Prosecution Insights
Last updated: July 17, 2026
Application No. 17/916,388

MODULATORS OF ALPHA-1 ANTITRYPSIN

Non-Final OA §DOUBLEPATENT§DP
Filed
Sep 30, 2022
Priority
Apr 03, 2020 — provisional 63/004,713 +1 more
Examiner
SONG, JIANFENG
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Vertex Pharmaceuticals Incorporated
OA Round
3 (Non-Final)
56%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
477 granted / 852 resolved
-4.0% vs TC avg
Strong +34% interview lift
Without
With
+33.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
53 currently pending
Career history
925
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
46.9%
+6.9% vs TC avg
§102
9.8%
-30.2% vs TC avg
§112
1.6%
-38.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 852 resolved cases

Office Action

§DOUBLEPATENT §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 . 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/25/2026 has been entered. Withdrawn Rejections: Applicant's amendments and arguments filed on 03/25/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application. Claims 1, 8-12, 21-38 are pending, claims 1, 8-12, 21-34 are under examination. Information Disclosure Statement The information disclosure statement (IDS) submitted on 03/25/2026 is being considered by the examiner. 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, 8-12, 21-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 11, 14-17, 19-23, 25-40, 46 and 51 of copending Application No. 17916484 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application teaches the position isomer of applicant’s claimed compound of formula (VIa), (VIb) or (VIC) according to the following analysis. Applicants claim 1 recites compound of formula (VIa), (VIb) or (VIC). PNG media_image1.png 403 956 media_image1.png Greyscale The copending application a compound of formula (VIIa) and (VIIe) (claim 26) and (IXa) (claim 28). PNG media_image2.png 440 402 media_image2.png Greyscale PNG media_image3.png 418 408 media_image3.png Greyscale PNG media_image4.png 492 334 media_image4.png Greyscale The difference of a compound of formula (VIIa) and (VIIe) and (IXa) and applicant’s claimed compound of formula (VIa), (VIb) or (VIC) is the position of hydroxy at the ring, they are position isomer. MPEP 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Therefore, one artisan in the art would immediately recognize the obvious variant of applicant’s claimed invention over copending application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5. 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, Brian-Yong Kwon can be reached at (571)272-0581. 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. /JIANFENG SONG/Primary Examiner, Art Unit 1613
Read full office action

Prosecution Timeline

Sep 30, 2022
Application Filed
Jul 23, 2025
Non-Final Rejection mailed — §DOUBLEPATENT, §DP
Oct 23, 2025
Response Filed
Nov 20, 2025
Applicant Interview (Telephonic)
Nov 25, 2025
Final Rejection mailed — §DOUBLEPATENT, §DP
Mar 25, 2026
Request for Continued Examination
Mar 26, 2026
Response after Non-Final Action
Apr 29, 2026
Non-Final Rejection mailed — §DOUBLEPATENT, §DP (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
56%
Grant Probability
90%
With Interview (+33.5%)
2y 7m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 852 resolved cases by this examiner. Grant probability derived from career allowance rate.

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