What are some examples of products that have been found to have or lack markedly different characteristics?

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 MPEP provides several examples of products that have been found to have or lack markedly different characteristics from their natural counterparts. These examples are based on court decisions and help illustrate the application of the analysis.

Products found to have markedly different characteristics:

• Chakrabarty’s genetically modified bacterium: “This bacterium had a changed functional characteristic, i.e., it was able to degrade at least two different hydrocarbons as compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon.“
• Myriad’s cDNA: “This claimed cDNA had the same functional characteristics (i.e., it encoded the same protein) as the naturally occurring gene, but had a changed structural characteristic, i.e., a different nucleotide sequence containing only exons, as compared to the naturally occurring sequence containing both exons and introns.“

Products found to lack markedly different characteristics:

• Myriad’s isolated DNA: “The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes.“
• Ambry Genetics’ DNA primers: “The court disagreed, concluding that the primers’ structural characteristics were not markedly different than the corresponding strands of DNA in nature, because the primers and their counterparts had the same genetic structure and nucleotide sequence.“
• Roslin’s cloned mammals: “The court was unpersuaded, explaining that the clones were exact genetic replicas of the donors and thus did not possess markedly different characteristics.“

These examples demonstrate that both structural and functional changes can potentially lead to markedly different characteristics, but the changes must be significant and not merely incidental or inherent to the natural product.