Prosecution Insights
Last updated: September 29, 2026
Application No. 18/030,520

MODULATORS OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR

Non-Final OA §102§112
Filed
Apr 06, 2023
Priority
Oct 07, 2020 — provisional 63/088,883 +1 more
Examiner
MARTIN, KEVIN STEPHEN
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Vertex Pharmaceuticals Incorporated
OA Round
3 (Non-Final)
77%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allowance Rate
118 granted / 154 resolved
+16.6% vs TC avg
Strong +23% interview lift
Without
With
+23.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
60 currently pending
Career history
184
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
24.1%
-15.9% vs TC avg
§102
16.4%
-23.6% vs TC avg
§112
41.6%
+1.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 154 resolved cases

Office Action

§102 §112
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 . 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 15, 2026 has been entered. Claims Status The amendments filed July 15, 2026, have been acknowledged and entered. Claims 1-5, 7, 9-15, 23-24, 27 and 74-76 are pending. Information Disclosure Statements Acknowledgement is made of the Information Disclosure Statement filed on July 15, 2026. All references have been considered except where marked with a strikethrough. Election/Restriction The present examination is based on Applicant's election of species corresponding to Compound 29 in the reply filed on October 21, 2025. The search has been expanded in view of Applicant amendments to a compound of Formula I wherein ring A is PNG media_image1.png 190 157 media_image1.png Greyscale and art was found. The full scope of claims 1, 3, 23-24, 27 and 74-76 are under examination. Claims 4-5, 7 and 9-15 (in full) and claim 2 (in part, other than the above indicated subgenus) are additionally withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected species. Withdrawn Rejections Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant' s amendments and/or remarks. Claim Objections Claim 23 is objected to because of the following informalities: Compound 38 recited in claim 23 appears to be potentially missing an atom at the position indicated below. Examiner notes that the specification teaches a compound 38 with a Cl atom in the position indicated (see page 87). PNG media_image2.png 177 322 media_image2.png Greyscale Appropriate correction or clarification is requested Claims 24 and 27 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. Rejections Necessitated by Applicant Amendment Claim Rejections - 35 USC § 102 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. Claims 1-2 and 74 are rejected under 35 U.S.C. 102(a)(1) as being Anticipated by Chemical Abstract Services (CAS)(Registry Nos. (RN) 1790606-92-6 and 1790217-54-7 2015)(hereinafter “CAS”). CAS teaches RN Nos. 1790606-92-6 and 1790217-54-7 which correspond to instant Formula I wherein A is PNG media_image1.png 190 157 media_image1.png Greyscale substituted by 1 R1 group wherein R1 is C1 alkyl; and Z is phenyl substituted by two C1 alkyl groups or Z is phenyl substituted by 1 C2 alkoxy group. PNG media_image3.png 286 472 media_image3.png Greyscale Claim Rejections - 35 USC § 112b 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 2-3, 23 and 74-76 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. The claims are indefinite for the reasons that follow: Claims 2-3, 23 and 74-76 recite the limitation “deuterated derivative” in the first line of each claim. There is insufficient antecedent basis for this limitation in the claims because the claims depend from claim 1 which does not recite this limitation. This rejection could be overcome by amending claim 1 to recite this limitation. Support for such an amendment can be found throughout the specification, for instance at paragraphs [0010]-[0011]. Claims 2 recites the limitation “optionally substituted” in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim because claim 2 depends from claim 1 which has been amended to require that ring A is substituted. It is suggested that Applicant delete “optionally” from claim 2. Claim 2 further recites Ring A is selected from PNG media_image4.png 160 441 media_image4.png Greyscale . There is insufficient antecedent basis for these limitations in the claim because claim 2 depends from claim 1 which has been amended to require that ring A is structure A-1a. It is suggested that Applicant delete the structures A-1b and A-1c from claim 2. Claim 3 depends depend from claim 2, includes these limitations, and thus is also indefinite. Claim 23 depends from claim 1 and recites compounds 62, 65 and 68 (pictured below) which correspond to Formula I wherein Z is phenyl substituted with halo (Cl). There is insufficient antecedent basis for these compounds in the claim because claim 23 depends from claim 1 which does not recite that Z may be phenyl substituted with halo. PNG media_image5.png 165 181 media_image5.png Greyscale PNG media_image6.png 155 139 media_image6.png Greyscale PNG media_image7.png 163 179 media_image7.png Greyscale Claim Rejections - 35 USC § 112d The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 2-3, 23 and 74-76 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims are rejected because they recite limitations which are outside the scope of the base claim. These broader limitations are indicated below: Claims 2-3, 23 and 74-76 recite the limitation “deuterated derivative” which is not recited in claim 1; Claim 2 recites “optionally substituted” and that Ring A is selected from A-1b and A-1c which are not recited in claim 1; and Claim 23 recites compounds 62, 65 and 68 which are not included in the scope of Formula I because claim 1 does not allow for Z to be substituted with halo as required by compounds 62, 65 and 68. The claims are broader in scope than claim 1 and are therefore rejected for failing to further limit the subject matter of the claim upon which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Allowable Subject Matter Claims 24 and 27 are objected to as indicated above. The following is a statement of reasons for the indication of allowable subject matter: the closest reference to the instant claims is CAS which was discussed in the art rejection herein. CAS does not teach a composition comprising the compounds cited in the reference or that there is any biological activity associated with the compounds indicated in the rejection. There is no teaching which would have motivated a person of ordinary skill in the art before the effective filing date of the instant claims to selectively modify the reference compounds into the claimed invention with any reasonable expectation of success. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm. 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 Murray can be reached at (571) 272-9023. 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. July 24, 2026 /KEVIN S MARTIN/Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Apr 06, 2023
Application Filed
Nov 26, 2025
Non-Final Rejection mailed — §102, §112
Feb 20, 2026
Response Filed
Apr 10, 2026
Response after Non-Final Action
Apr 16, 2026
Final Rejection mailed — §102, §112
Jul 15, 2026
Request for Continued Examination
Jul 17, 2026
Response after Non-Final Action
Jul 28, 2026
Non-Final Rejection mailed — §102, §112 (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
77%
Grant Probability
99%
With Interview (+23.4%)
3y 5m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 154 resolved cases by this examiner. Grant probability derived from career allowance rate.

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