CTNF 18/769,916 CTNF 97488 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Claims 1 and 2 are pending in the application. Claims 1 and 2 are rejected. Priority This application is a continuation of U.S. Application No. 17/192,985, filed on March 5, 2021, which is a continuation of U.S. Application No. 16/913,064, filed on June 26, 2020, which is a continuation of U.S. Application No. 16/443,929, filed on June 18, 2019, which is a continuation of U.S. Application No. 16/168,533, filed on October 23, 2018, which is a continuation of U.S. Application No. 15/865,848, filed on January 9, 2018, which is a continuation of U.S. Application No. 15/300,618, filed on September 29, 2016, which is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US15/23805, filed on April 1, 2015, which claims benefit of Provisional Application No. 62/061,591, filed on October 8, 2014, which claims benefit of Provisional Application No. 61/973,942, filed on April 2, 2014. Information Disclosure Statement The Information Disclosure Statement(s) (IDS) filed on January 21, 2026 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached. Double Patenting 08-33 AIA 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp. The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. (1 of 3) Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,902,722 B2 (“the ‘722 patent”). Claim 6 of the ‘722 patent recites the instantly claimed ( S )-1-((2',6-bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine. See column 258, lines 28-29. Claim 9 of the ‘722 patent also recites the instantly claimed ( S )-1-((2',6-bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine. Furthermore, the ‘722 patent discloses that “when used to treat diabetic neuropathy, compounds of the disclosure may be administered in combination with...LX-4211.” See column 11, lines 22-24 and 41. With respect to the fact that the claims of the ‘722 patent are drawn to compounds/compositions while instant claim 1 is drawn to a method of treating diabetic neuropathy, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co . 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC , 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA , Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. “[T]he specification of an earlier patent may be used in the obviousness-type double patenting analysis.” See In re Basell , 547 F.3d 1378. Therefore, instant claims 1 and 2 would have been obvious in view of claims 1-10 of the ‘722 patent. (2 of 3) Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,544,120 B2 (“the ‘120 patent”). Claim 1 of the ‘120 patent recites the instantly claimed ( S )-1-((2',6-bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine. See column 408, lines 52-53. In addition, the ‘120 patent discloses that “when used to treat diabetic neuropathy, compounds of the disclosure may be administered in combination with...LX-4211.” See column 11, lines 6-8 and 25. With respect to the fact that the claims 1 and 2 of the ‘120 patent are drawn to a compound/composition while instant claim 1 is drawn to a method of treating diabetic neuropathy, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co . 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC , 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA , Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. “[T]he specification of an earlier patent may be used in the obviousness-type double patenting analysis.” See In re Basell , 547 F.3d 1378. Therefore, instant claims 1 and 2 would have been obvious in view of claims 1-3 of the ‘120 patent. (3 of 3) Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,155,760 B2 (“the ‘760 patent”). Claim 1 of the ‘760 patent recites the instantly claimed ( S )-1-((2',6-bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine. See column 247, lines 11-12. In addition, the ‘760 patent discloses that “when used to treat diabetic neuropathy, compounds of the disclosure may be administered in combination with...LX-4211.” See column 11, lines 22-24 and 41. With respect to the fact that the claim 1 of the ‘760 patent is drawn towards a composition while instant claim 1 is drawn to a method of treating diabetic neuropathy, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co . 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC , 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA , Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. “[T]he specification of an earlier patent may be used in the obviousness-type double patenting analysis.” See In re Basell , 547 F.3d 1378. Therefore, instant claims 1 and 2 would have been obvious in view of claim 1 of the ‘760 patent. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CLAYTOR can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /D.M.S./Examiner, Art Unit 1626 /REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 Application/Control Number: 18/769,916 Page 2 Art Unit: 1626 Application/Control Number: 18/769,916 Page 3 Art Unit: 1626 Application/Control Number: 18/769,916 Page 4 Art Unit: 1626 Application/Control Number: 18/769,916 Page 5 Art Unit: 1626 Application/Control Number: 18/769,916 Page 6 Art Unit: 1626 Application/Control Number: 18/769,916 Page 7 Art Unit: 1626
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