Prosecution Insights
Last updated: May 29, 2026
Application No. 17/906,650

PHD INHIBITOR COMPOUNDS, COMPOSITIONS, AND USE

Final Rejection §112
Filed
Sep 19, 2022
Priority
Mar 20, 2020 — provisional 62/992,585 +1 more
Examiner
SAMSELL, RILLA MARIE
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Akebia Therapeutics, Inc.
OA Round
2 (Final)
71%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
71%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allowance Rate
50 granted / 70 resolved
+11.4% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
37 currently pending
Career history
106
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
35.3%
-4.7% vs TC avg
§102
15.3%
-24.7% vs TC avg
§112
27.1%
-12.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 70 resolved cases

Office Action

§112
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 the Claims Claims 23, 84, 86, and 107-113 are pending. Acknowledgment is made of the amendment of claims 23, 84, and 86; the cancellation of claims 1-15; and the addition of new claims 108-113 in the reply filed 01/16/2026. Information Disclosure Statement The information disclosure statement (IDS) submitted on 01/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Restriction/Election Requirement Applicant’s elected species of compound 36 from paragraph [0288] of the specification, shown below, appears allowable. PNG media_image1.png 109 224 media_image1.png Greyscale Therefore, the search has been expanded to include the full scope of the claims. Claims 23, 84, 86, and 107-113 are currently under examination. Withdrawn Objections/Rejections Applicant’s amendment to the claims, filed 01/16/2026, overcomes the objection to the claims 4, 15, and 84 for minor informalities. The objection to claims 4, 15, and 84 has been withdrawn. Applicant’s amendment to the claims, filed 01/16/2026, overcomes the rejection of claims 3 and 4 under 35 U.S.C. 112(b) for indefiniteness. The rejection of claims 3 and 4 has been withdrawn. Applicant’s amendment to the claims, filed 01/16/2026, overcomes the rejection of claim 4 under 35 U.S.C. 112(d) for failing to include the limitations of the claim upon which it depends. The rejection of claim 4 has been withdrawn. Applicant’s amendment to the claims, filed 01/16/2026, overcomes the rejection of claims 1-4, 7-9, and 86 under 35 U.S.C. 102(a)(1) as being anticipated by, and claims 6, 11-13, and 15 under 35 U.S.C. 103 as being unpatentable over, Nie et al. (WO 2014089364 A1). The position of the carboxylic acid and the halogen on the compound taught by Nie et al. no longer reads on the instant claims. The rejection of claims 1-4, 6-9, 11-13, and 86 has been withdrawn. Applicant’s amendment to the claims, filed 01/16/2026, overcomes the rejection of claims 1, 2, 6-9, 11, 12, and 86 under 35 U.S.C. 102(a)(1) as being anticipated by Beck et al. (cited in previous office action). The compounds of Beck et al. contain a pyridine ring rather than a phenyl ring, which no longer reads on the amended claims. The rejection of claims rejection of claims 1, 2, 6-9, 11, 12, and 86 has been withdrawn. Applicant’s amendment to the claims, filed 01/16/2026, overcomes the rejection of claims 1, 2, 6-9, 11, 12, and 86 under 35 U.S.C. 102(a)(1) as being anticipated by Flamme et al. (WO 2006114213 A1). The compounds of Flamme et al. contain a pyridine ring rather than a phenyl ring, which no longer reads on the amended claims. The rejection of claims rejection of claims 1, 2, 6-9, 11, 12, and 86 has been withdrawn. Applicant’s amendment to the claims, filed 01/16/2026, overcomes the rejection of claims 1, 2, 6-9, 11, 12, and 86 under 35 U.S.C. 102(a)(1) as being anticipated by Thede et al. (WO 2008067874 A1). The compounds of Thede et al. contain a pyridine ring rather than a phenyl ring, which no longer reads on the amended claims. The rejection of claims rejection of claims 1, 2, 6-9, 11, 12, and 86 has been withdrawn. Applicant’s amendment to the claims, filed 01/16/2026, overcomes the rejection of claims 1-4, 6-9, 11-13, 15, 84, 86, and 107 on the ground of nonstatutory double patenting over copending Application No. 17/906,653. The newly amended claims no longer contain Formula A which overlapped in scope with Application ‘653. Application ‘653 does not teach compounds containing a carboxylic acid group on the 2-pyridinyl ring. The rejection of claims 1-4, 6-9, 11-13, 15, 84, 86, and 107 has been withdrawn. New Rejections Necessitated by Claim Amendment Claim Rejections - 35 USC § 112 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. Claim 84 is 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. Claim 84 teaches compound 16, shown below, where R5 of Formula (III) is -OH. PNG media_image2.png 110 327 media_image2.png Greyscale However, Claim 23 requires that the R5 substituent is CN or halogen. Therefore, claim 2 fails to further limit the subject matter of the claim upon which it depends. Therefore, claim 84 fails to include all the limitations of the claim upon which it depends. Claim 107 is objected to as being dependent upon a rejected claim. Allowable Subject Matter Claims 23, 86, and 108-113 are allowed. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Conclusion Claim 84 is rejected. Claim 107 is objected to. Claims 23, 86, and 108-113 are allowed. THIS ACTION IS MADE FINAL. 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 RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 9-5. 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, 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. /R.M.S./Examiner, Art Unit 1624 /JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

Sep 19, 2022
Application Filed
Oct 17, 2025
Non-Final Rejection mailed — §112
Jan 16, 2026
Response Filed
Feb 19, 2026
Final Rejection mailed — §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
71%
Grant Probability
71%
With Interview (+0.0%)
3y 2m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 70 resolved cases by this examiner. Grant probability derived from career allowance rate.

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