US Patent 5,749,905
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`DECLARATION OF WAYNE C. McDANIEL, Ph.D.
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`I.
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`BACKGROUND AND QUALIFICATIONS
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`(1) My name is Wayne Charles McDaniel. I am currently Associate Director of
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`the Technology Management and Industry Relations office at the University of Missouri-
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`Columbia. I am also an Adjunct Professor of Electrical and Computer Engineering at the
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`University of Missouri. During my career, I have worked extensively in biomedical
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`engineering research involving cardiac therapy and defibrillation. I am expert in the areas of
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`internal atrial and ventricular defibrillation, external ventricular defibrillation, experimental
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`methods for defibrillation research, and cardiac safety of stun guns.
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`(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
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`Electrical Engineering with a biomedical engineering emphasis from the University of
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`Missouri-Columbia.
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`(3)
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`From 2001 to 2011, I held the position of Senior Licensing and Business
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`Development Associate of the Technology Management and Industry Relations office at the
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`University of Missouri-Columbia. From 1987 to 2001, I was a Research Assistant Professor
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`of Cardiothoracic Surgery at the University of Missouri-Columbia. From 1993 to 2001, I was
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`Acting Director of Cardiothoracic Surgery Laboratory Investigation at the University of
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`Missouri.
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`1
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`LIFECOR905-1003
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`
`
`DECLARATION OF WAYNE C. McDANIEL, Ph.D.
`
`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
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`internal atrial and ventricular defibrillation, external ventricular defibrillation, experimental
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`methods for defibrillation research, 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
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`Electrical Engineering with a biomedical engineering emphasis from the University of
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`Missouri-Columbia.
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`(3)
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`From 2001 to 2011, I held the position of Senior Licensing and Business
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`Development Associate of the Technology Management and Industry Relations office at the
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`University of Missouri-Columbia. From 1987 to 2001, I was a Research Assistant Professor
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`of Cardiothoracic Surgery at the University of Missouri-Columbia. From 1993 to 2001, I was
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`Acting Director of Cardiothoracic Surgery Laboratory Investigation at the University of
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`Missouri.
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`1
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`LIFECOR905-1003
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`US Patent 5,749,905
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`(4)
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`I have over 35 years of experience in the biomedical engineering field and
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`have published extensively in electrical ventricular defibrillation. For over twenty-five years,
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`I have conducted and received numerous grants for research relating to cardiac therapy and
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`defibrillation.
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`(5)
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`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 transthoracic
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`defibrillators, including automatic external defibrillators.
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`(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 with
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`Edmark, Biphasic, and Quadriphasic waveforms,” “Double-pulse transthoracic defibrillation
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`in the calf using percent fibrillatory cycle length as spacing determinate,” and “Relationship
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`between efficacy and frequency domain characteristics of defibrillatory shocks.”
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`(7)
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`I have given 46 presentations at national or international meetings, including
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`a presentation entitled “Multiphasic truncated exponential waveforms require less peak
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`current for atrial defibrillation than optimal biphasic waveforms” to the 22nd Annual Scientific
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`Sessions of the North American Society for Pacing and Electrophysiology, in Boston,
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`Massachusetts in May of 2001 and a presentation entitled “Comparison of the Efficacy of
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`Two Transthoracic Biphasic Waveform Defibrillators” to the Europace 2003 Congress in
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`Dec. 2003 in Paris, France. I have presented at 33 colloquiums and symposiums, including
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`presentations on ventricular and atrial defibrillation.
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`2
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`US Patent 5,749,905
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`(8)
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`I am the sole inventor on U.S. Patent No. 6,738,664 entitled “Method of and
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`apparatus for atrial and ventricular defibrillation or cardioversion with an electrical waveform
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`optimized in the frequency domain,” which issued on May 18, 2004.
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`(9)
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`A copy of my C.V. is attached as Appendix A.
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`II.
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`STATUS AS AN INDEPENDENT EXPERT WITNESS
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`(10)
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`I have been retained in this matter by Fish & Richardson P.C. to provide
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`various opinions regarding U.S. Patent No. 5,735,879 (“the ‘879 patent); U.S. Patent No.
