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 .
Status of Claims
Claims 1, 3-4, 6, 9, 14-17, 21, 24-25, 27, 32-33, 35-36, and 38-40 are pending. Claims 32, 33, 35, 36 and 38-40 are withdrawn as being directed to an unelected invention. Claims 1, 3-4, 6, 9 , 14-17, 21, 24, 25, and 27 are pending and under exam.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 112
Regarding claims 6 and 16, were rejected for reciting the phrase "such as."
The rejection is withdrawn following cancellation of indefinite language.
Claims 9 and 17 were rejected for reciting “T cells are conventional (CD4+, CD8+) T cells.”
The rejection is withdrawn following amendment of the claim language to indicate that the T-cells are CD4+ or CD8+ T-cells.
Claim Rejections - 35 USC § 102
Claims 1, 4, 9, 15 and 17 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murakami et al (Blood (2018) (Supplement 1): 5154; hereinafter "Murakami"; See PTO-892).
Claims 3, 21, 24-25 and 27 were rejected under 35 U.S.C. 102(a)(2) as being anticipated by PCT/US20/37333 (Published Dec 17, 2020, as supported by U.S. Provisional application 62/860,748 filed on Jun 12, 2019; hereinafter "Ports").
The rejection is withdrawn pursuant to Applicant amendment of the claim to recite in vitro pre-treatment with venetoclax for enhancing therapeutic efficacy of T cells. It is submitted that the cited art does not teach or suggest pre-treatment of CD4+ or CD8+ or DNT cells to obtain enhanced T-cells
Claim Rejections - 35 USC § 103
Claims 6, 14, and 16 were rejected under 35 U.S.C. 103 as being unpatentable over Murakami et al (Blood (2018) (Supplement 1): 5154; hereinafter "Murakami"; See PTO-892) in view of PCT/US20/37333 (Published Dec 17, 2020, as supported by U.S. Provisional application 62/860,748 filed on Jun 12, 2019; hereinafter "Ports").
The rejection is withdrawn pursuant to Applicant amendment of the claim to recite in vitro pre-treatment with venetoclax for enhancing therapeutic efficacy of T cells. It is submitted that the cited art does not teach or suggest pre-treatment of CD4+ or CD8+ or DNT cells to obtain enhanced T-cells
NEW REJECTIONS NECESSITATED BY CLAIM AMENDMENTS
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, 6, 9, 14-17, 21, 24-25, and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1: The claim requires pretreatment of CD4+ T cell, CD8+ T Cell with Venetoclax to produce enhanced T-cells.
While the specification provides adequate written description for pretreatment of double-negative T cells (DNTs) with Venetoclax, the specification does not reasonably convey possession of pretreatment of CD4⁺ and CD8⁺ T cells to enhance their therapeutic efficacy, as claimed.
Specifically, the specification discloses multiple examples in which DNT cells are pretreated ex vivo with Venetoclax under defined conditions (e.g., 50–400 nM for overnight or 18 hours), followed by demonstration of enhanced cytotoxic and anti-tumor activity against AML cell lines and primary patient samples, including persistence of enhanced effector function after removal of the drug (see, e.g., FIG. 2).
In contrast, with respect to CD8⁺ T cells, the specification merely describes contacting CD8⁺ T cells with Venetoclax for purposes of measuring cellular or mitochondrial reactive oxygen species (ROS) levels and memory phenotype distribution (see, e.g., FIG. 7). However, the specification does not disclose any experiments demonstrating enhanced cytotoxic activity, enhanced anti-tumor activity, or therapeutic efficacy of Venetoclax-pretreated CD8⁺ T cells, nor does it demonstrate that such treatment produces “enhanced T cells” as claimed. All functional cytotoxicity and anti-tumor activity data are limited to double-negative T cells.
Similarly, the specification does not provide any working examples or data demonstrating pretreatment of CD4⁺ T cells with Venetoclax resulting in enhanced cytotoxic or anti-tumor activity.
Although the specification defines “enhanced T cells” in functional terms and states that enhanced T cells “may be” conventional T cells, such generalized statements do not substitute for a disclosure demonstrating possession of the full claimed scope, particularly where the claimed embodiments involve biologically distinct T-cell subsets with different survival requirements and functional properties.
Accordingly, the specification fails to reasonably convey to a person of ordinary skill in the art that the inventors had possession of the claimed method as it pertains to CD4⁺ and CD8⁺ T cells.
Thus, Applicants were not in possession of the full scope of the claimed invention at the time of filing of the instant invention.
Claims 3-4, 6, 9, 14-17, 21, 24-25, and 27 are rejected for their dependency.
Conclusions
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 JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633