IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Gliner, et al.
`U.S. Patent No.: 5,749,905 Attorney Docket No.: 38855-0003IP1
`Issue Date:
`May 12, 1998
`Appl. Serial No.: 08/691,755
`Filing Date:
`August 2, 1996
`Title:
`ELECTROTHERAPY METHOD UTILIZING PATIENT-DEPENDENT
`ELECTRICAL PARAMETERS
`
`
`
`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. 5,749,905
`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) .............................................. 4 
`V. 
`SUMMARY OF THE ‘905 PATENT ............................................................................. 8 
`A.  Description ................................................................................................................. 8 
`B.  Summary of the Prosecution History of the ‘905 Patent ..................................... 11 
`VI. 
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE IPR CLAIM OF
`THE ‘905 PATENT IS UNPATENTABLE .................................................................. 13 
`VII.  MANNER OF APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`INTER PARTES REVIEW IS REQUESTED ............................................................. 20 
`A.  Rejections Based on Bell as Primary Reference.................................................. 20 
`1. 
`[GROUND 1] – Bell Anticipates Claim 1. .................................................. 20 
`2. 
`[GROUND 2] – Bell in view of Schuder renders obvious Claim 2. ........... 22 
`3. 
`[GROUND 3] – Bell in view of Schuder and Bach Render claims 4, 5, and
`7-11 Obvious ............................................................................................ 24 
`[GROUND 4] – Bell in view of Schuder and Ukkestad Render claims 3 and
`6 Obvious ................................................................................................. 32 
`B.  Rejections Based on Pless as Primary Reference ............................................... 34 
`1. 
`[GROUND 5] – Pless Anticipates claims 1, 2, 4, 5, and 7-11 .................. 34 
`2. 
`[GROUND 6] – Pless in view of Ukkestad Render Claims 3 and 6 Obvious
` .................................................................................................................. 40 
`C.  Obviousness-Type Double Patenting .................................................................... 41 
`1. 
`[GROUND 7] – Obviousness-Type Double Patenting Over Claim 1 of U.S.
`Patent 5,749,904 ...................................................................................... 41 
`[GROUND 8] – Obviousness-Type Double Patenting Over Claim 1 of U.S.
`Patent 5,607,454 ...................................................................................... 43 
`VIII.  CONCLUSION .......................................................................................................... 45 
`
`4. 
`
`2. 
`
`i
`
`

`

`EXHIBITS
`
`
`LIFECOR905-1001 U.S. Patent No. 5,749,905 to Bradford E. Gliner, et al. (“‘904
`Patent”)
`LIFECOR905-1002 Prosecution History of the ‘905 Patent
`LIFECOR905-1003 Declaration of Dr. Wayne McDaniel
`LIFECOR905-1004 U.S. Patent No. 3,862,636 to Bell (“Bell”)
`LIFECOR905-1005 U.S. Patent No. 4,850,357 to Bach (“Bach”)
`LIFECOR905-1006 U.S. Patent 5,749,904 to Bradford E. Gliner, et al. (“‘Gliner ‘904
`Patent”)
`LIFECOR905-1007 U.S. Patent No. 5,352,239 to Pless (“Pless”)
`LIFECOR905-1008 U.S. Patent No. 3,886,950 to Ukkestad (“Ukkestad”)
`LIFECOR905-1009 J.C. Schuder, et al., “Transthoracic Defibrillation of 100 KG
`Calves with Bidirectional Truncated Exponential Shocks,” Trans
`Am Soc. Artif. Intern. Organs, Vol. XXX (1984) (“Schuder”)
`LIFECOR905-1010 U.S. Patent No. 5,607,454 to Cameron et al. (“Cameron ‘454”)
`LIFECOR905-1011 Koninklijke Philips Electronics NV v. Defibtech LLC, Case No.
`C03-1322JLR, Order dated Dec. 21, 2005
`LIFECOR905-1012 Koninklijke Philips Electronics NV v. Cardiac Science, Inc., Civil
`No. 03-1064, Memorandum Opinion and Order dated Apr. 20,
`2006
`LIFECOR905-1013 American Heritage Dictionary (3d ed. 1992), p. 1167
`
`
`
`
`
`
`ii
`
`

