`DISTRICT OF MINNESOTA
`
`
`Cardiac Science, Inc.,
`a Delaware Corporation,
`
`
`
`
`
`Plaintiff,
`
`
`
`
`v.
`
`Civil No. 03-1064 (DWF/RLE)
`
`MEMORANDUM
`OPINION AND ORDER
`
`
`
`Koninklijke Philips Electronics N.V.,
`a Netherlands corporation d/b/a
`Royal Philips Electronics;
`Philips Electronics North America
`Corporation, a Delaware corporation; and
`Philips Medical Systems North America
`Company, a Delaware corporation,
`
`
`
`
`
`
`
`Defendants;
`
`
`and
`
`Koninklijke Philips Electronics N.V.,
`a Netherlands corporation; and
`Philips Electronics North America
`Corporation, a Delaware corporation,
`
`
`
`Counter Defendant.
`
`
`________________________________________________________________________
`
`Adam R. Wichman, Esq., Bruce E. Black, Esq., David K. Tellekson, Esq., Heather C.
`Wilde, Esq., James E. Hanft, Esq., and Robert L. Jacobson, Esq., Darby & Darby PC; and
`Dennis C. Bremer, Esq., and Matthew J. Goggin, Esq., Carlson Caspers Vandenburgh &
`Lindquist, counsel for Plaintiff and Counter Defendant.
`
`
`
`
`
`
`Counter Claimants,
`
`
`
`
`v.
`
`Cardiac Science, Inc.,
`a Delaware corporation,
`
`1
`
`LIFECOR905-1012
`
`
`
`Adam R. Steinert, Esq., Eugene L. Chang, Esq., Gary Serbin, Esq., John M. DiMatteo,
`Esq., Kimberly May Rosen, Esq., Spyros S. Loukakos, Esq., Steven H. Reisberg, Esq.,
`Willkie Farr & Gallagher LLP; and Lawrence J. Field, Esq., David D. Axtell, Esq.,
`Douglas R. Boettge, Esq., and Harold D. Field, Jr., Esq., Leonard Street and Deinard, PA,
`counsel for Defendant and Counter Claimant.
`________________________________________________________________________
`
`
`Introduction
`
`
`
`The above-entitled matter came before the undersigned United States District
`
`Judge on February 7-8, 2006, on the issue of patent claim construction pursuant to
`
`Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).
`
`Background
`
`
`
`This litigation involves numerous patents for automatic external defibrillators
`
`(“AEDs”), which are portable electronic devices that allow a person with no medical
`
`training to administer a defibrillation shock to a person who is in sudden cardiac arrest.
`
`Plaintiff Cardiac Science, Inc. (“Cardiac Science”) asserts that defibrillator products
`
`made and sold by Defendants Koninklijke Philips Electronics, N.V., Philips Electronics
`
`North America Corporation, and Philips Medical Systems North America, Inc.
`
`(collectively, “Philips”) infringe ten U.S. Patents owned by Cardiac Science, namely,
`
`U.S. Patent Nos. 5,402,884 (the “’884 Patent”); 5,579,919 (the “’919 Patent”); 5,645,571
`
`(the “’571 Patent”); 5,700,281 (the “’281 Patent”); 5,797,969 (the “’969 Patent”);
`
`5,984,102 (the “’102 Patent”); 6,088,616 (the “’616 Patent”); 5,897,576 (the “’576
`
`Patent”); 6,029,085 (the “’085 Patent”); and 6,366,809 B1 (the “’809 Patent”)
`
`(collectively, the “Cardiac Science Patents”). Cardiac Science further asserts a
`
`declaratory judgment action for invalidity and noninfringement of the following
`
`
`
`2
`
`
`
`U.S. Patents owned by Philips: U.S. Patent No. 6,016,059 (the “’059 Patent”); 5,879,374
`
`(the “’374 Patent”); 5,800,460 (the “’460 Patent”); 6,047,212 (the “’212 Patent”); and
`
`5,607,454 (the “’454 Patent”). Philips ’ Third Amended Answer with Amended
`
`Counterclaims (the “Answer”) asserts noninfringement and invalidity of the Cardiac
`
`Science Patents. Philips also asserts unenforceability due to inequitable conduct of the
`
`‘571 Patent, the ‘969 Patent, the ‘281 Patent, and the ‘616 Patent. Finally, the Answer
`
`contends that Cardiac Science has infringed the following U.S. Patents owned by Philips:
`
`the ‘059 Patent, the ‘374 Patent, the ‘460 Patent, the ‘212 Patent, the ‘454 Patent, and
`
`U.S. Patent Nos. 5,591,213 (the “’213 Patent”), 6,230,054 B1 (the “’054 Patent”),
`
`5,773,961 (the “’961 Patent”), 5,899,926 (the “’926 Patent”), 5,904,707 (the “’707
`
`Patent”), and 5,868,792 (the “’792 Patent”). In its Reply to Defendants’ Third Amended
`
`Answer with Amended Counterclaims (the “Reply”), Cardiac Science asserts, among
`
`other affirmative defenses, that the following Philips patents are unenforceable due to
`
`inequitable conduct: the ‘213 Patent, the ‘059 Patent, the ‘374 Patent, the ‘460 Patent,
`
`the ‘212 Patent, the ‘454 Patent, the ‘961 Patent, and the ‘054 Patent.
