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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 October 2025 has been entered.
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 16 October 2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 16 October 2025, it is noted that claim 34 has been amended to exclude obeticholic acid. 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 Wenzel (US 5532274 A), Kawada et al. (WO 2016/072179 A1; machine translation cited), and pharmtech.com.
Wenzel teaches a method for making a tablet formulation comprising partially or completely saponified polyvinyl alcohol polymer as a binder (entire teaching; abs) to form the granulated material and tablet (col. 2, lns. 40-51) and does not require obeticholic acid, partially addressing claim 34. The formulation is made by mixing the polyvinyl alcohol polymer with aqueous solutions (Examples 14 and 15), addressing claim 36. The particle may be a maximum size of 1.00 mm (Example 15) in one embodiment, where it is interpreted that the particle size may be smaller, addressing claims 45, 46, 52, and 53. Wenzel describes a wet granulation through mixing active compounds in the form of powder solid with a binder solution (Examples), addressing claims 47 and 48. There is a need to adjust release times for drugs in film tablets, tablets, capsules, etc., depending on the pharmaceutical standards in different countries (col. 1, lns. 41-54).
Wenzel 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 Wenzel 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.
Wenzel teaches that the particle may be a maximum size of 1.00 mm (Example 15) in one embodiment. 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 26 October 2025 have been fully considered but they are not persuasive.
Matono has been removed as prior art and the arguments against them will not be addressed.
The Applicant argues that the prior art teachings do not teach the amendment of excluding obeticholic acid (Remarks, pgs. 4-5).
Applicant’s argument is not found persuasive. Wenzel teaches a method for making a tablet formulation comprising partially or completely saponified polyvinyl alcohol polymer as a binder (entire teaching; abs) to form the granulated material and tablet (col. 2, lns. 40-51). The composition does not require obeticholic acid. Since Wenzel 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. Therefore, the teachings combined address all of the limitations, including the exclusion of obeticholic acid, in claim 34.
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). One of ordinary skill in the art would have been led to use Kawada’s method steps of producing the PVA polymer, as Kawada teaches a solid tablet composition comprising PVA as a film coating agent and Matono teaches granulated and film coating agents using PVA polymers. Since Matono’s teaching includes several embodiments for the PVA polymer, a skilled artisan would have been reasonably motivated to use Kawada’s method steps of preparing the PVA polymer to achieve favorable saponification values.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613