Prosecution Insights
Last updated: August 16, 2026
Application No. 18/655,876

METHODS OF PREPARING 1'-CYANO NUCLEOSIDES

Final Rejection §103
Filed
May 06, 2024
Priority
Mar 12, 2020 — provisional 62/988,661 +2 more
Examiner
BERRY, LAYLA D
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Gilead Sciences Inc.
OA Round
2 (Final)
66%
Grant Probability
Favorable
3-4
OA Rounds
6m
Est. Remaining
75%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allowance Rate
952 granted / 1445 resolved
+5.9% vs TC avg
Moderate +9% lift
Without
With
+8.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
37 currently pending
Career history
1480
Total Applications
across all art units

Statute-Specific Performance

§101
3.9%
-36.1% vs TC avg
§103
34.3%
-5.7% vs TC avg
§102
19.6%
-20.4% vs TC avg
§112
25.2%
-14.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1445 resolved cases

Office Action

§103
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 . CONTINUING DATA This application is a DIV of 18/108,480 02/10/2023 PAT 12012431 18/108,480 is a DIV of 17/198,829 03/11/2021 PAT 11613553 17/198,829 has PRO 62/988,661 03/12/2020 This office action is in response to Applicant’s amendment submitted May 22, 2026. Claims 80-81, 83, 85-86, 93, and 95 are pending. Claim Interpretation The claims recite adding reagents to a ninth reactor. The claims do not recite any limitations drawn to steps carried out in previous reactors, so the claims are interpreted to require adding reagents to a reactor in general regardless of its number. The limitations of previous claim 89 were incorporated into claim 80. The following new rejection is the same as the one previously made for claim 89, but now includes claims 80-81, 83, 85-86, 93, and 95. 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. 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. Claim(s) 80-81, 83, 85-86, 93, and 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axt (WO2016069825 A1, cited on IDS). Axt teaches the following reaction in paragraphs [0249]-[250]: PNG media_image1.png 184 737 media_image1.png Greyscale Axt teaches addition of 3.4 equivalents of 1M BCl3 in dichloromethane to a compound of claimed formula (I), followed by addition of methanol (an additive) and potassium bicarbonate to afford a compound of claimed formula (VII). Formula (I) was cooled to -20°C before addition of BCl3, and the reaction temperature was maintained between -20°C and -15°C. Axt does not teach that methanol is added to the Lewis acid before combining with formula (I). Methanol is added after the Lewis acid is combined with the starting compound. It would have been obvious to one of ordinary skill in the art at the time the application was filed to add methanol to the Lewis acid before addition of formula (I) instead of after. MPEP 2144.04 states that legal precedent as a source of supporting rationale for obviousness includes changes in the sequence of adding ingredients. Selection of any order of mixing ingredients is prima facie obvious. Response to Arguments Applicant argues that the claimed process produces unexpected results in the form of improved purity and yield. Table 1 is reproduced here. PNG media_image2.png 205 682 media_image2.png Greyscale Applicant’s arguments are not persuasive to overcome the rejection because the evidence of unexpected results is not commensurate in scope with the claimed invention. Claim 80 is drawn to the use of any Lewis acid and any additive. The results in Table 1 are specific to the combination of BCl3 and B(OMe)3. MPEP 2145 states that evidence of unexpected results must be reasonably commensurate in scope with the claimed invention, and that the skilled artisan must be able to ascertain a trend in the exemplified data that would allow him to reasonably extend the probative value thereof. In this instance, only one example is given to show unexpected results. Data for other Lewis acids and additives is not given in the specification, so there is no way for the skilled artisan to ascertain a trend. MPEP 2145 also states that there must be a nexus (connection or correspondence) between the submitted evidence and the claimed invention. In this instance, it is unclear whether the improved result is due to combining the Lewis acid and the additive before combining with Formula (I), or due to the Lewis acid, or due to the additive, or some combination of the three. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F. 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. /LAYLA D BERRY/Primary Examiner, Art Unit 1693
Read full office action

Prosecution Timeline

May 06, 2024
Application Filed
Feb 23, 2026
Non-Final Rejection mailed — §103
May 22, 2026
Response Filed
Jun 30, 2026
Final Rejection mailed — §103 (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
66%
Grant Probability
75%
With Interview (+8.9%)
2y 9m (~6m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1445 resolved cases by this examiner. Grant probability derived from career allowance rate.

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