How do you select the appropriate counterpart for the markedly different characteristics analysis?

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.

To learn more:

• markedly different characteristics analysis
• natural counterpart
• nature-based products
• patent eligibility