`

`INTRODUCTION
`I.
`Petitioner 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 1-11 (“the IPR
`
`Claims”) of U.S. Patent No. 5,749,905 (“‘905 Patent”) of Bradford E. Gliner, et al. (“Patent-
`
`ee” 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 ‘905 Patent claims methods for delivering electrotherapy to a patient using a
`
`simple technique in which energy delivered to the heart is controlled based on a monitored
`
`patient-dependent electrical parameter (e.g., combinations of voltage, current, and charge
`
`over time). But the patent 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”; LIFECOR905-1004) and U.S. Patent 5,352,239 (“Pless”;
`
`LIFECOR905-1007) expressly disclose the feature that was asserted during prosecution to
`
`distinguish over the cited art, namely, “adjust[ing] energy delivered to the patient based on a
`
`value of an electrical parameter monitored during discharge.” (LIFECOR905-1002, Amend-
`
`ment filed 3/31/97 at 2; emphasis in original.) And the other claim limitations are taught ei-
`
`ther by Bell or Pless and/or another reference presented in this petition. Moreover, at least
`
`one of the claims in the ‘905 patent is invalid for obviousness-type double patenting over
`
`one or more other patents in the same family. Petitioner respectfully submits Inter Partes
`
`Review should be instituted, and the challenged claims be canceled as unpatentable.
`
`1
`
`

`

`II.
`
`MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1)
`A.
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(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 ‘905
`
`Patent. Petitioner has been named as a defendant in a litigation concerning the ‘905 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 In-
`
`ter Partes Review of other patents in that litigation, U.S. Patent Nos. 5,735,879 (“the ‘879
`
`Patent”); 5,749,904 (“the ‘904 Patent”); 6,047,212 (“the ‘212 Patent”); 5,607,454 (“the ‘454
`
`Patent”); 5,836,978 (“the ‘978 Patent”); 5,803,927 (“the ‘927 Patent”); and 5,593,427 (“the
`
`‘427 Patent”) (collectively, “the Philips Waveform Patents,” all of which are owned by Kon-
`
`inklijke Philips N.V. and/or Philips Electronics N. Am. 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:
`IPR38855-0003IP1@fr.com
`Phillips@fr.com
`
`
`BACKUP COUNSEL
`Dorothy Whelan, Reg. No. 33,814
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`T: 612-337-2509
`F: 877-769-7945
`Email:
`IPR38855-0003IP1@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-
`
`0003IP1@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 ‘905 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 ‘905 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
`
`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. [LIFECOR905-1003].
`
`3
`
`

`

`
`
`Ground
`Ground 1
`Ground 2
`
`‘905 Patent Claims
`1
`2
`
`Ground 3
`
`4, 5 and 7-11
`
`Ground 4
`
`3 and 6
`
`Basis for Rejection of the IPR Claims
`Anticipated under 35 U.S.C. § 102 over Bell
`Obvious under 35 U.S.C. § 103 over Bell in view of
`Schuder
`Obvious under 35 U.S.C. § 103 over Bell and Schuder
`in view of Bach
`Obvious under 35 U.S.C. § 103 over Bell and Schuder
`in view of Ukkestad
`Ground 5 1, 2, 4, 5, and 7-11 Anticipated under 35 U.S.C. § 102 by Pless
`Ground 6
`3 and 6
`Obvious under 35 U.S.C. § 103 over Pless in view of
`Ukkestad
`Obviousness-type Double Patenting over claim 1 of
`U.S. Patent 5,749,904
`Obviousness-Type Double Patenting over claim 1 of
`U.S. Patent 5,607,454
`The ‘905 Patent issued from an application claiming priority to August 6, 1993. Ac-
`
`Ground 7
`
`Ground 8
`
`1
`
`4
`
`cordingly, Bell is prior art under 35 U.S.C. § 102(b), having issued on January 1, 1974.
`
`Pless is prior art under at least 35 U.S.C. § 102(e), having been filed on March 24, 1993.
`
`Schuder is prior art under 35 U.S.C. § 102(b), having been published in 1984. Ukkestad is
`
`prior art under 35 U.S.C. § 102(b), having issued on June 3, 1975. The ‘904 patent is
`
`properly-applied for obviousness-type double patenting, have been filed July 31, 1996 (be-
`
`fore the application for the ‘905 patent was filed) and having common inventors. The prior
`
`art references were each cited, and thus made of record, but only Bell and Bach were relied
`
`on by the examiner, and are being presented in a new light here.
`
`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
`
`4
`
`

