How does the markedly different characteristics analysis apply to product-by-process claims?

The markedly different characteristics analysis applies to product-by-process claims involving nature-based products in a specific way. The MPEP states:

“For a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.“

Key points to consider:

• The focus is on the product itself, not the process by which it is made.
• The analysis compares the claimed product to its naturally occurring counterpart.
• If the product has markedly different characteristics from its natural counterpart, it may be eligible for patenting (subject to other requirements).
• If the product does not have markedly different characteristics, it is considered a product of nature exception, regardless of the process used to create it.

For example, in the case of a cloned animal, the analysis would compare the characteristics of the cloned animal to those of its naturally occurring counterpart, rather than focusing on the cloning process itself.

It’s important to note that even if a product-by-process claim is found to be directed to a product of nature exception, it may still be eligible if it integrates the exception into a practical application or provides significantly more than the exception.

Markedly Different Characteristics Analysis for Product of Nature Exceptions MPEP 2106.04(c) Informative
Requirement for Markedly Different Characteristics Analysis MPEP 2106.04(c) Informative
Comparison to Natural Animals Required for Product of Nature Analysis MPEP 2106.04(c) Informative
Guidelines for Markedly Different Characteristics Analysis MPEP 2106.04(c) Informative
Markedly Different Characteristics Analysis for Nature-Based Products MPEP 2106.04(c) Informative