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 the Claims
Claims 1-2, 4, 6, 8-13, 16, 18-19, 22, 46-49, and 51-53 are pending.
Claims 2, 6, 8, 10-11, and 51-53 are withdrawn.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/US21/30265, filed 04/30/2021; and further claims priority to provisional Patent Application numbers 63/053,349 and 63/017,729, filed on 07/17/2020 and 04/30/2020, respectively.
Information Disclosure Statement
All references from IDS(s) received 10/31/2022 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I without traverse in the reply filed on 10/14/2025 is acknowledged.
Claims 51-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/14/2025.
Applicant’s election of the compound below without traverse in the reply filed on 10/14/2025 is acknowledged.
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Claims 2, 6, 8, 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as not reading on the elected species.
The applicant says that claims 13 and 20 read on the elected specie. The Examiner assumes the Applicant meant 22 because claim 20 is cancelled, and therefore examined claim 22.
Claims 1, 4, 9, 12-13, 16, 18, 19, 22, and 46-49 will be examined upon their merits.
No anticipatory art was found of the elected specie, so the Examiner expanded her scope pursuant to MPEP 803. The expanded species are described in each 103 rejection. See 103 analysis below. No 103 rejection could be made over the elected specie and the elected specie would be considered allowable.
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, 4, 9, 12-13, 16, 19, and 46-49 are rejected under 35 U.S.C. 103 as being unpatentable over Cho, A. et al. (US8415308B2; 2013; “Cho”).
This rejection applies to the expanded specie, where R1a and R4a are H, R5-R7 are H, R2a is either Za or Za-C(O), and if R2a is Za- then Za- is Xa(CH2)nYa(CH2)n- where n is 0, Ya is CH2, and Xa is CHO.
Cho teaches an overlapping genus structure with the elected specie.
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Cho teaches a structural example of close to the expanded specie, see below.
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(Cho, Claim 17, 3rd compound)
Cho fails to teach a structural example where R1 is H, however the genus structure of Claim 1 allows for R1 to be H. Therefore, the genus teaches that one would expect similar properties if either a -H or -Me were in the -R1 position. It would have been prima facie obvious to substitute a -H for a -Me in the indicated position because structurally similar compounds are expected to have similar properties. Here the genus links these compounds as having similar properties.
Cho also teaches the compound as a pharmaceutical composition, as required by instant claim 46, that can delivered orally as a tablet, as required by instant claim 47. Cho also teaches the compound can be delivered with a second pharmaceutical agent, as required by instant claim 48, where that second pharmaceutical agent can be another drug for treating HCV (therefore an antiviral), as required by instant claim 49 (Page 4-5, Col. 4-5, Lines 57-67 and 1-12).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the genus structure and structural examples taught by Cho and substitute the -Me in the R1 position for an -H. A skilled artisan would be motivated to do so because Cho teaches both as possibilities in a limited list of embodiments for the -R1 position.
Therefore claims 1, 4, 9, 12-13, 16, 19, and 46-49 would be obvious to a person skilled in the art at the time.
Claims 1, 4, 9, 12-13, 16, 18-19, 22 and 46-49 are rejected under 35 U.S.C. 103 as being unpatentable over Cho, A. et al. (US8415308B2; 2013; “Cho”) in view of Bloom, J. (“Another COVID Contender, N-Hydroxycytidine Looks Pretty Good. Especially If You're a Mouse;” American Council on Science and Health, April 09, 2020; https://www.acsh.org/news/2020/04/09/another-covid-contender-n-hydroxycytidine-looks-pretty-good-especially-if-youre-mouse-14701;“Bloom”).
This rejection applies to the second expanded specie, found from instant claim 22, see below. Claims 1, 4, 9, 12-13, 16, 19, and 46-49 were rejected based on the teachings of Cho, see 103 analysis above, and the teachings are incorporated herein.
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Cho teaches an overlapping genus structure with the elected specie.
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Cho fails to teach a structural example where instant R2a would have such a long carbon chain. However, Cho does teach where R3 can be a C1-8 alkyl or -OR4, where R4 can be a C1-8 alkyl. It would be obvious to a person skilled in the art to extract the genus structure and structural examples taught by Cho and adjust the carbon chain length of R3 to be longer. A skilled artisan would be motivated to do so because the hydroxyl groups contribute to lower bioavailability. Masking the -OH groups is a known strategy to give an ester prodrug of antivirals, as taught by Bloom (figure 2). A person skilled in the art would be motivated to adjust the prodrug “mask” carbon chain length to adjust for lipophilicity and drug delivery purposes. Therefore, claims 18 and 22 are rejected through the teachings of Cho in view of Bloom.
Applying KSR example rationale (E), it would have been prima facie obvious to extract the genus structure and structural examples taught by Cho and adjust the carbon chain length of R3 to be longer. A skilled artisan would be motivated to do so because the hydroxyl groups contribute to lower bioavailability. A person skilled in the art would be motivated to adjust the prodrug “mask” carbon chain length to adjust for lipophilicity and drug delivery purposes, as taught by Bloom.
Therefore claims 1, 4, 9, 12-13, 16, 18-19, 22 and 46-49 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1, 4, 9, 12-13, 16, 18-19, 22 and 46-49 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621