Prosecution Insights
Last updated: April 19, 2026
Application No. 18/353,525

URSODEOXYCHOLIC ACID DERIVATIVES FOR THE TREATMENT OF POLYCYSTIC DISEASES

Final Rejection §103
Filed
Jul 17, 2023
Examiner
WELLS, LAUREN QUINLAN
Art Unit
1622
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
UNIVERSIDAD DE SALAMANCA
OA Round
4 (Final)
43%
Grant Probability
Moderate
5-6
OA Rounds
2y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 43% of resolved cases
43%
Career Allow Rate
92 granted / 213 resolved
-16.8% vs TC avg
Strong +58% interview lift
Without
With
+57.8%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
79 currently pending
Career history
292
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
34.4%
-5.6% vs TC avg
§102
14.7%
-25.3% vs TC avg
§112
27.2%
-12.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 213 resolved cases

Office Action

§103
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 . DETAILED ACTION This Office Action is in response to Applicant’s Arguments and Amendment filed, 09/18/2025, wherein the Amendment amended claims 1, and 8, and cancelled claim 3. Claims 1-2 and 4-9 are pending. Priority This application claims priority to the following: PNG media_image1.png 48 519 media_image1.png Greyscale PNG media_image2.png 64 655 media_image2.png Greyscale Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/958,429. Election/Restrictions In the response filed 06/11/2024, Applicant elected Group I, compounds of formula (I’) and compositions thereof, and further elected compound PNG media_image3.png 124 307 media_image3.png Greyscale as the species of the compound of formula (I’). In the course of the search, the entire genus of formula (I’) was searched. The elections of species requirement is hereby withdrawn. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. Claim 8 is withdrawn from consideration as being directed toward a non-elected invention. Claims 1-2, 4-7, and 9 are examined on the merits herein. REJECTIONS WITHDRAWN The status for each rejection and/or objection in the previous Office Action is set out below. 35 U.S.C. § 103 over US 5,646,316 to Jacobson Applicant’s amendment to independent claim 1 that deletes “Y is selected from:. . .a single bond,” is sufficient to overcome this rejection. NEW REJECTIONS The Amendment to claim 1, wherein “a single bond” is deleted from the definition of “Y” has resulted in the below new prior art rejection. Claim Rejections - 35 USC § 103 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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. (New) Claims 1-2, 5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Scozzafava (Carbonic Anhydrase Inhibitors. Preparation of Potent Sulfonamides Inhibitors Incorporating Bile Acid Tails, Bioorganic & Medicinal Chemistry Letters, published 2002, PTO-892) in view of STN Registry No. 461651-79-6 (published 2002, PTO-892). Scozzafava teaches compound “2O” as a carbonic anhydrase inhibitor: PNG media_image4.png 389 658 media_image4.png Greyscale (Scozzafava--pg. 1554, Table 1; pg. 1556, Scheme 1, (1-5)A-T; pgs. 1552-1553; abstract; STN Registry No. 461651-79-6, pgs. 1-3), which meets the limitations of instant formula (I’) when X is H Y is CH2 n is 1 Z is a substituted aryl (i.e., a substituted thiadiazole ring). Regarding claim 1, while Scozzafava teaches a compound of instant Formula (I’), it differs from that of instant claim 1 in that it does not depict the stereochemistry of the substituent groups, as depicted in claim 1. It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the spatial arrangement of the atoms of the compound of Scozzafava, to arrive at instant Formula (I’). One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because: -the compound of Scozzafava and the instantly claimed compound are stereoisomers (compounds differing only in the spatial arrangement of one of their atoms), and -per MPEP 2144.09, these compounds 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). As such, an ordinary skilled artisan would have been motivated to make such modifications to predictably arrive at a structurally and functionally similar compound that is optimized for a specific function. Regarding claim 9, Scozzafava teaches these compounds for use in the development of calcium anhydrase inhibitor drugs (abstract; pg. 1556, “Conclusions”). As such, an ordinary skill artisan would be motivated to formulate compound 2O of Scozzafava in a composition, to predictably arrive at a pharmaceutically acceptable formulation that can be administered to a subject as a drug to inhibit carbonic anhydrase. Response to Arguments In view of the amendments to the claims and the above modified rejection, the Remarks of 09/18/2025, are not pertinent to the above new rejection. Free of the Prior Art/Allowable Subject Matter Claims 4 and 6-7 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. The closest prior art to claims 4 and 6-7 is Scozzafava (Carbonic Anhydrase Inhibitors. Preparation of Potent Sulfonamides Inhibitors Incorporating Bile Acid Tails, Bioorganic & Medicinal Chemistry Letters, published 2002, PTO-892). Scozzafava teaches compound “2O” as a carbonic anhydrase inhibitor: PNG media_image4.png 389 658 media_image4.png Greyscale (pg. 1554, Table 1; pg. 1556, Scheme 1, (1-5)A-T; pgs. 1552-1553; abstract), which meets the limitations of instant formula (I’) when X is H Y is CH2 n is 1 Z is an optionally substituted aryl (i.e., a substituted thiadiazole ring). Scozzafava differs from that of claims 4-5 and 7 in that it does not teach Y as other than a –(CH2)1- and does not teach Z as -OH, an aryl substituted with at least one of NH2 or a phenyl, a substituted phenyl, or a substituted furan ring, which are distinct features of the compounds of instant claims 4-5 and 7. Conclusion No claims are allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30. 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, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. 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. /L.Q.W./Examiner, Art Unit 1622 /JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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Prosecution Timeline

Jul 17, 2023
Application Filed
Sep 08, 2024
Non-Final Rejection — §103
Dec 16, 2024
Response Filed
Jan 13, 2025
Final Rejection — §103
Mar 24, 2025
Response after Non-Final Action
Apr 07, 2025
Request for Continued Examination
Apr 08, 2025
Response after Non-Final Action
Jun 15, 2025
Non-Final Rejection — §103
Sep 18, 2025
Response Filed
Nov 16, 2025
Final Rejection — §103 (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

5-6
Expected OA Rounds
43%
Grant Probability
99%
With Interview (+57.8%)
2y 11m
Median Time to Grant
High
PTA Risk
Based on 213 resolved cases by this examiner. Grant probability derived from career allow rate.

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