DETAILED ACTION
The amendment submitted on June 11, 2026 has been entered. Claims 104, 124, and 180-183 are pending in the application and are 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, as 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 (2011). In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-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Withdrawn Rejections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 104 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sanchez et al., Proc. Nat’l Acad. Sci. USA 2012;109(42):E2895-903 in view of Laakso et al., Neurology 1996;46(3):678-81 is withdrawn because the examiner finds applicant’s arguments to be persuasive. Briefly, the examiner agrees with applicant that the hAPP mouse model described in Sanchez et al. should be understood in the context of Alzheimer’s disease, not Parkinson’s disease. See applicant’s Remarks, submitted June 11, 2026, at pp. 5-7. Furthermore, the examiner notes that Laakso et al. admits that measuring “hippocampal atrophy” is not specific and therefore is of “limit[ed] use in clinical practice” (p. 681), which calls into question the reasonable expectation of success upon which the theory of obviousness was predicated. The rejections under pre-AIA 35 U.S.C. 103(a) Murty, Gallagher, Curran and Davies are likewise with-drawn.
Response to Arguments
With respect to double patenting, applicant cites two Federal Circuit and PTAB decisions, specifically, Allergan USA, Inc. v. MSN Laboratories Private Ltd. and Ex Parte Baurin, that purport to stand for the proposition that the cited reference patents are not a “proper ODP reference.” See applicant’s Remarks at pp. 7-8. The authorities cited by applicant do not reflect current Office policy is set forth in MPEP1 804. In fact, Allergan and Baurin are not even mentioned in the MPEP, so the examiner does not view them as binding authorities. Applicant’s arguments have been fully considered but are not persuasive. The rejections for double patenting are therefore main-tained. The examiner suggests a terminal disclaimer.
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 Good-man, 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 accompa-nied 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(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 that 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/eterminaldisclaimer.
Claims 104, 124, and 180-183 remain rejected on the ground of nonstatutory double patenting as being unpatentable over Patent No. 10,159,648 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘648 Patent (cited in the prior action) claims a method of treating cognitive impairment associated with mental retarda-tion, Parkinson's disease, autism, compulsive behavior, or substance addiction (claim 15) by administering 220 mg or 190 mg of levetiracetam (claims 1 and 6).
Claims 104, 124, and 180-183 remain rejected on the ground of nonstatutory double patenting as being unpatentable over Patent No. 10,925,834 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘834 Patent (cited in the prior action) claims a method of treating cognitive impairment associated with mental retarda-tion, Parkinson's disease, autism, compulsive behavior, or substance addiction (claim 10) by administering a dosage form of levetiracetam that “provides a steady state plasma concentration of levetiracetam in a subject of between 1.9 μg/ml and 4.4 μg/ml” (claims 1 and 4). Figs. 7-8 of the ‘834 Patent, and the discussion therein, indicate that tablets of 190 mg or 220 mg of levetiracetam result in this steady state plasma concentration, so the examiner concludes that there exists overlap between the dosage amounts claimed in the ‘834 Patent and the dosage amounts of the instant claims.
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 advi-sory 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 10, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
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