IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Gliner, et al.
`U.S. Patent No.: 5,836,978 Attorney Docket No.: 38855-0004IP1
`Issue Date:
`November 17, 1998
`Appl. Serial No.: 08/909,656
`Filing Date:
`August 12, 1997
`Title:
`ELECTROTHERAPY METHOD FOR PRODUCING A MULTIPHASIC
`DISCHARGE BASED UPON A PATIENT-DEPENDENT ELECTRICAL
`PARAMETER AND TIME
`
`
`
`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. 5,836,978
`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) ........................................... 2 
`A.  Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ................................................ 2 
`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 ‘978 PATENT ............................................................................. 9 
`A.  Description ................................................................................................................. 9 
`B.  Claims ....................................................................................................................... 13 
`C.  Summary of the Prosecution History of the ‘978 Patent ..................................... 15 
`VI. 
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE IPR CLAIM OF
`THE ‘978 PATENT IS UNPATENTABLE .................................................................. 17 
`VII.  MANNER OF APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`INTER PARTES REVIEW IS REQUESTED ............................................................. 18 
`A.  Rejections Based on Bell as Primary Reference.................................................. 19 
`1. 
`[GROUND 1] – Claims 1, 3, 4, 5, 6, 7 are obvious under 35 U.S.C. § 103
`over Bell in view of Schuder 1984. ........................................................... 19 
`[GROUND 2] – Claim 2 is obvious under 35 U.S.C. § 103 over Bell and
`Schuder 1984 in view of Kroll ................................................................... 25 
`B.  Rejections Based on Bach as Primary Reference ............................................... 27 
`1. 
`[GROUND 3] – Claims 1 and 3-7 is anticipated under 35 U.S.C. § 102 by
`Bach ......................................................................................................... 27 
`[GROUND 4] – Claim 2 is obvious under 35 U.S.C. § 103 over Bach in
`view of Kroll .............................................................................................. 32 
`C.  Obviousness-type Double Patenting ..................................................................... 34 
`1. 
`[GROUND 5] – Nonstatutory obviousness-type double patenting of claim 1
`over claim 6 of U.S. Patent No.5,735,879 (Gliner) ................................... 34 
`VIII.  CONCLUSION .......................................................................................................... 37 
`
`
`2. 
`
`2. 
`
`i
`
`

`

`EXHIBITS
`
`U.S. Patent No. 5,836,978 to Bradford E. Gliner, et al. (“‘978
`Patent”)
`Prosecution History of the ‘978 Patent
`Declaration of Wayne C. McDaniel, Ph.D.
`U.S. Patent No. 3,782,389 (Bell)
`Schuder 1984 et al., Transthoracic Defibrillation of 100 Kg
`Calves with Bidirectional Truncated Exponential Shocks,
`Transactions – American Society for Artificial Internal Organs,
`Vol. 30, Issue 1 (1984).
`U.S. Patent No. 5,431,686 (Kroll)
`U.S. Patent No. 4,850,357 (Bach)
`Koninklijke Philips Electronics NV v. Defibtech LLC, Case No.
`C03-1322JLR, Order dated Dec. 21, 2005
`U.S. Patent No. 5,735,879 (Gliner)
`American Heritage Dictionary (3d ed. 1992), page 1167
`
`LIFECOR978 -1001
`
`LIFECOR978 -1002
`LIFECOR978 -1003
`LIFECOR978 -1004
`LIFECOR978 -1005
`
`LIFECOR978 -1006
`LIFECOR978 -1007
`LIFECOR978 -1008
`
`LIFECOR978 -1009
`LIFECOR978 -1010
`
`
`ii
`
`

