Ballard Medical Products v. Allegiance

• Decision Date: 09 October 2001
• Parties: (Fed. Cir. 2001) BALLARD MEDICAL PRODUCTS, Plaintiff-Appellant, v. ALLEGIANCE HEALTHCARE CORP., and SORENSON CRITICAL CARE, INC., Defendants-Appellees. 00-1393 DECIDED:
• Court: U.S. Court of Appeals — Federal Circuit

Page 1352

268 F.3d 1352 (Fed. Cir. 2001)

BALLARD MEDICAL PRODUCTS, Plaintiff-Appellant, v. ALLEGIANCE HEALTHCARE CORP., and SORENSON CRITICAL CARE, INC., Defendants-Appellees.

00-1393

United States Court of Appeals for the Federal Circuit

DECIDED: October 9, 2001

Appealed from: United States District Court for the District of Utah

Judge Bruce S. Jenkins

[Copyrighted Material Omitted] Roy W. Hardin, Locke Liddell & Sapp LLP, of Dallas, Texas, argued for plaintiff-appellant. With him on the brief were Craig L. Weinstock, John Wilson Jones, and Steven S. Boyd.

David V. Trask, Trask Britt, of Salt Lake City, Utah, representing Sorenson Critical Care, Inc., argued for defendants-appellees. With him on the brief was John P. Aston, Prince, Yeates & Geldzahler, of Salt Lake City, Utah, representing Allegiance Healthcare Corp.

Before MAYER, Chief Judge, BRYSON, and DYK, Circuit Judges.

BRYSON, Circuit Judge.

Ballard Medical Products owns U.S. Patent Nos. 4,569,344 ("the '344 patent") and 4,696,296 ("the '296 patent"), which are drawn to ventilating and aspirating tracheobronchial catheters. Ballard sued Sorenson Critical Care, Inc., and Allegiance Healthcare Corp. (collectively "Sorenson") for infringement of multiple claims of the '344 and '296 patents. On summary judgment, the district court ruled that Sorenson had not infringed the disputed patents either literally or under the doctrine of equivalents. We affirm.

I

A tracheobronchial catheter of the type at issue in this case performs both ventilation and aspiration of a patient's breathing passages. During ventilation, the catheter pumps air into and out of the patient's respiratory system. During aspiration, the catheter uses vacuum pressure to evacuate fluids that have accumulated in the patient's lungs.

The two claims that Ballard treats as representative for purposes of appeal are claim 1 of the '344 patent and claim 4 of the '296 patent. Claim 1 of the '344 patent reads as follows, in pertinent part:

1. An indwelling ventilating/aspirating apparatus by which a medical patient is subjected to involuntary respiratory therapy and by which fluids from the trachea and/or bronchi are evacuated, the apparatus comprising:

* * * * *

normally closed normally internal sealed and internally sterile vacuum control mechanism sealed against external entry of contamination, the vacuum control mechanism comprising valve means . . . the valve means comprising biased normally closed internal seal means, means by which the valve may be selectively manually locked in a closed position to prohibit inadvertent as well as intentional actuation of the valve means, means by which the valve means may be selectively manually place[d] in an unlocked closed position accommodating subsequent selective manual actuation of the valve means, means by which the valve means are manually displaced from the unlocked closed position to an unlocked open position accommodating aspiration of fluids from the trachea-bronchi of the patient along the catheter tube and across the valve means responsive to communication of said vacuum suction to the distal tip of the catheter tube, as long as the valve means are manually retained in the open position counter to the bias imposed upon the biased seal means, and means which isolate said vacuum suction from atmospheric contamination.

Claim 4 of the '296 patent reads as follows, in pertinent part:

4. An indwelling ventilating aspirating apparatus by which a medial patient is subjected to involuntary respiratory therapy and by which secretions from the trachea and/or bronchi are evacuated, the apparatus comprising:

* * * * *

vacuum control valve structure comprising valve body means having fluid flow passageway means and valve means operable within the valve body means between non-activated and activated positions to respectively prohibit and accommodate vacuum caused fluid flow along the passageway means, the control valve structure further comprising (a) means biasing the valve means into the non-activated vacuum prohibiting position, (b) actuator means for manually displacing the valve means from the non-activated to the activated position counter to the bias, means and the valve means and thus prevents bacterial contamination within the passageway means and along the catheter tube, and (c) means by which said valve structure is connected to the other end of the envelope.

