DETAILED ACTION
This office action is in response to the Applicant’s filing dated March 18th, 2026.
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 is a 371 of PCT/US2022/019776 filed on March 10th, 2022; and has a PRO of 63/208,641 filed on June 9th, 2021 and 63/159,107 filed on March 10th, 2021.
Status of Claims
Claims 1-3, 5, 11, 17, 23, 27, 31, 36, 38, 45, 47, 54, 58, 60-63 and 66 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on March 18th, 2026.
Election/Restrictions
Applicant’s election without traverse of Group I and species election of Form A of the phosphate salt of Compound (I) in the reply filed on March 18th, 2026 is acknowledged.
Claims 58, 61-63 and 66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 18th, 2026.
A prior art search was conducted for the elected species.
This search retrieved prior art.
Therefore, the Examiner’s search will not be extended unnecessarily to additional species
in/for/during this Office action.
Claims 11, 17, 23, 27, 31, 36, 38, 45, 47 and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 18th, 2026.
Claims 1-3, 5 and 60 read on the elected species and will be examined herein.
Claim Objections
Claim 5 is 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.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (WO 2020/210293 A1), cited in a previous Office action.
Regarding claims 1-3 and 60, Kim teaches Compound 4 (page 45, Example 4, paragraph [00187]; page 86, claim 10) shown below:
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Which is a compound having the same structure as instant Compound (I). Kim further teaches that Compound 4 can be in unsolvated salt forms, explicitly identifying phosphate salts (page 7, paragraphs [0038-0039]). Kim further teaches pharmaceutical compositions comprising Compound 4 or salts thereof and a pharmaceutically acceptable excipient (page 88, claim 16); and explicitly teaches Compound 4 in composition with DMSO (page 45, paragraph [00188], line 11).
Kim does not explicitly teach the disclosed phosphate salt of Compound 4 in the instantly claimed molar ratio of 1:1.
It would be prima facie obvious to one of ordinary skill in the art to prepare the disclosed phosphate salt of Compound 4 using a 1:1 molar ratio of Compound 4 to phosphoric acid, as phosphate salts are conventional pharmaceutically acceptable acid addition salts and a 1:1 stoichiometric ratio represents a routine and predictable starting point for salt formation. Optimization of such stoichiometric relationships through routine experimentation would have been within the level of ordinary skill in the art. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Taken together, all of this would result in the compound salt and composition of instant claims 1-3 and 60 with a reasonable expectation of success.
Conclusion
Claims 1-3 and 60 are rejected.
Claims 5 is objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L JOHNSON whose telephone number is (571)272-1672. The examiner can normally be reached Monday - Friday 08:00AM - 5:00PM EST with Flex on Fridays.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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