In this case, the Federal Circuit determined the sufficiency of evidence to rebut a nexus between objective evidence and non-obviousness; and to establish the objective indicia of copying.
Medtronic petitioned for inter-partes review of U.S. Patent Nos. 8,048,032; RE45,380; and RE45,776 that cover catheters to treat stenosis, that is, a narrowing of the lumen of a patient’s arteries due to the buildup of plaque. In the IPR proceeding, Teleflex opposed the prior art grounds as not achieving the alleged benefits of the prior art combinations without additional modifications. Teleflex also cited secondary considerations of non-obviousness, including alleging that Medtronic had copied Teleflex’s Guideliner product that embodied the claims); that GuideLiner was copied by other competitors; enjoyed a high level of commercial success, received significant praise in the industry, and solved long-felt needs within the medical community for catheters with increased back-up support. Medtronic appealed the Board’s decision as to the claims that recite a side opening and were held to not be obvious.
- Whether the Ressemann reference disclosed the combination of features as to preclude a nexus between the objective evidence of non-obviousness.
- Whether the Board’s silence on Ressemann’s lack of the missing feature established that Ressemann disclosed the missing feature.
- Whether the circumstantial evidence of copying, in lack of evidence of direct efforts to copy, was insufficient to find that Medtronic had copied Teleflex’s product.
- Teleflex’s evidence of objective indicia of non-obviousness had a nexus to the Side Opening Claims.
- Medtronic failed to make a showing that objective evidence resulted from features that were known as a combination in the prior art.
- The Board’s analysis of the nexus was legally correct and supported by substantial evidence.
- Direct evidence of copying is not necessary to establish copying.
- The Board’s finding of copying is supported by substantial evidence.
- The totality of objective indicia support a finding of non-obviousness.
A presumption of nexus applies because asserted objective evidence is tied to a specific product.
The Board found that Medtronic only showed each feature was individually known.
Medtronic’s argument of legal error was a veiled attempt to overturn the Board’s fact finding that the prior art reference did not disclose the combination of features.
Medtronic mischaracterized the combination of features as: (1) rapid exchange functionality, i.e.¸ having a relatively short lumen at the distal end of the catheter; (2) increased back-up support; and (3) a side opening.
Teleflex and the Board relied on a combination of the side opening and coaxial lumens, not the improved functionality that Medtronic argued was collectively disclosed in the Ressemann reference.
The absence of a finding that Ressemann does not have a coaxial lumen cannot establish the fact that the reference has those features.
The burden of proof was on the petitioner to show that Ressemann had the coaxial lumen.
Medtronic did not argue that the Board’s finding of nexus was not supported by substantial evidence.
Evidence of access and substantial similarity is evidence of copying.
There is no dispute as to accessibility by the public of Guideliner on the market at the time Medtronic was developing its extended catheter product.
The Board also found Teleflex’s expert’s testimony on substantial similarity persuasive.
The Board acknowledged differences between the accused product and copied product, but found differences not as significant as similarities.