Boston Scientific Corporationv.UAB Research Foundation

Patent Trial and Appeal Board

Oct 19, 2015

09391026 (P.T.A.B. Oct. 19, 2015)

Trials@uspto.gov Paper 9
Tel: 571-272-7822 Entered: October 19, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

BOSTON SCIENTIFIC CORPORATION,
Petitioner,
v.
UAB RESEARCH FOUNDATION,
Patent Owner.

Case IPR2015-01038
Patent 6,266,563 B1

Before PHILLIP J. KAUFFMAN, BENJAMIN D. M. WOOD, and
JAMES A. WORTH, Administrative Patent Judges.

WORTH, Administrative Patent Judge.
DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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I. INTRODUCTION
Petitioner, Boston Scientific Corporation (“Boston Scientific”), filed a
Petition (Paper 1, “Pet.”) requesting inter partes review of claims 1–20 of
U.S. Patent No. 6,266,563 B1 (“the ’563 patent,” Ex. 1001). Patent Owner,
UAB Research Foundation (“UAB”), filed a Preliminary Response (Paper 8,
“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314.
To institute an inter partes review, we must determine that the
argument and evidence presented in the Petition shows “a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set
forth below, we do not institute an inter partes review for the challenged
claims.
A. Related Matters
Petitioner identifies the following district court proceeding as a related
matter: The Board of Trustees of the University of Alabama at Birmingham
v. Boston Scientific Corp., No. 2:14-cv-01800 (N.D. Ala.) (filed Sept. 22,
2014). Pet. 1; Paper 4, 2.
B. The ’563 Patent (Ex. 1001)
The ’563 patent is titled “Method and Apparatus for Treating Cardiac
Arrhythmia,” and relates to an implantable system for the antitachycardia
pacing of the heart of a patient in need of such treatment. Ex. 1001, at [54],
[57]. One of the problems in the art of implantable defibrillators is that
conversion thresholds increase with time, such that therapy is terminated
after four separate attempts at defibrillation. Id. at 1:37–40. At the same
time, it is desirable to lower shock strength in order to reduce the size of the
implantable device and of its capacitor. Id. at 1:19–22.
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The ’563 patent discloses an implantable defibrillator comprising “a
plurality of primary electrodes, at least one auxiliary electrode, a power
supply, and a control circuit.” Id. at 4:12–15. The power supply may
include a 20–400 microfarad capacitor. Id. at 8:5–6. The electrodes are
depicted in Figure 1, below:

As shown in Figure 1, Electrode A (50) is positioned in the superior vena
cava or innominate vein, electrode B (51) is positioned in the right ventricle,
electrode C (52) is positioned within a vein on the posterolateral surface of
the left ventricle (e.g., the posterior cardiac vein or great cardiac vein), and
the external portion of the device’s housing (16) serves as electrode D. Id. at
Fig. 1, 6:62–7:2.
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The electrodes are configured for delivering a defibrillation pulse or
primary pulse that may be from 5 or 10 Joules to 30, 40, or 50 Joules. See
id. at 6:5–15, 8:58–60. The electrodes also are configured for delivering an
auxiliary pulse from 0.01 or 0.05 to 1 or 2 Joules, simultaneous with or in
sequential relationship to the defibrillation pulse. Id. at 4:21–23, 8:57–58,
13:51–60. Although the Specification refers to pulses as “primary” or
“auxiliary,” this distinction appears to refer to function and not structure in
that each of the electrodes may deliver either primary or auxiliary pulses.
Ex. 1001, Tables 1–4. The ’563 patent discloses that certain dual shock
treatments lowered the defibrillation threshold. Id. at 18:24–26. Various
pairings of electrodes may be employed for the primary and auxiliary pulses.
See id., Tables 1–5.
The ’563 patent also discloses that “[t]he antitachycardia pacing may
be delivered from the primary electrode placed through the coronary sinus
ostium and within a vein on the surface of the left ventricle alone, or may be
coupled to or yolked to an additional electrode, such as an electrode
positioned in the right ventricle.” Id. at 6:5–15.
C. Illustrative Claims
Claims 1, 7, and 14 are independent claims. Claim 1, reproduced
below, is illustrative of the subject matter at issue.
1. An implantable system for the delivery of
antitachycardia pacing to a patient's heart, comprising:
a plurality of primary stimulation electrodes configured
for sensing cardice [sic] signals and delivering antitachycardia
pacing to said heart;
a first one of said primary stimulation electrodes
configured for positioning through the coronary sinus ostium
and within a vein on the surface of the left ventricle of said
heart;
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a power supply; and
a control circuit operatively associated with said power
supply and said primary stimulation electrodes, said control
circuit configured for delivering antitachycardia pacing through
said primary stimulation electrodes;
wherein said control circuit includes a capacitor.

