What is the rebuttable presumption of identity in patent law?

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 rebuttable presumption of identity in patent law refers to the USPTO’s assumption that a replacement deposit is identical to the original deposit. This concept is explained in MPEP 2407.04:

“37 CFR 1.805(e) indicates that the Office will apply a rebuttable presumption of identity between the replacement deposit and an original deposit where a patent making reference to the deposit is relied on during any Office proceeding.”

This presumption means that the USPTO assumes the replacement deposit contains the same material as described in the patent, unless evidence is presented to prove otherwise. It simplifies the examination process and maintains consistency in patent proceedings involving biological materials.