`

`I.
`
`INTRODUCTION
`
`ZOLL Lifecor Corporation (“Petitioner” or “Lifecor”) petitions for Inter Partes Review
`
`(“IPR”) under 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42 of claims 1-7 (“the IPR Claims”) of
`
`U.S. Patent No. 5,836,978 (“‘978 Patent”) of Bradford E. Gliner, et al. (“Patentee” or “Gliner,
`
`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 ‘978 Patent claims methods for delivering electrotherapy to a patient using a
`
`simple technique in which delivery of energy to the patient’s heart is based on a monitored
`
`electrical parameter (e.g., voltage or energy), and a measured period of time. But the pa-
`
`tent was improvidently granted without full consideration to the wide body of applicable prior
`
`art, such as that relied on in this petition. For example, both U.S. Patent 3,782,389 (“Bell”;
`
`LIFECOR978-1004) and U.S. Patent 4,850,357 (“Bach”; LIFECOR978-1007) expressly dis-
`
`close a limitation that was asserted during prosecution to distinguish over the cited art,
`
`namely, a method in which “the electrical parameter and time are monitored simultaneous-
`
`ly.” (Amendment filed 4/28/97 at 3). And the other claim limitations are taught either by Bell,
`
`Bach, and/or Schuder 1984, the other reference presented in this petition. Moreover, Pa-
`
`tent Owner has obtained multiple patents in the same family without submitting terminal dis-
`
`claimers, and at least one of the claims in the patent is invalid for obviousness-type double
`
`patenting over one or more of such related patents. Petitioner respectfully submits that Inter
`
`Partes Review should be instituted, and the challenged claims be canceled as unpatenta-
`
`1
`
`

`

`ble.
`
`II.
`
`
`MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1)
`
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`A.
`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 ‘978
`
`Patent. Petitioner has been named as a defendant in a recently-filed litigation concerning
`
`the ‘978 Patent, 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. 5,607,454 (“the ‘454 Patent”), U.S. Pa-
`
`tent No. 5,749,904 (“the ‘904 Patent”), U.S. Patent No. 5,803,927 (“the ‘927 Patent”), and
`
`U.S. Patent No. 5,593,427 (“the ‘427 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
`
`BACKUP COUNSEL
`Dorothy P. Whelan, Reg. No. 33,814
`3200 RBC Plaza
`60 South Sixth Street
`
`2
`
`

`

`Minneapolis, MN 55402
`T: 858-678-4304
`F: 877-769-7945
`Email:
`IPR38855-0004IP1@fr.com
`Phillips@fr.com
`
`
`Minneapolis, MN 55402
`T: 612-337-2509
`F: 877-769-7945
`Email:
`IPR38855-0004IP1@fr.com
`Whelan@fr.com
`
`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-
`
`0004IP1@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.
`
`REQUIREMENTS FOR IPR UNDER 37 C.F.R. §§ 42.104
`
`IV.
`
`
`Grounds for Standing Under 37 C.F.R. § 42.104(a)
`A.
`Petitioner certifies that the ‘978 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 ‘978 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 grounds
`
`3
`
`

`

`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 rejec-
`
`tion are set forth in the declaration of Dr. Wayne McDaniel (LIFECOR978-1003).
`
`Ground
`Ground 1
`
`‘978 Patent Claims
`1, 3-7
`
`Ground 2
`
`2
`
`Ground 3
`
`Ground 4
`
`1, 3-7
`
`2
`
`Basis for Rejection of the IPR Claims
`Obvious under 35 USC 103 over US 3,782,389 (Bell)
`(LIFECOR978-1004) in view of Schuder 1984 et al.,
`Transthoracic Defibrillation of 100 Kg Calves with Bidi-
`rectional Truncated Exponential Shocks, Transactions –
`American Society for Artificial Internal Organs, Vol. 30,
`Issue 1 (1984) (“Schuder 1984”) (LIFECOR978-1005)
`Obvious under 35 USC 103 over Bell (LIFECOR978-
`1004) and Schuder 1984 (LIFECOR978-1005) in view
`of US 5,431,686 (Kroll) (LIFECOR978-1006)
`Anticipated under 35 USC 102 by US 4,850,357 (Bach)
`(LIFECOR978-1007)
`Obvious under 35 USC 103 over Bach (LIFECOR978-
`1007) in view of US 5,431,686 (Kroll) (LIFECOR978-
`1006)
`Obviousness-type double-patenting over claim 6 of U.S.
`Patent 5,735,879 (Gliner) (LIFECOR978-1009)
`
`1
`
`Ground 5
`
`The ‘978 Patent issued from an application claiming priority to August 6, 1993. Ac-
`
`cordingly, Bell is prior art under 35 U.S.C. § 102(b) because it issued on January 1, 1974,
`
`and thus was patented more than one year prior to the earliest priority date of the ‘978 Pa-
`
`tent. Schuder 1984, which was published in 1984, also is prior art under 35 U.S.C. §
`
`102(b). Similarly, Bach is prior art under 35 U.S.C. § 102(b) because it issued on July 25,
`
`1989. Kroll is prior art under at least 35 U.S.C. § 102(e), having been filed on February 18,
`
`1992. Two of these references (Bell and Bach) were cited in an IDS, and thus made of rec-
`
`4
`
`

