is capable of being recognized by CD8 T cells.
At the Abstract, Flohr et al. teach that “[t]he present invention relates to novel formulations of tumour-associated peptides binding to human leukocyte antigen (HLA) class I or II molecules as vaccines for the use in immunotherapeutic methods. In particular, the present invention relates to formulations for the immunotherapy of cancer…” At p. 2, Flohr et al. teach pharmaceutical compositions comprising peptides or salts thereof. At p. 28, Flohr et al. teach pharmaceutical peptide compositions that comprise pharmaceutically acceptable carriers, such as aqueous carriers (which would contain water) and buffers, and Flohr et al. teach that said peptides may be administered with a cytokine. At p. 4 and 5, Flohr et al. teach various cytokines that may be used as adjuvants, including IL-2, IL-7, IL-12, IL-15, and IL-21. At p. 11, Flohr et al. teach that peptides of the invention may be chlorides or acetates.
One of ordinary skill in the art would have also been motivated to modify the conflicting claim to recite a peptide preparation in the form of a pharmaceutically acceptable salt, wherein the salt is a chloride or an acetate, because the resultant peptide preparation would be useful in cancer immunotherapy. The invention of the conflicting claims and Flohr et al. meets the limitations of claims 3 and 4.
One of ordinary skill in the art would have also been motivated to modify the conflicting claim to recite a peptide preparation in the form of a pharmaceutically acceptable salt that comprises an adjuvant, such as IL-2, IL-7, IL-12, IL-15, or IL-21, a buffer, and an aqueous carrier, because the resultant peptide preparation would be useful in cancer immunotherapy. Furthermore At p. 11, Flohr et al. teach that peptides of the invention may be chlorides or acetates. The invention of the conflicting claims and Flohr et al. meets the limitations of claims 5-13 and 20.
Claim 19 is included in this rejection, because it is a product-by-process claim that recites the pharmaceutically acceptable salt of claim 1 that is produced by solid phase peptide synthesis or produced by a yeast cell or bacterial cell expression system. According to MPEP 2113, Product-by process claims are not linited to the manipulations of the recited steps, only the structure implied by the steps - “[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….”
Therefore the claimed invention is prima facie obvious over the conflicting claim in view of Flohr et al.
Claims 14 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,059,755, as applied to claims 1 and 2, in view of Pfeifer et al. (WO 2007/068411, international publication date: 06/21/2007).
With respect to claim 1, although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims recite a composition comprising a peptide in the form of a pharmaceutically acceptable salt and an adjuvant, wherein said peptide consists of the amino acid sequence GLAEFQENV (SEQ ID NO: 243).
With respect to claim 2, given that both sets of claims recite identical peptides, specifically, a peptide in the form of a pharmaceutically acceptable salt, wherein said peptide consists of the amino acid sequence GLAEFQENV (SEQ ID NO: 243), the peptide in both claim sets would be expected to bind to an MHC class-I molecule, and wherein said peptide, when bound to said MHC, is capable of being recognized by CD8 T cells.
Pfeifer et al. teach that peptides may be modified to provide an enhanced antigenic effect via pegylation, see p. 45.
Based upon these teachings, one of ordinary skill in the art would have been motivated to modify the conflicting claim to recite a pegylated peptide preparation, because the resultant peptide preparation would be useful in cancer immunotherapy due to an enhanced antigenic effect. The invention of the conflicting claims and Pfeifer et al. meets the limitations of claim 14.
With respect to claim 18, at p. 67, Pfeifer et al. teach that peptide preparations may be stored in PBS (phosphate-buffered saline).
Therefore the claimed invention is prima facie obvious over the conflicting claim in view of Pfeifer et al.
Claims 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,059,755, in view of Pfeifer et al. (WO 2007/068411, international publication date: 06/21/2007), as applied to claims 1, 2, 14, and 18, and further in view of Flohr et al. (AU 2009201589, publication date: 11/12/2009).
The teachings of Pfeifer and Flohr et al. are detailed above.
As indicated above Pfeifer et al. teach that peptides may be modified to provide an enhanced antigenic effect via pegylation, see p. 45. Based upon these teachings, one of ordinary skill in the art would have been motivated to modify the conflicting claim to recite a pegylated peptide preparation, because the resultant peptide preparation would be useful in cancer immunotherapy due to an enhanced antigenic effect.
Furthermore one of ordinary skill in the art would have also been motivated to modify the invention of the conflicting claim and Pfeifer et al. to recite a peptide preparation in the form of a pharmaceutically acceptable salt, wherein the salt is a chloride or an acetate, because the resultant peptide preparation would be useful in cancer immunotherapy. The invention of the conflicting claims, Pfeifer et al., and Flohr et al. meets the limitations of claims 15 and 16.
With respect to claim 17, based upon the teachings of Flohr et al., one of ordinary skill in the art would have been motivated to modify the conflicting claim to recite a peptide preparation in the form of a pharmaceutically acceptable salt that comprises an adjuvant, a buffer, and an aqueous carrier, because the resultant pharmaceutical composition would be useful in cancer immunotherapy.
Therefore the claimed invention is prima facie obvious over the conflicting claim in view of Pfeifer et al. and Flohr et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F, 9:00-6:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642