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 .
DETAILED ACTION
Election of Species and Status of the Claims
Applicant’s election without traverse of Group I, comprising claims 100 and 107-109, as well as ‘L-NG-propyl-L-arginine (N-PLA)’ as the single specific active agent that reduces or inhibits nNOS activity in the response filed on March 12th 2026 is acknowledged. Claims 100 and 107-112 are pending. Claims 110-112 are withdrawn from further consideration as being directed towards a nonelected invention. Claims 100 and 107-109 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on November 10th 2023 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Interpretation
Claim 100 recites “A method for the treatment of autism spectrum disorder in a subject in need…” For the purpose of examination, the claim will be read as the more commonly used, “A method for the treatment of autism spectrum disorder in a subject in need thereof…”
Duplicate Claims
Applicant is advised that should claim 108 be found allowable, claim 109 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 100 and 107-109 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Montezuma (Montezuma et al., (2020). Anticompulsive-like effect of nitric oxide synthase inhibitors in marble-burying test. Journal for Reproducibility in Neuroscience, 1, 1381).
Claims 100 and 107-109 are directed towards the treatment of autism spectrum disorder (ASD)1 via administration of the neuronal nitric oxide synthase (nNOS) inhibitor, L-NG-propyl-L-arginine (N-PLA).
Montezuma teaches administration of L-NG-propyl-L-arginine to decrease repetitive/obsessive behaviors (Montezuma, pg. 3, Figure A), and that such administration successfully decreases compulsive behaviors. As this meets the parameters of applicant’s definition of “treatment of ASD” (specification, pg. 27), Montezuma anticipates claims 100 and 107-109.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Defined by applicant as the improvement in at least one undesired parameter, characterization, or behavior associated with ASD, including repetitive behaviors (Specification, pg. 27)
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