IP Law Daily, PATENT—Fed. Cir.: Guide extension catheter reduced to practice before filing date of potential prior art, (May 24, 2023)

By Anne H. Gibson, J.D., LL.M.

Dissent argued that inventors’ evidence was not sufficiently corroborated by records of actual testing to show that patents’ intended purpose had been met.

Teleflex Innovations S.À.R.L. (“Teleflex”), holder of patents for a guide extension catheter, showed that its patents were reduced to practice prior to the filing date of another, similar patent, and so were not unpatentable, the U.S. Court of Appeals for the Federal Circuit has held. The patents had been challenged by Medtronic, Inc. and Medtronic Vascular, Inc. (collectively, “Medtronic”), which argued that they were preempted by prior art. In affirming the Patent Trial and Appeal Board’s inter partes review decisions in favor of Teleflex, the court found that Teleflex’s evidence that the guide extension catheter had been reduced to practice prior to the critical date was adequately corroborated. In a dissenting opinion, Circuit Judge Dyk took the position that the invention had not been reduced to practice, in part because of a lack of evidence of testing (Medtronic, Inc. v. Teleflex Innovations S.À.R.L., May 24, 2023, Lourie, A.).

The challenged patents in the case were developed by Vascular Solutions Inc. (“VSI”) and later acquired by Teleflex. The patents, U.S. Patents 8,048,032, RE45,380, RE45,776, RE45,760, and RE47,379, were contained in a common application that was filed on May 3, 2006. They are directed to guide extension catheters. Teleflex stated that the invention was originally conceived in early 2005 and was developed under the name “GuideLiner.” Two versions were developed, a “rapid exchange” version that practices the challenged patents, and an “over-the-wire” version that does not.

Medtronic, Inc. and Medtronic Vascular, Inc. filed 13 petitions for inter partes review, five of which were consolidated into the present case. It asserted that U.S. Patent 7,736,355, to Itou et al. (“Itou patent”), filed on September 23, 2005, was prior art as to the challenged patents under pre-America Invents Act “first to invent” provisions, and so they were unpatentable. Teleflex argued that the Itou patent was not prior art, because the challenged patents were conceived prior to its filing date and were either reduced to practice prior to that date or diligently pursued until their filing date in May 2006. The Board agreed with Teleflex and Medtronic appealed.

Reduction to practice. The court first turned to the question of whether the challenged patents had been reduced to practice before the critical date, the date when the Itou patent was filed. To establish this, the court noted, it must be shown that “(1) [the inventors] constructed an embodiment or performed a process that met all the limitations of the [claimed invention]; and (2) [the inventors] determined that the invention would work for its intended purpose.” Medtronic challenged the Board’s findings that these elements were met on three grounds: (1) the Board did not correctly identify the intended purpose; (2) the Board erred in not requiring comparative testing to show that the intended purpose was accomplished; and (3) the Board erred by relying solely on uncorroborated testimony of the inventors.

Intended purpose. The Board found that the intended purpose of the challenged patents was “providing increased backup support as compared with a guide catheter alone.” Medtronic argued that it should additionally include “facilitating the delivery of interventional devices through tough or chronic occlusions.” The Federal Circuit disagreed with Medtronic’s more narrow interpretation of the intended purpose. “Although the challenged patents do mention crossing ‘tough’ or ‘chronic’ occlusions, we find that to be a specific example within a broader general purpose.” Medtronic argued that the Board should have looked only at intrinsic evidence from the patents themselves in determining their intended purpose. The court found that, while the intrinsic evidence did in fact support the Board’s broader interpretation, it was not inappropriate to look at extrinsic evidence as well, such as expert and inventor testimony, which it found also supported the broader intended purpose in this case. The court went so far as to suggest that an even broader intended purpose of “simply functioning as a guide extension catheter” could be appropriate.

Invention worked for intended purpose. The Federal Circuit then turned to Medtronic’s argument that, even if the intended purpose were “providing improved backup support for a guide catheter,” Teleflex had not shown that it had accomplished this with a comparative test. In other words, it had not proven that its guide extension catheter had met its intended purpose by “improving” on the use of a guide catheter alone. Although Teleflex argued that Medtronic had not raised this argument below, the court found it was not forfeited. However, the court found that the testing that had been performed, even if it was not specifically comparative, was “sufficient to show that the claimed invention worked for its intended purpose as determined by the Board.” This is a question of fact, the Federal Circuit noted, which it reviewed only for substantial evidence. “Here, the Board thoroughly reviewed and analyzed the evidence of testing in the record, and we decline to remake or reweigh its factual findings.” The Board determined that comparative testing per se was not required, but rather that an inventor observing the tests and believing that they showed an improvement was all that was needed. The Federal Circuit agreed.

Sufficient corroboration. Finally, the Federal Circuit examined Medtronic’s argument that the evidence presented by Teleflex of actual reduction to practice was not sufficiently corroborated. The court disagreed with Medtronic. The court found the testimony of a former technician and a former vice president of VSI, the company that had developed the challenged patents prior to their acquisition by Teleflex, corroborated the evidence given by the inventors of the device. Further, it found that documentary evidence consisting of order forms for parts of prototypes, engineering drawings, and a model constructed for a sales presentation, all dating to before September 2005, also corroborated the inventors’ testimony. The court thus found the testimony of reduction to practice sufficiently corroborated.

The Federal Circuit determined that the determination of actual reduction to practice prior to the critical date was adequately supported, and affirmed the Board’s determination that the Itou patent did not qualify as prior art to the challenged patents. The court accordingly affirmed the Board’s ruling that Medtronic had not shown that the challenged patents were unpatentable.

Dissent. Circuit Judge Timothy Dyk dissented, arguing that the Teleflex’s evidence of reduction to practice prior to the critical date was not sufficiently corroborated. In particular, Judge Dyk argued that, based on precedent, “testing is required to establish a reduction to practice.” Judge Dyk noted that the testimony of the inventors never described any specific tests showing the prototypes would work for their intended purpose or the results of any tests they did conduct.

Judge Dyk also opined that Teleflex should have been required to provide internal documents corroborating any testing. While the majority indicated that this would “impose an ‘impossible standard of “independence” on corroborative evidence,’” this was “hardly the case,” in Judge Dyk’s view. “A rule that favors the retention of relevant documents does not create an ‘impossible standard’ for inventors seeking to enforce a patent for a claimed invention,” Judge Dyk said. Because of the lack of corroborating evidence as to actual testing, Judge Dyk “would reverse the Board’s holding that the invention had actually been reduced to practice before Itou’s priority date.”

The Case is Nos. 21-2356, 21-2358, 21-2361, 21-2363, 21-2365.

Attorneys: Tasha Joy Bahal (Wilmer Cutler Pickering Hale and Dorr LLP) for Medtronic, Inc. and Medtronic Vascular, Inc. J. Derek Vandenburgh (Carlson, Caspers, Vandenburgh & Lindquist PA) for Teleflex Innovations S.À.R.L.

Companies: Medtronic, Inc.; Medtronic Vascular, Inc.; Teleflex Innovations S.À.R.L.

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