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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/14/2026 has been entered.
Claims 1-2, 13-17, 22-23 and 25-44 are pending and examined on the merits herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 13, 15-17, 26, 28-32, 35-37, and 40-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,551,585 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘585 claims a topical oil-in-water formulation comprising 1.5% ruxolitinib phosphate by weight of the formulation on a free base basis, water, oil component, solvent component, emulsifying/stabilizing component, and trolamine, wherein trolamine is present in an amount sufficient to adjust the pH of the formulation (claim 1). As such, ruxolitinib is the only active agent.
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
‘585 teaches its compositions for the treatment of prurigo nodularis, wherein the composition is applied twice a day (Col. 4, lines 13-28; Col. 32, lines 8-13; Col. 33, lines 33-49).
Regarding administration for at least 12 weeks in instant claims 14, 29, and 40, an ordinary skilled artisan would have been motivated to select at least 12 weeks, as the amount of time to administer the formulation of ‘585, to predictably arrive at a method of treating prurigo nodularis that is effective to treat symptoms until they are fully resolved; "[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." MPEP 2144.05(II)
Regarding claims 15-17, 28-30, 35, and 40 the wherein clauses express the desired result of the positive step of topically administering, to an affected skin area, 1.5% w/w ruxolitinib, twice a day, the method of instant claim 1. Since ‘585 teaches the claimed method, these limitations are met.
MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Claims 1-2, 13-17, 22-23, 27-31, 33, 35-36, 38, 40-41, and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-11, and 13-23 of copending Application No. 19/298,956 (claim set dated 08/13/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘956 claims a method of treating prurigo nodular in a subject by administering a therapeutically effective amount of ruxolitinib (claim 1).
‘956 claims ruxolitinib phosphate (claim 2).
‘956 claims topically administering the ruxolitinib to an effected skin area (claims 3-4).
‘956 claims 1.5% ruxolitinib on a free base basis (claims 5-7, 9-10).
‘956 claims administration twice per day (claim 11).
‘956 claims administration for at least 12 weeks (claim 13).
‘956 claims a cream formulation (claim 14).
‘956 claims the subject achieves an IGA score of 0 or 1 with greater than or equal to 2 grade improvement from baseline (claim 15).
‘956 claims the subject achieves an improvement in a subject’s response to Itch NRS from baseline (claim 16).
‘956 claims the subject achieves about a 5% to about a 95% improvement in response to Itch NRS, Prurigo Activity Score, Itchy Quality of Life, Dynamic Pruritus Score, and DLQI, from baseline (claim 17-21).
‘956 claims the subject has an itch Numerical Rating Scale of at least 4 at baseline (claim 22).
‘956 claims the subject is 18 or older (claim 23).
‘956 does not claim an active agent other than ruxolitinib.
Further regarding claims 15-17, 28-30, 35, and 40 the wherein clauses express the desired result of the positive step of topically administering, to an affected skin area, 1.5% w/w ruxolitinib, twice a day, the method of instant claim 1. Since ‘585 teaches the claimed method, these limitations are met.
MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Free of the Prior Art and Allowable Subject Matter
Claims 1-2, 13-17, 22-23, and 25-44 are free of the prior art.
Claims 25, 34, 39, and 44 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is Molloy (“Successful treatment of recalcitrant nodular prurigo with tofacitinib,” published 10/07/2023, PTO-892 of 02/13/2025) which teaches the treatment of nodular prurigo with tofacitinib administered orally (title), wherein tofacitinib is taught as a JAK inhibitor (pg. 919, Col. 1, 1st full paragraph).
The reference does not teach ruxolitinib, let alone 1.5% w/w ruxolitinib, for topical administration, or administration twice per day, which are distinct features of the instantly claimed method.
Moreover, 07/23/2025 Remarks, pgs. 11-12, shows in Table 1 (pg. 5029, Clark), the enzyme IC50 values for tofacitinib and ruxolitinib on JAK1, JAK2, JAK3, and TyK2. The table clearly shows that a) ruxolitinib is about twice as potent as tofacitinib for JAK1, b) ruxolitinib is about eight times more potent than tofacitinib for JAK2, c) tofacitinib is at least eight times more potent than tofacitinib than ruxolitinib for JAK3, and c) ruxolitinib is sixteen times more potent than tofacitinib for TYK2.
In summary, ruxolitinib is selective for JAK1, Jak2 and TYK2, while tofacitinib is selective for JAK2.
07/23/2025 Remarks, pg. 13, states that Clark on pg. 5031, Col. 2, further teaches “As indicated in Table 1, unlike tofacitinib, ruxolitinib and baricitinib exhibit specificity for JAK1 and JAK2 over JAK3 in kinase assays.”
As such, Clark clearly teaches that tofacitinib and ruxolitinib are not equivalent, and that tofacitinib is a JAK 1/3 inhibitor while ruxolitinib is a JAK 1/2 inhibitor. Thus, there would be no reasonable expectation of success that substituting tofacitinib, a JAK 1/3 inhibitor, with ruxolitinib, a JAK1/2 inhibitor, would treat prurigo nodularis (PN).
Additionally on pgs. 19-20 of the 07/23/2025 Remarks, Applicant points out that Molloy, the primary reference, teaches the treatment of a single patient with PN with tofacitinib. While the patient’s PN is treated, Molloy further reports, on pg. 919, that there is also a case report of treatment failure of PN with tofacitinib, and that it is unclear whether that was due to adverse events or inefficacy.
As such, since it is not predictable that tofacitinib will treat PN, it is further not predictable that ruxolitinib will treat PN; there is no reasonable expectation of success.
Conclusion
Claims 1-2, 13-17, 22-23, 26-33, 35-39, and 40-42 are rejection.
Claims 25, 34, 29, and 44 are objected to.
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/LAUREN WELLS/Examiner, Art Unit 1622