DETAILED ACTION
The Office Action is in response to the Applicant's reply filed January 12, 2026 to the non-final rejection made on August 12, 2025.
Claims 1, 6-8, 10-12, 17-18, and 22-25 are currently pending and are examined on the merits herein.
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 .
Application Priority
This application filed 11/01/2024 has a PRO 63/546,888 filed on 11/01/2023.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph of claims 1, 6-8, 10-18, 20, 22-25 is not persuasive. The rejection is herewith maintained. The Examiner points out a carrier may have dual activity, and act to treat acne, the atopic dermatitis, or the psoriasis. While Applicant’s specification may exemplify a formulation with the DIM and specific carriers in amounts that will not have therapeutic efficacy, the claims are broadly drawn to a carrier having an aqueous and oil phase. The argument is not persuasive.
Applicant’s arguments over the 35 U.S.C. 102(a)(1) rejection over Melnik (WO2014177123A1) of claims 1, 6-8, 10-12, 17, and 22-25 is persuasive in part. The rejection is herewith modified. While Melnik does not specify the DIM in the oil phase, the Examiner points out water-insoluble drugs will naturally move into and partition within the oil phase of an emulsion, as they have a higher affinity for non-polar environments.
The following rejections are made in view of amendments made to the claims:
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, 6-8, 10-12, 17, and 22-25 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 claims are drawn to the composition wherein the composition is essentially free of any additional therapeutically active agent to treat the acne, the atopic dermatitis, or the psoriasis. However, the Examiner is unclear how Applicant is defining therapeutically active agents to treat the acne, the atopic dermatitis, or the psoriasis? A carrier may have dual activity, and act to treat acne, the atopic dermatitis, or the psoriasis.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6-8, 10-12, 17, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Melnik (WO2014177123A1) in view of Alpert (US 20170231952 A1).
Melnik teaches 3,3'-Diindolylmethane also inhibits the mTORC1 signaling pathway, leading to cell cycle arrest and antiproliferative activity. For acne treatment, 3,3'-diindolylmethane in a daily dose of 2 × 200 mg to 2 × 500 mg in capsule form is administered orally with meals, external treatment with 3,3'-diindolylmethane takes place in the form of 0.5% to 3% Gels or lotions or solutions (reads on pharmaceutically acceptable carrier).
Melnik fails to specify the 3,3'-diindolylmethane in the oil phase of the lotion.
Alpert teaches a DIM or a BR-DIM and one or more additive, adjuvants and/or excipients. Diindolylmethane is a lipophilic oil-soluble compound.
It would have been obvious to one of ordinary skill at the time of filing for the DIM to partition within the oil phase. The motivation for DIM to partition within the oil phase is because Alpert teaches the Diindolylmethane is a lipophilic oil-soluble compound. Hence, a skill artisan would have reasonable expectation for the water-insoluble drug to have a higher affinity for the oil phase and to partition within the oil phase.
Conclusion
No claims allowed.
The arguments are not persuasive and the rejection is made FINAL.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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