The Federal Circuit has affirmed most of a lower court’s ruling finding that transcatheter heart valve products with balloon-expandable frames didn’t infringe the patents at issue in the case.
The case is Aortic Innovations LLC v. Edwards Lifesciences Corp.
The appeal involved devices for transcatheter aortic valve replacement, a procedure in which a prosthetic heart valve replaces a diseased aortic valve.
Appellant Aortic Innovations LLC (“Aortic”) owns the four asserted patents in this case: US Patent Nos. 10,881,538 (“’538 patent”), 10,966,846 (“’846 patent”), 10,987,236 (“’236 patent”), and 11,129,735 (“’735 patent”).
The patents derive from the same predecessor application, claim priority to the same provisional applications, and share a common specification.
Aortic appealed from a stipulated district court judgment of non-infringement of four asserted patents, arguing that the district court’s construction of “outer frame,” on which the stipulated judgment of non-infringement was based, was erroneous.
The Federal Circuit agreed with the district court’s construction, affirmed the judgment as to three of the asserted patents, and dismissed the appeal on the fourth patent for lack of jurisdiction.
As the court explained,
It was known in the art that a transcatheter aortic valve replacement device collapses down to a narrow diameter and is delivered to the site of the patient’s diseased aortic valve via a delivery catheter. Once at the site, the device is removed from the catheter sheath and expanded in one of the following two ways, anchoring the device in place. First, it can expand via a balloon-expandable frame. This is a frame that requires a balloon inflating at the center of the device to expand from the collapsed state to the deployed state. Second, it can expand via a self-expanding frame, which expands due to its shape-memory material that springs back to an expanded shape after being released from the delivery catheter.
The common specification discloses two types of devices. The first is an “endograft device” for endovascular repair of ascending aortic aneurysms, directed primarily to treatment of aortic diseases. The second is a “transcatheter valve.” The claims of the patents are directed to the transcatheter valve.
According to the summary section of the specification, a “transcatheter valve” “includes a frame component having a balloon-expandable frame extending distally from a proximal end of the frame component and a self-expanding frame secured to the balloon-expandable frame.”
On appeal, the parties disputed the construction of the claim term “outer frame” in claim 1 of the ’735 patent.
This claim recites, in part:
- An endovascular transcatheter valve assembly comprising:
an outer frame,
wherein the outer frame is formed from a metallic material and defines an open cell configuration
wherein the outer frame includes an inflow end at a proximal portion thereof and an outflow end at a distal portion thereof,
wherein the outer frame is formed by a plurality of struts that adjoin each other at the inflow end to form apices:
an inner frame that engages a prosthetic heart valve having prosthetic leaflets, wherein the inner frame includes a cylindrically extending inner graft covering extending at least partially radially outwardly of the prosthetic heart valve and radially inwardly of the outer frame for providing sealing to the prosthetic heart valve,
wherein the outer frame is secured to the inner graft covering by stitching a proximal portion of the outer frame; an outer seal for preventing paravalvular leaks that at least partially extends over at least two most proximal rows of cells formed in the outer frame,…
(Emphasis added by court.)
As the Federal Circuit explained,
The district court determined that the patentee acted as his own lexicographer and redefined the term “outer frame” to be “a self-expanding frame.” … The district court grounded this redefinition on the point that the terms “outer frame,” “self-expanding frame,” and “self-expanding outer frame” interchangeably refer to the same structure in two embodiments…
The Federal Circuit noted that “A patent’s consistent and clear interchangeable use of two terms can result in a definition equating the two terms.”
Following claim construction, the parties jointly stipulated to non-infringement of the patents because the defendant’s product doesn’t have a self-expanding frame.
The Federal Circuit concluded,
Given that the district court construed claim 1’s “inner frame” to be balloon-expandable, a construction no party disputes on appeal, then claim 1’s “outer frame” must be self-expanding.
Thus, the Federal Circuit affirmed the district court’s judgment as to three of the patents.
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