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 .
Applicant’s amendment filed on December 15, 2025 has been fully considered.
The previous claim rejection made under 35 U.S.C. 103 over Boehm et al. (US 20050152974 A1), indicated in the Office action dated September 17, 2025, has been withdrawn in view of the claim amendments submitted on December 15, 2025.
A new rejection has been made to address the amended claims.
Claims 18, 21, 37, 39, 44 and 46 remain withdrawn from consideration as being drawn to nonelected inventions. New claims 47 and 48 are also withdrawn from consideration, as these are process claims depending on claims 37 and 44, respectively.
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.
Claims 1, 3, 9-12, 15, 24-27, 29, 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Boehm et al. (US 20050152974 A1, published July 14, 2005) (“Boehm” hereunder).
Regarding the present claims 3, 15 and 32, Boehm teaches a controlled-release atomoxetine dosage form which releases 30-80% of the drug is released after 1 hour the drug is place in 0.1N HCl, 40-85 % after 2 hour, 45-90 % after 3 hour, and 50-95 % of the drug after 4 hours. See [0294-0295].
The reference further discloses a press coat formulation comprising 5 mg atomoxetine in an immediate-release coatining, 55 mg atomoxetine between the core and the coatining composition. See [0168]. In this example the reference teaches that the 0-4 hour cumulative release of atomoxetine in 0.1 N hydrochloric acid may be at least about 25- 50%, more preferably about 35-40% of the loaded dose. It is viewed that such amount released represent the amount of the immediate release portion, and meets the presently claimed limitation, “about 10% to about 50 % of the total weight of the active agent in the composition”. Also disclosed in Boehm is a press-coat formulation comprising atomoxetine in the core: press coat: immediate-release coat in the ratio of 3:2:1, with the core composition comprising 30 mg, a coating composition comprising 20 mg, and an immediate-release loading dose comprising 10 mg of atomoxetine hydrochloride. The portion of the coating composition and/or core composition can be considered as the “extended release portion” of the present claims.
Boehm further teaches that its sustained-release oral dosage forms provide steady-state and a maximum plasma concentration of the drug Cmax and a plasma concentration of the drug at about 24 hours after administration wherein the ratio of Cmax to C24 is less than bout 4:1. See [0019]. Although the reference does not specifically disclose the drug release profile after 6 or 8 hours in the in vitro dissolution test, the reference teaches and suggests that the sustained-released formulation is designed to release 50-95 % of the drug after 4 hours the drug is administered. Since the reference teaches sustained-release should provide a drug release for at least 8 or at least 12 hours in at steady-state, one of ordinary skill in the art before the effective filing date of the present application would have been motivated to make such sustained-release formulation comprising atomoxetine or its salt. The skilled artisan would have had a reasonable expectation of making such sustained-release dosage form, as the reference suggests the ranges of the release rate and the release time which overlap with the limitations of the present claims, and also teaches rate-retarding materials to be used and the parameters that affects release rates such as altering the relative amount of the retarding materials used, the type of the material used, altering the manner a plasticizer is used and using other excipients, etc. See [0079--81]. The reference further teaches that the dose of atomoxetine HCl include 18, 40, 80, 100 mg in the dosage form; making a dosage form comprising such amount of the active ingredient as suggested by the reference would have been prima facie obvious. See [0064].
Regarding claim 9, Boehm teaches a sustained -release powder made from a slurry comprising atomoxetine hydrochloride (45.7 grams) and EUDRAGIT, a release-retarding material (50 grams). The ratio of the amount of the active agent to the amount of sustained release agent is about 1:1.09 and well within the presently claimed range. As indicated above, the release rate depends on facts other than the relative amount of the retarding materials, one of ordinary skill in the art would have had numerous parameters, including the relative amount of the sustained release agent, to manipulate and achieve the targeted release profile.
Regarding claims 12, Boehm further teaches multiple dose layered pellets or tablets, optionally in combination with pellets or tablets having instant-release. See [0097]. The reference states, “[t]The immediate and pulsed delayed-release of the drug can be achieved according to different principles, such as by single dose layered pellets or tablets, by multiple dose layered pellets or tablets, or by two or more different fractions of single or multiple dose layered pellets or tablets, optionally in combination with pellets or tablets having instant-release.” Incorporating a pre-determined amount of the atomoxetine in each distinct release layer to obtained a targeted release profile would have been well within the ordinary skill in the art. The reference also teaches that same or different release-retarding materials can be used in the different subunit of the dosage form. See [0323].
Regarding claims 24 and 26, since Boehm teaches and suggests that the release characteristic of the atomoxetine or its salts can be designed to treat symptoms when the symptoms are problematic. See [0004]. Given the teachings and suggestions on how to adjust the release rate of the active ingredients, adjusting the parameters to make the multi-release dosage form to meet a targeted release profile would have been well within the ordinary skill in the art. See [0314].
Regarding claim 27, the sustained release agents disclosed in Boehm include the release retarding agents such as alkyl cellulose, hydrogenated vegetable oils, poly(methacrylic acid), etc. See [0064-0071].
Regarding claim 34, incorporating a pre-determined amount of the atomoxetine in each distinct release layer to obtained targeted therapeutic effects and release profiles would have been well within the ordinary skill in the art.
Regarding claim 49, the release-modifying agents suitable for the prior art include hydroxypropylmethylcellulose (hyprocellulose), hydroxypropylcellulose, etc. See [0070]. Although the reference does not specifically disclose the drug release profile after about 10 hours in the in vitro dissolution test, the reference teaches and suggests that the sustained-released formulation is designed to release 50-95 % of the drug after 4 hours the drug is administered. Since the reference teaches sustained-release should provide a drug release for at least 8 or at least 12 hours in at steady-state, one of ordinary skill in the art before the effective filing date of the present application would have been motivated to make such sustained-release formulation comprising atomoxetine or its salt. The skilled artisan would have had a reasonable expectation of making such sustained-release dosage form, as the reference suggests the ranges of the release rate and the release time which overlap with the limitations of the present claims, and also teaches rate-retarding materials to be used and the parameters that affects release rates such as altering the relative amount of the retarding materials used, the type of the material used, altering the manner a plasticizer is used and using other excipients, etc. See [0079--81].
Regarding claim 50, the reference teaches press coat formulations can contain atomoxetine in the amount 18 mg, 25 mg or 40 mg. See [0168].
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 9-12, 15, 24-27, 29, 32, 34, 49 and 50 have been considered but are moot because the new ground of rejection as indicated above.
Conclusion
No claims are allowed.
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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/GINA C JUSTICE/Primary Examiner, Art Unit 1617