Obviousness Does Not Require Absolute Predictability of Success

PharmaStem Therapeutics, Inc. v. Viacell, [05-1490, -1551](July 9, 2007)[BRYSON, Newman, Prost] The Federal Circuit affirmed the trial courts grant of JMOL that U.S. Patent Nos. B1 5004681 and 5,192,553 were not infringed, and reversed the trial courts denial of JMOL that the patents were invalid.
BRIEF: The '681 patent required a sufficient supply of stem cells to effect successful hematopoietic reconstitution in adults. The trial court found that PharmaStem did not attempt to prove by testing or by reference to data collected by the defendants tht at least some of the cord blood samples preserved by defendants satisfied the requirements of the '681 patent's claims. Instead, plaintiff attempted to prove infringement solely from statements in defendant's advertising. Thus the trial court granted JMOL. The Federal Circuit agreed, noting that while there is no prohibition against using admissions of a party in its advertising, none of the statements represented that the requirements of the claims were met. Instead, defendant's advertising emphasized the potential therapeutic usefulness of the stored blood. PharmaStem also relied upon the fact that at least some of the defendants tested the blood before deciding whether to cryopreserve the sample, but the Federal Circuit said that there was no indication that the testing related to meeting the requirements of the claims.
Regarding the contributory infringement of the '553 patent, the trial court found that plaintiff did not show that Viasell sold the cryopreserved blood units, the evidence showing that defendant merely stored and distributed the blood units for others. Because liablity for contributory infringement is clearly dependent upon the accused infringer's sellling or offering to sell a component of the patent process, the court held the jury verdict could not stand,and granted JMOL. The Federal Circuit agreed, stating that the statute unambiguously reqired that the contributory infringer sell a component, and the defendants were mere bailees of the stored blood, not vendors.
The trial court denied defendant's motion for JMOL that the patents were invalid for anticipation, obviousness, or indefiniteness. The Federal Circuit reversed, finding that the patents were invalid for obviousness, and not reaching the novelty and indefiniteness defenses. The Federal Circuit found that the prior art suggested the invention, and said that issued turned on whether there was a reasonable expectation of success. PharmaStem argued that there would not be a reasonable expectation of success until it was know that the umbilical blood contained stem cells, which did not occur until after the inventors discovered this. However, the Federal Circuit found that this argument was inconsistent with the prior art references, and the specifications of the patents in suit. The Federal Circuit reitereated that "Admissions n the specification rearding the prior art are binding on the patentee for purposes of a later inquiry into obviousness." The Federal Circuit concluded that a reasonable jury could not have found the invention to be non-obvious. While the inventors may have proved conclusively what was strongly suspected, and while their work may have significantly advanced the state of the science of homatopoietic transplantations by eliminating doubt about the presence of stem cells, their experiments and the conclusions drawn from them were not inventive. Obviousness does not require absolute predictability of success. For many inventions that seem quite obvious, tehre is no absolute predictability of success until the invention is reduced to practice.
SIGNIFICANCE: Contributory infringement requires a sale of a component. Obviousness does not require absolute predictability. Say as little as possible about the prior art, because admissions from the specification can make the claimed invention obvious.