DETAILED ACTION
Applicants claim amendments in the response filed 7/13/2026 are acknowledged and entered into the record.
Accordingly, Claims 8, 19-23 and 27 have been previously withdrawn.
Claims 1, 2, 11, 13, 18, 24-26, 28, 29 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections Maintained - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 2, 11, 13, 18, 24-26, 28, and 29 are rejected under 35 U.S.C. 103 as being obvious over Weiner et al. (WO/2014/144885, listed on IDS filed 8/5/2024) in view of Lonberg et al. (US Patent 9,505,839).
The claims are drawn to a composition for enhancing an immune response against an antigen in a subject in need thereof comprising a monoclonal LAG-3 antibody and a HPV antigen, prostate antigen, RSV antigen, influenza antigen, Plasmodium falciparum antigen, C. difficile, and tumor antigen encoded by a nucleic acid molecule.
Weiner et al. teach increasing immune response in a subject in need thereof by administering a combination of a vaccine comprising one or more nucleic acid or amino acid sequences of cancer antigens that are no longer self-antigens and stimulate an immune response, such as HPV (including HPV16), PSA, PSMA, STEAP, WT1, NYES01, tyrosinase and HCV (including E1 and E2), and a checkpoint inhibitor. Weiner et al. teach when the vaccine is combined with checkpoint inhibitors it increases the stimulation of both the cellular and humoral immune responses and using checkpoint inhibitor antibodies prevents suppression of T-cell and/or B-cell response and the cancer antigens to be recognized by the immune system helps to overcome other forms of immune suppression by tumor cells (see paragraph [0026]). Weiner et al. does not teach using a monoclonal LAG3 antibody as the checkpoint inhibitor. This deficiency is made up for by Lonberg et al.
Lonberg et al. teach blockade of LAG3 by monoclonal antibodies can enhance the immune response and can be used in conjunction with other immunogenic agents and discloses LAG-3 blockade is likely to be more effective when combined with a vaccination protocol. Lonberg et al. discloses examples of tumor vaccines that can be used include peptides of melanoma antigens, such as MAGE and/or tyrosinase (see paragraph [160]) and proteins from viruses including HPV (see paragraph [164]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to make a composition comprising a combination of a monoclonal anti-LAG3 checkpoint inhibitor antibody with an antigen vaccine protocol to enhance immune response based on the teachings of Weiner et al. and Lonberg et al. Wiener et al. teach successful immune response by the combination of checkpoint inhibitors and antigens HPV, PSA, PSMA, STEAP, WT1, NYES01, tyrosinase and HCV and Lonberg et al. teach combining LAG3 antibodies and other vaccines, such as HPV, can enhance immune response. Therefore, one of ordinary skill in the art would be motivated to use checkpoint inhibitor antibodies in combination with antigen vaccines to arrive at the claimed composition, for increased immune response in a subject in need thereof.
Response to Arguments
Applicant's argue in the response filed 7/13/2026 “Weiner does not teach using a monoclonal LAG3 antibody as the checkpoint inhibitor whatsoever” and “in seeking information about the LAG3 antibody, including its compatibility of use with antigens, would not find such information in Weiner-- and would thus look to the disclosure of Lonberg.” Applicant’s further argue in view of Weiner “a skilled artisan will not be able to predict exactly which antigen to combine with the LAG3 antibody with a reasonable expectation of success” because Weiner is silent on LAG3 antibodies. Applicant’s argue Lonberg does not disclose that the LAG3 antibody can be used in conjunction with a synthetic antigen selected from the group recited in instant claim 1. Applicants argue that while In re Kerkhoven might be applicable to two modes of treatment, each of which is taught by the prior art to be useful for the same purpose, a skilled artisan will appreciate that the claimed subject matter is made up of distinct components, i.e. monoclonal antibody and antigen, which have distinct individual purposes. These arguments have been fully considered but they are not persuasive.
Both Weiner et al. and Lonberg et al. are drawn to combination treatment with the objective to stimulate the immune response while targeting a particular antigen. Lonberg et al. specifically disclose a method comprising administering a vaccine comprising one or more nucleic acid sequences targeting a cancer antigen or viral antigen that are no longer self-antigens and stimulate an immune response and a checkpoint inhibitor antibody (see claims of Lonberg et al.). Weiner et al. disclose a method comprising administering a checkpoint inhibitor antibody, anti-LAG3, in combination with tumor vaccines and are in fact more effective when combined (see paragraph [162]) and enhances the immune response against the vaccine. Both references clearly teach the combination of a vaccine antigen and a checkpoint inhibitor antibody and the motivation to combine such to enhance an immune response therapeutically. Although the two components are not structurally the same they are both taught by Lonberg et al. and Weiner et al. to be used therapeutically to enhance an immune response, therefore one of ordinary skill in the art would be motivated with a reasonable expectation of success to combine anti-LAG3 with a vaccine comprising one or more nucleic acid sequences targeting a cancer antigen or viral antigen for an enhanced therapeutic immune response. The rejection of record is hereby maintained.
Double Patenting Maintained
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, 2, 11, 13, 18, 24-26, 28, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,116,838 in view of Weiner et al. (WO/2014/144885).
The claims of US Patent 11,116,838 are drawn to a composition comprising a monoclonal TIM-3 antibody or monoclonal LAG-3 antibody and a nucleic acid molecule comprising a nucleotide sequence encoding a synthetic hTERT antigen. The claims of US Patent 11,116,838 do not teach the combination with the recited antigens in instant claim 1, but this deficiency is made up for by Weiner et al.
Weiner et al. teach increasing immune response in a subject in need thereof by administering a combination of a vaccine comprising one or more nucleic acid or amino acid sequences of cancer antigens that are no longer self-antigens and stimulate an immune response, such as HPV (including HPV16), HIV, HBV (including HBV surface antigen), PSA, PSMA, STEAP, WT1, NYES01, tyrosinase and HCV (including E1 and E2), and a checkpoint inhibitor. Weiner et al. teach when the vaccine is combined with checkpoint inhibitors it increases the stimulation of both the cellular and humoral immune responses and using checkpoint inhibitor antibodies prevents suppression of T-cell and/or B-cell response and the cancer antigens to be recognized by the immune system helps to overcome other forms of immune suppression by tumor cells (see paragraph [0026]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to make a composition comprising a monoclonal anti-LAG3 antibody and to substitute the hTERT encoded antigen recited in the claims of US Patent 11,116,838 with an encoded antigen of instant claim 1 based on the teachings of Weiner et al. Weiner et al. teach successful immune response by the combination of checkpoint inhibitors and antigens HPV, HBV, PSA, PSMA, STEAP, WT1, NYES01, tyrosinase and HCV to enhance immune response. Therefore, one of ordinary skill in the art would be motivated to make compositions comprising a LAG-3 monoclonal antibody in combination with other antigen vaccines to arrive at the claimed composition, for increased immune response in a subject in need thereof.
Response to Arguments
Applicant's argue in the response filed 7/13/2026 “because no claims have been found to be allowable in the present application, Applicants respectfully request that this rejection be held in abeyance until such time as claims are found to be otherwise allowable. Therefore, the rejection is hereby maintained.
Conclusion
Claims 1, 2, 11, 13, 18, 24-26, 28, and 29 are rejected.
No Claim is allowed.
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 MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner can normally be reached on M-F 9AM - 5PM.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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