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 .
Status of Claims
Claims 1-19 are pending in the application. Claims 1-19 are examined herein.
Priority
This application claims priority to PRO 63/409,255 filed 09/23/2022.
Applicant’s claim for the benefit of a prior filed application under 35 U.S.C. 119(e) or under or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or earlier-filed nonprovisional application or provisional application for which benefit is claimed). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/409,255 fails to provide adequate support and enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘255 application does not disclose a citrate salt of viloxazine. Accordingly, claims 7-16 have an effective filing date of 09/21/2023, the filing date of the instant application, while claims 1-6 and 17-19 get the priority benefit of the ‘255 provisional application and have an effective filing date of 09/23/2022.
Information Disclosure Statement
The information disclosure statement filed on 12/11/2023 has been considered. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Howe et al. (GB 1427097, publication date 03 March 1976, hereinafter Howe, in the IDS).
Regarding instant claim 7, Howe teaches optically active morpholine derivatives of formula I (Title; Pg. 1, Lns. 57-77).
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Howe teaches an exemplary morpholine derivative, (2S)-2-(o-ethoxyphenoxymethyl)morpholine (Pg. 2, Lns. 46-50). This compound of Howe corresponds to viloxazine as evidenced by Para. [0003] of the instant specification. Howe teaches suitable acid addition salts of the morpholine derivatives to include a citrate salt (Pg. 2, Lns. 51-59). Howe anticipates claim 7 with respect to the citrate salt of viloxazine.
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.
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.
Claims 1-2, 7-8, 11, 14 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Howe et al. (GB 1427097, publication date 03 March 1976, hereinafter Howe, in the IDS) in view of Bastin et al. (Salt Selection and Optimisation Procedures for Pharmaceutical New Chemical Entities, 07/19/2000, hereinafter Bastin).
The teachings of Howe are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claim 7 (with respect to the tartrate salt), Howe teaches the acid addition salt can be a tartrate. Howe do not teach the DL-tartrate.
Bastin teaches selection of an appropriate salt form for a new chemical entity provides the pharmaceutical chemist and formulation scientist with the opportunity to modify the characteristics of the potential drug substance and to permit the development of dosage forms with good bioavailability, stability, manufacturability, and patient compliance (Abstract). Bastin teaches the salt form selected will influence a range of properties such as melting point, hygroscopicity, chemical stability, dissolution rate, solution pH, crystal form, and mechanical properties (Abstract). Bastin teaches key tests to be considered to involve measurement of optical properties (Table 3; Table 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Howe and Bastin to have prepared a DL-tartrate salt of viloxazine to arrive at the salt of instant invention, with a reasonable expectation of success. The motivation being to circumvent the disadvantages of other salt forms and provide robust candidates for further pharmacological and/or commercial development (Bastin, Abstract; Pg. 428, second column, third full paragraph).
Regarding instant claim 8, Howe renders the tartrate salt of instant claim 7 prima facie obvious. Howe teaches preparation of various salt forms of viloxazine using a given ratio of the racemic viloxazine vs organic acid (Pg. 5, Lns. 48-61).
According to MPEP 2144.05(II)(A), "[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). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratios of viloxazine to DL-tartaric acid, absent any criticality of these ratios.
Further, regarding the naphthalene-2-sulfonate salt of viloxazine of instant claims 7 and 11, Howe teaches salts of viloxazine. Bastin teaches common pharmaceutical salts belonging to the sulfonic acid class to include napsylate or naphthalene sulfonate (Table 1). Therefore, given the teachings of Howe and Bastin, one of ordinary skill in the art would have been motivated to prepare the naphthalene-2-sulfonate salt of viloxazine to provide additional candidates for further pharmacological and/or commercial development (Bastin, Abstract). Additionally, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratios of viloxazine to naphthalene-2-sulfonic acid, absent any criticality of these ratios. See MPEP 2144.05(II)(A) cited above.
Similarly, regarding the viloxazine to citric acid ratio as in instant claim 14, given the teachings of Howe and Bastin, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratios of viloxazine and citric acid, absent any criticality of these ratios. See MPEP 2144.05(II)(A) cited above.
Further, regarding the fumarate salt of viloxazine of instant claims 1-2, Howe teaches salts of viloxazine. Bastin teaches common pharmaceutical salts belonging to the carboxylic acid class to include fumarate (Table 1). Therefore, given the teachings of Howe and Bastin, one of ordinary skill in the art would have been motivated to prepare the fumarate salt of viloxazine to provide additional candidates for further pharmacological and/or commercial development (Bastin, Abstract). Additionally, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratios of viloxazine to fumaric acid, absent any criticality of these ratios. See MPEP 2144.05(II)(A) cited above.
Regarding claims 17-18, the teachings of Howe in view of Bastin render the fumarate salt of instant claim 1 prima facie obvious. Howe teaches pharmaceutical compositions comprising a morpholine derivative or a pharmaceutically-acceptable acid addition salt thereof, in association with a pharmaceutically-acceptable diluent or carrier thereof (Pg. 4, Lns. 62-68). Howe teaches oral dosage forms to include capsules (Pg. 4, Lns. 96-99). This renders the limitations of instant claims 17-18 prima facie obvious.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Howe et al. (GB 1427097, publication date 03 March 1976, hereinafter Howe, in the IDS) in view of Bastin et al. (Salt Selection and Optimisation Procedures for Pharmaceutical New Chemical Entities, 07/19/2000, hereinafter Bastin) as applied to claims 1-2, 7-8, 11, 14 and 17-18 above, and further in view of Breder et al (WO 2020/028207 A2, 11 March 2010, hereinafter Breder, in the IDS).
Regarding instant claim 19, the teachings of Howe in view of Bastin render the pharmaceutical composition of instant claim 18 prima facie obvious. Howe and Bastin do not teach a method of treating attention-deficit hyperactivity disorder comprising administering the pharmaceutical composition.
Breder teaches a method for treatment of ADHD or ADHD-related disorders by a pharmaceutical agent exhibiting combined serotonergic or noradrenergic reuptake transporters and monoamine receptor activity (Abstract). Breder teaches the use of viloxazine in the treatment of ADHD (Para. [0004]; Claim 1). Breder teaches the term "viloxazine" includes viloxazine and all pharmaceutically acceptable salts thereof, as well as all isomers, stereomers and polymorphs thereof (Para. [0031]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Howe, Bastin and Breder to have utilized the pharmaceutical composition of the fumarate salt of viloxazine in a method of treating a subject afflicted with attention-deficit hyperactivity disorder (ADHD) to arrive at the instant method claim with a reasonable expectation of success in treating such a condition. The motivation being to provide a treatment with improved adverse effect profile (Breder, Para. [0032]).
Allowable Subject Matter
The crystalline forms of the fumarate salt of viloxazine, the DL-tartrate salt of viloxazine, the naphthalene-2-sulfonate salt of viloxazine and the citrate salt of viloxazine have been found to be free of prior art.
Claim 3-6, 9-10, 12-13 and 15-16 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.
Conclusion
Claims 1-2, 7-8, 11, 14 and 17-19 are rejected.
Claim 3-6, 9-10, 12-13 and 15-16 are objected to.
No claims are allowed.
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/P.S.R./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627