How do you determine if a characteristic is “markedly different”?

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.

Determining whether a characteristic is “markedly different” is a critical part of the analysis for patent eligibility of nature-based products. The MPEP provides guidance on this evaluation:

“The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart.“

Key points to consider:

• The characteristic must be changed as compared to the natural counterpart.
• The change must be caused by the inventor’s efforts or influences.
• Inherent or innate characteristics of the natural counterpart cannot be considered markedly different.
• Incidental changes are not sufficient to establish a marked difference.

Examples of markedly different characteristics include:

• A bacterium with additional plasmids that give it the ability to degrade multiple hydrocarbons (as in the Chakrabarty case).
• cDNA with a different nucleotide sequence than its natural DNA counterpart (as in the Myriad case).

Examples of characteristics that were not considered markedly different include:

• Isolated genes that have the same nucleotide sequence as natural genes (Myriad case).
• Primers with the same nucleotide sequence as portions of natural DNA (Ambry Genetics case).
• Cloned animals with the same genetic material as their donors (Roslin case).

It’s important to note that the analysis is case-specific, and the determination of whether a characteristic is markedly different depends on the nature of the claimed product and its relationship to the natural counterpart.