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May 13, 2003


The opinion of the court was delivered by: Rebecca R. Pallmeyer, United States District Judge


Plaintiff Dr. Sakharam D. Mahurkar is a nephrologist and inventor of catheters, for which he owns several patents. In his Second Amended Complaint, filed August 26, 2002, Plaintiff charges Defendants C.R. Bard, Inc., Bard Access Systems, Inc., and Bard Healthcare, Inc. with infringing two of his patents under 35 U.S.C. § 271(a), (b), and (c): United States No. 4,808,155 (the "`155 patent") and No. 4,895,561 (the "`561 patent"). These patents describe two different catheters.*fn1 In December 2002, the court conducted a Markman hearing at which the parties presented their respective interpretations of a number of claims in each patent. See Markman v. Westview Instruments, Inc., 52 F.3d 961, 979 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). Following is the court's construction of those claims.


The role of kidneys in the body is to remove toxins from blood; when kidneys fail to function properly due to disease or injury, blood must be cleansed externally in a process called hemodialysis. Mahurkar v. Arrow Int'l, Inc., 160 F. Supp.2d 927, 930 (N.D.Ill. 2001). The patents-in-suit and the accused Bard products concern double lumen catheters for use in hemodialysis. In hemodialysis, blood is removed from a patient diverted to a blood treatment unit where it is cleansed, and then returned to the patient. (Pl.'s Brief at 1.) Hemodialysis catheters are devices that are inserted into a patient's vein for removal and return of blood. Arrow Int'l, 160 F. Supp.2d at 930. A "double lumen" hemodialysis catheter has two separate lumens, or channels, one for removing uncleansed blood and one for returning cleansed blood. (Pl.'s Brief at 1.)

Plaintiff is a certified nephrologist — a doctor specializing in the treatment of kidneys — who has lived in Chicago for approximately 30 years. (Plaintiff's Opening Brief on Claim Construction, hereinafter "Pl.'s Brief" at 2.) Until his retirement in 1993, Plaintiff conducted research and taught nephrology and internal medicine at Cook County Hospital in Chicago. (Id.) Plaintiff first developed a dual lumen catheter in 1980. (Id.) He has since become a prolific inventor and has, to date, been awarded 29 United States patents. (Id.)

Defendant C.R. Bard is a New Jersey corporation in the business of manufacturing, distributing, and selling catheters in the United States under a variety of brands. (C.R. Bard's Answer to Second Amended Complaint ¶ 2.) Defendant Bard Access Systems is a Utah corporation that, like C.R. Bard, distributes and sells a variety of catheters. (Bard Access Systems Answer to Second Amended Complaint ¶ 3.) Defendant Bard Healthcare is a Texas corporation and imports into the United States certain of the accused catheters which it sells to Bard Access Systems.*fn2 (Bard Healthcare's Answer to Second Amended Complaint ¶ 4.)

In Count I of his Second Amended Complaint, Plaintiff claims that Defendants infringed the `561 patent by making, using, importing, distributing, selling and/or offering for sale Flexxicon II Precurve catheters, Niagara curved catheters, Softcell curved catheters, Optiflow, Hemoglide, Niagara Slim-Cath and other catheter assemblies with a preformed bend in the catheter or catheter connecting system. (Second Amended Complaint ¶¶ 19, 20, 21.) Count II alleges that the Defendants infringed the `155 patent by making, using, importing, distributing, selling and/or offering for sale the same products.*fn3 (Id. ¶¶ 26, 21.)

