DETAILED ACTION
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 .
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-18 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howell et al (WO 2020/191041; published 9/24/2020).
Scope of prior art
Howell teaches identifying subjects with vitiligo who will be responsive to treatment with JAK inhibitor (Page 26). Howell also teaches treating the identified subject with a JAK inhibitor (page 46, last paragraph). As JAK inhibitor, Howell teaches JAK1 selective inhibitor (page 37 last paragraph) and the specific inhibitor of claim 3 including phosphoric acid salt thereof (page 39, compound 4; page 45, lines 3-8). With regards to coadministration of steroid, Howell teaches corticosteroids (p47, lines16-19). On page 28, line 10, art teaches treatment of non-segmental vitiligo. Regarding effective dose Howell teaches that an effective amount of the JAK inhibitor can suitably determined by a healthcare practitioner considering patient characteristics, progression of the disease and prior exposure to the drug (page 46, lines 30-34).
Ascertaining the difference
Howell teaches treating subjects with vitiligo by administering JAK1 selective inhibitor but does not teach the specifically claimed effective dose. Howell also does not reduce the invention to actual practice, where a subject is treated with a JAK1 selective inhibitor.
Obviousness
A person of ordinary skill in the art, prior to the earliest effective filing date of the current application, would have found it obvious to identify subjects with vitiligo who will be responsive to treatment with selective JAK1 inhibitor and to treat said subject by administering and effective amount of a selective JAK1 inhibitor. It would have been obvious to administer the currently claimed compound of claim 3 or its phosphoric acid salt because Howell identifies this species as a selective JAK1 inhibitor suitable for treatment of vitiligo.
Regarding the claimed daily dose, Howell teaches that suitable effective dose can be determined by a healthcare professional based on subject characteristics. In view of this teaching, it would have been obvious to determine effective dose for each individual subject.
Howell provides teaching, suggestion and motivation for practicing the currently claimed method. Howell also establishes an expectation of success because he teaches how to select subjects who will be responsive to treatment.
Regarding administration of an additional JAK inhibitor. Howell identifies ruxolitinib as a JAK inhibitor that can be used in treatment of vitiligo. It would have been obvious to administer compound 4 (page 39) in combination with ruxolitinib because both agents are indicated for treatment of vitiligo. A skilled artisan would expect an additive effect from coadministration of the two agents.
Regarding claims 20-21 directed to oral and topical administration of the steroid. Howell teaches administration of corticosteroid but does not recite the route of administration. A skilled artisan would have found it obvious to administer the costicosteroid by either oral or topic route as there are a limited number of administration routes.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howell et al (WO 2020/191041) as applied to claim 1 above, and further in view of Kumari et al (Arch Dermatol, 1984, 120, p631-635).
Ascertaining the difference
Howell teaches treatment vitiligo by administration of a JAK1 selective inhibitor and another agent but does not teach clobetasol propionate.
Secondary reference
Kumari teaches treatment of vitiligo by administration of topical clobetasol propionate.
Obviousness
A person of ordinary skill in the art would have found it obvious to administer selective JAK1 inhibitor in combination with clobetasol propionate to a subject in need of treatment of vitiligo. Both agents are described in the art as having therapeutic utility in treatment of vitiligo. It would have been obvious to combine the two in a method of treatment with an expectation that the combination will be more effective than each agent as monotherapy.
2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME 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 reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Claim(s) 1, 5-8, 13, 14, 15, 16, 17, 18, 19, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tasset et al (WO 2018/087202).
Scope of prior art
Tasset teaches a method of treating vitiligo comprising administration of a JAK1 inhibitor (paragraphs [0167] – [0169], [0192]-[0193]. Tasset teaches combination of the JAK1 inhibitor and another therapeutic agent for treatment of vitiligo wherein the second agent is a corticosteroid such as desoximetasone (paragraph [0226]-[0229]). In paragraph [0286] art teaches administration of JAK1 inhibitor in combination with another agent that has the same activity. With regards to the amount of compound I administered Tasset teaches administration of an effective amount which can be determined by a physician based on patient’s age, weight, response of the individual patient and severity of symptoms (paragraph [0201]). Lastly, Tasset teaches transdermal and oral delivery methods for the composition (paragraph [0202]).
Ascertaining the difference
Tasset does not disclose the currently claimed doses.
