Can biological material descriptions be supplemented after the filing date of 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.

Generally, supplementing biological material descriptions after the filing date is not allowed and can lead to issues:

• New matter rejections under 35 U.S.C. 112(a)
• Loss of priority date for added material
• Potential invalidity of the patent

MPEP 2406.01 states: “Information which is presented in the specification after the filing date (using information provided with the deposit of biological material) cannot be used to supplement the original disclosure to render the application enabling if it was not enabling as filed.” This emphasizes the importance of providing a complete and enabling description at the time of filing. Any attempt to add substantive information later may be considered new matter and could jeopardize the patent application.