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MAHURKAR v. C.R. BARD

DR. SAKHARAM D. MAHURKAR, Plaintiff,
v.
C.R. BARD, INC., BARD ACCESS SYSTEMS, INC. and BARD HEALTHCARE, INC., Defendants.



The opinion of the court was delivered by: REBECCA PALLMEYER, District Judge

MEMORANDUM OPINION AND ORDER

Plaintiff Dr. Sakharam D. Mahurkar is a nephrologist and inventor of catheters used in hemodialysis. Dr. Mahurkar holds several patents for catheters and related equipment, which he vigorously defends in the federal courts. In this case, Dr. Mahurkar 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): U.S. Patent No. 4,808,155 (the "`155 patent") for a "Simple Double Lumen Catheter" and U.S. Patent No. 4,895,561 (the "`561 patent") for the "Dual Lumen Catheter Connecting System." In his Second Amended Complaint filed on August 26, 2002, Dr. Mahurkar alleges that Defendants make, use, import, distribute, sell, and/or offer for sale a number of infringing products, including pre-curved Softcell, Optiflow, Hemoglide, Niagara, Niagara SlimCath, and Flexxicon II catheter assemblies. The court held a Markman hearing in December 2002 and has construed the claims in both patents. See Mahurkar v. C.R. Bard, Inc., No. 01 C 8452, 2003 WL 21078033 (N.D. Ill. May 13, 2003) ("Mahurkar I"), aff'd on reconsideration, 2003 WL 22844237 (N.D. Ill. Dec. 1, 2003) ("Mahurkar II"). The parties have since filed a litany of motions.

At issue here are Defendants' Motion for Summary Judgment of Noninfringement of the `561 Patent, Plaintiff's Motion for Summary Judgment on Literal Infringement of the '561 Patent, Plaintiff's Motion for Summary Judgment on Defendants' Licensee Affirmative Defense, Plaintiff's Motion for Summary Judgment on Defendants' Invalidity Defense to the `155 Patent, and Defendants' Motion to Bar Expert Testimony and Strike Plaintiff's "Supplemental" Report. For the reasons explained below, the motions are granted in part and denied in part.

  BACKGROUND

  The procedural history of the case leading to the Markman hearing, the background of the `155 and `561 patents, and the prior litigation between the parties were described in this court's May 13, 2003 and December 1, 2003 Memorandum Opinions and Orders. See Mahurkar I, 2003 WL 21078033, at *1-3, and Mahurkar II, 2003 WL 22844237, at *1. This opinion assumes the reader's familiarity with these earlier decisions and will summarize the relevant facts here only briefly.

  The role of kidneys in the body is to remove toxins from the blood. When kidneys fail to function properly due to disease or injury, blood must be cleansed externally in a process called hemodialysis, which involves removing blood from a patient, diverting it to a blood treatment unit where it is cleansed, and then returning it to the patient. Mahurkar v. Arrow Int'l, Inc., 160 F. Supp.2d 927, 930 (N.D. Ill. 2001); Mahurkar I, 2003 WL 21078033, 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. The patents and products at issue in this case concern "double lumen" catheters for use in hemodialysis, that is, catheters having two separate lumens, or channels, one for removing uncleansed blood and one for returning cleansed blood. Mahurkar I, 2003 WL 21078033, at *1. DISCUSSION

  I. Motion for Summary Judgment as to `561 Patent

  Both parties have moved for summary judgment with respect to the `561 patent. Dr. Mahurkar claims that the pre-curved Softcell, Optiflow, Hemoglide, Niagara, Niagara SlimCath, and Flexxicon II catheters (the "accused products") all literally infringe the `561 patent because they have "dual-lumen catheters" and "connecting means" which satisfy the elements of Claim 34 of the `561 patent. Defendants insist that their products do not infringe the `561 patent, either literally or under the doctrine of equivalents. The court considers each motion below.

  A. Background

  Patients suffering from chronic kidney failure require long-term hemodialysis, including blood cleansing several times a week for the remainder of their lives or until they receive compatible kidney transplants. Mahurkar I, 2003 WL 21078033, at *2. To limit puncture damage caused by inserting a new catheter during each treatment, chronic patients usually retain the same catheter in their bodies for a period of several weeks. Unless properly configured, the catheter, especially its tip, can cause extensive pain and trauma to a patient's vein during its extended residence. Id.