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`5,749,905 (“the ‘905 patent”); U.S. Patent No. 6,047,212 (“the ‘212 patent); U.S. Patent No.
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`5,607,454 (“the ‘454 patent); U.S. Patent No. 5,836,978 (“the ‘978 patent”); U.S. Patent No.
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`5,749,904 (“the ‘904 patent”); U.S. Patent No. 5,593,427 (“the ‘427 patent”); and U.S. Patent
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`No. 5,803,927 (“the ‘927 patent”) (collectively, “the Philips Waveform Patents”). I am being
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`compensated at the rate of $300 per hour for my work. My fee is not contingent on the
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`outcome of this matter or on any of the opinions I provide below.
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`(11)
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`I have been advised that Fish & Richardson represents ZOLL Lifecor Corp. in
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`this matter. I have no financial interest in ZOLL Lifecor Corp.
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`(12)
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`I have been advised that Philips Electronics North America Corp. (“Philips” or
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`“Patent Owner”) owns the Philips Waveform Patents. I have no financial interest in Philips
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`Electronics North America Corp. or in the Philips Waveform Patents.
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`III.
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`MATERIALS CONSIDERED
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`3
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`US Patent 5,749,905
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`(13)
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`In arriving at the opinions set forth herein, I have reviewed the Philips
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`Waveform Patents and relevant portions of their respective file histories.
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`(14) Additional materials that I have reviewed and relied upon in arriving at the
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`opinions set forth herein are: (1) Bell (Appendix B); (2) Pless (Appendix C); (3) Bach
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`(Appendix D); (4) Schuder (Appendix E); (5) De Coriolis (Appendix F); (6) Ukkestad
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`(Appendix G); and (7) Gliner ‘904 (Appendix H).
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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 materials listed
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`in Appendices B-H, I conclude that the relevant field of the Philips Waveform Patents for
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`purposes of my testimony is waveforms used for defibrillation, and apparatus and
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`techniques for generating and delivering such waveforms. I have been advised that the
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`relevant timeframe is August 1993, which is the date that the applications that led to the
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`Philips Waveform Patents were filed.
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`(16) As described in Section I above, I have extensive experience in the field of
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`defibrillation waveforms, and apparatus and techniques for generating and delivering such
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`waveforms.
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
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`(17)
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`I have been advised that “a person of ordinary skill in the relevant field” is a
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`mythical person to whom an expert in the relevant field could assign a routine task with
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`reasonable confidence that the task would be successfully carried out. Here, the relevant
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`US Patent 5,749,905
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`field is waveforms used for defibrillation, and apparatus and techniques for generating and
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`delivering such waveforms. Because these devices are used to deliver a shock to a
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`patient’s heart, people engaged in developing these devices and related methods need to
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`have a high level of skill. Based upon my experience in this area, one of ordinary skill in the
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`art in this field at the relevant time frame would have had an advanced (post-Bachelor’s)
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`degree in electrical engineering, biomedical engineering, or some closely related field, with
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`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 defibrillation,
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`pacing, and/or cardiac medical devices (which experience could have overlapped in whole
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`or part with the at least 5 years of experience in the fields of electrical engineering or
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`biomedical engineering), or the equivalent of such experience. The person of ordinary skill
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`in the art also must have been intimately familiar with the design of, theory behind,
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`principles of operation of, and intended use of defibrillators, as well as the principles of
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`human physiology that underlie the indications of use for defibrillators (cardiac arrest and
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`ventricular fibrillation), and the theories as to why the delivery of certain shocks may be
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`useful to correct these conditions.
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`(18) Based on my experiences, I have a good understanding of the capabilities of
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`a person of ordinary skill in the relevant field. Indeed, in addition to being a person of at
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`least ordinary skill in the art, I have worked closely with many such persons over the course
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`US Patent 5,749,905
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`of my career, and I have regularly taught material fundamental to the art in my role as
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`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 cardiac
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`arrest occurs when the heart stops beating in an organized way and instead begins
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`fibrillating in a random manner. Many of the hearts of sudden cardiac death victims appear
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`essentially normal at the time of autopsy, causing some investigators to refer to them as
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`hearts that were “too good to die.” One major cause of sudden cardiac death is a
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`phenomenon called ventricular fibrillation (VF) which occurs in structurally good hearts over
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`900 times a day in the U.S. alone in out-of-hospital patients. In VF, the individual muscle
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`fibers of the heart no longer contract in unison, but rather there are waves of contraction
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`that run randomly through the heart. A direct consequence of VF is the inability of the heart
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`to pump blood, which means the patient will suffer irreversible brain damage and then death
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`if not treated promptly.
