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
This application is a 371 of PCT/EP2021/052165, filed 01/29/2021 which claims
benefit of foreign priority of EP 20305090.1, filed 01/31/2020.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on dates 12/19/2022,
08/24/2023, 11/29/2023, 03/29/2024, 08/06/2024, 11/01/2024, 01/30/2025, 01/31/2025, 03/05/2025, 03/26/2025, 05/22/2025, 07/24/2025, 08/06/2025, 11/10/2025 and 12/05/2025 were
filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information
disclosure statements are being considered by the examiner.
Status of the Application
Claims 1-13, 15, and 18-21 are pending. Claims 2, 5-6 and 11-13 been amended. New claims 19-21 have been added. Claims 14, and 16-17 have been cancelled by applicant. Claims 1-13, 15, and 18-21 are examined herein insofar as they read on the elected invention and species.
Inventorship
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.
Specification
The lengthy specification (121 pages as filed 07/15/2022) has not been checked
to the extent necessary to determine the presence of all possible minor and typographical errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tazi (WO 2016/009065 Al - provided by Applicants as foreign reference 2 in IDS Dated 05/22/2025).
Tazi discloses compound 24, 8-chloro-N-(4-(trifluoromethoxy) phenyl) quinolin-2-amine is disclosed as a derivative of formula (Ib) and discloses “Suitable physiologically acceptable acid addition salts of compounds of formula (I) include hydrobromide, tartrate, citrate, trifluoroacetate, ascorbate, hydrochloride, tartrate, triflate, maleate, mesylate, formate, acetate and fumarate.
The compounds of formula (I) and or salts thereof may form solvates or hydrates and the invention includes all such solvates and hydrates.
The terms "hydrates" and "solvates" simply mean that the compounds (I) according to the invention can be in the form of a hydrate or solvate, i.e. combined or associated with one or more water or solvent molecules. This is only a chemical characteristic of such compounds, which can be applied for all organic compounds of this type.” (pg. 20, lines 8-17).
The teachings of Tazi anticipate the limitations of independent claim 4 wherein a pharmaceutically acceptable salt of 8-chloro-N-(4-(trifluoromethoxy)phenyl)quinolin-2-amine is cited.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claims 4, and 19-21 rejected under 35 U.S.C. 103 as being unpatentable over Tazi (WO 2016/009065 Al - provided by applicants as foreign reference 2 in IDS Dated 05/22/2025).
The instant claims are directed to a The instant claims are drawn to co-crystals of 8-chloro-N-(4-(trifluoromethoxy) phenyl) quinolin-2-amine in a pharmaceutical composition including a solvate and an excipient administered to a patient for the treatment of an inflammatory disease.
Tazi '065 et al. teach a pharmaceutical composition of quinoline derivatives for the treatment of inflammatory diseases wherein the compound of 8-chloro-N-(4-(trifluoromethoxy) phenyl) quinolin-2-amine is disclosed as a derivative of formula (lb) in the form of compound 24 (pg. 48). Tazi also teaches "suitable physiologically acceptable acid addition salts of compounds of formula (I) include hydrobromide, tartrate, citrate, trifluoroacetate, ascorbate, hydrochloride, tartrate, triflate, maleate, mesylate, formate, acetate and fumarate. The compounds of formula (I) and or salts thereof may form solvates or hydrates and the invention includes all such solvates and hydrates" (p. 20, lines 8-17). Tazi '065 discloses that administration of the compounds of formula I showed improvement of inflammatory diseases such as Inflammatory Bowel Disease (IBD) and Rheumatoid Arthritis (RA) conditions (pg. 29, lines 15-20). Tazi '065 teaches excipients are selected according to dosage form and desired mode of administration and in any pharmaceutical form for enteral or parenteral administration which enable daily administration of 0.1-1,000 mg of active substance (p.69, lines 9-19).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to administer a compound of 8-chloro-N-(4-(trifluoromethoxy) phenyl) quinolin-2-amine solvate in a pharmaceutical composition to a patient for the treatment of an inflammatory disease with an excipient because Tazi '065 showed that it was an effective combination in treating inflammatory diseases and that adding an excipient enables the daily administration of 0.1-1.000 mg of an active substance to a subject..
A person having ordinary skill in the art would have been motivated to combine an 8-chloro-N-(4-(trifluoromethoxy) phenyl) quinolin-2-amine solvate and an excipient as disclosed by Tazi '065 because of the resulting dramatic improvement of inflammatory diseases of Inflammatory bowel disease (IBD) and Rheumatoid Arthritis (RA) derived from such treatment. A person of ordinary skill, following the teachings of Tazi '065 would have had a reasonable expectation of success in treating an inflammatory condition in a patient in need thereof.
Allowable Subject Matter
The following is an examiner's statement of reasons for allowance: Claims 1-3
and 5-13, 15 and 18 make a contribution over the prior art of record. The closest prior art found is Rabe (WO 2017/158201 Al) who discloses crystalline forms of compound (8-chloroquinolin-
2-yl)-(4-trifluoromethoxy-phenyl)-amine, also known as ABX-464 using (C1-C4) alcohol, non-polar, aprotic solvents, e.g. cyclohexane or benzene (page 8, lines 26-35). Rabe teaches x-ray powder diffractogram of 8-chloro-quinolin-2-yl)-(4-trifluoromethoxyphenyl)-amine at angles 7.3, 14.6, 18.3, 23.0 and 24.8, and in particular at angles 7.3, 14.6, 18.3, 23.0, 10 24.8, 28.3 and 29.5. with remarkable peaks at angles 18.6, 22.3, 24.1, 29.0 and 42.6 (page 8, lines 1-12). Rabe does not fairly teach a crystallization of ABX464 with the use of L-proline, gentisic or malonic acid, or 4, 4'Bipyridine to produce powder X-ray diffractogram peaks of degree 2-Theta angle at
12.0; 19.2; 21.2; and 24.3 (±0.2) or 16.0; 17.0; 17.8; 20.3; 22.5; and 22.7 (±0.2) or 8.5; 13.0; 15.7; 16.7; 20.9; 22.0; 23.1; 23.6 and 24.7 (±0.2).
Conclusion
Claims 1-3 and 5-13, 15 and 18 are allowed, claims 4, and 19-21 are rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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