`

`ord, but neither were applied or otherwise addressed during prosecution. The particular
`
`Schuder 1984 article relied on herein was not of record in the original ‘978 patent prosecu-
`
`tion. Kroll was of record and applied during prosecution but is being relied on this petition
`
`for a different purpose, and thus is being presented in a new light.
`
`Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
`C.
`The subject patent is expired, such that 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) (words of a claim “are generally given their ordinary and customary meaning” as
`
`understood by a person of ordinary skill in the art in question at the time of the invention)).
`
`In determining the ordinary and customary meaning, the words of a claim are first given
`
`their plain meaning. (Id.) According to Phillips, the structure of the claims may breathe ad-
`
`ditional meaning into the claims, and the specification and file history also may be used to
`
`better construe a claim insofar as the plain meaning of the claims cannot be understood.
`
`Moreover, Phillips offers that even treatises and dictionaries may be used, albeit under lim-
`
`ited circumstances, to determine the meaning attributed by a person of ordinary skill in the
`
`art to a claim term at the time of filing.
`
`Other than claim terms addressed immediately below, for which information concern-
`
`ing constructions appropriate for this Petition is set forth, the remaining terms in the claims
`
`are not believed to require additional clarification for purposes of the present IPR.
`
`i.
`
`PROPOSED CONSTRUCTIONS
`
`5
`
`

`

` “monitoring” – For purposes of this Petition, the term “monitoring” is construed as
`
`“sampling on a regular or ongoing basis.” American Heritage Dictionary (3d ed.
`
`1992) at 1167; LIFECOR978-1010. This construction is consistent with the ‘978 pa-
`
`tent’s specification. For example, claim 1 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 illustrate three different embodiments (rele-
`
`vant portions shown below):
`
`
`
`As can be seen in these figures, in each of the three embodiments, voltage–an elec-
`
`trical parameter–is sampled, on an ongoing basis, in the decision loops indicated by
`
`steps 14, 54, and 92/93, respectively, until the condition “VOLTAGE < VTHRESH” is
`
`satisfied.
`
`6
`
`

`

` “energy source” - For purposes of this Petition, the term “energy source” is con-
`
`strued as “a source of energy that is capable of delivering a therapeutic shock to a
`
`patient.” This construction is consistent with constructions set forth in Markman or-
`
`ders issued in litigations relating to the Philips Waveform Patents, and is harmonious
`
`with constructions offered by Patentee during those proceedings. (See Koninklijke
`
`Philips Electronics NV v. Defibtech LLC, Case No. C03-1322JLR, Order dated Dec.
`
`21, 2005 at 14; LIFECOR978 -1008).
`
` “patient-dependent electrical parameter” – For purposes of this Petition, the term
`
`“patient-dependent electrical parameter” is construed as “one or more electrical val-
`
`ues, such as voltage, current, charge, etc. that varies depending 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 constructions
`
`discussed in Markman orders issued in litigations relating to the Philips Waveform
`
`Patents, and is harmonious with constructions offered by Patentee during those pro-
`
`ceedings. (Id. at 11; LIFECOR978 -1008).
`
` “discharge parameter” – For purposes of this Petition, the term “discharge parame-
`
`ter” is construed as “a property of the delivered electrotherapeutic pulse, for exam-
`
`ple, pulse (or phase) duration.” This construction is consistent with the specification
`
`and claims of the ‘978 Patent. For example, although the exact term “discharge pa-
`
`7
`
`