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`(20) Electrical defibrillation is a treatment of choice for ventricular fibrillation and
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`consists of delivering a therapeutic dose of electrical energy to the patient’s heart, which
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`depolarizes a critical mass of the heart muscle. This depolarization terminates the
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`dysrhythmia, allowing the patient’s normal sinus rhythm to be reestablished. Defibrillators,
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`which were first developed in the mid-1900s, are devices that restore normal contractions in
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`US Patent 5,749,905
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`the heart muscle by delivering a powerful shock via electrodes attached to the patient. The
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`goal of a defibrillation shock is to deliver the appropriate amount of current to the patient to
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`reestablish normal sinus rhythm, while minimizing damage to the patient’s heart. The shock
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`is generally delivered by charging an energy source, such as a capacitor over time, and
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`then 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 that can
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`be characterized by a time versus voltage graph that shows the “waveform” of the shock.
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`For example, if a shock is delivered freely, the “waveform” is simply an exponentially
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`decaying shape that approaches zero after a relatively long period of time. For successful
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`defibrillation, the amount of current delivered to the heart varies between patients on
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`account of a given patient’s body mass, temperature and diaphoresis—collectively referred
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`to as patient impedance. To account for patient impedance, the waveform of the shock can
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`be modified, or shaped, by altering the initial and/or terminal voltage used in delivering the
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`shock, as well as the duration of the shock. Such shaping allows one to modify the amount
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`of current released into the patient.
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`(22) Modern defibrillators can either be external units, where electrodes are placed
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`on the patient’s torso to deliver a shock to the patient’s heart, or internal devices, in which
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`case a small electrical impulse generator is implanted into the body of a patient at risk of
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`cardiac arrhythmia. The implantable device monitors the patient’s cardiac rhythms and
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`automatically delivers a therapeutic shock if dysrhythmia is detected. Because external
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`US Patent 5,749,905
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`defibrillators indirectly deliver therapeutic shocks to the heart (i.e., through layers of fat,
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`tissue, and skin), it is important to be able to modify different aspects of the waveform for
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`patients of different sizes and body types.
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`VII. BRIEF HISTORY OF DEFIBRILLATORS
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`(23) The earliest recorded defibrillation in humans with internal electrodes was
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`accomplished in 1947. The first electrical waveform used for defibrillation was 60 Hz
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`alternating current (AC), which is also used as standard household current. Similarly, the
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`first recorded defibrillation of a human with external electrodes was accomplished in 1956,
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`also by an AC waveform defibrillator.
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`(24) AC waveform defibrillators were replaced in the 1960s by the development of
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`the Lown and Edmark waveform defibrillators. These defibrillators comprised a resistor (R),
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`an inductor (L), and a capacitor (C), and were therefore referred to as RLC defibrillators.
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`RLC defibrillators were considered to be an advancement over AC defibrillators in that they
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`were portable and did not need to be tethered to a power line. Both the Lown and Edmark
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`waveforms delivered predominantly monophasic waveforms. However, under certain
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`patient resistances, one or more negative phases would be observed. Therefore, both
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`Edmark and Lown waveform defibrillators would generate multiphasic waveforms under the
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`right 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 followed a
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`US Patent 5,749,905
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`similar study of monophasic square waveforms. This study found that a long slow decay on
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`a waveform would reduce the efficacy, whereas truncating the descending triangular
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`waveform yielded a superior waveform. This study laid the foundation for capacitor
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`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 long-
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`duration waveforms significantly improved defibrillation success. The Schuder lab
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`pioneered this monophasic truncated exponential (MTE) waveform (which is sometimes
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`called the Schuder waveform) for defibrillation. One advantage to the MTE waveform was
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`the reduction of the peak current, which was believed to cause cardiac damage with the
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`Edmark and Lown waveforms. Another advantage to the MTE waveform (when
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`implemented in clinical devices) was that one could compensate for differing thoracic
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`impedance values seen with different patients by delivering a constant value of delivered
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`energy across a wide range of patient impedances. This was done by monitoring a patient-
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`related electrical parameter and 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 the first
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`implantable defibrillator and incorporated the MTE waveform in that defibrillator. The MTE
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`waveform was particularly well suited for the implantable defibrillator, in that it could be
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`generated without the use of an inductor, which would be too large and heavy for use in an
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`implantable device.
