When should the markedly different characteristics analysis be performed?

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.

The markedly different characteristics analysis should be performed when evaluating nature-based product limitations in a claim. However, it’s important to note that not all claims containing nature-based products require this analysis.

According to the MPEP, “Examiners should keep in mind that if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.“

The analysis should be applied in the following situations:

• When the claim is to a nature-based product by itself (e.g., “a Lactobacillus bacterium”)
• When the claim is to a nature-based product produced by combining multiple components
• When the claim is to a nature-based product in combination with non-nature based elements
• For product-by-process claims involving nature-based products
• For certain process claims that are essentially no different from a product claim

It’s important to apply the analysis only to the nature-based product limitations in the claim, not to the entire claim if it includes other non-nature-based elements.