DECLARATION OF WAYNE C. McDANIEL, Ph.D.
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`
`
`
`I.
`
`BACKGROUND AND QUALIFICATIONS
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`(1) My name is Wayne Charles McDaniel. I am currently Associate
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`Director of the Technology Management and Industry Relations office at the
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`University of Missouri-Columbia. I am also an Adjunct Professor of Electrical and
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`Computer Engineering at the University of Missouri. During my career, I have
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`worked extensively in biomedical engineering research involving cardiac therapy and
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`defibrillation. I am expert in the areas of internal atrial and ventricular defibrillation,
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`external ventricular defibrillation, experimental methods for defibrillation research,
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`and cardiac safety of stun guns.
`
`(2)
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`I hold a Bachelor of Arts in Biology, a Master of Science in Electrical
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`Engineering with a biomedical engineering emphasis, and a Doctorate of Philosophy
`
`in Electrical Engineering with a biomedical engineering emphasis from the University
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`of Missouri-Columbia.
`
`(3)
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`From 2001 to 2011, I held the position of Senior Licensing and
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`Business Development Associate of the Technology Management and Industry
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`Relations office at the University of Missouri-Columbia. From 1987 to 2001, I was a
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`Research Assistant Professor of Cardiothoracic Surgery at the University of
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`
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`1
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`LIFECOR454-1003
`
`
`
`
`
`
`I.
`
`BACKGROUND AND QUALIFICATIONS
`
`(1) My name is Wayne Charles McDaniel. I am currently Associate
`
`Director of the Technology Management and Industry Relations office at the
`
`University of Missouri-Columbia. I am also an Adjunct Professor of Electrical and
`
`Computer Engineering at the University of Missouri. During my career, I have
`
`worked extensively in biomedical engineering research involving cardiac therapy and
`
`defibrillation. I am expert in the areas of internal atrial and ventricular defibrillation,
`
`external ventricular defibrillation, experimental methods for defibrillation research,
`
`and cardiac safety of stun guns.
`
`(2)
`
`I hold a Bachelor of Arts in Biology, a Master of Science in Electrical
`
`Engineering with a biomedical engineering emphasis, and a Doctorate of Philosophy
`
`in Electrical Engineering with a biomedical engineering emphasis from the University
`
`of Missouri-Columbia.
`
`(3)
`
`From 2001 to 2011, I held the position of Senior Licensing and
`
`Business Development Associate of the Technology Management and Industry
`
`Relations office at the University of Missouri-Columbia. From 1987 to 2001, I was a
`
`Research Assistant Professor of Cardiothoracic Surgery at the University of
`
`
`
`1
`
`LIFECOR454-1003
`
`
`
`Missouri-Columbia. From 1993 to 2001, I was Acting Director of Cardiothoracic
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`Surgery Laboratory Investigation at the University of Missouri.
`
`(4)
`
`I have over 35 years of experience in the biomedical engineering field
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`and have published extensively in electrical ventricular defibrillation. For over
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`twenty-five years, I have conducted and received numerous grants for research
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`relating to cardiac therapy and defibrillation.
`
`(5)
`
`I was one of the pioneers of the biphasic waveform that is now used in
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`virtually all automatic implantable cardioverter defibrillators and virtually all
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`transthoracic defibrillators, including automatic external defibrillators.
`
`(6)
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`I have authored or co-authored 34 published articles relating to cardiac
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`therapy and defibrillation, including articles titled “Transthoracic Defibrillation of Dogs
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`with Edmark, Biphasic, and Quadriphasic waveforms,” “Double-pulse transthoracic
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`defibrillation in the calf using percent fibrillatory cycle length as spacing determinate,”
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`and “Relationship between efficacy and frequency domain characteristics of
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`defibrillatory shocks.”