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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 the MTE
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`waveform for defibrillation. Biphasic waveforms differ from monophasic waveforms in that
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`the shock delivered to the patient’s heart in a monophasic shock is delivered in one
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`direction only from one electrode to the other. In biphasic waveform defibrillation, the shock
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`passes in one direction from one electrode to the next and then reverses direction, traveling
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`back to the original electrode. That is, in a biphasic waveform the pulse alternates between
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`positive and negative polarities.
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`(29) The Schuder lab began a series of studies of the biphasic waveform with the
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`first study involving what are now called biphasic truncated exponential (BTE) waveforms.
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`The first study involving implantable electrodes was promising (published in 1981), so the
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`Schuder lab modified its high power research defibrillator to enable it to generate biphasic
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`waveforms for external defibrillation of human-sized animals (device made public in 1982).
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`The first study with the modified research defibrillator involved symmetric rectangular
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`biphasic waveforms (equal constant currents and equal phase durations), which was
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`published in 1983. Then a study of asymmetric rectangular biphasic waveforms (unequal
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`constant currents and equal phase durations) was published in 1984.
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`(30) The studies of Schuder and Jones attracted the attention of both an
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`implantable defibrillator manufacturer (Cardiac Pacemaker Inc.) and an external defibrillator
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`manufacturer (Physio Control). Cardiac Pacemakers Inc. (CPI) and Physio Control worked
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`collaboratively with the Schuder lab, the Jones lab, and other labs such as Ray Ideker’s lab.
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`About once per year during this time period, representatives of each of the labs and each of
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`the companies met for a research conference. It was known to all researches involved at
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`the time that the biphasic waveforms showed promise to dramatically improve both the
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`implantable defibrillators made by CPI and the transthoracic defibrillators made by Physio
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`Control.
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`(31)
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`In 1984 the Schuder lab published its study of asymmetric biphasic truncated
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`exponential (BTE) waveforms (exponentially decaying currents and equal phase durations)
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`used in the transthoracic defibrillation of 100 kg calves. This study examined the efficacy of
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`several waveforms that were capable of being generated by a single capacitor bank.
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`Specifically, when a single capacitor BTE waveform is generated clinically, a single
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`capacitor bank is used, and the voltage and current delivered to a patient decay as the
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`capacitor discharges. At some point during this discharge, the shock is interrupted and the
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`polarity is reversed before reinitiating the shock. Then at some later point, the shock is
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`terminated.
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`(32) By 1985 it was known that biphasic waveforms were an improvement over
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`monophasic waveforms for both internal defibrillation and external defibrillation. It was
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`further known that the best known method of generating biphasic waveforms for both
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`internal and external defibrillation involved the use of a single capacitor biphasic truncated
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`exponential waveform. The Schuder lab’s 1984 BTE waveform study further established
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`US Patent 5,749,905
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`that the individual pulse durations ranging from 2.8 to 7.54 ms (overall pulse durations of 5.6
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`to 15.08 ms) showed positive results. The study also showed that the ideal capacitance
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`values for human defibrillation were in the range of 64 to 196 microfarads. The general
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`recognition of the biphasic waveform as more effective defibrillation waveform was again
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`illustrated in a 1988 paper from the Schuder lab entitled “General Superiority of Biphasic
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`Over Uniphasic Shocks in Cardiac Defibrillation.” This paper summarized all of the studies
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`to date of biphasic waveforms for defibrillation and concluded that biphasic waveforms were
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`more effective for defibrillation than monophasic waveforms.
