Velander, et al. v. Garner, et al.

Board's Decision on Obviousness Supported by Substantial Evidence


November 05, 2003

Kovalick, Vincent P.


Last Month at the Federal Circuit - December 2003

Judges: Schall (author), Prost, and Gajarsa (dissenting)

In Velander v. Garner, No. 02-1366 (Fed. Cir. Nov. 5, 2003), the Federal Circuit affirmed the Board's decision that all allowed claims of the patent application in question were unpatentable as obvious over the prior art.

The patented technology relates to the production of nonhuman mammals that have been genetically altered so that they produce the enzyme fibrinogen in its biologically active state. The enzyme is recovered from the milk of the mammal. In an interference proceeding involving U.S. Patent Application No. 08/443,184 ("the '184 application"), the Board determined that the allowed claims were unpatentable as obvious over the prior art. The interference involved competing claims to a transgenic animal (and methods to make such an animal) that produces fibrinogen and secretes it into its milk.

After the interference was declared between the '184 application and U.S. Patent No. 5,639,940 ("the '940 patent"), Ian Garner and others (collectively "Garner") moved to have the claims in question declared unpatentable. Garner identified the elements of the claims in the prior art and contended that the motivation to combine these elements could be found in a publication by Dr. Lothar Hennighausen ("the Hennighausen review") and in U.S. Patent No. 4,873,316 ("the Meade patent"). Garner contended that the Meade patent disclosed a method for the production of heterologous proteins in the milk of transgenic animals, while the Hennighausen review suggested the production of commercial quantities of plasma proteins in transgenic animals, and, therefore, fibrinogen was an obvious target for expression in transgenic animals.

Applicant, Velander, did not dispute that the elements of the claims were in the prior art nor that the prior art contained some motivation to combine those elements. Rather, he argued that, given the variables that affect protein expression levels, as of the critical date, one of ordinary skill in the art would not have had a reasonable expectation of success in practicing the invention claimed. Velander asserted that the Board improperly placed on him the burden of proving an expectation of failure in the prior art rather than requiring Garner to prove a reasonable expectation of success to substantiate obviousness. The Federal Circuit dismissed this argument, however, observing that the Board clearly understood the burdens and applied them appropriately.

The Federal Circuit reviewed the conflicting expert testimony submitted by declarations from both parties and concluded that, although this was a close case, substantial evidence supported the Board's decision. The Court summarized the case as boiling down to the question of whether, as of the critical date, one of ordinary skill in the art would have had a reasonable expectation of success in producing a recoverable amount of biologically active fibrinogen from a transgenic, nonhuman female mammal that produces recoverable amounts of biologically active human fibrinogen in its milk. Given all the evidence, the Court could not say that Velander had established that the Board's decision was not supported by substantial evidence. Although other evidence in the record supported Velander's argument, the Federal Circuit ruled that if the evidence supports several reasonable but contradictory conclusions, it will not find the Board's decision unsupported by substantial evidence simply because the Board chose one conclusion over another plausible alternative.

Judge Gajarsa dissented, concluding that there was no reasonable basis for the Board's decision and that the finding of obviousness lacked substantial evidence.