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 .
Election/Restrictions
Applicant’s election with traverse of Group I, (drawn to a method for the treatment of ASD), in the reply filed on 07/28/2025 is acknowledged.
Claims 13-16 (Group II and II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1, 3 and 6-12 have been examined on the merits.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office
action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 7-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lynn Durham (US 10,940,140B2) “Durham” in view of Ben-Ari Y, Trends Neurosci. 2017 Sep;40(9):536-554 “Ben-Ari”.
Regarding claim 1 and 7-9, Durham (abstract) teaches a method of treating patients suffering from autism spectrum disorder (ASD) phenotype 1 by administering an effective amount of a substance capable of raising intracellular cAMP levels. Durham (col. 3) teaches treatment of ASD with the following compounds:
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Durham does not explicitly teach treating an ASD patient with either upregulation or downregulation.
However, Ben-Ari (page 538 and 541) teaches a patient with ASD has downregulation of KCC2 (encoded by SLC12a5) and once treated with bumetanide, patients displayed a significant improvement in symptoms.
Regrading repolarization of membrane, Ben-Ari (page 536-539, and 547) teaches that bumetanide can modulate transmembrane Cl- gradient and inhibit NKCC1, and that NKCC1 is an electroneutral neuronal Cl- importer and promote GABAergic mediated hyperpolarization. This indicates that treatment with bumetanide can induce repolarization of excitable cell membrane.
Therefore, it would have been obvious to a person of ordinary skill in the art (POSITA) to combine the teaching to of Durham and Ben-Ari to arrive at the claimed invention, because both references relate to treating ASD with bumetanide.
Regarding claim 12, Durham (col. 13) as applied to claim 1, teaches the following:
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Claim Objections
Claims 3, 6, and 10-11 are objected as being dependent, directly or indirectly, on rejected claim 1.
Claims 3, 6, and 10-11 are free of the art of record. The closest prior art is Lynn Durham (US 10,940,140B2). While Durham teaches a method of treating patients suffering from autism spectrum disorder (ASD) phenotype 1 by administering an effective amount of a substance capable of raising intracellular cAMP, however Durham does not teach any of the claimed subject matter. The claim is not allowed because it relies on claim 1 that has been rejected. As a result, until this issue is remedied or resolved, the claim cannot be subject of allowance.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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