`Heartstream Ref. 93-0O3—US1.C2
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`"Hewlett.-Packard Ref. 90980060-4
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`CERTIFICA'I'E.OF'-FACSIIVIILE TRANSMISSION UNDER 37 C.F.R. §1.'B D.
`that this correspondence is‘bdng SfiflV £55, [3'Kfl@-,
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`IN THE UNITED STA 7735 PA TENT AND TRADEMARK OFFICE
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`
`
`
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`In Re Application of:
`Bradford ~E. Gliner, et al.
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`Group Art Unit
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`
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`Serial No.:
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`08/946,843
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`Examiner: K. Schaetzle
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`Filing Date: 8 Oct 1997
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`Title: ELECTROTHERAPY METHOD
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`
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`DECLARATION OF DANIEL]. POWERS
`UNDER 37 C.F.R. §. 1.132
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`1, Daniel]. Powers, declare as follows:
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`1.
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`I am a Project Manager with the Hewlett-Packard Company and am
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`responsible for developing defibrillators.
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`2.
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`I have been employed by the Hewlett-Packard Company since April of
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`1998 (when Hewlett—Packard acquired Heartstream, Inc.). I began working at
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`Heartstream in January of 1993.
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`3.,‘ ,»
`Ann Arbor.
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`Iphave a B.S. in Electrical Engineering from the University of Michigan at
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`4.
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`I have over 10 years of experience in the field of medical products,
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`specializing in defibrillator design and development. I have a high degree of familiarity
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`with defibrillator circuits.
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`5.
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`I am one of the inventors for the above-referenced patent application.
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`6.
`Irhave reviewed the Office action dated 20: [an .1999, which was issued by '
`the U.S. Patent and Trademark Office in connection with the prosecution of this
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`application. In reviewing the Office action, I also reviewed U.S. Patent 5,634,938 to
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`Page ll of 4
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`_ 1
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`
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`Swanson and European ‘Patent EP 0491649 to Pless which were cited by the Examiner in
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`support of his argument.
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`7.
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`In the Office action dated 20 [an 1999, the Examiner contends that
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`Swanson teaches an external biphasic defibrillator. The Examiner directs Applicants’
`attention to col. 6, lns. 47-65 of Swanson in support of his argument which provides:
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`The system 10 . .. represents an implantable or external defibrillator
`system. In an implantable system, electrodes 18 and 20 may be
`implanted on or about the heart, one may be subcutaneous, and
`each may comprise one or more electrode, though only one is
`shown for each. In the case of an external defibrillator, the circuitry
`may be disposed external to the body of a patient but connect with
`implantable electrodes. Alternatively, the external unit may
`Connect
`at least two cutaneous electrodes placed on the body.
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`Swanson, US. Patent 5,634,938, col. 6, lines 55-65 (emphasis added).
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`8.
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`As an electrical engineer in the engineering arts, I would be unable to
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`build a high voltage, high energy biphasic external defibrillator based on these
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`statements in combination with the remainder of the reference, which specifically
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`teaches. how to build an implantable biphasic defibrillator.
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`9.
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`Even if higher voltage switches were used in the Swanson et a]. circuit, the
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`circuit could not be used in an external defibrillator. The Swanson circuit depends on
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`the load being stable and well controlled; this results because the electrodes are .
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`attached to the heart internally. As a result, there is no means described in Swanson for
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`protecting against a load fault. Since load faults may occur in the external application
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`of defibrillator electrodes, any circuit that is used must provide a means for protecting
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`the circuit against the load faults. Developing a circuit design that protects the circuit
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`from load faults is a major design challenge.
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`10.
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`- Swanson contrasts its teaching against conventional devices, which use
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`125 p.F capacitors charged to 780 volts, by teaching that:
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`The lower voltage needed to charge the capacitor C3 simplifies the
`design of the pulse generator circuitry. This allows switches to be
`used with lower voltage and current ratings. Switches with lower
`2
`Heartstream Ref. 93-003—US1.C2
`HP Ref. 909800604
`
`Serial No. 08/946,843
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`of 4
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`Page 2 of 4
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`ratings are more readily available, and reliability is improved if
`peakvoltages and currents are reduced.
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`Swanson, U.S. Patent 5,634,938, col. 7, lines 58-64 {emphasis added).
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`Thus Swanson recognizes the advantage of using switches with lower voltages and
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`current ratings. However, nowhere does Swanson address the problems associated
`with using switches with higher voltage and current ratings which would necessarily be
`required for a highvoltage, high energy external defibrillator.
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`4 11.
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`In order to build a high voltage, high energy biphasic defibrillator which
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`is used externally, the. circuit must be designed so that it can withstand voltages in
`excesslof 1500 volts. This design must take into consideration the fact that readily
`available switches have an upper limit voltage rating of 1200-1400 volts. The circuit of
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`Swanson would beunable to tolerate voltages in excess of 1500 volts.
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`12.
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`Because of the higher voltages present in the external defibrillator, a major
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`design challenge becomes terminating phase one. This problem is further exacerbated
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`by shorter phase.durations. Swanson teaches waveforms >15msec total duration (col.'6,
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`line 43). Therefore the teaching of Swanson could not be easily adapted to be used in an
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`external defibrillator capable of delivering a waveform shorter than 15msec.
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`13.
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`Pless measures the capacitor voltage until it reaches a threshold value.
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`Once the threshold value is set, phase one is ended. Thus, Pless does not use a timer to
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`control the duration of phase one.
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`14.
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`I would not be able to design and build a high voltage, high energy
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`biphasic external defibrillator based on the teachings of Swanson, or Swanson in
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`combination with Pless without overcoming the design challenges described above.
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`I hereby declare that all statements made herein of my own knowledge are true
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`and that all statements made on information and belief are believed to be true; and
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`further that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both, under
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`section 1001 of Title 18 of the United States Code, and that such willful false statements
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`>1)
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`4
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`Page 3 of 4
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`3
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`'
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`Heartstream Ref. 93-003—US1.C2
`HP Ref. 90980060-4
`
`Serial No. 08/ 946,843
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`Page 3 of 4
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`may jeopardize the valifiity of the application, any patent issuing thereon, or any patent
`to whicn this verified statefnent is directed.
`
`Dated:
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`2
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`
`
`Hewlett-Packard/Heartsh-eam
`2401 Fourth Avenue, Suite 500
`= Seattle Washington 98121
`Telephone: 206.664.7630
`Facsimile: 206.664.9694
`
`4
`
`Heartstream Ref. 93-003-US1.C2
`HP Ref. 909800604
`
`Serial No. 08/ 946,843
`
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