DETAILED ACTION
Applicant’s claim amendments in the response filed 03/17/2026 are acknowledged.
Claims 1, 4-12, 16-19 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Double Patenting Maintained
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.
Claims 1, 4-12, 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19/191635.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the copending application, which are directed to methods comprising administering to the subject a bispecific polypeptide comprising a first binding region that binds endogenous IL-2 or IL-15, and a second binding region that binds to a marker expressed by a target cell. The instant claims and those of the copending application are directed to the same method administering the same multi-targeted construct and therefore overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-12, 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19/191622.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the copending application, which are directed to methods comprising administering to the subject a bispecific polypeptide comprising a first binding region that binds endogenous IL-2 or IL-15, and a second binding region that binds to a marker expressed by a target cell. The instant claims and those of the copending application are directed to the same method administering the same multi-targeted construct and therefore overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-12, 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending applications USSN 19/205170.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the copending application, which recite a bispecific molecule which comprises a cytokine-binding domain and a target-binding domain, wherein the cytokine is IL-2 or IL-15, wherein the bispecific molecule is a bispecific antibody, wherein the bispecific molecule redirects a cytokine to a target cell, and wherein the bispecific molecule treats a disease when administered to a subject. The instant claims and those of the copending applications are directed to the same multi-targeted construct and therefore overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
Response to Arguments
Applicant's state “should all claims be found to be otherwise allowable, Applicant is willing to discuss filing of a terminal disclaimer to obviate the rejections. Therefore the double patenting rejections of record are hereby maintained.
All other previous rejections are hereby withdrawn in view of applicants claim amendments and arguments in the response filed 3/17/2026.
Conclusion
Claims 1, 4-12, 16-19 are rejected.
No Claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner can normally be reached M-F 9AM - 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, JULIE WU can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meera Natarajan/Primary Examiner, Art Unit 1643