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 .
Claims 1 and 36-44 are presented for examination.
Applicant’s request for continued examination filed January 30, 2026 has been received and entered.
Accordingly, the rejections made under non-statutory double patenting as being unpatentable being unpatentable over claims 1-6 of U.S. Patent No. 8,969,371 B1; claim 1 of U.S. Patent No. 9,119,850 B2; claims 1-20 of U.S. Patent No. 10,231,964 B2; claims 1-20 of U.S. Patent No. 10,828,294 B2; claims 1-20 of U.S. Patent No. 10,835,527 B2; and claims 1-20 of U.S. Patent No. 11,998,542 B2 as set forth in the previous Office action dated December 30, 2025 at pages 2-4 as applied to claims 1 and 36-44 are hereby WITHDRAWN due to applicants’ amendment to claim 1.
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 and 36-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,633,575 B2; clams 1-20 of U.S. Patent No. 10,403,170 B2; and claims 1-15 of U.S. Patent No. 11,139,056 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application teaches a method of treating a subject at increased risk of an adverse cardiovascular event comprising administering to said subject an amount of sustained release naltrexone or a pharmaceutically acceptable salt thereof and sustained release bupropion or a pharmaceutically acceptable salt thereof, and the patented applications teach methods of treating a subject at increased risk of a major cardiovascular outcome comprising for overweight or obesity administering to said subjects a therapeutically effective amounts of sustained release naltrexone or a pharmaceutically acceptable salt thereof and sustained release bupropion or a pharmaceutically acceptable salt thereof.
Note the present application's method includes all overweight and obese subjects with or without type-2 diabetes. Also note the present application's therapeutically effective amount of sustained release naltrexone or a pharmaceutically acceptable salt thereof and sustained release bupropion or a pharmaceutically acceptable salt thereof, encompasses all the therapeutically effective amounts of the sustained release combination set forth in the patented applications.
Note in the present application, the subject’s achieved percentage of weight loss of at least 4% of initial body weight is encompassed by the patented applications’ broad method.
Claims 1 and 36-44 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629