`
`Discussion
`
`Claim Construction Principles
`
`Patent claim construction, i.e., the interpretation of the patent claims that define
`
`I.
`
`
`
`the scope of the patent, is a matter of law for the court. Markman v. Westview
`
`Instruments, Inc., 52 F.3d 967, 970-71 (Fed. Cir. 1995), aff’d 517 U.S. 370 (1999).
`
`Proper claim construction requires an examination of the intrinsic evidence of record,
`
`including the claims of the patent language, the specification, and the prosecution history.
`
`
`
`3
`
`
`
`Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The terms
`
`used in the patent are presumed to carry “the meaning that the term would have to a
`
`person of ordinary skill in the art at the time of the invention.” Phillips v. AWH Corp.,
`
`415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc) (citation omitted), cert. denied,
`
`--- S.Ct. ---, 2006 WL 386393 (U.S. Feb. 21, 2006). The specification is “the single best
`
`guide to the meaning of a disputed term.” Id. at 1315. The specification may prescribe a
`
`special definition given to a claim term, or a disavowal of claim scope by the inventor.
`
`Id. at 1316. In such cases, the inventor’s intention that is expressed in the specification is
`
`dispositive. Id. The court may use a dictionary or technical treatise to “assist in
`
`understanding the commonly understood meaning” of a term, so long as any meaning
`
`found in such sources does not contradict the definition that is found in the patent
`
`documents. Id. at 1322-23. In addition, the court may not import limitations from the
`
`specification into the claims. Id. at 1323.
`
`
`
`The parties have asked the Court to construe a multitude of claim terms for the
`
`various patents. For the most part, the Court will address the claim terms in the order that
`
`the parties addressed them at the Markman hearing.
`
`II.
`
`The Cardiac Science Patents
`
`
`
`
`
`A.
`
`The ‘969 Patent
`
`The ‘969 Patent, entitled “One Button Lid Activated Automatic External
`
`Defibrillator,” was issued on August 25, 1998. (‘969 Patent at 1.) Generally, the patent
`
`describes an AED that automatically performs periodic self-tests on the operational status
`
`
`
`4
`
`
`
`of the defibrillator. ( Id. at c. 1, ll: 14-19.) The patent is a continuation of the application
`
`that issued as the ‘571 Patent. (Id. at c. 1, ll: 5-10.)
`
`
`
`
`
`The disputed claim language of the ‘969 Patent reads as follows:
`
`1. A one button method of applying a defibrillation shock to a patient
`using an automated external defibrillator (AED) having a case including an
`electrode compartment, a pair of electrodes stored within the electrode
`compartment, an openable lid covering the electrode compartment, a high
`voltage circuit, and an operator-actuated rescue switch, the method
`including the steps of:
`opening the lid covering the electrode compartment to expose the
`electrodes therein wherein the electrodes are electrically connected
`to the AED prior to the opening of the lid and wherein the step of
`opening the lid causes the AED to be powered ON;
`retrieving the electrodes stored in the compartment;
`applying the electrodes to the patient;
`pausing while the high voltage circuit charges; and
`actuating the operator-actuating rescue switch a single time to apply a
`defibrillation shock to the patient via the electrodes.
`
`
`. . .
