The USPTO issued a memorandum to the examining corps entitled Recent Subject Matter Eligibility Rulings (Rapid Litigation Management v. CellzDirect and Sequenom v. Ariosa) on July 14, 2016. The Patent 213 Blog has previously reviewed each of these cases. The USPTO notes that the decisions do not change the subject matter eligibility framework and that the subject matter eligibility guidance previously issued is consistent with both CellzDirect and Sequenom. The USPTO did, however, acknowledge that the CellzDirect decision provided guidance on the proper inquiry for determining whether the claims are “directed to” a judicial exception.

In the CellzDirect decision, the Federal Circuit found the claims patentable under step one of the Alice framework (which corresponds to Step 2A in the USPTO’s analytical framework). Specifically, the court characterized the claims as being directed to “a new and useful laboratory technique for preserving hepatocytes” and determined that such processes carried out to achieve “a new and useful end is precisely the type of claim that is eligible for patenting.”

The July memorandum takes notice of several important points in the CellzDirect decision. Specifically, the USPTO quoted the portion of the CAFC’s opinion outlining the requirements under the “directed to” inquiry. In CellzDirect, the panel noted the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole, was a patent-ineligible concept.” In discussing this point, the July Memorandum notes that the claims in CellzDirect were not simply an “observation or recitation” of the ability of hepatocytes to survive multiple freeze-thaw cycles but were directed to specific process steps that manipulated the hepatocytes to “in accordance with their ability to survive multiple freeze-thaw cycles.” The July Memorandum stresses determination of the “focus” of the claims under the directed to inquiry. The claims in CellzDirect, as focused on the process for achieving the desired outcome, were not directed to the judicial exception. The USPTO noted that a similar approach was used in the recent Enfish decision.

The “directed to” INQUIRY requires an analysis of whether the end result of the process, the essence of the whole, was a patent-ineligible concept.

Finally, the distinction made by the Federal Circuit between the claims in CellzDirect on one hand and Sequenom and Mayo on the other was noted. The claims in Mayo and Sequenom, rather than being focused on a process for achieving a desired outcome “were found to be directed to a patent-ineligible concept when they ‘amounted to nothing more than observing or identifying the ineligible concept itself.’”

Regarding Sequenom, the July Memorandum specifically notes that the U.S.S.C.’s denial of cert “does not elevate” the significance of the original decision or alter the way in which the original decision is applied.