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Criticism Of Prior Art In Patent Limits Claims Literally And By Equivalence

Posted on | November 14, 2008 | No Comments

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2009-1006 Edwards Lifescience v. Medtronic

ND/CA 03-3817
Judge Jeffrey White

Plaintiff Edwards Lifescience appeals from the grants of summary judgment of non-infringement by Judge Jeffrey White in favor of defendants Cook Inc. and W.L. Gore.  The accused products are various types of endovascular stent grafts used to treat abdominal or thoracic aortic aneurysms.  Cook sponsors a web site with a description of its products and a short animation of the procedure.

The key term on summary judgment was claim requirement of "malleable wires."  The court construed this to mean that the wires had to be physically expended into contact with the aorta rather than expanding by virtue of their own resilience.

During claim construction the Court found that the patent itself differentiated and disclaimed resilient wires as undesirable and distinct from the claimed malleable wires:

[T]he Court concludes that the inventors disclaimed self-expanding wires in the specification. The inventors describe prior art intraluminal grafts as being comprised of “a sleeve in which is disposed a plurality of self expanding wire stents.” (‘458 Patent, col. 1, ll. 20-22.) They then state that “[t]here are a number of problems associated with such known grafts,” including the “lack of precise control of the expansion of the graft in the lumen.” The inventors then state that their invention is “directed to an alternative form of intraluminal grafts which provides an alternative to the known grafts.” (Id., col. 1, ll. 32-42.) Thereafter, the inventors describe the wires that form part of the invention as malleable or state that the device is expanded by use of balloons. (See, e.g., id., col. 1, ll. 49, 60-63, col. 2, ll. 8- 15, col. 3, ll. 8-10, col. 5, ll. 32-36, 58-60, 66-67, col. 6, ll. 5-7.) Thus, when the Court reads the claims in light of the specification, it concludes that a person of ordinary skill in the art would clearly understand that this invention requires malleable, rather than resilient, wires.

On summary judgment the Court found that the accused products all used resilient wires.  The Court wrote with respect to Cook:

The manner in which Cook’s accused devices are deployed into a patient also is undisputed, with one exception. The accused devices are compressed and constrained within a sheath, which is part of a delivery catheter. This delivery catheter is inserted into a patient’s vessel, pushed to a diseased portion of the vessel, and, after the accused device is positioned satisfactorily, the sheath is withdrawn. As the pressure of the sheath is removed from the accused device, the wires regain their original shape and expand to fit within the vessel. . . . In sum, the wires in Cook’s accused devices initially expand within a vessel because of a release of pressure upon them, rather than by an exertion of pressure upon them.

The exception was the use of a balloon during the procedure, but the Court found that the balloon in the accused device was used to "seat" the device and not to expand the wires as claimed by the Edwards's patents.

The Court concluded that Edwards could not show literal infringement, and infringement by equivalence was foreclosed by the disclaimer of "resilient" wires, further finding that expanding the claims to reach such wires would vitiate the "malleable" limitation.

More reading:

 Cook SJ; Gore SJ

Counsel:

Edwards: Sidley Austin (Chicago)
Cook: Brinks Hofer Gilson Lione (Chicago); Howard Rice Nemerovski Canady Falk & Rabkin (San Francisco); Sonnenschein Nath Rosenthal (San Francisco)
Gore: Dickstein Shapiro (New York); Morgan & Finnegan (New York); Sonnenschein

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