`

`rameter” is not used, the specification explains what it means, among other loca-
`
`tions, in connection with FIGs. 3-5, which, according to the specification, demon-
`
`strate a defibrillation method “in which information related to patient impedance is fed
`
`back to the defibrillator to change the parameters of the delivered electrotherapeutic
`
`pulse.” (‘978 patent at 5:3-7). And FIGs. 3-5 illustrate that an example of one such
`
`change pulse parameter is pulse (or phase) duration:
`
`
`
`In FIG. 3 (relevant portion shown above), during discharge pulse time and voltage
`
`are monitored in steps 12 and 14, respectively, and used to determine when to “STOP DIS-
`
`CHARGE IN FIRST PHASE” in step 16. Depending on the values of the monitored time
`
`and monitored voltage (the latter of which will vary from patient to patient depending on the
`
`8
`
`

`

`patient’s impedance), the first phase of the discharge will be stopped at different times. (Id.
`
`at 5:8-53). Consequently, as can be seen from FIGs. 4 and 5 above, the phase duration
`
`(“E”) will vary depending on the monitored voltage and time (that is, the value of E in FIG. 4
`
`is greater than the value of E in FIG. 5.) (Id.) Or in the words of the ‘978 patent, “infor-
`
`mation related to patient impedance [i.e., voltage] is fed back to the defibrillator to change
`
`the parameters of the delivered electrotherapeutic pulse [i.e., pulse duration].” (Id. at 5:3-7).
`
`Accordingly, “discharge parameter” is properly construed as “a property of the delivered
`
`electrotherapeutic pulse, for example, pulse (or phase) duration.”
`
`V.
`
`SUMMARY OF THE ‘978 PATENT
`
`A.
`
`Description
`
`Generally, the ‘978 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. (‘978 Patent at 1:7-17; LIFECOR978-1001). This technique is referred to as “defib-
`
`rillation,” meaning that the goal is to stop the patient’s heart from “fibrillating”–that is, twitch-
`
`ing irregularly rather than beating in a normal rhythmic pattern. The ‘978 Patent notes two
`
`basic types of defibrillators-implantable and external. (Id. at 1:23-24). An external defibrilla-
`
`tor essentially consists of an energy source (e.g., a voltage or current source) coupled to a
`
`patient via a pair of electrodes attached to the patient’s torso at one end, and to the energy
`
`source at the other end. (Id. at 1:33-49). Various circuitry is included to control application
`
`of electrical energy to the patient’s heart.
`
`9
`
`

`

`At the time of the ‘978 Patent, it was well-known that, in applying a shock to a pa-
`
`tient’s heart via electrodes attached to the patient’s torso, the shock could be a single posi-
`
`tive-voltage shock (“monophasic”) or a positive voltage pulse followed by a negative voltage
`
`pulse (“biphasic). (Id. at 1:46-53). When the voltage on the power source is allowed to fall
`
`naturally over time in a biphasic waveform, the result is known as a biphasic, exponentially
`
`decaying, truncated waveform such as shown in FIG. 1 of the ‘978 Patent. ([Id.).
`
`Phase 1
`
`Phase 2
`
`
`To illustrate this, the waveform of FIG. 1 is “biphasic”: a first phase during which
`
`voltage is applied for duration E, and a second phase during which voltage (using the oppo-
`
`site polarity) is applied for duration F. (Id. at 3:49-58). The gently curved shape of the
`
`waveform 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, rather than
`
`being allowed to decay smoothly all the way down to zero. In the waveform of FIG. 1, the
`
`first phase is truncated such that the terminal voltage is B, and the second phase is truncat-
`
`10
`
`

