CTFR 18/178,440 CTFR 80346 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Receipt and entry of the response dated 3/2/2026 is acknowledged. Claim Rejections - 35 USC § 112 07-30-01 AIA 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. 07-31-03 AIA Claim s 31-52 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for chimeric polypeptides comprising a CD8 alpha hinge domain and a Notch transmembrane domain , does not reasonably provide enablement for any other chimeric polypeptides as claimed . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. This rejection is maintained for reasons made of record in the Office Action dated 10/3/2025 and for reasons set forth below . Response to Arguments 07-37 AIA Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) the rejection is erroneous and does not account for the “means for” language of the claims: 2) the specification provides examples of multiple suitable domains for linking; 3) the instant specification sets forth ample teachings regarding how the skilled artisan could perform further experiments to determine functional hinge domains . Regarding 1), such is false. The “means for” language was addressed in the rejection, indeed it was addressed in every paragraph of the rejection. A reading of the rejection finds that any alleged support for the claimed synNotch linker was not ignored, but considered and found to be wanting. Regarding 2), none of the domains (e.g. CD28, OX40) asserted by applicants to also be functional in the claimed SynNotch system are taught to be capable of forming the required functional linkage of the binding domain and the NRR-like domain. Thus, these additional domains do not provide any evidence for further enablement of the instant intervention beyond the CD8 hinge domain, which is taught to form said linkage. Further, the “means for” language of the instant claim is not considered to narrow the claimed scope to only those domains asserted by applicant’s, i.e. CD8, CD28 IgG4 and OX40. Regarding 3), asserting that the skilled artisan should have to conduct painful trial-and-error experimentation with multiple hinge and Notch domain combinations in order to determine which might be functional as claimed is not a convincing argument against the instant rejection. Rather, it merely states that applicants have not provided the necessary disclosure for the claimed breadth of invention. Therefore, the skilled artisan must conduct such experimentation to fill in the gaps of the instant disclosure . Double Patenting 08-33 AIA 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. 08-34 AIA Claim s 31-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of U.S. Patent No. 11,202,801 . Although the claims at issue are not identical, they are not patentably distinct from each other because the instant clams are anticipated by the ‘801 claims . 08-34 AIA Claim s 31-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-29 of U.S. Patent No. 11,617,766 . Although the claims at issue are not identical, they are not patentably distinct from each other because the instant clams are anticipated by the ‘766 claims . These rejections are maintained for reasons made of record in the Office Action dated 10/3/2025 and for reasons set forth below . Response to Arguments 07-37 AIA Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. Applicants essentially assert that the rejection is premature. Hence, the rejection stands . Conclusion 07-39 AIA THIS ACTION IS MADE FINAL. 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 Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5. 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, Tracy Vivlemore can be reached at 571 272-2914. 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. /MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638 Application/Control Number: 18/178,440 Page 2 Art Unit: 1638 Application/Control Number: 18/178,440 Page 3 Art Unit: 1638
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