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October 2, 2009

Claim Aneurism

Edwards Lifesciences sued Cook over four patents claiming intraluminal grafts to treat aneurisms. The claimed invention was construed to require a "malleable wire," which the accused products lacked, having instead "self-expanding wires." Hence non-infringement. In summary judgment. Affirmed on appeal because the specification narrowly disclosed the claimed invention, which the prosecution history corroborated.

Edwards Lifesciences v. Cook and W.L. Gore & Associates (CAFC 2009-1006) precedential

The asserted patents, all sharing a common specification: 6,582,458; 6,613,073; 6,685,736; 6,689,158.

The subject matter problem: weakness in a blood vessel that could lead to rupture. The solution: replace the weak portion with artificial tubing (graft). The patent disclosed using overlapping tubing, using specific techniques.

An aneurism is a weakness in a blood vessel, such as the aorta, that can cause enlargement or dilation of the vessel. If an aneurism is not repaired, the vessel can rupture, resulting in serious injury or death. To avoid the adverse consequences of open surgery, the medical profession has developed techniques for repairing aneurisms endovascularly, or intraluminally, allowing surgeons to make a small incision and guide a specially made device through the arteries to the aneurism. In endovascular aneurism repair, a graft reinforced with a metal framework, also called a stent-graft, is compressed onto a delivery catheter, which is guided through the artery to the aneurism site. Once at the site, the graft is expanded into position against the walls of the blood vessel. Stents, and therefore stent-grafts, are generally classified into two types, self-expanding and balloon expandable. A self-expanding stent or stent-graft is inserted into a blood vessel inside a catheter. Upon release from the catheter, it automatically expands to the size of the vessel. See id. at col.1 ll.20-31. A balloon expandable stent or stent-graft, on the other hand, is guided through a catheter on an inflatable balloon until it extends from the catheter into the vessel. See id. at col.1 ll.54-63. At that point, the balloon is inflated, expanding the stent or stent-graft to the size of the vessel, and then the balloon is deflated and removed. See id.

The specification describes one method of treating an aneurism using two overlapping grafts, whereby the degree of overlap can be adjusted to change the overall length of the graft. '458 patent col.4 ll.4-17.

Claim construction case law opener.

We begin a claim construction analysis by considering the language of the claims themselves. See Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). However, "claims must be read in view of the specification, of which they are a part." Id. at 1315 (quotation marks omitted). "[A] court should also consider the patent's prosecution history, if it is in evidence. . . . Like the specification, the prosecution history provides evidence of how the [Patent Office] and the inventor understood the patent." Id. at 1317 (citations and quotation marks omitted). Furthermore, courts may "rely on dictionary definitions when construing claim terms, so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents." Id. at 1322-23 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584 n.6 (Fed. Cir. 1996)).

Edwards had argued for a broad construction, that its 'graft' claim term, and equivalents, should not be burdened with the limitation of being necessarily intraluminal. But Edwards' spec used 'graft' and 'intraluminal graft' interchangeably.

We agree with Cook that, in light of the specification's written description, the claimed "graft" devices must all be intraluminal. Although the construction of a claimed term is usually controlled by its ordinary meaning, we will adopt an alternative meaning "if the intrinsic evidence shows that the patentee distinguished that term from prior art on the basis of a particular embodiment, expressly disclaimed subject matter, or described a particular embodiment as important to the invention." CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366-67 (Fed. Cir. 2002). Similarly, we will adopt a definition that is different from the ordinary meaning when "the patentee acted as his own lexicographer and clearly set forth a definition of the disputed claim term in either the specification or prosecution history." Id. at 1366. In this case, the specification consistently uses the words "graft" and "intraluminal graft" interchangeably. It states that "an intraluminal graft as defined above" is carried through a catheter "until the graft extends into the vessel." '458 patent col.1 ll.57-59 (emphases added); see also id. at col.5 ll.11, 17, 21, 24, 26, 27, 55, 58, 64, 65, 67, col.6 ll.1, 9 (interchangeably referring to the device identified by numeral 10 as "graft 10" and "intraluminal graft 10."). The interchangeable use of the two terms is akin to a definition equating the two.