`

`ed such that the terminal voltage is D. These three, well-known waveform characteristics
`
`(biphasic, exponential decay, truncation) were determined over many years of research and
`
`experimentation, all well-known prior to the ‘978 Patent.
`
`Also well-known before the ‘978 patent was the fact that different patients–as a result
`
`of differing physiological characteristics–possessed different impedance levels, that is, a
`
`measure of the resistance to electrical current passing through the patients’ skin and other
`
`tissue. (Id. at 2:1-30). Therefore, as a consequence of basic physical laws, upon being
`
`subjected to electricity of a given waveform, patients with higher impedance receive less
`
`electrical energy than patients with lower impedance, all other factors being equal. (Id.).
`
`This difference in effect between high and low impedance patients is illustrated in FIGs. 1
`
`and 2 of the ‘978 Patent:
`
`Low Tilt Waveform
`(High impedance patient)
`
`High Tilt Waveform
`(Low impedance patient)
`
`FIG. 1, which corresponds to a high impedance patient, shows that at the end of the
`
`first and second phases, the terminal voltages B and D, respectively, remain relatively high
`
`
`
`11
`
`

`

`compared to their counterparts in FIG. 2, which corresponds to a low impedance patient.
`
`This is because, in a high impedance patient, the patient’s elevated resistance to current
`
`causes the initial voltage A to decay at a slower rate in comparison to the decay rate of the
`
`lower impedance patient corresponding to FIG. 2. In other words, the rate of voltage decay
`
`for a given patient is an example of a “patient-dependent electrical parameter” that varies
`
`with that patient’s unique physiology (e.g., impedance level). (Id. at 4:41-45). As a result of
`
`their differing physiological characteristics, the high impedance patient corresponding to
`
`FIG. 1 receives less total electrical energy during durations E and F than the low impedance
`
`patient corresponding to FIG. 2, given that E and F represent the same phase durations be-
`
`tween the two figures.
`
`Fortunately, differences in impedance among patients can be compensated for, as
`
`was well-known in the art, by varying phase duration (e.g., “E” in FIG 1.) and/or varying the
`
`phase’s terminal voltage (e.g., “B” in FIG 1.), thereby delivering a maximized amount of
`
`electrical energy to each patient, regardless of the patient’s impedance value. (Id.at 2:30-
`
`35). In other words, the ‘978 Patent admitted that it was known in the art to apply longer or
`
`shorter electrical pulses to a patient, based on that particular patient’s impedance level, to
`
`compensate for a patient-dependent parameter (e.g., the patient’s impedance). (Id.at 2:6-
`
`19).
`
`Given this prior art background, the purported invention recited by the claims is sim-
`
`ple and straightforward, namely, a method of applying electrotherapy that involves “simulta-
`
`12
`
`

`

`neously monitoring a patient-dependent electrical parameter [e.g. voltage or energy] and
`
`time during [a] discharging step,” and “adjusting a discharge parameter [e.g., phase dura-
`
`tion] based on a value of the monitored electrical parameter and the monitored time.” (Id. at
`
`8:17-21). This self-evident design choice–that is, monitoring decay voltage and time, and
`
`then adjusting discharge based on those factors–is the reason that the ‘978 Patent was al-
`
`lowed, and indeed was both the point of distinction asserted during prosecution, and the
`
`stated reason for allowance. (Notice of Allowability mailed 3/17/98 at p.134; LIFECOR978-
`
`1002). But, as established below, these exact same features were disclosed in the prior art
`
`nearly 20 years before the ‘978 patent was filed. (See, e.g., Bell at 4:30-42; LIFECOR978-
`
`1004).
`
`Claims
`B.
`The ‘978 patent discloses three different embodiments in which voltage is monitored
`
`over time (i.e., the “patient-dependent electrical parameter”) in addition to monitoring time,
`
`and both are used to “adjust[] a discharge parameter,” as required by all challenged claims.
`
`Specifically, the flowcharts of Figs. 3, 6, and 9 (relevant portions shown below) disclose var-
`
`iations on this same theme.
`
`13
`
`

