DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group III and species “PDCD1” in the reply filed on 3/27/2026 is acknowledged. The traversal is on the ground(s) that the claims can be readily evaluated in one search without placing undue burden. This is not found persuasive because the groups are directed to products and methods and have distinct method steps, objectives, and materials that would require separate searches. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/27/2026.
Claims 24-31 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 - 35 USC § 102
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)(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.
Claims 24-31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wherry et al. (PgPub 2022/0211759).
The claims are drawn to a non-exhausted T cell that has been modified with an exogenous nucleic acid comprising any sequence encoding a TCR expressed in an exhausted T cell in a subject with cancer. The claim further recites “wherein the exhausted T cell expresses one or more exhaustion markers” OR “one or more surface proteins”, however this marker or surface protein is not required to be the same used to modify the non-exhausted T cell, it merely needs to be expressed by an exhausted T cell.
Wherry et al. teaches that T cell exhaustion is associated with an epigenetic and transcriptional profile that is separate and distinct from that seen in non-exhausted T cells. Wherry et al. discloses engineered T cell comprising one or more alterations in one or more high priority epigenetic pathways. In some embodiments, the alterations comprise genetic modifications introduced via genome engineering approaches or epigenetic modifications using inhibitors or activators of epigenetic regulators. In some embodiments, the high priority epigenetic pathway is or has been targeted to reverse or prevent exhaustion of the T cell (see paragraph [0147]). Wherry et al. disclose “transcriptional targets” which are exhausting-specific genes (see paragraph [0150]) including PDCD1 and TOX. Wherry et al. further discloses exhaustion-specific genes may encode regulatory proteins to maintain the exhaustion phenotype including PD1, Tim-3, LAG3 and CD39 (see paragraph [0147]). Wherry et al. teach obtaining autologous or allogeneic T cells and altering DNA sequence of one or more exhaustion-specific genes and engineering the T cells to target a therapeutically-relevant antigen (see claims). Wherry et al. teach exhausted T cell can be a CD4+ or CD8+ T cells (see paragraph [0100]). Wherry et al. teach each and every limitation of instant claims 24-31.
Conclusion
Claims 24-31 are rejected.
No claims are allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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