`
`(7)
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`I have given 46 presentations at national or international meetings,
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`including a presentation entitled “Multiphasic truncated exponential waveforms
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`require less peak current for atrial defibrillation than optimal biphasic waveforms” to
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`the 22nd Annual Scientific Sessions of the North American Society for Pacing and
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`Electrophysiology, in Boston, Massachusetts in May of 2001 and a presentation
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`
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`2
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`
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`entitled “Comparison of the Efficacy of Two Transthoracic Biphasic Waveform
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`Defibrillators” to the Europace 2003 Congress in Dec. 2003 in Paris, France. I have
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`presented at 33 colloquiums and symposiums, including presentations on ventricular
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`and atrial defibrillation.
`
`(8)
`
`I am the sole inventor on U.S. Patent No. 6,738,664 entitled “Method
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`of and apparatus for atrial and ventricular defibrillation or cardioversion with an
`
`electrical waveform optimized in the frequency domain,” which issued on May 18,
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`2004.
`
`(9)
`
`A copy of my C.V. is attached as Appendix A.
`
`II.
`
`STATUS AS AN INDEPENDENT EXPERT WITNESS
`
`(10)
`
`I have been retained in this matter by Fish & Richardson P.C. to
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`provide various opinions regarding U.S. Patent No. 5,735,879 (“the ‘879 patent);
`
`U.S. Patent No. 5,749,905 (“the ‘905 patent”); U.S. Patent No. 6,047,212 (“the ‘212
`
`patent); U.S. Patent No. 5,607,454 (“the ‘454 patent); U.S. Patent No. 5,836,978
`
`(“the ‘978 patent”); U.S. Patent No. 5,749,904 (“the ‘904 patent”); U.S. Patent No.
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`5,593,427 (“the ‘427 patent”); and U.S. Patent No. 5,803,927 (“the ‘927 patent”)
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`(collectively, “the Philips Waveform Patents”). I am being compensated at the rate of
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`$300 per hour for my work. My fee is not contingent on the outcome of this matter or
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`on any of the opinions I provide below.
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`
`
`3
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`
`
`(11)
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`I have been advised that Fish & Richardson represents ZOLL Lifecor
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`Corp. in this matter. I have no financial interest in ZOLL Lifecor Corp.
`
`(12)
`
`I have been advised that Philips Electronics North America Corp.
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`(“Philips” or “Patent Owner”) owns the Philips Waveform Patents. I have no financial
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`interest in Philips Electronics North America Corp. or in the Philips Waveform
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`Patents.
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`III.
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`MATERIALS CONSIDERED
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`
`
`(13)
`
`In arriving at the opinions set forth herein, I have reviewed the Philips
`
`Waveform Patents and relevant portions of their respective file histories.
`
`(14) Additional materials that I have reviewed and relied upon in arriving at
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`the opinions set forth herein are: (1) Bell (Appendix B); (2) Pless (Appendix C); (3)
`
`Kroll (Appendix D); (4) Schuder (Appendix E); (5) Swanson (Appendix F); (6) De
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`Coriolis (Appendix G); (7) Ideker (Appendix H); (8) Fain (Appendix I); (9) Baker
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`(Appendix J); (10) Packer (Appendix K); (11) Hahn (Appendix L); (12) Bach
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`(Appendix M); (13) Adams (Appendix N); (14) Herleikson (Appendix O); and (15)
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`Schuder 1988 (Exhibit LIFECOR454-1015).
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`IV.
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`DESCRIPTION OF THE RELEVANT FIELD AND RELEVANT TIMEFRAME
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`(15) Based on my review of the Philips Waveform Patents and the
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`materials listed in Appendices B-P, I conclude that the relevant field of the Philips
`
`Waveform Patents for purposes of my testimony is waveforms used for defibrillation,
`
`
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`4
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`
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`and apparatus and techniques for generating and delivering such waveforms. I have
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`been advised that the relevant timeframe is August 1993, which is the date that the
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`applications that lead to the Philips Waveform Patents were filed.
`
`(16) As described in Section I above, I have extensive experience in the
`
`field of defibrillation waveforms, and apparatus and techniques for generating and
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`delivering such waveforms.
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
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`(17)
`
`I have been advised that “a person of ordinary skill in the relevant field”
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`is a mythical person to whom an expert in the relevant field could assign a routine
`
`task with reasonable confidence that the task would be successfully carried out.
