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 .
Claim Status
Claims 1-24 are pending. Claims 21-24 are withdrawn. Claims 1-20 are rejected.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-20 and the elected species 6-chloro-N-(ethyl-d5)-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine in the reply filed on May 22nd, 2026 is acknowledged. Applicant’s elected invention is not allowable under 35 USC 103.
Claims 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/154039 A1 by Dasse in view of Gautam et al. Clinical Practice Guidelines for the Management of Generalised Anxiety Disorder (GAD) and Panic Disorder (PD). Indian J Psychiatry 2017;59:67-73.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches deuterated analogs of etifoxine such as 6-chloro-N-(ethyl-d5)-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine” (title; paragraph [0078]). Regarding instant claims 1, 7-8, 11, and 17-18, Dasse discloses that the compound is useful for treating anxiety (paragraph [0094]).
Regarding claims 7 and 17, the prior art specifies anxiety disorders including panic disorder without agoraphobia, panic disorder with agoraphobia, etc. (paragraph [00100]).
The prior art teaches that when a position is designated specifically as "D" or "deuterium", the position is understood to have deuterium at an abundance that is at least 3340 times greater than the natural abundance of deuterium as required by instant claims 9 and 19 (paragraph [0044].
Regarding instant claims 1, 3-6 and 11-16, the prior art teaches that the compound may be administered orally in a total daily dose of about 0.01 mg/kg/dose to about 100 mg/kg/dose, in as many divided doses as is convenient (paragraph [00123]). This embraces the once or twice a day administration in instant claims 3, 12-13, and 16. The prior art range overlaps with the 100 mg or less dose of claims 4 and 14, 20 to 100 mg dose of claim 5, 50 mg to 100 mg dose of claim 15, and 60 mg dose of claims 6 and 16.
Additionally, Dasse states that the compound may exist as a racemic mixture corresponding to instant claims 10 and 20 (paragraph [0049]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Regarding instant claims 1-2 and 11, the prior art discloses a method of treatment comprising administering 6-chloro-N-(ethyl-d5)-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine within the claimed ranges and frequencies; however, Dasse et al. is silent to the ARCmax and ARAUC0-12.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Although the prior art does not explicitly teach that the compound is administered at a dose and frequency that exhibits an ARCmax and ARAUC0-12 over a period of 7 days that is equal to or greater than 1.0 Dasse teaches methods of treatment wherein the claimed compound is administered within the claimed dose and frequency. Gautam et al. discuss (title) “Clinical Practice Guidelines for the Management of Generalised Anxiety Disorder (GAD) and Panic Disorder (PD)” and disclose that drug treatment of GAD is sometimes a 6-12 month treatment and that in patients with panic disorder and agoraphobia, anti-anxiety drug treatment should be 6 to 8 months or longer to prevent relapses (pages S70 and S71). Accordingly, a person of ordinary skill
performing the prior art treatment would be motivated to administer the compound to a subject for at least 7 days and could expect that the treatment exhibits an ARCmax and ARAUC0-12 over a period of 7 days that is equal to or greater than 1.0 as required by the instant claims.
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 17 of U.S. Patent No. 10,080,755 in view of WO 2016/154039 A1 by Dasse and Gautam et al. Clinical Practice Guidelines for the Management of Generalised Anxiety Disorder (GAD) and Panic Disorder (PD). Indian J Psychiatry 2017;59:67-73.
Claim 6 of the patent discloses a method of modulating the GABAA receptor complex in a subject by administering 6-chloro-N-(ethyl-d5)-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine. Dasse teaches that this compound acts as a modulator the GABAA receptor complex (paragraph [0089]) and discloses a method of treating anxiety by administering the compound which is the basis of a rejection under 35 USC 103. The teachings and rationale of Dasse and Gautam et al. relative to claims 1-20 as discussed above are incorporated here by reference. The instant claims are deemed to be obvious variants of the subject matter of the patent for the same reasons as under 35 USC 103.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,736,901 and claims 1-17 of U.S. Patent No. 11,672,805 in view of WO 2016/154039 A1 by Dasse and Gautam et al. Clinical Practice Guidelines for the Management of Generalised Anxiety Disorder (GAD) and Panic Disorder (PD). Indian J Psychiatry 2017;59:67-73.
Claim 9 of patent ‘901 and claim 1 of patent ‘805 disclose a method of treating anxiety by administering 6-chloro-N-(ethyl-d5)-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine which serves as the basis of a rejection under 35 USC 103. The teachings and rationale of Dasse and Gautam et al. relative to claims 1-20 as discussed above are incorporated here by reference. The instant claims are deemed to be obvious variants of the subject matter of the patents for the same reasons as under 35 USC 103.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,433,896 in view of WO 2016/154039 A1 by Dasse, Gautam et al. Clinical Practice Guidelines for the Management of Generalised Anxiety Disorder (GAD) and Panic Disorder (PD). Indian J Psychiatry 2017;59:67-73., and Hingray et al. The Relationship Between Epilepsy and Anxiety Disorders. Curr Psychiatry Rep 21, 40 (2019).
Claims 2 and 3 of the patent disclose a method of treating epilepsy by administering 6-chloro-N-(ethyl-d5)-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine. Dasse teaches a method of treating epilepsy and anxiety disorders including panic disorder with agoraphobia by administering this compound (paragraph [0092]). Hingray et al. discuss the relationship between epilepsy and anxiety disorders and provide an overview of anxiety symptoms and anxiety disorders (AD) in adults patients with epilepsy (PWE). Specifically, Hingray et al. teach (abstract):
AD are diagnosed in the interictal period and occur independently of seizures. Four specific AD in PWE can be objectified: anticipatory anxiety of epileptic seizures (AAS), seizure phobia, epileptic social phobia, and epileptic panic disorder. Secondly, the bidirectional pathophysiological relationship between anxiety and epilepsy will be described. Anxiety is a trigger for seizures in some patients, and the notion of stress and arousal is essential to understand the relationship between anxiety and seizure…
Despite lack of evidence-based approaches, it is recognized that management of epilepsy is not only about controlling seizures, but also depends heavily on detecting, correctly diagnosing, and appropriately managing anxiety symptoms and AD comorbidities, in order to maximize quality of life.
Additionally, Hingray et al. define epileptic panic disorder as a specific panic disorder associated with agoraphobia (page 4, Specific Interictal Anxiety Disorder in PWE, iv).
A person of ordinary skill seeking to treat epilepsy in the method of the patent would have been motivated to test known methods of treating the conditions and comorbidities such as anxiety disorder such as the methods disclosed by Dasse. Treatment of anxiety with the patent’s compound serves as the basis of a rejection under 35 USC 103. The teachings and rationale of Dasse and Gautam et al. relative to claims 1-20 as discussed above are incorporated here by reference. The instant claims are deemed to be obvious variants of the subject matter of the patent for the same reasons as under 35 USC 103.
Conclusion
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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