Notice of Pre-AIA or AIA Status 1. 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 Application, Amendments, and/or Claims 2 . The preliminary amendment filed 08 July 2024 has been entered in full . Claim s 1-2, 6-8, 11-13, 15-17, 19, 23, 25-26 and 28 ha ve been amended, claims 3-5, 10, 14, 18, 22, 24, 27 and 29-30 have been canceled, and claim 31 has been added. Therefore, claims 1-2, 6-9, 11-13, 15-17, 19-21, 23, 25-26, 28 and 31 are pending and the subject of this Office Action. Specification 3. The abstract of the disclosure is objected to because it contains the indefinite phraseology “such”. The person of ordinary skill in the art cannot ascertain whether the subsequent text is intended subject matter for the invention or exemplary. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). 4. The disclosure is objected to because of the following informalities: The use of the term, i.e., UniProt, Tween, GraphPad, CytoFlex, Cytotox, TSKgel, BiTE, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as TM , SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Objections 5. Claim 1 is objected to because of the following informalities: It is suggested for the purpose of clarity that claim 1 be amended to recite, for example, “ An isolated antibody or antigen-binding fragment thereof that specifically binds to OX40, comprising a set of six CDRs, complementarity-determining regions (CDR) CDR-H1, CDR-H2, CDR-H3, CDR- L1, CDR-L2, and CDR-L3 , wherein…”. Appropriate correction is required. 6. For purpose of clarity, a mend Claim 2 6 to recite one of the following: Version #1 A method of preparing the isolated antibody or antigen binding fragment claim 1 a OX40 antibody or antigen-binding fragment thereof , comprising: culturing a host cell comprising a nucleic acid encoding the antibody or antigen-binding fragment thereof of claim 1 under conditions that allow for the production expression of the antibody or antigen-binding fragment thereof , and recovering the antibody or antigen-binding fragment thereof from the culture. Version #2 A method of preparing the isolated antibody or antigen binding fragment claim 1 making a OX40 antibody or antigen-binding fragment thereof , comprising: culturing a host cell comprising a nucleic acid encoding the antibody or antigen-binding fragment of claim 15 under conditions that allow for the production expression of the antibody or antigen-binding fragment thereof , and recovering the antibody or antigen-binding fragment thereof from the culture. Claim Rejections - 35 USC § 112 7 . The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. 8 . Claims 28 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. 9. Regarding claims 19, 28 and 29, the phrase "optionally" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). 10. Regarding claim 20, the phrases “for example” and "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). 11. Claim 20 recites the limitations " VH B or VH B -CH1-VLA-CL- Fc ", “ VLA-CL-VH B -CH1-Fc ”, “ VHA-CH1-VL B -CL-Fc ”, and “ VL B or VL B -CL-VHA-CH1- Fc ”. There is insufficient antecedent basis for this limitation in the claim. Claim 19, from which claim 20 depends, does not recite these limitations. 1 2 . Claim 28 is rejected as being indefinite because it is unclear what is meant by the limitation “a disorder wherein OX40-mediated activity is advantageous”. Since neither the Specification nor the art provides a limiting definition of what constitutes “a disorder wherein OX40-mediated activity is advantageous“ , the metes and bounds of the claim cannot be determined . 1 3 . Claim 31 is rejected as being indefinite because it is unclear what is meant by the limitation “a disorder wherein PD-L1-associated activity is detrimental”. Since neither the Specification nor the art provides a limiting definition of what constitutes “a disorder wherein PD-L1-associated activity is detrimental” , the metes and bounds of the claim cannot be determined . 14. Claims 21, 23 and 25 are rejected for depending from an indefinite claim. Double Patenting 1 5 . 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 . 1 5 . Claim s 8-9, 11-12 and 31 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-13 of U.S. Patent No. 12,516,133 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘ 133 Patent recite a genus of antibodies or antigen-binding fragments thereof that bind to PD-L1 that comprises a set of the instantly claimed CDRs . The claims of the ‘133 patent also recite a method for treating cancer or other disease associated with PD-L1-mediated suppression of T cell activation comprising administering said PD-L1 antibody or antigen-binding fragment thereof. Therefor the claims are overlapping in scope. Summary 1 6 . Claims 8-9, 11-12, 19-2 1, 23, 25 , 28 and 31 stand rejected . Claims 2, 6-7, 13 and 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Advisory Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON M LOCKARD whose telephone number is (571) 272-2717 . The examiner can normally be reached M-F 9-6 EST. 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 on (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 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. /JON M LOCKARD/ Examiner, Art Unit 1647 April 4, 2026