Obviousness
A person of ordinary skill in the art would have found it obvious to follow the teachings of Tasset and treat a vitiligo in a subject in need by administering to said subject an effective amount of JAK 1 inhibitor that is compound I in combination with desoximetasone. Tasset teaches JAK1 inhibitor (compound 1) for treatment of vitiligo and also teaches coadministration with a corticosteroid such as desoximetasone. Since Tasset teaches that a physician can determine the effective dose of the compound to administer, it would have been obvious to determine the optimal dose for an individual subject based on the characteristics set forth in paragraph [0201].
Claim(s) 1, 3-9, 11-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tasset et al (WO 2018/087202) as applied to claims 1, 5-8, 13, 14, 15, 16, 17, 18, 19, 20 and 21 above, and further in view of Li et al (US 20140343030).
Ascertaining the difference
Tasset teaches treatment of vitiligo by administration of a JAK1 inhibitor in combination with desoximetasone but does not teach the specific JAK1 inhibitor of claims 3, 4 and 12. Tasset also does not teach administration of two JAK inhibitors, which is the subject matter of claims 8 and 9.
Secondary reference
Li teaches JAK1 inhibitors that are useful in treatment of inflammatory and autoimmune disorders (vitiligo is an autoimmune disorder) ((abstract, [0017]-[0018]). The currently claimed JAK inhibitor is taught in example 7, paragraph [0461]; and its activity as a selective JAK1 inhibitor is in is taught in paragraph [0493]. Li teaches both, free base and phosphoric acid salt (Paragraphs [0485]-[0487]). In table 11, on page 38, Li indicates that both, the free base and the phosphoric acid salt of the compound have similar activity (examples 7 and 17). In paragraph [0377] Li teaches unit doses comprising 1 to 100mg of JAK1 inhibitor.
Obviousness
A skilled artisan, prior to the earliest effective filing date of the current application would have found it obvious to try to substitute the compound of Example 7 of Li, as free base or as phosphoric acid salt, instead of compound I of Tasset in a method of treating vitiligo. Tasset provides a teaching that JAK1 inhibitors can be used in treatment of vitiligo. Li is analogous art because he teaches JAK1 inhibitors can be used in treatment of autoimmune disorders and vitiligo is an autoimmune disorder. Li further teaches the currently claimed compound (claims 3, 4 and 12) as a selective JAK1 inhibitor. A skilled artisan would expect that both, compound I of Tesset and the compound of Example 7 (free base and salt) would be effective in treating vitiligo. The compounds share activity as JAK1 inhibitors. Li teaches effective unit dose from 1 to 100mg. A skilled artisan would have found it obvious determine the optimal dose for a given patient.
Regarding claims 8 and 9. It would have been obvious to administer more than one JAK1 inhibitor to a subject with vitiligo. Tesset teaches that JAK1 inhibitors can be used in treatment of vitiligo. Since both, the compound of Tesset and the compound of Li are JAK1 inhibitors, a skilled artisan would expect that an additive effect can be obtained by combining the two in a single method of treatment.
Claim(s) 1 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tasset et al (WO 2018/087202) as applied to claim 1 above, and further in view of Desai et al (Practical Dermatology, 2020, July, 30-31).
Ascertaining the difference
Tasset teaches treatment of vitiligo by administration of a JAK1 inhibitor and desoximetasone but does not teach co administration with ruxolitinib.
Secondary reference
Dasai teaches Ruxolitinib as a therapeutic agent for treatment of vitiligo (pages 30-31).
Obviousness
A skilled artisan would have found it obvious to combine JAK1 inhibitor desoximetasone and ruxolitinib as a multi drug therapy for treatment of vitiligo. All three are described in the art as being useful for the same purpose.
2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME 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 reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
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 and 3-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,957,661 in view of Tasset et al (WO 2018/087202).
Claims of the ‘661 patent teach all of the limitations of the current claims except for coadministration of the JAK1 inhibitor with a corticosteroid desoximetasone in a method of treating vitiligo. Tasset teaches that treatment of vitiligo can be carried out by administration of a JAK1 inhibitor and desoximetasone (paragraph [0228]). A skilled artisan would have found it obvious to practice the method of the ‘661 patent and to co-administer desoximetasone as suggested by Tasset. Noth Tasset and ‘661 are directed to treatment of vitiligo by administration of a JAK1 inhibitor.
Conclusion
Claims 1 and 3-21 are pending
Claims 1 and 3-21 are rejected
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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