`

`
`
`
`
`FIG. 3
`
`
`
` FIG. 6
`
`
`
`
`
` FIG. 9
`
`In the embodiment of FIG.3, discharge is stopped when a predetermined time dura-
`
`tion has lapsed, or when the measured voltage has decayed to a predetermined level,
`
`whichever occurs last. (‘978 Patent at 5:6-51; LIFECOR978-1001). In the embodiment of
`
`FIG. 6, discharge is stopped when a predetermined time duration has lapsed, or the meas-
`
`ured voltage has decayed to a predetermined level, whichever occurs first. (Id. at 5:52-
`
`6:2). As discussed below, this “whichever occurs first” embodiment was disclosed in Bell 20
`
`years prior to the ‘978 Patent. The embodiment of FIG. 9 is a combination approach in
`
`which time is monitored at step 91, but discharge continues until the measured voltage has
`
`decayed to a predetermined level. ([Id. at 6:3-37). Although the three embodiments vary in
`
`detail, all three share the common feature that both time and voltage are monitored and in-
`
`volved in determining when to stop discharging the defibrillator.
`
`Claims 1 and 6 of the ‘978 Patent–the independent claims–are genus claims in that
`
`they encompass all three embodiments. That is, claims 1 and 6, which recite “simultane-
`
`14
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`

