Last updated: August 17, 2026

How Does Predictability Affect Enablement?

Whether a patent application is enabled is dependent upon, among other things, the subject matter of the invention. A line of cases related to "predictable" inventions suggests that a single example of making and using the claimed invention is sufficient for enabling a person to practice the scope of patent application without undue experimentation.

In a second line of cases related to "unpredictable" inventions such as biotechnology, pharmaceutical, AI, and to a lesser degree medical device inventions, courts have held that a range of examples is desired to meet the enablement requirement. In 2023, a landmark decision in Amgen Inc. v. Sanofi by the Supreme Court heavily impacted enablement for all such technology fields. Amgen had claimed an entire class of antibodies and only described their functions, not structure. Furthermore, they only shared 26 examples and gave a vague “roadmap” and “conservative substitution” for the vast amount of other unspecified antibodies. The Supreme Court unanimously ruled that if a patent claims an entire class, it would have to enable someone to make and use that entire class as well. The USPTO has since updated its guidelines to reflect this ruling in addition to using In re Woods.

Thus, it is our practice at Torrey Pines Law Group to describe as many alternative embodiments of an unpredictable invention as possible. If a variety of homologous polynucleotide or polypeptide sequences are effective in the invention, we ask our clients to describe them in examples. Examples are likewise requested with respect to alternative vectors, cell lines, salts, indications, analogs, algorithms, and the like. This provides the best opportunity to fully enable a patent application and issue a patent.

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