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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
U.S. Patent No - claims
11,007,189 – 1-16.
11,147,808 – 1-29
11,207,281 - 1-22
11,253,492 – 1-28
11,273,134 – 1-20
11,285,118 – 1-20
11,285,146 – 1-20
11,291,665 - 1-13
11,291,638 – 1-20
11,298,352 – 1-20
11,344,544 – 1-20
11,364,233 – 1-27
11,382,874 – 1-20
11,419,867 – 1-20
11,426,370 – 1-17
12,194,036 – 1-18
12,544,345 – 1-8
12,472,155 – 1-24
12,364,674 - 1-25
12,478,622 - 1-26
12,472,174 – 1-14
12,263,161 - 1-22
12,194,005 - 1-19
12,239,642 - 1-22
12,370,154 - 1-23
12,433,884 – 1-21
12,472,156 - 1-2
12,564,587 – 1-12
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the above listed patents are directed to a method of treating agitation in a subject with Alzheimer’s disease or to a method of increasing dextromethorphan plasma levels in a subject wherein dependent claims further limit the subject as having Alzheimer’s disease and in need of treatment for agitation. In all patents the claims are directed to administration of combination of dextromethorphan and bupropion at currently claimed amounts. Where the claims fail to recite the currently claimed administration schedule, a person of ordinary skill would have found it obvious to determine the optimal administration schedule for the combination of dextromethorphan and bupropion and duration of treatment. Where claims do not specifically recite the pharmacokinetic parameters, specifically Cavg for dextromethorphan, that occur as a result of administering the claimed combination, the claimed Cavg is inherently when optimal dose of the claimed combination is administered to a subject. Current claims comprise a limitation directed to increase in Cavg of dextromethorphan in the claimed population compared to population that does not receive it in combination with bupropion. This limitation is also inherently met because bupropion acts to inhibit metabolism of dextromethorphan. Since the claims of the reference patents all comprise limitations directed to administration of currently claimed dose of bupropion, it is inherent that the increase in dextromethorphan plasma concentration is as claimed.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19373642 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘642 application is directed to a method of treating agitation (claim 1) in a subject experiencing Alzheimer’s disease (claim 2). The method comprises administration of 105mg of bupropion in combination with dextromethorphan. While the amount of dextromethorphan is not recited in the ‘642 claims, a skilled artisan would have found it necessary to determine the effective and safe amount of dextromethorphan to administer to a patient. Since the subject population and disease to be treated is the same in the ‘642 application and in current claims in determining the amount of dextromethorphan to administer, the skilled artisan would invariably arrive at the currently claimed dose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reply to applicant’s arguments
Applicants have traversed the rejections of record on the grounds that administration of the doses recited in the claims of the reference patents would not necessarily result in the currently claimed pharmacokinetic parameters. This argument is not persuasive. The dose administered in the reference applications is within the scope of the doses currently claimed. If the currently claimed 105mg of bupropion and 44-46 mg of dextromethorphan results in the claimed parameters (see claim 6) then claims directed to administration of the same dose of each agent would result in the same pharmacokinetic parameters.
Conclusion
Claims 1-20 are pending
Claims 1-20 are rejected
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 YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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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.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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