`
`5. An automated external defibrillator (AED) having a case and a lid
`and a pair of electrodes wherein the AED has a processor for performing
`initialization and self-checking functions including:
`a) monitoring a lid switch;
`b) powering ON the AED when the lid switch is activated;
`c) initiating a rescue mode when the lid switch is activated;
`d) initiating lid opened self-test when the lid switch is activated;
`e) initiating a place electrode prompt;
`f) monitoring the impedance of the electrodes;
`g) initiating a check electrode prompt if the impedance does not fall
`within a preselected range;
`h) beginning a first analyze sequence if the impedance falls within the
`preselected range;
`i) generating a high voltage charge when a shockable rhythm is
`detected;
`j) enabling an operator actuated button for release of a defibrillation
`shock; and
`k) initiating a push button to rescue prompt.
`
`
`
`
`5
`
`
`
`. . .
`
`7. The defibrillator as in claim 5 wherein the lid open self-test of
`function (d) further includes the functions of:
`checking the charge state of batteries of the AED;
`checking the interconnection and operability of the electrodes;
`checking the state of memory in the AED;
`checking the functionality of a real time clock of the AED; and
`checking the functionality of an analog to digital converter of the AED.
`
`. . .
`
`10. An automated external defibrillator (AED) having a case and a lid
`and a pair of electrodes wherein the AED has a processor for performing
`initialization and self-checking functions including:
`a) monitoring a lid switch;
`b) powering ON the AED when the lid swi tch is activated;
`c) initiating a rescue mode when the lid switch is activated;
`d) monitoring the impedance of the electrodes;
`e) beginning a first analyze sequence if the impedance falls within the
`preselected range;
`f) generating a high voltage charge when a shockable rhythm is
`detected; and
`g) enabling an operator actuated button for release of a defibrillation
`shock.
`
`
`
`. . .
`
`12. The defibrillator of claim 10 wherein the lid open self-test of
`function (d) further includes the functions of:
`checking the charge state of batteries of the AED;
`checking the interconnection and operability of the electrodes;
`checking the state of a memory in the AED;
`checking the functionality of a real time clock of the AED; and
`checking the functionality of an analog to digital converter of the AED.
`
`
`. . .
`
`15. An automated external defibrillator (AED) having a case and a lid
`and a pair of electrodes wherein the AED has a processor for performing
`initialization and self-checking functions including:
`a) monitoring a lid switch;
`b) powering ON the AED when the lid switch is activated;
`
`
`
`6
`
`
`
`c) initiating a rescue mode when the lid switch is activated;
`d) beginning a first analyze sequence;
`e) generating a high voltage charge when a shockable rhythm is
`detected; and
`f) enabling an operator actuated button for release of a defibrillation
`shock.
`
`
`(‘969 Patent, c: 8, ll: 31-48; c: 8, l: 58 – c. 9, l: 12; c: 9, ll: 34-50; c: 10, ll: 4-13; c: 10,
`
`ll: 18-31.)
`
`“beginning a first analyze sequence”
`
`1.
`
`Claims 5, 10, and 15 of the ‘969 Patent describe a function of the AED as
`
`
`
`“beginning a first analyze sequence.” Cardiac Science contends that this phrase should
`
`be construed as “starting a sequence of analysis.” Philips, on the other hand, asserts that
`
`this phrase should be construed as “starting to perform analysis for the first time only
`
`after a pre-selected impedance is detected.”
`
`
`
`The specification describes this function as follows:
`
`After detecting an impedance indicating the proper placement of electrodes
`50, and without further action by the operator (i.e., automatically),
`processor 74 begins a first analyze sequence by initiating the generation of
`a “Do not touch patient. Analyzing rhythm.” voice prompt, and analyzing
`the patient’s cardiac rhythm.
`
`(‘969 Patent at c. 5, ll: 53-58.) The specification proceeds to describe, in sequential
`
`order, the manner in which the invention performs all of the functions listed in the claim
`
`language. (Id. at c. 6, ll: 23-64.) The specification states that the “second series of
`
`analyze/charge/shock sequences is identical to the first series described above, except the
`
`energy content of the defibrillation pulse can be about two hundred joules or three
`
`hundred joules.” ( Id. at c. 6, ll: 26-29.)
`
`
`
`7
`
`
`
`Philips places significant emphasis on the word “first,” and asserts that because
`
`there is no need to differentiate the first from the second analyze sequences, the term
`
`“first” must mean first in time. Cardiac Science, on the other hand, contends that Philips
`
`is attempting to import limitations into the claim term. Cardiac Science asserts that the
`
`numerical designators in the claims are merely terms used as placeholders to designate
`
`the separate analyze sequences that are claimed. Thus, Cardiac Science maintains that
`
`the term “first” does not mean the first in time, but rather the first of two or more analyze
`
`sequences.
