DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/20/206 has been entered.
Applicant’s arguments filed 5/20/2026 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 .
Claim Rejections Maintained - 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 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. The claims are further drawn to wherein the patients have a WI-NRS score of >7 prior to treatment and achieves an improvement in WI-NRS score of >4 points at week 12 or 24 of the treatment.
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 at 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 “intensely pruritic papules” 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 administering the same dose and treatment schedule of dupilumab specifically to a patient having prurigo nodularis with greater than 20 nodules (based on patient images). 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 5/20/2026 have been fully considered but not found to be persuasive. Applicant’s argue Tanis “teaches away” from the q2w dosing schedule of the subject claims and is in favor of a more frequent dosing regimen. However applicants do acknowledge therapeutic results of the adjusted dosing are not known based on Tanis disclosure that the patients insurance denied the increase to weekly dosing. However, Tanis et al. does state the patient reported that her pruritic had significantly improved by >50% and she noticed she wasn’t scratching constantly. Applicant’s argue surprising and unexpected therapeutic endpoints of the present claims in the patient population having prurigo nodularis. Applicant’s claimed method steps are the same exact method steps taught by Tanis et al. and therefore would be expected to have the same therapeutic endpoints. It is unclear why performing the same exact method, with the same antibody dupilumab, at the same dose and interval would have resulted in a different outcome in the patient taught by Tanis et al. If applicants are arguing the treatment method taught by Tanis et al., which appears to be the same exact method instantly claimed, is not effective, applicants are essentially arguing the claimed method is not enabled. Applicants have not provided any evidence in regards to the outcome of the patient taught by Tanis et al. at 12 or 24 weeks and why it would be different than that of the instantly claimed method. The burden is on the applicant to prove that the patient taught by Tanis et al. receiving the same treatment protocol as instantly claimed would not achieve the same results at 12 or 24 weeks (see In re Best 526F.2d 1252, 195 USPQ 430 (CCPA 1977)), which applicants have failed to provide. Therefore, the rejection of record is hereby maintained.
All other previous rejections have been withdrawn in view of applicants arguments in the
response filed 5/20/2026.
Conclusion
Claims 21-23, 25, 27, 29-31, 40, 48, 51-52, 55-66 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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