DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims.
Claims 2, 7-16, 18-19, 21 and 29-30 are pending.
Applicants’ arguments filed on 09/22/2025, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 09/22/2025, have been fully considered. Applicants have amended claims 2, 7-8 and 18-19. Applicants have cancelled claims 5-6 and 17. Therefore, claims 2, 7-16, 18-19, 21 and 29-30 are subject of the Office action below.
Withdrawn Rejections
The rejection of claims 2, 5-19, 21 and 29-30 under pre-AIA 35 U.S.C. 102(b) as being anticipated by:
1) Gasior of record (J. Pharmacology & Experimental Therapeutics, 1997); and
2) Kerrigan of record (Epilepsy Research, 2000),
is overcome by the Applicants’ amendments, and is hereby withdrawn. Specifically, Applicants have: a) amended claims 2, 7-8, 18-19, so that claims 2, 7-8, 18-19, no longer recite “a neurosteroid” or “neurosteroidal”; and b) cancelled claims 5-6 and 172.
Maintained Rejections
The provisional rejection of claims 2, 7-16, 18-19, 21 and 29-30 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 17/601,705, is maintained for the reasons of record set forth in the previous Office action.
Response to Applicants’ Arguments/Remarks
Applicants have not properly addressed the specific grounds of rejections as discussed in the previous Office action setting. Applicants request that the rejection be held in abeyance until all other claim rejections are withdrawn (see page 5 of Remarks).
Response
Applicants’ comments are acknowledged. However, the rejections will be maintained until a terminal disclaimer is filed or the claims are amended to obviate the rejections.
Claim Rejections - 35 USC § 103
New Grounds of Rejection Necessitated by Applicants’ Amendments
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 7-16, 18-19, 21 and 29-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gasior of record (J. Pharmacology & Experimental Therapeutics, 1997).
By way of a background, Applicants’ invention is directed to a method for preventing, inhibiting delaying, and/or mitigating seizures with a neurosteroid (see, e.g., ¶ 0002 of the specification). The specification (see, e.g., see Example 1, ¶s 0073-0077), provides a working example, comprising administering (i.v. or i.m.) a neurosteroid (allopregnanolone, 3α-hydroxy-5α-pregnan-20-one or 5α, 3α-P, see specification at ¶ 0073), dissolved in cyclodextrin, to mice prior to administration of seizure-inducing agent (PTZ).
Under the broadest reasonable interpretation (BRI), consistent with the specification, independent claim 2 is being interpreted as a method for treating, reducing, and/or mitigating symptoms associated with and/or caused by an epileptic condition1 in a subject in need thereof, with allopregnanolone.
Similar to the Applicants’ invention (see discussions above), Gasior (see Abstract), discloses anticonvulsant and behavioral effects of neuroactive steroids such as allopregnanolone (3α-hydroxy-5α-pregnan-20-one, see discussions above), where the steroids are dissolved in hydroxypropyl-β-cyclodextrin and, were injected (subcutaneously) 15 minutes before testing in mice; the seizure-inducing agents (cocaine, MDA or PTZ), were injected after the steroid injections (thereby inhibiting or aborting an impending seizure in a subject in need thereof) [see section “Methods” at pages 544-545].
The above disclosure of testing of anticonvulsant effects on drug induced seizures in mice [see Fig. 2] is interpreted as a method of treating, reducing, and/or mitigating symptoms associated symptoms associated with an epileptic condition [see section “Discussion” beginning at page 549]. Gasior further disclose that protection against PTZ-induced seizure was achieved by three of four neuroactive steroids, while 87.5% protection was produced by allopregnanolone in doses of 3 and 10 mg/kg [see right column at page 547 and Fig.5 at page 548]. Gasior conclude that “these findings help to define neuroactive steroids as a novel class of anticonvulsant agents with potential clinical applicability.” [see page 550, left column, last full sentence].
Gasior (see page 282), states:
“Because the PTZ test in rodents is predictive of anticonvulsant drug efficacy in absence (petit mal) (Swinyard, 1969) and myoclonic (Loscher and Schmidt, 1988) epilepsy in humans, the protective efficacy of neuroactive steroids against PTZ suggests their potential clinical value.” Emphasis added.
Accordingly, at the time of the instant invention, one skilled in the art would have understood that Gasior contemplates a method for administering allopregnanolone to a human subject having symptoms associated with and/or caused by an epileptic condition, in order to treat, reduce, and/or mitigate symptoms associated with and/or caused by an epileptic condition, in the human subject. A person skilled in the art would have envisaged a method for of treating, reducing, and/or mitigating symptoms associated symptoms associated with an epileptic condition in a human subject in need thereof, comprising administering allopregnanolone to the human subject, in the disclosures of Gasior.
Therefore, one skilled in the art would have had a reasonable expectation that the administration of allopregnanolone to a human subject having symptoms associated with and/or caused by an epileptic condition, would treat, reduce, and/or mitigate symptoms associated with and/or caused by an epileptic condition, in the human subject.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Accordingly, claims 2, 7-16, 18-19, 21 and 29-30 are obvious over Gasior.
Conclusion
No claim is allowable.
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.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 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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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
1 selected from the group consisting of status epilepticus, seizure clusters and tonic seizures.