A. Background on the `155 Patent

The `155 patent is entitled "Simple Double Lumen Catheter." Plaintiff intended the catheter described by the `155 patent to improve patient comfort and reduce trauma on a patient's vein. (Pl.'s Brief at 3.) Plaintiff explains that a patient suffering from chronic kidney failure requires long-term hemodialysis including blood cleansing several times a week for the remainder of her life or until she receives a compatible kidney transplant. (Id.) To limit the puncture damage that would be inflicted on a patient's veins from implanting a new catheter each time, chronic patients usually retain the same catheter in their body continuously over a period of several weeks. (Id.) Unless property configured, the catheter, especially its tip, can cause extensive pain and trauma to the patient's vein during its extended residence. (Id.) Plaintiff explains that prior to his invention of the `155 patent, catheters typically featured a sharp tip (or distal end) which facilitated puncturing the patients skin and vessel wall during implantation, (Id. at 4), but could become caught in the walls of the patient's blood vessel and cause trauma. Plaintiff's patented invention is a catheter that does "not traumatize or become caught in the walls of a blood vessel into which the catheter is inserted. . . ." (`155 patent, Ex. A to Second Amended Complaint, col. 3, lines 48-51.) The patent specification notes that trauma to the patient is avoided because the catheter "does not have the conical tip or taper that is characteristic of other catheters." (Id., col. 3, lines 60-61.) Without a sharp tip, the catheter of the `155 patent is implanted "in the direction of blood flow in a large vein, surgically under direct vision or over a Seldinger's guide wire through a sheath. . . ." (Id., col. 4, lines 16-17.) In order to prevent cleansed blood from mixing with uncleansed blood, the lumens described by the `155 patent are spatially separated longitudinally along the catheter axis by a divider. (Id., col. 3, lines 31-33, 55-57.)*fn4

B. Background on the `561 Patent

The `561 patent, entitled "Dual-Lumen Catheter-Connecting System," was issued to Dr. Mahurkar on January 23, 1990. The `561 patent concerns the portion of the catheter assembly that connects the catheter tube to the blood treatment unit. Prior to the invention of the `561 patent, extension tubes on catheters were generally straight. When straight catheters were placed in certain veins, such as the subclavian vein (under the clavicle), or the jugular vein (in the neck), the extension tubes protruded awkwardly above the patient's shoulder, or towards the patient's ear. (Id.) In addition to being uncomfortable for patients, these straight catheters had a tendency to become dislodged, sometimes resulting in bleeding that can be profuse and can even be fatal. (Id. at 6.) The patented invention improves patient comfort for certain types of catheter placements, and reduces the likelihood that catheters will pull out of the vein during or between hemodialysis treatments. (Pl.'s Brief at 5.)

Plaintiff's `561 patent addressed this risk by bending a portion of the catheter assembly that retrains outside of the patient's vein so that the extension tubes could "be positioned in convenient anatomical sites during the periods between successive treatments to avoid patient discomfort and accidental displacement of the catheter." (`561 patent, Ex. B to Second Amended Complaint, col. 1, lines 13-16.) Since the extension tubes are curved back toward the distal end of the catheter (the end that is inserted into the patient's vein), they do not stick out, and tugging on the extension tubes will not cause the catheter to become dislodged. (Pl.'s Brief at 7.)

C. Prior Litigation Between the Parties

The present suit is not the first litigation between Plaintiff and Defendants. In 1992, Plaintiff sued C.R. Bard, Bard Access Systems, and a third corporation not a party to the present lawsuit for infringement of his `155 patent. A jury found the accused catheters (different catheters from those accused in this suit) to infringe the `155 patent and the Federal Circuit affirmed, although it remanded for a new calculation of the plaintiff's damages. Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572 (Fed. Cir. 1996). That earlier case produced no published opinions regarding claims construction. As mentioned below, Dr. Mahurkar has brought suit against other alleged infringers as well, including Arrow International, Inc. Mahurkar v. Arrow Int'l, Inc., 160 F. Supp.2d 927 (N.D.Ill. 2001).


The parties in this case dispute a number of claim terms in the `155 and `561 patents. The court will address each of the disputed terms in turn. In each instance, the court will examine the claim language itself, giving the terms "their ordinary and accustomed meanings as understood by one of ordinary skill in the art." Bell Atlantic Network Services, Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). It is well settled that when "interpreting an asserted claim, the court should first look to the intrinsic evidence of the record," such as "the patent itself, including the claims, the specification and, if in evidence, the prosecution history." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996), citing Markman, 52 F.3d at 979. "In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term." Id. When intrinsic evidence is sufficient, it is inappropriate for the court to rely on extrinsic evidence. Id. Where one party did not respond in writing to another party's proposed claim term, the court has assumed that the term is no longer disputed, and will not address it in this opinion.

I. `155 Patent

The parties dispute terms in claims 1 and 3 of the `155 patent, and the court will ...

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