What role do screening tests play in biological material patent applications?

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.

Screening tests play a crucial role in biological material patent applications, particularly when determining whether a deposit is necessary. The MPEP 2404.02 states:

“No deposit is required, however, where the required biological materials can be obtained from publicly available material with only routine experimentation and a reliable screening test.”

The role of screening tests in this context includes:

• Verifying the identity and characteristics of the biological material
• Demonstrating that the material can be reliably obtained or isolated
• Supporting the claim that no undue experimentation is required
• Helping to establish the enablement of the invention

A reliable screening test can be a key factor in convincing patent examiners that a deposit is unnecessary, as it shows that the biological material can be consistently identified and obtained using routine methods.