DETAILED ACTION
The amendment submitted on May 4, 2026 has been entered. Claims 2-10 and 13-24 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first-to-invent provisions of Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284 (2011). In the event the determination of the status of the application as subject to pre-AIA 35 U.S.C. 102 and 103 (or as subject to AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from pre-AIA to AIA or vice versa) for a 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.
Withdrawn Rejections/Objections
The amendment to para. 0052 of the specification to designate the trademarks is acknowledged.
The objection to claim 6 is withdrawn in view of applicant’s corrective amendment.
The rejection of claim 15 under pre-AIA 35 U.S.C. 112, second paragraph, as being indefi-nite is withdrawn because the claim has been amended so that “the NMDA receptor antagonist” has proper antecedent basis.
The rejection of claim 21 under pre-AIA 35 U.S.C. 112, second paragraph, as being indefi-nite is withdrawn because the trademarks have been deleted.
The rejection of claims 2-4, 6, and 10-21 under pre-AIA 35 U.S.C. 103(a) as being unpatent-able over Gasior (J. Pharmacol. Exp. Ther. 282, 543-53 (1997)) is withdrawn because the examiner is persuaded that “the skilled person would not have had any reason or motivation to combine allopregnanolone and a subtherapeutic dose of a benzodiazepine” because the reference discloses that this combination “failed to alter the anticonvulsant activity.” See applicant’s Remarks, submitted May 4, 2026, at pp. 12-13.
The rejection of claims 2-21 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gasior in view of Morton (US 2007/0081948 A1) is withdrawn for substantially the same reasons.
New Grounds for Rejection Claim Rejections – 35 USC § 112
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. Claim 13 depends from a cancelled claim, so its scope is indefinite.
Maintained Rejections Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2, 4, 10, 13, and 18-21, as amended, remain rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Gasior (J. Pharmacol. Exp. Ther. 282, 543-53 (1997)).
Gasior (cited in the prior action) discloses administration of increasing doses of neuro-steroids, such as allopregnanolone (3α,5α-P), given in combination with a fixed, “ineffective” dose of diazepam (DZP; p. 545, “Drugs and administration regimen,” see also Table 3 and Fig. 6 at p. 549) for “protection” against convulsions and seizures that would be useful in clinical prac-tice (see Abstract). Inasmuch as the dose of benzodiazepine is “ineffective,” the examiner concludes that it is “subtherapeutic” as recited in the instant claims. The reference also discloses dosage amounts of various neurosteroids approaching zero (Fig. 6 at p. 549), which appears to include dosage amounts so small as to be considered subtherapeutic. The reference explicitly discloses combinations of both diazepam and a neurosteroid, separately administered (see, e.g., Table 3 and Fig. 6 at p. 549, as well as the discussion thereof; see also, p. 545, “Drugs and admin-istration regimen”). When administered together, the combination provides a marked enhance-ment of the anti-convulsant potency of the benzodiazepine (p. 544, right column), and such combination therapy is active in different experimental models of seizures (p. 552, last para-graph). Protective dosage amounts of allopregnanolone (3α,5α-P) are about 10 mg/kg or higher (Figs. 3 and 5), which meets the limitations of claim 13. With respect to claim 19, it appears that everyone has at least some risk of being exposed to a nerve agent or a pesticide that can cause seizures (the examiner appreciates that it may be a de minimis risk, but it is nevertheless nonzero), so preventing a seizure that may be caused by any of the compounds recited in claims 20-21 is inherent the method of Gasior. See MPEP 2112.
Response to Arguments
Applicant argues that Gasior discloses that “DZP (0.1 mg/kg) failed to alter the anticon-vulsant potency of 3α,5α-P against PTZ,” so the reference cannot anticipate the claims. See applicant’s Remarks, submitted May 4, 2026, at pp. 12-13. “A reference is no less anticipatory if, after disclosing the invention, the reference then disparages it.” See MPEP 2131.05. The exam-iner agrees that the reference teaches away from low dosage amounts, but it nevertheless teaches all the limitations of the claims. The anticipation rejection is therefore proper.
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 possi-ble 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 Good-man, 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 accompa-nied 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(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 that 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/terminaldisclaimer.
Claims 2-10 and 13-21, as amended, remain rejected and new claims 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over Patent No. 10,426,786 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘786 Patent claims a method of preventing or terminating a seizure comprising administration a benzodiazepine and allopregnanolone in a subtherapeutic dose, wherein the subject has been exposed to a nerve agent or a pesticide that can cause seizures. See claim 1 of the Patent. Dependent claim 7 is drawn to inhalational or intrapulmonary route of administration, and dependent claim 12 is drawn to co-administration with an NMDA receptor antagonist. With respect to new claims 22-24, the Patent discloses this subject matter at col. 3, l. 3 and col. 10, ll. 40-55. The examiner therefore maintains that the instant claims are prima facie obvious over the subject matter claimed in the ‘786 Patent. Applicant has not offered any arguments in rebuttal thereof.
Claims 2-10 and 13-21, as amended, remain rejected and new claims 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over Patent No. 11,510,929 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ’929 Patent, of which the present application is a continuation claims a method of preventing or mitigating a seizure comprising: (a) determining that a subject is at risk of being exposed to a nerve agent or pesticide that can cause seizures, and (b) administering to the subject of an effective amount of a benzodiazepine and allopregnanolone, wherein each of the benzodiazepine and the allo-pregnanolone are administered in a subtherapeutic dose, and wherein the subtherapeutic dose of the benzodiazepine is in the range of 0.3 μg/kg to 3.0 μg/kg. See claim 1 of the ‘929 Patent. Dependent claim 9 is drawn to aerosolized administration, and dependent claim 13 is drawn to co-administration with an NMDA receptor antagonist. The examiner maintains that the instant claims are prima facie obvious over the claims of the ‘929 Patent.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/ interviewpractice. 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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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
August 19, 2026
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