`

`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
`
`as understood by a person of ordinary skill in the art in question at the time of the invention).
`
`In determining the ordinary and custom meaning, the words of a claim are first given their
`
`plain meaning. Id. According to Phillips, the structure of the claims may breathe additional
`
`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. Moreo-
`
`ver, Phillips offers that even treatises and dictionaries may be used, albeit under limited cir-
`
`cumstances, 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
`
` “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. [LIFECOR905-1013]. This construction is consistent with the ‘904 patent’s specifica-
`
`tion. For example, claim 1 recites “monitoring a patient-dependent electrical parame-
`
`5
`
`

`

`ter.” Support for this feature appears in the specification, among other places, in FIGs. 3, 6,
`
`and 9, which illustrate three different embodiments (relevant portions shown below):
`
`
`
`As can be seen in these 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 “VOLTAGE < VTHRESH” is satisfied.
`
` “energy source”
`For purposes of this Petition, the term “energy source” is construed 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 orders 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 [LIFECOR905-1011].
`
`6
`
`

`

` “patient-dependent electrical parameter”
`For purposes of this Petition, the term “patient-dependent electrical parameter” is
`
`construed as “one or more electrical values, such as voltage, current, charge, etc. that var-
`
`ies 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 con-
`
`sistent 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 proceedings. See Koninklijke Philips Electronics NV v. Defibtech LLC, Case No. C03-
`
`1322JLR, Order dated Dec. 21, 2005, at 11. [LIFECOR 905-1011]
`
` “multiphasic (truncated exponential) waveform”
`For purposes of this Petition, the term “multiphasic (truncated exponential) wave-
`
`form” is construed as “a defibrillation shock having 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 har-
`
`monious with constructions offered by Patentee during 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 [LIFECOR905-1012].
`
` “shaping”
`For purposes of this Petition, the term “shaping” is construed as “selecting appropri-
`
`ate waveform parameters, for example, by adjusting the duration, tilt, and/or total delivered
`
`7
`
`

`

`energy of one or more phases of the waveform.” This construction is consistent with the
`
`‘904 Patent’s specification. See, e.g., ‘904 Patent at 9:27-35 (“By controlling the waveform
`
`shape, the system controls the duration, tilt and total delivered energy of the waveform.”).
`
`V.
`
`SUMMARY OF THE ‘905 PATENT
`
`A.
`
`Description
`
`Generally, the ‘905 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. [‘905 Patent at 1:7-20]. 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 ‘905 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 1:51-55]. 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 ‘905 Patent below. [Id.; see also Declaration of Dr. Wayne McDaniel at 35
`
`(LIFECOR905-1003). ].
`
`8
`
`

`

`Phase 1
`
`Phase 2
`
`
`
`This waveform is “biphasic”—i.e., Phase 1, during which voltage is applied for duration E,
`
`and Phase 2, during which voltage (using the opposite polarity) is applied for duration F.
`
`The gently decreasing curve results from the natural “exponential decay” in the voltage from
`
`the capacitor as it drains. The waveform is “truncated” in that, at the end of each phase (at
`
`terminal voltage B for Phase 1, and terminal voltage D for Phase 2), the flow is cut off ab-
`
`ruptly rather than being allowed to decay smoothly all the way down to zero voltage. 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
`
`‘905 Patent. [Id.].
`
`Also well-known before the ‘905 Patent was the fact that different patients possessed
`
`different impedance levels—that is, a measure of the resistance to electrical current passing
`
`through the patients’ torsos. [Id. at 2:3-31]. Therefore, as a consequence of basic physical
`
`laws, upon being subjected to electricity of a given waveform, patients with higher imped-
`
`9
`
`

