DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. The amendment, filed 11/14/25, has been entered. Claims 15-16, 18-21, and 23-24 are pending. Claims 1-14, 17, and 22 are cancelled. Claims 15 and 24 are amended. Claims 18-21 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/24/25. Claims are under examination.
Withdrawal of Objections/Rejections
3. The following are withdrawn from the Office Action, filed 08/14/25:
The objections to claims 15, 17 and 24, found on page 3 at paragraphs 6, 7, and 8, are withdrawn in light of Applicant’s amendments thereto or are moot in light of Applicant’s cancellation thereof.
The rejection of claims 17 and 22 under 35 U.S.C. 112(b) as being indefinite, found on page 3 at paragraph 10, is moot in light of Applicant’s cancellation thereof.
The rejection of claims 15-17 and 22-24 under 35 U.S.C. 112(a) as failing to comply with the written description requirement, found on page 4 at paragraph 12, is withdrawn in light of Applicant’s amendments thereto or is moot in light of Applicant’s cancellation thereof.
Maintained Rejection: Claim Rejections - 35 USC § 102
4. 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.
5. 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.
6. Claims 15-16 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mamonkin et al. 2016 (TNFR Costimulatory Domains Impair Expansion of CD5 CAR T cells due to enhanced fas-mediated apoptosis; Cancer-Targeted Gene Therapy; vol 24 (supplement 1)).
Mamonkin teaches T cells comprising a Chimeric Antigen Receptor (CAR) comprising a 4-1BB signaling domain having with a disrupted TRAF2 binding site (e.g. see paragraph 2; meeting limitations found in instant claims 15 and 16). With regards to the type of T-cell in dependent claim 23 (i.e. regulatory T-cell), it is the Office’s position that this species within the T-cell genus (e.g. regulatory, helper, cytotoxic, memory, and NKT), can be at once envisaged from the prior art because the species within this genus are sufficiently limited and well delineated; see MPEP 2131.02(III) and In re Petering (wherein the courts determined that a reference describing a generic formula encompassing about 20 compounds was found to anticipate each of the 20 species without specifically naming them).
Therefore, Mamonkin anticipates the invention as claimed.
Applicant’s Arguments and Response to Arguments
7. All of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record. For example:
With regards to the argument that because claim 15 does not require the mutation formerly found in claims 17 and 22 and these dependent claims have been cancelled so the rejection is moot (see Remarks page 3), the Office disagrees with Applicant’s interpretation and notes that claims 17 and 22 were dependent claims (i.e. necessarily narrower than claim 15 from which they depended) and thus cancelling claims 17 and 22 does not negate that the art teaches the requirements of claim 15. Therefore, this argument is not persuasive because although claim 15 does not require the mutations formerly found in dependent claims 17 and 22 (i.e. the narrower limitations), nothing in claim 15 restricts the co-expressed polypeptides from having them (i.e. the broader limitations are still taught by the art, as set forth above).
Therefore, all of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record.
Maintained Rejection: Claim Rejections - 35 USC § 102
8. Claims 15-16 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gomes-Silva 2017 (Tonic 4-1BB Co-stimulation in Chimeric Antigen Receptors Impedes T Cell Survival and Is Vector-Dependent; Cell Reports 21: 17-26).
Gomes-Silva teaches T-cells modified with chimeric antigen receptors (CARs) comprising 4-1BB endo-domains mutated with multiple substitutions in both the N-terminal and C-terminal motifs of TRAF2 thereby abrogating TRAF binding with TRAF1, TRAF2, and TRAF 3 (e.g. page 19, left column; page 24, Experimental Conditions; Figure 3A; meeting limitations found in instant claims 15 and 16). With regards to the type of T-cell in dependent claim 23 (i.e. regulatory T-cell), it is the Office’s position that this species within the T-cell genus (e.g. regulatory, helper, cytotoxic, memory, NKT), can be at once envisaged from the prior art because the species within this genus are sufficiently limited and well delineated; see MPEP 2131.02(III) and In re Petering (wherein the courts determined that a reference describing a generic formula encompassing about 20 compounds was found to anticipate each of the 20 species without specifically naming them).
Therefore, Gomes-Silva anticipates the invention as claimed.
Applicant’s Arguments and Response to Arguments
9. All of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record. For example:
With regards to the argument that because claim 15 does not require the mutation formerly found in claims 17 and 22 and these dependent claims have been cancelled so the rejection is moot (see Remarks page 4), the Office again disagrees with Applicant’s interpretation and again notes that claims 17 and 22 were dependent claims (i.e. necessarily narrower than claim 15 from which they depended) and thus cancelling claims 17 and 22 does not negate that the art teaches the requirements of claim 15. Therefore, this argument is not persuasive because although claim 15 does not require the mutations formerly found in dependent claims 17 and 22 (i.e. the narrower limitations), nothing in claim 15 restricts the co-expressed polypeptides from having them (i.e. the broader limitations are still taught by the art, as set forth above).
Therefore, all of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record.
Maintained Rejection: Double Patenting
10. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
11. Claims 15-16 and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. U.S. 11,434,290. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to substantially the same immune effector cells with substantially the same structural requirements. For example:
Instant claims are drawn to immune effector cells, co-expressing a heterologous chimeric antigen receptor (CAR) polypeptide and a one or more heterologous TRAF proteins.
Similarly, patented claims are also drawn to an immune effector cell, co-expressing the chimeric antigen receptor (CAR) polypeptides of claim 1 and one or more exogenous TRAF2 and/or TRAF3 proteins.
Therefore, the already patented claims are a species (e.g. more specific CAR and TRAF protein elements) of the instant claims’ broader genus and thereby anticipate them; see MPEP 2131.02.
Applicant’s Arguments/Response to Arguments
12. Applicant requests this rejection is held in abeyance until there is allowable subject matter indicated. Applicant’s request is noted and denied; See 37 C.F.R. 1.111(b), which allows that some objections may be held in abeyance but includes no provision for holding rejections in abeyance. Therefore, to avoid a notice of non-responsiveness, the rejection must be addressed in the next correspondence. Meanwhile, the rejection is maintained for reasons of record until proper arguments and/or amendments are received and reviewed.
Conclusion
13. No claims are allowed.
14. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
15. 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.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
17. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY MAILLE LYONS/Examiner, Art Unit 1645
January 12, 2026