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 .
Applicant’s amendments, filed 6/11/2026, is acknowledged.
Claims 1, 3-21, 24-50, 52, 53, 55-57, 61-64, 67, 70-73, 76, 77, 79-81, 83-87, and 89-94 are cancelled.
Claims 2, 22, 23, 51, 54, 58-60, 65, 66, 68, 69, 74, 75, 78, 82, and 88 are currently pending.
Claim 2 is an independent claim.
Election/Restrictions
Pursuant to the procedures set forth in MPEP § 821.04(b), claim 88, directed to the process of making or using the product of the invention of Group I, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claim 78, directed to the invention of a nucleic, is not eligible for rejoinder and has NOT been rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between Groups I and III, as set forth in the Office action mailed on 12/11/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicants are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
After consideration, the search and examination has been extended to cover the unelected species of invention (i.e., instant claim 75).
Claim 78 stands withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or Species.
Claims 2, 22, 23, 51, 54, 58-60, 65, 66, 68, 69, 74, 75, 82, and 88 are under examination as reading on a bispecific anti-TIGIT antibody and a method of treatment comprising administration of the antibody.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/3/2026 and 4/9/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner in their entireties.
Response to Arguments
Applicant’s filing of a Terminal Disclaimer for Application 17/923,999 has obviated the Nonstatutory Double Patenting rejections involving this reference.
Applicant’s establishment of common ownership of WO2021227940 is acknowledged (Remarks filed 6/11/2026 pg. 10-11):
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The previous 35 U.S.C. 102 and 103 rejections using this art are withdrawn, as WO2021227940 is invalidated as prior art.
In view of the amendments and remarks filed on 12/04/2025, the following rejections and objections remain.
Claim Objections
Claims 2, 22, 23, 51, 54, 58-60, 65, 66, 68, 69, 74, 75, and 82 are objected to because of the following informalities:
Claim 2 currently recites “…TIGIT protein comprises HCDR1…” and should most likely recite “…TIGIT protein comprises a HCDR1…” to correct a minor typographical error.
Claim 22 currently recites “…TIGIT protein comprises VH and VL…” and should most likely recite “…TIGIT protein comprises a VH and a VL…” to correct a minor typographical error.
Claim 51 currently recites “…PD-L1 protein comprises HCDR1…” and should most likely recite “…PD-L1 protein comprises a HCDR1…” to correct a minor typographical error.
Claim 60 currently recites “…TIGIT protein form scFv…” and should most likely recite “…TIGIT protein forms a scFv…” to correct a minor typographical error.
Claim 69 currently recites “…PD-L1 protein form scFv…” and should most likely recite “…PD-L1 protein forms a scFv…” to correct a minor typographical error.
Claims 23, 54, 58, 59, 65, 66, 68, 74, 75, and 82 are objected to as being dependent upon an objected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
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 88 is 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 methods of treating TIGIT-related diseases comprising administration of a polyspecific anti-TIGIT/anti-PD-L1 antibody comprising a TIGIT binding arm of the structures of any of the antibody clones 900324, 900423, 900424, 900428, HB0030, HB0031, HB0032, and HB0033 and a PD-L1 binding arm comprising the structure of the antibody clone 900339, does not reasonably provide enablement for methods of treating, preventing, or alleviating TIGIT-related diseases comprising administration of a polyspecific anti-TIGIT/anti-PD-L1 antibody with a defined anti-TIGIT arm and an undefined anti-PD-L1 arm (i.e., a broad genus of anti-PD-L1 binding antibodies with no recited structure and the function of “treat, prevent, or alleviate a TIGIT-related disease”). 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 is a new ground of rejection necessitated by Applicant’s amendments.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
Breadth of claims and nature of invention:
Claim 88 encompasses methods of preventing, alleviating, or treating TIGIT-related diseases comprising administration of a polyspecific anti-TIGIT/anti-PD-L1 antibody with a defined anti-TIGIT arm and an undefined anti-PD-L1 arm, as defined by the amino acid sequences of the antibody, especially in the CDR regions critical for binding.
The instant specification discloses bispecific anti-TIGIT/anti-PD-L1 antibodies that take advantage of synergism of targeting both antigens (¶[0005]): “…exerting the synergistic
effect of dual targets as compared a single anti-PD-LI antibody (such as HB0023) and a single anti-TIGIT antibody (such as HB0030)…”
Amount of direction and existence of working examples:
The specification discloses bispecific anti-TIGIT/anti-PD-L1 antibodies (Tables 8 and 9), including 900681, 900682, 900683, 900684, 900685, 900686, 900687, 900691, 900692, and 900693, all of which further comprise the anti-PD-L1 binding arm comprising the antibody clone 900339. The bispecific antibodies were found to successfully treat cancer (¶[000292]-[000295], Table 16).
The specification does not disclose any other bispecific antibody structures comprising different anti-PD-L1 binding arms could successfully treat cancer in vivo, including taking advantage of the synergistic effects of targeting TIGIT and PD-L1. Neither the instant specification nor the prior art provides guidance on other bispecific anti-TIGIT/anti-PD-L1 structures that can be used to successfully treat TIGIT related diseases such as cancer.
Additionally, regarding the claimed methods of preventing TIGIT-related diseases, the burden of enabling the prevention of a disease (i.e. the need for additional testing) would be greater than that of enabling a treatment due to the need to screen those mammals susceptible to such diseases and the difficulty of proof that the administration of the drug was the agent that acted to prevent the condition. Further, the specification does not provide guidance as to how one skilled in the art would go about screening those patients susceptible to a TIGIT-related disease such as a TIGIT-expressing cancer within the scope of the presently claimed invention. Nor is sufficient guidance provided as to a specific protocol to be utilized in order to prove the efficacy of the presently claimed bispecific anti-TIGIT/anti-PD-L1 antibodies in preventing TIGIT-related diseases. For example, the specification discloses that experimental mice were first injected with tumor cells, and then administered specific bispecific anti-TIGIT/anti-PD-L1 antibody structures, followed by measurement of tumor growth (Table 16, ¶[000292]-[000295]). The specification does not show that anti-TIGIT/anti-PD-L1 bispecific antibodies being injected prior to the inoculation with tumor cells. Therefore, the specification at most discloses a method of treating TIGIT-related diseases not preventing them.
The specification does not reasonably provide enablement to make and use the invention of instant claim 88. The specification does enable one with ordinary skill to make and use the methods discussed supra.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Conclusion
Claims 23, 54, 58, 59, 65, 66, 68, 74, 75, and 82 are objected to as being dependent upon an objected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm 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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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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