What factors are considered when evaluating a treatment or prophylaxis limitation 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.

According to MPEP 2106.04(d)(2), there are three main factors to consider when evaluating a treatment or prophylaxis limitation in Step 2A Prong Two:

1. The particularity or generality of the treatment or prophylaxis: The limitation must be “particular,” i.e., specifically identified so that it does not encompass all applications of the judicial exception(s).
2. Whether the limitation(s) have more than a nominal or insignificant relationship to the exception(s): The treatment or prophylaxis must have more than a nominal or insignificant relationship to the exception(s).
3. Whether the limitation(s) are merely extra-solution activity or a field of use: The treatment or prophylaxis limitation must impose meaningful limits on the judicial exception and cannot be extra-solution activity or a field-of-use.

Examiners are advised to consider these factors in conjunction with other considerations, such as mere instructions to apply an exception (MPEP § 2106.05(f)), insignificant extra-solution activity (MPEP § 2106.05(g)), and field of use and technological environment (MPEP § 2106.05(h)).