Opinion ID: 208013
Heading Depth: 3
Heading Rank: 3

Heading: The Wires in Intraluminal Devices Must Be Malleable

Text: Edwards next argues that, even if all of the claimed graft devices require wires, those wires need not be malleable but may instead be resilient. According to Edwards, the word malleable does not appear in any of the claims. Further, Edwards argues that claim 14 of the '158 patent requires resilient wire, so the inventors could not have disclaimed resilient wire. Edwards also asserts that, in the specification, the word malleable only describes three particular embodiments and does not limit the whole invention. Further, according to Edwards, the alleged disclaimer in the specification disparaging the prior art's lack of precise control of the graft's expansion is not limited to resilient wires. Finally, Edwards argues that malleable wires were removed from some claims during prosecution, showing the intent for a broader definition of wires, and the inventors requested an interference with another application that described resilient, self-expanding wires, showing an intent to claim such wires. Appellees respond that the court correctly required the wire in the claimed graft devices to be malleable, as the inventors clearly disclaimed resilient wire throughout the written description, including in the description of the prior art and in requiring that the wires be able to bell outward by balloon expansion. Further, according to Appellees, the resilient skirt required by claim 14 of the '158 patent is separate from the other wires, which must be malleable. Appellees assert that the prosecution history of claim amendments is trumped by the specification's clear disavowal of scope. Appellees argue that, in attempting to distinguish claims that did not expressly require malleable wires over prior art, the inventors stated that the wires were required to be malleable. We agree with Appellees that the wires required by the claims must be malleable, as the inventors disclaimed the use of resilient, or self-expanding, wires. As the court properly noted, the inventors disparaged prior art resilient wires in their background art section of the specification. The specification states that [i]t is known to form ... an intraluminal graft of a sleeve in which is disposed a plurality of self expanding wire stents.... There are a number of problems associated with such known grafts. '458 patent col.1 ll.15-33; see Claim Construction Order, 2007 WL 2128333, at , 2007 U.S. Dist. Lexis 55634, at . The problems that the specification then discusses include a lack of precise control of the expansion of the graft in the lumen. '458 patent col.1 ll.36-37; see Claim Construction Order, 2007 WL 2128333 at , 2007 U.S. Dist. Lexis 55634, at . The specification then describes the wires of the invention as malleable and states that the device is expanded by use of balloons. See, e.g., '458 patent col.1 ll.49, 60-63, col.2 ll.8-15, col.3 ll.8-9, col.5 ll.32-36, 58-60, 66-67, col.6 ll.5-7; see also Claim Construction Order, 2007 WL 2128333, at , 2007 U.S. Dist. Lexis 55634, at -33. Where the general summary or description of the invention describes a feature of the invention... and criticizes other products ... that lack that same feature, this operates as a clear disavowal of these other products.... Astrazeneca AB v. Mut. Pharm. Co., 384 F.3d 1333, 1340 (Fed.Cir.2004). Thus, as the court properly concluded, when the claims are read in light of the specification, a person of ordinary skill in the art would clearly understand that this invention requires malleable, rather than resilient, wires. Claim Construction Order, 2007 WL 2128333, at , 2007 U.S. Dist. Lexis 55634, at . Although, as Edwards points out, claim 14 of the '158 patent requires a downstream end of the bifurcated base graft structure [that] is provided with at least one resilient reinforcement wire, that resilient wire is in the skirt portion of the graft described in the specification. As the specification states, the skirt may be provided with at least one resilient annular reinforcement wire.... This ... arrangement is particularly suitable in the case of `trouser grafts' wherein one leg of the graft will have a skirt which cannot be expanded by a balloon catheter. '458 patent col.4 ll.41-48. As the specification is careful to explain, only the skirt cannot be expanded by a balloon catheter, as all of the rest of the graft is made of malleable wire that is normally expanded by a balloon catheter. Edwards' prosecution history argument also does not alter our conclusion. Although, during prosecution, the inventors canceled claims requiring malleable wires and replaced them with claims requiring only wires, they conducted the prosecution as if the wires were required to be malleable. As Appellees point out, in attempting to distinguish claims without an express malleable wire limitation over certain prior art, Edwards stated that the written description expressly teaches that the wire forms are malleable, deformable, non-springy material and that they are not self-expanding. Thus, as with the intraluminal interpretation discussed in part 1 supra, the change in claim language does not affect the breadth of the claims because the inventors' statements indicated that the claims remained narrow. See Alloc, 342 F.3d at 1371-72. Edwards cannot now reclaim what it disclaimed during prosecution and throughout the specification, viz., resilient wires.