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 .
Applicant’s amendments filed 11/18/2024 have been entered.
Claims 22-38 are pending.
Claims 37-38 have been added in the amendments filed 11/18/2024.
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) 22-25, 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2022/040600 (‘600) in view of Kim et al., KR1020190123607 a.k.a KR102402501 (Kim et al. and ‘600 are references of record from IDS filed 9/24/2024) and WO2021/191812 (‘812) from IDS filed 6/10/2025.
‘600 teaches the compound as recited in the instant claim 22 and a pharmaceutical acceptable salt (see compound 62 in Table 1 and claim 68 for example). ‘600 teaches the compound as useful in treating NASH (see claim 72 for example). ‘600 teaches a composition containing the compound (see claim 69).
‘600 does not expressly teach the herein claimed salt.
‘812 teaches a tris salt of a structurally similar compound, which is also a GLP-1 agonist for treating complication of diabetes including NASH (see page 3, lines 1-9; page 4, lines 1-9).
Kim et al. teaches tromethamine salts exhibits excellent stability against moisture and heat and high oxidative stability (see [0008], [0017], [0018]).
It would have been obvious to one of ordinary skill in the art at the time of filing to prepare a tris salt of the herein claimed compound.
One of ordinary skill in the art would have been motivated to a tris salt of the herein claimed compound since it would be reasonable expected to product a salt form of the herein claimed compound that is more stable against heat, moisture, and high oxidative environment.
Allowable Subject Matter
Claims 26-32 and 37-38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627
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