Prosecution Insights
Last updated: April 19, 2026
Application No. 18/557,217

PROCESS FOR PREPARING PEXIDARTINIB

Non-Final OA §112
Filed
Oct 25, 2023
Examiner
PATEL, SAGAR S
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Johnson Matthey Public Limited Company
OA Round
1 (Non-Final)
76%
Grant Probability
Favorable
1-2
OA Rounds
2y 8m
To Grant
99%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allow Rate
345 granted / 455 resolved
+15.8% vs TC avg
Strong +34% interview lift
Without
With
+33.8%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
30 currently pending
Career history
485
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
32.8%
-7.2% vs TC avg
§102
20.7%
-19.3% vs TC avg
§112
23.6%
-16.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 455 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 29 – 47 are pending. Claims 30 – 42 and 45 – 47 are rejected. Claims 29 and 43 – 44 contain allowable subject matter. Priority PNG media_image1.png 62 392 media_image1.png Greyscale Information Disclosure Statement The information disclosure statement (IDS) submitted on October 25, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. Claims 30 – 42 and 45 – 47 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Claims 30 – 42 and 45 – 47 are directly or indirectly dependent cancelled claims 1 – 2, 10 and 13. There is insufficient antecedent basis for this limitation in the claims. The metes and bounds are not clearly set forth and the claims are considered incomplete. Thus, reference to cancelled claim renders the claims indefinite. In order to overcome the rejection, Applicant may amend each of the claims 30 – 42 and 45 – 47 to be directly or indirectly dependent on independent claim 29, 43 or 44. Claims 30, 32, 35 and 39 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 30 recites the broad recitation “… Group 10 transition metal catalyst is a nickel catalyst, a palladium catalyst, or a platinum catalyst”, and the claim also recites “… preferably a palladium catalyst” (emphasis added) which is the narrower statement of the range/limitation. Claim 32 recites the broad recitation “… solvent which comprises an alcohol or a mixture of alcohols”, and the claim also recites “… preferably tert-amyl alcohol and/or isopropanol” (emphasis added) which is the narrower statement of the range/limitation. Claim 35 recites the broad recitation “… Group 8 transition metal catalyst is an iron catalyst, a ruthenium catalyst, or an osmium catalyst”, and the claim also recites “… preferably a ruthenium catalyst, more preferably Ru-SNS” (emphasis added) which is the narrower statement of the range/limitation. Claim 39 recites the broad recitation “… Group 8 transition metal catalyst is an iron catalyst, a ruthenium catalyst, or an osmium catalyst”, and the claim also recites “… preferably a ruthenium catalyst, more preferably Ru-SNS” (emphasis added) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Allowable Subject Matter The following is a statement of reasons for the indication of allowable subject matter: Claim 29 is directed to a process for the preparation of a compound of formula (VI), PNG media_image2.png 342 672 media_image2.png Greyscale PNG media_image3.png 475 672 media_image3.png Greyscale The closest prior art is Ibrahim et al. WO 2016/179412 A1, as disclosed in IDS dated October 25, 2023. Ibrahim et al. teach the compound of formula I. See, e.g., paragraphs [0005]. The compound of formula I is presented below: PNG media_image4.png 156 370 media_image4.png Greyscale Ibrahim et al. also teach the process for synthesizing said compound (see, e.g., paragraphs [0011]-[0013]): PNG media_image5.png 1274 883 media_image5.png Greyscale PNG media_image6.png 266 883 media_image6.png Greyscale However, Ibrahim does not explicitly teach or provide sufficient guidance for the process of using the compounds of instant formula (V) and formula (IX) for the preparation of said final compound. Therefore, the claims contain allowable subject matter. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST. 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. /Sagar Patel/Examiner, Art Unit 1626 /KAMAL A SAEED/Primary Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Oct 25, 2023
Application Filed
Feb 04, 2026
Examiner Interview (Telephonic)
Feb 07, 2026
Non-Final Rejection — §112 (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
76%
Grant Probability
99%
With Interview (+33.8%)
2y 8m
Median Time to Grant
Low
PTA Risk
Based on 455 resolved cases by this examiner. Grant probability derived from career allow rate.

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