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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 September 2025 has been entered.
Status of the Claims
Claims 1-14, 18-21, and 23-25 are pending in the instant application.
Claim 1 is amended.
Claims 1-14, 18-21, and 23-25 are examined herein.
Priority
The instant application claims benefit of foreign priority to EP23192553.8, filed on 22 August 2023. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 22 August 2023.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 26 March 2025 and 25 September 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 25 September 2025 has been entered.
With respect to the 103 rejection, Applicant’s arguments have been considered but are not found persuasive. The prior art does establish that obeticholic acid (OCA) is contraindicated in Primary Biliary Cholangitis (PBC) patients that have progressed to cirrhosis (FDA; cited by Applicant on 1449 IDS). OCA is a farnesoid X receptor (FXR) agonist, elafibranor is a peroxisome proliferator-activated receptor (PPAR) agonist. While both are utilized in the treatment of PBC they have different mechanisms of action, and one skilled in the art would be motivated to avoid the toxicity associated with OCA by utilizing a drug of a different class. Therefore the rejection is maintained.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
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.
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.
Claim(s) 1-14, 18-21, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schattenberg et al. (Journal of Hepatology. 2021 ;74: 1344–1354) in view of Floreani (Diseases of the Liver and Biliary Tree. Chapter 8: Primary Biliary Cholangitis. 2021; 123-133) and Darteil et al. (WO2011064350).
Regarding claim 1, Schattenberg teaches administering elafibranor, once daily at a dose of 80 mg-120 mg, for the treatment of Primary Biliary Cholangitis (PBC) (page 1344).
Schattenberg does not teach the treatment in patients with cirrhosis, nor does Schattenberg disclose how the composition was administered.
Floreani teaches that PBC leads to liver cirrhosis and portal hypertension (page 124).
Schattenberg teaches elafibranor can be used to treat PBC and Floreani teaches liver cirrhosis is a progression of PBC. Therefore, it would be obvious to one of ordinary skill in the art to administer elafibranor in the treatment of PBC with liver cirrhosis.
Darteil discloses a compound of Formula I (below) for the treatment of liver diseases, which encompasses elafibranor when: X1 is G1-R1, where G1 is sulfur and R1 is methyl; A is CH = CH; R4 is methyl; R5 is methyl; and X2 is G2-R2, where G2 is oxygen and R2 is an alkyl group substituted by -COOR3, where R3 is H. Darteil discloses the compound can be administered as a pharmaceutical composition (claims 9 and 10) and states oral administration is the preferred route (page 20, line 11).
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It would be prima facie obvious to one of ordinary skill in the art to administer the compound taught by Schattenberg in the preferred route, as taught by Darteil, for the treatment of PBC with liver cirrhosis, which is taught by the combination of Schattenberg and Floreani. Furthermore, it is well known in the art that oral administration is the most common and preferred method of administration due to convenience and increased patient compliance. Therefore, if a compound can be formulated to be administered orally, it would be obvious to administer that compound orally. Thus, the combination of Schattenberg, Floreani and Darteil teach the limitations of the instant invention.
Regarding claim 2 and 3, Schattenberg teaches administering elafibranor in patients with a Child-Pugh score of A as the study did not include those with a score of B or C (page 1345, column 2).
Regarding claim 4 and 5, while Schattenberg teaches the study did not include subjects with a Child-Pugh score of B or moderate hepatic impairment it would be obvious to one of ordinary skill in the art to extend the treatment to patients with more severe chronic liver disease than those evaluated in a phase II clinical trial with a reasonable level of success as phase III clinical trials include a larger patient population.
Regarding claim 6 and 7, Schattenberg teaches administering elafibranor in patients with PBC (page 1344).
Floreani teaches that PBC progresses to cirrhosis (page 124). Therefore it would be obvious to one of ordinary skill in the art that a subject with PBC would be at risk of cirrhosis or cirrhosis progression.
Regarding claim 8, Schattenberg teaches administering elafibranor in patients with PBC (page 1344).
Floreani teaches that PBC progresses to portal hypertension (page 124). Therefore it would be obvious to one of ordinary skill in the art that a subject with PBC would be at risk of portal hypertension.
Regarding claim 9, Schattenberg teaches administering elafibranor in patients with PBC resulting in lower alkaline phosphatase (ALP) levels and slowing down the progression of the disease (page 1344).
Regarding claim 10, Schattenberg teaches administering elafibranor in patients with PBC (page 1344).
Floreani teaches that PBC progresses to cirrhosis (page 124). Therefore it would be obvious to one of ordinary skill in the art that a subject with PBC would be at risk of cirrhosis or cirrhosis progression.
Regarding claim 11, Schattenberg teaches administering elafibranor in patients with a Child-Pugh score of A as the study did not include those with a score of B or C (page 1345, column 2).
Regarding claim 12, Schattenberg teaches administering elafibranor in patients with PBC resulting in lower alkaline phosphatase (ALP) levels and slowing down the progression of the disease (page 1344).
Schattenberg does not teach the treatment in patients with cirrhosis.
Floreani teaches that PBC leads to liver cirrhosis and portal hypertension (page 124).
Schattenberg teaches elafibranor can be used to treat PBC and Floreani teaches liver cirrhosis is a progression of PBC. Therefore, it would be obvious to one of ordinary skill in the art to administer elafibranor in the treatment of PBC with liver cirrhosis.
Regarding claim 13, Schattenberg teaches administering elafibranor in patients with PBC (page 1344).
Floreani teaches that PBC progresses to portal hypertension (page 124). Therefore it would be obvious to one of ordinary skill in the art that a subject with PBC would be at risk of portal hypertension.
Regarding claim 14, Schattenberg teaches administering elafibranor in patients with a Child-Pugh score of A as the study did not include those with a score of B or C (page 1345, column 2).
Regarding claims 18-20, Schattenberg teaches administering elafibranor in patients that have had an incomplete response to ursodeoxycholic acid (UDCA) or is intolerant (page 1345).
Regarding claim 21, Schattenberg teaches administering elafibranor in patients at a dose of 80 mg (page 1345, Study Design).
Regarding claim 23, Darteil discloses the compound can be formulated in the form of pills, gel caps, capsules, or devices assuring a prolonged and/or slow release (claim 10).
Regarding claim 24, Schattenberg teaches elafibranor is administered once daily at a dose of 80 mg (page 1345, Study Design).
Claim(s) 1-14, 18-21, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schattenberg et al. (cited above) in view of Floreani (cited above) and Darteil (cited above) and further in view of Rudic et al. (Cochrane Database Syst Rev. 2012;2012(12):i-93)
The teachings of Schattenberg, Floreani, and Darteil are disclosed above and incorporated by reference herein.
The combination fails to teach UDCA.
Regarding claim 25, Rudic teaches the administration of UDCA for the treatment of PBC (page 1).
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong A of KSR applies – combining known compounds for the same purpose of treating PBC. The combination of Schattenberg, Floreani, and Darteil teach the administration of elafibranor for the treatment of PBC as recited in instant claim 1. Rudic teaches that UDCA is an FDA approved therapeutic agent for the treatment of PBC. It would be prima facie obvious to one of ordinary skill in the art to combine two therapeutic agents known in the art for treating the same condition, with a reasonable expectation of success.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Conclusion
Claims 1-14, 18-21, and 23-25 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621