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 arguments filed 12/8/2025 have been fully considered but they are not persuasive.
The terminal disclaimer filed on 12/8/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of U.S. Patent Nos. 11,905,332; 11,548,947; 11,453,721; 11,396,544; and 11,912,767 and U.S. Patent Application 18/077137 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The double patenting rejections with respect to these patents and application have been withdrawn.
Double Patenting
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 77-78, 84-85, 88-89, and 93-94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-60, 61-67, 81, and 89-100 of copending Application No. 17/890,078 (3/7/3025 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other.
The co-pending 17/890,078 application is a continuation of 16/719,273, now U.S. Patent No. 11,453,721. The co-pending application and the instant application do not share a common priority claim. A double patenting rejection is not prohibited.
The co-pending claims are directed to nucleic acid molecules encoding CD28 HCVR and LCVR corresponding to the instant claims. The co-pending claims also are directed to expression vectors, host cells, and methods of producing bi-specific antigen-binding molecules that bind human CD28 and human MUC16. Co-pending SEQ ID NO: 17 encodes co-pending SEQ ID NO: 18. Co-pending SEQ ID NO: 9 encodes co-pending SEQ ID NO: 10. See Tables 6 and 7 in the specification and co-pending claim 56, in particular. Co-pending SEQ ID NO: 10 corresponds to instant SEQ ID NO: 18. Co-pending SEQ ID NO: 18 corresponds to instant SEQ ID NO: 10. See in particular co-pending claims 89-90. As such, the co-pending claims would put one of ordinary skill in the art in possession of antibodies, including bi-specific antibodies, encompassed by the instant claims. Formulation of pharmaceutical compositions is recited in co-pending claim 67.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant application has the earlier patent term filing date with respect to the co-pending application; however, this is not the last remaining rejection.
Claims 77-78, 81-85, 88-89, and 92-94 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,415,856. Although the claims at issue are not identical, they are not patentably distinct from each other.
Application 18/165,515 issued as U.S. Patent No. 12,415,856 on 16 September 2025. This double patenting rejection converts the provisional rejection in the Office action mailed 6/9/2025. It was noted in this Office action that the ‘515 claims had been allowed.
The ‘856 claims are directed to CD28 x EGFR bispecific antibodies where the CD28 HCVR (SEQ ID NO: 10) has CDRs corresponding to SEQ ID NOS: 12, 6, and 14. The EGFR HCVR (SEQ ID NO: 2) has CDRs corresponding to SEQ ID NOS: 4, 6, and 8. The common CD28 and EGFR LCVR (SEQ ID NO: 16) has CDRs corresponding to SEQ ID NO: 18, the sequence GAS, and SEQ ID NO: 22. (See at least CD28 antibody of mAb14226 in Table 3 and EGFR antibody of mAb12999P2 in Table 1.)
The sequence identifiers in the ‘’856 claims do not correspond to those of the instant claims. The sequences for the CD28 antibody mAb14226P2 in the instant specification correspond to the HCVR (SEQ ID NO: 10) which has CDRs corresponding to SEQ ID NOS: 12, 14, and 16. The common CD28 LCVR (SEQ ID NO: 18) has CDRs corresponding to SEQ ID NOS: 20, 22, and 24. (See at least CD28 antibody of mAb14226P2 in Table 1.)
That is, both the issued and instant claims are directed to bispecific antigen-binding molecules where the CD28 portion can correspond to mAb14226P2.
As such, the bispecific antigen-binding molecules of co-pending claims 1-10 are embodiments of instant claim 84. The bi-specific antigen-binding molecules of the issued claims, particularly issued claim 2, would have put one of ordinary skill in the art in possession of the antibody or antigen-binding fragment of instant claim 77, part (a), and instant claims 78, 81, and 85. With respect to instant claims 82-83, issued claim 8 indicates that the heavy chain constant regions can be from IgG1 and issued claim 9 indicates that the heavy chain constant regions can be from IgG4. Issued claim 10 is directed to pharmaceutical compositions as in instant claim 88-89 and 92-94.
Claims 79-80, 86-87, 90-91, and 95-96 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record does not disclose nor fairly suggest an antibody or antigen binding fragment that binds CD28 having an HCVR comprising SEQ ID NO: 58 and an LCVR comprising SEQ ID NO: 66 or having the CDRs of SEQ ID NOS: 60, 62, 64, 68, 70, and 72.
Conclusion
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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