What is the significance of “undue experimentation” in patent enablement?

“Undue experimentation” is a critical concept in patent enablement. It refers to the level of experimentation required for a person skilled in the art to make and use the full scope of the claimed invention. The MPEP states:

“The Federal Circuit has repeatedly held that ‘the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.'” (MPEP 2164.08)

If the amount of experimentation required is considered “undue,” the claim may be rejected for lack of enablement. 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 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

The presence of undue experimentation can lead to a rejection under 35 U.S.C. 112(a) for lack of enablement.

To learn more:

• undue experimentation
• enablement
• patent claims
• skilled artisan