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`Here, the relevant field is waveforms used for defibrillation, and apparatus and
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`techniques for generating and delivering such waveforms. Because these devices
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`are used to deliver a shock to a patient’s heart, people engaged in developing these
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`devices and related methods need to have a high level of skill. Based upon my
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`experience in this area, one of ordinary skill in the art in this field at the relevant time
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`frame would have had an advanced (post-Bachelor’s) degree in electrical
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`engineering, biomedical engineering, or some closely related field, with at least 5
`
`years of work experience in one or more of these fields, and at least 5 years of
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`experience in developing (e.g., designing or implementing) medical devices for
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`defibrillation, pacing, and/or cardiac medical devices (which experience could have
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`
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`5
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`
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`overlapped in whole or part with the at least 5 years of experience in the fields of
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`electrical engineering or biomedical engineering), or the equivalent of such
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`experience. The person of ordinary skill in the art also must have been intimately
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`familiar with the design of, theory behind, principles of operation of, and intended use
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`of defibrillators, as well as the principles of human physiology that underlie the
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`indications of use for defibrillators (cardiac arrest and ventricular fibrillation), and the
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`theories as to why the delivery of certain shocks may be useful to correct these
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`conditions.
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`(18) Based on my experiences, I have a good understanding of the
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`capabilities of a person of ordinary skill in the relevant field. Indeed, in addition to
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`being a person of at least ordinary skill in the art, I have worked closely with many
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`such persons over the course of my career, and I have regularly taught material
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`fundamental to the art in my role as professor and researcher over the past 35 years.
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`VI.
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`BACKGROUND OF THE RELEVANT TECHNOLOGY
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`(19) Sudden cardiac death is the most common mode of death in our adult
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`population, accounting for an estimated 30 percent of all natural deaths. Sudden
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`cardiac arrest occurs when the heart stops beating in an organized way and instead
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`begins fibrillating in a random manner. Many of the hearts of sudden cardiac death
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`victims appear essentially normal at the time of autopsy, causing some investigators
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`to refer to them as hearts that were “too good to die.” One major cause of sudden
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`
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`6
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`
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`cardiac death is a phenomenon called ventricular fibrillation (VF) which occurs in
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`structurally good hearts over 900 times a day in the U.S. alone in out-of-hospital
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`patients. In VF, the individual muscle fibers of the heart no longer contract in unison,
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`but rather there are waves of contraction that run randomly through the heart. A
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`direct consequence of VF is the inability of the heart to pump blood, which means
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`the patient will suffer irreversible brain damage and then death if not treated
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`promptly.
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`(20) Electrical defibrillation is a treatment of choice for ventricular fibrillation
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`and consists of delivering a therapeutic dose of electrical energy to the patient’s
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`heart, which depolarizes a critical mass of the heart muscle. This depolarization
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`terminates the dysrhythmia, allowing the patient’s normal sinus rhythm to be
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`reestablished. Defibrillators, which were first developed in the mid-1900s, are
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`devices that restore normal contractions in the heart muscle by delivering a powerful
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`shock via electrodes attached to the patient. The goal of a defibrillation shock is to
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`deliver the appropriate amount of current to the patient to reestablish normal sinus
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`rhythm, while minimizing damage to the patient’s heart. The shock is generally
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`delivered by charging an energy source, such as a capacitor over time, and then
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`closing a switch to release the charge. A shock takes just a fraction of a second.
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`(21) The flow of electrical current released during the shock has a shape
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`that can be characterized by a time versus voltage graph that shows the “waveform”
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`
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`7
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`
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`of the shock. For example, if a shock is delivered freely, the “waveform” is simply an
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`exponentially decaying shape that approaches zero after a relatively long period of
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`time. For successful defibrillation, the amount of current delivered to the heart varies
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`between patients on account of a given patient’s body mass, temperature and
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`diaphoresis—collectively referred to as patient impedance. To account for patient
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`impedance, the waveform of the shock can be modified, or shaped, by altering the
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`initial and/or terminal voltage used in delivering the shock, as well as the duration of
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`the shock. Such shaping allows one to modify the amount of current released into
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`the patient.
