Prosecution Insights
Last updated: September 29, 2026
Application No. 18/030,519

MODULATORS OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR

Non-Final OA §102
Filed
Apr 06, 2023
Priority
Oct 07, 2020 — provisional 63/088,876 +1 more
Examiner
KUCKLA, ANNA GRACE
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Vertex Pharmaceuticals Incorporated
OA Round
3 (Non-Final)
51%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allowance Rate
23 granted / 45 resolved
-8.9% vs TC avg
Strong +55% interview lift
Without
With
+55.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
55 currently pending
Career history
88
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
33.6%
-6.4% vs TC avg
§102
24.2%
-15.8% vs TC avg
§112
23.9%
-16.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 45 resolved cases

Office Action

§102
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 . Status of Claims Claims 9-10, 15-18 and 66-67 are pending in the instant application. Claims 9, 15 and 17-18 are amended and claims 1-8, 11-15 and 19-65 are cancelled via the amendment filed August 24th, 2026. Priority This is a 35 U.S.C. 371 National Stage filing of Application No. PCT/US2021/053864 filed October 6th, 2021, which claims priority to provisional application 63/088,876, filed October 7th, 2020. Information Disclosure Statement The Information Disclosure Statement (IDS) filed 08/24/2026 was considered by the Examiner. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 24th, 2026, has been entered. Withdrawn Objections Applicant’s arguments and amendments filed August 24th, 2026, with respect to objection of claims 17-18 have been fully considered and are persuasive. The objection of claims 17-18 has been withdrawn. Applicant has overcome this objection as the rejection of the base claim, claim 9, has been overcome. See Withdrawn Rejections section below. Withdrawn Rejections Applicant’s arguments and amendments filed August 24th, 2026, with respect to 102(a)(1) rejection of claims 9-10 and 66 over Changunda have been fully considered and are persuasive. The 102(a)(1) rejection of claims 9-10 and 66 has been withdrawn. Applicant has overcome this rejection by amending claim 9 to remove the option for R1 to be alkoxy. Applicant’s arguments and amendments filed August 24th, 2026, with respect to 102(a)(1) and 102(a)(2) rejection of claims 9, 15, 16 and 66 over William have been fully considered and are persuasive. The 102(a)(1) and 102(a)(2) rejection of claims 9, 15, 16 and 66 has been withdrawn. Applicant has overcome this rejection by amending claim 9 to remove the option for Z to be optionally substituted NH2. Response to Remarks Applicant’s arguments with respect to the claim objections have been considered but are moot as Applicant’s amendments have overcome the objection. Applicant’s arguments with respect to the 102 rejections of claim(s) 9-10, 15-16 and 66 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s amendments have necessitated a new grounds rejection presented below. Restriction/Election Applicant’s election without traverse of “Compound 142” to prosecute the invention of Group II, a compound of Formula II, in the reply filed on October 3rd, 2025 is acknowledged. As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of the Compound 142 appears allowable. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 17 and 18, as well as structural species: PNG media_image1.png 361 467 media_image1.png Greyscale . Since a non-elected species has been found not allowable, examination has been limited to claims directed to the elected species, which are presently claims 9-10, 15-18 and 66. Claims 9-10, 15-18 and 66 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration. Claim 67 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention or species. Election was made without traverse in reply filed October 3rd, 2025. New Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 9-10, 15 and 66 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan et al (Org. Lett. 2015, 17, 3536−3539). Yan teaches the following compound (Schemes): PNG media_image1.png 361 467 media_image1.png Greyscale . Regarding claim 9, this compound is embraced by instant formula II, wherein W, X and Y are C, R1 is -phenyl substituted with 1 C1 alkyl, R2 is -C(O)C1 alkoxy, R3 is hydrogen, R4 is -phenyl, Z is -phenyl substituted with C1 alkyl. Regarding claim 10, this compound is of Formula IIa. Regarding claim 15, R1 is -phenyl substituted with 1 C1 alkyl. Regarding claim 66, Yan teaches that the compound above, was in a reaction with multiple solvents (Schemes). Regarding the preamble of the instant claim “A pharmaceutical composition”, MPEP 2111.02(II) notes “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the preamble is not considered limiting since it does not affect the structure of the compound of formula (I). Allowable Subject Matter Claims 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5. 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, Clinton A 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. 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. /A.G.K./Examiner, Art Unit 1626 /FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
Read full office action

Prosecution Timeline

Apr 06, 2023
Application Filed
Nov 04, 2025
Non-Final Rejection mailed — §102
Jan 26, 2026
Response Filed
Jan 27, 2026
Response Filed
May 22, 2026
Final Rejection mailed — §102
Aug 24, 2026
Request for Continued Examination
Aug 25, 2026
Response after Non-Final Action
Sep 03, 2026
Non-Final Rejection mailed — §102 (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
51%
Grant Probability
99%
With Interview (+55.3%)
3y 5m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 45 resolved cases by this examiner. Grant probability derived from career allowance rate.

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