Prosecution Insights
Last updated: April 19, 2026
Application No. 18/248,071

MODULATORS OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR

Final Rejection §112§DP§Other
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 §Other
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 2/13/2026 in response to the Non-Final Rejection is acknowledged and has been entered. Claims 1-9 and 11-23 are currently pending and under consideration. Information Disclosure Statement The information disclosure statement filed on 2/13/2026 has been considered except where lined through. Objections/Rejections withdrawn: The objection of claim 2 under 37 CFR 1.75 as being a substantial duplicate of claim 1 is withdrawn in view of Applicants arguments. The provisional rejection of Claims 1-9 and 11-23 on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 and 11-25 of copending Application No. 18/248,068 (reference application) is withdrawn in view of Applicants arguments. The provisional rejection of Claims 1-9 and 11-23 on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 and 10-18 of copending Application No. 18/248,071 (reference application) is withdrawn in view of Applicants arguments. The provisional rejection of Claims 1-9 and 11-23 on the ground of nonstatutory double patenting as being unpatentable over claim 1-8, 10-15 of copending Application No. 18/030,529 (reference application) is withdrawn in view of Applicants arguments.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 1-8 and 10-18 are 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. Moreover, claim 1 recites variable RN3, but does not define what RN3 encompasses. As such, the claims are indefinite. Regarding claim 2, claim 2 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. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-9 and 11-23 remain provisionally rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the generic compound of Formula I of the reference applications compound anticipates the scope with the compound of Formula I of the instant application. . Note: RF of the reference application has not been defined, as such, could encompass a hydrogen if no other RF’s are present. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. In response to this rejection, Applicants contend that the claimed compounds contain key structural differences and are patentably distinct. Specifically, Applicants contend that the compounds of the ‘530 application contain a macrocyclic nitrogen substituted with RF vs. the NYN claimed in the instant application. Moreover, Applicants contend that the doctrine of nonstatutory double patenting is a judicially created doctrine intended to prevent “the unjustified or improper timewise extension of the right to exclude granted by a patent.”. Thus, Applicants contend that since both the instantly claimed application and the copending application have the same filing date and claim priority to provisional applications each filed on October 7, 2020, their patent terms under 35 USC 154(a) are equal and would not create and unjustified extension of the other’s term, and vice versa. These arguments have been considered, but are not found persuasive. The RF difference has been addressed above. Regarding the time wise extension, the Examiner acknowledges that the doctrine of nonstatutory double patenting is a judicially created doctrine intended to prevent “the unjustified or improper timewise extension of the right to exclude granted by a patent.” However, the examiner recognizes that the doctrine of nonstatutory double patenting also seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). The submission of a terminal disclaimer in compliance with 37 CFR 1.321(b) to overcome a double patenting rejection ensures that a patent owner with multiple patents claiming obvious variations of one invention retains all those patents or sells them as a group. Van Ornum, 686 F.2d at 944-45, 214 USPQ at 767. As such, the provisional rejection is maintained. 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 10, 2025
Non-Final Rejection — §112, §DP, §Other
Jan 30, 2026
Examiner Interview Summary
Feb 13, 2026
Response Filed
Mar 23, 2026
Final Rejection — §112, §DP, §Other (current)

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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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