DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/2025 has been entered.
Accordingly, Claims 8, 19-23 have been previously withdrawn. Newly added claim 27 is withdrawn based on original election of species. Claims 1, 2, 11, 13, 18, and newly added claims 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, HIV antigen, HBV antigen, HCV 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), 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]). 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, HBV, and HCV (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, HBV, PSA, PSMA, STEAP, WT1, NYES01, tyrosinase and HCV and Lonberg et al. teach combining LAG3 antibodies and other vaccines, such as HPV, HBV, HCV, 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 12/11/2025 “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.“ 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 the “LAG-3 blockade is particularly useful against established infections by agents such as HIV that present altered antigens over the course of the infections. These novel epitopes are recognized as foreign at the time of anti-human LAG-3 administration, thus provoking a strong T cell response that is not dampened by negative signals through LAG-3” thus providing strong motivation to combine a LAG-3 antibody with a vaccine that encodes for an antigen recited in instant claim 1 as taught by Weiner et al. Furthermore, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two modes of treatment, each of which is taught by the prior art to be useful for the same purpose in order to make a protocol that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Therefore, the rejection of record is hereby maintained.
New Grounds of Rejection
(based on reconsideration)
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, 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.
All other objections/rejections are hereby withdrawn in view of applicants amendments to the
claims in the response filed 12/11/2025.
Conclusion
Claims 1, 2, 11, 13, 18, 24-26, 28, and 29 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643