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
Following Applicant’s amendment filed on 01/07/2026, claim 1 is currently amended. Claims 1-11 are currently pending and under examination.
Claim Rejections - 35 USC § 102
Claims 1, 2, and 7 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Caspar-Bauguil et al. (Scand. J. Immunol., 1994, 40(3): 277-371).
Applicant's arguments filed 01/07/2026 have been fully considered but they are not persuasive. Applicant argues that Casper-Bauguil does not teach or suggest that "the variant of the T-cell receptor suppresses alloreactivity of T cells" as amended claim 1 recites.
The teachings of Caspar-Bauguil in relation to present application were discussed in previous Office Action dated 10/09/2025.
Although Caspar-Bauguil does not expressly state that the disclosed TCR variant “suppresses alloreactivity of T cells,” this limitation is inherently satisfied. Amended claim 1 does not recite a new sequence or structural feature distinguishing the claimed variant from CDR deficient α/β constant region construct disclosed by Caspar Bauguil, but merely recites an additional functional property of the same construct. When expressed in a T cell as taught by Caspar-Bauguil, the structurally identical or substantially identical construct necessarily possesses the same ability to interfere with functional TCR/CD3 mediated activity and thereby suppress TCR mediated alloreactivity. The prior art need not have recognized or expressly described an inherent property of the disclosed product. A newly recognized function or property of an otherwise old product does not render the product novel (MPEP 2112).
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pgs. 4-5, filed 01/07/2026, with respect to the rejection of claims 1-11 under 35 U.S.C. 103 as being unpatentable over Jakobsen (US8361794), in view of Bethune et al. (eLife, 2016, 5(e19095):1-24) and Xu et al. (Cell Discovery, 2018, 4(6):1-13) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Applicant’s amendment filed on 01/07/2026.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Jakobsen (US8361794), in view of Sentman (US9273283B2).
As discussed in the office action dated 10/09/02025, Jakobsen teaches T cell receptors (TCRs) with non-native (introduced) inter-chain disulfide bonds between extracellular constant regions of the TCR alpha and beta chains to ensure correct pairing and receptor stability (Brief Description; Col 4, lines 5-38) as taught in in claims 1-3, and 8 of the instant application. They also teach the implementation of such receptors in cells using routine vector/nucleic acid methods (Protocols 4-5) as taught in claims 4-7 and 9-11 of the instant application.
While Jakobsen teaches these TCR variants assembled from two polypeptides that comprise TCR constant regions of the alpha and beta chains, and stabilized via inter-chain disulfide bonds, they do not expressly teach a variant TCR that also does not have an antigen recognition site, and wherein the variant of the TCR suppresses alloreactivity of T cells.
Sentman addresses these deficiencies by teaching a dominant negative, truncated TCR components including TCR α, β, γ, and δ chain components that retain cytoplasmic, transmembrane, and portion of the extracellular region but lack all or part of the outer ligand binding domain (Column 13, lines 54-64). In a preferred embodiment, the constructs do not encode the Vα and Vβ regions, thereby removing the CDR containing α and β chain variable regions (Column 13, lines 64-66). Sentman further teaches that overexpression of truncated TCR components produces a TCR complex that cannot bind peptide MHC ligands and therefore lacks antigen recognition function (Column 13, lines 54-57).
Sentman also teaches that the truncated components competitively interfere with endogenous TCR function and experimentally demonstrations suppression of allogenic T cell responses: T cells expressing the disclosed inhibitory constructs exhibited average reductions in IFN-γ production of approximately 49% and 60% when cultured with allogenic PBMCs (Example 4).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the paired α/β TCR polypeptides of Jakobsen according to Sentman by removing the Vα and Vβ ligand binding regions while retaining the respective TCR constant regions. The motivation would have been to provide a paired TCR derived construct lacking an antigen recognition site that competitively inhibits endogenous functional TCR assembly or signaling and thereby suppresses T cell alloreactivity. One of ordinary skill would have had a reasonable expectation of success because Sentman expressly teaches the competitive inhibitory mechanism and demonstrates reduced responses to allogenic cells. Accordingly, Jakobsen in view of Sentman renders obvious the subject matter of claims 1-11.
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.
Applicant states that they will address the provisional rejections of record when these provisional rejections become non-provisional rejections.
A notice of allowance in the co-pending Application No. 17/418,457 was mailed on 06/26/2026.
Since applicant has not filed a TD, the rejection of non-provisional ODP is maintained for reason of record.
Conclusion
No claim is allowable.
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 DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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