DETAILED ACTION
Claims 1-20 are pending in the present application file.
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 .
Priority
The claim to priority as a 371 filing of PCT/US2023/021067 filed on May 4, 2023, which claims benefit of 63/338,320 filed on May 4, 2022 is granted in the present application file.
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 3 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.
Regarding claims 3 and 18, the phrases "such as," “for example,” and “e.g.” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Caocci et al. (Leukemia, 2014, 225-227) in view of Cassella et al. (American Academy of Dermatology Annual Meeting, 2020, 16 pages).
Caocci et al. teaches the administration of ruxolitinib to a patient to treat myelofibrosis. Ruxolitinib corresponds to compound (I) where all deuterium atoms are replaced by hydrogen atoms. The administration started at 20 mg/b.i.d. until HBV-DNA titers increased six months later. The administration of ruxolitinib was then reduced to 15 mg/b.i.d.and HBV-DNA titers became undetectable. The dosage of ruxolitinib was subsequently raised back to 20 mg/b.i.d. for two months before permanent reduction to 15 mg/b.i.d. as a maintenance dose.
Caocci et al. does not teach where rexolitinib is replaced by Compound (I) or the specific dosages listed in claims 1 and 4-9.
Cassella et al. teaches the oral administration of Compound (I) to treat alopecia, which is also a condition related to inhibiting JAK1/2. The dosage administered is either 4, 8, or 12 mg/BID for a total daily dosage of 8, 16, or 24 mg. See pages 4-16. The 8 and 12 mg BID doses were chosen for Phase 3 clinical trials. See page 16.
The person of ordinary skill in the art would be motivated to combine the teachings of Caocci et al. and Cassella et al. in order to arrive at the presently claimed invention as Caocci et al. teaches that administration of the non-deuterated rexolitinib reactivates cells that harbor HBV, and that reduction of the dosage of recolitinib allow for the treatment to continue and HBV-DNA titers to become undetectable. As Cassella et al. teach a deuterated analog of the same structure of Caocci et al., the compounds would be known to the person or ordinary skill in the art as capable of treating the same conditions and having similar function when administered. Therefore, there is a likelihood of success that a reduction in dosage after an initial dosage would be also beneficial using the deuterated analog of Cassella et al. in order to prevent reactivation of a dormant HBV infection.
With respect to claims 1-4 and 16-20, Cassella et al. teaches an administration of 24 weeks and Caocci et al. teach administration for 6 months, which is about 26 weeks. Cassella et al. teaches administration of Compound (I) at a daily dose of 8, 16, and 24 mg. Additionally, Caocci et al. teaches a reduction from 20 to 15 mg/b.i.d., with the dosage in the second period being 75% of the initial dosage to treat myelofibrosis.
With respect to claims 5-15, both Caocci et al. and Cassella et al. teach dosages of either Compound (I) or the non-deuterated rexolitinib with targeted daily dosages. Additionally, Caocci et al. teach a dose reduction after 6 months, and then a permanent reduction after another period of 2 months or about 8 weeks. To arrive at whether to administer once or twice a day and the specific dosages/dose reduction listed in the claims would be within the realm of routine optimization for the person of ordinary skill in the art to administer the compound. "[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) There is currently no evidence of record of secondary considerations, and Caocci et al. teach a benefit to reducing the dosage after a period of time in order to manage latent HBV infections.
Therefore, the claims are 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 1-15 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/033,730 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
The ‘730 application is drawn to methods of using the same compounds with the same oral dosages and dose reductions to treat the hair loss disorder alopecia areata. Therefore, the ‘730 application anticipates present claims 1-15 and 19-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10-15, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13, 14, and 21 of U.S. Patent No. 10,561,659 in view of Caocci et al. (Leukemia, 2014, 225-227).
The ‘659 patent teaches methods of treating alopecia using compound (I) in an amount of either 16 or 24 mg/day including twice daily administration. While the ‘659 patent does not reference a dose reduction, Caocci et al. teaches a dose reduction for the treatment of another JAK related condition in order to prevent the reactivation of a dormant HBV infection as described above.
To arrive at whether to administer once or twice a day and the specific dosages/dose reduction listed in the claims would be within the realm of routine optimization for the person of ordinary skill in the art to administer the compound. "[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) There is currently no evidence of record of secondary considerations, and Caocci et al. teach a benefit to reducing the dosage after a period of time in order to manage latent HBV infections.
Claims 1-8, 10-15, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,364,699 in view of Caocci et al. (Leukemia, 2014, 225-227).
The ‘699 patent teaches methods of treating alopecia using compound (I) in an amount of either 16 or 24 mg/day including twice daily administration. While the ‘699 patent does not reference a dose reduction, Caocci et al. teaches a dose reduction for the treatment of another JAK related condition in order to prevent the reactivation of a dormant HBV infection as described above.
To arrive at whether to administer once or twice a day and the specific dosages/dose reduction listed in the claims would be within the realm of routine optimization for the person of ordinary skill in the art to administer the compound. "[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) There is currently no evidence of record of secondary considerations, and Caocci et al. teach a benefit to reducing the dosage after a period of time in order to manage latent HBV infections.
Claims 1-15 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51-52 of copending Application No. 18/755,253 in view of Caocci et al. (Leukemia, 2014, 225-227).
The ‘253 application teaches methods of treating alopecia using compound (I) in an amount of 8-32 mg/day. While the ‘253 application does not reference a dose reduction, Caocci et al. teaches a dose reduction for the treatment of another JAK related condition in order to prevent the reactivation of a dormant HBV infection as described above.
To arrive at whether to administer once or twice a day and the specific dosages/dose reduction listed in the claims would be within the realm of routine optimization for the person of ordinary skill in the art to administer the compound. "[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) There is currently no evidence of record of secondary considerations, and Caocci et al. teach a benefit to reducing the dosage after a period of time in order to manage latent HBV infections.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-20 are rejected.
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/JOSEPH R KOSACK/ Primary Examiner, Art Unit 3991
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