How does the USPTO define direct self-replication of biological materials?

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.

The United States Patent and Trademark Office (USPTO) defines direct self-replication of biological materials in MPEP 2403.01 as follows:

“Direct self-replication includes those situations where the biological material reproduces by itself.”

This means that the biological material can reproduce independently, without requiring the presence of another self-replicating biological material. The MPEP indicates that representative examples of materials capable of direct self-replication are defined in the rule, although specific examples are not provided in this section.