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

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

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).