IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Cameron, et al.
`U.S. Patent No.: 5,607,454 Attorney Docket No.: 38855-0005IP1
`Issue Date:
`March 4, 1997
`Appl. Serial No.: 08/227,553
`Filing Date:
`April 14, 1994
`Title:
`ELECTROTHERAPY METHOD AND APPARATUS
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT NO. 5,607,454
`PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`

`

`TABLE OF CONTENTS
`
`I. 
`II. 
`
`INTRODUCTION ......................................................................................................... 1 
`MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1) ........................................... 1 
`A.  Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ................................................ 1 
`B.  Related Matters Under 37 C.F.R. § 42.8(b)(2) .......................................................... 2 
`C.  Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ..................................... 2 
`D.  Service Information ................................................................................................... 3 
`III. 
`PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................................ 3 
`IV. 
`REQUIREMENTS FOR IPR UNDER 37 C.F.R. §§ 42.104 ........................................ 3 
`A.  Grounds for Standing Under 37 C.F.R. § 42.104(a) ................................................ 3 
`B.  Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested .............................. 3 
`C.  Claim Construction under 37 C.F.R. §§ 42.104(b)(3) .............................................. 5 
`V. 
`SUMMARY OF THE ‘454 PATENT ............................................................................. 8 
`A.  Brief Description ....................................................................................................... 8 
`B.  Summary of the Prosecution History of the ‘454 Patent ..................................... 11 
`VI. 
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE IPR CLAIM OF
`THE ‘454 PATENT IS UNPATENTABLE .................................................................. 11 
`VII.  MANNER OF APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`INTER PARTES REVIEW IS REQUESTED ............................................................. 14 
`A.  Rejections Based on Bell as Primary Reference.................................................. 14 
`1. 
`[GROUND 1] – Claims 1, 2, 13, 15, 16, 21, 23-26, 29, 30, 35, 36, 45, 51
`are obvious under 35 U.S.C. § 103(a) over Bell in view of Schuder 1984.
` .................................................................................................................. 14 
`[GROUND 2] – Claims 4 and 5 are obvious under 35 U.S.C. § 103(a) over
`Schuder and Bell in view of Fain. ............................................................. 24 
`[Ground 3] – Claims 17, 52 are obvious under 35 U.S.C. § 103(a) over
`Bell and Schuder 1984 in view of De Coriolis. ......................................... 25 
`[Ground 4] – Claims 31-34, 41-44 are obvious under 35 U.S.C. § 103(a)
`over Bell and Schuder 1984 in view of Herleikson. .................................. 28 
`[GROUND 5] – Claims 27, 28, 37, 38 are obvious under 35 U.S.C. §
`103(a) over Bell and Schuder in view of Adams. ..................................... 29 
`B.  Rejections Based on Pless as Primary Reference ............................................... 31 
`1. 
`[GROUND 6] – Claims 1, 3, 13, and 15 are anticipated under 35 U.S.C. §
`102(e) by Pless. ....................................................................................... 31 
`[GROUND 7] – Claims 4 and 5 are obvious under 35 U.S.C. § 103(a) over
`Pless in view of Fain. ................................................................................ 35 
`
`2. 
`
`i
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`

`

`4. 
`
`5. 
`
`3. 
`
`[GROUND 8] – Claims 2, 17, and 52 are obvious under 35 U.S.C. §
`103(a) over Pless and Fain in view of De Coriolis. ................................... 40 
`[GROUND 9] – Claims 27, 28, 37, 38 are obvious under 35 U.S.C. §
`103(a) over Pless in view of Adams. ........................................................ 43 
`[GROUND 10] – Claims 31-34, 41-44 are obvious under 35 U.S.C. §
`103(a) over Pless and Fain in view of Herleikson. ................................... 45 
`A.  Rejections Based on Schuder 1988 as Primary Reference ................................. 46 
`1. 
`[GROUND 11] – Claims 51 and 52 are anticipated by Schuder 1988 under
`35 U.S.C. § 102(b). .................................................................................. 47 
`B.  Obviousness-type Double Patenting ..................................................................... 51 
`1. 
`[GROUND 12] – Claims 1 is unpatentable for obviousness-type double
`patenting over claim 10 of U.S. Patent 5,709,905 .................................... 51 
`[GROUND 13] – Claims 15 is unpatentable for obviousness-type double
`patenting over claim 14 of U.S. Patent 5,735,879 .................................... 54 
`[GROUND 14] – Claims 24 is unpatentable for obviousness-type double
`patenting over claim 6 of U.S. Patent 5,803,927 ...................................... 55 
`[GROUND 15] – Claims 15 is unpatentable for obviousness-type double
`patenting over claim 13 of U.S. Patent 5,735,879 .................................... 58 
`VIII.  CONCLUSION .......................................................................................................... 60 
`
`
`2. 
`
`3. 
`
`4. 
`
`ii
`
`

