All patent applications, including provisional applications, must teach enablement of the claimed inventions. This is required by 35 U.S.C. §112, paragraph 1. See provisional-patent and the patent application. The specification of the application must describe the manner and process of making and using the invention in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention.
The court has boiled this requirement down to the “enablement requirement is satisfied when one skilled in the art, after ready the specification, could practice the claimed invention without undue experimentation”. AK Steel, 344 F.3d 1234 at 1244 (F.C.C.A. 2003), In re Wands, 858 F.2d 731 at 736-37 (F.C.C.A. 1988).
The court in Wands, discussed “undue experimentation”. It requires analysis of reasonableness having due regard for the nature of the invention and state of the art. The test is not merely quantitative since a considerable amount of experimentation is permissible, it is merely routine or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed.
It is important to note that the claims of the application define the invention. During the prosecution of the application, the claims often are amended. It is essential that the amended claims are enabled by the original specification of the application. Since enablement is a question of law, it will not be decided by the jury in an infringement action. Since patents are presumed valid, the infringer has the burden of proving invalidity by clear and convincing evidence. Whether a claim is anticipated by the prior, i.e., it is not new, is a question of fact which can be decided by a jury. To continue, the scope of the patent is determined as a question of law by the judge based upon review of the claims. Whether the claims, as determined by the judge, have been infringed, is a question of fact that can be decided by a jury.
The point of all this is that the court again recently held the claims of a patent holder invalid based upon a challenger successfully demonstrating the specification did not meet the enablement test. Reference Liebel-Flarsheim Company and Mallinckrodt, Inc., v. Medrad, Inc. 06-1156-1157