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 .
Priority
This application, filed 6 June, 2023, is a national stage application of PCT/JP2021/045287, filed 9 December, 2021, which claims foreign priority benefit of Application JP2020-210030, filed 18 December, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 January, 2025, is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 28 January, 2025, in the matter of Application N° 18/256,153. Said documents have been entered on the record.
Claims 1, 11, and 14 are amended. Claims 2-10 are canceled. No new matter is introduced.
Thus, Claims 1 and 11-14 represent all claims currently under consideration.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Response to Amendment
Claims 2-10 have been canceled. Therefore, the rejections of these claims under 35 U.S.C. 112(a)/(b), 102(a)(1), 103, and Double Patenting are moot.
Applicant’s amendment is sufficient to overcome the rejections of Claims 1 and 11-14 under 35 USC 112(a)/(b), 102(a)(1), 103, and Double Patenting.
Below can be found new grounds of rejection necessitated by 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.
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 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamatsu et al. (US 2013/0274472 A1, cited in the IDS), hereinafter Nakamatsu.
Nakamatsu teaches a preparation containing the sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide, referred to as “compound A”, having superior solubility (title & abstract; para [0001]). Nakamatsu further teaches superior lyophilized preparation can be produced by adding additives to an aqueous solution of the sodium salt of compound A to be subjected to lyophilization (para [0018]), additives such as a pH regulator, buffer, and a stabilizer (para [0098]), stabilizers such as L-aspartic acid (para [0102]). Nakamatsu further teaches the solubility of the sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide can be further improved in a lyophilized preparation with the addition of a base additive (para [0096]); bases such as monoethanolamine, diethanolamine, and triethanolamine are taught as suitable pH regulators (para [0098], [0100]).
Nakamatsu teaches the composition also as an injectable preparation comprising compound A in an amount from 10-6000 mg; the content of additive to improve solubility ranges from 0.1-100% (w/w) relative to the content of compound A (para [0107-0108]). Nakamatsu further teaches an aqueous solution comprising compound A and an additive (para [0117], [0206]). Nakamatsu teaches an example wherein water is added to the preparation to obtain a volume of 10 mL for injection (para [0206]). Nakamatsu further teaches the pH of the aqueous solution of Compound A and base is satisfactorily 4.0 to 10, preferably 6.5 to 8.5, and more preferably 6.5 to 7.5 (para [0097]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have arrived at the pharmaceutical composition of the claims comprising the sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide and at least one compound selected from diisopropanolamine, N-ethyldiethanolamine, bicine, tricine, serine, and aspartic acid, wherein the composition is an aqueous solution or a lyophilized preparation in consideration of Nakamatsu. Nakamatsu teaches a lyophilized composition comprising the sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide and an additive for further improving the solubility of the compound, with organic amine bases and aspartic acid included as suitable additives. As such, one of ordinary skill in the art would have been motivated to have incorporated aspartic acid into a pharmaceutical composition comprising the sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide, in order to further improve solubility. As Nakamatsu teaches the preparation to comprise from 10-6000 mg of the sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide, and Nakamatsu provides an exemplary volume of the injectable composition of 10 mL, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated the sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide in the composition in a concentration from 10-6000 mg/10 mL, which corresponds to a range from 1 mg/mL to 600 mg/mL, which includes the concentration range of 100 mg/mL or higher as referenced in the instant Specification (Pg. 15, Line 8). Wherein the composition comprises 0.05-5 equivalents of the additive Component (2) to 6-fluoro-3-hydroxy-2-pyrazine carboxamide or a salt thereof, Nakamatsu teaches the content of additive, (e.g., bases, buffers, stabilizers, etc.) to improve solubility ranges from 0.1-100% (w/w) relative to the content of compound A. One of ordinary skill in the art would have arrived at the amount of 0.05 or more equivalents of aspartic acid to the sodium salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide based on this guidance from Nakamatsu, in the absence of evidence indicating the criticality of the range recited by instant claim 3. See MPEP 2144.05 (II): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
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 11-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 3-4, and 6 of copending Application No. 18/256,603 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical composition comprising 6-fluoro-3-hydroxy-2-pyrazine carboxamide or a salt thereof; and an amine that can be selected from diisopropanolamine and N-ethyldiethanolamine (see copending Claims 1 and 3). Additionally, both sets of claims recite the composition in lyophilized form (copending claim 6 & instant claim 14), or as an aqueous solution (copending claim 4 & instant claim 11). Additionally, the amount of amine to 6-fluoro-3-hydroxy-2-pyrazine carboxamide or a salt thereof overlaps (0.2 equivalents or more as recited by copending claim 3; 0.05 to 5 equivalents as recited by copending claim 1). Therefore, the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627