While enablement is a fact specific inquiry and it may be difficult to take more from this case than the fact that pig testing can substitute for human testing in certain medical device technologies, it is noteworthy that the court recognized as well as sanctioned the proposition that the invention may not be entirely complete at the time of filing: “[c]ontinuing development is often contemplated and necessary, while early filing is often essential.”
Background / Facts: The patent here was directed to a collapsible stent that carries a valve for insertion into the heart by a balloon catheter. The only ground on which CoreValve challenged validity of the patent was for lack of enablement based on the undisputed fact that at the time the application was filed, the stent/valve prosthesis had been implanted only in pigs. CoreValve also pointed out that the various experimental implants in pigs were not always successful, and that design changes were made after the application was filed.
Issue(s): Whether testing in pigs is enabling for use in humans when such use has not been achieved at the time of filing.
Holding(s): Yes. “[I]t has long been recognized that when experimentation on human subjects is inappropriate, as in the testing and development of drugs and medical devices, the enablement requirement may be met by animal tests or in vitro data.” Testing for the full safety and effectiveness of a prosthetic device is more properly left to the Food and Drug Administration. Title 35 does not demand that such human testing occur within the confines of PTO proceedings. In this case, there was evidence that the stent/valve prosthetic device was successfully implanted in pigs, in accordance with the procedure described in the specification, and that pigs are a standard experimental animal for heart valve research.