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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/4/25 was filed after the mailing date of the previous Office Action on 8/12/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 57, 59, 60, 62-64 and 68 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Sonti et al (US 2018/0064656 A1 hereafter Sonti).
Sonti teaches a topical pharmaceutical oil-in0water emulsion comprising 0.25% to about 0.50% by weight of 3.5-Dihydroxy-4-isopropyl-trans-stilbene of pharmaceutical salt hereof [0082], an oil phase comprising about 5% to about 20% by weight [0095], a co-solvent in an amount 5% to about 20% by weight of the composition [0154], a water phase in an amount 55% to about 75% by weight of the formulation [0100], a surfactant in an amount of about 5% to about 15% by weight of the composition [0104], wherein the surfactant comprising PEG-32 stearate [0110] and an antioxidant [0122-0123], meeting the limitations of claim 57. The pharmaceutical oi-in-water emulsion comprising propylene glycol [0146-0153], meeting the limitations of claim 59. The formulation comprising the antioxidant where the antioxidant is present about 0.05% to about 0.1% by weight of the composition, and where the antioxidant is butylate hydroxytoluene, butylated hydroxyanosile [0123], meeting the limitations of the claims 60. The formulation further comprises preservatives and additional dermatologically acceptable excipients including chelating agents, co-solvents and mixtures thereof [0127-0131], meeting the limitations of claim 62. The topical oil-in-water formulation has a droplet size having a D90 of 0.05-1 microns [0070], meeting the limitations of claim 63. The topical oil-in-water formulation has a droplet size having a D50 of about 5 microns [0068], meeting the limitation of claim 64. The topical oil-in-water formulation is used in the treatment of dermatological conditions like atopic dermatitis [0376], meeting the limitations of claim 68. These disclosures render the claims anticipated.
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.
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.
Claim(s) 57, 59-64 and 68-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Sonti et al (US 2018/0064656 A hereafter Sonti) in view of Gibson et al (EP 0 580 409 A2 hereafter Gibson).
As discussed above, Sonti discloses a topical oil-in0water emulsion comprising an 3,5-dihydroxy-4-isopropyl-trans-stilbene, an oil phase, a co-solvent, a water phase, a surfactant and an antioxidant. Regarding the concentration of the co-solvent in claim 69, it is the position of the Examiner that Sonti render this limitation obvious. Sonti discloses that the co-solvent is present up to 20%, and that the additional dermatological agents resent can further include further co-solvents and permeation enhancers [0127-0131]. These additional permeation enhancers can also be propylene glycol, where the permeation enhancers are present up to about 40% [0163-0165]. This would combine to be above 30% of the composition meeting the limitation of claim 69. As discussed above the surfactants can be non-ionic surfactants and PEG castor oils [0103-0107], the oil phase can be fatty acids or fatty alcohols [0083-0086], meeting the limitations of claim 70. The pH of the formulation is adjusted by pH buffers so that the formulation has a pH from 4.5-6.5 [0135]. The emulsion is present as a cream or ointment, and comprises thickeners and emollients, yet is silent to the specific viscosity of the topical formulation. A specific viscosity of a topical emulsion is well known in the art as seen in the Gibson patent.
Gibson discloses a topical formulation comprising an active agent, oils, surfactants and water in an oil-in-water emulsion (abstract, pg. 10, lin. 45-55). The surfactant is present at 2-40% (pg. 9, lin. 50- pg. 10, lin. 11). The formulation comprises up to 80% water (pg. 14, lin. 30). The topical formulation further comprises penetration enhancers present at 0.5-10% along with antioxidants (pg. 22, lin. 10- 30). The viscosity of the lotion or crème formulation is up to 100,000 m.Pas (pg. 24, lin. 40-50). It would have been obvious to include viscosity enhancing agents into the formulation of Sonti as they solve the same problem.
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable topical formulation useful in treating dermatological conditions. It would have been obvious to combine the viscosity enhancers of Gibson into the Sonti as they solve the same problem and provide similar dosage forms. One of ordinary skill in the art would have been motivated to combine the prior art in order to produce a thick topical crème useful in treating atopic dermatitis.
Response to Arguments
Applicant’s arguments with respect to claim(s) 57, 59-64, 68-71 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618