`

`LIFECOR454-1001
`
`LIFECOR454-1002
`LIFECOR454-1003
`LIFECOR454-1004
`LIFECOR454-1005
`LIFECOR454-1006
`LIFECOR454-1007
`LIFECOR454-1008
`LIFECOR454-1009
`LIFECOR454-1010
`
`
`
`
`
`
`
`
`LIFECOR454-1011
`
`LIFECOR454-1012
`
`LIFECOR454-1013
`
`LIFECOR454-1014
`
`EXHIBITS
`
`U.S. Patent No. 5,607,454 to David Cameron, et al. (“‘454 Pa-
`tent”)
`Prosecution History of the ‘454 Patent
`Declaration of Dr. Wayne McDaniel
`U.S. Patent No. 3,782,389 to Bell (“Bell”)
`U.S. Patent No. 5,083,562 to de Coriolis (“de Coriolis”)
`U.S. Patent No. 5,352,239 to Pless (“Pless”)
`U.S. Patent No. 5,230,336 to Fain (“Fain”)
`WO 94/02202 to Adams (“Adams”)
`U.S. Patent No. 5,357,969 to Herleikson (“Herleikson”)
`Schuder et al., “Transthoracic Defibrillation of 100 kg Calves
`with Bidirectional Truncated Exponential Shocks,” Trans Am Ar-
`tif Intern Organs Vol. XXX, pg. 520-525 (1984) (“Schuder
`1984”)
`Koninklijke Philips Electronics NV v. Defibtech LLC, 397
`F.Supp.1257, 1262 (W.D. Wa. 2005)
`Koninklijke Philips Electronics NV v. Defibtech LLC, Case No.
`C03-1322JLR, Order dated Dec. 21, 2005
`Koninklijke Philips Electronics NV v. Cardiac Science, Inc., Civil
`No. 03-1064, Memorandum Opinion and Order dated Apr. 20,
`2006
`Schuder et al., “Comparison of Effectiveness of Relay-
`Switched, One-Cycle Quasisinusoidal Waveform with Critically
`Damped Sinusoid Waveform in Transthoracic Defibrillation of
`100-Kilogram Calves,” Medical Instrumentation Vol. 22 No. 6,
`pg. 281-285 (1988)
`
`iii
`
`

`

`INTRODUCTION
`
`I.
`
`ZOLL Lifecor Corporation (“Lifecor” or “Petitioner”) petitions for Inter Partes Review
`
`(“IPR”) under 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42 of claims 1-59 (“the IPR Claims”)
`
`of U.S. Patent No. 5,607,454 (“the ‘454 Patent”) of David Cameron, et al. (“Patentee” or
`
`“Cameron, et al.”). As explained in this petition, there exists a reasonable likelihood that
`
`Lifecor will prevail with respect to at least one claim challenged in this petition.
`
`The ‘454 Patent claims methods for delivering electrotherapy to a patient using a
`
`simple technique in which a biphasic waveform of electrical energy being delivered to a pa-
`
`tient is shaped based a monitored electrical parameter. But the patent was improvidently
`
`granted without providing a reason for allowance, and without full consideration to the wide
`
`body of applicable prior art, such as that relied on in this petition. For example, U.S. Patent
`
`5,352,239 (“Pless”; LIFECOR454-1006) expressly discloses such a method of shaping a
`
`biphasic waveform. (See, e.g., LIFECOR454-1006, 6:28-39, 7:30-46). The other claim limi-
`
`tations are taught either by Bell and/or the other references presented in this petition.
`
`Moreover, the Patent Owner has obtained multiple patents in the same family without sub-
`
`mitting terminal disclaimers, one or more claims of which invalidate one or more claims in
`
`the patent for obvious-type double patenting. Petitioner respectfully submits Inter Partes
`
`Review should be instituted, and the challenged claims be canceled as unpatentable.
`
`MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1)
`
`II.
`
`
`A.
`
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`1
`
`

