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 .
Claim Status
Claim 44-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 17, 2025.
Claims 1, 3-5, 11, 13, and 15 are under consideration in this office action.
Withdrawn Objections/Rejections
Any objection or rejection of record pertaining to cancelled claim 14 is rendered moot by applicant’s cancellation of said claim.
The objection of claims 1, 4, and 15 are withdrawn in view of applicant’s amendment.
The rejection of claim 15 under 35 U.S.C. 101 is withdrawn in view of applicant’s amendment to substitute “method” for “use”.
The rejection of claims 1, 3-5, 11, and 13-15 under 35 U.S.C. 112(b) for being indefinite is withdrawn in view of applicant’s amendment.
The rejection of claims 1, 3-5, 11, and 13-15 under 35 U.S.C. 112(a) for failing to meet the written description requirement is withdrawn in view of applicant’s amendment to limit the tumor-specific antigen to HER2 and mesothelin.
The rejection of claims 1, 3-5, 11, 13, and 15 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Chang is withdrawn in view of applicant’s amendment to limit the tumor-specific antigen to HER2 and mesothelin.
Claim Objections
Claim 5 is objected to because of the following informalities:
Brain “gliomas” in claim 5 (ln 3) should be the singular “glioma” in order to be consistent with the other cancers listed in the claim. This objection is maintained because applicant failed to correct the informality.
New Rejection Necessitated by Amendment
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160361360A1, published December 15, 2016 (“Chang”; PTO-892 from 1/26/2026) in view of Ding et al, published November 6, 2019 (instant PTO-892).
The claims are directed to a method of treating cancer by administering IFN-g and a CAR-T cell preparation that targets the tumor-specific antigen HER2 or mesothelin.
Chang teaches compositions comprising CAR-T constructs [0011] and methods for the treatment of cancer in a subject [0182]. The targeting domain of the CAR-T construct may be directed to the tumor-specific antigen HER2 [0020], as in claim 1. The CAR-T cell therapy of Chang may be combined with one or more other immunomodulators to enhance the immune response, including interferon-g [0031], as in the interferon-g limitation of instant claim 1.
Regarding claim 11, Chang teaches that the CAR-T cell therapy may be used in combination with checkpoint inhibitors [0024], including the anti-PD1 antibody MK-3475 [0084] and the anti-PD-L1 antibody MPDL3280A ([0086], [0192]). While Chang does not provide alternate names for MK-3475 and MPDL3280A, it is known in the art that pembrolizumab is MK-3475 (pg 12, column 1, para 4) and atezolizumab is MPDL3280A (pg 11, column 2, para 3), as evidenced by Massari et al (PTO-892 from 1/26/2026). Therefore, Chang teaches the limitations of claims 11 and 13 directed to PD-L1 inhibitor atezolizumab and the PD-1 inhibitor pembrolizumab.
Chang teaches that the CAR-T therapy may be used for treating ovarian cancer, breast cancer, glioma, colorectal cancer, renal cancer, liver cancer, lung cancer, melanoma, and bladder cancer ([0026], [0193]), as in instant claims 5 and 15.
Chang teaches that anti-HER2 CAR-T cells are used for cancer therapy [0009] and that IFN-g can be administered with CAR-T cells [0077]. Although Chang teaches that IFN-g is used for the treatment of malignant osteopetrosis and chronic granulomatous disease, this reference does not teach a method of treating cancer with IFN-g.
Ding et al teaches that IFN-g is a crucial cytokine for innate and adaptive immunity and contributes to the antitumor immune response through its immunostimulatory and immunomodulatory effects (pg 2, column 1, para 2). IFN-g plays an essential role in improving therapeutic response to chemotherapy, radiation therapy, and anti-PD-1 therapy (pg 2, column 1, para 2-3). When administered in combination with the anti-PD-1 antibody, IFN-g facilitated antitumor immunity by stimulating T-cell proliferation and increasing cytotoxicity of T lymphocytes (pg 2, column 2, para 3). Combination treatment of IFN-g and the anti-PD-1 antibody nivolumab was associated with the greatest reduction in tumor volume (figure 4), demonstrating the utility of IFN-g in the treatment of subject having a tumor.
Because Chang teaches that anti-HER2 CAR-T cells are useful for treating cancer and Ding et teaches IFN-g and an immune checkpoint inhibitor for the treatment of cancer, it would have been obvious to one of ordinary skill in the art to select the anti-HER2 CART cells and IFN-g claimed for a method of treating patient with a solid tumor. Chang teaches the combination therapy of a CAR-T cell and an immunomodulator for the treatment of cancer and expressly identifies both anti-HER2 CAR-T cells and IFN-g as agents of each group, respectively. Although Chang provides multiple embodiments within each group, the selection of anti-HER2 CAR-T cells and IFN-g would have been an obvious choice among the disclosed alternatives in view of Ding et al, which teaches the utility of IFN-g in a method of treating cancer. Accordingly, a person of ordinary skill in the art looking to practice the combination therapy taught by Chang would have had reason to select IFN-g. The claimed combination involves the selection of known therapeutic agents for their known use in treating the same disease, and each element claimed is merely performing their known uses and predictable application of those elements.
While Chang is silent regarding the method sensitizing the tumor cell, upregulating ICAM-1, and enhancing the killing effect of claims 1 and 3-4, it is clear that the same patient population treated with the same combination of agents would have the same characteristics and effects as the instantly claimed composition since there is no evidence to the contrary.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-5, 11, 13, and 15 have been considered but are moot because the new ground of rejection does not rely on the specific combination of references in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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