DETAILED ACTION
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 amendment and remarks filed on 02/27/2026 are acknowledged.
Claims 1-8, 18-19 and 31-35 are pending.
Claims 18-19 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/19/2025.
Claims 1-8 and 31-35 are presently under consideration.
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claims 1-8 and 31-35 stand rejected under 35 U.S.C. 102(a)(2) as being anticipated by White et al. (US 20160244521), as evidenced by Rech et al. (2009) and Flynn et al. (2017), all of record.
The grounds of rejection presented in section 9 of the previous Office action are maintained.
Applicant’s arguments have been fully considered but have not been found convincing.
Applicant argues that the “focus” of White is on anti-PVRIG antibodies, and that there is “no direct and ambiguous disclosure of using an anti-CD25 antibody and a PD-1 antagonist in the treatment of a solid tumor found in White” (p. 7 of the Remarks). Applicant further argues that paragraph [0327], cited in the rejection, “provides numerous alternative combinations, all for use in combination with an anti-PVRIG antibody” (p. 7-8).
This is not persuasive, because regardless of White’s “focus,” and regardless of other embodiments described by White, White teaches the subject matter of the present claims, as articulated in the previous office action.
Therefore, the grounds of rejection presented in section 9 of the previous Office action are maintained for the reasons of record, and are incorporated by reference herein as if reiterated in full.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 1-8 and 31-35 stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 11879014, 10752691, 11697688, 11802161, 11814434, 11851494, 11873341, and 11919960 (all of record).
The grounds of rejection presented in sections 11 and 12 of the previous Office action are maintained.
Applicant’s arguments have been fully considered but have not been found convincing.
First, Applicant states that (i) the claims of each of the listed patents are directed to a species relative to the genus of the presently claimed invention, and (ii) each of the listed patents has a later filing date relative to the instant application (p. 8). Based on this, applicant concludes that the present claims could not have been anticipated by the claims of the listed patents (Id).
Applicant’s conclusion is incorrect, because determination that inventions are patentably indistinct is based on the analysis of the scope of the claims regardless of the filing dates. See MPEP § 804(II)(B): “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).”
Therefore, the grounds of rejection presented in sections 11 and 12 of the previous Office action are maintained for the reasons of record, and are incorporated by reference herein as if reiterated in full.
7. Claims 1-8 and 31-35 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Applications USSN 18/470875, 17/819234, and 18/859717.
The grounds of rejection presented in sections 13 and 14 of the previous Office action are maintained.
Applicant’s arguments have been fully considered but have not been found convincing.
Applicant states that the present claims have been amended (p. 9).
This is unpersuasive, because Applicant does not show that the amendment renders the claims patentably distinct from the claims of the cited copending applications.
Therefore, the grounds of rejection presented in sections 13 and 14 of the previous Office action are maintained for the reasons of record, and are incorporated by reference herein as if reiterated in full.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. The following prior art is cited of record but not presently relied upon:
Bernett et al. (US 20170037131) teaches methods of treating cancer by depleting Tregs with anti-CD25×anti-PD-1 bispecific antibodies comprising an IgG1 Fc region (e.g. [0004], [0096], [0105], [0426], [0427]).
9. Conclusion: no claim is allowed.
10. THIS ACTION IS MADE FINAL. 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 ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644