  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 jugular vein in the neck, the extension tubes protruded awkwardly above a patient's shoulder, or towards the patient's ear. These straight catheters were uncomfortable and had a tendency to become dislodged during use or create additional trauma in the vein during extended residence. Id. (See also `561 patent, Ex. A to Pl. `561 Facts, col. 1, line 21 to col. 2, line 31.)*fn1 Dr. Mahurkar's `561 patent, issued on January 23, 1990, addressed this risk by bending a portion of the catheter assembly that remains outside the patient's vein so that the catheter could be "positioned in convenient anatomical sites during the periods between successive treatments to avoid patient discomfort and accidental displacement of the catheter." Id. (quoting `561 Patent, Ex. B to Second Amended Complaint, col. 1, lines 13-16); (Pl. `561 Facts ¶¶ 2-5, 39; Def. `561 Fact Resp. ¶¶ 2-5, 39.)*fn2

  1. Claim Construction of the `561 Patent

  As noted, the court held a Markman hearing in December 2002 and has construed the disputed claims in the `561 patent. At issue here is Claim 34, which states:
A dual-lumen catheter assembly comprising:
a dual lumen catheter, and connecting means attached to the proximal end of said catheter and forming a pair of internal passageways which communicate at one end thereof with the dual lumens in said catheter, said passageways curving back toward the distal end of said catheter so that forces exerted on said connecting means at the other ends of said passageways will tend to move said catheter in the same direction as*fn3 said exerted forces.
(`561 Patent, col. 11, lines 14-23.) Claim 36, which is dependent upon Claim 34, also states: "The catheter assembly of claim 34 wherein each of said curved passageways is U-shaped." (Id., col. 11, lines 31-32.)*fn4 The parties disputed the meaning of two terms in these Claims: "catheter" and "connecting means." The court found that "catheter" as used in the `561 patent means "a tubular device for withdrawing fluids from, or introducing fluids into, a cavity of the body, such as a blood vessel." Mahurkar I, 2003 WL 21078033, at *8. The catheter extends "from the distal end, the end that is first inserted into the patient's body, to the proximal end, where the connecting means attaches the catheter to the remainder of the apparatus." Id.

  The court determined that "connecting means" is a means-plus-function clause. Pursuant to 35 U.S.C. § 112 ¶ 6, a claim element "may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof." Claim elements written in this format are construed to cover the corresponding structures described in the specification, and equivalents thereof. Id. The court therefore identified the corresponding structures disclosed in the specification that are linked or associated with the function. Chiuminatta Concrete Concepts, Inc. v. Cardinal Indus., Inc., 145 F.3d 1303, 1308 (Fed. Cir. 1998). Specifically, the court found that the "connecting means" may be "(1) a Y-shaped connector connected to extension tubes that curve back toward the distal end of the catheter, and equivalents thereof; [or] (2) a unitary connecting member forming two internal U-shaped passageways, each of which is in communication with one of the lumens of the catheter, and equivalents thereof." Mahurkar I, 2003 WL 21078033, at *10. "[T]he proximal end of the catheter tube is straight and is attached either to the Y-shaped connector or the unitary connecting member, which can be curved." Id. "[T]he catheter itself must be visibly attached to a distinct portion, the connecting means, and the catheter tube must be straight, not curved." Id. In addition, the connecting means "must be something physically separate from the catheter." Id.

  On reconsideration, the court confirmed that "the proximal end of the dual-lumen catheter, and the endpoint of the catheter itself, is the point where the two lumens end." Mahurkar II, 2003 WL 22844237, at *5. The `561 patent defines lumens as follows: "[d]ual-lumen hemodialysis catheters are normally supplied with certain auxiliary components permanently pre-attached to the catheter. These auxiliary components facilitate the connection of the two lumens of the catheter (which are extremely small within the catheter) to a pair of long flexible tubes which carry blood to and from the hemodialysis unit." Id. The court explained that "the lumens end at the point where they are connected to the auxiliary components" and, thus, at the endpoint of the catheter itself. Id.

  2. The Accused Products

  As noted, Mahurkar charges that six of Defendants' products infringe the `561 patent. The court begins by describing the accused products, of which five (the "Softcell Group") are structurally similar, and a sixth, the Flexxicon II, is of a different design.