`

`
`
`Petitioner, ZOLL Lifecor Corporation, is the real party-in-interest.
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2)
`B.
`Petitioner is not aware of any disclaimers or reexamination certificates for the ‘454
`
`Patent. Petitioner has been named as a defendant in a litigation concerning the ‘454 Pa-
`
`tent, Koninklijke Philips N.V. and Philips Electronics North America Corp. v. ZOLL Lifecor
`
`Corp, Civil No. 12-1369 (W.D.PA.). Lifecor has also petitioned—on this same day—for Inter
`
`Partes Review of other patents at issue in that litigation, 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. 5,593,427 (“the ‘427 Patent”), U.S. Patent No.
`
`5,836,978 (“the ‘978 Patent”), U.S. Patent No. 5,749,904 (“the ‘904 Patent”), and U.S. Pa-
`
`tent No. 5,803,927 (“the ‘927 Patent”) (collectively, “the Philips Waveform Patents,” all of
`
`which are owned by Koninklijke Philips N.V. and/or Philips Electronics North America Corp.
`
`(“Patent Owner” or “Philips”)).
`
`Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`C.
`Petitioner provides the following designation of counsel:
`
`LEAD COUNSEL
`John C. Phillips, Reg. No. 35,322
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`T: 858-678-4304
`F: 877-769-7945
`Email:
`IPR38855-1005IP1@fr.com
`Phillips@fr.com
`
`BACKUP COUNSEL
`Dorothy P. Whelan, Reg. No. 33,814
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`T: 612-337-2509
`F: 877-769-7945
`Email:
`IPR38855-1005IP1@fr.com
`Whelan@fr.com
`
`2
`
`

`

`
`
`Service Information
`D.
`Please address all correspondence and service to counsel at the address provided
`
`in Section I(C). Petitioner also consents to electronic service by email at IPR38855-
`
`1005IP1@fr.com.
`
`PAYMENT OF FEES – 37 C.F.R. § 42.103
`III.
`Petitioner authorizes the Patent and Trademark Office to charge Deposit Account
`
`No. 06-1050 for the fee set in 37 C.F.R. § 42.15(a) for this Petition, and further authorizes
`
`payment for any additional fees to be charged to this Deposit Account.
`
`IV.
`
`REQUIREMENTS FOR IPR UNDER 37 C.F.R. §§ 42.104
`A.
`Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner certifies that the ‘454 Patent is eligible for IPR and that Petitioner is not
`
`barred or estopped from requesting IPR. The present petition is being filed within one year
`
`of service of the original complaint against Petitioner in the district court litigation.
`
`Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`B.
`Petitioner requests Inter Partes review of the IPR Claims of the ‘454 Patent on the
`
`grounds set forth in the table below, and requests that each of the claims be found un-
`
`patentable. An explanation of how the IPR Claims are unpatentable under the statutory
`
`grounds identified below is provided in the form of detailed description and claim charts that
`
`follow, setting forth the identification of where each element can be found in the cited prior
`
`art, and the relevance of that prior art. Additional explanation and support for each ground
`
`of rejection is set forth in in the declaration of Dr. Wayne McDaniel (LIFECOR454-1003).
`
`3
`
`

