DETAILED ACTION
Claims 1-29 are currently pending in the instant application and are rejected.
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 .
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 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 12,043,607. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to compounds of the formula:
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(conflicting claims 1 and 3), compositions comprising the compound (conflicting claims 2 and 4), and methods of treatment of non-small cell lung cancer (conflicting claims 5, 10, 15, 20, 25, 30), endometrial cancer (conflicting claim 6, 11, 16, 21, 26, 31), pancreatic cancer (conflicting claim 7, 12, 17, 22, 27, 32), cervical cancer (conflicting claim 8, 13, 18, 23, 28, and 33), cancer of unknown primary (conflicting claim 9, 14, 19, 24, 29, and 34), additionally comprising and anti PD-1 antibody (conflicting claims 15-24), specifically pembrolizumab (conflicting claims 25-34). The compound of the formula:
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corresponds to the instant formula (I):
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wherein R1, R3, R4, R6 and R8 are each H; R2 is
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; R5 is NH2; R7 is -Me; A is:
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; and L1 is a bond. Additionally, the compound of the ‘607 patent anticipates the compound:
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of instant claim 20.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 10, 34, 35, 47-53, 57, and 73 of copending Application No. 19/101,393 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods for treating cancer with compounds of the formula (I):
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with an anti-PD antibody (conflicting claim 1 and 10) wherein the anti-PD-1 antibody is pembrolizumab (conflicting claims 34 and 35) wherein the cancer is NSCLC, pancreatic cancer, endometrial cancer, cervical cancer, and cancer of unknown primary (conflicting claims 50-53) The compound utilized in the method claims of the ‘393 application corresponds to the instant formula (I):
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wherein R1, R3, R4, R6 and R8 are each H; R2 is
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; R5 is NH2; R7 is -Me; A is:
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; and L1 is a bond. Additionally, the compound of the ‘393 application anticipates the compound:
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of instant claim 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 10 September 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
Prosecution Insights