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`(33) Following these advancements, further methods of modifying the biphasic
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`waveform have subsequently been employed in defibrillators. For example, internal and
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`external defibrillators containing an output circuit having four legs arranged in the form of
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`the letter “H” have been developed. “H-bridge” circuits were employed in defibrillators to
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`conduct a range of defibrillation pulse energies. Selectively switching on pairs of the
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`switches in an H-bridge circuit allows the pulse from a single capacitance to alternate
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`between positive and negative polarities. Another way researchers modified biphasic
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`waveforms was by adjusting the truncation or “tilt” of the waveform. Tilt specifically refers to
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`the percentage 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
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`to the patient, thereby reducing the energy requirements of the defibrillator and preventing
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`myocardial damage from overexposure.
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`(34)
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`In sum, by August of 1993 it was well known that one could compensate for
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`differing patients’ impedances by (a) varying the predetermined duration of time over which
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`discharge occurred, (b) measuring voltage decay (or equivalent electrical parameter) and
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`stopping discharge when it reached a predetermined level, or (c) various combinations of
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`both. At the same time, by 1993 it would have been obvious to apply knowledge and
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`techniques learned from monophasic waveform research and implementations to biphasic
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`waveform implementations, and to apply knowledge and techniques learned from
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`implantable defibrillator research and implementations to external defibrillator
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`implementations.
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`VIII. THE ‘905 PATENT
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`(35) The ‘905 Patent is entitled “Electrotherapy Method Utilizing Patient
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`Dependent Electrical Parameter,” and its disclosure relates to an electrotherapy method and
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`apparatus for delivering an electrical shock to a patient’s irregularly beating heart to cause
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`the heart to resume its natural beating rhythm. (‘905 Patent at 1:9-29). The electrical shock
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`is applied as a biphasic truncated exponential waveform. (Id. at 5:1-37, FIG. 5). To deliver
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`the waveform, an energy source, such as one or more of a plurality of capacitors, is charged
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`to a predetermined voltage, and subsequently discharged through electrodes that are in
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`electrical contact with the patient. (Id. at 6:55-64). During the first phase of the waveform,
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`an electrical parameter, such as voltage, current, or charge monitored over time across the
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`electrodes, is checked. (Id. at 7:5-36). The first phase is truncated when e.g., voltage,
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`reaches a predetermined level. (Id. at 7:5-13). The second phase of the waveform can
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`have an initial parameter, such a start current, that is based on the electrical parameter
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`measured during the first phase. (Id. at 7:14-26).
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`(36) The ‘905 Patent claims priority to an application filed August 6, 1993. The
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`stated main difference between earlier electrotherapy apparatus and methods and the ‘905
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`Patent is the disclosure in the ‘905 Patent of an external defibrillator and defibrillation
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`method that automatically compensates for patient impedance differences by changing the
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`nature of the delivered electrotherapeutic pulse. (Id. at 2:34-56). Automatically
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`compensating for patient impedance differences maximizes therapeutic efficacy across an
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`entire population of patients. (Id. at 2:3-31). Methods and apparatus for automatically
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`compensating for patient impedance differences were well-known by the time of the ‘905
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`Patent’s priority date.
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`(37)
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`I have reviewed Bell (Appendix B). Bell is one of many prior art examples
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`disclosing an external defibrillator that measures electrical parameters, e.g., voltage and
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`current, while delivering a shock to the patient and uses the measured electrical parameters
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`to determine when to stop delivering the shock. (Bell at 2:5-13, 3:3-13, FIGs. 1 and 2). In
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`particular, Bell discloses that when the delivered energy, which is computed from voltage
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`and current on the electrodes, reaches a predetermined energy output, four storage
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`capacitors 22 are disconnected from the patient. (Id. at 3:3-25).
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`(38)
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`It was well-known that the voltage across and the current through the
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`electrodes decay due to the natural discharge pattern of the capacitors, from which the
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`voltage and current originate, and that, when the delivered energy reaches a predetermined
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`energy level, the voltage and current on the electrodes have decayed to corresponding end
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`voltage and current levels. Accordingly, based upon my experience and knowledge, it is my
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`view that a person of ordinary skill in the art, reading Bell, would have recognized that
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`discharging capacitors across the electrodes results in discharging the capacitors across
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`the electrodes until a minimum end current corresponding to the predetermined energy
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`output is reached.
