How does an invention rely on biological material in a patent application?

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.

An invention can rely on biological material in a patent application in various ways, as described in MPEP 2404:

“The invention may rely on a biological material for the purposes of making or using the invention, either as a preferred mode or an alternative mode of operation.“

This means that biological material can be integral to an invention in several contexts:

• As a component necessary for making the invention
• As an element required for using or implementing the invention
• As part of the preferred embodiment or best mode of the invention
• As an alternative method or variant of the invention

Inventors should clearly describe how the biological material relates to their invention in the patent application, regardless of whether a deposit is required or not.