How should biological materials be identified in a patent application?
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.
According to MPEP 2406.01, biological materials must be specifically identified in the patent application as filed. The MPEP provides an example of proper identification:
“The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed.“
Key points for identifying biological materials:
- Provide a specific, unique identifier for the biological material (e.g., WI-L2-729 HF2 for the cell line).
- Describe the methods of obtaining and using the biological material.
- Include sufficient detail to distinguish the material from other similar materials.
- Ensure the identification is consistent with the description requirement of 35 U.S.C. 112.
Proper identification is crucial for establishing an antecedent basis for the biological material that will be or has been deposited.