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
Claims 21-22 are pending in the present application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/10/2025 has been entered.
Response to Arguments/Amendments
Rejections made in the Office Action mailed August 12, 2024 that do not appear below have been overcome by Applicant’s amendments to the claims and have been withdrawn.
Claim Rejections - 35 USC § 102
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.
Claims 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akkari et al. (WO 2017/060874 A1; published 04/13/2017).
Akkari teaches the synthesis of the acylsulfonamides in the preparation of compounds suitable for the treatment of mediated and modulated by the CFTR gene. See Method Y1 on page 545.
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Akkari discloses a list of sulfonamides used in the synthesis in Table XIV in pages 542-545, including compound S13 pictured below.
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S13 corresponds to a racemic version of a compound of present claims 21 and 22. Akkari discloses where the preparation of the sulfonamides, including S13, involves purification by flash chromatography with a composition of solvents comprising DCM (see present claim 21). See Method X4B on pages 538-539 and in particular the illustrative synthesis of sulfonamide S14 in paragraph 712 on page 539.
Regarding the limitation of a specific enantiomer of the sulfonamide, MPEP (III) notes:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) […]
In this situation, a person of ordinary skill in the art would recognize the teaching to either be a racemate or a structure generic to only stereoisomers where one would be the S-type and the other would be the R-type. Neither the instant claims nor specification contain a limitation that requires the S-type enantiomer embodiments embraced by the instant claims be found in the absence of (or in any particular excess relative to) the R-type enantiomer, or vice versa.
The composition and compound are therefore embraced by present claims 21-22.
Claims 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2165496-71-7, which entered STN on 12/27/2017.
CAS Registry No. 2165496-71-7 is drawn to (3S)-3-Fluoro-1-pyrrolidinesulfonamide, which has the following structure:
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Regarding the limitation of a solvent comprising dichloromethane (DCM), MPEP 2131.02 notes:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) […]
In this situation, would a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the compound and DCM, a common solvent employed in the field of organic pharmaceutical synthesis for reaction mixture, workup procedures, purification and flash chromatography.
The prior art structure would at least be embraced by the compound of present claims 21 and 22.
Conclusion
Claims 21-22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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