DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/05/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The 112, first paragraph new matter rejection has been withdrawn in view of the Amendment filed 05/05/2026.
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 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following patents because it is noted that the preset inventor has a quite a large number of applications, and patents that are directed to the method of treating neurological disorder, including depression, Alzheimer, ALS, and the like. The following references are just to name a few that comprise combination of bupropion and dextromethorphan as sole active agents for the treatment of neurological disorder such as depression: 11,717,518; 11,839,612; 11,925,636; 11,986,444; 12,036,191; 12,042,473; 12,239,642; 12,263,161;12,364,674; 12,478,622; 12,544,345 in view of 12,357,697 B2 and 2014/0051718 A1 and further in view of 10,898,453 (‘453). The claims of the 12,357,697 B2 patent disclose combination of dextromethorphan, bupropion and cysteine, wherein bupropion and cysteine are in the claimed ratio. The refences fail to teach a bilayer tablet comprising dextromethorphan and bupropion in two separate layers. However, one of ordinary skill in the art would have been motivated to, by routine experimentation preparing a dosage form that comprises bupropion and dextromethorphan in two separate layers with the expectation to: obtain a stable composition that comprises multiple active agents in a single dosage form; and deliver the active agents with sustain release, controlled release or pulsatile release profile. See for example the teaching in the claims of the 11,730,706 reference, which clearly shows a multilayer dosage form for the delivery of multiple active agents is well known and desired in the art.
It is noted that the Amendment filed 01/14/2026 has broaden the scope of the claims with respect to the method of treating neurological disorder in place for the “method of treating depression” as originally filed. It is known in the art that neurological disorder encompassed a wide variety of disorders such as depression, Alzheimer, ALS, seizure, schizophrenia and the like. See for example the teaching in the USPN 20140051718 A1 reference.
The ‘453 patent teaches depression a treatment for nicotine addiction comprising administering combination of dextromethorphan and bupropion.
Thus, one of ordinary skill in the art would have been motivated to, by routine experimentation obtained the claimed invention given the teaching in the ‘453 patent in view of the above mentioned patents. This is because the ‘453 patent teaches treating nicotine addiction comprising administering a combination of dextromethorphan and bupropion is known in the art.
Response to Arguments
Applicant’s arguments filed 05/05/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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, ROBERT A. WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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