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`(22) Modern defibrillators can either be external units, where electrodes are
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`placed on the patient’s torso to deliver a shock to the patient’s heart, or internal
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`devices, in which case a small electrical impulse generator is implanted into the body
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`of a patient at risk of cardiac arrhythmia. The implantable device monitors the
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`patient’s cardiac rhythms and automatically delivers a therapeutic shock if
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`dysrhythmia is detected. Because external defibrillators indirectly deliver therapeutic
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`shocks to the heart (i.e., through layers of fat, tissue, and skin), it is important to be
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`able to modify different aspects of the waveform for patients of different sizes and
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`body types.
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`Brief History of Defibrillators
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`8
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`
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`(23) The earliest recorded defibrillation in humans with internal electrodes
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`was accomplished in 1947. The first electrical waveform used for defibrillation was
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`60 Hz alternating current (AC), which is also used as standard household current.
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`Similarly, the first recorded defibrillation of a human with external electrodes was
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`accomplished in 1956, also by an AC waveform defibrillator.
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`(24) AC waveform defibrillators were replaced in the 1960s by the
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`development of the Lown and Edmark waveform defibrillators. These defibrillators
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`comprised a resistor (R), an inductor (L), and a capacitor (C), and were therefore
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`referred to as RLC defibrillators. RLC defibrillators were considered to be an
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`advancement over AC defibrillators in that they were portable and did not need to be
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`tethered to a power line. Both the Lown and Edmark waveforms delivered
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`predominantly monophasic waveforms. However, under certain patient resistances,
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`one or more negative phases would be observed. Therefore, both Edmark and
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`Lown waveform defibrillators would generate multiphasic waveforms under the right
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`circumstances.
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`(25)
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`In 1966, John Schuder et al. published a study of the transthoracic
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`defibrillation efficacy of triangular and trapezoidal waveforms in dogs. This study
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`followed a similar study of monophasic square waveforms. This study found that a
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`long slow decay on a waveform would reduce the efficacy, whereas truncating the
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`
`
`9
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`
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`descending triangular waveform yielded a superior waveform. This study laid the
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`foundation for capacitor discharge defibrillators not containing an inductor.
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`(26)
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`In 1971, Schuder et al. extended this work to true capacitive discharge
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`waveforms (as opposed to triangular waveforms above) and found that truncation of
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`long-duration waveforms significantly improved defibrillation success. The Schuder
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`lab pioneered this monophasic truncated exponential (MTE) waveform (which is
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`sometimes called the Schuder waveform) for defibrillation. One advantage to the
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`MTE waveform was the reduction of the peak current, which was believed to cause
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`cardiac damage with the Edmark and Lown waveforms. Another advantage to the
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`MTE waveform (when implemented in clinical devices) was that one could
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`compensate for differing thoracic impedance values seen with different patients by
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`delivering a constant value of delivered energy across a wide range of patient
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`impedances. This was done by monitoring a patient-related electrical parameter and
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`terminating the shock based on that measured value.
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`(27) Around the same time, the Schuder lab published a research study of
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`the first implantable defibrillator and incorporated the MTE waveform in that
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`defibrillator. The MTE waveform was particularly well suited for the implantable
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`defibrillator, in that it could be generated without the use of an inductor, which would
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`be too large and heavy for use in an implantable device.
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`
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`10
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`
`
`(28)
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`In the early 1980s, John Schuder, in collaboration with Janice Jones,
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`theorized that a biphasic waveform would cause less post-shock dysfunction than
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`the MTE waveform for defibrillation. Biphasic waveforms differ from monophasic
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`waveforms in that the shock delivered to the patient’s heart in a monophasic shock is
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`delivered in one direction only from one electrode to the other. In biphasic waveform
`
`defibrillation, the shock passes in one direction from one electrode to the next and
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`then reverses direction, traveling back to the original electrode. That is, in a biphasic
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`waveform the pulse alternates between positive and negative polarities.
