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, filed 15 February, 2023, is a national stage application of PCT/IB2021/000594, filed 31 August, 2021, which claims the benefit of U.S. Provisional Applications 63/227,279, filed 29 July, 2021, and 63/072,848, filed 31 August, 2020.
Information Disclosure Statement
Five information disclosure statements (IDS) submitted on 15 May, 2023, 13 December, 2023, 18 February, 2025, 5 March, 2025, and 25 March, 2025 are acknowledged and have been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 2 October, 2023, in the matter of Application N° 18/041,745. Said documents have been entered on the record.
Claims 1-72 are canceled. Claims 73-92 are new. No new matter was introduced.
Election/Restrictions
Claims 73-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1 December, 2025.
Thus, Claims 82-92 represent all claims currently under consideration.
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.
Claims 82-92 are rejected under 35 U.S.C. 103 as being unpatentable over Schaefer et al. (US Patent 8,362,073, published 29 January, 2013, cited in the IDS), hereinafter Schaefer.
Patent shares Assignee and one Inventor with instant Application.
Schaefer teaches compounds of Formula I, to include a crystalline form of Compound I, pharmaceutical compositions thereof, discloses their use in fibrotic conditions such as systemic sclerosis, and processes for preparing the carboxylic acid compounds via base-mediated saponification of ester precursors, followed by acidification and isolation of the corresponding free acids.
Regarding Claims 82-85
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, Schaefer teaches a process of preparation of 2-[ 4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino ]indane-2-carboxylic acid, shown top right,
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wherein 2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino ]indane-2-carboxylic acid methyl ester, shown bottom right (as in instant Claims 82-84, Step 1 - Formula 6a, wherein R2 is a C1 alkyl, methyl) was dissolved in dioxane, lithium hydroxide and water, and stirred for 30 mins at 60 ℃. The mixture was partitioned between hydrochloric acid and ethyl acetate (EA), the aqueous phase extracted with EA, and the combined organic extracts were washed with brine, dried over sodium sulfate, filtered and evaporated to dryness. The residue was stirred overnight in EA, filtered, and the crystals were dried in vacuo (‘073, Col 73-74, Example 14.)
Although Schaefer employs lithium hydroxide as the base for ester hydrolysis, the reference broadly teaches hydroxide-mediated saponification as the operative transformation (‘073, Col 47, Lines 25-30 and Col 104, Example 108). One of ordinary skill in the art, before the effective filing date of the claimed invention, would have recognized sodium hydroxide and potassium hydroxide as routine alternative hydroxide reagents for ester saponification, motivated by availability, cost, solubility, and ease of handling. One would have had a reasonable expectation of success in substituting NaOH (as in instant Claim 85) or KOH for LiOH because all three reagents perform the same chemical function – generation of hydroxide ions to cleave ester bonds – and their interchangeability in saponification reactions is well established and predictable.
Additionally, although Schaefer does not explicitly recite cooling the reaction mixture to about 10 ℃ to effect crystallization, one of ordinary skill in the art would have been motivated to cool the reaction mixture as a routine isolation technique to promote crystallization of the product, with a reasonable expectation of success based on well-established and predictable solubility behavior of carboxylic acids.
Regarding Claims 86-92, across numerous examples, the reference demonstrates that ester intermediates are converted to their corresponding carboxylate salts using hydroxide reagents under aqueous or mixed solvent conditions, optionally with heating, and are subsequently acidified to yield the target carboxylic acids, which are isolated by conventional workup techniques such as crystallization and filtration. Solid state forms are known to depend on solvent, temperature, and acid selection. Optimization of crystallization conditions to obtain a desired solid form would have been of ordinary skill in the art. Characterization (e.g., XRPD peaks) of a crystalline form does not confer patentability where the compound, its therapeutic use, and solid-state preparation were already known, absent evidence that the claimed form exhibits unexpected properties or arises from non-routine processing.
As the compound prepared by the claimed process was already known (instant Specification, Pg. 6, Para 0043 recites “The preparation and uses of Compound I have been previously described [list of previous Patents]”) the instantly claimed process represents an optimization of known manufacturing techniques rather than the creation of a new chemical entity and would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 82-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 15 of U.S. Patent No. 8,362,073.
Although the claims at issue are not identical, they are not patentably distinct from each other because the disclosure of U.S. Patent No. 8,362,073 provides that the compound 2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indane-2-carboxylic acid (i.e. 2-(4-methoxy-3-(3-methylphenethoxy)benzamido)-2,3-dihydro-1H-indene-2-carboxylic acid) is in crystalline form.
Since claims 9 and 15 of U.S. Patent No. 8,362,073 disclose the exact same compound, and the disclosure provides that this compound is also in crystalline form, Applicant’s claims are not patentably distinct from those of U.S. Patent No. 8,362,073, even if U.S. Patent No. 8,362,073 did not expressly report the properties of the crystalline compound that Applicant reports. The burden is now on the Applicant to prove that the crystalline compound of U.S. Patent No. 8,362,073 does not have and cannot have the properties of Applicant’s crystalline compound.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627