July 5, 2016

Not All Processes That Employ Only Independently Known Steps are Unpatentable

In Rapid Litigation Management Ltd. v. Cellzdirect, Inc., [2015-1570] (July 5, 2016), the Federal Circuit vacated summary judgment that U.S. Patent No. 7,604,929 on hepatocytes capable of surviving multiple freeze-thaw cycles was invalid under §101 as directed to a patent ineligible law of nature.

The Federal Circuit analyzed the claims, directed to a method of producing a desired preparation of multi-cryopreserved hepatocytes” finding that the claims are “simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles” as the district court erroneously found.  Instead, the Federal Circuit said, the claims are directed to a new and useful laboratory technique for preserving hepatocytes.  The Court said:

This type of constructive process, carried out by an artisan to achieve ‘a new and useful end’ is precisely the type of claim that is eligible for patenting.

The Federal Circuit observed that the inventors discovered the cells’ ability to survive multiple freeze-thaw cycles, but that is not where they stopped nor was that what they patented.  As the first party with the knowledge of the cells’ ability, they were in an excellent position to claim applications of that knowledge.

Although the Federal Circuit found the subject matter patentable at Step 1 of the Alice/Mayo two part test, the Federal Circuit said that it would have passed Step 2 of the test even though each of the individual steps was well known.  The Federal Circuit said that not all processes that employ only independently known steps are unpatentable.  To the contrary, the claims must be viewed as a whole, considering their elements both individually, and as an ordered combination.

In the present case the steps of freezing and thawing were well known, but a process of preserving cells by repeating those steps was itself far routine and conventional.  Repeating a step that the art taught should be performed only once “can hardly be considered routine or conventional.”  To require something more at step two ” would be to discount the human ingenuity that comes from applying a natural discovery in a way that  achieves a new and useful end.”