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 .
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 16-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,194,036 (‘036), in view of US 12,433,884 ‘(884). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘036 patent discloses a method of treating agitation associated with Alzheimer's disease in a human patient who has moderate hepatic impairment comprising: determining that a human patient has moderate hepatic impairment, defined as Child-Pugh B, and administering twice daily, by mouth, one tablet containing about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide to the human patient who has moderate hepatic impairment and is experiencing agitation associated with Alzheimer's disease, wherein the dextromethorphan AUC0-12 of the human patient is 85% to 161% of the dextromethorphan AUC0-12 of human patients with healthy hepatic function.
The ‘036 patent does not expressly teach a dosing regiments require by the present claims, however, it is well known in the art to treat agitation associated with Alzheimer's disease in a human being suffering from agitation associated with Alzheimer's disease, comprising orally administering a first tablet once daily for one week followed by twice daily for one week, then a second tablet twice daily to the human being; wherein the first tablet contains about 105 mg of bupropion hydrochloride or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, and about 30 mg of dextromethorphan hydrobromide or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan; and the second tablet contains about 105 mg of bupropion hydrochloride or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, and about 45 mg of dextromethorphan hydrobromide or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan; wherein the dextromethorphan and the bupropion are the only therapeutically active agents in the first or second tablet; and wherein the human being is an extensive metabolizer of dextromethorphan. See Claim 1 of the ‘884 patent.
Thus, it would have been prima facie obvious to one of ordinary skill in art at the time the invention was made to obtain the claimed invention given the claims of the ‘036 patent in view of the claims of the ‘884 patent. This is because the ‘884 patent teaches using the claimed dosing regiments for the treatment of agitation associated with Alzheimer’s disease in human is known in the art.
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.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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