`

`Basis for Rejection of the IPR Claims
`Obvious under 35 U.S.C. § 103(a) over Bell in view of
`Schuder 1984.
`
`Obvious under 35 U.S.C. § 103(a) over Bell and
`Schuder 1984 in view of Fain.
`Obvious under 35 U.S.C. § 103(a) over Bell and
`Schuder 1984 in view of De Coriolis.
`Obvious under 35 U.S.C. § 103(a) over Bell and
`Schuder 1984 in view of Adams.
`Obvious under 35 U.S.C. § 103(a) over Bell and
`Schuder 1984 in view of Herleikson
`Anticipated under 35 U.S.C. § 102(e) by Pless.
`Obvious under 35 U.S.C. § 103(a) over Pless in view
`of Fain.
`
`Ground
`Ground 1
`
`Ground 2
`
`Ground 3
`
`‘454 Patent Claims
`1, 2, 3, 13, 15, 16,
`21, 23-26, 29, 30, 35,
`36, 45, 51
`4 and 5
`
`17, 52
`
`Ground 4
`
`27, 28, 37, 38
`
`Ground 5
`
`31-32, 41-42
`
`Ground 6
`Ground 7
`
`Ground 8
`
`1, 3, 13, 15
`4, 5, 16, 21, 23-26,
`30, 35, 36, 45, and
`51
`17, 52
`
`Ground 9
`
`27, 28, 37, 38
`
`Ground 10
`
`31-32, 41-42
`
`Ground 11
`
`51, 52
`
`Obvious under 35 U.S.C. § 103(a) over Pless and
`Fain in view of De Coriolis.
`Obvious under 35 U.S.C. § 103(a) over Pless and
`Fain in view of Adams.
`Obvious under 35 U.S.C. § 103(a) over Pless and
`Fain in view of Herleikson
`Anticipated under 35 U.S.C. § 102(e) by Schuder
`1988.
`Nonstatutory obviousness-type double patenting over
`claim 10 of U.S. Patent No. 5,709,905
`Nonstatutory obviousness-type double patenting over
`claim 14 of U.S. Patent No. 5,735,879
`Nonstatutory obviousness-type double patenting over
`claim 6 of U.S. Patent No. 5,803,927
`Nonstatutory obviousness-type double patenting over
`claim 13 of U.S. Patent No. 5,735,879
`The ‘454 Patent issued from an application claiming priority to August 6, 1993. Ac-
`
`Ground 12
`
`Ground 13
`
`Ground 14
`
`Ground 15
`
`1
`
`15
`
`24
`
`15
`
`cordingly, Bell is prior art under 35 U.S.C. § 102(b), having issued January 1, 1974. Schud-
`
`er 1984, published in 1984, also is prior art under 35 U.S.C. § 102(b). Schuder 1988, pub-
`
`lished in 1988, also is prior art under 35 U.S.C. § 102(b). Similarly, De Coriolis is prior art
`
`4
`
`

`

`35 U.S.C. § 102(b), having issued January 28, 1992. Pless is prior art under at least 35
`
`U.S.C. § 102(e), having been filed March 24, 1993. Fain is prior art under at least 35 U.S.C.
`
`§ 102(e), having been filed August 16, 1991. Adams is prior art under at least 35 U.S.C. §
`
`102(e), having been filed July 16, 1993. Herleikson is prior art under at least 35 U.S.C. §
`
`102(e), having been filed March 18, 1993. Six of these references (Pless, Bell, De Coriolis,
`
`Fain, Schuder 1988 and Adams) were cited in an IDS, and thus made of record, but were
`
`not applied or otherwise addressed during prosecution. The particular Schuder 1984 article
`
`relied on herein was not of record in the original ‘454 Patent prosecution.
`
`Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
`C.
`A claim in an unexpired patent is to be given its broadest reasonable interpretation
`
`(BRI) in light of the specification in which it appears. 37 C.F.R. § 42.300(b); see also In re
`
`Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984). The ’454 patent has not expired, and
`
`thus its claims should at present be given their broadest reasonable interpretation. Howev-
`
`er, the patent will expire March 14, 2014 – likely about the time that a decision on this Peti-
`
`tion will be issued. Once it has expired, its claims and claim terms are properly given their
`
`“ordinary and customary meaning.” Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir.
`
`2005). Petitioner is not aware of a manner relative to this proceeding how the two different
`
`claim construction standards would produce different interpretations.
`
`Other than claim terms addressed immediately below, the remaining terms in the
`
`claims are not believed to require additional clarification for purposes of the present IPR.
`
`5
`
`

