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 .
DETAILED ACTION
Status of the Claims
1. Two claim sets are filed for claims 1-43 on 4/24/2023. There are no apparent differences between the claim sets. In the Reply of 12/11/2023, Claims 1, 2, 5, 9, 11-14, 16-18, 23, 24, 27, 34, and 38-41 are amended, claims 3, 6-8, 10, 15, 19-22, 25, 26, 28-33, 35-37, 42, and 43 are canceled and new claims 44-46 are added. In the Response of 6/26/2026, Claims 4, 5, 9, 13, 18, 23, 24, 34, 39, and 41 are amended and claims 1-2 and 16-17 are canceled.
Claimed species for prophylaxis (prevention) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/12/2026.
Claims 4-5, 9, 11-14, 18, 23-24, 27, 34, 38-41, and 44-46 are all the claims.
The IDS of 6/26/2026 raises new grounds for rejection. The Office Action is final.
Priority
2. USAN 18/250,347, filed 04/24/2023, is a National Stage entry of PCT/ US2021/038086, International Filing Date: 06/18/2021, PCT/US2021/038086, Claims Priority from Provisional Application 63/106,329, filed 10/27/2020.
Information Disclosure Statement
3. As of 8/17/2026, two (2) IDS are filed: 12/11/2023; and 6/25/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Specification
4. The objection to the abstract of the disclosure is withdrawn. The abstract is amended to delete both parenthetical text and exemplary language “(for example, T-cells)”.
5. The objection to the disclosure because of informalities is withdrawn. Both clean and marked-up copies of the specification are filed.
a) The specification is amended to rectify the improper use of the term Biacore, DNASTAR, Megalign, RNeasy, GeneRacer, NORMOSOL, PLASMA-LITE, lipofectin, sonitron, NCBI, which is a trade name or a mark used in commerce.
b) The specification is amended to include a sequence identifier for the peptide sequences > 4 amino acids in length.
Claim Objections
6. The objection to Claims 9, 12-13, 34 and 39 because informalities are withdrawn.
a) Claim 9 is amended to recite “wherein the immunoreactivity to the epitope of the sequence SLLMWITQC (SEQ ID NO: 1)...”
b) Claim 13 is amended to depend from claim 4.
c) Claim 34 is amended to recite “an epitope of an NY-ESO-1 and/or LAGE-1 a protein
d) Claim 39 is amended to delete “capable of inhibiting”.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
7. The rejection of Claims 1-2, 4-5, 11-14, 16-18, 23-24, 27, 34, 38-41, and 44-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements is moot for the canceled claims and withdrawn for the pending claims. Claim 4 is amended to recite the immunoreactivity to the epitope SLLMWITQC (SEQ ID NO: 1) and/or SLLMWITQCFL (SEQ ID NO: 28) is (a) HLA-A2 restricted.
Claim Rejections - 35 USC § 112(a)
Written Description
8. The rejection of Claims 1-2, 4-5, 9, 11-14, 16-18, 23-24, 27, 34, 38-41 and 44-46 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 is moot for the canceled claims (claims 1-2 and 16-17) and withdrawn for the pending claims. Claim 4 is amended to recite (1) all three CDR sequences for each of the α- and β-chains and (2) that "the immunoreactivity to the epitope of the sequence SLLMWITQC (SEQ ID NO: 1) and/or SLLMWITQCFL (SEQ ID NO: 28) is HLA-A2 restricted."
Objections Maintained
Specification
9. The objection to the disclosure because of informalities is maintained.
Applicants’ response is appreciated, and it is understood the epitopes are identical, but does not overcome the objection. Notably, inasmuch as NY-SEO-1 and LAGE-1a are closely related cancer-testis antigens (CTAs), and they share high sequence and peptide homology, they are not the same protein. The specification and sequence listing define SEQ ID NO:1 as residues NY-ESO-1:157-165 and SEQ ID NO: 28 as residues NY-ESO-1:157-167.
The specification does not define the residues corresponding to the LAGE-1a protein that share identity with SEQ ID NOS: 1 and 28, respectively. Appropriate correction is required.
The objection is maintained.
New Grounds for Rejection
Double Patenting
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.
10. Claims 4-5, 9, 11-14, 18, 23-24, 27, 34, 38-41, and 44-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 11, 1314, 22-25, 30-32, 38, 42-43, 48, 65 and 80 of copending Application No. 18/550006 (reference application US 20240156869 (IDS 6/26/2026)). The reference application is not afforded safe harbor under 35 USC 121 because it does not share not continuity nor a restriction/speciation with the claims of the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are overlapping for the species of TCR reactive with an epitope of an antigen, e.g., NY-ESO-1 and/or LAGE-1a, comprising the sequence SLLMWITQC (ref SEQ ID NO: 33 vs instant SEQ ID NO: 1), wherein the ref TCR alpha chain of SEQ ID NO: 32 comprises the instant claimed CDR1-3 of SEQ ID NOS: 5-6-7, and the ref TCR beta chain of SEQ ID NO: 27 comprises the instant claimed CDR1-3 of SEQ ID NOS: 11-12-13, methods of producing an engineered TCR into a T cell, and methods of treating a cancer with the engineered T cell.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
11. No claims are allowed.
12. Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 6/26/2026
prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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, Wu Julie can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
Prosecution Insights