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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed January 21st, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
Claim Objections
Claims 172 and 173 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.
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.
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Claims 170, 174 – 179, and 181 – 185 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 4, 6, 17, 24, 26 – 27, and 29 of U.S. Patent No. US 9775844 B2 to Kutok et. al. (herein after Kutok’844).
Kutok’844 recite a method of treating a PI3K-gamma mediated disorder in a subject, comprising administering to the subject a therapeutically effective amount of a compound of the formula:
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(instant claims 170 and 179) or a pharmaceutically acceptable salt thereof (reference claim 1). Furthermore, Kutok’844 recite a method wherein the subject has a PI3K-gamma mediated disorder selected from cancer, an inflammatory disease, or an autoimmune disease (reference claim 2); wherein the disorder is cancer and the cancer is a solid tumor (reference claim 3); wherein the disorder is a cancer selected from one or more of: a cancer of the pulmonary system, a brain cancer, a cancer of the gastrointestinal tract, a skin cancer, a genitourinary cancer (instant claim 179), head and neck cancer, a sarcoma, a carcinoma, and a neuroendocrine cancer (reference claim 4); wherein the disorder is a cancer selected from one or more of: a medullobastoma, a basal cell carcinoma, a glioma, a hepatocellular cancer, a gastrointestinal stromal tumor (GIST), a melanoma, a neuroectodermal tumor, a soft-tissue sarcoma, fibrosarcoma, myxosarcoma, liposarcoma, a chondrosarcoma, an osteogenic sarcoma, a chordoma, an angiosarcoma, an endotheliosarcoma, a lymphangiosarcoma, a lymphangioendotheliosarcoma, a synovioma, a mesothelioma, a leiomyosarcoma, a bladder carcinoma, an epithelial carcinoma, a squamous cell carcinoma, an adenocarcinoma, a bronchogenic carcinoma, a renal cell carcinoma, a hepatoma, a bile duct carcinoma, a carcinoid tumor, diffuse type giant cell tumor, and glioblastoma (reference claim 17).
Furthermore, Kutok’844 recite a method wherein the therapeutically effective amount of the compound is about 2 mg per day, about 1 -3 mg per day, about 1 -5 mg per day, about 1-10 mg per day, about 0.5-20 mg per day, about 0.1-50 mg per day (instant claim 176 – 178 and 183 – 185), about 0.1-75 mg per day, about 0. 1 - 1 00 mg per day, about 0.1-250 mg per day, about 0.1 -500 mg per day, about 0.1-1000 mg per day, about 1 -50 mg per day, about 1-75 mg per day, about 1-100 mg per day, about 1 -250 mg per day, about 1 -500 mg per day, about 1 - 1000 mg per day, about 10-50 mg per day, about 10-75 mg per day, about 10-100 mg per day, about 10-250 mg per day, about 10-500 mg per day, about 10-1000 mg per day, about 100-500 mg per day, or about 100-1000 mg per day (reference claim 6); which further comprises administering an immunomodulator to the subject (reference claim 24); wherein the immunomodulator is a PDL-1 inhibitor or an anti-PDL-1 antibody (reference claim 26); wherein the PD-L1 inhibitor or the anti-PDL-1 antibody is YW243.55.S70, MDPL3280A, MSB0010718C, MDX-1105, or MEDI-4736 (reference claim 27); wherein the immunomodulator is a PD-1 inhibitor or an anti-PD-1 antibody (reference claim 28; instant claims 170 and 179); and wherein the PD-1 inhibitor or the anti-PD-1 antibody is nivolumab (reference claim 30; instant claims 175 and 182), pembrolizumab (reference claim 31; instant claims 174 and 181), pidilizumab, AMP-244, or AMP-5 14 (reference claim 29).
While the instant application recites a method of treating head and neck squamous cell carcinoma, that is a species of squamous cell carcinoma; the conflicting invention of Kutok’844 recites a method of treating a PI3K-gamma mediated disorder wherein the disorder squamous cell carcinoma, a broad genus, or head and neck cancer, that is another broad genus. The instant recitation of for a method of treating head and neck squamous cell carcinoma is both a species of squamous cell carcinoma and head and neck cancer. Furthermore, both the instant application and the invention of Kutok’844 recite the administration of
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in the conflicting methods as active steps. Furthermore, given the advanced skill level for one of ordinary skill in the pharmaceutical arts it would have been obvious to such artisan that the broad genus recitation of squamous cell carcinoma and head and neck cancer includes the species head and neck squamous cell carcinoma.
Discussion of the Prior Art
Claims 170, 172 – 179, and 181 – 185 are direct to a method of treating head and neck cancer in a subject, comprising administering to the subject a therapeutically effective amount of a compound of the formula:
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or a pharmaceutically acceptable salt thereof, in combination with an anti-PD-1 antibody.
The closet prior art of International Publication Number US 2013/0267521 A1 to Castro et. al. (herein after Castro’521; cited on the IDS dated April 28th, 2023) teach compounds capable of selectively inhibiting one or more isoform(s) of class I PI3K without substantially affecting the activity of the remaining isoforms of the same class (page 1 paragraph 0010). Specifically, Castro’521 teach compounds of Formula (I)
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(page 23 paragraph 0221). More specifically, Castro’521 teach compound 154 of structure
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(page 160 paragraph 0922). Castro’521 teach that a patient can be treat with compounds of the disclosure, including compounds of reference formula (I), for the treatment of head and neck cancer (claim 170), squamous cell carcinoma, and renal cancer (page 90 paragraph 0632).
However, Castro’521 fails to teach a method wherein a compound of the formula:
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is administered in combination with an anti-PD-1 antibody. Moreover, neither Castro’521 nor the prior art provides a motivation for modifying prior art compound 154 to get the instant compound of structure
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. Given that the prior art of Castro’521 fails to anticipate or render obvious the method of the instant claims; instant claims 170 – 189 are free of the prior art.
Conclusion
Claims 170, 174 – 179, and 181 – 185 are rejected. Claims 172 – 173 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627