What is considered “undue experimentation” in patent law?
“Undue experimentation” in patent law refers to the excessive or unreasonable amount of experimentation required for a person skilled in the art to make and use the claimed invention based on the disclosure in the patent application. This concept is crucial in determining whether an application meets the enablement requirement under 35 U.S.C. 112(a).
MPEP 2164.06(a) states:
“The test is not merely quantitative, since a considerable amount of experimentation is permissible, if 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.”
Factors considered in determining whether experimentation is undue include:
- The breadth of the claims
- The nature of the invention
- The state of the prior art
- The level of one of ordinary skill in the art
- The predictability or unpredictability of the art
- The amount of direction provided by the inventor
- The existence of working examples
- The quantity of experimentation needed to make or use the invention based on the content of the disclosure
If the required experimentation is deemed undue, the patent application may be rejected for lack of enablement.
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