Figure 1 below, which is taken from the '344 and '296 patents, depicts the structure of the Ballard invention that is the subject of the asserted patents:

[Tabular or Graphical Material Omitted]

The valve that is the focus of the dispute in this case is labeled 40. The common written description of the '344 and '296 patents explains that it is important that the valve remain closed during ventilation because suction would interfere with the catheter's ability to ventilate the patient. Periodically, an operator can open the valve manually, which introduces vacuum pressure into the catheter and aspirates the patient's lungs.

Figures 3 and 8 from the '344 and '296 patents, shown below, detail the structure of the Ballard valve in the closed and open positions, respectively. [Tabular or Graphical Material Omitted]

When the valve is in the closed position, the actuator 280 and the plunger 286 are in the raised position so that the sealing member 288, which is made of a shape-retaining highly elastic substance such as synthetic rubber, blocks both vacuum pressure and fluid flow across the valve bore 322. To open the valve, the operator manually depresses the actuator. Depressing the actuator causes the plunger to stretch the sealing member so that the valve bore is no longer entirely blocked. Opening the valve bore introduces vacuum pressure into the catheter and draws fluid back through the catheter from the patient's lungs. In the absence of manual pressure, the elastic sealing member biases the plunger and actuator to return to the closed position. To prevent accidental opening of the valve, which would cause unintended aspiration, the operator can rotate the actuator so that posts 302 and 304 in the actuator align with valve body posts 354 and 356, which prevents the actuator from being depressed.

The accused TRACH-EZE device made by defendant Sorenson is shown in the following figure, taken from Sorenson's U.S. Pat. No. 5,919,174:

[Tabular or Graphical Material Omitted]

In the closed position, the plunger of the Sorenson valve is raised so that valve seal 38 is positioned along plane 49, thus preventing any fluid flow along passageway 51. In the open position, the plunger is depressed so that seal 38 descends into well 53. Fluid may then flow through passageway 51 around the shaft of the plunger. O-ring seal 37 impedes the flow of fluid up into the valve mechanism. While the valve is in the closed position, the cap 15 may be rotated to a position that prevents depression of the plunger, thus locking the valve in the closed position.

Ballard filed suit against the defendants, alleging infringement of claims 1-20 and 26 of the '344 patent and claims 4-6 of the '296 patent. The district court held an extended pretrial conference at which summary judgment and claim construction issues were considered. Subsequently, the court issued an order granting Sorenson's motion for summary judgment of noninfringement. The court based its ruling on materials the patentee submitted to the Patent and Trademark Office ("PTO") during the prosecution of the '344 patent distinguishing the valve of the claimed catheter from various prior art devices. Those statements, the court concluded, required that the '344 and '296 patents be construed to exclude catheter systems having a valve structure of the sort used in the accused Sorenson device. The court also concluded that prosecution history estoppel foreclosed Ballard from establishing infringement based on the doctrine of equivalents.

II

A

Ballard first argues that the district court improperly failed to conduct a detailed, limitation-by-limitation construction of each of the asserted claims. According to Ballard, this court's decision in Markman v. Westview Instruments, Inc., 52 F.3d 967, 34 USPQ2d 1321 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996), required the district court to conduct a complete claim construction of the asserted claims before addressing the issue of infringement.

Contrary to Ballard's contention, Markman does not require a district court to follow any particular procedure in conducting claim construction. It merely holds that claim construction is the province of the court, not a jury. To perform that task, some courts have found it useful to hold hearings and issue orders comprehensively construing the claims in issue. Such a procedure is not always necessary, however. If the district court considers one issue to be dispositive, the court may cut to the heart of the matter and need not exhaustively discuss all the other issues presented by the parties. District courts have wide latitude in how they conduct the proceedings before them, and there is nothing unique about claim construction that requires the court to proceed according to any particular protocol. As long as the trial court construes the claims to the extent necessary to determine whether the accused device infringes, the court may approach the task in any way that it deems best.

Nor do Ballard's arguments concerning the terminology in the district court's opinion suffice to overturn the judgment. Ballard complains that the district court incorrectly invoked prosecution history estoppel to limit claim scope for literal infringement despite our case law that holds prosecution history estoppel to be inapplicable to literal infringement. See, e.g., Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578, 34 USPQ2d 1673, 1679 (Fed. Cir. 1995); Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 1571, 219 USPQ 1137, 1141 (Fed. Cir. 1983).

It is...