DETAILED ACTION 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. 1. Formal Matters Claims 1-15 and 17-20 are pending and are the subject of this Office Action. 2. Application Data Sheet Thought the Application Data Sheet correctly recites Applicant as “ Glaxosmithkline ”, the published application (US 2024/0166747) recites “ Gla Z osmithkline ”. A Corrected Filing Receipt has been mailed. 3 . Claim Rejections - 35 USC § 112(a) – written description 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. Claim 8 i s re jected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim recites that the TIGIT antibody is EOS884488. However, other than the VH and VL sequences of SEQ ID NO:362 and 363, t he specification and claim do not provide any structural information regarding this antibody, nor is the Examiner able to find any information in a search of the art . The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the physical characteristics that identify EOS884488 other than the VH/VL sequences (e.g. framework regions; complete VH and VL sequences) , o ne of skill in the art would reasonably conclude that the disclosure fails to provide adequate written description of the claimed antibody . Thus, Applicant does not appear to be in possession of the claimed antibody at the time the invention was made. 4. Nonstatutory 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 . A. Claim s 1-6, 9, 12-15 and 17-20 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claim s 1-5, 7-13 and 15-20 of U.S. Patent No. 12,528,864 (17/902,305) in view of Sheng et al. (U.S. Patent No. 10,537,637) further in view of Dougall et al . Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to methods of treating cancer using the same CD96 antibody . The only difference is that the instant claims combine this antibody with PD-1 and TIGIT inhibitors. However, Sheng et al. does teach the use of PD-1 and TIGIT antagonists for the treatment of cancer (Abstract; column 1, lines 10-16), as well as the idea of trispecific checkpoint inhibitor therapy using antagonists to PD-1, TIGIT antagonists and “any other biological peptide” (Brief Description of Figure 18 ; column 38 under “Combination Therapies” ). Therefore, not only does Sheng teach the use of the remaining two checkpoint inhibitors for the treatment of cancer, but also states that a third may be used, providing motivation for the instant claims. While Sheng teach CD96 (column 43, lines 25-39), it is recited in a laundry list. However, Dougall teaches CD96, as well as TIGIT, for the treatment of cancer (entire document) as well as the use of CD96 in combination with existing checkpoint inhibitor therapies including TIGIT and PD-1 antagonists (first two paragraphs under “Conclusion”) . Furthermore, and regardless, In re Kerkhoven (205 USPQ 1069, CCPA 1980) summarizes: "It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose in order to form a combination that is to be used for the very same purpose: the idea of combining them flows logically from their having been individually taught in the prior art." Regarding claim 12, though neither reference teaches the ratio, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955) . Furthermore, "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch , 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and, therefore, obvious) and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018) (“it is not inventive to discover the optimum or workable ranges by routine experimentation.”). B. Claims 1-4, 6, 9, 12-15 and 17-20 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claim s 1-3, 5-8 and 9-20 of U.S. Patent No. 11,479,607 (17/530,849) in view of Sheng et al . further in view of Dougall et al. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a composition comprising the instantly claimed antibody, as well as encoding nucleic acids, vectors, engineered host cells expressing the antibody and pharmaceutical compositions comprising the antibody . The teachings of Sheng and Dougall are seen above under paragraph A of this section. See also In re Kerkhoven (205 USPQ 1069, CCPA 1980). Regarding claim 12, see In re Aller ; In re Boesch ; Merck & Co. v. Biocraft Labs. Inc.; E.I. DuPont de Nemours & Co. v. Synvina C.V. C. Claim s 1-6, 9, 12-15 and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 42 and 44-6 0 of copending Application No. 19/426,159 (reference application) in view of Sheng et al . further in view of Dougall et al. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to the identical CD96 antibody as used in the instant claims . The copending claims do not teach the combined use of CD96, TIGIT and PD-1 antagonists. However, t he teachings of Sheng and Dougall are seen above under paragraph A of this section. See also In re Kerkhoven (205 USPQ 1069, CCPA 1980). Regarding claim 12, see In re Aller ; In re Boesch ; Merck & Co. v. Biocraft Labs. Inc.; E.I. DuPont de Nemours & Co. v. Synvina C.V. It is noted that the copending claims are also drawn to nucleic acids encoding the CD96 antibody, as well as vectors, host cells and methods of making the antibody. However, t he instant application is not a DIV of the copending application and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008) . