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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/18/2026 has been entered.
Status of the Application
Claims 8, 10-13, 15-20 and 22-24 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 03/16/2026 are acknowledged. Claims under consideration in the instant office action are claims 8, 10-13, 15-20 and 22-24.
Applicants' arguments, filed 03/16/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 8, 10-13, 15-20, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hanf (WO 2017/167935, as disclosed in IDS).
Hanf teaches the use of elafibranor for treating cholestatic diseases such as primary sclerosing cholangitis (PSC) (see abstract). Hanf teaches “Oral administration is the preferential route of administration for pharmaceutical compositions comprising elafibranor for the treatment of a cholestatic disease. The frequency and/or dose relative to the administration can be adapted by one of ordinary skill in the art, in function of the patient, the pathology, the form of administration, etc. Typically, elafibranor can be administered for the treatment of a cholestatic disease at doses varying between 0.01 mg and 1 g per administration, preferentially from 1 mg to 150 mg per administration, and more preferably from 70 mg to 130 mg. Administration can be performed daily or even several times per day, if necessary.” (pg. 10, lines 14-16). Hanf teaches such compositions formulated in the form of a tablet (pg. 4, lines 11-13).
Hanf does not teach at a dosage of between 30 mg/day and 60 mg/day or 40 mg/day.
Even though the range for dosages as taught by Hanf is not the same as the claimed dosage, Hanf does teach an overlapping range of dosages, and it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05(I). Furthermore, the determination of dosages is well within the purview of those skilled in the art through routine experimentation, and it has been held that “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). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the dosage in order to increase the efficacy for treating PSC.
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
Response to Arguments
Applicant argues that “The data indicates that subjects treated with elafibranor at doses of 40 mg, 60 mg, and 80 mg all showed improved alkaline phosphatase levels compared to placebo group. See the Declaration, Table 1. The Declaration also indicates that subjects treated with elafibranor at a dose of 40 mg showed a similar improvement in total bilirubin levels compared to subjects treated with double the dose, i.e., 80 mg; all elafibranor-dosed subjects showed an improvement in total bilirubin levels compared to the placebo group. See the Declaration, Table 2. These results demonstrate that elafibranor may be used from 40 to 60 mg/day to treat PSC. They also demonstrate that half (and even less) the dose exemplified in Hanf gives a suitable result. See the Declaration, page 2, items 12 and 13.” The Examiner respectfully disagrees since although Applicant has demonstrated that a 40 mg dosage of elafibranor provided a similar level bilirubin reduction as compared to an 80 mg dosage (pg. 2 of Declaration), Applicant has not provided such data for 60 mg, which might demonstrate that a whole range of dosages can provide a similar efficacy that is not unique to the dosage levels of 40 mg and 60 mg. Additionally, Hanf does suggest lower dosages of elafibranor, since Hanf does teach that elafibranor can be administered for the treatment of a cholestatic disease at doses varying between 0.01 mg and 1 g per administration (pg. 10, lines 14-16).
Conclusion
Claims 8, 10-13, 15-20 and 22-24 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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