`
`The Court finds that, consistent with the claim language, the function of
`
`“beginning a first analyze sequence” does not occur until a preselected impedance is
`
`detected. (Id. at c. 9, ll: 6-7; c. 9, ll: 45-46.) The specification offers no other
`
`explanation of this function other than that the first analyze sequence begins after
`
`detecting whether the impedance indicates the proper placement of electrodes. (Id. at
`
`c. 5, ll: 53-58.) In addition, the sequence of analysis/charge/shock may be relevant.
`
`Although the specification states that each sequence is identical, the specification also
`
`describes sequential increases to the energy content of the defibrillation pulses. ( Id. at
`
`c. 6, ll: 19-21, 29-30, 35-39.)
`
`Consistent with the claim language and the specification, the Court construes the
`
`term “beginning a first analyze sequence” as “starting to perform analysis for the first
`
`time after a preselected impedance is detected.”
`
`
`
`8
`
`
`
`2.
`
`“generating a high voltage charge when a shockable
`rhythm is detected”
`
`
`Claims 5, 10, and 15 of the ‘969 Patent describe a function of the AED as
`
`
`
`“generating a high voltage charge when a shockable rhythm is detected.” Philips asserts
`
`that this phrase should be construed as “starting to charge the high voltage capacitor at
`
`the time the device recognizes fibrillation.” Cardiac Science contends that the term
`
`“generating” means “producing,” but does not offer further construction for the phrase.
`
`
`
`In support of its construction, Philips points to language from the specification,
`
`which states that “[w]hen a shockable rhythm is detected, processor 74 begins a first
`
`charge sequence by initiating the generation of a ‘Charging.’ voice prompt, and causes
`
`high voltage generation circuit 86 to operate in the charge mode.” (‘969 Patent at c. 6,
`
`ll: 7-10.) Cardiac Science, however, asserts that the specification distinguishes between
`
`generating the high voltage charge and charging the capacitors. Cardiac Science also
`
`asserts that dictionaries commonly define the term “generate” as “to produce,” rather than
`
`“to start.”1
`
`
`
`The specification does not distinguish between the charge mode of the high
`
`voltage generation circuit and the charging of the capacitors. The high voltage generation
`
`circuit consists, in part, of the capacitors. As the patent specification explains:
`
`In response to charge controls provided by the processor 74, high voltage
`generation circuit 86 is operated in a charge mode during which one set of
`
`The parties appear to agree that an initial source of dispute, whether “generating”
`1
`means “discharging,” is no longer at issue, because Cardiac Science conceded at oral
`argument that it was not attempting to equate “generating” with “discharging.” (Tr. at
`60.)
`
`
`
`9
`
`
`
`semiconductor switches (not separately shown) cause a plurality of
`capacitors (also not shown), to be charged in parallel to the 12 V potential
`supplied by power generation circuit 84.
`
`(‘969 Patent at c. 4, ll: 3-9.) The device looks for a shockable rhythm, or fibrillation,
`
`and when that rhythm is detected, the device has to generate a very high voltage charge
`
`so that it can attempt to defibrillate the heart. As to this claim term, the word
`
`“generating” refers to the charging of the high voltage generation circuit, including the
`
`capacitors. (Id. at c. 6, ll: 7-10.) Thus, the Court finds that the term “generating a high
`
`voltage charge when a shockable rhythm is detected” should be construed as “initiating a
`
`charge in the high voltage generation circuit at the time that the device detects a
`
`shockable rhythm (or recognizes fibrillation).”
`
`“electrode compartment”
`
`3.
`
`Claim 1 of the ‘969 Patent describes an “electrode compartment.” Philips asserts
`
`
`
`that this term should be defined as “a part of an enclosed space within the defibrillator
`
`case to hold the electrodes.” Cardiac Science contends that the term “compartment” is
`
`commonly understood and need not be construed. Alternatively, Cardiac Science asserts
`
`that the term should be construed as “a defined space for containing electrodes.”
