Federal Circuit Reverses Ptab S Invalidation of Patent Claims for an Artificial Heart Valve Snyders vs St Jude

On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.”  St. Jude Medical LLC (“St. Jude”) filed for an inter partes review (IPR) at the PTAB for U.S. Patent No. 6,821,297, entitled “Artificial Heart Valve, Implantation Instrument and Method Therefor,” owned by Snyders Heart Valve LLC (“Snyders”).

In invalidating the claims, the PTAB interpreted the patent claim limitation of a “frame sized and shaped for insertion between the upstream region and the downstream region.”  The PTAB found that the limitation also covers a frame that fits in place after removal of a damaged heart valve.  The cited prior art allegedly also disclosed a valve insert sized to fit the valve after the damaged native valve was removed.  Therefore, the PTAB found that the prior art anticipated the claims.

The Federal Circuit held that the PTAB erred in determining that the “sized and shaped” limitation “does not require the frame be sized and shaped for insertion into a damaged heart valve,” but “only that the frame is sized and shaped for insertion in a position between the upstream region and the downstream region.”  The Federal Circuit reasoned that the PTAB’s construction was incorrect because “it covers frames sized and shaped for installation with the native valve removed, rather than only with the native valve in place.”  The Federal Circuit cited language in the patent specification allegedly stressing that the disclosed artificial heart valve can be inserted without removing the native valve, an alleged express improvement on the prior art.

The Federal Circuit’s decision is available here.

Written by: Nima Zargari, Ph.D.