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Question:
What is the issue of correlation as related to matters of invitro/in vivo?
Answer:
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 08.2017. Depending on future changes to the MPEP, the question and answer may or may not be applicable in later Editions or revisions.
Chapter Details:
“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. If there is no correlation, then the examples do not constitute “working examples.”
Section Summary:
This question and answer comes from section 2164.02 of the MPEP. The following is a brief summary of section 2164.02.
2164.02 Working Example
Compliance with the enablement requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, does not turn on whether an example is disclosed.
An example may be “working” or “prophetic.” A working example is based on work actually performed.
A prophetic example describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved. Further details on the working example are discussed here.