`

`PROPOSED CONSTRUCTIONS
` (i) “monitoring”
`For purposes of this Petition, “monitoring” is construed as “sampling on a regular or
`
`ongoing basis.” This construction is consistent with the ‘905 Patent’s specification. For ex-
`
`ample, claim 4 recites “monitoring a patient-dependent electrical parameter.” Support for
`
`this feature appears in the specification, among other places, in FIGs. 3, 6, and 9, which il-
`
`lustrate three different embodiments. As can be seen in those figures, in each of the three
`
`embodiments, voltage – an electrical parameter – is sampled, on an ongoing basis, in the
`
`decision loops indicated by steps 14, 54, and 92/93, respectively, until the condition “VOLT-
`
`AGE < VTHRESH” is satisfied.
`
`(ii) “a function of”
`For purposes of this Petition, “a function of” is construed as “based on.” This con-
`
`struction is consistent with constructions set forth in Markman orders issued in litigations
`
`relating to the Philips Waveform Patents, and is harmonious with constructions Patent
`
`Owner offered in those proceedings. (See Koninklijke Philips Electronics NV v. Defibtech
`
`LLC, Case No. C03-1322JLR, Order dated Dec. 21, 2005 at 10; LIFECOR -1012).
`
`(iii) “energy source”
`For purposes of this Petition, “energy source” is construed as “a source of energy
`
`that is capable of delivering a therapeutic shock to a patient.” This construction is con-
`
`sistent with constructions set forth in Markman orders issued in litigations relating to the
`
`6
`
`

`

`Philips Waveform Patents, and is harmonious with constructions Patent Owner offered in
`
`those proceedings. (Id. at 14).
`
`(iv) “truncated biphasic (multiphasic) exponential waveform”
`For purposes of this Petition, this term is construed as “a defibrillation shock having
`
`two (at least two) truncated exponential phases of opposite polarity.” This construction is
`
`consistent with constructions set forth in Markman orders issued in litigations relating to the
`
`Philips Waveform Patents, and is harmonious with constructions Patent Owner offered in
`
`those proceedings. (See Koninklijke Philips Electronics NV v. Cardiac Science, Inc., Civil
`
`No. 03-1064, Memorandum Opinion and Order dated Apr. 20, 2006 at 94; LIFECOR -1013).
`
`(v) “patient-dependent electrical parameter”
`
`For purposes of this Petition, “patient-dependent electrical parameter” is construed
`
`as “one or more electrical values, such as voltage, current, charge, etc. that varies depend-
`
`ing on an aspect of a patient’s particular physiology (e.g., impedance) and are sufficient to
`
`identify a value for that aspect of the physiology.” This construction is consistent with con-
`
`structions discussed in Markman orders issued in litigations relating to the Philips Waveform
`
`Patents, and is harmonious with constructions Patent Owner offered in those proceedings.
`
`(See Koninklijke Philips Electronics NV v. Defibtech LLC, Case No. C03-1322JLR, Order
`
`dated Dec. 21, 2005 at 11; LIFECOR -1012).
`
` (v) “means for selectively limiting current flow through the electrodes”
`
`7
`
`

`

`For purposes of this Petition, this term is construed as a switch for connecting and
`
`disconnecting a resistance from the circuit to limit current flow, or an equivalent structure.
`
`(See ’454 Patent, 6:52-56).
`
`(vi) “means for determining whether current flowing to the electrodes is below
`a predetermined threshold”
`For purposes of this Petition, this term is construed as a current sensor, or an equiv-
`
`alent structure. (See ’454 Patent, 6:66-7:3).
`
`(vii) “means for delivering a multiphasic waveform without the use of an induc-
`
`tor”
`
`For purposes of this Petition, this term is construed as a waveform circuit for produc-
`
`ing a biphasic waveform, or an equivalent structure. (See ’454 Patent, 10:4-7).
`
`V.
`
`SUMMARY OF THE ‘454 PATENT
`A.
`Brief Description
`
`Generally, the ‘454 Patent discloses and claims a method for applying an electrical
`
`shock to a patient’s irregularly beating heart to cause the heart to resume its natural beating
`
`rhythm. (‘454 Patent at 1:7-17). This technique is referred to as “defibrillation,” meaning
`
`that the goal is to stop the patient’s heart from “fibrillating” – that is, twitching irregularly ra-
`
`ther than beating in a normal rhythmic pattern. At the time of the ‘454 Patent, it was well-
`
`known that, in applying a shock to a patient’s heart via electrodes attached to the patient’s
`
`torso, the shock could be a single positive-voltage shock (“monophasic”), or a positive volt-
`
`age phase followed by a negative voltage phase (“biphasic”). (Id. at 1:46-53). When the
`
`8
`
`