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. D. Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,479,607 in view of Sheng et al, further in view of Dougall et al. and further in view of U.S. Patent No. 12,528,864 . The teachings of the ‘864 and ‘607 patents, as well as Sheng and Dougall , are seen above. N one of ‘607 , Sheng o r Dougall teach the CD96 antibody of SEQ ID NO:165 and 166 . However, the ‘864 patent does. It would have been obvious to have used this antibody for that of the ‘607 patent, which comprises identical VL and VL sequences . E. Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over each of (1) of U.S. Patent No. 12,528,864, (2) U.S. Patent No. 11,479,607 and (3) copending Application No. 19/426,159, each in view of Sheng et al., each further in view of Dougall et al. and each further in view of Cooper et al. (U.S. Patent No. 10/329,349) . The teachings of the ‘864 and ‘607 patents, as well as the ‘159 application and Sheng are seen above. None teach the TIGIT antibody recited in the claim. However, Cooper does. It would have been obvious to have substituted this anti-TIGIT antibody for that of Sheng. Regarding the ‘159 application, this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. SEQ ID NO:362 Patent No. 10329349 GENERAL INFORMATION APPLICANT: ITEOS THERAPEUTICS SA TITLE OF INVENTION: ANTI-TIGIT ANTIBODIES CURRENT APPLICATION NUMBER: US/16/159,506 CURRENT FILING DATE: 2018-10-12 PRIOR APPLICATION NUMBER: PCT/US2018043968 PRIOR FILING DATE: 2018-07-26 PRIOR APPLICATION NUMBER: US62/606159 PRIOR FILING DATE: 2017-07-27 PRIOR APPLICATION NUMBER: EP17184102.6 PRIOR FILING DATE: 2017-07-31 PRIOR APPLICATION NUMBER: BE20175535 PRIOR FILING DATE: 2017-07-31 PRIOR APPLICATION NUMBER: US62/660640 PRIOR FILING DATE: 2018-04-20 SEQ ID NO 221 LENGTH: 121 TYPE: PRT ORGANISM: Homo sapiens Query Match 100.0 %; Score 638; Length 121; Best Local Similarity 100.0%; Matches 121 ; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGYTFTSYYMHWVRQAPGQGLEWMGVIGPSGASTSY 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 QVQLVQSGAEVKKPGASVKVSCKASGYTFTSYYMHWVRQAPGQGLEWMGVIGPSGASTSY 60 Qy 61 AQKFQGRVTLTRDTSTSTVYMELSSLRSEDTAVYYCARDHSDYWSGIMEVWGQGTTVTVS 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 AQKFQGRVTLTRDTSTSTVYMELSSLRSEDTAVYYCARDHSDYWSGIMEVWGQGTTVTVS 120 Qy 121 S 121 | Db 121 S 121 SEQ ID NO:36 3 Patent No. 10329349 SEQ ID NO 216 LENGTH: 108 TYPE: PRT ORGANISM: Homo sapiens Query Match 100.0 %; Score 567; Length 108; Best Local Similarity 100.0%; Matches 108 ; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 EIVLTQSPGTLSLSPGERATLSCRASQSVRSSYLAWYQQKPGQAPRLLIYGASSRATGIP 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 EIVLTQSPGTLSLSPGERATLSCRASQSVRSSYLAWYQQKPGQAPRLLIYGASSRATGIP 60 Qy 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYFSPPWTFGGGTKVEIK 108 |||||||||||||||||||||||||||||||||||||||||||||||| Db 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYFSPPWTFGGGTKVEIK 108 F. Claims 10 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over each of (1) of U.S. Patent No. 12,528,864, (2) U.S. Patent No. 11,479,607 and (3) copending Application No. 19/426,159, each in view of Sheng , each further in view of Dougall et al. and each further in view of Pe r ez et al . The teachings of the ‘864 and ‘607 patents, as well as the ‘159 application , Sheng and Dougall are seen above. None teach dostarlimab . However, Pe r ez (entire document) teaches dostarlimab as a PD-1 antagonist for the treatment of NSCLC . It is noted that TSR-042 is also known as dostarlimab , as referenced under the section entitled “Trial Registration” regarding NCT02715284. It would have been obvious to have substituted this anti- PD-1 antibody for that of Sheng. Regarding the ‘159 application, this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 8 is not currently rejected under 35 USC 103 since it is not clear if this antibody is novel to the invention, or if it was known in the prior art at the time. Consideration will be made after Applicants’ amendments and/or arguments. 5 . Conclusion No claim is allowable. Advisory information Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ROBERT S LANDSMAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT 571-272-0888 . The examiner can normally be reached M-F 8 AM – 6 PM (eastern). 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, Joanne Hama, can be reached at 571-272-2911 . 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). /ROBERT S LANDSMAN/ Primary Examiner, Art Unit 1647