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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/19/26 has been entered.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Sonti et al (US 2018/0064656 A1 hereafter Sonti) in view of Gibson et al (EP 0 580 409 A2 hereafter Gibson).
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 glyceryl (glycerol) monostearate [0110] and an antioxidant [0122-0123], meeting some limitations of claim 57. Additionally, the formulation comprises penetration enhancer such as propylene glycol, present from up to 40% of the formulation [0165]. These additional agents can be used as additional co-solvent, raising the co-solvent concentration above 30%, additionally 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.
While Sonti discloses a topical formulation comprising and oil phase, co-solvents, water and surfactants, but the formulation is silent to the viscosity of the formulation. Also, 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 filed 5/19/26 have been fully considered but they are not persuasive. Applicant argues that the combination of Sonti and Gibson do not render the claims obvious as the combination does not disclose the surfactant limitation of the claims. It remains the position of the Examiner the Sonti and Gibson continues render the claims obvious. Sonti discloses the same active agent, present in a range of the claim 57, along with an oil phase, co-solvent phase that is above 30%, a water phase and a surfactant including glycerol monostearate. Sonti disclose co-solvents meeting the limitations of claim 59, the antioxidant of claim 60, the particle size of the emulsion meeting claims 63 and 64. Gibson disclose a similar topical formulation comprising the same components where the viscosity meeting the limitations of claims 61. Applicant argues that the selection of specific components are merely picking and choosing amongst a long list of ingredients, however the list of co-solvents in the claims is exhaustive and the prior art combination provides a similar topical formulation, functioning in the same manner with the same components as the instant claims. The same components are chosen from a shorter list of ingredients than those of the instant dependent claims 59. It is the position of the Examiner that the prior art provides the same components arranged in the same way and the choosing of the specific components would have been obvious as the prior art establishes the level of skill in the art. 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. For these reasons, the claims remain rejected.
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
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