DETAILED ACTION
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 .
2. Applicant's reply filed on 4/7/2026 is acknowledged. Claims 1-69 are canceled. Claims 70-83 are new. Claims 70-83 are pending.
3. Claims 70-83 are under examination.
Objections and Rejections Withdrawn
4. All claim objections and rejections in the office action mailed on 10/8/2025 are withdrawn in view of applicant’s cancellation of the claims.
Objections Maintained
5. The objection to the specification because sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO: X” or the like) in accordance with 37 CFR 1.831(c) is maintained
Applicant’s amendment to the specification is NOT entered because the amendment was made to the published application (Pre-Grant Pub). The amendment to the specification must be made to the original disclosure (the most recently amended version), not the Pre-Grant Pub.
Applicant is reminded that sequences in Tables 2, 3 and 6a are not identified by SEQ ID NO in addition to page 10, line 20.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
6. The objection to the disclosure because it contains an embedded hyperlink and/or other form of browser-executable code is maintained for the same reasons set forth above (see para 5).
Applicant is remined that the term “www” should be removed or spelled out.
New Grounds of Objection and Rejection
Claim Objections
7. Claims 70-83 are objected to because of the following informalities:
Claim 70 is objected to for a typographical error, see “of is” in part (d).
Claim 70 is further objected to because there is insufficient antecedent basis for the terms “the HVR-H1”, “the HVR-H2”, “the HVR-H3”, “the HVR-L1”, “the HVR-L2” and “HVR-L3” in the claim. The objection can be overcome by replacing the phrase “comprising a heavy chain and a light chain variable region sequence” in line 2 with
--comprising a heavy chain variable region comprising HVR-H1, HVR-H2 and HVR-H3, and a light chain variable region comprising HVR-L1, HVR-L2 and HVR-L3--.
Claims 71-82 are objected to for reciting “antibody fragment” in line 1 of each claim and line 2 of claim 82. There is insufficient antecedent basis for this term. Claims 71-82 depend or ultimately depend from claim 70. Claim 70 recites “antigen binding fragment”. The “antibody fragment” in claims 71-82 should be corrected to “antigen binding fragment”.
Claims 72-73 are objected to for recitation of the term “derived from”. The term “derived'' is not one, which has a universally accepted meaning in the art nor is it one which has been adequately described in the specification. The primary deficiency in the use of this term is the absence of an ascertainable meaning for the term.
The objection may be overcome by deleting the term “derived from” or changing the phrase “are derived from” to “comprise”.
Claims 77, 79 and 82 are objected to for recitation of the phrase “any one of claim” in line 1. There is only one claim following the phrase “any one of”.
Claim 83 is objected to because there is insufficient antecedent basis for the term “the heavy chain” and “the light chain. The objection may be overcome by the following amendment:
An isolated anti-TIGIT antibody comprising a heavy chain comprising a light chain comprising the sequence of SEQID NO:19.
Double Patenting
8. 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.
9. New claims 70-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-23 and 26-28 of copending Application No. 17/771,227 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of copending Application No. 17/771,227 (reference application) discloses an anti-TIGIT antibody comprising a light chain sequence and a heavy chain sequence which respectively correspond to SEQ ID NO: 27 and SEQ ID NO: 28. The amino acid sequence of SEQ ID NO:27 comprises instant SEQ ID NOs: 6, 7 and 8; the amino acid sequence of SEQ ID NO:28 comprises instant SEQ ID NOs: 13, 14 and 15, see sequence alignments below:
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780
739
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755
757
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The amino acid sequence of SEQ ID NO:28 is 100% identical to instant SEQ ID NO: 18, and the amino acid sequence of SEQ ID NO:27 is 100% identical to instant SEQ ID NO: 19 (see sequence alignments below). The amino acid sequence of SEQ ID NO:27 would comprises the light chain framework sequences recited in instant claims 75-76, and a CL domain; the amino acid sequence of SEQ ID NO:28 would also comprises the heavy chain framework sequences recited in instant claims 74 and 76, a CH1, CH2 and CH3 domain of IgG1. The antibody is a fully human antibody.
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678
668
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394
652
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Conclusion
10. No claims are allowed.
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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-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, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG SANG/Primary Examiner, Art Unit 1646
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