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`(29) The Schuder lab began a series of studies of the biphasic waveform
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`with the first study involving what are now called biphasic truncated exponential
`
`(BTE) waveforms. The first study involving implantable electrodes was promising
`
`(published in 1981), so the Schuder lab modified its high power research defibrillator
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`to enable it to generate biphasic waveforms for external defibrillation of human-sized
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`animals (device made public in 1982). The first study with the modified research
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`defibrillator involved symmetric rectangular biphasic waveforms (equal constant
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`currents and equal phase durations), which was published in 1983. Then a study of
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`asymmetric rectangular biphasic waveforms (unequal constant currents and equal
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`phase durations) was published in 1984.
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`(30) The studies of Schuder and Jones attracted the attention of both an
`
`implantable defibrillator manufacturer (Cardiac Pacemaker Inc.) and an external
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`
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`11
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`
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`defibrillator manufacturer (Physio Control). Cardiac Pacemakers Inc. (CPI) and
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`Physio Control worked collaboratively with the Schuder lab, the Jones lab, and other
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`labs such as Ray Ideker’s lab. About once per year during this time period,
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`representatives of each of the labs and each of the companies met for a research
`
`conference. It was known to all researchers involved at the time that the biphasic
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`waveforms showed promise to dramatically improve both the implantable
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`defibrillators made by CPI and the transthoracic defibrillators made by Physio
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`Control.
`
`(31)
`
`In 1984 the Schuder lab published its study of asymmetric biphasic
`
`truncated exponential (BTE) waveforms (exponentially decaying currents and equal
`
`phase durations) used in the transthoracic defibrillation of 100 kg calves. This study
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`examined the efficacy of several waveforms that were capable of being generated by
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`a single capacitor bank. Specifically, when a single capacitor BTE waveform is
`
`generated clinically, a single capacitor bank is used, and the voltage and current
`
`delivered to a patient decay as the capacitor discharges. At some point during this
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`discharge, the shock is interrupted and the polarity is reversed before reinitiating the
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`shock. Then at some later point, the shock is terminated.
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`(32) By 1985 it was known that biphasic waveforms were an improvement
`
`over monophasic waveforms for both internal defibrillation and external defibrillation.
`
`It was further known that the best known method of generating biphasic waveforms
`
`
`
`12
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`
`
`for both internal and external defibrillation involved the use of a single capacitor
`
`biphasic truncated exponential waveform. The Schuder lab’s 1984 BTE waveform
`
`study further established that the individual pulse durations ranging from 2.8 to 7.54
`
`ms (overall pulse durations of 5.6 to 15.08 ms) showed positive results. The study
`
`also showed that the ideal capacitance values for human defibrillation were in the
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`range of 64 to 196 microfarads. The general recognition of the biphasic waveform
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`as a more effective defibrillation waveform was again illustrated in a 1988 paper from
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`the Schuder lab entitled “General Superiority of Biphasic Over Uniphasic Shocks in
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`Cardiac Defibrillation.” This paper summarized all of the studies to date of biphasic
`
`waveforms for defibrillation and concluded that biphasic waveforms were more
`
`effective for defibrillation than monophasic waveforms.
`
`(33) Following these advancements, further methods of modifying the
`
`biphasic waveform have subsequently been employed in defibrillators. For example,
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`internal and external defibrillators containing an output circuit having four legs
`
`arranged in the form of the letter “H” have been developed. “H-bridge” circuits were
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`employed in defibrillators to conduct a range of defibrillation pulse energies.
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`Selectively switching on pairs of the switches in an H-bridge circuit allows the pulse
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`generated by a single capacitance to alternate between positive and negative
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`polarities. Another way researchers modified biphasic waveforms was by adjusting
`
`the truncation or “tilt” of the waveform. Tilt specifically refers to the percentage
`
`
`
`13
`
`
`
`difference between the ending voltage value and the initial voltage value.
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`Modifications to the tilt of the waveform allow for control of the amount of energy
`
`delivered to the patient, thereby reducing the energy requirements of the defibrillator
`
`and preventing myocardial damage from overexposure.
