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 Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Friedman (US PGPUB 2017/0218337, of record) as evidenced by Morath et al (J Leuk Biol, 2020, of record).
Friedman teaches methods of making T cells expressing CARs (encoded by a vector) by culturing said cells in the presence of an AKT inhibitor, such as MK-2206 (¶’s [0009] – [0010].
The Akt inhibitor may reduce Akt activity by at least 25% (¶’s [0217]-[0218], [0256]) and inhibit both Akt1 and Akt2 with an IC50 of less than 10000nM (¶’s [0218], [0246]-[0247]). The cells may be cultured with IL-2 or IL-15 (¶ [0207]). The expression vector may be viral and used to transduce the T cells (¶[0161]), which may be central memory T cells (¶[0179]-[0180]) and be enriched or expanded CD8+ T cells (¶ [0178]-[0179]). The CAR has a target binding domain, a CD8 or CD28 transmembrane domain, a CD28 costimulatory domain and a CD3zeta signaling domain (¶’s [0050]-[0053]). The CAR may have one or more of the costimulatory domains selected from CD28, 41BB and OX40 (¶[0050]). A hinge or spacer may be between the binding domain and the transmembrane domain (¶ [0263], [0289]). The binding domain may be an scFv (¶ [0287]), which may be directed to a tumor antigen (¶ [0263]). The Akt inhibitor may be added during both an activating and expansion stage (claim 1). The T cells of Friedman are considered to be alphabeta T cells (expressing a TCR with alpha and beta chains, ~95% of T cells), gammadelta T cells (TCR with gamma and delta chains, ~5% of T cells) or more likely, a mixture of both. See Morath et al.
Conclusion
No claim is allowed.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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