  a. Softcell, Optiflow, Hemoglide, Niagara, and Niagara SlimCath

  The Softcell, Optiflow, Hemoglide, Niagara, and Niagara SlimCath catheters (the "Softcell Group") all have (1) a catheter tube, (2) a Y-connector, and (3) two straight extension tubes.*fn5 (Def. `561 Facts ¶ 5.)*fn6 The catheter tubes of the Softcell Group have two lumens — a "return" lumen and an "intake" lumen, which are side-by-side within the catheter tubing. (Id. ¶¶ 6.) According to Defendants, the lumens continue through a curved portion of the apparatus which is still part of the "catheter," and end at a Y-connector which is a separate, auxiliary component that is physically attached to the proximal end of the catheter tube. (Id. ¶¶ 7, 8.) Dr. Mahurkar, on the other hand, asserts that the lumens end where the separate "curved tubular portion" begins, not at the Y-connector. He notes that in construing Claim 34, the court determined that the proximal end of the catheter tube is straight. In his view, if the catheter tube must be straight, so must the lumens. Dr. Mahurkar acknowledges that the Softcell Group catheters have a Y-connector that is part of the "connecting means," but he claims that in Softcell Group catheters, "the Y-connector is distanced from the catheter tube by the portion of the connecting means including the preformed curve." (Pl. `561 Fact Resp. ¶¶ 7, 8.)*fn7

  For purposes of summary judgment, there is no dispute that during the manufacturing process for the Softcell Group, a curve is induced in a continuous piece of catheter tubing using curving mandrels*fn8 for each of the lumens, a curving fixture, and a heat source. (Def. `561 Facts ¶¶ 10, 12.) External components, such as "cuffs," "suture wings," and "suture wing retainers" are added to the outside of the tubing during the manufacturing process but are not part of the tube itself. (Id. ¶¶ 13, 14; Pl. `561 Fact Resp. ¶¶ 13, 14.)

  b. Flexxicon II

  The Flexxicon II catheter has a co-axial body with two concentric tubes enclosing two internal lumens that act as channels for blood flow. (Def. `561 Fact Resp. ¶ 38.) In other words, the "intake" and "return" lumens are not side-by-side as in the Softcell Group catheters, but instead consist of a small inner tube within a larger outer tube.*fn9 (Def. `561 Resp., at 4.)*fn10 The inner tube is formed from a single, pre-curved piece of tubing that runs continuously from the distal end to the Y-hub. Thus, the channel of the inner tube stretches uninterrupted from the distal end, through a pre-curved portion of tubing, to the Y-hub. (Def. `561 Fact Resp. ¶¶ 39, 41.) The outer tube, on the other hand, is manufactured by bonding two sections of tubing together approximately where the catheter tubing begins to curve. The bonding is so smooth, however, that it does not interrupt the blood flow through the outer channel, which runs continuously from the distal end, through the curved segment, to the Y-hub. (Id. ¶¶ 42, 43.)

  B. Standard of Review

  Summary judgment is proper when "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." FED. R. CIV. P. 56(c). In determining whether there is a genuine issue of fact, the court must view the evidence and draw all reasonable inferences in favor of the party opposing the motion. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). Summary judgment on the issue of literal infringement is proper "when no genuine issue of material fact exists, in particular, when no reasonable jury could find that every limitation recited in the properly construed claim either is or is not found in the accused device." Goldenberg v. Cytogen, Inc., 373 F.3d 1158, 1163-64 (Fed. Cir. 2004) (quoting Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998)).

  Determination of patent infringement requires a two-step analysis: (1) construction of the meaning and scope of the claims, and (2) comparison of the allegedly infringing device to the construed claim. Novartis Pharmaceuticals Corp. v. Eon Labs Mfg., Inc., 363 F.3d 1306, 1308 (Fed. Cir. 2004). "Literal infringement of a § 112 ¶ 6 claim requires that the relevant structure in the accused device perform the identical function recited in the claim and be identical or equivalent to the corresponding structure in the specification." Lockheed Martin Corp. v. Space Systems/Loral, Inc., 324 F.3d 1308, 1320 (Fed. Cir. 2003). Two structures may be "equivalent" under § 112 ¶ 6 if "they perform the identical function, in substantially the same way, with substantially the same result." Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364 (Fed. Cir. 2000). An accused product that does not literally infringe a patent may nonetheless be infringing under the doctrine of equivalents. Unlike "equivalents" under § 112 ¶ 6, "equivalents under the doctrine of equivalents need only perform a substantially similar function" and not an identical function. Kemco Sales, 208 F.3d at 1364. Summary judgment of non-infringement is appropriate where no reasonable jury could find that an accused device "performs the identical function with the same structure, materials, or acts described in the specification or an equivalent thereof." IMS Technology, Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1430 (Fed. Cir. 2000).

  C. Analysis

  Dr. Mahurkar claims that the accused products all have "dual-lumen catheters" and "connecting means" which satisfy the elements of the `561 patent. As noted, the court construed "connecting means" to be "(1) a Y-shaped connector connected to extension tubes that curve back toward the distal end of the catheter, and equivalents thereof; [or] (2) a unitary connecting member forming two internal U-shaped passageways, each of which is in communication with one of the lumens of the catheter, and equivalents thereof." Mahurkar I, 2003 WL 21078033, at *10. The parties agree that the accused products do not include connecting means defined by a Y-connector fastened to bent extension tubes. (Def. `561 Facts ¶ 15; Pl. `561 Fact Resp. ¶ 15; Def. `561 Fact Resp. ¶ 46.) Thus, infringement must be determined with reference to whether the accused products have a dual-lumen catheter and a "unitary connecting member" as described in the patent. Mahurkar I, 2003 WL 21078033, at *10.

