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 .
Claims 1-20 are presented for examination.
Applicants’ drawings and preliminary amendment filed July 10, 2024 have been received and entered.
Applicants’ information disclosure statement filed October 21, 2024 has been received and entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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 claims 1-23 of U.S. Patent No. 12,138,233 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application teaches a method for transitioning a gamma hydroxy butyrate (GHB) dose regimen of a patient, the method comprising: (1) administering GHB, a prodrug or a pharmaceutically acceptable salt thereof to a patient in need thereof in a first administration period, wherein the GHB is administered as a divided, twice daily (DTD) dose of about 4.5 g to about 9 g per night; (2) administering GHB in a transition period, wherein the GHB is administered as a once daily (OD) dose; (3) administering GHB in a maintenance period, wherein the GHB is administered as an OD dose that is higher than the dose administered during the transition period, and the patented application teaches a method of treating idiopathic hypersomnia in a patient in need thereof, the method comprising: a twice daily dosing regimen, comprising (a) administering to an adult patient with idiopathic hypersomnia an initial daily dose of less than or equal to about 4.5 grams of a mixed salt oxybate divided equally or unequally into 2 doses; and (b) titrating the daily dose to provide a therapeutically effective amount of the mixed salt oxybate, wherein the maximum daily dose is about 9 grams divided equally or unequally into 2 doses; or a once daily dosing regimen, comprising (a) administering to an adult patient with idiopathic hypersomnia an initial daily dose of less than or equal to about 3 grams of the mixed salt oxybate; and (b) titrating the daily dose to provide a therapeutically effective amount of the mixed salt oxybate, wherein the maximum daily dose is about 6 grams; wherein the mixed salt oxybate comprises about 5%-40% sodium oxybate, about 10%-40% potassium oxybate, about 5%-30% magnesium oxybate, and about 20%-80% of calcium oxybate (% mol. eq.).
Note in the patented application, column 18, lines 23-32, teaches titration (the gradual adjustment of a medication dose to find the optimal level that maximizes benefits while minimizing side effect), by switching a patient from a twice a day dose of the mixed salt oxybate (same as GHB) to a once a dose.
Note in the patented application, column 11, lines 13-45, teaches the salts of oxybate (GHB) and their amounts.
Finally, in the patented application, column 19, lines 1-17, teaches the titration adjustment can be tolerated during periods of up to seven days.
Clearly, the patented application encompasses the transitional dose regimen of the present application.
Clams 1-20 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629
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