DETAILED ACTION
The Office Action is in response to the Applicant's reply filed June 12, 2026 to the office action made on January 13, 2026.
Claims 1, 7-8, 10, and 13 are pending. The claims corresponding to the elected subject matter are claims 1 and 7 and are herein acted on the merits.
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 .
Application Priority
This application filed 05/14/2020 is a continuation 15/761,532, Filing Date: 03/20/2018 which is a 371 of PCT/US2016/052922 filed 09/21/2016, and claims priority to provisional 62/348,855, filed 06/10/2016, PRO 62/238,511 filed 10/07/2015 and PRO 62/221,531 filed 09/21/2015.
Response to Arguments
Applicant's arguments over the 35 U.S.C. 103(a) rejection of claims 1-2, 4-7 over Morgan (WO 2012158885) is persuasive due to amendments made to the claims. Therefore, the rejection is herewith modified.
The following rejections are made:
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 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.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan (WO 2012158885) in view of Vertex (Treatment with VX-661 and Ivacaftor in a Phase 2 Study Resulted in Statistically Significant Improvements in Lung Function in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation April 18, 2013).
The claims are examined to the extent that they read on a method of treating a condition that is mediated by CFTR in a subject comprising administering to the subject an amount in the range of 150 mg to 200 mg, once per day, of a compound represented by the following structural formula 1.
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Morgan teaches the compound
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and pharmaceutically acceptable salts thereof. The reference teaches compositions comprising a compound 106 of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering a CFTR potentiators (see abstract). The compound 106 taught in the prior art is identical to that claimed and the “natural isotopic abundance” is property of a known drug. In one embodiment, an effective amount of a compound of this invention can range from about 0.02 to 2500 mg per treatment. In more specific embodiments the range is from about 0.2 to 1250 mg or from about 0.4 to 500 mg or most specifically from 2 to 250 mg per treatment. Treatment typically is administered one to two times daily (para [74]). In one embodiment the subject is a patient in need of such treatment. Such diseases include cystic fibrosis, Hereditary emphysema, etc (para [79]). In certain embodiments, the compound is administered orally. Compositions of the present invention suitable for oral administration may be presented as discrete units such as capsules, sachets, or tablets each containing a predetermined amount of the active ingredient; a powder or granules; a solution or a suspension in an aqueous liquid or a non-aqueous liquid; an oil-in-water liquid emulsion; a water-in-oil liquid emulsion; packed in liposomes; or as a bolus, etc. (para [58] ). Morgan teach the use of a second therapeutic agent useful in the treatment of a variety of conditions, including cystic fibrosis (para [67]-[68] ).
The reference fails to specific amount 150 mg of compound I nor the co-administration of the specific tezacaftor.
Vertex teaches the use of VX-661 (tezacaftor) in combination with ivacaftor in treating cystic fibrosis in ages 18 and older.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use 150 mg of the active in combination with tezacaftor. The motivation to use 150 mg of the active is because Morgan teaches that most specifically 2 to 250 mg of the active is effective for treatment and Vertex teaches the use of VX-661 (tezacaftor) in combination with ivacaftor. Hence a skilled artisan would have had reasonable expectation of success in using the claimed amount, as taught in the prior art, for treatement of cystic fibrosis.
Conclusion
No claims allowed.
The arguments are not persuasive and the rejection is made FINAL.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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