What is required to satisfy 35 U.S.C. 112 regarding how to use a claimed invention?

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.

To satisfy 35 U.S.C. 112 regarding how to use a claimed invention, the following conditions are sufficient:

• A statement of utility in the specification that contains a connotation of how to use
• The art recognizes that standard modes of administration are known and contemplated

As stated in the MPEP, If a statement of utility in the specification contains within it a connotation of how to use, and/or the art recognizes that standard modes of administration are known and contemplated, 35 U.S.C. 112 is satisfied. (MPEP 2164.01(c))

It’s important to note that the applicant is not required to demonstrate that the invention is completely safe.