Further, the only devices described in the specification are intraluminal, supporting an interpretation that is consistent with that description. See SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed. Cir. 2001) ("Where the specification makes clear that the invention does not include a particular feature, that feature is deemed to be outside the reach of the claims of the patent, even though the language of the claims, read without reference to the specification, might be considered broad enough to encompass the feature in question."). For example, as the district court noted, the specification states that, when an aneurism extends up to or beyond an arterial bifurcation, "it is possible to place a [trouser] graft according to the present invention . . . wholly within the primary artery." '458 patent col.4 ll.18-22 (emphases added); see Claim Construction Order, 2007 U.S. Dist. Lexis 55634, at *28. Thus, the specification assumed that the graft that it was describing was intended to be within the artery, or intraluminal.

Moreover, "when the preferred embodiment is described in the specification as the invention itself, the claims are not necessarily entitled to a scope broader than that embodiment." Chimie v. PPG Indus. Inc., 402 F.3d 1371, 1379 (Fed. Cir. 2005) (quotation marks omitted); see Honeywell Int'l, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed. Cir. 2006) (construing claim term to include fuel filter because "[o]n at least four occasions, the written description refers to the fuel filter as 'this invention' or 'the present invention'"); SciMed, 242 F.3d at 1343 (construing term to include feature characterized as "the present invention"). Here, the specification frequently describes an "intraluminal graft" as "the present invention" or "this invention," indicating an intent to limit the invention to intraluminal devices. See, e.g., '458 patent col.1 ll.11-12, 40-41, 45-46, col.3 ll.33, 39-40, 45, col.4 ll.5-6, 20, 56.

Edwards then argued, even if intraluminal, "such intraluminal devices need not have wires. According to Edwards, certain claims require wires, and others do not."

We agree with Appellees that the claimed graft devices must have wires because they are intraluminal and because each of the claims recites an attachment that requires wires. As the district court noted, the parties agreed at trial that intraluminal devices require wires. Claim Construction Order, 2007 U.S. Dist. Lexis 55634, at *22; Order Granting Cook Summary Judgment, 2008 U.S. Dist. Lexis 21248, at *13 n.1. Further, every embodiment described in the specification and shown in the drawings includes wires.

Edwards had argued claim differentiation to otherwise demonstrate that a broad construction was merited.

According to Edwards, because, for example, claim 2 of the '736 patent adds "a wire structure" to the graft of claim 1, the graft of claim 1 must be broader than a graft with a wire structure. However, claim differentiation is a rule of thumb that does not trump the clear import of the specification. See Netcraft Corp. v. eBay, Inc., 549 F.3d 1394, 1400 n.1 (Fed. Cir. 2008) ("While claim differentiation may be helpful in some cases, it is just one of many tools used by courts in the analysis of claim terms."). Here, the specification and the parties' agreement in the district court make clear that the claimed graft devices require wires.

The same path was trod over whether the wires had to be malleable, again coming back to the spec, with the prosecution history corroborating.

"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 U.S. Dist. Lexis 55634, at *33.

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.

Edwards then argued that malleable wires "may still display some resilience."

We agree with Appellees that, in the context of the specification, malleable wires and resilient wires are mutually exclusive. As the court correctly held, the specification defines "malleable" to exclude any substantial resilience, and that definition overrides any ordinary meaning of the word "malleable" that might allow for substantial resilience. The specification states that the wires "are maleable [sic] and may be bent into any desired shape, ie [sic] they are not resilient to any substantial extent so that they have to be physically expanded into contact with the aorta rather than expanding by virtue of their own resilience." '458 patent col.5 ll.32-36.

Edwards argued that summary judgment of non-infringement was unjustified, as it had a factual dispute. The appeals court didn't buy that either.

The court was also correct to grant summary judgment of noninfringement under the doctrine of equivalents. As we have discussed supra, the inventors disclaimed resilient wires and cannot use the doctrine of equivalents to recapture the disclaimed scope. See Honeywell, 452 F.3d at 1321.

Affirmed.

Posted by Patent Hawk at October 2, 2009 11:10 PM | Claim Construction

Comments

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