D. The Alleged Grounds of Unpatentability
Petitioner contends that claims 1–20 are unpatentable on the following
grounds:
Reference Basis Claims challenged
Nickolls1, Adams2, and the knowledge of a
person of ordinary skill in the art
§ 103 1–20

II. ANALYSIS
A. Claim Construction
Petitioner proposed constructions of “antitachycardia pacing” and
“control circuit.” Pet. 8. Patent Owner disputes the construction of
“antitachycardia pacing.” Prelim. Resp. 4–5.
We determine that none of the terms in the challenged claims requires
express construction for purposes of this Decision in order to resolve the
issues presented by the Petition. See Vivid Techs., Inc. v. Am. Sci. & Eng’g,
Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).

1 Nickolls, U.S. Patent No. 5,181,511, iss. Jan. 26, 1993 (Ex. 1009).
2 Adams, U.S. Patent No. 5,433,729, iss. July 18, 1995 (Ex. 1010).
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B. Obviousness over Nickolls (Ex. 1009), Adams (Ex. 1010),
and the Knowledge of a Person of Ordinary Skill in the Art
Relying on the Declaration of David G. Benditt (Ex. 1006), Petitioner
contends that Nickolls, Adams, and the knowledge of a person of ordinary
skill in the art at the time of the invention would have rendered obvious
claims 1–20. Pet. 22–60. Patent Owner disagrees. Prelim. Resp. 11–19.
For the reasons that follow, we determine that Petitioner has not
established a reasonable likelihood of prevailing on its assertion with respect
to claims 1–20.
1. Overview of Nickolls
Nickolls discloses an apparatus and method for antitachycardia pacing
(“ATP”) using a virtual electrode, in which three or more electrodes are
connected to create a virtual electrode at the focus site upon delivery of the
therapy to the heart based on the relative distances of the electrodes from the
focus site. Ex. 1009, at [54], [57]. The disclosure states “the term ‘virtual
electrode’ refers to an electric field the strength of which is above the
stimulation threshold of adjacent cardiac tissue,” and is “created by applying
suitable voltages to two or more electrodes, and a zero voltage to a reference
electrode.” Id. at 5:52–58.
A determination is made as to which sensing electrodes are nearest the
site of the tachycardia by identifying which electrodes register the earliest
fiducial points on an electrocardiogram, i.e., peaks, points of maximum
slope, and inflections. Id. at 6:29–38. The ATP therapy is in the form of
simultaneous pacing waves which approach the focus site from different
directions, effectively from all sides if the selected electrodes surround the
site, otherwise from a point or line or area near the site. Id. at 6:25–30. The
system delivers therapy to the atria or the ventricles. Id. at 6:65–7:2.
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The leads are preferably anchored to the right free wall of the heart,
the apex or the right ventricle of the heart, the right septal wall of the heart,
and the high right atrium of the heart. Id. at 10:66–11:5. In addition, leads
may be epicardial or subcutaneous patches. Id. at 11:61–65.
2. Overview of Adams
Adams, titled “Atrial Defibrillator, Lead Systems, and Method,”
discloses a fully automated implantable atrial defibrillator for delivering a
pulse of defibrillating electrical energy to the atria of a human heart,
cardioversion, and bradycardia pacing. Ex. 1010, 1:1–3, 1:12–27. The
system conserves battery power by activating the atrial fibrillation detector
only when the ventricular rate indicates a probability of atrial fibrillation.
Id. at 2:41–45.
The atrial defibrillator uses an endocardial lead “at locations which
minimize the energy which must be delivered to the atria for cardioverting
or defibrillating” the atria. Id. at 2:55–59. The system and method “assures
that the delivered electrical energy is confined to the atria and little of the
electrical energy is passed through the ventricles.” Id. at 2:45–50.