`
`(34)
`
`In sum, by August of 1993 it was well known that one could
`
`compensate for differing patients’ impedances by (a) varying the predetermined
`
`duration of time over which discharge occurred, (b) measuring voltage decay (or
`
`equivalent electrical parameter) and stopping discharge when it reached a
`
`predetermined level, or (c) various combinations of both. At the same time, by 1993
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`it would have been obvious to apply knowledge and techniques learned from
`
`monophasic waveform research imlemetnations to biphasic waveform
`
`implementations, and to apply knowledge and techniques learned from implantable
`
`defibrillator research/implementations to external defibrillator implementations.
`
`VII.
`
`THE ‘454 PATENT
`
`
`
`(35) The ‘454 Patent is entitled “Electrotherapy Method and Apparatus,”
`
`and its disclosure relates to an electrotherapy method and apparatus for delivering
`
`an electrical shock to a patient’s irregularly beating heart to cause the heart to
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`resume its natural beating rhythm. (‘454 Patent at 1:12-23). The electrical shock is
`
`applied as a biphasic truncated exponential waveform. (Id. at 3:31-40, FIG. 1). To
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`deliver the waveform, an energy source, such as one or more of a plurality of
`
`
`
`14
`
`
`
`capacitors, is charged to a predetermined voltage, and subsequently discharged
`
`through electrodes that are in electrical contact with the patient. (Id. at 4:9-30).
`
`During the first phase of the waveform, an electrical parameter, such as voltage,
`
`current, or charge, is measured across the electrodes. (Id. at 5:18-31). The first
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`phase is truncated when the measured electrical parameter reaches a
`
`predetermined level. (Id.)
`
`(36) The ‘454 Patent claims priority to an application filed August 6, 1993.
`
`Methods and apparatus for automatically compensating for patient impedance
`
`differences were well-known by the time of the ‘454 Patent’s priority date.
`
`(37)
`
`I have reviewed Bell (Appendix B). Bell is one of many prior art
`
`examples disclosing an external defibrillator that measures electrical parameters,
`
`e.g., voltage and current, while delivering a shock to the patient and uses the
`
`measured electrical parameters to determine when to stop delivering the shock.
`
`(Bell at 2:5-13, 3:3-13, FIGs. 1 and 2). Bell further discloses a safety feature in
`
`which the output pulse width is limited to a maximum value for any given setting. (Id.
`
`at 4:15-18). Bell explains that in the case of a high patient resistance, the
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`defibrillator would attempt to deliver the selected energy but would take too long and
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`the time out input will terminate the discharge before the measured voltage and
`
`current indicate that the selected energy value is reached. (Id. at 4:30-40). Based
`
`on my knowledge and experience in this field and my review of Bell, I believe that a
`
`
`
`15
`
`
`
`person having ordinary skill in the art would have recognized that Bell provides a
`
`method for applying electrotherapy to a patient including discharging the energy
`
`source across the electrodes in the predetermined polarity until the end of a
`
`predetermined time period or until an electrical unit measured across the electrodes
`
`reaches a predetermined level, whichever occurs first.
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`(38) Based upon my review of Bell, I conclude that Bell does not use an
`
`inductor in his wave-shaping control mechanism.
`
`(39) One of the stated objects of Bell is “to provide a defibrillator which is
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`lightweight and portable.” (Bell, 1:46-47). As the ’454 Patent does not disclose any
`
`specific utility for the volume of 150 cubic inches for the defibrillator housing recited
`
`in claim 24, it is my opinion that such a housing is an obvious design choice in light
`
`of the teaching of Bell that lightweight and portable defibrillators were desirable.
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`Similarly the limitation of claim 35 that the defibrillator weigh less than four pounds is
`
`obvious in light of the above. Further, even without the explicit teaching of Bell, the
`
`benefits of making defibrillators lightweight and portable were well known in the art at
`
`the time of the ’454 patent, and thus limiting the dimensions and weight of the
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`defibrillator was an obvious design choice.
