DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 17, 2026 has been entered.
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 persuasive in view of amendments made to the claims. The rejection is herewith maintained.
Applicant’s arguments over the 35 U.S.C. 103 rejection over Melnik (WO2014177123A1) in view of Alpert (US 20170231952 A1) of claims 1, 6-8, 10-12, 17, and 22-25 is not persuasive. The rejection is herewith maintained. Applicant argues Alpert’s sole working example is an oral formulation and fails to disclose how to formulate any topical composition. The Examiner points out that the claims are drawn to topical compositions and not to a method of making. Further, Examiner states that although the reference discloses a preferable composition, the reference does not teach away from the topical form. A preferable method does not eliminate all other possibilities. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
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A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
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Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." Id. at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
The following rejections are made in view of amendments made to the claims:
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) and Bishop et al. (WO 2021254752 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, comprising an emulsifier.
Alpert teaches a DIM or a BR-DIM and one or more additive, adjuvants and/or excipients. Diindolylmethane is a lipophilic oil-soluble compound.
Bishop et al. teaches topical cosmetic compositions in the form of an emulsion, and suitable for use in the invention, generally include surface active ingredients, such as emulsifiers and solubilizers, to enable two or more immiscible components to be combined homogeneously and to help stabilize the composition. Emulsifiers that may be used to form O/W or W/O emulsions include potassium cetyl phosphate.
It would have been obvious to one of ordinary skill at the time of filing for the DIM to partition within the oil phase comprising the emulsifier. The motivation for DIM to partition within the oil phase comprising the emulsifier is because Alpert teaches the Diindolylmethane is a lipophilic oil-soluble compound and Bishop teaches to enable two or more immiscible components to be combined homogeneously and to help stabilize the composition one would add an emulsifier. 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 and to be homogenous while stabilized. The prior art does not require the use of a retinoid compound.
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 Bishop et al. (WO 2021254752 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, comprising an emulsifier.
Bishop et al. teaches topical cosmetic compositions in the form of an emulsion, and suitable for use in the invention, generally include surface active ingredients, such as emulsifiers and solubilizers, to enable two or more immiscible components to be combined homogeneously and to help stabilize the composition. Emulsifiers that may be used to form O/W or W/O emulsions include potassium cetyl phosphate.
It would have been obvious to one of ordinary skill at the time of filing for the DIM to partition within the oil phase comprising the emulsifier. The motivation for DIM to partition within the oil phase comprising the emulsifier is because Bishop teaches to enable two or more immiscible components to be combined homogeneously and to help stabilize the composition one would add an emulsifier. Hence, a skill artisan would have reasonable expectation to have a homogenous stabilized formulation. The prior art does not require the use of a retinoid compound.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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