What is considered a “biotechnological process” under pre-AIA 35 U.S.C. 103(b)?

Pre-AIA 35 U.S.C. 103(b) provides a specific definition for a “biotechnological process.” According to the statute, it includes:

1. A process of genetically altering or inducing a single- or multi-celled organism to:
   • Express an exogenous nucleotide sequence
   • Inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence
   • Express a specific physiological characteristic not naturally associated with the organism
2. Cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody
3. A method of using a product produced by the above processes

This definition is crucial for determining whether a process qualifies for the special treatment under pre-AIA 35 U.S.C. 103(b).

To learn more:

• biotechnological process
• pre-AIA 35 U.S.C. 103(b)
• genetic alteration
• cell fusion
• patent law