What is considered biological material capable of self-replication?

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.

Biological material capable of self-replication includes material that can reproduce either directly or indirectly. According to MPEP 2403.01:

“Biological material includes material that is capable of self-replication either directly or indirectly. Direct self-replication includes those situations where the biological material reproduces by itself.”

Examples of directly self-replicating materials are provided in the rule. Indirect self-replication refers to situations where the biological material can only replicate in the presence of another self-replicating biological material, such as when inserted into a host.