DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 17, 2025 has been entered.
Claims 1, 5-8, 10-13 are pending. The claims corresponding to the elected subject matter are claims 1, 5-7 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 not persuasive. Therefore, the rejection is herewith maintained. Applicant argues a PTAB decision regarding amounts and an obviousness type rejection. Further, Applicant argues “to establish a once-daily dosing regimen for Compound (I) with a reasonable expectation of success, a person of ordinary skill in the art would need to rely on human pharmacokinetic data (such as Tmax, Cmax, AUC, and T1/2), which Morgan does not provide. It was not until Applicant obtained human clinical trial data that a 150 mg once-daily dosing regimen for Compound (I) could be reliably established, consistent with the data described in Applicant's specification.” Lastly, applicant states: The FDA approval further supports the fact that the claimed dosage and regimen of Compound (I) is unexpectedly superior to the several ranges disclosed of Morgan, and, accordingly, the non-obviousness of Applicant's claims.
The Examiner will not respond to arguments to a PTAB decision made on an unrelated case, with a different claim set. Each application is determined on its own record of prior art and evidence. An unrelated case will not share the same record, claims, or arguments. Further, with respect to the PK parameters, the discovery of a previously unappreciated property of a known drug does not make that composition patentably novel. Finally, the Examiner states Applicant has not provided any surprising or unexpected data with respect to the specific compound or amount generally taught by Morgan. Applicant solely states the amount is approved by the FDA and is therefore unexpectedly superior to the several ranges disclosed. However, a side-by-side comparison of the claims with a range outside of those claimed, having unexpected properties would be appropriate. The arguments do not overcome the 35 U.S.C. § 103 rejection over Morgan (WO 2012158885). The rejections are maintained, for the reasons on record.
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 1-2, 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan (WO 2012158885).
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]).
The reference fails to specific amount 150 mg of compound I.
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. 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. Hence a skilled artisan would have had reasonable expectation of success in the claimed amount, as taught in the prior art.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622