How can a treatment or prophylaxis limitation qualify for 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.

For a treatment or prophylaxis limitation to qualify for consideration in Step 2A Prong Two, it must meet certain criteria. According to MPEP 2106.04(d)(2):

“Examiners should keep in mind that in order to qualify as a ‘treatment’ or ‘prophylaxis’ limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition.”

Examples of qualifying limitations include:

• “Administering amazonic acid to a patient”
• “Administering a course of plasmapheresis to a patient”

Conversely, limitations that do not qualify include:

• Intended use statements (e.g., “for treating a patient”)
• Field of use limitations (e.g., “a pharmaceutical composition”)
• Non-specific actions (e.g., “prescribing a topical steroid to a patient with eczema”)