Prosecution Insights
Last updated: May 29, 2026
Application No. 18/278,530

PRODRUGS OF AZO COMPOUNDS AND THEIR SALTS

Non-Final OA §102
Filed
Aug 23, 2023
Priority
Feb 24, 2021 — IN 202121007881 +1 more
Examiner
JARRELL, NOBLE E
Art Unit
1699
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Amneal Pharmaceuticals LLC
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
2m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
830 granted / 1021 resolved
+21.3% vs TC avg
Moderate +9% lift
Without
With
+9.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
59 currently pending
Career history
1077
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
22.3%
-17.7% vs TC avg
§102
18.6%
-21.4% vs TC avg
§112
32.6%
-7.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1021 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 . Election/Restrictions Applicant’s election without traverse of a compound of formula VIII in the reply filed on 2026 January 9 is acknowledged. A search of the following scope has been done is shown below. PNG media_image1.png 268 358 media_image1.png Greyscale PNG media_image2.png 554 526 media_image2.png Greyscale PNG media_image3.png 44 474 media_image3.png Greyscale Set L29 represents compounds that are eliminated by the proviso that both instances of R1 and R3 are both NH2. Consequently a search of the examined claims is limited to a compound of formula (VIII). Consequently claims 37, 38, 56, and 57 are examined on the merits. Claims 1-36 and 39-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2026 January 9. Information Disclosure Statement The information disclosure statements (IDS) submitted on 2023 November 22, 2025 May 30, and 2026 January 6 have been submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. Claim Objections Claims 37, 38, 56, and 57 are objected to because of the following informalities: the phrase “pharmaceutically acceptable salts or solvates thereof” should be --or a pharmaceutically acceptable salt of solvate thereof”. Appropriate correction is required. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. Claim(s) 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WILBERT (US 3493555, published 1970 February 3). Wilbert describes example 6 (column 6, line 20 to column 4, line 7). In this compound, the following examined definitions apply: R1 and R3 are each C(O)-cyclopropyl; and R’7 is H. PNG media_image4.png 134 340 media_image4.png Greyscale Claim(s) 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BURGUENO-TAPIA (Magnetic Resonance in Chemistry, 2004, 43, 256-260). BURGUENO-TAPIA describes compound 4 (page 256). In this compound, the following examined definitions apply: R1 and R3 are each C(O)-Me; and R’7 is H. PNG media_image5.png 256 196 media_image5.png Greyscale Conclusion Claims 37, 38, 56, and 57 are not allowed. The following is a statement of reasons for the indication of allowable subject matter: compounds of claim 38 are free of the prior art of record because Wilbert does not describe compounds in which examined variable R1 or R3 is an C(O)-OMe or C(O)-Me group. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM. 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, Fereydoun Sajjadi can be reached at 571-272-3311. 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. /NOBLE E JARRELL/Primary Examiner, Art Unit 1699 3
Read full office action

Prosecution Timeline

Aug 23, 2023
Application Filed
Mar 31, 2026
Non-Final Rejection mailed — §102 (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
81%
Grant Probability
90%
With Interview (+9.0%)
2y 11m (~2m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1021 resolved cases by this examiner. Grant probability derived from career allowance rate.

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