Case 1: Rapid Litigation Management v. CellzDirect:

On July 5, 2016, the Federal Circuit held the claimed methods of cryopreserving hepatocyte cells patent eligible under 35 U.S.C. § 101 because they are not directed to a judicial exception.

The claims recite a method of producing a preparation of hepatocytes "capable of being frozen and thawed at least two times,'' comprising performing density gradient fractionation to separate viable and non-viable hepatocytes, recovering the viable hepatocytes, and cryopreserving the recovered viable hepatocytes.

• The Federal Circuit determined that although the "inventors certainly discovered the cells' ability to survive multiple freeze-thaw cycles ... that is not where they stopped, nor is it what they patented."
• Instead, the inventors "employed their natural discovery to create a new and improved way ofpreserving hepatocyte cells for later use."
• As a result, the court held the claims eligible under the first step of the Mayo/Alice framework (Step 2A in the USPTO's subject matter eligibility guidance).

In reaching its conclusion, the Federal Circuit highlighted several important points regarding the subject matter eligibility analysis, in particular regarding whether a claim is directed to law of nature (Step 2A).

First, the court emphasized that 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."

• The end result of the claims at issue is not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles, but instead the claims recite a number of process steps (e.g., fractionating, recovering, and cryopreserving) that manipulate the hepatocytes in accordance with their ability to survive multiple freeze-thaw cycles to achieve a desired outcome (a preparation of multi-cryopreserved viable hepatocytes).
• Because these claims were focused on a process for achieving this desired outcome, the court determined that they, like thousands of other claims that recite methods of producing things or methods of treating disease, were not directed to a judicial exception.
• This need to analyze the focus of the claims in Step 2A was also emphasized in the Federal Circuit's Enfish decision (discussed in the May 19, 2016 memorandum to examiners).

Second, the court noted that these claims that apply a law of nature are distinguishable from the claims in Mayo and Sequenom that were found to be directed to a patent-ineligible concept when they "amounted to nothing more than observing or identifying the ineligible concept itself."

Case 2: Sequenom v. Ariosa:

On June 27, 2016, the Supreme Court issued an order denying a petition for a writ of certiorari in Sequenom v. Ariosa, which leaves in place the Federal Circuit panel decision from June 2015 invalidating Sequenom's method claims as patent ineligible subject matter.

In the panel decision, the Federal Circuit applied the two-step framework set out in Mayo and Alice (Steps 2A and 2B in the USPTO's subject matter eligibility guidance) to determine that the claims were directed to a natural phenomenon (the presence of cffDNA in maternal serum or plasma), and that they did not recite an inventive concept that transforms cffDNA into a patentable invention because the amplifying and detecting steps are routine and conventional.