`

`voltage on the energy source is allowed to fall naturally, the result is known as a biphasic,
`
`exponentially decaying, truncated waveform such as shown in FIG. 1 of the ’454 Patent.
`
`(Id.).
`
`The waveform is “biphasic”—i.e., a first phase during which voltage is applied for du-
`
`ration E, and a second phase during which voltage (using the opposite polarity) is applied
`
`for duration F. The gently curved shape of the waveform arising from the natural discharge
`
`pattern of the capacitor from which the applied voltage originates is the “exponential decay”
`
`in the waveform. And the waveform is “truncated” in that, at the end of each phase of the
`
`waveform, the voltage is cut off abruptly (at terminal voltage B for phase 1, and terminal
`
`voltage D for phase 2), rather than being allowed to decay smoothly all the way down to ze-
`
`ro. These three, well-known waveform characteristics (biphasic, exponential decay, trunca-
`
`tion) were determined over many years of research and experimentation, all well-known pri-
`
`or to the ‘454 Patent. (Id.).
`
`Also well-known before the ‘454 Patent was the fact that different patients had differ-
`
`ent impedance levels – that is, a measure of the resistance to electrical current passing
`
`through the patient’s torso. (Id. at 2:1-30). Therefore, as a consequence of basic physical
`
`laws, patients with higher impedance receive less electrical energy than patients with lower
`
`impedance, all other factors being equal. (Id.). Such differences in impedance can be
`
`compensated for, as was well known in the art, by varying phase duration (e.g., “E” in FIG
`
`1.) or varying the phase’s initial and/or terminal voltages (e.g., “A” and “B” in FIG 1., respec-
`
`9
`
`

`

`tively), thereby delivering a maximized amount of electrical energy to each patient, regard-
`
`less of the patient’s impedance value. (Id.). In other words, the ‘454 Patent acknowledged
`
`that it was known to compensate for varying impedances among patients by varying the
`
`amplitude (i.e., voltage levels) and/or duration (i.e., time period) of the pulse accordingly.
`
`(Id.).
`
`Given all the admitted prior art in the ‘454 Patent’s Background section, the purport-
`
`ed invention recited by the claims is simple and straightforward, namely, monitoring a pa-
`
`tient-dependent electrical parameter and shaping the delivered waveform based on the val-
`
`ue of the parameter such that the relative duration of the waveform phases is based on the
`
`parameter. (Id. at claim 1). Monitoring a patient-dependent electrical parameter and shap-
`
`ing a delivered waveform based on the parameter was well known in the art at the time of
`
`the ’454 patent, as shown by the Pless reference. Pless discloses a defibrillator for deliver-
`
`ing multiphasic waveforms that monitors the voltage delivered to the patient over time and
`
`shapes the waveform based on the voltage. (See LIFECOR454-1006, 6:29-39, 7:30-46).
`
`In sum, it was well-known that the various waveform characteristics could be moni-
`
`tored and modified to fine tune the extent and manner of applying electricity to a patient’s
`
`heart during defibrillation. What the ‘454 Patent claims to have invented is merely a trivial
`
`variant of the techniques that it admits are prior art. More importantly, as will be discussed
`
`in detail below, the methods claimed in the ‘454 Patent had already been invented by others
`
`– namely, by the patentees named in the prior art patents relied on herein.
`
`10
`
`

