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
The following continuity data is acknowledged in the present application file:
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Claims 3, 5, 11, 14, 17, 20, 22, and 28-29 have been canceled. Claims 1-2, 4, 6-10, 12-13, 15-16, 18-19, 21, and 23-27 are pending and before the Examiner.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22 May 2026 has been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-2, 4, 6-10, 12-13, 15-16, 18-19, 21, and 23-27 are rejected under 35 U.S.C. 103 as being obvious over US Patent No. 12,102,618 (Coric et al., Filing Date: 12 November 2017).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 1 and 26, Coric teaches a method for treating ataxia in a patient in need thereof a riluzole prodrug such as troriluzole (abstract). It discloses that in one aspect, the ataxia is spinocerebellar ataxia genotype type 3 (SCA3) [col. 3, line 55-55], comprising administering to the patient a dosage of the riluzole prodrug [col. 4, line 38-39]. However, Coric does not teach troriluzole as troriluzole hydrochloride monohydrate, but it discloses that certain preferred riluzole prodrugs have structures that include enantiomers, diasteroemers, hydrates, solvates [col. 7, line 23-39], and pharmaceutically acceptable salts derived from pharmaceutically acceptable inorganic or organic bases and acids [col. 6, line 24-26, page 4]. Therefore, the formation of the instantly claimed compound is prima facie obvious use of a known technique to improve similar products in the same way (See MPEP § 2143 I (C)); the claimed compound is known in the art as the formation of salts, hydrates, and solvates are commonly employed in the pharmaceutical arts to yield predictable results, such as improving the dissolution and bioavailability of the compound [col. 6, line 20-24]. The artisan would be motivated to select this compound and have a reasonable expectation of success. Furthermore, the "mere selection of a particular salt from among a finite number of predictable options is generally considered obvious" (See MPEP § 2143 I (E)). One of ordinary skill in the art would have been able to narrow the group of potential salt-formers to arrive at the claimed invention with reasonable expectation of success.
Regarding claims 4 and 6, Coric teaches that the dosage form of the riluzole prodrug is administered to the patient in the form of a capsule or tablet [col. 4, line 56-59 and col. 10, line 1-2,] or in the form of an orally disintegrating tablet [col. 10, line 3-8].
Regarding claims 2, 7-10, 12-13, 15-16, 18-19, 21, and 23-24, Coric teaches that the dosage form of the riluzole prodrug is administered to the patient at a dosage of 200 mg, once per day [col. 4, line 43-45], 100 mg, twice per day [col 4, line 45-46], or for a duration of about 8 to 48 weeks [col. 4, line 60-61]. Coric does not explicitly teach wherein the patient at week 4 showed a least squares [LS] mean change difference of at least -0.46 compared to placebo, or wherein the patient at week 8 showed a least squares [LS] mean change difference of at least -0.12 compared to placebo or wherein the patient at week 12 showed a least squares [LS] mean change difference of at least -0.46 compared to placebo, or wherein the patient at week 24 showed a least squares [LS] mean change difference of at least -0.17 compared to placebo, or wherein the patient at week 36 showed a least squares [LS] mean change difference of at least -0.72 compared to placebo, or wherein the patient at week 48 showed a least squares [LS] mean change difference of -0.55 compared to placebo (nominal p-value = 0.053, 95% Cl: -1.12, 0.01). However, it would have been obvious to one of ordinary skill in the art to optimize the therapeutic metrics of Coric by routine experimentation to have reasonable expectation of success compared to the placebo.
Regarding claim 25, Coric teaches the dosage form administered for 48 weeks but it does not explicitly teach wherein the dosage form is administered daily for an additional 48 weeks. However, it would have been obvious to one of ordinary skill in the art to repeat the dosing duration by routine experimentation to optimize the therapeutic effects of the compound.
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, 4, 6-10, 12-13, 15-16, 18-19, 21, and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 26-32, and 34 of copending Application No. 16762165 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference teaches a method for treating spinocerebellar ataxia genotype type 3 (SCA3) using a riluzole prodrug, troriluzole, but it does not teach troriluzole hydrochloride monohydrate as claimed. However, the scope of the reference encompasses the instant claims as it would have been prima facie obvious for one of ordinary skill in the art to convert the riluzole compound of the reference into troriluzole hydrochloride monohydrate because doing so will optimize the priorities, dissolution and bioavailability of the compound (See 103 rejection statement above).
The artisan would be motivated to make and use the claimed compound and have a reasonable expectation of success as the mere selection of a particular salt from among a finite number of predictable options is generally considered obvious and one of ordinary skill in the art would have been able to narrow the group of potential salt-formers to arrive at the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4, 6-10, 12-13, 15-16, 18-19, 21, and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-13 of U.S. Patent No. 12102618. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference teaches a method for treating spinocerebellar ataxia genotype type 3 (SCA3) using a riluzole prodrug, troriluzole, but it does not teach troriluzole hydrochloride monohydrate as claimed. However, the scope of the reference encompasses the instant claims as it would have been prima facie obvious for one of ordinary skill in the art to convert the compound of the reference into a pharmaceutically acceptable salt and hydrate form as described above.
Claims 1 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12005047. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference teaches a method for treating hereditary spinocerebellar ataxia using a riluzole prodrug, but it does not teach troriluzole hydrochloride monohydrate as claimed. However, the scope of the reference encompasses the instant claims as it would have been prima facie obvious for one of ordinary skill in the art to convert the compound of the reference into a pharmaceutically acceptable salt and hydrate form as described above to treat different subtypes of hereditary spinocerebellar ataxia, such as SCA3.
Conclusion
Claims 1-2, 4, 6-10, 12-13, 15-16, 18-19, 21, and 23-27 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARINE P SEUDIEU SEUDIEU whose telephone number is (571)272-0459. The examiner can normally be reached Mon-Fri 8 AM - 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.S./Examiner, Art Unit 1626
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
