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 .
This application is a domestic application, filed 26 July 2023; and claims benefit as a CON of 16/979,108, which is a 371 of PCT/US2019/021168, filed 07 March 2019, now abandoned; which claims benefit of provisional application 62/639,725, filed 07 March 2018.
Claims 429-450 are pending in the current application. Claims 439-450, drawn to non-elected inventions, are withdrawn. Claims 434-437, drawn to non-elected species, are withdrawn. Claims 429-433 and 438 are examined on the merits herein.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 429-438, in the reply filed on 04 May 2026 is acknowledged.
Claims 439-450 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04 May 2026.
Applicant’s election of species of
PNG
media_image1.png
152
174
media_image1.png
Greyscale
in the reply filed on 04 May 2026 is acknowledged.
Claims 434-437 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 of species was made traverse in the reply filed on 04 May 2026.
Search and examination has expanded to the alternatives of the 2nd, 4th, 6th, and 7th compound recited in claim 433.
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.
Claims 429-433 and 438 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2016/134054 A1, published 25 Aug 2016, provided by Applicant in IDS filed 22 Jan 2024) in view of Meier et al. (Antiviral Research, 2006, 71, p282-292, cited in PTO-892) and Mayes et al. (WO 2014/099941 A1, published 26 June 2014, provided by Applicant in IDS filed 22 Jan 2024).
Chen et al. teaches compounds such as the nucleotide of formula (I) effective in inhibiting HCV polymerase (abstract). Chen et al. teaches in one aspect the compound formula (I) such as Compound No. 54 where X is O, R1 is H, R2 is OH, R3 is OH, R4 is H, and R5 is F (page 1, paragraph 4, and Table 1 at page 3), corresponding to the claimed Formula XXVIII where R2 is OH and R3 is OH. In another aspect of the invention the compound has Formula III, as well as prodrugs thereof,
PNG
media_image2.png
180
144
media_image2.png
Greyscale
, where the variables X, R1, R2, R3, R4, and R5 are as defined in Table 1 (page 7, paragraph 7). In another aspect of the invention the compound has formula VI’’,
PNG
media_image3.png
160
146
media_image3.png
Greyscale
, where the variables X, R1, R2, R3, R4, and R5 are as defined in Table 1, and P1 is a protected monophosphate prodrug substitution (paragraph 13, spanning pages 8-9).
Chen et al. does not specifically disclose the compound of claimed Formula XXVIII wherein R1 is
PNG
media_image4.png
100
62
media_image4.png
Greyscale
( claim 429 and elected species).
Meier et al. teaches pronucleotides represent a promising tool to improve the biological activity of nucleoside analogs in antiviral and cancer chemotherapy. The cycloSal-approach is one of several conceptually different pronucleotide systems. This approach can be applied to various nucleoside analogs. A salicyl alcohol as a cyclic bifunctional masking unit is used, and shown to afford a chemically driven release of the particular nucleotide from the lipophilic phosphate triester precursor molecule (page 282, abstract). Meier et al. teaches the proof-of-principle example of the anti-HIV active 2’,3’-dideoxy-2’,3’-didehydrothymidine (d4T) cycloSal triesters 2a-2h (page 283, figure 2), where the cycloSal substituents of compounds 2c, 2d, 2e, 2a, and 2g correspond to the corresponding substituents of the 1st, 2nd, 4th, 6th, and 7th compound recited in claim 433, respectively. Meier et al. teaches the structure activity relationship of the cycloSal triesters is known (page 286, section 6 and figure 5). Meier et al. teaches the cycloSal-approach may be applied to different nucleoside analogs (section 7 spanning pages 286-288, and page 287, figure 6).
Mayes et al. teaches 4’-fluoro nucleoside compounds, compositions and methods for the treatment of Flaviviridae infections, including HCV infections (abstract). Mayes et al. teaches the working embodiment of the compound 2b
PNG
media_image5.png
146
180
media_image5.png
Greyscale
and the known synthesis thereof (Example 1 at page 98). Mayes et al. teaches the compound 102
PNG
media_image6.png
150
248
media_image6.png
Greyscale
shown to have inhibitory activity against HCV polymerase (example 2 at pages 124-125). Mayes et al. generally teaches the use of compound including prodrugs thereof (page 76, paragraphs 214-217).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Chen et al. in view of Meier et al. and Mayes et al. in order to select the prodrug form of the Chen et al. compound where X is O, R1 is H, R2 is OH, R3 is OH, R4 is H, and R5 is F to be the cycloSal prodrug taught by Meier et al. One of ordinary skill in the art would have been motivated to combine Chen et al. in view of Meier et al. and Mayes et al. with a reasonable expectation of success because all of cited prior art are drawn to the antiviral activity of nucleoside analogs, Chen et al. teaches an embodiment of the compound as a protected monophosphate prodrug encompassing the claimed compound, Meier et al. teaches the cycloSal prodrug as a known approach to improve the biological activity of antiviral nucleoside analogs, and Mayes et al. provides further guidance to select the particular embodiment from within the scope taught by Chen et al. with the expectation that this compound has activity inhibiting HCV polymerase.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
Prosecution Insights