DETAILED ACTION
This office action is in response to applicant’s filing dated November 25, 2025.
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 .
Status of claims
Claims 1-4, 7, 10, 16, 20-21, 23, 25, 27, 29, 32, and 41-45, are pending in the instant application. Acknowledgment is made of Applicant’s amendments filed November 25, 2025. Acknowledgment is made of Applicant’s cancelation of claims 12-15, 28 and 33 and addition of a new claims 41-45.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 7, 10, 16, 20-21, 23, 25, 27, 29, 32 and newly added claims 41 – 45, drawn to a, drawn to a compound disclosed in claim 1 and a therapeutical composition thereof in the reply filed on November 25, 2025 is acknowledged.
Applicant’s election without traverse of the compound of structure
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as a single species in the reply filed on November 25, 2025 is acknowledged. Claims 10, 16, 20, 23, 25, 29, 41, 42 and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 November 25, 2025.
Claims 1-4, 7, 21, 27, 32, 43 and 44 are presently under consideration as they relate to the elected species, compound of formula:
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.
Priority
The present application was filed on April 14, 2023, and claims the benefits of priority of U.S. Provisional Application No.63/331,670, filed on April 15, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/31/2023 and 11/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Acknowledgement is made of the drawings received on 04/14/2023. These drawings are accepted.
Claim Objections
Claims 2, 3, 4, 7, 43 and 44 are objected to as being dependent upon a rejected base claim, but would be allowable if claim 2, 3 or 7 is rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1 and 21 recite “optionally substituted” without specifying possible substituents, which encompasses infinite number of potential alternatives and render claims ambiguous.
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 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Shing et al (Org. Biomol. Chem., 2014,12, 9439-9445, cited in IDS, filed 11/25/2025, hereinafter Shing) in view of https://www.wisdomlib.org/concept/pharmaceutical-formulation.
Instant claim are drawn to a compound of formula
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, where R1 is nitrogen-containing monocyclic or bicyclic heterocyclyl; each of R2, R3, R4,R5, R6, R7, R8, R9, R10, R11, R12, and R13 is, independently, H, deuterium or hydroxyl, and each dashed line represents a single or double bond, provided that no more than one double bond is present. Instant claims are further drawn to a pharmaceutical composition comprising a compound according to claim 1, or a pharmaceutically acceptable salt thereof, and pharmaceutically acceptable excipient.
Shing teaches compounds of formula
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, where base is adenine, thymine or uridine (page 9440, scheme 1), such as compounds
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or
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(page 9443, schemes 14 and 15). The compounds taught by Shing were tested for antiviral activity against enterovirus, Coxsackie B3 virus (page 9444, “biological study”), which indicates that said compounds are intended to be used as an active component in drug formulations. Although Shing does not explicitly teach pharmaceutical composition, which comprises synthesized compounds and pharmaceutically acceptable excipient, however, the definition of pharmaceutical composition or formulation as a “combination of active ingredients and excipients for safe and effective delivery”, according to https://www.wisdomlib.org/concept/pharmaceutical-formulation, assumed to include an active ingredient and an excipient.
Thus, since prior art teaches compounds having the same or similar chemical structures and possessing the same pharmacological activities, it would have been prima facies obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try to make various known compounds, satisfying genus formula of claim 1, in search for new compounds with similar or better desired properties, to come to claimed compounds, with the reasonable expectation of success.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
Claims 1, 21 and 32 are rejected.
Claims 2, 3, 4, 7, 43 and 44 are objected to.
Claim 27 is free of art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./ Examiner, Art Unit 1691
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691