What factors are considered when evaluating a treatment or prophylaxis limitation in Step 2A Prong Two?

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)).

To learn more:

• Treatment Limitation
• Prophylaxis Limitation
• Patent Eligibility
• Step 2A Prong Two
• Evaluation Factors