`

`ance receive less electrical energy than patients with lower impedance, all other factors be-
`
`ing 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 ter-
`
`minal voltage (e.g., “B” in FIG 1.), thereby delivering a maximized amount of electrical ener-
`
`gy to each patient, regardless of the patient’s impedance value. [Id.]. In other words, the
`
`‘905 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, by truncating an applied
`
`waveform (i.e., stopping the discharge of the capacitor). [See also Declaration of Dr.
`
`Wayne McDaniel at 26-34 (LIFECOR905-1003)].
`
`Given all this admitted prior art set forth in the ‘905 Patent’s Background section, the
`
`purported invention recited by the claims is simple and straightforward, namely, stopping
`
`capacitor discharge based on a value of a monitored patient-dependent electrical parameter
`
`(e.g., certain combinations of voltage, current, time, and charge). [‘905 Patent at 7:54 to
`
`8:6]. But, as established below, this exact same feature was disclosed in the prior art nearly
`
`20 years before the ‘904 Patent was filed. [See, e.g., Bell at 3:5-11 (LIFECOR905-1004);
`
`Pless (LIFECOR905-1007)].
`
`Other aspects of the ‘905 Patent’s claims include using a plurality of capacitors, such
`
`using more than one capacitor in place of a single capacitor. But that too was well-known in
`
`electrical engineering generally and with defibrillators more specifically. [See, e.g.,
`
`Ukkestad at Abstract (LIFECOR905-1008)]. Yet other claims speak of an initial parameter
`
`10
`
`

`

`or ending parameter of a waveform being voltage or current. [‘905 Patent at 8:16-54] But
`
`the ‘905 Patent admitted that it was known in the art to alter the shape of a defibrillation
`
`shock based on a monitored impedance (which the patent identifies via voltage and cur-
`
`rent), and the prior art cited below reinforces that point. [‘904 Patent at 2:64-3:16.].
`
`In sum, it was well-known that the various waveform characteristics could be modi-
`
`fied, such as based on monitoring of the delivered waveform, to fine tune the extent and
`
`manner of applying electricity to a patient’s heart during defibrillations. What the ‘905 Pa-
`
`tent claims to have invented is merely a trivial variant of the techniques that the ‘905 Patent
`
`admits are prior art. More importantly, as will be discussed in detail below, the methods
`
`claimed in the ‘905 Patent had already been invented by others—namely, by the inventors
`
`named in the prior art relied on herein.
`
`B.
`
`Summary of the Prosecution History of the ‘905 Patent
`
`The ‘905 Patent, filed August 2, 1996, is a continuation of a patent application filed
`
`August 6, 1993. The Applicant filed a Preliminary Amendment the same day, adding new
`
`claims 35-45, and cancelling the prior claims. An Office Action dated December 30, 1996,
`
`rejected all pending claims as: (a) anticipated by U.S. Patent 3,862,636 to Bell; (b) antici-
`
`pated by U.S. Patent 4,850,357 to Bach; (c) obvious over a combination of Bach and
`
`5,183,562 to de Coriolis; (d) obvious over Bach alone; or (e) invalid for obviousness-type
`
`double patenting over co-pending Application No. 08/601,234 (now U.S. Patent 5,601,612)..
`
`[See LIFECOR904-1002]
`
`11
`
`

`

`In a March 31, 1997, “Request for Reconsideration,” the Applicant asserted that Bell
`
`selected an energy dose “prior to delivery of the shock,” and thus did not “adjust energy de-
`
`livered … during discharge.” Such response, however, merged features from the separate
`
`“monitoring” and “adjusting” limitations in the pending claims so as to confuse the meaning
`
`of the claims, as described below.
`
`For the Bach anticipation rejections, Applicant asserted that Bach was a constant-tilt
`
`system with fixed ending parameters, and thus did not meet the claim requirement of “ad-
`
`justing energy based on a value of a monitored electrical parameter” or “shaping a wave-
`
`form so that an ending parameter of a waveform phase depends on a value of the electrical
`
`parameter.” [Id. (emphasis in original).]. Again, though, that argument merged the “moni-
`
`toring” and “adjusting”/”shaping” limitations in a way that improperly rewrote the claims, as
`
`discussed in more detail below. Applicant referred to those same arguments with respect
`
`to the prior art obviousness rejections.
`
`Notably, Applicants did not question the Office on two points: (a) about the combina-
`
`tion of de Coriolis (teaching multiple capacitors) with Bell, or (b) about the “interrelation of
`
`current and voltage [being] well-known in the field of electronics,” and thus supporting
`
`claims that recite those items as an initial parameter. [Id.] With respect to the double-
`
`patenting rejection, Applicants did not dispute that the applied claims rendered the target
`
`claims unpatentable, but instead asserted that the Office could not look to the patent speci-
`
`fication, and that terminal disclaimers should not be required post-GATT (under which all
`
`12
`
`

