General Industry Skepticism Alone Is Not Enough To Defeat An Obviousness Invalidity Challenge
Has the Federal Circuit Court of Appeals announced a new bright-line rule regarding industry skepticism and its role as evidence against a finding of motivation to combine prior art references? Some might think so, but a careful analysis of Auris Health, Inc. v. Intuitive Surgical Operations, Inc.,[1] may lead to different conclusions. Regardless of which side of the debate you’re on, the Auris case reminds us of the sometimes delicate interplay between motivation to combine and secondary indicia of non-obviousness in U.S. obviousness invalidity challenges.
The Auris case began as an inter partes review (IPR) proceeding in which Auris Health, Inc. challenged the validity of all five claims of Intuitive Surgical Operations, Inc.’s U.S. Patent No. 8,142,447, a patent relating to robotic surgery systems. The ’447 patent sought to address obstacles faced by surgical teams when surgical instruments need to be swapped out on a robotic surgery system during surgery. The invention of the ’447 patent included a robotic system with a servo-pulley mechanism that would allow clinicians to more quickly swap out surgical instruments, reducing surgery time, improving safety, and increasing system reliability. Auris challenged the ’447 patent as obvious in view of two references, referred to as Smith and Faraz.
The Patent Trial and Appeal Board agreed that Auris’s asserted prior art combination disclosed each limitation of the challenged claims, but found that Auris failed to show that a skilled artisan would have been motivated to combine the references. Auris argued during the IPR that a skilled artisan would have been motivated to combine the references to reduce the number of assistants on a surgical team by “roboticizing” some of their tasks. Intuitive responded that such a motivation to combine did not exist because “surgeons were skeptical about performing robotic surgery in the first place, [so] there would have been no reason to further complicate Smith’s already complex robotic surgical system with [Faraz’s] roboticized surgical stand.”
The Board ultimately agreed with Intuitive that there was a lack of motivation to combine Smith and Faraz. Auris appealed, challenging the Board’s reliance on general skepticism about the field of robotic surgery to find a lack of motivation to combine the prior art references.
On appeal, the United States Court of Appeals for the Federal Circuit vacated the Board’s Final Written Decision and remanded for the Board to further consider the parties’ motivation-to-combine evidence. The Federal Circuit concluded that the Board inappropriately relied on evidence of general skepticism about the field of robotic surgery to find a specific lack of motivation to combine the Smith and Faraz prior art references.
The Court of Appeals emphasized the distinction between the motivation to combine inquiry and industry skepticism in obviousness analysis. First, the motivation-to-combine question asks whether a skilled artisan “not only could have made but would have been motivated to make the combinations … of prior art to arrive at the claimed invention.” Quoting the United States Supreme Court’s opinion in KSR Intl’l Co. v. Teleflex Inc.,[2] a case most often cited in the U.S. for statements of law relating to obviousness invalidity, the Court of Appeals highlighted that when it comes to the “would have” question, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Therefore, the Federal Circuit concluded that “generic industry skepticism cannot, standing alone, preclude a finding of motivation to combine.”
The Federal Circuit further explained that while evidence of industry skepticism certainly has a role in obviousness analysis, that role is as a secondary consideration of non-obviousness in a “significantly different context,” and even then, evidence of skepticism must be specific to the invention, not generic to the field. According to the Court of Appeals, there was not specific evidence of industry skepticism related to the specific combination of prior art references in this case. Instead, according to the Federal Circuit, the Board “almost exclusively relied on evidence of general skepticism about the field of robotic surgery to find a lack of motivation to combine Smith and Faraz.” Because the Federal Circuit also found that it would be inappropriate to weigh evidence presented during the IPR in the first instance on appeal, the case was remanded to the Board to examine the sufficiency of the record evidence regarding motivation to combine references using the correct criteria.
Circuit Judge Reyna published a separate dissenting opinion, disagreeing with the majority’s decision because in his view, substantial evidence supported the Board’s determination that Auris failed to show a motivation to combine and that finding was not contrary to the law of obviousness. Circuit Judge Reyna highlighted several examples of additional evidence the Board considered in concluding that there was no motivation to combine Auris’s asserted prior art references. He also expressed concern that the majority opinion would be understood as announcing an inflexible and rigid rule that it would be “impermissible” for the Board to consider evidence of artisans’ skepticism toward robotic surgery in determining motivation to combine. Such a rule, in Circuit Judge Reyna’s view, would be in direct tension with KSR and its progeny.
Whether the Federal Circuit intended to announce such a bright-line rule is unclear; however, we can be sure that some will characterize this decision as announcing such a rule while others will take the opposite position. What we do know is that it is always better to have as specific evidence as possible supporting your position. For example, in this particular case, the result might have been different had Intuitive’s expert specifically concluded that a skilled artisan would not have been motivated to combine Smith and Faraz because a skilled artisan would not have wanted to further complicate Smith’s already complex robotic surgical system with Faraz’s roboticized surgical stand, without an emphasis on general industry skepticism towards robotic surgery. In any event, we are reminded to be careful regarding similarities and differences between motivation-to-combine analysis and secondary considerations of non-obviousness. Though some overlap exists, parties in litigation must be sure to present evidence through the proper legal lens or to challenge those who fail to do so.
