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 .
Election/Restrictions
Applicant's election with traverse of the invention of group I (claims 1-9) in the reply filed on 06/26/2026 is acknowledged. The traversal is on the ground(s) that claim 10 has been amended to require the limitations of claim 1. This is not found persuasive because as amended, the inventions are still directed toward related processes that are patentably distinct. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different mode of operation and effect, wherein invention I produces . To accomplish this, the methods employ materially different reaction conditions (reagents, solvent, temperatures) and are mutually exclusive. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants. Examiner will consider rejoining claims upon indication that a generic or linking claim of the elected invention is allowable.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-23 and 28-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/29/2026.
Priority
Examiner acknowledges that, according to the Filing receipt received 04/02/2026, that the instant application 19/556,476 filed 03/04/2026 is a continuation of PCT/EP2024/076410 filed 09/20/2024 which claims foreign priority of EPO application 23306579.6 filed 09/22/2023. Claims 1-9 have been awarded the effective filing date of 09/22/2023.
Information Disclosure Statement
The Information Disclosure Statement filed on 03/04/2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is less than 50 words and does not concisely describe the entire disclosure, which also includes methods of making crystalline forms and methods of treatment. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 5, 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4, 5, and 8 recite “the amount of starting N-(4-chloro-2-iodo-phenyl)-1,3-benzothiazole-6-sulfonamide” (emphasis added). This limitation lacks antecedent basis as the term “starting” is not supported, inherently or explicitly, by claim 1.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montalbetti et al. (US 2021/0300913 A1; IDS filed 03/04/2026) in view of Heidenreich et al. (Synlett; 2002) and Mao et al. (Catalysts; 2021).
Montalbetti et al. discloses a method of making deuterated lanifibranor, comprising reacting N-(4-chloro-2-iodophenyl)-2-deuterio-1,3-benzothiazole-6-sulfonamide with 1.1 eq. 5-hexynoic acid, 0.1 eq. copper iodide, 0.05 eq. Pd(PPh3)4, and 1.5 eq. triethylamine in anhydrous DMF (N,N-dimethylformamide) at 80oC for 2 hours (paragraph [0031]-[0032]). The structures of N-(4-chloro-2-iodophenyl)-2-deuterio-1,3-benzothiazole-6-sulfonamide, 5-hexynoic acid, and deuterated lanifibranor are as below, respectively (drawn by STN).
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90
266
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198
274
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Examiner notes that the scope of the instant invention has been interpreted to encompass deuterated lanifibranor and a starting material of N-(4-chloro-2-iodophenyl)-2-deuterio-1,3-benzothiazole-6-sulfonamide (see specification, p. 3 lines 25-28 and p. 12 lines 21-24).
Montalbetti et al. does not disclose that the palladium catalyst is Pd/C. This limitation is obvious over Heidenreich et al. and Mao et al.
Heidenreich et al. discloses an optimized heterogeneous Pd/C catalyst for cross-coupling Heck, Suzuki, and Sonogashira reactions (Abstract). Heidenreich et al. discloses that coupling of aryl iodides with terminal alkynes results in high yields of up to 80% and conversions of up to 74% in 30 minutes using low Pd concentrations (p. 1120, col. 2, par. 2; Scheme 3). Heidenreich et al. additionally discloses that the Pd/C catalyst allows for complete Pd separation and recovery (Abstract).
Mao et al. discloses a Pd/C catalyst used in Sonogashira cross-coupling of a terminal alkyne with a quinolinyl iodide derivative, which resulted in the formation of a pyrrole fused to the ring structure of the starting material (p. 15, Scheme 5 as below).
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As shown in Scheme 25 above, the reaction was carried out with CuI as a co-catalyst and in the presence of a triethylamine base. Mao et al. additionally discloses that the heterogeneous Pd/C catalyst system offers particular advantages, such as recycling and reuse of Pd/C and its high tolerance for moderate or harsh reaction conditions (p. 1, Abstract and paragraph 2).
It would have been prima facie obvious for one of ordinary skill in the art to substitute the Pd(PPh3)4 of Montalbetti et al. with Pd/C. One would have been motivated to do so, with reasonable expectation of success, as Pd/C has been demonstrated in the art to function as a catalyst in terminal alkyne cross-coupling reactions, including formation of indoles (pyrrole fused to benzene). Moreover, one would find the substitution of Pd/C to be advantageous for its improved reusability and stability under harsh conditions. One of ordinary skill in the art would therefore expect Pd/C to yield similar, if not improved, results in synthesizing lanifibranor via the coupling reaction of N-(4-chloro-2-iodophenyl)-2-deuterio-1,3-benzothiazole-6-sulfonamide and 5-hexynoic acid.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MADELINE E BRAUN/Examiner, Art Unit 1624 07/14/2026
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