Trs. of Columbia University v. Illumina, Inc.

In a non-precedential opinion, the U.S. Court of Appeals for the Federal Circuit heavily deferred to the factual findings of the Patent Trial and Appeal Board (PTAB or Board) in affirming the PTAB’s decision of invalidity in an inter partes review (IPR) proceeding. Trs. of Columbia University v. Illumina, Inc., Case No. 14-1550 (Fed. Cir., July 17, 2015) (Wallach, J.).

The three patents at issue in Illumina relate to methods of determining the sequence of DNA, a double stranded molecule that contains genetic code. Each strand is made up of units called nucleotides that include a sugar, one or more phosphate groups, and a base.

An early method of DNA sequencing involved use of a modified sugar and label attached to the base, but this method proved too slow to efficiently sequence an entire genome. Until, the discovery was made that a modified base improved stability, this sequencing method also presented difficulties in ensuring that the label remained attached to base. A later method of DNA sequencing achieved a higher rate of speed and efficiency by using removable, labeled “caps” on the sugar. However, this method produced poor results resulting from the use of a label on the cap. The claimed methods purported to address this problem by retaining the removable cap on the sugar and attaching the label to the modified base via a cleavable linker.

The claims at issue were directed to, in general, a method that involved a labeled, modified base, in which the label was attached to the base through a cleavable linker, and a removable cap on the sugar. After the PTAB ruled that the claims at issue were invalid as anticipated or obvious in view of the prior art, the patent owner appealed.

On appeal the patent owner argued that the claimed combination was not disclosed in the prior art, which only discussed a process involving use of a removable label on the sugar and not a modified base. The patent owner further argued that there would be no motivation to combine the prior art references to arrive at the claimed invention. The Federal Circuit rejected the patent owner’s arguments, citing the PTAB’s findings that the prior art disclosed using a removable cap on the sugar and a label on the base attached by a cleavable linker. The Court agreed with the PTAB’s finding that a skilled artisan would have been motivated to use a modified base in view of the teachings in other prior art references.

With respect to anticipation, the Federal Circuit rejected the patent owner’s argument that the prior art at issue did not disclose all of the claimed features arranged as in the claim. While acknowledging that the claimed method was not specifically disclosed as an embodiment in the prior art reference, the Court nonetheless affirmed the PTAB’s finding of anticipation because the claimed embodiment “could be envisaged clearly by one of ordinary skill in the art upon reading” the prior art reference.