United States: “Substantial Evidence” Includes That Not Relied on by the Board

In a case involving an interference between a patent and an allowed patent application, both directed toward the production of human fibrinogen protein in non-human milk, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent and Trademark Office Board of Patent Appeals and Interference (the Board) that the claims were obvious, as being supported by "substantial evidence." Even though a determination of obviousness is a question of law to be decided de novo, the Federal Circuit deferred to the underlying factual determinations made by the Board regarding reasonable expectation of success in support of its obviousness determination. In doing so, the Court considered references not relied on by the Board. Velander et al. v. Garner et al., Case No. 02-1366 (Fed. Cir. Nov. 5, 2003). Fibrinogen is a serum protein synthesized by the liver and utilized in the blood to form a clot. The production and isolation of recombinant fibrinogen provides a potentially unlimited source of the naturally scarce protein. The count in interference related to mammals capable of producing "recoverable amounts" of biocompetent human fibrinogen protein in the milk of transgenic non-human mammals carrying heterologous DNA segments encoding each of fibrinogen’s
Aa, Bb and g chains and methods of making biocompetent fibrinogen therefrom.

Garner moved for a finding that Velander’s claims were obvious over a reference disclosing the commercial desirability of producing human serum proteins in non-human milk (Hennighausen) in view of a reference disclosing methods for the production of heterologous protein in the milk of transgenic mammals (Meade). Velander admitted that the combination of prior art references contained all the limitations in its claims and one of skill in the art would be motivated to combine them. Thus, the only issue for the Board to decide was whether one of ordinary skill in the art would glean from the prior art a reasonable expectation of success to make and use the claimed mammal.

The Board heard from a number of Velander’s expert witnesses who generally opined that a skilled artisan would not have reasonably expected to succeed. However, the Board discounted those expert opinions because they were not corroborated by any published references. The Board also discounted other opinions specifically relating to issues of heterologous protein and hormone purification from, and expression in, milk, as not sufficiently calling into question whether the claimed "recoverable amounts" of fibrinogen could be expressed. The Board noted that absolute predictability is not a requirement for obviousness. Velander appealed.

The Federal Circuit dismissed Velander’s argument that the Board had erred by placing the burden on Velander to prove an expectation of failure beyond Garner’s alleged expectation of success. The Court determined that the Board was aware of the proper legal standard, but was simply not swayed by Velander’s arguments, noting the arguments were either uncorroborated opinions or failed to consider problems relevant to the invention as claimed. Rather, the Court found that in discounting Velander’s experts, the Board acted as a proper trier of fact, determining the weight and credibility to be given to uncorroborated, conclusory statements. The Court indicated that under the "substantial evidence" standard, it would not reverse the Board in situations where the evidence supports several reasonable, but contradictory, conclusions.

In support of its conclusion, the Court considered Garner’s citation of several new references not relied on by the Board that went to the issue of whether several proteins with similar structural characteristics had successfully been produced in transgenic milk systems. The Court relied, at least in part, on these new references in refusing to second guess the Board’s assessment of the evidence.

In his dissenting opinion, Judge Gajarsa, argued that the Court’s review of substantial evidence should be limited to the record relied on by the Board. The dissent indicates that the Board had not taken into account the new references relied on by Garner in the appeal and that without these references, the Board’s opinion is not supported by substantial evidence as it makes unwarranted assumptions with regard to differences between the prior art and the claims at issue as seen by a person of skill in the art. By considering such evidence, Judge Gajarsa asserted that the Federal Circuit is simply substituting for the grounds for administrative action, those the Court would consider to have a more adequate and proper basis.