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
In the reply filed 12 December 2025, Applicant has amended claims 1 and 67. Claims 3-28, 33, 35, 39-47, 50-57, 59-62, 64, 66, 70, 72-73, 75, 77, 79-81, 83-85, 87-88, 91-100, 103, 105-112, 115-122, 124-128, 130-133, 135-136, 138-144, 147-149, 151, 153, 155-157 are cancelled and claims 145, 146, 150, and 154 stand withdrawn.
Therefore, 1, 2, 29-32, 34, 36-38, 48, 49, 58, 63, 65, 67-69, 71, 74, 76, 78, 82, 86, 89, 90, 101, 102, 104, 113, 114, 123, 129, 134, 137, 145, 146, 150, 154, 158, and 159 are herein pending.
Election/Restrictions
Applicant previously elected without traverse of Group I, claims 1, 2, 29-32, 34, 36-38, 48, 49, 58, 63, 65, 67-69, 71, 74, 76, 78, 82, 86, 89, 90, 101, 102, 104, 113, 114, 123, 129, 134, 137, 158, and 159 drawn to a method for manufacturing tumor reactive T cells, in the reply filed on 25 April 2025.
Claims 145-146,150,154 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 2, 29-32, 34, 36-38, 48-49, 58, 63, 65, 67-69, 71, 74, 76, 78, 82, 86, 89, 90, 101, 102, 104, 113, 114, 123, 129, 134, 137, 158, and 159 are under examination.
Priority
This application was filed 09/28/2021 and is a 371 application of PCT/US2020/025541 filed on 03/27/2020, which claims benefit to the Provisional Application 62978298, 62941610, and 62826974 filled on 02/18/2020, 11/27/2019 and 03/29/2019 respectively. Thus, the earliest possible priority for the instant application is 03/29/2019.
Withdrawn Claim Objections
The objection to Claims 1 and 67 have been withdrawn due to applicant’s amendment.
Maintained Claim Rejections - 35 USC § 102
Claims 1, 2, 36-38, 49, 63, 65, 76, 78, 82, 86, 89, 90, 101-102, 104, 113-114, 123, 129, 134, 137, and 158-159 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yossef et al., (JCI Insight. 2018;3(19): e122467; Cited in IDS filed 06/01/2022; hereinafter “Yossef”). This rejection is maintained for reasons of record set for the in the office action mailed on 06/12/2025. Further explained below.
Response to Traversal
Applicant's arguments filed on 12 December 2025 are acknowledged.
Applicant argues that Yossef et al. conduct a method that includes all the ordered steps as described. The Patent Office has taken disparate disclosures and combined them into a singular method that is not described in Yossef. In particular, the claimed method involves particular culture steps that include expanding the T cells (step (a)) and co-culturing with APCs that present neoantigen peptides (step (b)) prior to enriching from the co-culture a population of tumor reactive T cells (step (c)). By contrast Yossef et al. directly selects T cells based on certain markers (PD-1 for example). Yossef et al. then expands cells in microwells to identify enriched reactive T cells and ends the process by sequencing of TCRs and Yossef et al., teaches that the isolated TCRs can be used for the purpose of engineering the identified TCR into T cells to generate a personalized, neoantigen targeted TCR-gene therapy. See remark p. 10 last ¶ to p. 11 1st ¶.
Applicant's arguments have been fully considered but they are not persuasive. Regarding the claim 1 “wherein one or more steps of the culturing is carried out in the presence of at least one of a T cell adjuvant that is an apoptosis inhibitor that inhibits caspase activation or activity, a costimulatory agonist, or a checkpoint inhibitor” Examiner interprets that the checkpoint inhibitor PD1 is present in the selected T cells (CD3+, PD-1+, CD134, CD137 positive T cells p. 13 1st ¶) as. Furthermore, claim 1 does not require the addition of an exogenous checkpoint inhibitor PD1. Therefore, Yossef discloses an isolation and culturing of neoantigen-reactive T cells for personalized cancer immunotherapy, wherein the culturing T cells by a process that comprises: 1(d) incubating the population of T cells enriched in tumor reactive T cells with a second T cell stimulatory agent (i.e., recombinant cytokine IL-2) under conditions to stimulate expansion of T cells in the population; and wherein the culturing is carried out in the presence of T cell adjuvant a checkpoint inhibitor (i.e., PD-1) (p. 13 1st ¶ of Yossef).
Maintained Claim Rejections - 35 USC § 103
Claims 1, 2, 29-32, 34, 36-38, 49, 63, 65, 76, 78, 82, 86, 89, 90, 101-102, 104, 113-114, 123, 129, 134, 137, and 158-159 are rejected under 35 U.S.C. 103 as being unpatentable over Yossef et al., (JCI Insight. 2018;3(19): e122467; Cited in IDS filed 06/01/2022; hereinafter “Yossef”), in view of Lawrence et al., (Toxicology and Applied Pharmacology 265 (2012) 103–112; hereinafter “Lawrence”). This rejection is maintained for reasons of record set for the in the office action mailed on 06/12/2025. Further explained below.
Claims 67, 68, 69, 71 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Yossef et al., (JCI Insight. 2018;3(19): e122467; Cited in IDS filed 06/01/2022; hereinafter “Yossef”), in view of Gros et al., (J Clin Invest. 2014;124(5):2246-2259; Cited in IDS filed 06/01/2022; hereinafter “Gros”). This rejection is maintained for reasons of record set for the in the office action mailed on 06/12/2025. Further explained below.
Response to Traversal
Applicant's arguments filed on 12 December 2025 are acknowledged.
Applicant argues that even if all the features of the claims could be accounted for in the cited art, again they cannot, Applicants note that Yossef et al. actually teaches away from the present claims. Applicants respectfully remind In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983). Yossef et al. teaches that techniques to enrich for tumor reactive T cells in sufficient number for expansion and reinfusion into a subject is challenging. See first paragraph at page 2, and 2nd paragraph of Discussion at page 10. Yossef et al. thus ultimately suggests a method to identify and isolate reactive TCR themselves for genetic engineering of T cells rather than expanding neoantigen reactive TILs. This provides a clear teaching away from the claimed solution. See remark p. 13 3rd ¶.
Applicant's arguments have been fully considered but they are not persuasive. In response to Applicant's arguments in regard to identify and isolate reactive TCR themselves for genetic engineering of T cells, as per Yossef teaching away from the claimed invention, MPEP 2145 X(D1) states that "the prior art' s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). In the art Yossef also teaches a culturing T cells by a process that incubating a population of cells comprising T cells from a biological sample (e.g., Metastatic lesions) obtained from a subject (e.g., cancer patients) (p.2 2nd ¶ of Yossef) that has a tumor with a first T cell stimulatory agent in the presence of irradiated allogeneic feeder cells, IL-2, and OKT3 antibody (Figure 1 of Yossef) to stimulate expansion of T cells of the population to produce a population of stimulated T cells (p.2 4th ¶ of Yossef).
Therefore, the cited art, alone or in combination, is able to account for all the features of the claims; because Yossef teaches the present claims and any modification of Yossef to arrive at the present claims would at a minimum be a change in the principle of operation of Yossef and actually render Yossef workable for its intended purpose.
Conclusion
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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684