DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawn rejections
Rejections of claims 38-46 on the ground of nonstatutory double patenting over claims of US patents
10,441,579; 10,206913; 9,675,599; 8,304,432; and 10,722,504 are withdrawn in view of the terminal disclaimers filed on 6/30/26.
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 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 38-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 12 of U.S. Patent No. 10/238,642. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1, 6 and 12 of the ‘642 patent are directed to a method of treatment comprising administration of compound of formula I as an HCl salt (claims 1 and 6) at a dose of 10mg/day (claim 12). In order to practice the invention of the ‘642 patent one skilled in the art would require the instantly claimed composition. It would be obvious for one skilled in the art to prepare the solid crystalline HCl salt of compound (I) into a tablet in order to utilize it in the method described in the ‘642 patent. In order to prepare the pharmaceutical composition claimed used in ‘642 a practitioner would have found it necessary to look in the description for the definition of the claimed term. Column 32 of the description describes exemplary tablet for oral administration. Since description describes the pharmaceutical composition in a form of a tablet, it would have been obvious to prepare the composition of claim 1 of ‘642 as a tablet according to the procedure recited in the description.
Reply to applicants’ remarks
Applicants traversed the above rejection of the grounds that the claims of the ‘642 application while reciting administration of compound of formula I as an HCl salt, do not recite the limitation directed to “tablet”. Examiner maintains that in order to practice the invention, a skilled artisan would have found it necessary to consult the specification in order to determine the form of the administered composition. Throughout the specification of the ‘642 patent formulation of the composition into a tablet form is described (for example column 17, lines 10-15. While applicants are correct that tablet is not the only described form of administration, administration of a tablet is within the scope of the claims of ‘642. Description not only mentions tablet, but also provides specific examples of tablets that can be prepared (column 11, sections E, F, G, H). Alternatively, illustrated compositions in columns 10-12 only include capsules, tablets, syrup and intravenous solutions. Selecting a Tablet out of 4 possible formulations is obvious because a skilled artisan can readily envision all of the possibilities. Since claim 18 of the ‘642 patent requires administration of the active component in a solid form, only tablet and capsules remain as suitable pharmaceutical forms for administration.
Conclusion
Claims 38-46 are pending
Claims 38-46 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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