DETAILED ACTION
This is an initial Office action for non-provisional application 18/359250 filed July 26, 2023, which is a 371 of PCT/IB2022/050818 filed January 31, 2022, which claims priority to a provisional of 63/144912 filed February 2, 2021.
Claims 1-20 are pending. Claim 21 is cancelled.
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 . 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.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 should recite “The method of claim 1…”.
Appropriate correction is required.
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 2, 14-15 and 18 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.
Claim 2 is indefinite because it’s claim dependency is unclear (it’s dependent on itself). For purposes of examination, claim 2 will be interpreted as being dependent on claim 1.
Regarding claim 14, it is dependent on claim 1 and refers to “the Worst Itch NRS4 score”. There is insufficient antecedent basis for this limitation in the claim as the Worst Itch Numerical Rating Scale was not previously mentioned. In order to overcome rejection, it should be referred to as “a Worst Itch NRS4 score”.
Regarding claim 15, it is dependent on claim 1 and refers to “the Work Productivity and Activity Impairment Questionnaire (WPAI-CHE) Scale”. There is insufficient antecedent basis for this limitation in the claim as the Work Productivity and Activity Impairment Questionnaire (WPAI-CHE) Scale was not previously mentioned. In order to overcome rejection, it should be referred to as “a Work Productivity and Activity Impairment Questionnaire (WPAI-CHE) Scale”.
Regarding claim 18, it is dependent on claim 1 and refers to “the improvement in response”. There is insufficient antecedent basis for this limitation in the claim as an improvement was not previously mentioned.
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.
Claims 1-2 and 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al (The Lancet, July 23, 2020, pp.255-266, 396 (10246); cited in the IDS filed 7/26/23) in view of Elsner et al (JEADV 2020, 34 (Suppl.1), 13-21; cited in the attached PTO-892).
Regarding claim 1, Simpson et al discuss an effective and well tolerated phase2b trial in which a Janus kinase 1 inhibitor, abrocitinib (N-((1S, 3S)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide), was administered to treat moderate to severe atopic dermatitis (Summary, Background, whole document). In the study, patients were randomly orally administered 100 mg abrocitinib, 200 mg abrocitinib or placebo once daily for 12 weeks (Summary, Methods). The results of the trial showed that adolescent and adult patients given 100 mg or 200 mg abrocitinib once daily for 12 weeks had significant improvement in the signs and symptoms of atopic dermatitis when compared with placebo (pg. 264, Discussion).
Although Simpson et al teach administering subjects a therapeutically effective amount of abrocitinib to treat atopic dermatitis; Simpson et al do not explicitly teach administering abrocitinib to treat moderate to severe chronic hand eczema in a subject in need thereof.
Elsner et al discuss a spectrum of therapeutic options for chronic hand eczema (abstract; whole document). Among those options, Elsner et al teach JAK inhibitors, including those that elicit signals from the IL-2 and IL-4 receptor families, are small molecules that can penetrate the epidermal barrier. Elsner et al conclude that such inhibitors could be potentially useful for treating hand eczema both systemically and topically (pg. 18; JAK inhibitors).
Therefore, it would have been obvious before the effective filing date of the claimed invention to administer Simpson’s abrocitinib to subjects with atopic dermatitis and more specifically those with severe chronic hand eczema as discussed in Elsner et al. One would have been motivated to do so since abrocitinib is a JAK-1 inhibitor and Elsner et al teach JAK inhibitors can be used to treat severe chronic hand eczema. A skilled artisan would also have a reasonable expectation of success to deliver Simpson’s abrocitinib to subjects with severe chronic hand eczema since chronic hand eczema is a more specific type of atopic dermatitis and hands are commonly affected in subjects suffering from atopic dermatitis.
Regarding claims 2 and 4-6; Simpson et al teach its patients were randomly orally administered 100 mg abrocitinib, 200 mg abrocitinib or placebo once daily for 12 weeks (Summary, Methods).
Regarding claims 7-8; Simpson et al in view of Elsner et al do not explicitly teach treatment periods of up to 16 weeks or up to 52 weeks. However, it would have been obvious to optimize the treatment period depending on the conditions of the study or the severity of the subject being treated. It is noted that the specification provides no criticality with respect to the claimed treatment period. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
Regarding claims 9-18 and the claimed results achieved with the IGA response score, TLSS score, Worst Itch NRS4 score, WPAI-CHE score, and improvement in response; the combined teachings of Simpson et al and Elsner et al suggest the active method step of claim 1 and thus, the claimed improvement and score results would naturally result from the teachings of Simpson et al and Elsner et al. Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. See In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977) and MPEP 2112. Further, it should be noted that Simpson et al teach its subjects received an IGA response score of ≥2 point reduction in score from baseline by week 12 (see Summary, Methods), which meets at least the limitations of claims 9 and 11.
Regarding claims 19-20, Elsner et al teach topical corticosteroids have been the mainstay of topical treatment of hand eczema that include clobetasol propionate foam and mometasone furoate cream (pg. 15, column 1). Therefore, it would have been obvious before the effective filing date of the claimed invention to co-administer topical corticosteroids in the form of creams in addition to abrocitinib within the teachings of Simpson et al modified by Elsener et al. One would have been motivated to do so Elsner et al teach topical corticosteroids delivered as ointments like JAK inhibitors can treat severe chronic hand eczema. It is obvious to add more than one active ingredient to achieve the same intended purpose. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al (The Lancet, July 23, 2020, pp.255-266, 396 (10246); cited in the IDS filed 7/26/23) in view of Elsner et al (JEADV 2020, 34 (Suppl.1), 13-21; cited in the attached PTO-892) as applied to claims 1-2, 4-6 and 9-20 above and in further view of Shanmugam et al (US 2020/0109453; cited in the attached PTO-892).
The teachings of Simpson et al and Elsner et al are discussed above and are incorporated herein.
Simpson et al in view of Elsner et al do not teach administering 50 mg of abrocitinib as recited in claim 3.
However, Shanmugam et al teach methods of treating moderate to severe hidradenitis suppurativa (HS) by orally administering pharmaceutical compositions comprising abrocitinib in amounts of 50 mg QD (paragraphs 0113, 0119).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to administer amounts of abrocitinib in therapeutically effective amounts of 50 mg. A skilled artisan would have been motivated to do so since Shanmugam et al teach such amounts can be safely administered to subjects with chronic inflammatory skin conditions. Further, applicant is reminded that dosage is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). It is noted that the specification provides no criticality with respect to the therapeutically effective amount of abrocitinib. An ordinary skilled artisan would manipulate the dosage depending on a patient’s weight, age, tolerance, sex, and condition being treated.
Conclusion
Claims 1-20 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL E BREDEFELD whose telephone number is (571)270-5237. The examiner can normally be reached 8:00-5:00 Monday-Friday.
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/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786