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 II, 2, 4, 9-10 and 12 drawn to a combination comprising four antigens of SEQ ID NOS: 32, SEQ ID NO: 220, epitope of SEQ ID NO: 859, and the peptide comprising the SEQ ID NO: 255 with elected species A that is drawn to antigenic peptides in combination in the reply filed on 12/22/2025 is acknowledged.
Upon further considering the pending claims, because claim 2 is depended on claim 1, therefore, claim 1 and its depended claims 3-8 are rejoined with the elected group II are considered.
Claims 1-10 are considered with the elected species (A). 5, 5, 7-8 5
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, 3, 5, 7-8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 13, 18, 25-30 of U.S. Patent No. 12, 016,910 (910B1) in view of WO2013135553A1 (5553A1)
The rejection claims 1 and 3 are directed to a product drawn to a combination of three peptides comprising:(il) an antigenic peptide (a) having an amino acid sequence comprising or consisting of SEQ ID NO: 32, an antigenic peptide (b) having an amino acid sequence comprising or consisting of SEQ ID NO: 220, and a helper peptide having an amino acid sequence comprising or consisting of SEQ ID NO: 859, wherein the rejected claims 5, 7, 8 and 10 are drawn to a method for using the product cited in claims 1 and 3 for treating a cancel or initiating an enhancing or prolonging an anti-tumor-response in a subject in need thereof, wherein the cancer can be any one selected from glioma, kidney cancer, skin cancer, lung cancer, ovarian cancer ,breast cancer, colorectal cancer, liver cancer, pancreatic cancer, head and neck cancer, urothelial cancer, and prostate cancer.
The reference claims 12-13, 18 are also drawn to a product of combination of the peptides comprising or consisting of SEQ ID NO: 32 and 220 , wherein the claims 25-30 are drawn to a method for treating a cancer using the product cited above, wherein the cancer can be one selected from glioma, kidney cancer, skin cancer, lung cancer, ovarian cancer ,breast cancer, colorectal cancer, liver cancer, pancreatic cancer, head and neck cancer, urothelial cancer, and prostate cancer.
However, the reference claims do not teach using the help peptide of UCP2 comprising or consisting of the short peptide with 15 amino acid residues , i.e. KSVWSKLQSIGIRQH set forth in SEQ ID NO: 859 as the most preferable adjuvant peptide of the universal cancer peptides (UCP) to produce an enhanced immune response against a cancer with UCPs neoepitopes.
WO “5553A1” disclose a series of T cell helper peptides for UCPs with 15 to 20 amino acids deriving from human telomerase reverse transcriptase, which peptide is capable of (i) binding to HLA class II and (ii) stimulating a CD4 Th response, wherein one of the peptide derived comprising, or consisting of, an amino acid sequence selected from the group consisting of KSVWSKLQSIGIRQH (SEQ ID NO: 1 ), which has 100% identity to the claimed T cell helper peptide.(Abstract and claims. Furthermore, WO “5553A1” also teaches that the first aspect of the invention is thus a peptide of 15 to 20 amino acids deriving from human telomerase reverse transcriptase, which peptide is capable of (i) binding to HLA class II and (ii) stimulating a CD4 Th response. In a most preferred embodiment, the peptide comprises, or consists of, an amino acid sequence selected from the group consisting of KSVWS KLQS I G I RQ H (SEQ ID NO: 1). Therefore, it would have been obvious for any person with an ordinarily skill in the art to be motivated by combining the teachings from the references claims drawn to the produces comprising the combination of the peptides comprising or consisting of SEQ ID NO: 32 and 220 and the T cell help peptide disclosed by Patent “0680B2” for treating a cancer with a reasonable expectation of the success. (Summary of the invention and Claims 1 and 13-15). Hence, the rejected claims 1, 3, 5, 7-8 and 10 are not considered to be patentable distinct over the reference claims 12-13 and 18-25 furth in view of teaching by WO “5553A1” for any person ordinarily skilled in the art.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671