`
`The heart of the parties’ dispute is whether the space of the compartment needs to
`
`be completely enclosed or not. Philips asserts that the defibrillator case lid 28 encloses
`
`the electrode compartment in the ‘969 Patent. (‘969 Patent at c. 2, ll: 26-33.) However,
`
`Cardiac Science maintains that the space need not be enclosed. Specifically, Cardiac
`
`Science asserts that the electrode compartment is still referred to as a compartment even
`
`when the lid is open, thus demonstrating that Philips’ construction is inappropriate. ( Id.
`
`
`
`10
`
`
`
`at c. 2, ll: 26-29.) The dictionary definition could support either party’s construction.
`
`Merriam-Webster’s defines “compartment” both as “a separate division or section” and
`
`“one of the parts into which an enclosed space is divided.” Merriam-Webster’s
`
`Collegiate Dictionary 252 (11th ed. 2003).
`
`The Court finds that Philips’ proposed construction is misguided. The “enclosed
`
`space” to which Philips refers, if anything, is that of the defibrillator case. Even
`
`following the dictionary definition of “compartment” that Philips advances, the electrode
`
`compartment would merely be a division of an enclosed space, that enclosed space being
`
`the defibrillator case. But the compartment itself need not be enclosed, as Cardiac
`
`Science is correct in asserting that the electrode compartment still remains a
`
`“compartment” even when the lid is open.
`
`With these considerations in mind, the Court construes the term “electrode
`
`compartment” to mean “a section within the defibrillator case that contains the
`
`electrodes.”
`
`“real-time clock”
`
`4.
`
`Claims 7 and 12 of the ‘969 Patent describe a “real-time clock.” Philips asserts
`
`that this term should be construed as “a device that keeps track of the actual date and
`
`time, and not just elapsed time.” Cardiac Science, on the other hand, contends that the
`
`term should be defined as “a component that keeps track of time.”
`
`In support of its construction, Philips points to the specification, which states that
`
`upon completion of the periodic self-tests, the processor causes a record of the self-test to
`
`be stored in memory. (‘969 Patent at c. 8, ll: 6-8.) The specification further states that
`
`
`
`11
`
`
`
`“[e]ach stored record includes data representative of the date and time of the test and the
`
`results of the test.” (Id. at c. 8, ll: 8-10.) The specification also references stored memory
`
`data in the form of the “real time” or “actual time” that certain events occurred related to
`
`the use and testing of the defibrillator unit. ( Id. at c. 7, ll: 56-67.)
`
`Consistent with the specification, the Court construes “real time clock” to mean “a
`
`clock that keeps track of the actual date and time.”
`
`
`
`
`
`
`
`5.
`
`“powered on”
`
`Claim 1 of the ‘969 Patent describes the method of Claim 1 “wherein the step of
`
`opening the lid causes the AED to be powered ON.” Philips contends that the term
`
`“powered ON” should be construed as “the AED is turned from off to on.” Cardiac
`
`Science asserts that “on means on” and the phrase needs no further construction.
`
`
`
`In support of its construction, Cardiac Science asserts that the patent describes a
`
`standby mode or quiescent state during which periodic and automatic self-tests of the
`
`AED components occur on a daily or weekly basis. (‘969 Patent at c. 7, ll: 24-56.)
`
`Cardiac Science contends that these self-tests require electronics and power. Thus,
`
`Cardiac Science asserts that the AED is neither “on” nor “off” but rather in the standby
`
`mode. Then, when the AED is needed for a rescue, the user opens the lid of the AED and
`
`the AED is turned from the standby mode to “ON.” Philips, on the other hand, asserts
`
`that the specification of the ‘969 Patent does not describe such a “standby” state. Instead,
`
`Philips contends that the patent describes the lid as an on/off switch. (Id. at c. 4, ll: 57-
`
`58; c. 8, ll: 19-22.) Thus, Philips maintains that opening the lid controls whether the
`
`AED is powered on or powered off.
`
`
`
`12
`
`
`
`
`
`The Court finds that although the word “standby” never appears in the ‘969 Patent,
`
`the specification describes a dormant state of the invention whereby the device performs
`
`various self-tests without actually being “powered on.” If the Court were to agree with
`
`Philips’ construction that the device is powered “off” until the lid is opened, it would
`
`imply that there is no functionality or power to the unit, and this is plainly not the case.
`
`For this reason, the Court agrees with Cardiac Science that opening the lid does not
`
`switch the device from “off” to “on.” Thus, the Court construes the term “on” to mean
`
`“on.”
