How does the “state of the prior art” impact the undue experimentation analysis?
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 “state of the prior art” is an important Wands factor in determining whether undue experimentation is required to practice an invention. This factor considers:
- Existing knowledge in the field at the time of the invention
- Available techniques and technologies
- Level of predictability in the art
As stated in MPEP 2164.01(a):
“The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement.”
If the prior art is well-developed and the field is predictable, less guidance may be needed in the patent specification to enable the invention. Conversely, if the invention is in a nascent field or involves unpredictable factors, more detailed disclosure may be required to avoid undue experimentation. Examiners consider the state of the prior art to assess what would be considered routine experimentation versus undue experimentation for a person skilled in the art.