DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/12/2026 has been entered.
Claims 1-2 and 5-19 are pending.
Claims 13-19 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/15/2025.
Claims 1-2 and 5-12 are presently under consideration.
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claims 1-2 and 6-19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Fuchs et al. (US 20200163997).
Fuchs teaches that infusion of allogeneic lymphocytes containing CD4+ T cells can break tolerance in host anti-tumor CD8+ T cells, even though the donor cells do not engraft long term in the recipient; and an infusion of alloreactive CD4+ T cells can reverse exhaustion of endogenous, tumor-specific CD8+ T cells resulting in tumor regression [0012]. In particular, Fuchs teaches treating cancer by infusion of activated Th1 CD4+ T cells (e.g. [0170]) followed by administration of an agent that blocks negative signaling in T-cells such as anti-CTLA-4 antibody ipilimumab or anti-PD-1 antibody nivolumab (e.g. [0096], [0009]). CD4+ T cells are activated and expanded further using beads coated with anti-CD3 and anti-CD28 (e.g. [0189]). Fuchs exemplifies colorectal cancer as one of the cancer treatable by the method (e.g. [0075]). Accordingly, Fuchs teaches the limitations of claims 1-2, 8, 10 and 12, while the limitations of claims 6-7, 9 and 11 are inherent in Fuchs’ teachings.
5. 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 of this title, 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.
6. Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Fuchs et al. (US 20200163997) in view of Kananathan et al. (2020; of record).
Fuchs teaches the method of claim 1, as articulated in section 4 above.
While Fuchs does not specifically exemplify tumors proficient in DNA mismatch repair or microsatellite stable tumors, Kananathan specifically points out AlloStim(R) treatment, i.e. administration of the same activated allogeneic CD4+ T-cells as presently recited, convers “cold” microsatellite stable tumors to inflamed phenotype responsive to immune checkpoint inhibitor therapy. This would have provided both the motivation and the expectation of success to those skilled in the art before the effective filing date of the claimed invention to apply Fuchs’ treatment method specifically to microsatellite stable tumors.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
7. Conclusion: no claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
