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
Status of the Claims
Claims 100, 108, and 110-116 are pending. Claims 110-112 are withdrawn from further consideration as being directed towards a nonelected invention. Claims 100, 108, and 113-116 are examined on their merits.
Specification
The amendment filed on July 30th 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The deletion of the phrase, “According to a specific embodiment,” and the deletion of the paragraph beginning on pg. 27 line 16 would change the definition of “autism spectrum disorder,” to one that is not supported by the original disclosure of the application.
Applicant is required to cancel the new matter in the reply to this Office Action.
35 U.S.C. § 102 Rejections Maintained
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.
The rejection of claims 100 and 108 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) is maintained.
Applicant’s arguments in the response filed on July 30th 2026 are acknowledged. Applicant’s proposed amendment to the specification introduces new matter by changing the definition of “autism spectrum disorder,” to one that is not supported by the original specification. Applicant argues that “an amendment narrowing the scope of a list in the specification is not new matter as alternative elements that are positively recited in the specification may be explicitly excluded.” Applicant cites MPEP 2173.05(i) for reference. Applicant’s arguments are found not persuasive, as MPEP 2173.05(i) discusses negative limitations in the claims. And not the removal of matter from the specification as a whole. As applicant’s arguments for overcoming the 102 rejections were based on the changing of this definition, the 102 rejections are accordingly maintained.
35 U.S.C. § 102(a)(1) Rejections Reiterated
Claims 100 and 108 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.
35 U.S.C. § 112(b) Rejections Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claims 113-115 rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 113, 114, and 115 are indefinite for the limitations, “wherein said reduction in nNOS activity is effected selectively or preferentially in the brain of the subject as compared to other tissues,” “wherein upon administration of the composition, a level of physiologically available nitric oxide in neuronal cells of the subject is reduced by at least 20%,” and “wherein upon administration of the composition, a concentration of nitro-tyrosine in the plasma of the subject is reduced by at least 20%,” respectively, because one of ordinary skill in the art could not reasonably determine how the phrase further limits the metes and bounds of the method of claim 100.
In case, the limitations amount to functional-descriptive language that appears to limit the results of administration of the composition, but no further limitations are described. Specifically, it is unclear how any of:
The compounds administered
The amounts administered
The method/route of administration
The patient population receiving administration
or any other limitation relating to the method of claim 100 are further limited. Instead, only the results of said administration are described. This activity is described in the specification in identical language (specification, paragraphs [0081]-[0083]), but at no point in the specification is it described how the method must be limited in order to achieve said activity.
35 USC § 102 Rejections Necessitated by Amendment
Claims 113-116 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).
It is unclear how claims 113-115 further limit the method of claim 100 (see the above 112(b) rejection of claims 113-115). Consequently, they are anticipated by Montezuma for the same reasons as claim 100.
Claim 116 is directed to the method according to claim 100, wherein the ASD is selected from autistic disorder, high-functioning autism, Asperger syndrome, pervasive developmental disorder not otherwise specified, and childhood disintegrative disorder. Following the definition of applicant’s “treatment of ASD,” claim 116 is directed towards the treatment of symptoms of any of the above specified disorders.
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 these repetitive behaviors are characteristic of each of the described autistic disorders,2 is meets the parameters of applicant’s definition of “treatment of ASD” (specification, pg. 27), and Montezuma anticipates claim 116.
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 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)
2 For evidentiary support, see DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, 1994, pg. 66-71), which describes repetitive/obsessive behaviors as a core feature of each of the aforementioned autistic disorders. It is further noted that DSM-IV was the last edition of the DSM which separated ‘autism spectrum disorder’ into the aforementioned disorders.
