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 1-3 are pending and now evaluated on its merit.
Priority
This application claims foreign benefit to EP22305324.0, dated 03/18/2022.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kapur et al. (US 20160208013 A1).
Regarding claims 1-3, Kapur teaches methods for treating a fibrotic disease of organ fibrosis by administering a composition that inhibits endoglin activity (abstract, para. 0012). The composition relates reducing cardiac damage, particularly cardiac damage as a result of chemotherapy or radiation therapy (relevant to claim 2) (para. 002). Kapur teaches endoglin was shown to be a central component of fibrogenic signaling in the RV and a positive regulator of TGFβ1-induced calcineurin/TRP expression, therefore reducing expression or activity of the membrane-bound receptor form of endoglin limits TGFβ1 signaling results in a reduction of organ fibrosis and improving survival (para. 0007). In a particular embodiment the composition results in a reduction, repairing, or remodeling of cardiac fibrosis (para. 009).
The invention taught by Kapur can be formulated or administered in combination with one or more anticancer drugs to improve clinical efficacy by reducing cardiotoxicity and cardiac damage side effects of prolonged use, wherein the anticancer drug is selected from a list of agents which includes dasatinib (para. 0087). The composition can additionally be administered in combination with one or more drugs that are used as secondary prevention drugs for cardiovascular diseases selected from a list of agents which includes lovastatin (para. 0089). Kapur additionally teaches the compounds of the present invention may be used in combination with either conventional methods of treatment or therapy (para. 0085).
In terms of claim 3, the limitation of myocardial infraction or hypertension merely further limits heart disease of claim 2 but does not recite the cardiac fibrosis of claim 2 is a heart disease in which the disease is myocardial infraction or hypertension.
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have administered a combination of dasatinib and lovastatin to treat cardiac fibrosis. One would have been motivated to do so because Kapur teaches a treatment of organ fibrosis, in particularly cardiac fibrosis by administration of an anticancer agent from a list which includes dasatinib and agent for cardiovascular disease from a list of agents which includes lovastatin. There is a reasonable expectation of treating cardiac fibrosis by administration of dasatinib and lovastatin from the teachings of Kapur.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