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An exemplary embodiment is depicted below in Figure 9:

Figure 9 illustrates the placement of the leads with electrodes. As relevant
to this proceeding, the system is composed of sense electrodes and
electrodes capable of providing defibrillation placed in specific locations
after being fed through specific veins:
The first lead 252 carries or includes a first elongated,
large surface area, electrode 256, a distal or tip sense electrode
258, and a ring or proximal sense electrode 260. The electrodes
258, 260, and 256 are spaced apart on the lead 252 so that,
when lead 252 is fed into the superior vena cava 20 and into the
right ventricle 12 through the right atrium 16 to a position
where electrode 258 is at the apex of the right ventricle, the first
elongated electrode 256 will be disposed in and in electrical
contact with the right atrium 16 of the heart 10. Also, electrodes
258 and 260 will be in electrical contact with the right ventricle
of the heart 10.
The second lead 254 includes a second elongated, large
surface area, electrode 262, a tip or distal sense electrode 264,
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and a ring or proximal sense electrode 266. The electrodes 264,
266, and 262 are spaced apart on the second lead 254 so that
when the lead 254 is fed into the superior vena cava 20 and into
a coronary vein, such as the great vein 23 through the right
atrium 16 and the coronary sinus 22 with electrodes 264 and
266 being adjacent the left ventricle within the great vein as
illustrated, the second elongated electrode 262 will be disposed
within the coronary sinus 22 just beneath the left atrium 18 and
adjacent to the left ventricle 14. Since the coronary sinus 22 is
in close proximity to the left atrium 18 and the left ventricle 14,
electrodes 264 and 266 will be in electrical contact with the left
ventricle and electrode 262 will be in electrical contact with the
left atrium 18.

