DETAILED ACTION
Applicant’s claim amendments filed 12/19/2025 are acknowledged and entered into the record.
Accordingly, Claims 21-23, 25, 27, 29-31, 40, 48, 51-52, 55-66 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
New Grounds of Rejection
(based on amendments)
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.
Claims 21-23, 25, 27, 29-31, 40, 48, 51-52, 55-66 are rejected under 35 U.S.C. 103 as being obvious over Molony et al. (WO/2021/119028 cited on IDS filed 8/15/2024).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The claims are drawn to a method of treating a subject having prurigo nodularis comprising administering subcutaneously to the subject an initial dose of about 600mg and a secondary dose of about 300mg every other week of the anti-IL-4R antibody dupilumab comprising CDRs having SEQ ID NOs: 3-8 and a VH having SEQ ID NO: 1 and VL having SEQ ID NO: 2.
Molony et al. teach methods of treating a subject having prurigo nodularis (PN) which include administering an anti-IL-4R antibody (e.g, an anti-IL-4Ra antibody, e.g, dupilumab). Molony et al. disclose a patient population with severe AD that is resistant to treatment or is inadequately controlled by systemic therapy. Molony et al. disclose the anti-IL-4R antibody having 100% identity to instantly claimed SEQ ID NOs: 1-8. Molony et al. disclose administration is one initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week. Molony et al. disclose administration is subcutaneous and via a pre-filled syringe, a pre-filled pen or an autoinjector. Molony et al. teach the active method steps of administering dupilumab to a patient suffering from prurigo nodularis and the claimed doses.
Although Molony et al. does not explicitly teach patients have WI-NRS itch scores or a certain number of nodules, Molony et al. teach patient populations having atopic dermatitis with intense pruritus (severe itch) and disclose people with PN have a history of other diseases including eczema (atopic dermatitis). One of ordinary skill in the art before the effective filing date of the instant application would have a reasonable expectation of success to treat a patient population having prurigo nodularis with 20-100 nodules and WI-NRS score >7 based on Molony et al. teaching methods of treating a wide range of skin-related disorders which have not adequately been controlled with topical prescription therapies by administering dupilumab. Molony et al. teach the active method steps of subcutaneously administering to the subject an initial dose of about 600 mg of dupilumab and one or more secondary doses of about 300 mg every other week and therefore would be expected to achieve the results instantly claimed in the patient population instantly claimed.
Claim(s) 21-23, 25, 27, 29-31, 40, 48, 51-52, 55-66 are rejected under 35 U.S.C. 103 as being unpatentable over Tanis et al. (cited on IDS filed 8/15/2024).
The claims are drawn to a method of treating a subject having prurigo nodularis comprising administering subcutaneously to the subject an initial dose of about 600mg and a secondary dose of about 300mg every other week of the anti-IL-4R antibody dupilumab comprising CDRs having SEQ ID NOs: 3-8 and a VH having SEQ ID NO: 1 and VL having SEQ ID NO: 2.
Tanis et al. teach treatment of prurigo nodularis (PN) with dupilumab. Tanis et al. disclose “treatment of PN with dupilumab significantly decreased pruritic and the size and number of new lesions after 2 months of treatment”. Tanis et al. teach dupilumab was administered at 600mg subcutaneously followed by 300mg every 2 weeks thereafter (see p.941 top left column) to a patient who failed many therapies for PN (see introduction). Tanis et al. disclose “Treatment of recalcitrant prurigo nodularis with dupilumab reduces the severity of the pruritic symptoms and the quality and number of papulonodules. Dupilumab should be considered as a viable treatment option in prurigo nodularis when standard therapy regimens have failed after and adequate trial” (last paragraph p.941). Although, Tanis et al. does not teach the CDR sequences or VH/VL sequences, the instant specification indicates the antibody comprising SEQ ID NO: 1 and SEQ ID NO: 2 (including CDRs SEQ ID NOs: 3-8) is dupilumab (see paragraph [0034] of instant specification). Tanis et al. teach the active method step of administering dupilumab to a patient suffering from prurigo nodularis and the claimed doses.
Although Tanis et al. does not explicitly teach patients having WI-NRS itch scores >7 or a certain number of nodules, it is evident from Fig 2 more than 20 nodules are present and the patient’s complaint of severe pruritic would meet these limitations. Therefore, one of ordinary skill in the art before the effective filing date of the instant application would have a reasonable expectation of success to treat a patient population having prurigo nodularis with 20-100 nodules and WI-NRS score >7 based on Tanis et al. teaching treatment in a single patient. Tanis et al. teach the active method steps of subcutaneously administering to the subject an initial dose of about 600 mg of dupilumab and one or more secondary doses of about 300 mg every other week and therefore would be expected to achieve the results instantly claimed in the patient population instantly claimed. Although Tanis et al. discloses the patient indicated the pruritic increased in intensity near the end of the biweekly dosing schedules, which prompted an increase in the dosing to weekly. In regards to the specific dosage and interval amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the prior art and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (ie dosage and intervals) optimization is obvious. Therefore, although Tanis et al. changes the dosage intervals and amounts the method initially met the limitations of the instant claims.
Response to Arguments
Applicant's arguments filed 12/19/2025 have been fully considered and new 103(a) rejections have been set forth above.
All other previous rejections have been withdrawn in view of applicants
amendments/arguments in the response filed 12/19/2025.
Conclusion
Claims 21-23, 25, 27, 29-31, 40, 48, 51-52, 55-66 are rejected.
No Claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/Meera Natarajan/Primary Examiner, Art Unit 1643