Prosecution Insights
Last updated: April 19, 2026
Application No. 18/557,236

PROPHYLACTIC AND/OR THERAPEUTIC AGENT FOR AMYOTROPHIC LATERAL SCLEROSIS

Non-Final OA §102
Filed
Oct 25, 2023
Examiner
HERNANDEZ, JACKSON J
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
National University Corporation Tokai National Higher Education And Research System
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
3y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allow Rate
15 granted / 30 resolved
-10.0% vs TC avg
Strong +51% interview lift
Without
With
+51.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
87 currently pending
Career history
117
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
34.9%
-5.1% vs TC avg
§102
11.8%
-28.2% vs TC avg
§112
24.7%
-15.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 30 resolved cases

Office Action

§102
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 . Information Disclosure Statement The information disclosure statement (IDS) submitted on October 25th, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The listing of references in the specification ([0003]) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The IDS filed on October 25th, 2023 had been signed by attorney Michael P. Kenney. The attorney’s signature was crossed out. The Examiner has considered and signed in the appropriate box of the IDS form. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (ACS Med. Chem. Lett. 2011, 2, 91–96) (“Johnson”). Applicant is advised that a recitation of the intended use of the claimed invention, such as an agent comprising PF-04457845 for use as prophylactic and/or therapeutic agent for the treatment of amyotrophic lateral sclerosis (sporadic or familial) in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02. Regarding claims 1-2, Johnson discloses PF-04457845 (instant compound) (abstract) as a highly potent, orally bioavailable urea FAAH inhibitor (title). PNG media_image1.png 151 396 media_image1.png Greyscale Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5. Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (571) 270-5239. 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. /JACKSON J HERNANDEZ/Examiner, Art Unit 1627 /SARAH PIHONAK/Primary Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

Oct 25, 2023
Application Filed
Jan 25, 2026
Non-Final Rejection — §102 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12595254
CRYSTAL FORM OF RESMETIROM, PREPARATION METHOD THEREFOR, AND USE THEREOF
2y 5m to grant Granted Apr 07, 2026
Patent 12565495
VMAT2 INHIBITOR AND PREPARATION METHOD THEREFOR AND APPLICATION THEREOF
2y 5m to grant Granted Mar 03, 2026
Patent 12565494
INHIBITORS OF HUMAN RESPIRATORY SYNCYTIAL VIRUS AND METAPNEUMOVIRUS
2y 5m to grant Granted Mar 03, 2026
Patent 12559485
CDK6/DYRK2 DUAL-TARGET INHIBITOR, AND PREPARATION METHOD THEREFOR AND USE THEREOF
2y 5m to grant Granted Feb 24, 2026
Patent 12522584
3,4-DIHYDROISOQUINOLINE COMPOUND AND USE THEREOF
2y 5m to grant Granted Jan 13, 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
50%
Grant Probability
99%
With Interview (+51.1%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 30 resolved cases by this examiner. Grant probability derived from career allow rate.

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