  1. Literal Infringement

  Dr. Mahurkar argues that the accused products all have "dual-lumen catheters" that extend from "the distal tip of the catheter to the distal end of the curved portion of the assembly, or in other words the point where the catheter assembly begins to bend." (Pl. `561 Mem., at 8.)*fn11 In his view, the point where the catheter tubing begins to bend is also the point where the "connecting means" begins; that is,
the curved tubular portion of the catheter assembly (the unitary connecting member) forms a pair of internal passageways that communicate at one end thereof (the distal end) with the dual lumens of the straight catheter portion, the passageways curving back towards the distal end of the catheter so that forces exerted on the unitary connecting member at the other ends of the passageways will tend to move the catheter in the same direction as the exerted forces — exactly as required under claim 34 of the `561 patent.
(Id. at 10.) Defendants claim that the "catheter" portion of the accused products extends from the distal end that is inserted into the patient all the way around the curved tubular portion to the Y-connector. According to Defendants, the Y-connector with the straight extension tubes alone forms the "connecting means." The court addresses the Softcell Group and Flexxicon II catheters separately given their differing structures.

  a. Softcell Group

  Dr. Mahurkar's argument in support of literal infringement is based in part on the court's determination that "the catheter tube must be straight, not curved." Mahurkar I, 2003 WL 21078033, at *10. Contrary to Dr. Mahurkar's suggestion, this conclusion does not mean that all catheter tubes, including the catheter tubes in the accused products, must be straight without any curving portions. The court merely construed the term "catheter" as claimed in the `561 patent. See, e.g., Optical Disc Corp. v. Del Mar Avionics, 208 F.3d 1324, 1333 (Fed. Cir. 2000) ("the claim scope is determined without regard to the accused device"). Thus, the fact that the Softcell Group products have a straight tubular segment that continues around a curved segment does not preclude a finding that the entire length of tubing in those products is "catheter." Indeed, the continuous nature of the tubing weighs in favor of such a conclusion. As the court explained in Mahurkar I, "the catheter itself must be visibly attached to a distinct portion, the connecting means," which "must be something physically separate from the catheter." 2003 WL 21078033, at *10 (emphasis added).

  Dr. Mahurkar insists that the straight portion of the tubing is "physically separate" from, and visibly and distinctly attached to, the curved portion of the tubing. (Pl. `561 Resp., at 13-14.)*fn12 His reasoning, however, is circular and inconsistent with the court's claim construction. Dr. Mahurkar argues that "[t]he catheter and the connecting means are visibly attached by the simple fact that there is no visible detachment between the two elements" and, at the same time, that the catheter (i.e., the straight tubular segment) is "physically separate and distinct from" the unitary connecting member (i.e., the curved tubular segment) because one is straight and the other is curved. (Id.) Dr. Mahurkar has not cited any authority for the proposition that a continuous piece of tubing becomes "physically separate" at some point where the tubing begins to curve. The court made clear in its Markman opinion that as claimed in the `561 patent, the catheter and the connecting means must be separate and distinct structures; in the court's view, a continuous, curved tube does not literally satisfy this requirement.

  Dr. Mahurkar's interpretation is also inconsistent with the court's conclusion that "the proximal end of the dual-lumen catheter, and the endpoint of the catheter itself, is the point where the two lumens end." Mahurkar II, 2003 WL 22844237, at *5. The patent defines "lumens" as follows: "[d]ual-lumen hemodialysis catheters are normally supplied with certain auxiliary components permanently pre-attached to the catheter. These auxiliary components facilitate the connection of the two lumens of the catheter (which are extremely small within the catheter) to a pair of long flexible tubes which carry blood to and from the hemodialysis unit." Id. The "extremely small" lumens in the accused products continue to the Y-connector, not merely to the point where the catheter tubing begins to bend.

  The court finds that no reasonable jury could conclude that the Softcell Group catheters have an identical structure that literally infringes the `561 patent. Thus, Dr. Mahurkar's motion for summary judgment on this issue is denied and Defendants' corresponding motion for summary judgment is granted. See Lockheed Martin, 324 F.3d at 1318 (summary judgment is proper if "no reasonable jury could return a verdict for the nonmoving party"). To the extent the parties seek ...


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