Prosecution Insights
Last updated: April 19, 2026
Application No. 18/518,267

COMPOUNDS AND METHODS FOR TREATING HYPERKALEMIA

Non-Final OA §DP
Filed
Nov 22, 2023
Examiner
HOWELL, THEODORE R
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ardelyx Inc.
OA Round
1 (Non-Final)
67%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
92%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allow Rate
671 granted / 1006 resolved
+6.7% vs TC avg
Strong +25% interview lift
Without
With
+25.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
51 currently pending
Career history
1057
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
34.2%
-5.8% vs TC avg
§102
20.5%
-19.5% vs TC avg
§112
16.9%
-23.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1006 resolved cases

Office Action

§DP
DETAILED ACTION The preliminary amendment submitted on March 7, 2024 has been entered. Claims 1-17 and 25-27 are pending in the application and are rejected for the reasons set forth below. No claim is allowed. Claim Objections Claims 1 and 25 objected to because of the following informality :The phrase “said mammal” should instead be “a mammal in need thereof.” Appropriate correction is required. 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 possi-ble 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 provi-sions 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 accompa-nied 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 1-17 and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,858,959 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claims 1-22 of the ‘959 Patent, of which the present application is a continuation, are directed to the same compounds of instant claim 1. The specification of the ‘959 Patent explains (see, e.g., col. 36-40) that these compounds are useful in the very same methods recited in the instant claims. The examiner therefore concludes that the instant claims are prima facie obvious over the claims of the ‘959 Patent. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. 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. THEODORE R. HOWELL Primary Examiner Art Unit 1628 /THEODORE R. HOWELL/Primary Examiner, Art Unit 1628 January 28, 2026
Read full office action

Prosecution Timeline

Nov 22, 2023
Application Filed
Jan 28, 2026
Non-Final Rejection — §DP (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
67%
Grant Probability
92%
With Interview (+25.4%)
2y 7m
Median Time to Grant
Low
PTA Risk
Based on 1006 resolved cases by this examiner. Grant probability derived from career allow rate.

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