How does the USPTO evaluate the level of experimentation required for an invention?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

The USPTO evaluates the level of experimentation required for an invention as part of the enablement assessment. According to MPEP 2164.01(a), this evaluation considers whether the experimentation needed is “undue.” The MPEP states:

“The determination that ‘undue experimentation’ would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.”

This means that examiners must consider all Wands factors, including the nature of the invention, the state of the prior art, the level of skill in the art, and the amount of guidance provided in the specification. The quantity of experimentation must be evaluated in light of these factors to determine if it is “undue” or beyond what would be reasonable for a person skilled in the art.