Prosecution Insights
Last updated: April 19, 2026
Application No. 18/310,501

ORAL LIQUID PHARMACEUTICAL COMPOSITIONS OF ISOTRETINOIN

Non-Final OA §103
Filed
May 01, 2023
Examiner
CHANDRAKUMAR, NIZAL S
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Idrs Labs Private Limited
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
2y 4m
To Grant
91%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
1273 granted / 1752 resolved
+12.7% vs TC avg
Strong +18% interview lift
Without
With
+17.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 4m
Avg Prosecution
76 currently pending
Career history
1828
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
30.0%
-10.0% vs TC avg
§102
12.0%
-28.0% vs TC avg
§112
35.3%
-4.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1752 resolved cases

Office Action

§103
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 of Group I claims 1-1 9 , in the reply filed on 10/12/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). As to the Applicant Remarks at top of numbered page 3 of 7, see bottom of page 5 onto page 6 of previous action filed 08/18/2025 . 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. Claim (s) 1-1 9 is/are 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 US 6383471 . Motwani teaches at page 21 1. A pharmaceutical solution comprising isotretinoin or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable carrier. 2. The pharmaceutical solution according to claim 1, wherein the carrier comprises a lipophilic carrier or a combination of lipophilic/hydrophilic carriers. 3. The pharmaceutical solution according to claim 2, wherein the lipophilic carrier comprises fatty acid esters, fatty acids, fatty alcohols, vegetable oil or a combination thereof. Motwani teaches at page 4 Motwani teaches at page 5 Vanderbist teaches at page 24 Vanderbist teaches at page 25 Vanderbist teaches many isotretinoin formulations, for example at page 10 Table I comprising: Labrafil® M 1944 CS is a nonionic surfactant that solubilizes poorly water-soluble APIs, increases bioavailability, and acts as a co-emulsifier. Gelucire is a class of multi-component excipients, not a single chemical, composed primarily of PEG (Polyethylene Glycol) esters of fatty acids, a smaller fraction of mono-, di-, and triglycerides, and some free PEG. Soybean oil in pharmaceutical compositions is used as an excipient for lipophilic drugs, an Active Pharmaceutical Ingredient (API) in parenteral nutrition (lipid emulsions), and a vehicle for sustained-release injectables, containing primarily unsaturated fatty acids Miglyol refers to a group of neutral triglyceride oils (like Miglyol 812 N) composed mainly of caprylic and capric acid esters, used as excipients (drug carriers, solvents, penetration enhancers) in oral, topical, parenteral, and rectal formulations . Edelson 75 7 teaches pharmaceutical compositions for dermal delivery of retinoid isotretinoin containing triglyceride , phosphatidylcholine oleic acid, glycol , antioxidant and surfactant . (see paragraph [0439]), claim 154, claim 1, claim 177 and further in claim 181 containing surfactant, phosphatidylcholines , glycol among other excipients. Similarly, Edelson 157 also teaches pharmaceutical compositions for dermal delivery of retinoids including isotretinoin (see paragraph [0 0 22]), triglyceride , phosphatidylcholine oleic acid, glycol , antioxidant and surfactant . L imitations of base claim and dependent claims and the difference s : Limitations of the base claim 1 and dependent claims with respect to the components of the liquid, oral composition, that is the active ingredient isotretinoin and inactive ingredients (excipients) are present in the above cited prior art. The difference here is that specific amounts/ranges of these components, such as >25% phosphatidylcholine ingredient in base claims 1, 8-10 the range 1-7% of active ingredient (claims 3-4), solub ilizing agent (claims 5-7), triglycerides claims 11-13 the range > 75%, surfactant claims 14-16, choice of surfactants claims 17-19 . Each ingredient is known in the art; however, the claimed composition as a whole would have been obvious . The cited references here and the admitted multiple references at pages 3-5 are all teach formulations of isotretinoin. Some of these admitted references do relate to solid or semi-solid formulations (and allegedly problematic for example for pediatric dose). The cited references are drawn to oral liquid formulation and the all the components are in different proportions have been demonstrated. Motwani’s liquid dosage form which contains triglyceride , oleic acid, glycol , antioxidant and surfactant but does not recite explicitly phosphatidylcholine . Edelson does disclose phosphatidylcholine in isotretinoin. Similarly, Chen (see claims) phosphatidylcholine explicitly mentioned in pharmaceutical composition s containing triglyceride , phosphatidylcholine oleic acid, glycol , antioxidant and surfactant for making formulations of many therapeutic agents including isotretinoin . Also see claims of US 6761903 B2 and US 6267985 B1 for triglyceride , oleic acid glycol , antioxidant , surfactant and phosphatidylcholine containing oral formulations and isotretinoin . The use of these excipients to make oral liquid formulations is based on their own inherent properties, to modify/enhance solubility, stability and bioavailability. The cited references are examples. The US Patent data base contains thousands of references drawn to liquid formulations containing these excipients. Since all the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. As such the difference is amounts of the claimed elements. it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). 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. Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976). As such there is nothing unobvious is seen in the claims. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NIZAL S CHANDRAKUMAR whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6202 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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, FILLIN "SPE Name?" \* MERGEFORMAT Andrew Kosar can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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 f
Read full office action

Prosecution Timeline

May 01, 2023
Application Filed
Sep 07, 2023
Response after Non-Final Action
Dec 09, 2025
Non-Final Rejection — §103
Mar 23, 2026
Response Filed

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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
73%
Grant Probability
91%
With Interview (+17.9%)
2y 4m
Median Time to Grant
Low
PTA Risk
Based on 1752 resolved cases by this examiner. Grant probability derived from career allow rate.

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