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`B.
`
`Summary of the Prosecution History of the ‘454 Patent
`
`The ‘454 Patent, filed April 14, 1994, issued from a continuation-in-part of an original
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`application filed on August 6, 1993. In the first Office Action, claims 1-12, 17, 19-25, 26-32,
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`and 34 were indicated as allowable, with only claims 13-16, which included limitations relat-
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`ed to connecting an additional impedance to the defibrillator circuit, and claim 33, which
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`merely recited delivering biphasic waveform to a patient, being rejected. (See
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`LIFECOR454-1002, p. 81). In response, the applicant cancelled claims 13-16, and added
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`new claims similar to the allowed claims. (See id. at 125). These new claims were also in-
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`dicated to be allowable in the next Office Action. (See id. at 132). Applicant then cancelled
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`claim 33, and a Notice of Allowability followed containing no reasons for allowance. (See
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`id.at 149). The ’454 Patent subsequently issued on March 4, 1997.
`
`VI.
`
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE IPR
`CLAIM OF THE ‘454 PATENT IS UNPATENTABLE
`Claims 1-5, 13, 15-17, 21, 23-38, 41-45, and 51 are unpatentable under one or more
`
`of 35 U.S.C. §§ 102 and 103. Thus, for the reasons set forth below, there is a reasonable
`
`likelihood that at least one of the claims is unpatentable. 35 U.S.C. 314(a).
`
`Bell describes a method for delivering a monophasic waveform to a patient through
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`electrodes attached to an energy source. (LIFECOR454-1004 (Bell), Abstract). The meth-
`
`od includes monitoring both current and voltage during energy delivery, and shaping the de-
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`livered waveform based on the monitored current and voltage. Although Bell does not ex-
`
`plicitly describe the claimed features relating to a multiphasic waveform, a multiphasic
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`11
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`

`

`waveform was widely known as a waveform for achieving defibrillation. For example, the
`
`Background section of the ‘454 Patent acknowledges that biphasic waveforms were well-
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`known and in widespread use in defibrillators before the ‘454 Patent. (See, e.g., ‘454 Pa-
`
`tent at 1:46-53). Moreover, Schuder 1984 discloses delivering a bidirectional truncated ex-
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`ponential waveform to a patient. (LIFECOR454-1010 (Schuder 1984), p. 1). Accordingly,
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`the combination of Bell and Schuder 1984 teaches (i) delivering a multiphasic waveform to a
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`patient; (ii) monitoring a patient dependent electrical parameter during delivery of the wave-
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`form; and (iii) shaping the waveform based on the monitored parameter.
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`Regarding claims 24-26 and 36, which recite upper bounds for various physical di-
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`mensions of claimed defibrillator, it would have been obvious to one of ordinary skill in the
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`art to construct a defibrillator with such dimensions in light of the stated goal of Bell to “pro-
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`vide a defibrillator which is light weight and portable.” (LIFECOR454-1004 (Bell), 1:46-47).
`
`Pless discloses delivering a biphasic waveform to a patient, monitoring a patient de-
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`pendent electrical parameter (voltage decay), and shaping a waveform based on the pa-
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`rameter (adjusting the duration of a waveform phase). (Id. at 6:28-39).
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`Fain discloses controlling the duration of another phase of the waveform phase
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`based on the value of the electrical parameter, and selecting phase durations for each
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`phase from the plurality of phase duration values. For example, Fain discloses pulse widths
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`for biphasic waveforms for different ranges of measured impedance.” (LIFECOR454-1007
`
`(Fain), 7:3-12, FIG. 3)). As shown in Fain’s FIG. 3, an impedance value of 19 or less will
`
`12
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`

