METHODS AND COMPOSITIONS FOR IMPROVING COGNITIVE FUNCTION

DETAILED ACTION The amendment submitted on July 7, 2026 has been entered. Claim 24 is pending in the application and is rejected for the reasons set forth below. No claim is allowed, although the application would be allowable if a terminal disclaimer were to be submitted, discussed below. Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first-to-invent provisions of the Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. In the event the determination of the status of the application as subject to pre-AIA 35 U.S.C. 102 and 103 (or as subject to AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. Withdrawn Rejections The rejection of claim 24 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/0165796 A1 by Kshirsagar et al. is withdrawn because the examiner is persuaded that the dosage amounts of the claimed composition are patentably distinct from the dosage amounts suggested by the prior art. The examiner agrees with applicant that “Kshirsagar details that the minimum levetiracetam dose therapeutically effective in treating epilepsy is 500 mg per day, more typically ranging from 1000 mg to 3000 mg per day. See KEPPRA™ labels submitted in applicant's May 17, 2024 Information Disclosure Statement.” See applicant’s Remarks, submit-ted July 7, 2026, at pp. 3-4. Response to Arguments With respect to double patenting over U.S. Patent No. 8,604,075 B2, applicant argues that the rejection is improper because of a restriction requirement issued in a prior-filed application. The double-patenting safe harbor, however, is only available when an application is a divisional. As explained in MPEP1 804.01 (emphasis added), “35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an applica-tion filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent.” The instant application is not a divisional; it is a continuation. The rejection is accordingly maintained. With respect to double patenting over U.S. Patent Nos. 10,159,648 B2 and 10,925,834 B2, applicant argues that these rejections should be withdrawn in view of Allergan v. MSN Labs. and Ex parte Baurin. See applicant’s Remarks at p. 5. Applicant’s argument is that the instant appli-cation would not give rise to an unjustified extension of patent rights. The Allergan and Baurin decisions are not binding authority on the examiner. They are not even mentioned in the Office’s policy manual, i.e., the MPEP. Applicant’s reliance on them is therefore not persuasive. Current Office policy is explained in MPEP 804. In addition to preventing an unjustified extension of patent rights, the Office’s other policy objective is to prevent possible harassment by multiple assignees. It is for this reason that the rejection for double patenting is proper. With respect to double patenting over Application Nos. 18/107,336; 18/411,753; and 18/852,724, applicant makes similar arguments as discussed above. See applicant’s Remarks at p. 5. Applicant states that these applications would have later statutory expiration dates, so the rejection is improper. As noted above, however, the expiration date is not the only considera-tion. Office policy requires the examiner to consider whether the applications should be co-owned to prevent possible harassment by multiple assignees. The rejections are therefore main-tained. Maintained Rejections 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 possi-ble 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 provi-sions 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 accompa-nied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejec-tion 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. Claim 24 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 8,604,075 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘075 Patent is directed to a method for treating age-related cognitive impairment in a human subject in need thereof, the method comprising the step of administering to said human subject levetiracetam or a pharmaceutically acceptable salt thereof at a daily dose of 125-250 mg. The accompanying specification explains that the levetiracetam may be in the form of an extended-release dosage form (col. 7, ll. 38-43). The instant claims is therefore prima facie obvious over the subject matter claimed in the ‘075 Patent. Claim 24 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,159,648 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘648 Patent is directed to an oral, one-dosage-unit, once-a-day pharmaceutical composition, wherein the composition comprises levetiracetam or a pharmaceutically acceptable salt, hydrate, solvate or polymorph thereof, wherein the levetiracetam or the pharmaceutically acceptable salt, hydrate, solvate or polymorph thereof in the composition is formulated in a single dosage unit for extended release, and wherein the composition comprises 220 mg of levetiracetam. Claim 24 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,925,834 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘834 Patent is directed to an extended-release pharmaceutical composition comprising levetiracetam. The accompanying specification explains that 220 mg is an example dosage amount of levetiracetam (col. 2, ll. 20-25). Claim 24 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 104, 124, and 180-183 of copending Application No. 18/107,336 (reference application). The ‘336 Application claims a method of using an extended-release dosage form (claim 124) of 0.1 mg to 350 mg of levetiracetam (claim 104). The range claimed in the ‘336 Application (0.1 to 350 mg) overlaps with the range claimed in the instant application (125 to 250 mg), so a prima facie case of obviousness exists. See MPEP 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented. Claim 24 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 66 of copending Application No. 18/411,753 (reference application). Claim 66 of the ‘753 Application is directed to an extended-release pharmaceutical composition of levetiracetam, and the accompanying specification (p. 6) explains that a suitable dosage amount is 125-250 mg. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented. Claim 24 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 18/852,724 (reference application). Claim 1 of the ‘724 Application is directed a pharmaceutical composition compris-ing 0.7 to 350 mg of levetiracetam, which overlaps with the dosage amount referred to in the instant claim. Claim 7 of the ‘724 Application further requires that the dosage amount is an extended-release form for one-a-day administration. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented. Conclusion THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. 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. THEODORE R. HOWELL Primary Examiner Art Unit 1628 /THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628 September 28, 2026 1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]