{1:35 minutes to read} Recently, the USPTO issued a memorandum for the examiners with regard to subject matter eligibility of livescience method claims. This memorandum is based upon a Federal Circuit case decided on July 5, 2016: Rapid Litigation Management vs. CellzDirect.

The Federal Circuit held that the claims recite a method of producing a preparation of hepatocytes “capable of being frozen and thawed at least two times.”

The claims include steps such as performing density gradient fractionation, recovering viable hepatocytes, and cryopreserving the recovered viable hepatocytes. In other words, the claims described routine steps. However, the Federal Court determined that the inventors “certainly discovered” the cells ability to survive multiple freeze-thaw cycles, but this is not what they patented. Thus, the Federal Court held that the inventors “employed their natural discovery to create a new and improved way of preserving hepatocyte cells for later use.”

Moreover, the Court held the claims eligible under Step 2A of the USPTO‘s subject matter eligibility guidance. The Court emphasized that the analysis showed that the claims recite a number of process steps that manipulate the hepatocytes in accordance with their ability to survive multiple freeze-thaw cycles to achieve the desired outcome. It is the achievement of the desired outcome that renders these claims patent-eligible. On the contrary, earlier claims discussed in the cases May and Sequenom amounted to nothing more than observing and identifying the ineligible concept itself.

Based upon this subtle difference we might hope that little by little the patent eligible subject matter directed to livescience will continue to increase. Please contact me with questions or comments at silvia@salvadorilaw.com.

Silvia Salvadori, PhD

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