DETAILED ACTION
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 response and amendments received June 5, 2026 are acknowledged.
Claims 5-7, 11, and 12 have been canceled.
Claims 1-4, 8, 13, 14, 17, and 19 have been amended,
Claims 1-4, 8-10, and 13-19 are pending in the instant application.
Claims 1-4, 8-10, and 17-19 stand withdrawn from consideration as being drawn to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03, for reasons of record set forth in the restriction requirement mailed November 5, 2025.
Claims 13-16 are under examination in this office action.
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.
The rejection of claims 11, 12, and 14-16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement has been withdrawn in view of applicant’s claim amendments received June 5, 2025 which adequately address the issues raised in the prior office action.
The rejection of claims 11, 12, and 14-16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement has been withdrawn in view of applicant’s claim amendments received June 5, 2026.
Claim Objections
The objections to claims 11-13 for informalities have bene obviated by the claim amendments received June 5, 2026.
Claims 13-16 are allowable. Claims 1-4, 8-10, and 17-19, previously withdrawn from consideration as a result of a restriction requirement, comprise all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions I-III, as set forth in the Office action mailed on November 5, 2025, is hereby withdrawn and claims 1-4, 8-10, and 17-19 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) 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.
The following are new grounds of rejection necessitated by applicant’s claim amendments received June 5, 2026.
Claims 1-3 and 8-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant has broadly claimed methods for treating immune/inflammatory diseases in a subject by administering an antibody that binds “T-cell immunoreceptor with immunoglobulin and ITIM domains” (TIGIT) wherein such antibodies are defined by six CDR sequences originally present in the M1-8 murine hybridoma as disclosed in the working example 1 of the instant specification. The specification further discloses data wherein M1-8 suppressed effector T cells in vitro (examples 2-4), activated regulatory T cells in vitro (example 5), and demonstrated therapeutic effects subsequent to administration in mouse models of lupus (example 6) and multiple sclerosis (example 7). No human clinical data of data from non-autoimmune disorders appears to have been disclosed.
The specification on page 12 states that “As used herein, the "immune/inflammatory disease" means a disease accompanied with inflammation due to breakdown of immune tolerance” and then proceeds to provide a list of exemplified diseases falling with in the genus of “immune/inflammatory”. Notably, such exemplified conditions appear to be more typically classified by artisans as being “autoimmune” diseases as the list includes rheumatoid arthritis, SLE, Sjogren’s, multiple sclerosis, type 1 diabetes, Graves’ disease, Chron’s disease, and autoimmune hepatitis. However, as evidenced by Ghorani et al., anti-cancer immune responses broadly involves a loss of tolerance to self-tissue (see entire document) and the growth of the cancer often has an inflammatory component (see for example Coussens et al.). Given that checkpoint inhibitor therapy in cancer typically seeks to remove immunosuppressive regulatory signaling such that immune effectors cells, such as CD8+ CTL can attack the tumor, and given that the instant claimed and administered anti-TIGIT antibodies act as agonists of TIGIT which increase regulatory T cell activity while suppressing effector function, practicing the instant claimed invention in a cancer setting, such as discussed above can be viewed as “immune/inflammatory” appears to be contraindicated. Note also that no data from a cancer setting indicating that such predictions based upon the teachings of the art are surprising not observed when actually reduced to practice, artisans would not reasonably accept that the claimed administration methods could treat all “immune/inflammatory” conditions even if they would reasonably expect therapeutic efficacy in the clinical conditions recited in instant claim 4.
Therefore, in view of the breadth of the claims, the guidance and direction of the instant specification, and the teachings of the art, artisans would not reasonably be able to practice the full breadth of the instant claimed administration methods without first engaging in additional unpredictable basic science research and experimentation.
Claim 4 is objected to as being dependent upon a rejected claim, but would be allowable if rewritten in independent form including all of the limitations of the independent claim and any intervening claims.
Claims 13-19 are allowable.
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 Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, 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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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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