Trilateral Project 24.1-Biotechnology 081

As above, the issue revolves around undue experimentation. considerations of the nature of the art and primarily the unpredictability of operating the invention across the breadth of the claim require a case-by-case analysis.

Dependent upon the degree of guidance in the specification and the date of filing, there may be issues of enablement related to how to make a plant or animal comprising the cDNA. There might also be issues as to how to produce and recover the claimed protein because the use of plants and animals per se is not analogous to as in vitro culturing procedure that can be used for single cells and microorganisms.