What is considered biological material capable of self-replication?

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.

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Topics: MPEP 2400 - Biotechnology, MPEP 2403.01 - Material Capable Of Self - Replication, Patent Law, Patent Procedure
Tags: biological material, biotechnology patents, patent law, Self-Replication