`
`(40) Bell also discloses a circuit for determining when the proper amount of
`
`energy has been delivered, and terminating energy flow through the electrodes.
`
`(Bell, 4:56-62). In my opinion, this circuitry is equivalent to the corresponding
`
`
`
`16
`
`
`
`structure for the “means for selectively limiting current flow through the electrodes”
`
`recited in claim 21 of the ’454 Patent (a switch for connecting and disconnecting a
`
`resistance from the circuit to limit current flow). See ’454 patent, 6:52-56.
`
`(41) Bell also discloses a current monitor for feeding instantaneous signals
`
`representing current readings to the defibrillator circuitry. (Bell, 3:5-9). In my
`
`opinion, the current monitor of Bell is equivalent to the stated corresponding
`
`structure for the “means for determining whether current flowing to the electrodes is
`
`below a predetermined threshold” of claim 21 of the ’454 Patent (a current sensor).
`
`See ’454 patent, 6:66-7:3.
`
`(42) Between the time Bell was filed and the filing of the ‘454 Patent,
`
`multiphasic waveforms became known and recognized as a preferred waveform for
`
`achieving defibrillation, as noted by the ‘454 Patent itself (‘454 Patent, 1:46-53) and
`
`described in Schuder (Appendix E). Schuder describes bidirectional truncated
`
`exponential waveforms implemented in clinical sized apparatus for transthoracic
`
`defibrillation (Schuder at 520, ¶3) and producing a negative pulse with a timed
`
`duration (Id. at 520, ¶4; Table I). Based on my knowledge and experience in this
`
`field, and my review of Bell and Schuder, I believe that a person having ordinary skill
`
`in the art at the time would have been motivated to combine Schuder’s multiphasic
`
`waveform with Bell’s waveform control scheme, including Bell’s control features,
`
`
`
`17
`
`
`
`because of the recognized increased effectiveness of multiphasic waveforms over
`
`monophasic waveforms.
`
`(43) Pless (Appendix C) describes a defibrillation method that involves
`
`generating biphasic waveforms (Pless at 3:4-7). Pless’ biphasic waveform can have
`
`a negative pulse with a timed duration (Id. at 7:35-41), a negative pulse that is
`
`terminated when the capacitor voltage decays to less than a selected trailing voltage
`
`(Id. at 5:11-22), or a negative pulse with a duration that is a percentage of the
`
`duration of the positive pulse (Id. at 3:32-35).
`
`(44)
`
`In my opinion, it was well-known that the voltage measured across the
`
`electrodes of a defibrillator decays due to the natural discharge pattern of the
`
`capacitors from which the voltage originates. It was also well-known that the voltage
`
`on the capacitor bank, as it decays, is mathematically related to the energy delivered
`
`to the patient. Therefore, detecting that a measured voltage has decayed to a
`
`predetermined terminal voltage level is the functional equivalent of monitoring the
`
`delivered energy and detecting when the selected delivered energy value is reached.
`
`This voltage-energy relationship is described in Pless. (Pless, Abstract). In
`
`particular, Pless discloses that a desired tilt, which is the ratio of the ending voltage
`
`value Vf to the starting voltage value Vi, can also be expressed as a desired energy
`
`since J = 0.5*C(Vi2-Vt2). (Pless at 1:34-47, 3:18-23). Based on my knowledge and
`
`experience in this field, and my review of Pless, I believe that a person having
`
`
`
`18
`
`
`
`ordinary skill in the art at the time would have recognized that discharging the
`
`capacitors across the electrodes until the delivered energy reaches the selected
`
`energy value is the mathematical equivalent of discharging capacitors across the
`
`electrodes until the voltage measured across the electrodes decays to a
`
`predetermined terminal voltage level corresponding to the selected energy value.
`
`(45) Based upon my review of Pless, I conclude that Pless does not
`
`describe the use of an inductor in his wave-shaping control mechanism.