`

`patents in a family typically expire on the same date). However, Applicant showed a will-
`
`ingness to file a terminal disclaimer. [Id.]
`
`In a second Office Action dated November 3, 1997, the Office repeated the double
`
`patenting rejection, noting that it had, in fact, applied claims-against-claims, and that GATT
`
`did not change the requirement to file a terminal disclaimer. But the Office withdrew the
`
`other rejections, saying only that it “concurs with the applicants’ reasoning.” [Id.] The Appli-
`
`cants then provided a terminal disclaimer, which notably referenced only U.S. Patent
`
`5,601,612, and no other of Applicant’s then-issued or pending patents (such as that refer-
`
`enced in the obviousness-type double patenting argument below). The Office issued a No-
`
`tice of Allowance and the ‘905 Patent issued.
`
`VI.
`
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE IPR
`CLAIM OF THE ‘905 PATENT IS UNPATENTABLE
`As detailed below and in the following claim charts, prior art references show that in-
`
`dependent claims 1, 4, and 9, and their dependent claims are unpatentable, and each and
`
`every feature of the IPR claims is met by one or combinations of the references cited in this
`
`petition. As such, there is a reasonable likelihood that at least one of the challenged claims
`
`is unpatentable.
`
`Referring to Ground 1 (charted below), Bell discloses a defibrillator 10 having a pair
`
`of electrodes or paddles 14 and 16 engageable with a patient to deliver electrotherapy to a
`
`patient by discharging an energy source (capacitors) across the electrodes [Bell at 2:5-24,
`
`FIGs. 1 and 2 (LIFECOR905-1004)]:
`
`13
`
`

`

`
`
`Bell also discloses that a patient-dependent electrical parameter is monitored via both a
`
`“current monitor 28” and a “voltage monitor 26” fed into a computer and control 34 that
`
`computes energy. (Bell at 3:5-9). Bell further teaches adjusting energy delivered to the pa-
`
`tient based on a value of the electrical parameter, as it notes that, by its monitoring “[w]hen
`
`the computer [sic, computed] energy equals the selected energy, the computer causes the
`
`energy source to be disconnected from the patient.” [Bell at Abstract; see also Bell at 3:9-
`
`11]. Thus, Bell discloses all the features of claim 1. [Declaration of Dr. Wayne McDaniel at
`
`37-39 (LIFECOR905-1003)].
`
`Patent Owner had distinguished Bell during prosecution by arguing that “the Bell de-
`
`vice does not adjust energy delivered to the patient based on a value of an electrical pa-
`
`rameter monitored during discharge.” Such argument suggested that Bell had to adjust the
`
`amount of energy to be delivered during discharge, but instead, the wording of claim 1 co-
`
`vers Bell’s monitoring of energy over time during discharge and adjustment of that parame-
`
`14
`
`

`

`ter before discharge. And in any event, Bell monitors and adjusts voltage and energy during
`
`discharge so as to match delivery to the particular patient, which is exactly what the ‘905
`
`patent teaches. [E.g., Declaration of Dr. Wayne McDaniel at 37-39 (LIFECOR905-1003)].
`
`Referring to Ground 2 (charted below) applicable to dependent claim 2, Bell disclos-
`
`es all of the limitations of base claim 1. Both Bell and Schuder (LIFECOR905-1009) dis-
`
`close energy sources that are capacitors, and Schuder discloses a multiphasic waveform.
`
`Though Bell and its disclosure of a monophasic waveform were relatively early (around
`
`1974), by the time of Schuder in 1984, and definitely by the 1993 priority date of the ‘905
`
`patent, the benefits of a multiphasic waveform were well-known, and included beneficial ef-
`
`ficacy caused by the interaction of the positive and negative phase in a patient’s tissue.
`
`[Declaration of Dr. Wayne McDaniel at 40 (LIFECOR905-1003)]. Thus, a skilled artisan
`
`working with the control scheme of Bell would have been readily motivated to use it with a
`
`multiphasic waveform like that disclosed in Schuder. [Id.] As such, there is a reasonable
`
`likelihood that claims 1-2 of the ‘905 Patent are unpatentable based on Bell in view of
`
`Schuder.
`
`
`
`Referring to Ground 3 (charted below) applicable to claims 4, 5, and 7-11, Bell dis-
`
`closes a defibrillator 10 having a pair of electrodes 14 and 16 connected to energy source
`
`(capacitors 22) for delivering electrotherapy (a defibrillating shock) to a patient, applicable to
`
`independent claim 4. [Bell at 2:5-24, FIGs. 1 and 2 (LIFECOR905-1004).]. Bell also dis-
`
`closes discharging the energy source to deliver electric energy, and as noted above,
`
`15
`
`