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`(39) Claim 1 of the ‘905 patent refers to adjusting energy delivered to a patient
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`based on a value of an electrical parameter. The particular values for terminating a
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`waveform in Bell could be adjusted or changed via an “energy control & computer 34” and
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`“energy selector 36” and such changes would in turn change the value of the particular
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`electrical parameter for ending a phase of the Bell waveform. Also, Bell discloses
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`terminating the discharge if a pre-selected time is reached, which then truncates the shock,
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`thereby delivering less energy than selected. (For example, Bell at 4:3-19.). Thus, Bell
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`discloses the feature of claim 1, of adjusting energy delivered to a patient based on a value
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`of an electrical parameter.
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`(40) Claims 2 and 4-11 of the ‘905 Patent include features relating to a multiphasic
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`waveform. Such waveforms had become known, in the time between Bell (around 1974)
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`and the filing of the ‘905 Patent, as a preferred waveform for achieving defibrillation, as
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`recognized by the ‘905 Patent itself and described in Schuder (Appendix E) and de Coriolis
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`(Appendix G; 5:14-17, 31-33, FIG. 4). Based on my knowledge and experience in this field,
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`and my review of Bell, Schuder, and de Coriolis, I believe that a person having ordinary skill
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`in the art at the time would have been motivated to combine de Coriolis’ biphasic waveform
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`with Bell’s waveform control scheme because of the recognized increased effectiveness of
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`biphasic waveforms over monophasic waveforms that had developed over those years. For
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`example, the Schuder group had demonstrated that biphasic waveforms caused less post-
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`shock dysfunction than monophasic waveforms, which is a very good feature of an external
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`defibrillator.
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`(41) de Coriolis also discloses a defibrillator circuit that delivers defibrillation
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`shocks to the heart as biphasic truncated exponential waveforms. (de Coriolis at 5:6-17,
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`FIGs. 4 and 5). The circuit includes a capacitor bank with two capacitors that are connected
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`to electrodes using electrode leads 26 and 33. (Id. at 6:21-23, 7:66-8:6, and FIG. 5).
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`Current is conducted along lead 33, through the heart, and along lead 26, which are all
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`connected in series across the capacitor bank. (Id. at 7:66-8:6 and FIG. 5). During the first
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`phase of discharge, the voltage across the capacitor bank is compared to a reference
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`voltage V2, and the capacitors are allowed to discharge to the reference voltage V2. (Id. at
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`5:31-42, 6:32-48, 6:63-64, 8:7-15, 9:48-49). In the second phase, voltage V2 is applied to
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`16
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`US Patent 5,749,905
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`the heart until the capacitors have discharged down to voltage V3, at which point the
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`second phase is truncated. (Id. at 5:42-51, 9:1-3, 9:58-59).
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`(42)
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`In my opinion, the comparator circuit performs the function of “monitoring a
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`patient-dependent electrical parameter during the discharging step,” where the parameter is
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`voltage (Id. at 6:32-48, 63-64, 8:7-14), and “shaping the waveform so that an initial[/ending]
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`parameter of a waveform phase depends on a value of the electrical parameter,” as recited
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`in claims 4 and 9 of the ‘905 Patent.
