The analysis of whether the claim includes other meaningful limitations may be relevant for both eligibility analysis Step 2A Prong Two, and Step 2B.
The claim should add meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment to transform the judicial exception into patent-eligible subject matter. The phrase “meaningful limitations” has been used by the courts even before Alice and Mayo in various contexts to describe additional elements that provide an inventive concept to the claim as a whole. The considerations described in MPEP § 2106.05(a)-(d) are meaningful limitations when they amount to significantly more than the judicial exception, or when they integrate a judicial exception into a practical application. This broad label signals that there can be other considerations besides those described in MPEP § 2106.05(a)-(d) that when added to a judicial exception amount to meaningful limitations that can transform a claim into patent-eligible subject matter.
Diamond v. Diehr provides an example of a claim that recited meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment. 450 U.S. 175, 209 USPQ 1 (1981). In Diehr, the claim was directed to the use of the Arrhenius equation (an abstract idea or law of nature) in an automated process for operating a rubber-molding press. 450 U.S. at 177-78, 209 USPQ at 4. The Court evaluated additional elements such as the steps of installing rubber in a press, closing the mold, constantly measuring the temperature in the mold, and automatically opening the press at the proper time, and found them to be meaningful because they sufficiently limited the use of the mathematical equation to the practical application of molding rubber products. 450 U.S. at 184, 187, 209 USPQ at 7, 8. In contrast, the claims in Alice Corp. v. CLS Bank International did not meaningfully limit the abstract idea of mitigating settlement risk. 573 U.S. 208, 110 USPQ2d 1976 (2014). In particular, the Court concluded that the additional elements such as the data processing system and communications controllers recited in the system claims did not meaningfully limit the abstract idea because they merely linked the use of the abstract idea to a particular technological environment (i.e., “implementation via computers”) or were well-understood, routine, conventional activity recited at a high level of generality. 573 U.S. at 225-26, 110 USPQ2d at 1984-85.
Classen Immunotherapies Inc. v. Biogen IDEC provides another example of claims that recited meaningful limitations. 659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011) (decision on remand from the Supreme Court, which had vacated the lower court’s prior holding of ineligibility in view of Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010)). In Classen, the claims recited methods that gathered and analyzed the effects of particular immunization schedules on the later development of chronic immune-mediated disorders in mammals in order to identify a lower risk immunization schedule, and then immunized mammalian subjects in accordance with the identified lower risk schedule (thereby lowering the risk that the immunized subject would later develop chronic immune-mediated diseases). 659 F.3d at 1060-61; 100 USPQ2d at 1495-96. Although the analysis step was an abstract mental process that collected and compared known information, the immunization step was meaningful because it integrated the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application.” 659 F.3d at 1066-68; 100 USPQ2d at 1500-01. In contrast, in OIP Technologies, Inc. v. Amazon.com, Inc., the court determined that the additional steps to “test prices and collect data based on the customer reactions” did not meaningfully limit the abstract idea of offer-based price optimization, because the steps were well-understood, routine, conventional data-gathering activities. 788 F.3d 1359, 1363-64, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015).
With respect to treatment or prophylaxis limitations, such as the immunization step in Classen, examiners should note that the other meaningful limitations consideration overlaps with the particular treatment or prophylaxis consideration that is evaluated in Step 2A Prong Two (see MPEP § 2106.04(d)(2)).
When evaluating whether additional elements meaningfully limit the judicial exception, it is particularly critical that examiners consider the additional elements both individually and as a combination. When an additional element is considered individually by an examiner, the additional element may be enough to qualify as “significantly more” if it meaningfully limits the judicial exception, and may also add a meaningful limitation by integrating the judicial exception into a practical application. However, even in the situation where the individually-viewed elements do not add significantly more or integrate the exception, those additional elements when viewed in combination may render the claim eligible. See Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ2d 1, 9 (1981) (“a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made”); BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1349, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016). It is important to note that, when appropriate, an examiner may explain on the record why the additional elements meaningfully limit the judicial exception.