What issues can arise when determining enablement for biotechnological inventions?

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.

When determining enablement for biotechnological inventions, a key issue that can arise is the availability of starting materials or apparatus necessary to make the invention. MPEP 2164.01(b) states: “In the biotechnical area, this is often true when the product or process requires a particular strain of microorganism and when the microorganism is available only after extensive screening.” This means that if a specific microorganism strain is crucial for the invention and is not readily available, the patent application may need to provide more detailed information on how to obtain or produce this strain to satisfy the enablement requirement.