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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/21/26 has been entered.
Maintained rejection
Rejection of claim 6 under 35 USC 103 over Medscape is maintained. Reply to applicants’ remarks follows the repeated text of the rejection of record.
Claim Rejections - 35 USC § 103
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medscape (ripretinib Rx https://web.archive.org/web/20200614140745/https://reference.medscape.com/drug/qinlock-ripretinib-4000074; publication online 6/13/2020).
Scope of prior art
On page 1, Medscape discloses that ripretinib is indicated for advanced gastrointestinal stromal tumor at a dose of 150mg/day. On page 2, with regards to Hepatic impairment, Medscape discloses that no dose adjustment is necessary for mild hepatic impairment. Regarding moderate or severe hepatic impairment, Medscape states that the recommended dosage has not been established.
Ascertaining the difference
Claims limit the subject population to individuals with pre-existing Child-Pugh class C severe hepatic impairment. While Med scape teaches 150mg dose for mild hepatic impairment (no dose adjustment is necessary), it teaches that the proper dose adjustment for treatment of subjects with severe hepatic impairment has not been established.
Obviousness
At issue is whether a person of ordinary skill in the art would have found it obvious to determine a proper dose for treatment of subjects GIST with pre-existing severe hepatic impairment.
A person of ordinary skill in the art would have found it obvious treat an individual with advanced gastrointestinal stromal tumor in a subject in need thereof by administering to said subject 150mg/day of ripretinib. Medscape teaches that 150mg dose is sufficient for treatment of the stromal tumor and that mild hepatic impairment does not affect the recommended dosage. While no dose recommendation for moderate to severe hepatic impairment is provided, a skilled practitioner would have found it obvious to determine the proper dose. It would have been obvious to start with 150mg daily dose suggested for advanced gastrointestinal stromal tumor and to adjust the dose if needed. For dose modification Medscape teaches starting with 150mg/day and reducing to 100mg/day if the dose is not well tolerated. According to Medscape guidance the currently claimed 150mg/day dose is the dose a skilled practitioner would start with in an effort to optimize the dose for a given subject. Administration of a 150mg dose to a subject with pre-existing Child-Pugh class C severe hepatic impairment is therefore obvious.
While Medscape recites “severe hepatic impairment” not “Child-Pugh class C severe hepatic impairment”, both recitations are directed to advanced liver disfunction.
Reply to applicants’ arguments
Remarks filed on 1/21/26 have been fully considered and found to be not convincing.
On page 1 of the remarks applicants argue that examiner used an obvious to try rational that requires selection from a finite number of identified, predictable solution, with a reasonable expectation of success. This statement is not correct. No argument directed to selection of parameters from a finite number of possibilities has been presented in the rejection of record.
Applicant argue that Medscape does not recommend a 150mg once daily dose for treatment of advanced gastrointestinal stomal tumor for a Child Pugh Class C patient. Applicants are correct. Medscape teaches 150mg once daily oral dose for treatment of gastrointestinal stomal tumors including for patients with mild hepatic impairment, but no dose recommendation for severe hepatic impairment.
Applicants further argue that a person of ordinary skill in the art would have no motivation to select the claimed 150mg once daily dose for treatment of advanced gastrointestinal stomal tumor for a Child Pugh Class C patient. Examiner disagrees with the applicant. The disease to be treated is advanced gastrointestinal stomal tumor. For treatment of said disease Medscape recommends 150mg/day oral dose. In order to determine if modification in dose or frequency is required for Child Pugh Class C patient, it would have been obvious to administer the once daily dose recommended for treatment of gastrointestinal stomal tumors and see if the recommended dose is well tolerated. The 150mg/day dose is not a random treatment regiment selected from numerous other possibilities, as argued by applicant. It is the recommended dose for treatment of advanced gastrointestinal stomal tumor. For these reasons applicants arguments are not found to be convincing and the rejection of record is maintained.
Conclusion
Claim 6 is pending
Claims 6 is rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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