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`(43) The feature of shaping the waveform as described in claims 4 and 9 is also
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`disclosed in Bach. For example, Bach discusses a “circuit for generating a biphasic voltage
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`pulse to restore rhythm to a fibrillating heart, the circuit utilizing a capacitor for providing the
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`voltage pulse. . . . The circuit further comprises an output sensing circuit that senses the
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`exponential decay of the capacitor and signals a control circuit to switch the thyristors such
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`that after one thyristor applies the voltage pulse to the heart in a first polarity, the other
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`thyristor applies the voltage pulse in the opposite polarity” Bach at Abstract. In Bach, the
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`initial voltage of the second phase (Vpk2) begins at “50 to 95% of Vpk1,” the initial voltage
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`of the first phase. (Bach at 2:1-22). In other words, the initial voltage of the second phase
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`depends the value of voltage in the first phase, and the circuit adjusts the energy delivered
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`to match that programmed by the user. As such, Bach discloses “shaping the waveform so
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`that an initial[/ending] parameter of a waveform phase depends on a value of the electrical
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`parameter,” and a combination of Bell, Schuder (showing biphasic waveform), and Bach
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`17
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`US Patent 5,749,905
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`(also showing biphasic waveform) teaches every feature of claim 4. I have already
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`discussed why a person of ordinary skill in the art would have a reason to use a biphasic
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`waveform, which had been determined to be therapeutically effective by researchers such
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`as Schuder after the date of the Bell patent, with the control approach of the Bell patent. A
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`person of ordinary skill in the art would be further motivated to incorporate the shaping of
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`Bach so as to make the two phases of the waveform correspond to basic waveform delivery
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`values like voltage, both for each waveform, and the waveforms in relation to each other,
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`that would improve the therapeutic effectiveness of the waveform.
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`(44) Various references, such as de Coriolis disclose monitoring voltage over time
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`as a patient-dependent electrical parameter. (Id. at 6:32-48, 63-64, 8:7-14). Measuring
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`current as the patient-dependent electrical parameter was also widely known for controlling
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`the shape of the waveform. For example, Bell discloses measuring current to generate a
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`waveform that is truncated when a selected energy level is reached. (Bell at 3:5-11).
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`Accordingly, based upon my experience, it is my opinion that a person of ordinary skill in the
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`art would have been motivated to include Bell’s current measurement in controlling the
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`shape of the waveform, to generate a waveform with certain parameters.
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`(45) Also, Bach, like Bell, describes discharging an electrical source until the end
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`of a predetermined time period or until an electrical unit measured across the electrodes
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`reaches a predetermined level, whichever occurs first (Bach, 2:25-58). Like Schuder, Bach
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`describes delivering a multiphasic waveform. (Id.). Bach further describes adjusting
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`18
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`US Patent 5,749,905
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`current during the multiphasic waveform (Id., 2:29-36). It is well-known that current is
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`related to voltage via Ohm’s law. Therefore, in my opinion, a person of ordinary skill,
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`reading Bach, would recognize the direct connection between adjusting current and voltage.
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`(46) Claims 3 and 6 of the ‘905 patent recite the use of multiple capacitors in a
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`defibrillator. Both Ukkestad and de Coriolis disclose defibrillators using multiple capacitors.
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`The use of one capacitor versus multiple capacitors would have been an obvious design
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`choice at the time that depended on the capacitance values desired to be achieved and
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`factors such as size, cost, efficiency, and available parts. In general engineering, it was
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`known to use single capacitors or multiple connected capacitors, and was also known in
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`defibrillator applications. Thus, a person of ordinary skill in the art would have been
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`motivated to use multiple capacitors in place of a single capacitor so as to achieve general
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`design goals that included cost and availability of components and size and electrical
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`efficiency of a capacitor assembly.
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`(47)
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`I have also reviewed the Pless patent. In my opinion, that patent discloses all
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`the features of claims 1, 2, 4, 5, and 7-11. The remaining claims 3 and 6 recite electrical
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`parameters corresponding to voltage and current, and I have discussed the teachings and
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`motivations to use such teachings above. As for Pless, it shows a method for delivering
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`electrotherapy by discharging an energy source across electrodes connected to an energy
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`source, e.g., its Abstract notes: “The device includes defibrillation electrode means adapted
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`to be connected to the heart for delivering a multiphasic defibrillation waveform thereto.” In
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`19
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`US Patent 5,749,905
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`Pless, a “trailing voltage detector” tracks voltage decay while a waveform is delivered, so as
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`to terminate the positive pulse of the multiphasic waveform, thus it “monitor[s] a patient-
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`dependent electrical parameter during the discharging step,” as stated in claims 1, 4, and 9.
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`Finally, it adjusts energy delivered based on a value of the electrical parameter (claim 1),
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`and shapes the wavef
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