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 .
Response
Applicant's response and amendment filed on 8/26/2025 have been acknowledged.
The status of claims
Claim 1 has been amended.
New claim 21 has been added.
Claims 10 and 14 have been canceled.
Claims 1-9, 11-13 and 15-21 are pending.
Claims 1-9, 10-13 and 15-21 with elected species of a). ipilimumab, iv). Immunotherapy , SEQ ID NO: 209, 210 and 151 are considered.
Remark
Claims amendment and Response to the restriction requirement filed on 2/27/2025 have been acknowledged. New claims 6-20 have been added.
Claims 1-20 are pending and considered with the elected species of a). ipilimumab, iv). Immunotherapy and considered
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.
The rejection of Claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over 1-36 of U.S. Patent No. 11,285, 203B2. Has been removed because a Terminal Disclaimer has been field and accepted.
The rejection of Claims 1, 11 and 13-16 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 12-14 and of U.S. Patent No. 11,560,408B2 has been removed because a terminal Disclaimer has been filed and accepted.
Claims 1-9, 11-14, 15-21 are still rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 13-14 of U.S. Patent No. 11,944,677B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflict claims are obvious each from other for an artisan ordinarily skill in the art.
In the response, Applicants traversed the rejection by asserting that the filling date of U.S. Patent No. 11,944,677B2 has later filling date compared to the current one.
Applicants’ argumenta’s been respectfully considered; however, it is not found persuasive, because the originally filling dates for both current Application and U.S. Patent No. 11,944,677B2 are same. The current Application is also a continuation of the US patent No. 11,944,677B2, which is filed on March 25, 2023, whereas the current Application was filed on March 29, 2024.
To this context, the Terminal Disclaimer are still required to file in order to overcome the double patenting rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-9, 13-14, 16-17, 19 and 21 are still rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0260792 ( “792”) in view of US Application No. 2014/0050753 (“753”) and US Application No. 2018/0311374 (“374”).
Applicants traverse the rejection by submitting that the reference does not teach the limitation newly added, i.e. the heterologous antigen(s) taught by the prior art comprises at least one antigen binds to a MHCI or MHCII molecule.
Applicants’ argument has been respectfully considered however, it is not found persuasive because reference “792” teaches that the RSV protein comprises a first epitope, which is capable of generating a Th1-assocaited CTL response, and a Th1 dominant immune response. Usually, the adaptive immune system, CTL is type of T cell that kills target cells and recognize its specific antigen epitope via MHCI and MHCII. Molecules In the immunological reaction, breakdown of the key roles of each MHC class in the RSV Th1 CTL response . CTLs are a subset of T cells defined by the CD8 co-receptor. For CTLs to be activated and kill a virus-infected cell, they must be presented with viral antigens through the MHCI pathway. If the CTL is properly activated by recognizing the viral antigen on the MHCI molecule, it will induce the death of the infected cell to stop the virus from spreading. In RSV, MHCI-restricted CTLs recognize peptides from proteins like the F, N, and M2 proteins, This therapy is evidenced by Tripp et al. (Journal of Virology, 1998, Vol. 72 (11), pages 8971-8975).
Therefore, this rejection is maintained and potentiated by Tripp, as described above (See the teaching by Tripp et al. page 1 and also Tables 1-4).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAO Q LI whose telephone number is (571)272-0904. The examiner can normally be reached M-F 8 am to 8 pm EST.
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
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