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
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Claims 5-11 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/27/2026.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto US9981960 (JP2014-111378 05/29/2014 = WO2015182723) and Afanasyev, Chem.Rev.2019,119,11857−11911.
Instant base claim 1: .
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Yamamoto teaches at column 307 and in Table at column 308 to column 311, thirteen compounds containing the invariable core structure of the instant formula (see above). Instant compounds R5 are alkyl replacements of H and cycloalkyl compounds of Yamamoto. Yamamoto also teaches alkyl compounds as synthetic intermediates, see column 279-280. As such the difference is specific R5 as instantly claimed.
Yamamoto teaches, at column 311-318 lines 60-65, how to make variety of N-substituents using the above pointed out Yamamoto H compound as starting materials. Yamamoto chemistry for doing this is the well-known (see below) ‘reductive amination’ reaction. This reaction exemplified by Yamamoto extensively, occurs between amine the Yamamoto H compound and a carbonyl compound. By using carbonyl compounds formaldehyde or acetaldehyde for claims 1-3 or benzaldehyde for claim 4 in Yamamoto ‘reductive amination’ chemistry one of skill in the art would arrive at instant compounds. As such instant compounds can also be regarded as ‘selective combinations’ for making Yamamoto compounds Formula I column 2.
According to (post-filing) Afanasyev Review, ‘reductive amination’ plays a paramount role in pharmaceuticals; see opening statement. Afanasyev teaches many examples of reductive amination reactions using carbonyl compounds (that is ketones and aldehydes) for making pharmaceuticals. As such one of skill in the art would make analogs of Yamamoto compounds using the starting materials of Yamamoto and method taught by Yamamoto (and also by Afanasyev), to arrive at instant compounds.
Also note that Yamamoto is same area of research. Instant specification page 2 line 14 compound and Yamamoto column 123 compound, both are same.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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