What is the “correlation” issue in patent enablement?
The “correlation” issue in patent enablement refers to the relationship between in vitro or in vivo animal model assays and a disclosed or claimed method of use. The MPEP 2164.02 explains:
“‘Correlation’ as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a ‘working example’ if that example ‘correlates’ with a disclosed or claimed method invention.”
Key points about correlation:
- It’s related to the presence or absence of working examples
- Depends on the state of the prior art
- A rigorous or invariable exact correlation is not required
- The examiner must give reasons for a conclusion of lack of correlation
The Federal Circuit in Cross v. Iizuka stated that “a reasonable correlation” between in vitro utility and in vivo activity is sufficient, based on the relevant evidence as a whole.
To learn more:
Topics:
MPEP 2100 - Patentability,
MPEP 2164.02 - Working And Prophetic Examples,
Patent Law,
Patent Procedure