PATENT
`Heartstream Ref. 93-0O3—US1.C2
`
`mt)
`
`"Hewlett.-Packard Ref. 90980060-4
`_
`
`CERTIFICA'I'E.OF'-FACSIIVIILE TRANSMISSION UNDER 37 C.F.R. §1.'B D.
`that this correspondence is‘bdng SfiflV £55, [3'Kfl@-,
`P
`"
`
`.. - n -bar
`La?‘-t Us
`za maq °l‘i
`
`
`
`IN THE UNITED STA 7735 PA TENT AND TRADEMARK OFFICE
`
`
`
`
`
`4._-¢uvmwwm mmmmn\¢:mm~L-.-.-..
`
`In Re Application of:
`Bradford ~E. Gliner, et al.
`
`Group Art Unit
`
`
`
`
`
`
`Serial No.:
`
`08/946,843
`
`Examiner: K. Schaetzle
`
`Filing Date: 8 Oct 1997
`
`Title: ELECTROTHERAPY METHOD
`
`
`
`DECLARATION OF DANIEL]. POWERS
`UNDER 37 C.F.R. §. 1.132
`
`1, Daniel]. Powers, declare as follows:
`
`1.
`
`I am a Project Manager with the Hewlett-Packard Company and am
`
`responsible for developing defibrillators.
`
`2.
`
`I have been employed by the Hewlett-Packard Company since April of
`
`1998 (when Hewlett—Packard acquired Heartstream, Inc.). I began working at
`
`Heartstream in January of 1993.
`
`3.,‘ ,»
`Ann Arbor.
`
`Iphave a B.S. in Electrical Engineering from the University of Michigan at
`
`4.
`
`I have over 10 years of experience in the field of medical products,
`
`specializing in defibrillator design and development. I have a high degree of familiarity
`
`with defibrillator circuits.
`
`5.
`
`I am one of the inventors for the above-referenced patent application.
`
`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
`
`application. In reviewing the Office action, I also reviewed U.S. Patent 5,634,938 to
`
`
`
`Page ll of 4
`
`_ 1
`
`Philips Exhibit 2024
`_p pZoll_’Lifeco:r V.. bhilips
`.
`.
`._.>..~.»::;t‘.‘;'$o‘.=.m=‘i‘.5:*>.*.i;:
`IPR2013-0.0607
`
`Page 1 of 4
`
`Philips Exhibit 2024
`Zoll Lifecor v. Philips
`IPR2013-00607
`
`

`
`Swanson and European ‘Patent EP 0491649 to Pless which were cited by the Examiner in
`
`support of his argument.
`
`7.
`
`In the Office action dated 20 [an 1999, the Examiner contends that
`
`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:
`
`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.
`
`Swanson, US. Patent 5,634,938, col. 6, lines 55-65 (emphasis added).
`
`8.
`
`As an electrical engineer in the engineering arts, I would be unable to
`
`build a high voltage, high energy biphasic external defibrillator based on these
`
`statements in combination with the remainder of the reference, which specifically
`
`teaches. how to build an implantable biphasic defibrillator.
`
`9.
`
`Even if higher voltage switches were used in the Swanson et a]. circuit, the
`
`circuit could not be used in an external defibrillator. The Swanson circuit depends on
`
`the load being stable and well controlled; this results because the electrodes are .
`
`attached to the heart internally. As a result, there is no means described in Swanson for
`
`protecting against a load fault. Since load faults may occur in the external application
`
`of defibrillator electrodes, any circuit that is used must provide a means for protecting
`
`the circuit against the load faults. Developing a circuit design that protects the circuit
`
`from load faults is a major design challenge.
`
`10.
`
`- Swanson contrasts its teaching against conventional devices, which use
`
`125 p.F capacitors charged to 780 volts, by teaching that:
`
`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
`
`-‘..‘..:1<.;.-ac-2-.‘.»‘..‘;:.
`
`-.-
`
`Page
`
`of 4
`
`Page 2 of 4
`
`

`
`ratings are more readily available, and reliability is improved if
`peakvoltages and currents are reduced.
`
`Swanson, U.S. Patent 5,634,938, col. 7, lines 58-64 {emphasis added).
`
`Thus Swanson recognizes the advantage of using switches with lower voltages and
`
`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.
`
`4 11.
`
`In order to build a high voltage, high energy biphasic defibrillator which
`
`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
`
`Swanson would beunable to tolerate voltages in excess of 1500 volts.
`
`12.
`
`Because of the higher voltages present in the external defibrillator, a major
`
`design challenge becomes terminating phase one. This problem is further exacerbated
`
`by shorter phase.durations. Swanson teaches waveforms >15msec total duration (col.'6,
`
`line 43). Therefore the teaching of Swanson could not be easily adapted to be used in an
`
`external defibrillator capable of delivering a waveform shorter than 15msec.
`
`13.
`
`Pless measures the capacitor voltage until it reaches a threshold value.
`
`Once the threshold value is set, phase one is ended. Thus, Pless does not use a timer to
`
`control the duration of phase one.
`
`14.
`
`I would not be able to design and build a high voltage, high energy
`
`biphasic external defibrillator based on the teachings of Swanson, or Swanson in
`
`combination with Pless without overcoming the design challenges described above.
`
`I hereby declare that all statements made herein of my own knowledge are true
`
`and that all statements made on information and belief are believed to be true; and
`
`further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both, under
`
`section 1001 of Title 18 of the United States Code, and that such willful false statements
`
`>1)
`
`4
`
`Page 3 of 4
`
`3
`
`'
`
`Heartstream Ref. 93-003—US1.C2
`HP Ref. 90980060-4
`
`Serial No. 08/ 946,843
`
`«
`
`..
`
`.
`
`.
`
`_...:$..u¢:.>l.2a.s4:i:ls7§I{*.:i.:é:.n»-Gi-- ;.:.
`
`Page 3 of 4
`
`

`
`may jeopardize the valifiity of the application, any patent issuing thereon, or any patent
`to whicn this verified statefnent is directed.
`
`Dated:
`
`2
`
`
`
`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
`
`..
`
`.-.-.».-:«-x~,~.'-.<.;.<:'.;‘a.‘.~.;,~.~;a.-L3.-=...L2....a-..
`
`'._- ....~;_';f;:....::e-.:.:.-.i.-
`
`_ _~'
`
`Page Zof 4
`
`Page 4 of 4