`
`(46) Fain (Appendix I), like Schuder and Pless, describes delivering a
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`biphasic truncated exponential waveform for delivering a defibrillator shock to a
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`patient. (Fain at 3:7-20). Fain discloses pulse widths for biphasic waveforms for
`
`different ranges of measured impedance. (Fain at 7:3-12, FIG. 3). For an
`
`impedance value of 19 ohms or less, Fain suggests phase durations of 3.0/3.0 ms
`
`for a biphasic waveform. (Id. at FIG. 3). An impedance value of 70 ohms or greater
`
`will yield phase durations of 12.0/12.0 ms for a biphasic waveform. (Id.) Fain also
`
`discloses that at both very high and very low impedance values, the pulse width has
`
`been limited to maximum and minimum durations in order to maintain an effective
`
`waveform. (Id. at 6:68-7:3). In my opinion, based on my experience, a person of
`
`ordinary skill would have been motivated to combine Fain’s waveform duration
`
`control with the waveform control schemes described in Bell or Pless to increase
`
`effectiveness of the waveform, as taught by Fain. In particular, Fain’s waveform
`
`
`
`19
`
`
`
`duration control would permit increased control over the total energy output for the
`
`debrillation method.
`
`(47) Claim 36 recites a capacitive energy source having a capacitance
`
`between 60 and 150 microfarads. I am unable to find any discussion in the ‘454
`
`Patent as to how or why this range was chosen, suggesting to me that it was an
`
`arbitrary design choice. Nevertheless, it was known, as of the filing date of the ‘454
`
`Patent, to choose the particular value of the capacitance based upon human
`
`impedance values, which vary from person to person. Human impedance values
`
`typically are in the range of 20 to 80 ohms, which would correspond to capacitance
`
`values in the range of 60 to 150 microfarads. Therefore, in my opinion, based upon
`
`my experience, a person of ordinary skill would have known to select capacitance
`
`values in the range of 60 to 150 microfarads to correspond to the known range of
`
`human impedance values.
`
`(48) Claims 27 and 37 specify that the energy source for the defibrillator is
`
`a primary battery. Claims 28 and 38 characterize the primary battery as a lithium-
`
`manganese dioxide primary battery. Neither Bell nor Pless specifically describes
`
`using the particular energy sources recited in these claims. Nevertheless, as of the
`
`filing date of the ‘454 Patent, lithium-manganese dioxide batteries were a recognized
`
`energy source for use in defibrillators. Adams (Appendix N) confirms my opinion.
`
`
`
`20
`
`
`
`Adams describes a defibrillator in which lithium-manganese dioxide batters were
`
`used to power low voltage circuitry. (Adams, 2:30-3:3).
`
`(49) Based on my review of Adams, it is my opinion that a person of
`
`ordinary skill in the art would have combined Adams with Pless or the Bell / Schuder
`
`combination to include the lithium managanese dioxide batteries of Adams because
`
`such batteries offer decreased cost versus comparable rechargeable batteries and
`
`have a service lifetime suitable for devices such as defibrillators. Such batteries
`
`also have a favorable stored energy to weight ratio making the defibrillator lighter
`
`and easier to carry to the scene of a cardiac arrest. The results of modifying the
`
`defibrillator of Pless or Bell and Schuder 1984 in this way would have been
`
`predictable at least because Adams teaches such a defibrillator.
`
`(50) Claims 31-34 and 41-44 recite including an ECG system in the
`
`defibrillator that may further include an LCD display and/or a PCMCIA memory card.
`
`An ECG system is a system for acquiring, storing, and presenting electrocardiogram
`
`(ECG) data. Such systems were well-known for use in defibrillators as of the filing
`
`date of the ‘454 Patent, as were LCD displays for displaying the ECG data.
`
`Herleikson (Appendix O) is a representative example. Moreover, PCMCIA was a
`
`well-known, industry standard interface technology as of the filing date of the ‘454
`
`Patent. In fact, it was one of the few choices available at the time that could be used
`
`for communication. In my view, based upon my experience, the choice of PCMCIA
`
`
`
`21
`
`
`
`would have been a logical choice for incorporation in an ECG system given the
`
`limited choices available.
`
`(51) Further, the central processing unit that displays an ECG
`
`representation on a display of Herleikson is an equivalent
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