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 .
Priority
This application, filed 13 October, 2023, is a national stage application of PCT/US2022/024840, filed 14 April, 2022, which claims the benefit of U.S. Provisional Application 63/238,500, filed 30 August, 2021, 63/189,939, filed 18 May, 2021, 63/175,378, filed 15 April, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 April, 2026 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 29 April, 2026, in the matter of Application N° 18/286,935. Said documents have been entered on the record.
Claims 17, 24-25, and 28 are amended. Claims 3-5, 32 and 35-37 are canceled. Claim 42 is new. No new matter was introduced.
Therefore, Claims 1-2, 17-18, 20, 22, 24-25, 28, and 42 represent all claims currently under consideration.
Response to Amendments/Arguments
Revision to remove hyperlinks from the Specification are accepted and the objection is withdrawn.
Claims 3-5, 32 and 35-37 have been canceled. Therefore, the rejections of these claims
under 35 U.S.C. 112(b) and 103 are moot.
Regarding the remaining rejections under 35 U.S.C. 102 (a)(1) and the provisional Non-statutory Double Patenting for Claims 1-2, 17-18, 20, 22, 24-25, and 28, Applicant's arguments filed 29 April, 2026 have been fully considered but they are not persuasive.
Applicant argues that the “daily amount” disclosed in Stamler and Huang (WO 2016/144901 A1) is not interchangeable with the claimed “maximum total daily dose,” asserting that the former merely reflects a dose administered in practice and does not define an upper dosing limit within a 24-hour period (Remarks, Pg. 6-8).
Stamler and Huang disclose that, with concurrent administration of a CYP2D6 inhibitor, the daily amount is less than or equal to 36 mg/day (‘901, Pg. 8, Para 042), which defines an upper permissible daily dosage amount under the disclosed conditions. Furthermore, Applicant’s additionally cited paragraphs 0435, 0458, and 0484 do not distinguish the claims from Stamler and Huang, but instead reinforce the rejection. Although these paragraphs discuss administration of higher doses in certain circumstances, each additionally states that when the subject is receiving a strong CYP2D6 inhibitor, the maximum daily dose is 36 mg/day. Thus, Stamler and Huang expressly teach a capped upper daily dosage under the same concurrent administration conditions recited in the instant claims. The fact that paragraph 042 uses the terminology “daily amount less than or equal to 36 mg” rather than the exact phrase “maximum total daily dose” does not patentably distinguish the claimed limitation.
As such, the rejections under 35 U.S.C. 102 (a)(1) and the provisional Non-statutory Double Patenting for Claims 1-2, 17-18, 20, 22, 24-25, and 28 are maintained. The rejections are updated solely to additionally include newly added Claim 42, as the newly recited dosage is likewise taught by the applied reference and does not patentably distinguish over the co-pending claims.
Claim Rejections - 35 USC § 102 (MAINTAINED)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 17-18, 20, 22, 24-25, 28 and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stamler and Huang (WO 2016/144901 A1, cited in IDS.)
Regarding Claims 1-2, Stamler and Huang teach a method of treating abnormal involuntary movement in a subject, comprising administering to the subject an initial daily amount of deutetrabenazine of at least about 6 mg per day; (‘901, Pg. 5-6, Para 023), wherein the daily amount of deutetrabenazine administered is less than or equal to about 36 mg for a subject concurrently receiving a strong CYP2D6 inhibitor (‘901, Pg. 8, Para 042.)
Regarding Claims 17-18, 20 and 22, Stamler and Huang teach wherein the abnormal involuntary movement is caused by a movement disorder (‘901, Pg. 6, Para 024), wherein the movement disorder is chosen from chorea, Huntington's Disease, and tardive dyskinesia (‘901, Pg. 6, Para 025.)
Regarding Claims 24, 25, 28 and 42, Stamler and Huang teach daily amount of deutetrabenazine is chosen from about 12 mg, about 18 mg, about 24 mg, and about 30 mg (‘901, Pg. 7, Para 036.) The recitation of “maximum” daily dose does not distinguish over the prior art as Stamler and Huang expressly disclose administration of deutetrabenazine at daily doses at or below the claimed maximum, which necessarily satisfies the claimed limitation.
As such, Stamler and Huang anticipate Claims 1-2, 17-18, 20, 22, 24-25, 28 and 42.
Double Patenting (MAINTAINED)
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 1-2, 17-18, 20, 22, 24-25, 28, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1-5, 19-20, 22, 24, 26, 30, 32, 34, and 38-39 of copending Application No. 18/286,944 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because they differ only in the manner in which CYP2D6 impairment is characterized, and would have been obvious variants of one another to a person skilled in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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