`

`Schuder discloses doing so in a multiphasic waveform. [Bell at Abstract and 2:5-13;
`
`Schuder at p., Fig. 1.]. Bell also discloses that a patient-dependent electrical parameter is
`
`monitored via both a “current monitor 28” and a “voltage monitor 26” over time and fed into
`
`a “computer and control 34” that computes energy. [Bell at 3:5-9.]. Bach teaches shaping
`
`the waveform so that an initial parameter of a waveform phase depends on the value of the
`
`electrical parameter, because it discloses a second voltage (Vpk2) that starts the second
`
`phase begins at “50 to 95% of Vpk1,” which is the peak voltage of the first phase. [Bach at
`
`2:1-22]. Thus, the initial voltage of the second phase depends on voltage in the first phase.
`
`As such, the combination of Bell, Schuder, and Bach teaches every limitation of claim 4.
`
`The motivation to use the multiphasic waveform of Schuder with the control scheme of Bell
`
`is discussed above. A skilled artisan would further be motivated to have an initial parameter
`
`of the second phase depends on the electrical parameter, so as to provide the therapeutic
`
`benefit of the relationship between the two phases identified in Bach. [Declaration of Dr.
`
`Wayne McDaniel at 43-45 (LIFECOR905-1003)].
`
`With respect to independent claim 9, it is similar to claim 4, though it expressly re-
`
`cites a multiphasic waveform and recites shaping so that an ending parameter of a wave-
`
`form phase (as opposed to a starting parameter in claim 4) depends on a value of the elec-
`
`trical parameter. But Bach (LIFECOR905-1005) discloses such a feature because its de-
`
`vice signals its control circuit 16 “[w]hen the output voltage at electrode 10 falls to a suitable
`
`low level” as part of its “timed stimulation to the electronic switches.” [Bach at 2:54-58
`
`16
`
`

`

`(LIFECOR905-1005)]. Thus, claim 9 marks nothing extra over claim 4. The dependent
`
`claims recite discharging a capacitor in a multiphasic waveform (discussed above for claim
`
`2), and the parameter being voltage (claims 7 and 10) or current (claims 8 and 11). But as
`
`just noted, Bach teaches an initial parameter of voltage, and current corresponds directly to
`
`voltage (via Ohm’s law)—a point that the original Examiner made and that Applicant did not
`
`challenge. Therefore, there is a reasonable likelihood that claims 4, 5, and 7-11 ‘905 Patent
`
`are unpatentable based on Bell.
`
`Referring to Ground 4 (charted below), applicable to claims 3 and 6, the claims simp-
`
`ly add that there are a plurality of capacitors delivering a multiphasic waveform. The pres-
`
`ence of and motivation to employ the multiphasic waveform of Schuder are discussed
`
`above. The use of multiple capacitors in place of a single capacitor is well known in electri-
`
`cal engineering in general, and also well-known with defibrillators, as was indicated by the
`
`Office’s earlier use of the multi-capacitor de Coriolis reference as a secondary reference to
`
`reject these claims during original prosecution, and Applicant’s failure to challenge such
`
`combination. Moreover, the Ukkestad reference also discloses multiple capacitors, and
`
`substituting multiple capacitors for one capacitor would be nothing more than an obvious
`
`design choice. [Declaration of Dr. Wayne McDaniel at 46 (LIFECOR905-1003)].
`
`Referring to Ground 5 (charted below), applicable to claims 1, 2, 4, 5, and 7-11,
`
`Pless discloses delivering electrotherapy to a patient by discharging an energy source
`
`across electrodes. [Pless, at Abstract (LIFECOR905-1007).]. Pless also discloses that a
`
`17
`
`

`

`patient-dependent electrical parameter is monitored via a “voltage detector 220” that checks
`
`decay in capacitor voltage over time so as to determine when to terminate a positive pulse
`
`of a waveform. [Pless at 6:28-39.]. Pless further teaches adjusting energy delivered to the
`
`patient based on a value of the electrical parameter, as it notes that when voltage “decays
`
`to 220 volts” a voltage detector