C.R. Bard, Inc. v. U.S. Surgical Corp.

• Decision Date: 29 October 2004
• Docket Number: No. 04-1135.,04-1135.
• Citation: 388 F.3d 858
• Parties: C.R. BARD, INC. and Davol Inc., Plaintiffs-Appellants, v. UNITED STATES SURGICAL CORP., Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

Page 858

388 F.3d 858

C.R. BARD, INC. and Davol Inc., Plaintiffs-Appellants, v. UNITED STATES SURGICAL CORP., Defendant-Appellee.

No. 04-1135.

United States Court of Appeals, Federal Circuit.

DECIDED: October 29, 2004.

Appeal from the United States District Court for the District of Delaware, Kent A. Jordan, J Claire Laporte, Foley Hoag LLP, of Boston, Massachusetts, argued for plaintiffs-appellants. With her on the brief was Peter B. Ellis.

Drew M. Wintringham, III, Clifford Chance US, LLP, of New York, New York, argued for defendant-appellee. With him on the brief was Mark W. Rueh.

Before NEWMAN, MICHEL, and PROST, Circuit Judges.

MICHEL, Circuit Judge.

C.R. Bard, Inc. and its subsidiary, Davol Inc., (collectively, "Bard") appeal from the December 10, 2003, final judgment of non-infringement of claim 20 of U.S. Patent No. 5,356,432 ("'432 patent") in favor of United States Surgical Corp. ("U.S. Surgical"). The appeal was submitted for decision following oral argument on September 8, 2004. Because the district court did not err in construing the mesh surgical plug of claim 20 as requiring a pleated surface, we affirm.

BACKGROUND

This patent case involves a device used to repair hernias. As explained by the district court, "[a] hernia is a relaxation or weakening of the muscle wall, usually in the lower abdomen, which permits tissue to protrude through the muscle wall defect." C.R. Bard, Inc. v. United States Surgical Corp., 102 F.Supp.2d 199, 201 (D.Del.2000) ("Claim construction order"). Put simply, a hernia defect is a hole in the muscle wall and the invention in this case is a device used to plug the hole. Indeed, devices such as the invention in this case are commonly called "plugs" in the art.

Traditionally, hernias were repaired by suturing together separated strands in the weakened muscle wall. Id. Prior to the '432 patent, the use of cylindrical plugs made of surgical mesh to repair hernias was known in the art. These mesh plugs filled at least some portion of the hernia defect and became fixed in place through "`fibroblasting,' wherein the muscle tissue attaches itself to the mesh." Id. Other mesh plugs were also known in the art, including a mesh plug rolled into a conical, rather than a cylindrical, shape and a mesh plug formed by suturing a square piece of mesh into a conical, four-lobed configuration. In addition to plugs, a method of repair in which a flat piece of surgical mesh was stapled or sutured over the hernia defect was also known.

On January 22, 1992, Drs. Ira Rutkow and Alan Robbins disclosed to Bard employees the invention that culminated in the device claimed in the '432 patent. See Claim construction order, 102 F.Supp.2d at 202 ("Bard's project notebook shows that Rutkow and Robbins contemplated using a 3-layered design, comprising an exterior, pleated layer, and two interior layers for support."). Although the exact relationship between Bard and Drs. Rutkow and Robbins does not appear to be in the present record, Bard claims, the district court stated, and U.S. Surgical does not dispute that Bard prosecuted the patent application that matured into the '432 patent on behalf of Drs. Rutkow and Robbins. See id.

The device claimed in the '432 patent is an implant that includes a mesh plug with a conformable surface and mesh filler material inside the plug. '432 patent, Abstract. The conformable surface allows the plug to fill irregularly shaped hernia defects more completely than other plugs. The mesh filler material provides bulk and stiffness to the implant.

The only claim at issue in this appeal is claim 20 of the '432 patent as amended during reexamination, which recites:

20. An implantable prosthesis for repairing a tissue or muscle wall defect, comprising:

a hollow plug, formed of a surgical mesh fabric having openings therein for tissue ingrowth, constructed and arranged to securely fit within and occlude the tissue or muscle wall defect and which is radially compressible upon insertion into the defect from a first configuration which is larger than the defect into a second configuration which approximates the shape of the defect, the surface of said hollow plug being conformable to irregularities in the tissue or muscle wall defining the defect upon insertion of said hollow plug into the defect, said hollow plug being extremely pliable, allowing localized portions of the hollow plug to adapt to irregularities in the tissue or muscle wall defect.

'432 Reexamination Certificate, col. 2, ll. 10-24 (original emphases and alteration noting deletion omitted; emphases added).

