CTNF 17/950,350 CTNF 83442 DETAILED ACTION Applicants claim amendments filed 2/11/2026 are acknowledged and entered into the record. Accordingly, claims 1-2, 4-5, 7, 14, 19, 21-25, 29, and 38 are pending and will be examined on the merits. 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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 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. 07-20-fti The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. Claims 1-2, 4-5, 7, 14, 19, 23-24, and 29 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Graus et al. (EP2067789A1, cited on IDS filed 2/8/2024) in view of Huang et al. (WO2012162067A2, cited on IDS filed 2/8/2024) The claims are drawn to a protein comprising a 1 st and 2 nd polypeptide wherein said 1 st and 2 nd polypeptide each comprise at least a hinge region, a CH2 region, and a CH3 region of an immunoglobulin heavy chain wherein positions L234, L235, and D265 are not L, L and D respectively and wherein the positions N297 and P331 of the IgG1 heavy chain are not Q and S. The claims are further drawn to wherein the protein binds CD3 or binds CD3 and a second different target (bispecific). Graus et al. teach antibodies that bind P-selectin and do not bind human complement factor C1q or human Fcy receptor on NK cells and thus not eliciting CDC or ADCC. Graus et al. teach combinations of mutations within the Fc region in order to mediate Fc receptor binding. Graus et al. disclose mutations in S228, L234, L235 and/or D265, and/ or contains the PVA236 or GLPSS331 mutation. Especially preferred are the mutations S228P (IgG4), L234A (IgG1), L235A (IgG1), L235E (IgG4), GLPSS331(IgG1) and/or PVA236 (IgG1). Preferred combinations of mutations are also shown in table 1. Graus et al. teach these antibodies have new and inventive properties causing a benefit for a patient suffering from inflammation disorders. Graus et al. does not teach a CD3 bispecific antibody. This deficiency is made up for by Huang et al. Huang et al. teach bispecific, humanized antibodies comprising a CD3-binding domain and further comprising a CD20 binding domain. Huang et al. further teaches in some embodiments the antibody comprises an IgG1 Fc region modified so that binding to effector ligands is reduced (see paragraphs 125-130). Huang et al. disclose molecules having a variant Fc region with decreased ADCC activity and combining an Fc variant with other Fc modifications to provide additive, synergistic, or novel properties to the modified antibody. For example, Huang teaches antibodies comprising substitutions with alanine (A) at position 234, 235 and 265. Huang et al. further teaches pharmaceutical and diagnostic compositions of said antibodies and kits thereof and methods of treatment. (see paragraphs 177-196) It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to make a CD3 bispecific antibody having the combination of mutations instantly claimed based on the teachings of Graus et al. and Huang et al. for therapeutic purposes. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success based on the teachings of Graus et al. and Huang et al. because Graus et al. teach antibody variants that contain Fc mutations which mediate Fc receptor binding for therapeutic purposes and Huang et al. teach bispecific CD3 antibody variants comprising similar Fc mutations and combining them with other Fc modifications for an additive, synergistic properties for therapeutic purposes. It would be obvious to combine the teachings of Graus et al. and Huang et al. to make a more efficient therapeutic antibody or bispecific antibody based on Fc region mutations. 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 1-2, 4-5, 7, 14, 19, 21-25, 29, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-18 of U.S. Patent No. 10,590,206 . Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of US Patent 10,590,206 are both drawn to a CD3 binding protein having the same Fc region substitutions L234F, L235E, D265A along with K409R and F405L . Conclusion Claims 1-2, 4-5, 7, 14, 19, 21-25, 29, and 38 are rejected. No Claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner can normally be reached on M-F 9AM - 5PM. 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, JULIE WU can be reached on 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 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. /Meera Natarajan/Examiner, Art Unit 1643 Application/Control Number: 17/950,350 Page 2 Art Unit: 1643 Application/Control Number: 17/950,350 Page 3 Art Unit: 1643 Application/Control Number: 17/950,350 Page 4 Art Unit: 1643 Application/Control Number: 17/950,350 Page 5 Art Unit: 1643 Application/Control Number: 17/950,350 Page 6 Art Unit: 1643