What are some examples of well-understood, routine, conventional activities in life science arts?
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 2106.05(d) provides several examples of laboratory techniques that courts have recognized as well-understood, routine, conventional activity in the life science arts when claimed in a merely generic manner or as insignificant extra-solution activity. These include:
- Determining the level of a biomarker in blood by any means
- Using polymerase chain reaction to amplify and detect DNA
- Detecting DNA or enzymes in a sample
- Immunizing a patient against a disease
- Analyzing DNA to provide sequence information or detect allelic variants
- Freezing and thawing cells
- Amplifying and sequencing nucleic acid sequences
- Hybridizing a gene probe
It’s important to note that while these techniques are considered well-understood, routine, and conventional, their specific application or combination with other elements in a claim may still contribute to patent eligibility. Each claim should be analyzed as a whole to determine if it amounts to significantly more than the judicial exception.