In the intrinsic record, the claimed plug is consistently described as having pleats. The Summary of the Invention states that "[t]he present invention is an implantable prosthesis" and that "[t]he implant includes a pleated surface which increases the pliability of the implant, allowing the prosthesis to conform to irregularities in the tissue or muscle wall surrounding the opening." '432 patent, col. 1, ll. 37 (first quotation); id. at col. 1, ll. 51-55 (second quotation; emphasis added). The Abstract describes "[a]n implantable prosthesis including a conical mesh plug having a pleated surface which conforms to the contours of the defect being repaired." Id., Abstract (emphasis added). Statements in latter sections in the specification describing preferred embodiments all refer to a pleated plug. E.g., id. at col. 2, ll. 56-60 ("The surface of the conical plug is pleated 18 which enhances the flexibility and pliability of the implant, allowing the device to conform to irregularities in the shape of the hernia without kinking.") (emphasis added); id. at col. 4, ll. 39-43 ("The resulting implant includes a hot molded conical plug with a pleated surface....") (emphasis added); id. at col. 5, ll. 37-40 ("The pleated surface is extremely pliable ....") (emphasis added). Finally, the prosecution history includes a number of arguments in which the claimed plug is distinguished on the basis that the claimed plug is pleated. In particular, during the reexamination, Bard stated that "the surface of the inventive plug is pleated." (Emphasis added.)

Bard brought suit against U.S. Surgical, claiming that U.S. Surgical made and sold a mesh plug that infringed claim 20 and induced surgeons to infringe method claim 21 of the '432 patent. In its claim construction order, the district court concluded that the plug in claim 20 must contain "pre-formed pleats."¹ 102 F.Supp.2d at 217. This conclusion was based alternatively on an examination of the specification and a conclusion that claim 20 contained means-plus-function limitations requiring pre-formed pleats. Id. at 215-17. Because the accused device admittedly did not include a pleated plug, the district court granted summary judgment that U.S. Surgical did not infringe claim 20 literally or under the doctrine of equivalents. C.R. Bard, Inc. v. United States Surgical Corp., 107 F.Supp.2d 489, 491-94 (D.Del.2000) ("Summary judgment order"). The district court, however, denied U.S. Surgical's motion for summary judgment on claim 21. Id. at 494. After Bard prevailed at a jury trial and in post-trial motions on claim 21, the parties settled their dispute involving claim 21. Bard timely appealed the final judgment as to claim 20, and we have jurisdiction under 28 U.S.C. § 1295(a)(1).

DISCUSSION

I. Applicable Law

"Determination of patent infringement requires a two-step analysis: (1) the scope of the claims must be construed; and (2) the allegedly infringing device must be compared to the construed claims." Mars, Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1373 (Fed.Cir.2004). We review the district court's claim construction de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454-56 (Fed.Cir.1998) (en banc). The district court's grant of summary judgment of non-infringement is also reviewed without deference. Mars, Inc., 377 F.3d at 1373.

A long line of cases indicates that the intrinsic record is the primary source for determining claim meaning. E.g., Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir.2001); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996); Autogiro Co. of Am. v. United States, 181 Ct.Cl. 55, 384 F.2d 391, 397-98 (1967). The intrinsic record includes the specification and the prosecution history. Masco Corp. v. United States, 303 F.3d 1316, 1324 (Fed.Cir.2002). Under this approach to claim construction, evidence extrinsic to the patent document "can shed useful light on the relevant art," but is less significant than the intrinsic record in determining the "legally operative meaning of disputed claim language." Vanderlande Indus. Nederland BV v. Int'l Trade Comm'n, 366 F.3d 1311, 1318 (Fed. Cir.2004). Particularly, our caselaw suggests that extrinsic evidence cannot alter any claim meaning discernible from intrinsic evidence. See, e.g., Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1367 (Fed.Cir. 2003) ("When an analysis of intrinsic evidence resolves any ambiguity in a disputed claim term, it is improper to rely on extrinsic evidence to contradict the meaning so ascertained.").

Language in some of our recent cases, however, suggests that the intrinsic record, except for the claims, should be consulted only after the ordinary and customary meaning of claim terms to persons skilled in the pertinent art is determined. See, e.g., Tex. Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1204 (Fed.Cir. 2002), cert. denied, 538 U.S. 1058, 123 S.Ct. 2230, 155 L.Ed.2d 1108 (2003). The language in these cases emphasizes technical and general-usage dictionaries in determining the ordinary meaning. Id. Under this approach, where the ordinary meaning of a claim term is thus evident, the inventor's written description of the invention, for example, is relevant and controlling insofar as it provides clear lexicography or disavowal of the ordinary meaning. See id. ("[T]he...