What is the “particular treatment or prophylaxis” consideration in Step 2A Prong Two?

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 “particular treatment or prophylaxis” consideration is a way to demonstrate that a claim integrates a judicial exception into a practical application. According to MPEP 2106.04(d)(2), “One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.”

This consideration is based on the Supreme Court’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., which held that claims reciting a specific method of treatment were patent-eligible.