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 07/08/2022 is a continuation of 16/071,209 which is a 371 of PCT/EP2017/051133 filed 01/20/2017.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed July 16, 2025 to the office action made on January 16, 2025.
Claims 27-28, and 30-35 are currently pending and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 1/20/2023 (2), are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
The arguments over the rejection of claims 27- 28 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is persuasive in view of amendments made to the claims. The rejection is herewith withdrawn.
The arguments over the rejection of claims 27- 28 under 35 U.S.C. 103 over Tanimoto et al. EP2813228A1 – IDS in view of Levy (Treatment of recalcitrant atopic dermatitis with the oral Janus kinase inhibitor tofacitinib citrate. J Am Acad Dermatol. 2015 Sep;73(3):395-9. ) is not persuasive. The rejection is herewith maintained. The new claims are addressed below. Applicant argues the prior art does not teach moderate to severe CHE, as claimed. Specifically, hand eczema is at least one of seven species that encompass eczema, with a variety of symptoms including dry skin, itching, scaling, redness, across different surfaces of the body. Applicant argues an outmost need for moderate to severe CHE and delgocitinib cream which has become the first treatment in the U.S. Applicant states the data shows 48% of patients show deep response to the treatment.
In response, while Applicant argues seven species that encompass eczema, Applicant has not shown a direct comparison, where the specifically claimed moderate to severe CHE treatment with delgocitinib topically administered with no corticosteroids has unexpected or surprising results. The Examiner points out that the primary reference, Tanimoto, teaches topical treatment of eczema with the compound of the claims. The formulation is not combined with any additional corticosteroids. It is Examiners suggestion that Applicant provide comparative data wherein the claimed method has surprising and unexpected results, over the closest art of record.
The following rejections are made:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 27-28 and 30-35 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tanimoto et al. EP2813228A1 – IDS, as applied to claims 13, 18-19 and 20 in view of Levy (Treatment of recalcitrant atopic dermatitis with the oral Janus kinase inhibitor tofacitinib citrate. J Am Acad Dermatol. 2015 Sep;73(3):395-9. ).
Tanimoto et al. teaches
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The reference teaches treatment of eczema (reads on chronic hand eczema, moderate to severe chronic hand eczema) as an oral preparation such as tablet, capsule, granule, powder, lozenge, syrup, emulsion and suspension, or a parenteral preparation such as external preparation, suppository, injection, eye drop, nasal drug and pulmonary drug. A dosage amount depends on subjects, diseases, symptoms, dosage forms, administration routes, etc., and is usually, for example, in the range from about 0.01 mg to 1 g per day with comprising Compound A, B or C as an active ingredient. The dose may be administered at a time or in several divided doses. An application amount of the external preparation to the affected area can be selected depending on the content of the active ingredient, etc., and can be applied, for example, at a time or in several divided amounts per day. Carrier substances for pharmaceutical materials, e.g., an excipient, a disintegrant, a binder, a fluidizer, and a lubricant for solid preparations, a solvent, a solubilizing agent, a suspending agent, a tonicity agent, a buffer, and a soothing agent for liquid preparations, and a base, an emulsifier, a humectant, a stabilizer, a stabilizing agent, a dispersant, a plasticizer, a pH regulator, an absorption promoter, a gelling agent, an antiseptic, a filler, a resolvent, a solubilizing agent, and a suspending agent for semisolid preparations. Further, an additive including a preserving agent, an antioxidant agent, a colorant, and a sweetening agent may be used, if needed. The "soothing agent" includes benzyl alcohol, etc.0060] The "base" includes water, animal or plant oils (e.g., olive oil, corn oil, peanut oil, sesame oil, castor oil, etc.), lower alcohols (e.g., ethanol, propanol, propylene glycol, 1, 3-butylene glycol, phenol, etc.) , higher fatty acid and ester thereof, waxes, higher alcohol, polyhydric alcohol, hydrocarbons (e.g., white petrolatum, liquid paraffin, paraffin, etc.), hydrophilic petrolatum, purified lanolin, absorptive ointment, hydrous lanolin, hydrophilic ointment, starch, pullulan, gum arabic, tragacanth gum, gelatin, dextran, cellulose derivative (e.g., methyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, etc.), synthetic polymer (e.g., carboxyvinyl polymer, sodium polyacrylate, polyvinyl alcohol, polyvinyl pyrrolidone, etc.), propylene glycol, macrogol (e.g., macrogol 200-600, etc.), and combinations of two or more kinds of these. With respect to the limitation wherein the treatment results in relief of pain or pruritus, the Examiner states treatment of eczema would in effect result in in relief of pain or pruritus. However, the prior art, also, teaches the compound of formula I in treating xeroderma (asteatosis). The condition results in skin drying and losing gloss to become rough due to a reduction in secretion of sebum and sweat. Further, Tanimoto teaches rice bran-like scales and shallow cracks arise to exhibit an ichthyosiform appearance when skin dries, and the patient may complain slight itching.
While Tanimoto et al. teaches treatment of eczema in general, the reference is silent to treatment of chronic moderate to severe eczema twice daily in amount of 2wt%.
Levy teaches a janus kinase inhibitor, tofacitinib citrate, in the treatment of moderate to severe AD. The reference discusses recent advances in our understanding of the pathogenesis of AD have led to the possibility of new, targeted treatments. An exaggerated type 2 helper T-cell (Th2) immune response is well established in the pathogenesis of AD, and dupilumab, a monoclonal antibody that inhibits signaling by interleukin (IL)-4 and IL-13, 2 cytokines that are required for Th2 immune responses, has demonstrated reductions in eczema severity when compared with topical corticosteroids in phase I and II clinical trials. Additionally, Levy teaches the phase IIa clinical trial of tofacitinib ointment for the treatment of atopic dermatitis.
It would have been obvious to one of ordinary skill of art at the time of filing to treat chronic moderate to severe hand eczema with a topical formulation. The motivation to treat chronic moderate to severe eczema twice daily in amount of 2wt% is because Tanimoto et al. teaches that external preparations are useful modes of administration, that the formulations comprises carriers, lubricants, soothing agents, and bases, and further that the external preparation can be applied, for example, at a time or in several divided amounts of about 0.01 mg to 1 g per day and the JAK inhibitor of formula I to treat eczema. Further, Levy teaches a JAK inhibitor, tofacitinib citrate, in the treatment of moderate to severe atopic dermatitis. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results. Furthermore, it is Examiners contention, absent evidence of criticality of the length of time of treatment, the limitation of administration for 8 weeks is obvious in order to achieve therapy.
Conclusion
No claims allowed.
Contact Information
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