Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc.

• Decision Date: 11 July 2002
• Docket Number: No. 01-1198.,01-1198.
• Citation: 296 F.3d 1106
• Parties: CARDIAC PACEMAKERS, INC., Guidant Sales Corporation, and Eli Lilly and Company, Plaintiffs-Appellants, v. ST. JUDE MEDICAL, INC., Pacesetter, Inc., and Ventritex, Inc., Defendants-Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

296 F.3d 1106

CARDIAC PACEMAKERS, INC., Guidant Sales Corporation, and Eli Lilly and Company, Plaintiffs-Appellants, v. ST. JUDE MEDICAL, INC., Pacesetter, Inc., and Ventritex, Inc., Defendants-Appellees.

No. 01-1198.

United States Court of Appeals, Federal Circuit.

July 11, 2002.

Lawrence M. Jarvis, McAndrews, Held & Malloy, Ltd., of Chicago, IL, argued for plaintiffs-appellants. With him on the brief were Timothy J. Malloy, Stephen F. Sherry and Sharon A. Hwang.

Denis R. Salmon, Gibson, Dunn & Crutcher LLP, of Palo Alto, CA, argued for defendants-appellees. With him on the brief were Mark A. Perry and H. Mark Lyon. Of counsel on the brief were Jeffrey M. Olson, Lyon & Lyon LLP, of Los Angeles, CA; and Michael I. Rackman, Gottlieb, Rackman & Reisman, P.C., of New York, NY.

Before NEWMAN, GAJARSA, and PROST, Circuit Judges.

GAJARSA, Circuit Judge.

The Plaintiffs-Appellants, Cardiac Pacemakers, Inc., Guidant Sales Corp., and Eli Lilly and Co. (together "Cardiac Pacemakers"), appeal an Order of Partial Final Judgment by the United States District Court for the Southern District of Indiana that claims 1-14 of United States Patent No. 4,572,191 (the "2C191 patent") are invalid for indefiniteness under 35 U.S.C. § 112, ¶ 2. Because the district court properly determined that the specification of the '191 Patent fails to disclose structure corresponding to the "third monitoring means" limitation, we affirm.

BACKGROUND

A. The '191 Patent

Cardiac Pacemakers owns the '191 patent, which pertains to implantable defibrillators. A defibrillator (or cardioverting device) is a device used to stimulate an ailing heart. Contractions in the heart muscle cause the heart to pump blood. These contractions are caused by electrical stimulation. Disturbances in the heart's natural electrical conduction mechanism can cause deviations from the heart's normal rhythm. Defibrillators deliver a pulse of energy to stimulate the heart, restoring normal cardiac rhythm. The implantable defibrillator claimed in the '191 patent is designed for people who experience recurring episodes of abnormal cardiac rhythm.

The sole independent claim at issue, claim 1, reads as follows:

1. A cardioverting device comprising:

detecting means for issuing an electrical signal representing the actual ECG activity of the heart of a wearer of the device;

storage means for storing energy to convert an abnormal cardiac rhythm to normal sinus rhythm;

delivery electrode means for discharging the stored energy into the heart of the wearer;

switch means for controlling the discharge of the stored energy into the heart of the wearer;

charging means for delivering to said storage means said energy to convert the abnormal cardiac rhythm;

first monitoring means for monitoring the operation of said storage means and issuing a first signal when said storage means has stored a predetermined amount of energy;

second monitoring means for monitoring the ECG signal produced by said detecting means and for detecting a preselected repeatable characteristic of the ECG signal, said monitoring means further including means for issuing a second signal each time said second monitoring means detects said preselected repeatable characteristic of the ECG signal; third monitoring means for monitoring the ECG signal produced by said detecting means for activating said charging means in the presence of abnormal cardiac rhythm in need of correction; and actuating means connected to said first and second monitoring means and requiring the simultaneous presence of said first and second signals at the time the stored energy is to be delivered to the heart of the wearer, said actuating means for actuating said switching means.

'191 Patent, col. 8, l. 56 to col. 9, l. 22 (emphasis added). The underscored claim language is the "third monitoring means" limitation for which the district court found no corresponding structure.

The specification discloses two embodiments. In each embodiment, the defibrillator is implanted under the patient's skin. Id. at col. 1, ll. 47-48. The first embodiment is designed for operation by a doctor (the "physician embodiment"). Id. at col. 1, ll. 61-65. The second embodiment is designed for operation by the patient (the "patient embodiment"). Id. at col. 2, l. 23.

