Prosecution Insights
Last updated: April 19, 2026
Application No. 18/248,068

MODULATORS OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR

Final Rejection §112§DP
Filed
Apr 06, 2023
Examiner
FETTEROLF, BRANDON J
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Vertex Pharmaceuticals Incorporated
OA Round
2 (Final)
48%
Grant Probability
Moderate
3-4
OA Rounds
4y 1m
To Grant
60%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allow Rate
84 granted / 177 resolved
-12.5% vs TC avg
Moderate +13% lift
Without
With
+13.0%
Interview Lift
resolved cases with interview
Typical timeline
4y 1m
Avg Prosecution
80 currently pending
Career history
257
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
28.5%
-11.5% vs TC avg
§102
19.6%
-20.4% vs TC avg
§112
28.4%
-11.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 177 resolved cases

Office Action

§112 §DP
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 . Application Status The amendment filed on 2/06/2026 in response to the Non-Final office action of 11/06/2025 is acknowledged and has been entered. Claims 1-9 and 11-25 are currently pending and under consideration. Objections/Rejections Withdrawn: The objection of Claim 4 under 37 CFR 1.75 as being a substantial duplicate of claim of claim 3 is withdrawn in view of Applicants amendment. The rejection of claim 11 for reciting compounds by their name in various tables within the specification is withdrawn in view of Applicants amendments The rejection of Claim(s) 1-8 and 12-25 under 35 U.S.C. 102(a)(2) as being Abela et al. (US12421251B2, 2025-09-23) is withdrawn in view of Applicants amendments and/or arguments. The rejection of Claims 1-8 and 12-25 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US12421251B2 is withdrawn in view of Applicants amendments and/or arguments. The provisional rejection of Claims 1-9 and 11-25 on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 and 10-18 of copending Application No. 18/030,527 (reference application) is withdrawn in view of Applicants amendments and/or arguments. The provisional rejection of Claims 1-9 and 11-25 on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 and 11-23 of copending Application No. 18/248,071 (reference application) is withdrawn in view of Applicants amendments and/or arguments. The provisional rejection of Claims 1-9 and 11-25 on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of copending Application No. 18/030,529 (reference application) is withdrawn in view of Applicants amendments and/or arguments. The provisional rejection of Claims 1-9 and 11-25 on the ground of nonstatutory double patenting as being unpatentable over claim 1-8, 10-18 and 21 of copending Application No. 18/030,530 (reference application) is withdrawn in view of Applicants amendments and/or arguments. The provisional rejection of Claims 1-7 and 11-25 on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 and 10-18 of copending Application No. 18/030,537 (reference application) is withdrawn in view of Applicants amendments and/or arguments. Rejections Maintained 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 1-9 and 11-25 remain 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. Regarding claim 1, claim 1 recites the variable RF and defines when two RF’s are present. However, the claims do not define what RF alone encompasses. As such, the claims are indefinite. In response to this rejection, Applicants contend that claim 1 has been amended and does not include “RF alone” but rather includes two RF to be present and the two RF together to form a ring structure. These arguments have been carefully considered, but are not found persuasive. In the instant case, the Examiner acknowledges that when there are two RF’s present, they come together to form a ring structure. However, the claims do not require that there always be only two. For example, variables RZN, RZC and RL1 have RF as an option in addition to numerous other options. Thus, RF for RZN could potentially be the only RF in the molecule, but it is undefined. Note: The claims do not contain a proviso wherein if one of RZN, RZC or RL1 is RF, at least one of the other two is RF….. the two of which together form a ring. Conclusion THIS ACTION IS MADE FINAL. 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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM. 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, Jeffrey S Lundgren can be reached at 571-272-5541. 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. /BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Apr 06, 2023
Application Filed
Nov 03, 2025
Non-Final Rejection — §112, §DP
Jan 30, 2026
Examiner Interview Summary
Feb 06, 2026
Response Filed
Mar 23, 2026
Final Rejection — §112, §DP (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
48%
Grant Probability
60%
With Interview (+13.0%)
4y 1m
Median Time to Grant
Moderate
PTA Risk
Based on 177 resolved cases by this examiner. Grant probability derived from career allow rate.

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