Prosecution Insights
Last updated: July 17, 2026
Application No. 18/842,157

CRYSTALLINE FORM OF DAROLUTAMIDE

Non-Final OA §112
Filed
Aug 28, 2024
Priority
Feb 28, 2022 — EU 22382169.5 +1 more
Examiner
JACKSON, SHAWQUIA
Art Unit
Tech Center
Assignee
Química Sintética S A
OA Round
1 (Non-Final)
78%
Grant Probability
Favorable
1-2
OA Rounds
4m
Est. Remaining
75%
With Interview

Examiner Intelligence

Grants 78% — above average
78%
Career Allowance Rate
1419 granted / 1820 resolved
+18.0% vs TC avg
Minimal -3% lift
Without
With
+-3.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
45 currently pending
Career history
1851
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
12.3%
-27.7% vs TC avg
§102
11.0%
-29.0% vs TC avg
§112
62.6%
+22.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1820 resolved cases

Office Action

§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 . DETAILED ACTION Claims 1, 3-14 and 16-21 are currently pending. Applicants have amended claims 1, 3-13 and 16, canceled claims 2 and 15 and added new claims 16-21 in the amendment filed on August 28, 2024. The claim 3 is rejected and claims 1, 4-14, 16-21 are considered allowable. I. Priority The instant application is a 371 of PCT/EP2023/054766, filed on February 27m 2023 and claims benefit of Foreign Application EPO 22383269.5, filed on February 28, 2022. II. Information Disclosure Statement The information disclosure statement (IDS) submitted on August 28, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. III. Rejections Claim Rejections - 35 USC § 112 The following is a quotation of the second paragraph of 35 U.S.C. 112: 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. Claim 3 is 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. Specifically, claim 3 is dependent on canceled claim and it is unclear what Applicants are attempting to claim as the subject matter. Therefore, the claim is considered indefinite. Applicants are suggested to amend claim 3 so that it depends on claim 1 and not canceled claim 2 to overcome the rejection. ***closest prior art is WO 2016/120530 A1 which teaches crystalline forms of the compound darolutamide but does not teach crystalline forms with the X-ray diffraction peaks 10.2, 14.4 and 17.8 ± 0.2 degrees 2-theta as defined in claim 1. The nanocrystalline form of the instant claims are neither taught or suggested by the prior art. IV. Conclusion Telephone Inquiry Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is (571)272-9043. The examiner can normally be reached on M-F 7AM-4PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached on (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Aug 28, 2024
Application Filed
Jul 01, 2026
Non-Final Rejection mailed — §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12668571
SUBSTITUTED 3-AMINO-4-METHYLBENZENESULFONAMIDES AS SMALL MOLECULE INHIBITORS OF UBIQUITIN-SPECIFIC PROTEASE 28
3y 4m to grant Granted Jun 30, 2026
Patent 12662458
SOLID FORMS OF A COMPOUND
3y 0m to grant Granted Jun 23, 2026
Patent 12655117
PREPARATION OF SUBSTITUTED AROMATIC CARBOXAMIDES
4y 0m to grant Granted Jun 16, 2026
Patent 12655126
IMIDAZOLE-PYRAZOLE DERIVATIVES AS ANTIBACTERIALS
3y 3m to grant Granted Jun 16, 2026
Patent 12655140
Compound containing structure of a heteroaromatic ring, pharmaceutical composition thereof and application thereof
2y 9m to grant Granted Jun 16, 2026
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
78%
Grant Probability
75%
With Interview (-3.4%)
2y 3m (~4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1820 resolved cases by this examiner. Grant probability derived from career allowance rate.

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