`
`
`
`B.
`
`The ‘571 Patent
`
`The ‘571 Patent, entitled “Automated External Defibrillator with Lid Activated
`
`Self-Test System,” was issued on August 8, 1995. (‘571 Patent at 1.) Generally, the ‘571
`
`Patent describes an automated external defibrillator that automatically performs self-tests
`
`on the defibrillator electrodes, battery charge state, and high voltage circuit operation on
`
`a daily and weekly basis. (Id. at 1.) The ‘571 Patent is a continuation-in-part of an
`
`assigned application, Ser. No. 08/509,990, filed August 1, 1995. (Id. at c. 1, ll: 6-9.)
`
`The disputed claim language of the ‘571 Patent reads as follows:
`
`1. An automated external defibrillator, comprising:
`a case;
`a pair of defibrillator electrodes electrically connected to one another
`within a package and including lead wires with connectors extending
`from the package being removably disposed within the case;
`electrode terminals being disposed within the case and configured for
`electrical interconnection to the lead wire connectors of the
`defibrillator electrodes;
`a battery compartment and battery terminals in the case, the battery
`compartment and terminals configured for holding and
`interconnecting to one or more batteries;
`
`
`
`13
`
`
`
`a high voltage circuit being disposed within the case and coupled to the
`battery terminals and the electrode terminals, for generating
`defibrillation pulses and applying the pulses to the electrode
`terminals;
`a maintenance indicator on the case; and
`a digital control system being disposed within the case and coupled to
`the electrode terminals, battery terminals, high voltage circuit and
`maintenance indicator, and including self test means for periodically
`and automatically performing a self-test of the functionality of one
`or more defibrillator components, and for actuating the maintenance
`indicator if a malfunctioning component is identified wherein the
`self-test means includes means for checking the defibrillator
`electrodes by providing selected communications through a circuit
`formed in part of the lead wires and the electrically connected pair of
`electrodes.
`
`
`3. An automated external defibrillator configured for use with a
`packaged pair of electrodes electrically connected to one another within the
`package and including lead wires with connectors extending from the
`package, the defibrillator including:
`a case;
`electrode terminals being disposed within the case and configured for
`electrical interconnection to defibrillator electrode connectors;
`a battery compartment and batter terminals in the case, the battery
`compartment and terminals configured for holding and
`interconnecting to one or more batteries;
`a high voltage circuit being disposed within the case and coupled to the
`battery terminals and the electrode terminals, for generating
`defibrillation pulses and applying the pulses to the electrode
`terminals;
`an impedance measuring circuit being disposed within the case for
`measuring the impedance between the electrode terminals;
`a battery level monitoring circuit being disposed within the case for
`measuring the charge state of the batteries;
`indicator on the case; and
`a digital control system being disposed within the case and coupled to
`the electrode terminals, battery terminals, high voltage circuit,
`impedance measuring circuit, battery level monitoring circuit and
`maintenance indicator, including:
`self test initiating means for periodically and automatically initiating
`defibrillator self-tests;
`
` . .
`
` .
`
`
`
`14
`
`
`
`battery test means for checking the charge state of the batteries
`during self-tests, and for actuating the maintenance indicator
`when low battery charge states are identified;
`electrode connection test means for checking the electrical
`interconnection of electrodes to the electrode terminals as a
`function of the measured impedance between the electrode
`terminals during self-tests, and for actuating the maintenance
`indicator when disconnected electrode states are identified;
`electronic memory; and
`memory test means for checking the functionality of the electronic
`memory during self-test, and for actuating the maintenance
`indicator when memory faults are identified.
`4. An automated external defibrillator, having a case and having
`defibrillator components, including a packaged pair of defibrillator
`electrodes electrically connected to one another within the package and
`including lead wires with connectors extending from the package, at least
`two electrode terminals configured for electrical interconnection to the
`defibrillator electrodes, at least one self contained power supply disposed
`within the case, a high voltage circuit electrically coupled to the at least one
`self-contained power supply and to the defibrillator electrode terminals, the
`high voltage circuit for generating defibrillation pulses and applying the
`pulses to the electrode terminals, and a digital control system coupled to the
`electrode terminals, the at least one self-contained power supply, and the
`high voltage circuit, and including self-test means controlled by the digital
`control system for periodically and automatically performing a self-test of
`one or more defibrillator components, and for providing a maintenance
`indication if a malfunctioning component is identified, the digital control
`system further controlling a rescue mode of operation, the rescue mode of
`operation including at least the steps of coupling the high voltage circuit to
`the battery terminals and the defibrillator electrode terminals, generating
`the defibrillation pulses, and applying the pulses to the defibrillator
`electrode terminals, comprising:
`a voice circuit operably coupled to the digital control system, and
`a speaker operably coupled to the voice circuit,
`whereby the digital control system provides commands to the voice
`circuit, and responsive thereto, the voice circuit generates audible
`voice prompts emitted by the speaker.