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`ously monitoring a patient-dependent electrical parameter during the discharging step,” and
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`“adjusting a discharge parameter based on a value of the monitored electrical parameter
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`and the monitored time,” capture the common feature of all three embodiments, namely,
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`that both time and voltage are monitored and involved in determining when to terminate dis-
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`charge. The dependent claims of the ‘978 Patent recite well-known and trivial implementa-
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`tion details such as specifying that electrical parameter is a voltage source or a current
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`source (claims 3 and 4), and that the waveform is a truncated exponential biphasic wave-
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`form (claim 7).
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`In sum, it was well-known that the various waveform characteristics could be moni-
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`tored and modified to fine tune the extent and manner of applying electricity to a patient’s
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`heart during defibrillation. What the ‘978 Patent purports to have invented is merely a trivial
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`variant of the techniques that the ‘978 Patent admits are prior art. More importantly, as will
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`be discussed in detail below, the methods claimed in the ‘978 Patent had already been in-
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`vented by others–namely, by the inventors named in the prior art references relied on here-
`
`in.
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`C.
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`Summary of the Prosecution History of the ‘978 Patent
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`The application that became the ‘978 Patent was filed as a continuing application,
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`claiming priority to an application filed August 6, 1993, which is the parent application for all
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`of the Philips Waveform Patents. In the initial office action, the claims were rejected as ob-
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`vious in view of Pless (US 5,352,239). (‘978 Prosecution history; LIFECOR978-1002 at 65).
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`15
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`In a subsequent office action response, however, applicant persuaded the examiner that
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`Pless did not render obvious the claimed invention because Pless “does not suggest that a
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`multiphasic waveform with an earlier phase that is adjusted based on a value of a monitored
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`electrical parameter and a later phase with a fixed duration should be used to apply electro-
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`therapy to a patient.” (Id. at 96-97).
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`In the next office action, the examiner rejected the claims as anticipated by Kroll (US
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`5,431,686). (Id. at 101-102). In response, applicant canceled the rejected claims and re-
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`placed them with claims that were broader in some respects and narrower in other respects.
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`(Id. at 115). With regard to broadening, the rejected claims were directed to the embodi-
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`ment of FIG. 3, that is, the whichever-occurs-last embodiment. (See, e.g., id. at 116; recit-
`
`ing “adjusting step comprises discharging the energy source across the electrodes in the
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`earlier phase until the end of a predetermined time period and until the monitored electrical
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`parameter reaches a predetermined value.”) The new claims, however, did not include lan-
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`guage tying the claims to the embodiment of FIG. 3 but rather required only “adjusting a
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`discharge parameter based on a value of the monitored electrical parameter and the moni-
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`tored time,” thereby enlarging the scope of the claims to include all three embodiments.
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`(Id.) With regard to narrowing, the new claims included a new requirement of “simultane-
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`ously monitoring a patient-dependent electrical parameter and time during the discharge
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`step.” (Id.) In that regard, applicant argued that Kroll did not satisfy the “simultaneously
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`monitoring” limitation because Kroll purportedly “begins monitoring time only after the elec-
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`16
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`trical parameter has ceased being monitored.” (Id. at 117).
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`The application was subsequently allowed based on the following reasons for allow-
`
`ance:
`
`
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`(Id. at 135). The ‘978 Patent issued on November 17, 1998.
`
`VI.
`
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE IPR
`CLAIM OF THE ‘978 PATENT IS UNPATENTABLE
`The prior art relied on in this petition establishes a reasonable likelihood that one or
`
`more of the challenged claims are unpatentable. More specifically, the references demon-
`
`strate that, at the time the original application to which the ‘978 Patent claims priority was
`
`filed, it was well-known to monitor either or both of time and voltage during discharge, and
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`then use those monitored values to determine when to stop discharge. For example, as es-
`
`tablished by the claim charts below, Bell explicitly discloses simultaneously monitoring time
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`and monitoring voltage/current over time (i.e., monitoring a patient-dependent electrical pa-
`
`rameter) during discharge of the defibrillator, and using that information in making the deci-
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`sion about when to terminate discharge (i.e., adjusting a discharge parameter). (See, e.g.,
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`Bell at 3:5-9, 3:56, 4:15-19, 4:37-40; LIFECOR978-1004). And although the waveform in
`
`Bell is monophasic rather than multiphasic, it would have been obvious to a skilled artisan at
`
`17
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`the time to apply Bell’s teachings to a biphasic waveform, such as taught by Schuder 1984
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`(not of record in original prosecution) because of the increased effectiveness of biphasic
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`waveforms over monophasic waveforms. (McDaniel Declaration at ¶¶ 37-38; LIFECOR978-
`
`1003).
`
`Similar to Bell, Bach also demonstrates that it was known to simultaneously monitor
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`both time and a patient-dependent electrical parameter while delivering a multiphasic wave-
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`form, and then use that information to decide when to terminate discharge of the defibrillator.
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`(See, e.g., Bach at 2:25-58; LIFECOR978-1007). Bach also teaches adjusting current dur-
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`ing the multiphasic waveform. (See, e.g., Bach, 2:29-36). Since adjusting current neces-
`
`sarily includes adjusting voltage, as taught by Ohm’s law, Bach inherently discloses adjust-
`
`ing voltage. (McDaniel Declaration at ¶ 39; LIFECOR978–1003).
`
`The Kroll reference describes a defibrillation method involving (i) delivering electrical
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`energy to a patient until a certain amount of voltage decay is detected, and (ii) continuing to
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`deliver electrical energy to the patient for an additional predetermined time period after the
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`amount of voltage decay is detected. (See LIFECOR978-1006 (Kroll), 9:48-68; McDaniel
`
`Declaration at ¶ 40; LIFECOR978–1003).
`
`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
`
`18
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`comparing the claim language as construed under the above-ascribed claim interpretations,
`
`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
`
`
`
`1.
`
`[GROUND 1] – Claims 1, 3, 4, 5, 6, 7 are obvious under 35
`
`U.S.C. § 103 over Bell in view of Schuder 1984.
`
`As shown in the following claim chart, the combination of Bell and Schuder 1984
`
`teaches each and every limitation of claims 1, 3, 4, 5, 6, 7 of the ‘978 Patent, rendering
`
`those claims unpatentable under 35 U.S.C. § 103 as obvious.
`
`Reasons to combine Bell and Schuder 1984
`
`A person of ordinary skill in the art would have combined Bell and Schuder 1984 be-
`
`cause the combination amounts to the use of a known technique to improve a similar meth-
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`od in the same way. (See KSR v. Teleflex, 550 U.S. 398, 417 (2007)). Bell is directed to a
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`defibrillation method in which a monophasic waveform is delivered to a patient’s heart.
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`(LIFECOR978-1004 (Bell), Abstract). Bell further teaches that a timeout period can be used
`
`to limit the maximum duration of a pulse. (Id. at 4:15-18). Schuder 1984 describes a defib-
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`rillation technique that involves adding a second phase of opposite polarity to a mo