Every patent claim must be enabled; that is, the application must have enough information to teach a knowledgeable person how to make and use the invention. But how much disclosure is enough? Consider an invention that includes a threaded bolt to hold two objects together. Infinite variations in the threads are possible, including variations in the shape of the threads, thread pitch, size, tolerances, drunkenness (irregularity), material of which the threads are composed, surface treatments of the material, and others. Must the patent application specifically disclose every possible variation to the threads to meet the enablement requirement for a patent claim that includes a threaded bolt?
Here’s what the law says, at section 112(a) of the patent statute:
“The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to … to make and use the [invention]… .”
Makes perfect sense. The patent application must disclose enough information to allow a knowledgeable person to make and use the invention. Simple – that is, until it’s not so simple.
In our example, rather than reciting the infinite variations of the threads of the bolt, a typical patent claim might state “…a bolt configured for threaded engagement with [something else].” Although the claim is to a physical object – a bolt, the claim defines the bolt by what it does, rather than by its physical specifications. In patent parlance, the claim to the bolt is a functional claim. Functional claims are absolutely necessary because otherwise the claim would have the impossible task of reciting each of the infinite variations of the threads of the bolt and of every other component of the invention.
Almost all patent claims include functional elements, and functional elements are perfectly fine. Section 112(f) of the patent statute says:
“An element in a claim… may be expressed as a means… for performing a specified function and such claim shall be construed to cover the corresponding structure… described in the specification… .”
O.K., so the functional claim only covers the specific structure contained in the specification. Does that mean that the specification must specifically describe each of the infinite number of possible thread variations of the bolt? The task of including the infinite variations is just as impossible in the specification as it is in the claims.
So how much does the patent application have to disclose to support a valid patent with a functional claim? The Supreme Court recently accepted a case to answer this very question. Amgen v Sanofi is a biotechnology patent case to a cholesterol-lowering family of drugs. The Amgen claims address man-made antibodies based on the function of those antibodies; namely, based on the molecules to which the antibodies will bind. Amgen disclosed 26 antibodies that met the claim limitations, but there were potentially millions more that were not yet discovered. Those undiscovered antibodies, of course, were not disclosed in the specification. Was the Amgen application sufficient to claim all of the myriad possible antibodies that were not disclosed because identification of all of the antibodies was not practicable or even possible, or are the Amgen patent claims unfair to other inventors and invalid under the law because Amgen did not actually possess the inventions that it claimed? It’s a conundrum and, hopefully, the Amgen case will give us a definitive answer within a year.
The Amgen case is very important to every inventor and to every patent because Amgen has the potential to fundamentally change functional claims, and functional claims are part of almost every patent.
— Robert Yarbrough, Esq.