In what was an otherwise run-of-the-mill affirmance of a decision by the Patent Trial and Appeal Board (PTAB) (albeit somewhat noteworthy in affirming the Board's determination that the challenged claims were not invalid), the Federal Circuit heard but deigned not to consider the question of whether claims to methods for achieving a therapeutic outcome needed to be supported by a showing of actual reduction to practice (i.e., that the method had been shown to be operative for the claimed result) in Medtronic, Inc. v. Teleflex Life Sciences Ltd. (precedential).

The case arose in two inter partes review decisions over a reissue patent U.S. Patent No. RE46,116 directed to methods for "using a guide extension catheter with a guide catheter." A portion of claim 25 of the '116 patent was reproduced in the opinion as being representative:

25. A method, comprising:
advancing a distal end of a guide catheter having a lumen through a main blood vessel to an ostium of a coronary artery; . . .

The original patent was filed in 2006 and the Board's assessment of the sufficiency of Medtronic's validity challenge was carried out under the provisions of the 1952 Patent Act. Accordingly, the Board considered evidence of conception in 2005 and diligence from its conception date until filing a patent application in May 2006 (constituting constructive reduction to practice). Medtronic asserted U.S. Patent No. 7,604,612 against claims 52 and 53 of the '116 patent for anticipation (the Board held for Medtronic and this decision was not appealed); asserted the combination of the '612 patent and U.S. Patent No. 7,736,355 for obviousness of claims 25-40, 42, 44-48, 52 and 53; and asserted the '612 and '355 patents in combination with U.S. Patent Application Publication No. 2005/0015073 for obviousness of claim 45 (wherein in each case in which it was asserted Medtronic argued the '355 patent was prior art under 35 U.S.C. § 102(e)).* The opinion notes that Medtronic did not challenge the sufficiency of Teleflex's evidence for conception prior to the critical date of the '355 patent (September 21, 2005). With regard to the '355 patent, the Board held that Teleflex had reduced to practice the invention claimed in the remaining challenged claims prior to the filing date of the ‘355 patent and had also satisfied the diligence requirements for its May 2006 filing date to qualify as a constructive reduction to practice. This decision, the opinion notes, was consistent with the Board's earlier decision on whether the '355 patent qualified as prior art for claims to Teleflex's corresponding apparatus claims.

The distinction ("unique to this case") that raised one of Medtronic's arguments in this appeal was the question of "whether or not in vivo testing was required for actual reduction to practice" because here the challenged claims recited the step of "advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery." The Board held such evidence was not necessary and that evidence from alternative physical models could suffice. This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Lourie, joined by Judges Prost and Chen. The sole issues raised in this opinion were "(1) whether or not in vivo testing was required for actual reduction to practice and (2) whether or not the patentee exercised reasonably continuous diligence until constructive reduction to practice," wherein the panel determined that Teleflex had established constructive reduction to practice and did not reach the issue of actual reduction to practice (noting that a showing of either species of reduction to practice was enough to affirm the Board's opinion). On this question, the Federal Circuit held that Medtronic had waived any challenge regarding the diligence issue by attempting to incorporate its arguments in that regard by reference to the Federal Circuit's judgment in a separate, related IPR. The panel rejected this attempt, first, because in that related case the Court had not vacated the Board's decision on sufficiency of asserted diligence, and second, that trying to "incorporate by reference twenty pages from another brief in another case, amounting to over 4,000 extra words" was "a clear violation of both the motions panel's order [denying Medtronic's motion for leave to expand its brief to 20,000 words] and our rules" (emphasis in opinion). The panel characterized this attempt as a strategic decision by Medtronic not to include arguments directed at the diligence issue into its principle brief and, its attempt having failed held that Medtronic's challenge of the Board's finding of diligence had been waived. Combined with Medtronic's decision not to contest conception of the claimed invention the panel affirmed the Board's decision that the '355 patent was not prior art and that Medtronic's obviousness challenges failed.

*Medtronic asserted unsuccessfully these references as well as U.S. Patent Application Publication No. 2007/0260219 in a second IPR against the '116 patent, but Federal Circuit decisions in three related cases rendered moot Medtronic's appeal of the Board's decisions in this IPR, which was not further discussed in this opinion.

Medtronic, Inc. v. Teleflex Life Sciences Ltd. (Fed. Cir. 2023)
Panel: Circuit Judges Lourie, Prost, and Chen
Opinion by Circuit Judge Lourie

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