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 .
Priority
This application repeats a substantial portion of prior Application No. PRO 63/524,372,
filed 06/30/2023, PRO 63/304,118, filed 01/28/2022, PRO 63/301,123, filed 01/20/2022, and
CIP of PCT/US2023/0613 81, filed 0 1/26/2023, and adds disclosure not presented in the prior
application. Because this application names the inventor or at least one joint inventor named in
the prior application, it may constitute a continuation-in-part of the prior application. Should
applicant desire to claim the benefit of the filing date of the prior application, attention is
directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit
claim may result in an additional fee under 37 CFR l. l 7(w)(l) or (2) being required, if the
earliest filing date for which benefit is claimed under35 U.S.C. 120, 121, 365(c), or 386(c) and
l .78(d) in the application is more than six years before the actual filing date of the application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/23/2024 was filed in
compliance with the provisions of 3 7 CFR 1. 97. Accordingly, the information disclosure
statements are being considered by the examiner.
The listing of references in the specification in paragraphs [167], [170]-[172], and [179] are not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Status of the application
Claims 15, and 19-20 are pending in this application. Claim 19 has been amended. Claim 20 is withdrawn. Claims 1-14, and 16-18 have been cancelled by applicant without prejudice or disclaimer. Claims 15 and 19 are currently under examination.
Applicant’s arguments, filed 08/17/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zinnes et al., (US PAT. 4,153,711).
The instant claims are directed to a compound of claim 15, CAS RN: 3056727-47-7 and in a composition with a pharmaceutically acceptable vehicle thereof.
Zinnes et al. teach “β-[2-[(dialkylamino)methyl]-1H-indol-3-yl]-α,α-diphenylpropionitriles and 4-[[2-[(dialkylamino)methyl]-1H-indol-3-yl]methyl]-2,4-dihydro-5-lower alkyl 2-phenyl-3H-pyrazol-3-ones and acid addition salts thereof which are useful pharmacological agents, especially as central nervous system depressants” (Abstract). Zinnes teach compounds of formula II are prepared by the precursor compound of column 2, line 15 (Below) wherein R1, R2 and R3 are defined as R1 and R2 are lower alkyl groups, R3 is hydrogen or a lower alkoxy group (col. 1, lines 18-20). Zinnes also teaches “[t]he compounds of the invention are new chemical compounds of value as central nervous system depressants. More specifically, the compounds when administered intraperitoneally to rodents, such as mice, at a dose of 100 mg/kg., sedation is produced. “ (col. 2, lines 43-48). Zinnes discloses “[t]he term "lower alkyl” is intended to mean an alkyl group of from one to six carbon atoms, such as methyl, ethyl, butyl, and isopentyl and the term "lower alkoxy” is intended to mean lower alkyl-O-.” (col. 1, lines 33-37). Zinnes also teaches a composition with a pharmaceutical carrier in reference claim 5. Zinnes also discloses the compound of 2-methyl-1,2,3,4-tetrahydropyrrolo [3,4-b]indole in example 4. (Col. 3, lines 31-58).
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Zinnes Formula II (Left) Zinnes Compound (Center) Applicants Compound (Right)
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to form a compound wherein R3 is a O-Me when Zinnes teaches a small range of options for the lower alkoxy element R3 through routine experimentation to fully explore more effective central nervous system depressants. See MPEP 2144.08A, 4(a), MPEP 2123 II, and MPEP 2144.05 II, B.
Examiner notes that applicants compound of instant claim 1 is encompassed by the scope of Zinnes compounds of formula II.
A person of ordinary skill in the art would have been motivated to select a O-Me group for R3 of Zinnes disclosure through routine optimization of a small selection of options in search of potential central nervous system depressants. See MPEP 2131.02 III and MPEP 2144.05 II B.
Conclusion
Claims 15, and 19 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623