`5. An automated external defibrillator, having a case and having
`defibrillator components, including at least electrode terminals configured
`for electrical interconnection to defibrillator electrodes, at least one
`self-contained power supply disposed within the case, a high voltage circuit
`electrically coupled to the at least one self-contained power supply and to
`the electrode terminals, the high voltage circuit for generating defibrillation
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`pulses and applying the pulses to the electrode terminals, and a digital
`control system coupled to the electrode terminals, the at least one
`self-contained power supply, and the high voltage circuit, and including
`self-test means controlled by the digital control system for periodically and
`automatically performing a self-test of one or more defibrillator
`components, and for providing a maintenance indication if a
`malfunctioning component is identified, the digital control system further
`controlling a rescue mode of operation, the rescue mode of operation
`including at least the steps of coupling the high voltage circuit to the battery
`terminals and the electrode terminals, generating the defibrillation pulses,
`and applying the pulses to the electrode terminals, comprising:
`a real time clock being operably communicatively coupled to the digital
`control system, the real time clock providing communication to the
`digital control system enabling the digital control system to maintain
`track of the steps of the rescue mode of operation.
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`. . .
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`7. An automated external defibrillator, having a case and having
`defibrillator components, including at least electrode terminals configured
`for electrical interconnection to defibrillator electrodes, at least one
`self-contained power supply disposed within the case, a high voltage circuit
`electrically coupled to the at least one self-contained power supply and to
`the electrode terminals, the high voltage circuit for generating defibrillation
`pulses and applying the pulses to the electrode terminals, and a digital
`control system coupled to the electrode terminals, the at least one
`self-contained power supply, and the high voltage circuit, and including
`self-test means controlled by the digital control system for periodically and
`automatically performing a self-test of one or more defibrillator
`components, and for providing a maintenance indication if a
`malfunctioning component is identified, the digital control system further
`controlling a rescue mode of operation, the rescue mode of operation
`including at least the steps of coupling the high voltage circuit to the battery
`terminals and the electrode terminals, generating the defibrillation pulses,
`and applying the pulses to the electrode terminals, comprising:
`a real time clock being operably coupled to the digital control system,
`the real time clock providing a real time basis for storing data related
`to the time of placement of the defibrillator electrodes on the patient,
`the initiation of a cardiac rhythm analysis voice prompt, the patient’s
`cardiac rhythm, the initiation of a charging voice prompt, the
`completion of a charge mode of operation of the high voltage circuit,
`and the initiation of a charge to the defibrillator electrodes.
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`10. An automated external defibrillator configured for use with a
`packaged pair of electrodes electrically connected to one another within the
`package and including lead wires with connectors extending from the
`package, the defibrillator including:
`a case;
`electrode terminals being disposed within the case and configured for
`electrical interconnection to defibrillator electrode connectors;
`a battery compartment and battery terminals in the case, the battery
`compartment and terminals configured for holding and
`interconnecting to one or more batteries;
`a high voltage circuit being disposed within the case and coupled to the
`battery terminals and the electrode terminals, for generating
`defibrillation pulses and applying the pulses to the electrode
`terminals;
`an impedance measuring circuit being disposed within the case for
`measuring the impedance between the electrode terminals by
`providing selected communications through a circuit formed in part
`of the lead wires and the electrically connected pair of electrodes;
`a battery level monitoring circuit being disposed within the case for
`measuring the charge state of the batteries;
`indicator on the case; and
`a digital control system being disposed within the case and coupled to
`the electrode terminals, battery terminals, high voltage circuit,
`impedance measuring circuit, battery level monitoring circuit and
`maintenance indicator, including:
`self-test initiating means for periodically and automatically initiating
`defibrillator self-tests;
`battery test means for checking the charge state of the batteries
`during self-tests, and for actuating the maintenance indicator
`when l