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 .
Current Status of 18/332,851
This application is responsive to the amended claims and applicant remarks of 11/21/2025. Claims 51-64 are pending and have been examined on the merits.
Priority
The instant application is a continuation of U.S. Patent Application No. 17/837,814, filed 06/10/2022, which claims priority to U.S. Provisional Application No. 63/209,862, filed 06/11/2021, and U.S. Provisional Application No. 63/266,234, filed 12/30/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 1 recites a method of inhibiting the main protease (Mpro) of SARS-CoV-2 through contacting Mpro with a compound of Formula (I). [0003]-[0006] describe Mpro as a known antiviral target and discuss structural features of previously reported Mpro inhibitors. The specification does not disclose experimental data demonstrating that the compounds of Formula (I) inhibit Mpro nor does the specification demonstrate the claimed compounds contacting Mpro. The data presented in Table 1 ([00446]) describe antiviral activity in infected cell assays. However, the specification does not disclose direct enzymatic inhibition assay for SARS-CoV-2 Mpro, nor does it provide structural, kinetic, or target engagement data demonstrating that the compounds of Formula (I) inhibit Mpro. Antiviral activity may arise through multiple mechanisms. Therefore the disclosure does not demonstrate possession of the claimed method of inhibiting Mpro through contacting Mpro as claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 51, 52, 57, and 58 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ermini (WO 2022/066776 A1, found in IDS filed 11/21/2025). Ermini is prior art because its priority date of September 23, 2020, predates the earliest effective filing date to which the instant application is entitled.
Ermini discloses compounds of Formula I (claim 1) and methods for treating coronavirus infection comprising administering these compounds to subjects in need thereof (claim 19). The methods include the treatment of SARS-CoV-2 (claim 21) and methods wherein the subject has COVID-19 (claim 22). The reference also discloses a method for inhibiting a coronavirus main protease (Mpro), the method comprising contacting the protease with an effective amount of a compound according to claim 1 (claim 27). Ermini discloses the following compound
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(claim 16) which has reads on the instantly claimed compound of formula (I) with the following substitutions: R1 is tetra-fluorinated phenyl; R2 is
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81
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; R3a is H; R3b is isobutyl; R4 is H; A is a bond; and R5 is indolyl.
Conclusion
Claims 51, 52, 57, and 58 are rejected.
Claims 53-56 and 59-64 are objected for being dependent upon a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625