DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is continuation of U.S. Application No. 17/332,878, filed on May 27, 2021, which is continuation of U.S. Application No. 16/680,093, filed on November 11, 2019, now U.S. Patent No. 11,045,478, which is continuation of U.S. Application No. 16/110,621, filed on August 23, 2018, now abandoned, which is continuation of U.S. Application No. 15/195,826, filed on June 28, 2016, now U.S. Patent No. 10,085,998, which is a continuation of U.S. Application No. 13/846,542, filed on March 18, 2013, now U.S. Patent No. 9,381,202, which is a continuation of U.S. Application No. 12/819,155, filed June 18, 2010, now abandoned, which is a division of U.S. Application No. 11/614,044, filed December 20, 2006, now U.S. Patent No. 7,799,777, which claims the benefit of U.S. Prov. App. No. 60/756,941, filed January 5, 2006, and U.S. Prov. App. No 60/854,740, filed October 27, 2006.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 10/26/2023 has/have been considered by the Examiner. The submission(s) is/are in compliance with the provisions of 37 CFR §§ 1.97 and 1.98. Enclosed with this Office Action is a return-copy of the Forms PTO-1449 with the Examiner’s signature and indication of those references that have been considered.
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 130-139 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-8 of U.S. Patent No. 11,786,536 (presented in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set is drawn to a kit comprising diazoxide choline. The reference claims recite the IUPAC name of a specific crystal salt of the currently claimed diazoxide choline. Both claims further recite the kit comprises instructions. The current claims recite more detailed instructions.
Printed Matter Does not Distinguish the Claimed Kit From the Reference Kit
The claims are drawn to a kit and printed matter:
“A kit comprising diazoxide choline and instructions for activating KATP channels in an obese, overweight, or obesity prone subject, wherein said instructions comprise directing administration to said subject: a therapeutically effective amount of a solid oral controlled release dosage form comprising polymorph B of diazoxide choline and at least one pharmaceutically acceptable excipient.”
The claimed instructions are not given patentable weight. USPTO personnel must consider all claim limitations when determining patentability of an invention over the prior art. However, to be given patentable weight, the printed matter and associated product must be in a functional relationship. A functional relationship can be found where the printed matter performs some function with respect to the product to which it is associated. Where a product merely serves as a support for printed matter, no functional relationship exists. These situations may arise where the claim as a whole is directed towards conveying a message or meaning to a human reader independent of the supporting product. Where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. Accordingly, the claimed instructions do not distinguish the current kit from the reference kit.
Claims 131-139 further recites limitations on the printed matter but is not given patentable weight.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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