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
This is a response to Applicant’s communication filed November 29, 2023. Application No. 18/565,188, is a 371 of PCT/KR2022/008238, filed on June 10, 2022, and claims the benefit of U.S. Provisional application No. 63/209,463, filed June 11, 2021. Claims 1-20 are pending.
Claim Rejections - 35 USC § 103
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., WO2016/061488 A1 (cited on the November 29, 2023, IDS), in view of Reiersen & Harden, 6(4) Evid. Based Child Health, 1082-1085 (2011) (hereafter Reiersen) (also cited on the November 29, 2023, IDS). Liu discloses ADX-N05 (aka JDZ-110, SKL-N05, ARL-N05, and solriamfetol (hydrochloride)) as a selective serotonin reuptake inhibitor (SSRI). Liu et al., WO ‘488, p. 3, para. [10]; see also Id., p. 7, paras. 26 and 27, for enantiomers; see Id., p. 18-19, para. [80]-[82] for dosages. Liu teaches that SSRIs are used to treat a variety of disorders including pain depression fibromyalgia, anxiety, sleep disorders, restless leg syndrome, ADHD, obesity, as well as certain addictions. Id; see also Id., p. 18, para. [77] and p. 19, para. [86], for additional disorders. The difference between the prior art and present invention is the use of such an SSRI in the treatment autism spectrum disorders (ASD) or one more symptoms thereof.
Reiersen teaches that SSRIs maybe used to treat core ASD symptoms. Reiersen, p. 1082, 2nd para. Accordingly, all of the elements of the present invention were known in the art at the time of the invention.
It would have been obvious to the ordinary artisan at the time of the invention to administer a compound of Formula (I) to treat autism spectrum disorder or a disorder thereof (as presently claimed) with a reasonable expectation of success. The compounds of Formula (I) are known SSRIs. SSRIs can be used to treat the core symptoms of ASD. The present invention combines prior art elements according to known methods to yield predictable results.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method of treating autism spectrum disorder (ASD), the specification does not reasonably provide enablement for a method of preventing (ASD). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are drawn to a method of preventing ASD and disorders thereof. The present specification teaches that the Test compound was examined in in vivo experiments on structural and behavioral abnormalities in MeCPT2-deficient animals (mice). Specification, p. 25-28. There is no discussion or evidence suggesting the ASD or related disorders can be prevention. In addition, the prior art fails to provide compensatory guidance. There is no correlation provided by the instant specification (or the prior art) between examining structural and behavioral abnormalities in MeCPT2-deficient animals (mice) and preventing ASD or any disorder thereof. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
Conclusion
No claims are allowed
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625