Prosecution Insights
Last updated: October 25, 2026
Application No. 18/310,501

ORAL LIQUID PHARMACEUTICAL COMPOSITIONS OF ISOTRETINOIN

Non-Final OA §103§112
Filed
May 01, 2023
Priority
Nov 01, 2020 — IN 202041047657 +1 more
Examiner
CHANDRAKUMAR, NIZAL S
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Idrs Labs Private Limited
OA Round
3 (Non-Final)
73%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
1300 granted / 1788 resolved
+12.7% vs TC avg
Strong +18% interview lift
Without
With
+18.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
87 currently pending
Career history
1888
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
29.1%
-10.9% vs TC avg
§102
11.0%
-29.0% vs TC avg
§112
36.8%
-3.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1788 resolved cases

Office Action

§103 §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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/12/2026 has been entered. Amended claims 1, 2, 5, 8, 17, 41 and withdrawn claims 20, 21, 26, 27 are pending. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Previously presented rejection of claims 1, 2, 5, 8, 17, 41 rejected under 35 U.S.C. 103 as being unpatentable over Motwani WO2010134047, Vanderbist WO200202417, Rao WO2016016742, Edelson US 20160213757, Edelson US 20110212157, and Chen US6383471 is maintained for reasons of record. Applicants arguments focus on the amendments to claims, with respect to the % amounts of active and inactive ingredients in the claims. Applicants Remarks focus on the following: PNG media_image1.png 84 684 media_image1.png Greyscale PNG media_image2.png 50 674 media_image2.png Greyscale Documents filed subsequent to Final Rejection 05/12/2026 are shown below: PNG media_image3.png 354 264 media_image3.png Greyscale None of the above relates to any ‘experimental results’ arrived at after the filing date of the Application, even if proper. As such amended claims now narrower specifically recited (previously considered) excipients, the claim language ‘at least’ and ‘about’ (in the context of what this term means as per definition in the specification) , the pointed out working Examples in the specification are all considered but are not persuasive. . That said the following authorized email communication’ is placed on record: PNG media_image4.png 510 1150 media_image4.png Greyscale As such the rejection is maintained. The suggestion noted in the email still is relevant. In this regard it is noted that the limitation ‘phosphatidylcholines’ relates to commercially available PHOSAL 53 MCT which is a water-free, liquid phospholipid concentrate manufactured by Lipoid that contains a minimum of 53% soybean-derived phosphatidylcholine dispersed in medium-chain triglycerides (MCT oil). Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103. 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: 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. Claims 1, 2, 5, 8, 17, 41 are 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. The terms ‘at least’ and ‘about’ with respect to the amount of specifically recited active and inactive ingredients in ranges render the boundaries of the composition for what protection is sought unclear. Applicants arguments focus on the amendment of base claim 1: Claim 1 to recite the transitional phrase "consisting essentially of' in place of "comprising," and has defined each recited component by a specific, internally consistent percentage range, with an express statement that the recited components together total 100% w/w of the composition. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 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, Andrew Kosar can be reached at (571) 272-0913. 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. /NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
Read full office action

Prosecution Timeline

Show 3 earlier events
Mar 23, 2026
Response Filed
May 12, 2026
Final Rejection mailed — §103, §112
Aug 03, 2026
Interview Requested
Aug 12, 2026
Request for Continued Examination
Aug 14, 2026
Response after Non-Final Action
Oct 05, 2026
Applicant Interview (Telephonic)
Oct 06, 2026
Examiner Interview Summary
Oct 06, 2026
Non-Final Rejection mailed — §103, §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
73%
Grant Probability
91%
With Interview (+18.2%)
2y 3m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 1788 resolved cases by this examiner. Grant probability derived from career allowance rate.

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