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 application was filed 07 May 2021 and is the national stage entry of PCT/JP2019/044505 filed 13 November 2019. The Applicant claims priority to foreign application JP2018-213350 filed 13 November 2018. A translated copy of the foreign document has not been provided. Therefore, the effective filing date of the application is 13 November 2019.
Examiner’s Note
The Applicant's amendments and arguments filed 09 March 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 09 March 2026, it is noted that claim 34 has been amended to further exclude levodopa and carbidopa. Support for the amendment can be found throughout the specification. No new matter has been added.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 34, 36, 45-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uramatsu (JP 2013087074 A; machine translation cited), Kawada et al. (WO 2016/072179 A1; machine translation cited), and pharmtech.com.
Regarding claim 34, Uramatsu teaches a tablet with a binder comprising polyvinyl alcohol (abs; entire teaching). The tablet is formed through wet granulation to mix the drug, binder, and excipient (pg. 1, para. 2), which is interpreted as “bringing a binder comprising a polyvinyl alcohol-based polymer into contact with a substance to be mixed with the binder.” The saponification degree of PVA is 85-90% (pg. 3, para. 6). The tablet does not require obeticholic acid, levodopa, or carbidopa.
Regarding claim 36, Uramatsu teaches an example where water is combined with PVA (pg. 4, para. 11-pg. 5, para. 2).
Regarding claims 45, 46, 52, 53, the average particle size is adjustable to 130 microns or less by using commercially available PVA copolymer (pg. 6, para. 6). If the granulated material is formed through PVA and a substance, such as water, it is interpreted as the resulting granulated material having a particle size of roughly 130 microns or less.
Regarding claim 47, the tablet is formed through wet granulation to mix the drug, binder, and excipient (pg. 1, para. 2).
Regarding claim 48, the tablet is combined with a medicinal drug (pg. 1, para. 2).
Uramatsu does not explicitly teach the limitation of preparing a supernatant with 230.0 mL of 1-propanol to 100.0 g of a 5.0% solution of polyvinyl alcohol-based polymer with a concentration of 0.65% by mass or more at 20 °C in claims 34, 49, and 50, and a viscosity in claim 51.
Kawada et al. teach a method for producing a film-coating composition comprising PVA which has a saponification of 85.0-89.0 mol% according to JIS K6726 (entire teaching, pg. 3, para. 6). The supernatant is prepared by adding 230.0 mL of 1-propanol to 100.0 g of a 5.0% by mass aqueous solution of PVA polymer and has a concentration of 0.75% or more, a transparency of 50% or less, and a supernatant concentration of 0.75% by mass at 20 °C (abs). The PVA polymer is added to water (Example 1), where in certain embodiments, the PVA polymer is pulverized, which is interpreted as granulated or in powder form (synthesis example 5). The PVA polymer may be a viscosity of 2 mPa*s (pg. 8, para. 9). Kawada teaches that PVA used in films can mask unpleasant taste, has good moisture resistance and gas barrier properties, and improves storage stability (pg. 2, paras. 1-3).
Pharmtech.com teaches that saponified PVA is commonly used as a binder or as a coating for tablets, where both binder and coating use achieve similar purposes or characteristics associated with low viscosity, masking of taste, inhibited oxidation, gas barrier capability, drug dissolution, and physical mechanical strength (pg. 8).
Since Uramatsu does not explicitly teach the limitation of preparing a supernatant with 230.0 mL of 1-propanol to 100.0 g of a 5.0% solution of polyvinyl alcohol-based polymer with a concentration of 0.65% by mass or more at 20 °C or viscosity in claims 34, 49, 50, and 51, one of ordinary skill in the art would have been led to use Kawada’s method steps of producing the saponified PVA polymer with a reasonable expectation of success. A skilled artisan would have been led to use the teachings together since pharmtech.com teaches that it is known in the art to use saponified PVA polymers as both binders and coatings to achieve similar favorable formulation properties, and Kawada provides specific parameters and measurements regarding the amounts of solvent and polymer to achieve these favorable formulation properties.
Uramatsu teaches that the average particle size is adjustable to 130 microns or less by using commercially available PVA copolymer (pg. 6, para. 6). That being said and in lieu of objective evidence of unexpected results, the particle size can be viewed as a variable that achieves the recognized result of successfully making the PVA polymer composition in claims 45, 46, 52, and 53. The optimum or workable range of particle size can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized particle sizes as nonobvious.
Response to Arguments
Applicant's arguments filed 09 March 2026 have been fully considered but they are not persuasive.
The Applicant argues that Wenzel fails to disclose or suggest a method for producing a granulated material, wherein the granulated material does not comprise levodopa or carbidopa (Remarks, pgs. 5-6).
Wenzel has been removed as prior art and the arguments against them will not be addressed.
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.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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