Four Decisions Designated Informative on 101: Positive Trend for Life Sciences?

July 2, 2019 – Article

In January, 2019, the USPTO issued new guidance about what constitutes an abstract idea that is ineligible for protection under Section 101. Among other things, the guidance emphasized that claims otherwise reciting a judicial exception (i.e., not patentable), would be permitted if they were directed to some type of practical application. See our previous post for more details. 

Yesterday, the PTAB designated four decisions as informative, all of which explicitly rely on the 2019 guidance. 

Two cases, Ex Parte Kimizuka and Ex Parte Savescu, were upheld as directed to unpatentable subject matter. In the first, a method of selecting a golf club tailored to an individual player was found to be a purely mental process, and the second was a software program that created a life-cycle workflow for a project, held to be a method of organizing human activity that was not integrated into a practical application.

But, two cases reversed examiner’s decisions holding the claims unpatentable, and provide helpful insight as to how a practical application can be incorporated into a claim.  Significantly, both were directed to medical imaging, hopefully indicating the beginning of a positive trend for life sciences patentabilty under 101.

In the first, Ex Parte Olson, the PTAB agreed with the examiner that the claims meet the first step of the Alice test, as they are directed to mathematical relationships. But, the Board held the examiner erred in understanding that the claims “integrate the judicial exception into a practical application.” In particular, the claims include several limitations that are specific to 3D heart imaging, focused on addressing problems arising in the context of a catheter navigation system used to create a three-dimensional image in connection with cardiac procedures. Although the Board concluded that these limitations were sufficient to integrate the judicial exception into a practical application, and thus rendered the claims patentable, the Board also found that the mathematical concepts were applied with a particular machine, i.e., the catheter navigation system.   Thus, the Board reversed the examiner’s decision.

The second case, Ex Parte Fautz, was similar. The PTAB agreed that the claims, directed to magnetic resonance imaging, recite a mathematical concept and are thus directed to an unpatentable abstract idea. But, the Board disagreed with the examiner’s characterization of the device’s operation as abstract overall. The Board pointed to specific additional elements in the claim reflecting a narrow improvement in technology that tied the mathematical concept to a practical application. In short, the claims improve sensitivity correction by using a specific method that could be applied to more magnetic resonance imaging devices than methods known in the art. Thus, the Board reversed the examiner’s decision.

Arguably the lessons from these cases are nothing new, as the same general idea has been around since Diamond v. Diehr: tying an abstract mathematical algorithm to a particular application should be sufficient to render a claim patentable. But, the value in these cases is the detailed analysis that tracks the 2019 USPTO guidance. This analysis provides a road map for practitioners to follow in both claim drafting and in addressing 101 rejections, which could ultimately lead to more claims surviving 101 rejections.