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`yield phase durations of 3.0/3.0 msec for a biphasic waveform. (Id. at FIG. 3). An imped-
`
`ance value of 70 ohms or greater will yield phase durations of 12.0/12.0 msec. (Id.) Ac-
`
`cordingly, a skilled artisan would have been motivated to combine Fain’s waveform duration
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`control with Bell’s or Pless’ waveform control schemes, among other reasons, to increase
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`effectiveness of the monophasic or biphasic waveform. (LIFECOR454-1003 (McDaniel
`
`Dec.), ¶ 46).
`
`De Coriolis teaches an H-bridge circuit for varying the polarity of a delivered wave-
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`form, the H-bridge including a plurality of switches. (LIFECOR454-1005 (De Coriolis), 5:6-
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`13). De Coriolis therefore discloses the limitations of dependent claims 17 and 52.
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`Adams teaches a defibrillator including lithium manganese dioxide primary batteries,
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`which are an example primary cell batteries based on dependent claim 28. Adams there-
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`fore teaches the limitations of dependent claims 27, 28, 37, and 38.
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`Herleikson teaches a defibrillator including an ECG system and a display that dis-
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`plays the ECG data produced by the ECG system. (LIFECOR454-1009 (Herleikson), 2:52-
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`65). As LCD displays were well-known at the time of the ’454 Patent, it would have been
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`obvious to modify Bell’s or Pless’ defibrillator to include the display of Herleikson, so that
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`ECG data can be presented to a user. (LIFECOR454-1003 (McDaniel Dec.), ¶ 51). Fur-
`
`ther, PCMCIA was a well-known, industry standard interface technology at the time of the
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`’454 Patent. Accordingly, a skilled artisan would have recognized that using PCMCIA inter-
`
`face technology in the defibrillators of Bell or Pless is simply an obvious design choice
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`13
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`based on the limited selection of interface technologies that could be used for communica-
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`tion. (LIFECOR454-1003 (McDaniel Dec.), ¶ 50).
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`Schuder 1988 describes a defibrillator for producing biphasic waveforms for delivery
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`to a patient. (LIFECOR454-1014 (Schuder 1988.), p. 281). Schuder 1988 further teaches a
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`switch for connecting and removing an additional impedance from the circuit if an electrical
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`parameter is within a defined range prior to the end of the discharging step. (See id.;
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`LIFECOR454-1003 (McDaniel Dec.), ¶ 55).
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`Accordingly, the foregoing references, specific portions of which are cited in the
`
`charts below, render the IPR claims invalid as specified in the proposed grounds.
`
`VII. MANNER OF APPLYING CITED PRIOR ART TO EVERY CLAIM FOR
`WHICH INTER PARTES REVIEW IS REQUESTED
`In this Section, Petitioner proposes various grounds of rejection for the IPR Claims
`
`and, thus, explains the justification for Inter Partes Review. Petitioner presents claim charts
`
`that compare the claim language as construed under the above-ascribed claim interpreta-
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`tions, with the disclosure of the prior art as understood by one of ordinary skill in the art.
`
`A.
`
`Rejections Based on Bell as Primary Reference
`
`[GROUND 1] – Claims 1, 2, 13, 15, 16, 21, 23-26, 29, 30, 35,
`1.
`36, 45, 51 are obvious under 35 U.S.C. § 103(a) over Bell in view of Schuder 1984.
`As shown in the following claim chart, claims 1, 2, 13, 15, 16, 21, 23-26, 29, 30, 35,
`
`36, 45, 51 are obvious under 35 U.S.C. § 103(a) over Bell in view of Schuder 1984.
`
`Reasons to combine Bell and Schuder 1984
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`14
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`

`A skilled artisan would have combined Bell and Schuder 1984 because the combina-
`
`tion amounts to the use of a known technique to improve a similar method in the same way.
`
`(See KSR v. Teleflex, 550 U.S. 398, 417 (2007)). Bell is directed to a defibrillation method
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`in which a monophasic waveform is delivered to a patient’s heart. (LIFECOR879-1004
`
`(Bell), Abstract). Bell further teaches monitoring the waveform to limit the amount of energy
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`delivered based on a timeout period. (Id. at 4:15-18). Schuder 1984 describes a defibrilla-
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`tion technique that involves adding a second phase of opposite polarity to a monophasic
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`waveform to produce a biphasic waveform in order to increase the effectiveness of the de-
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`fibrillation method. (LIFECOR879-1010 (Schuder 1984), p. 1). Accordingly, it would have
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`been obvious to modify Bell to use Schuder 1984’s biphasic waveform because to do so
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`maintains Bell’s timeout feature while improving the effectiveness of the defibrillation wave-
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`form. (See LIFECOR454-1003 (McDaniel Dec), ¶ 42).
`
`’454 Patent Claims
`1. A method for applying electrotherapy to
`a patient through electrodes connected to
`an energy source, the method comprising
`the following steps:
`
`charging the energy source to an initial
`level;
`
`discharging the energy source across the
`electrodes to deliver electrical energy to
`the patient in a multiphasic waveform;
`
`Bell + Schuder 1984
`“A computer controlled defibrillator comprising
`a set of electrodes which are engageable with
`a patient and which are connected to a
`source of electrical energy by a circuit
`means.” Bell, Abstract (emphasis added).
`“Initially the capacitors are charged and all
`SCRs are off. The cycle starts with the start
`input going to a positive 15 v.” Bell, 3:46-48
`(emphasis added).
`“A computer controlled defibrillat