How do you select the appropriate counterpart for the markedly different characteristics 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.

Selecting the appropriate counterpart is a crucial step in the markedly different characteristics analysis. The MPEP provides guidance on this process:

“Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.“

Here are some key points to consider:

• When the nature-based product is derived from a naturally occurring thing, that naturally occurring thing is the counterpart.
• The counterpart should be in its natural state, but care should be taken not to confuse it with other material that may occur naturally with or adjacent to it.
• When there are multiple potential counterparts, the comparison should be made to the closest naturally occurring counterpart.
• For combinations of multiple components, the closest counterparts may be the individual components of the combination.

For example, if a claim is for a modified gene, the counterpart would be the naturally occurring gene, not the entire chromosome it’s found in. If the claim is for a mixture of bacteria from different species, the counterparts would be each individual species in its natural state.