Is it possible to satisfy 35 U.S.C. 112 description requirements if the biological material didn’t exist at the filing date?

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.

While it’s extremely rare, the MPEP 2406.02 does not completely rule out the possibility of satisfying the description requirements of 35 U.S.C. 112 even if the biological material didn’t exist at the filing date. The MPEP states:

“While few, if any, situations can be imagined where the description requirement of 35 U.S.C. 112 can be satisfied where the biological material was not in existence at the time of filing, the rules will not preclude such a situation as there is no requirement in the patent law that an actual reduction to practice occur as a condition precedent to filing a patent application.”

This suggests that while highly unlikely, there’s no absolute prohibition against such scenarios in patent law.