DETAILED ACTION
Claims 21-40, submitted 07 January 2026, are pending in the application and subject to examination in the instant Office Action. Claims 1-20 have been cancelled.
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 .
Rejections – Withdrawn and New
The status of the previously reject claims, in the Office Action dated 08 September 2025, are detailed below.
Rejections under 35 U.S.C. § 112(a)
As Applicant has cancelled claims 1-6, 8, 13, and 15-20, the previous rejection is now moot. Thus, the rejection of the aforementioned claims as been withdrawn.
Rejections under 35 U.S.C. §103
As Applicant has cancelled claims 1-6, 8, 13, and 15-20, the previous rejection is now moot. Thus, the rejection of the aforementioned claims as been withdrawn.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
(New) Claims 21-40 are rejected under 35 U.S.C. 103 as being obvious over Missling et al. (WO 2019/222754 A1).
The applied reference has a common Assignee and Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Missling teaches a method of treating a neurodegenerative disease, wherein the neurodegenerative disease is Rett syndrome, (paragraph 0050) in a subject by administering to said subject a composition comprising a therapeutically effective amount of a sigma-1 receptor agonist. Missling additionally teaches when the sigma-1 receptor agonist is ANAVEX2-73, the therapeutically effective amount can range from about 0.5 mg to about 20 mg, about 1 mg to about 60 mg, about 30 mg to about 50 mg, or about 3 mg to about 5 mg (paragraph 0054). Finally, Missling teaches wherein the composition is administered by several different means such as parenteraly, intraperitoneally, intravascularly, transdermally, subcutaneously, or intrapulmonarily (paragraph 0060), and even includes oral administration (paragraph 0088).
With respect to claim 22, Missling teaches wherein an extended-release oral composition is administered at a dose which ranges from 1mg to about 100 mg/day, from about 40 to about 60 gm/day, or from about 10 to about 30 gm/day (paragraph 0063), which encompasses the range taught by the Applicant of about 1mg/day to about 60mg/day. This further reads on the limitations taught by claims 23-25 with claim ranges encompassed by the teachings of Missling.
With respect to claim 26, Missing teaches wherein the composition is formulated for transdermal administration at a dose which ranges from about 40mg to about 60 mg (paragraph 0087) which encompasses the range taught by the Applicant of about 1mg/day to about 60 mg/day. This further reads on the limitations taught by claims 27 and 28 of ranges of about 20 mg/day to about 50 mg/day and 30 mg/day to about 40 mg/day, respectively.
Regarding claim 29, while Missling does not explicitly teach the dosage for the transdermal composition wherein the dosage is administered from about 0.5 mg/day to about 20 mg/day, this reference does teach “In some aspects, dosage forms can comprise from about 1 mg to about 500 mg, or about 1 mg to about 100 mg of A2-73.” (paragraph 0085). It would have been prima facie obvious for a person having ordinary skill in the art to at least try through routine experimentation to treat a neurodegenerative disorder, in the instant case Rett syndrome, with a lower dose to determine the minimum effective dose for treatment.
With respect for claim 30, Missling teaches wherein a composition can be administered parenterally and defines the methods encompassed by parenteral administration as including subcutaneous, intravenous, intramuscular, intrathecal, or intrasternal injection, or infusion techniques (paragraph 0060). Missling additionally teaches when the sigma-1 agonist is A2-73, “the dosage form can comprise from about 1 mg to about 50 g, from about 1 mg to about 500 mg, from about 1 mg to about 100 mg…” (paragraph 0085). Finally, Missling states the following, “ Dosage forms also encompass those formulated for subcutaneous and/or intramuscular injection.” (paragraph 0091). Thus, it would have been prima facie obvious to treat Rett syndrome in a subject with A2-73 through parenteral administration in a dosage from about 0.5 mg/day to about 20 mg/day because Missling teaches overlapping ranges. This also reads on the method of administration and dosage ranges taught by instant claims 31-37.
Regarding claim 38, Missling teaches “A2-73 can also be administered over a period of about 1 day, about 7 days, about 30 days, about 60 days, about 120 days, or about 180 days or more. In some aspects, A2-73 is administered over a period of about 57 weeks, about 148 weeks, about 208 weeks, indefinitely, or until resolution of the condition being treated” (paragraph 0055), which reads on the limitation of the instant claim wherein the composition is administered to the subject for a period of at least 5 days, at least 10 days, at least 15 days, at least 60 days, at least 6 months, at least 1 year, at least 2 years, at least 3 years, at least 4 years, or at least 5 years.
With respect to claim 39, Missling teaches transdermal administration through a transdermal patch as the transdermal device (paragraph 0087).
With respect to claim 40, while Missling teaches the use of a transdermal patch, this reference does not teach whether the drug is administered is through a reservoir membrane type patch, a porous membrane type patch, or a solid matrix type patch. However, through routine experimentation, one skilled in the art would have been motivated to experiment with various types of patch to increase drug delivery efficacy.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Conclusion
No claims are allowed.
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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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622