Blast from the Past: In Vivo Testing is Not Required for an Actual Reduction to Practice

In Medtronic, Inc., Medtronic Vascular, Inc., v. Teleflex Life Sciences Limited, [2022-1721, 2022-1722] (November 16, 2023) the Federal Circuit affirmed two Final Written Decisions of the PTAB that the challenged claims of U.S. Patent RE46,116 had not been shown to be unpatenable.  The patent was directed to a method for using a guide extension catheter with a guide catheter.

Medtronic alleged invalidity of the claims based upon the Itou reference.  Teleflex argued that Itou was not prior art because the claimed invention was (1) conceived prior to Itou’s filing date of September 23, 2005 (i.e., the critical date), and (2) was either (a) actually reduced to practice before the critical date or (b) diligently pursued until its constructive reduction to practice through its effective filing in May 2006.  The Federal Circuit found that the invention was constructively reduced to practice.

Unique to this case was the question whether or not in vivo testing was required for actual reduction to practice because the claims at issue are method claims reciting “advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” The Board found that such testing was not required, noting Medtronic “was unable to identify any legal precedent requiring in vivo performance of a claimed in vivo method to show actual reduction to practice.” The Board found that the viability of the claimed method could be verified using a physical model that replicates the anatomy in which the method would likewise be performed in vivo.”

The Board also found that the Teleflex patent was entitled to an early priority date that removed Root as a prior art reference.  This issue was eliminated by prior decisions involving related patents.