What is the significance of “efficacy” in determining prior art operability for patent examinations?
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.
In patent examinations, the “efficacy” of a prior art reference is not a determining factor for its operability. As stated in MPEP 2121.02:
“A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; ‘proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.’”
This means that:
- A prior art reference can be considered operable even if it’s not highly effective.
- The reference only needs to enable a person of ordinary skill to practice the invention.
- Lack of efficacy does not automatically disqualify a reference as prior art.
Examiners focus on whether the reference enables the claimed invention, not on how well it performs.