Figures 1 and 2 of the '191 patent, which appear below, pertain to the physician embodiment. Id. at col. 3. ll. 22 27, 35-36. Figure 1 is a block diagram of the physician embodiment. Id. at col. 3, ll. 22-24. Figure 2 depicts the physician's console, which is represented by the general area 12 in Figure 1. Id. at col. 3, ll. 25-27. These Figures appear as follows:

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

The implantable portion of the cardio-verting device 10 associates with the external console 12 across the skin of the patient 14. Id. at col. 3, ll. 37-47. A physician uses the external console to control the implanted cardioverting device. The console includes a conventional electrocardiogram ("ECG") unit that allows signals representing the electrical activity of the heart to be taken from the patient's skin 14. The receiver and decoder 28 in the external console 12 allow this information to be displayed in the form of an ECG signal on the display portion of the console 32.¹ Impulses representative of the QRS complex of the patient's heartbeat can be derived from the ECG signal. The QRS complex is shown as signal 44 on display 32 in Figure 2. The QRS complex is the portion of the heart cycle associated with the contraction of the ventricles. Because effective delivery of the cardioversion pulse must occur at an appropriate part of the cardiac cycle, the claimed invention allows the pulse to be synchronized with a repeatable characteristic of the cycle, such as the QRS complex.

When a patient in whom the cardioverting device 10 has been implanted experiences an arrhythmia, the physician examines the patient and estimates the level of energy required to cardiovert the malfunctioning heart. He or she sets the rotary dial 36 on the console 12 to the appropriate energy level, sets switch 38 to test load, and turns the on/off switch 34 to the on position. At this point the physician can observe the ECG signals representative of the QRS complex 44 on the display. The physician then presses the load data button 41. Pressing the load data button 41 transmits instructions regarding the energy level the physician has selected for discharge into the ailing heart to the control register 48. The power inverter 52 receives these instructions and charges the storage capacitor 78 to the selected energy level. Next, the physician depresses the discharge button 40 and the test load is shocked at the appropriate time during the QRS complex. The test load allows verification that the device is operating at the proper discharge level before actually shocking the heart. After this verification, the physician flips switch 38 from the test load to the catheter discharge position, and then presses the load data button 41 and then the discharge button 40 to deliver a pulse to the heart. The physician then observes the display screen 42, where the signal 46 representative of the delivery of an electrical shock appears. The physician observes the information on the display and determines whether cardioversion has been successful. If it has been unsuccessful, the physician repeats the attempt, perhaps after selecting a higher energy level.

In the second embodiment, the patient operates the defibrillator without the aid of a physician. Figure 3, which depicts the patient embodiment, appears below.

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

In the patient embodiment the entire device is implanted with the exception of a command magnet 112. When a patient in whom the device has been implanted recognizes that he or she is experiencing an arrhythmia the patient positions the command magnet 112 over the implanted reed switch 114. The magnet causes the reed switch 114 to close. Closing reed switch 114 delivers operating power to the timer 116, which is set with a preset delay. Upon expiration of the preset delay, the timer 116 commands switch 118 to close, allowing it to conduct energy, and energy is delivered from the implanted battery 120 to the power inverter 52. Closing reed switch 114 also causes a "clear" signal to reset binary counter 124. Once cleared, the binary counter 124 commands the power inverter 52 to charge the discharge capacitor 78 to its lowest predetermined energy level. When discharge capacitor 78 reaches that energy level, a "ready" signal is passed to AND gate 82. AND gate 82 also receives QRS synchronization pulses that are generated by circuit 132 from the ventricular catheter 126, which senses the heart function. When AND gate 82 receives both the "ready signal" and a QRS synchronization pulse, it switches discharge switch 84 to its conductive state, causing the discharge capacitor 78 to discharge through the patient's heart. The discharge sets binary counter 124 to its second state, which represents a higher level of energy. The discharge also reinitiates the delay period of timer 116. This delay allows the patient to determine whether cardioversion was successful. If it was unsuccessful, the patient keeps the magnet 112 over the reed switch 114 and, once the preset delay elapses, switch 118 returns to its conductive state and binary counter 124 commands power inverter 52 to charge energy storage and discharge capacitor 78 to the higher energy level. When it reaches this energy level, capacitor 78 is once again discharged through the patient's heart in synchronization with the QRS complex.

On October 26, 1998, a non-party-competitor of Cardiac Pacemakers requested reexamination of the claims of the '191 Patent. The competitor argued that claims 1-14 of the '191 Patent were unpatentable due to double patenting. On April 6, 2000, the examiner...