In Medtronic, Inc., Medtronic Vascular, Inc. v. Teleflex Innovations S.A.R.L., the case addresses whether the final written decisions in a consolidated inter partes appeal (“IPR”) correctly found that U.S. Patent 7,736,355 (“the ’355 patent”) does not qualify as prior art to related U.S. Patents 8,048,032, RE45,380, RE45,776, RE45,760, and RE47,379 (collectively, “the challenged patents”) under pre-AIA’s first-to-invent provisions.

Background

The challenged patents all claim priority to a common application filed on May 3, 2006, and share a common specification. The challenged patents are directed to guided extension catheters that use a tapered inner catheter that runs over a standard coronary guidewire to reduce the likelihood that a guide catheter will dislodge from the coronary artery’s opening.

Teleflex, owner of the challenged patents that were developed by Vascular Solutions Inc. (“VSI”), asserted that the claimed invention of the challenged patents was conceived in early 2005. Medtronics filed five IPR petitions using the ’355 patent as the primary prior art reference under pre-AIA 35 U.S.C. § 102(e). Teleflex filed its responses and evidence addressing conception and reduction to practice, and argued that the ’355 patent does not qualify as prior art because the claimed inventions (1) were conceived prior to the filing date of the ’355 patent, and (2) were (a) actually reduced to practice before the filing date of the ’355 patent or (b) diligently pursued until their constructive reduction to practice through their effective filing in May 2006.

The U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) found that the evidence demonstrated that the claimed inventions were (1) conceived no later than August 2005, and (2) either (a) actually reduced to practice for their intended purpose in April and July 2005, or (b) diligently worked on toward constructive reduction to practice through May 3, 2006, thus finding that the ’355 patent does not qualify as prior art to the challenged patents under pre-AIA 35 U.S.C. § 102(e). The Board concluded that Medtronic failed to demonstrate that the challenged claims were unpatentable.

Issue(s)

Whether the Board correctly found that the ’355 patent failed to qualify as prior art to the challenged patents under pre-AIA’s first-to-invent provisions.

Holding(s)

The Federal Circuit affirmed the Board’s final written decisions finding that the ’355 patent failed to qualify as prior art to the challenged patents, thus finding the challenged claims were not proven to be unpatentable.

Reasoning

To establish actual reduction to practice before the filing date of the ’355 patent, 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.” Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998).

Medtronic argued that the Board erred in identifying the intended purpose of the claimed invention. While Medtronic argued that the Board should not have relied on extrinsic evidence to determine the intended purpose, and instead should rely on the patent’s specification and claims, the Court found that while patents themselves are the most important and persuasive evidence of a patent’s intended purpose, it is appropriate to consider extrinsic evidence, particularly when it does not contradict the patent itself. The Court agreed with the Board, and found that the intrinsic evidence, supported by extrinsic evidence, described the purpose of the claimed inventions to “relate to methods and apparatus for increasing backup support for catheters inserted into the coronary arteries from the aorta” and rejected Medtronic’s overly narrow proposed intended purpose.

Medtronic argued that, even if the Board’s finding of the intended purpose was correct, the Board erred in not requiring comparative testing to demonstrate that the invention worked for that purpose. While Medtronic argued that Teleflex cannot prove any testing was performed, much less testing to confirm intended purpose, the Court found that “the Board thoroughly reviewed and analyzed the evidence of testing in the records” and “the testing performed [was] sufficient to show that the claimed invention worked for its intended purpose.” Specifically, the Court found that the Board accurately determined that the tests “enabled the inventors to observe the forces exerted on the prototype and the durability of the prototype,” which were “sufficient to enable the inventors to confirm that the prototype would work for its intended purpose – providing increased backup support as compared with a guide catheter alone.”

Medtronic additionally argued that the Board erred in relying solely on uncorroborated inventor testimony as evidence of actual reduction to practice. Inventor testimony may serve as evidence of reduction to practice, but it must be corroborated by independent evidence. Cooper, 154 F.3d at 1330. The Court found that “the inventor’s testimony of actual reduction to practice, including that the invention worked for its intended purpose, sufficiently corroborated” since the testimony of the inventors were “supported by both documentary evidence and noninventor testimony.” Noninventor testimony included testimony from a former Research & Development Technician at VSI, who testified that “he was both personally involved in some of the testing, and recalls watching the inventors perform testing on the prototype on multiple occasions.” Documentary evidence included reports and invoices showing that “VSI ordered specialized ‘hypotubes’ for prototypes of the rapid exchange GuideLiner in the first half of 2005,” which the Board found that the “dimensions of that hypotubing are consistent with the dimensions provided in the patents themselves and engineering drawings specific to the rapid exchange GuideLiner.” While the Court agreed with Medtronic that some of the evidence in the record is unclear as to whether or not it relates to the over-the-wire GuideLiner or the rapid exchange GuideLiner, the Court found that when viewing the pertinent evidence in its entirety, the inventor’s story was corroborated.

The Court found the Board’s determination of actual reduction prior to the filing date of the challenged patents supported by substantial evidence affirmed the Board’s finding and ruling that the ’355 patent does not qualify as prior art to the challenged patents under pre-AIA 35 U.S.C. § 102(e).