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List two laboratory techniques the courts have recognized as well-understood, routine, conventional activities in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
- 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; and
- Hybridizing a gene probe.
The answer to this question can be found in chapter 2100 of the MPEP. This chapter covers Patentability.
The answer is from the 9th Edition, Revision 10.2019. Depending on future changes to the MPEP, the question and answer may or may not be applicable in later Editions or revisions.
This question and answer come from section 2106.05(d) of the MPEP. The following is a brief summary of section 2106.05(d).
2106.05(d) Well-Understood, Routine, Conventional Activity
Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry. This consideration is only evaluated in Step 2B of the eligibility analysis.