So, you’ve come up with an invention.  Great!  Now it’s time to apply for your patent.  So how much information must you supply in your patent application?  The general rule is that you must provide ‘enablement’; that is, you must provide enough information in the text and drawings so that a person knowledgeable in the field of the invention can make and use the invention as claimed, “without undue experimentation.”  

That’s all well and good, but why should an inventor care?  

Enablement is crucial to protecting your invention. If the USPTO or a court determines that a claim of a pending application or an issued patent is not ‘enabled,’ then the patent will not be issued or the issued patent will not be enforced.  Enablement is simple enough where a patent application teaches a specific thing (e.g., a bolt) or a specific way of doing something (e.g., attaching things together using a bolt), and the claims are limited to that specific thing or specific way of doing things.  Few patents are so limited. Most, if not all, patents include ‘functional’ claims; that is, claims that describe elements by the result to be achieved (e.g., an apparatus configured to attach two things together). Functional claims are particularly useful, and necessary, when the function is the invention and where the inventor cannot anticipate all of the ways that the function can be achieved.

The Federal Circuit Court came up with factors to consider in determining whether claims are valid or not based on enablement, known as the ‘Wands factors.’  A few of the Wands factors:

  • Quantity of experimentation.  The more experimentation needed, the more likely that the claim is not enabled.
  • Amount of guidance in the application.  The less guidance, the more likely the claim is not enabled.
  • Working examples.  The existence of working examples makes enablement more likely.
  • State of the art.  If the claimed invention is a leap forward in the art, the less likely that a claim is enabled. If it’s an incremental change, the more likely that the claim is enabled.
  • Breadth of the claims.  If the claims are broad, the less likely that the claims are enabled.  If the claims are narrow, the more likely the claims are enabled.

The issue of enablement for functional claims (claims based on the result achieved) is now pending before the Supreme Court.  The case is Amgen v Sanofi.  Amgen’s patent addresses artificial antibodies that help reduce a dangerous type of cholesterol in the blood of a patient.  The patent claims are purely functional and address any artificial antibody that binds to a particular location in the patient’s body and that blocks another molecule from binding to that location.  While the patent application discloses a few of the antibodies that meet these criteria, there are millions of others that have not been discovered yet and that were not disclosed in the patent application.  

Every court that has considered this case (the trial court and the Federal Circuit Court) concluded that Amgen’s functional claims were not enabled using the Wands factors and hence that the claims were unenforceable.   The Supreme Court held oral arguments on March 27, 2023.  It did not go well for Amgen.  The Supreme Court could simply affirm the decision of the Federal Circuit, without damage to the U.S. patent system.  But the Supreme Court does not accept a patent case to affirm the Federal Circuit.  The danger is that the Supreme Court will conclude that functional claims are not directed to patentable subject matter and outlaw functional claims entirely. Such mischief from the Supreme Court would up-end the patent system again, adversely affect most if not all patents and applications, and reduce the ability of inventors to protect their inventions. Let’s hope the Supreme Court exercises some restraint for once.

— Robert Yarbrough, Esq.