Id. at 15:47–16:7.
3. Analysis
Petitioner contends that claims 1–20 are obvious over Nickolls,
Adams, and the knowledge of a person of ordinary skill in the art. In the
Petition, Petitioner alleges how each limitation of the claims would be
understood to be disclosed by the combination of Nickolls, Adams, and the
knowledge of a person of ordinary skill in the art, and that such a
combination would have been obvious to a person of ordinary skill in the art.
Pet. 22–60.
As with the parties, we focus our analysis on the following limitation:
“a first one of said primary [stimulation] electrodes configured for
positioning through the coronary sinus ostium and within a vein on the
surface of the left ventricle of said heart,” as recited by independent claims
1, 7, and 14, where the electrodes are “configured for . . . delivering
antitachycardia pacing.” Petitioner relies on a combination of teachings for
this limitation. Pet. 25–29, 35, 41. Specifically, Petitioner asserts that
Nickolls discloses the delivery of antitachycardia pacing to the left ventricle
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via a patch electrode on the epicardial surface of the left ventricle or
subcutaneously over the left ventricle. Pet. 26 (citing Ex. 1009, 10:63–65,
5:59–64; Ex. 1006 ¶ 240). Petitioner further asserts that Adams discloses a
transvenous epicardial lead to deliver pacing to a comparable location as that
of the electrode of Nickolls, and contends that a person of ordinary skill in
the art would have been motivated to apply this teaching to the implantable
system of Nickolls to avoid an invasive surgical procedure or the other
disadvantages of a patch electrode. Id. at 26–28 (citing Ex. 1006 ¶¶ 201–16,
242, 245–247; Ex. 1010, 4:67–68, 5:28–34, 15:62–16:7, Fig. 9).
Patent Owner argues that Adams “explicitly discourages” placement
of a stimulation electrode on the surface of the left ventricle when Adams
“explains that the disclosed defibrillator is specifically designed to confine
the delivery of electrical energy to the atria and avoid the delivery of
electrical energy to the ventricles.” Prelim. Resp. 14–16 (citing Ex. 1010,
2:45–50, 2:17–23, 5:48–61, 14:27–31, 17:61–64). On this basis, Patent
Owner urges that Adams teaches away from the invention of the ’563 patent.
Id. at 15–16 (citing Optivus Tech., Inc. v. Ion Beam Applications S.A., 469
F.3d 978, 989 (Fed. Cir. 2006) (“A reference may be said to teach away
when a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference. . . .”)).
We disagree with Patent Owner’s assertion that Adams broadly
teaches away from providing electrical energy to the ventricles inasmuch as
Adams explicitly discloses providing bradycardia pacing to the right
ventricle. Ex. 1010, 7:12–17, 7:39–46, 8:7–19. However, we agree with
Patent Owner that Adams discloses that the delivery of atrial defibrillation is
directed to the atria in such a manner as to minimize delivery of electrical
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energy to the ventricles during the atrial defibrillation, i.e., in order to reduce
the risk of inducing ventricular fibrillation. Ex. 1010, 1:21–24, 2:17–23.
Whether or not there is a teaching away, Patent Owner argues that
Adams does not suggest placement of an electrode on the left ventricle for
the purpose of delivering ATP, and that the reason advanced by Petitioner
for the combination of Nickolls and Adams is conclusory. Prelim. Resp. 16–
17.3 Indeed, we agree with Patent Owner that Adams’s electrodes [264 and
266] which are adjacent, and in contact with, the left ventricle are sense
electrodes. See Prelim. Resp. 14 (citing Ex. 1005, 119); Ex. 1010, 15:60–62,
16:4–6. Petitioner contends that “[o]ne of ordinary skill in the art would
have also recognized that modifying Nickolls with the transvenous lead and
electrode(s) from Adams would result in those electrodes being configured

3 Patent Owner also requests assignor estoppel against Petitioner for arguing
during prosecution that Adams does not render obvious the claims of the
’563 patent. See Prelim. Resp. 1–2, 17–19 (relying on TorPharm, Inc. v.
Ranbaxy Pharms., Inc., 336 F.3d 1322, 1329 (Fed. Cir. 2003)). However,
we understand TorPharm to encourage the reviewing tribunal to make a
finding as to the patentability of the claims despite previous contrary
positions taken by a patentee. See id. (“a court’s responsibility is not to
speculate what a particular examiner would or would not have done in light
of the new information, but rather to assess independently the validity of the
claim against the prior art under section 102 or section 103.”). Further, the
USPTO as a creature of statute does not have a provision for considering
such an equitable estoppel. See, e.g., Esselte Corp. v. Dymo B.V.B.A., Case
IPR2015-00766, slip. op. at 19–20 (PTAB Aug. 28, 2015) (Paper 14); see
also Esselte Corp. v. Dymo, Case IPR2015-00779, slip op. at 4–7 (PTAB
Aug. 28, 2015) (Paper 13), Case IPR2015-00781, slip op. at 4–7 (PTAB
Aug. 28, 2015) (Paper 13); Dot Hill Systems Corp. v. Crossroads Systems,
Inc., Case IPR2015-00822, slip op. at 7–8 (PTAB Sept. 17, 2015) (Paper
18).
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for sensing cardiac signals and delivering antitachycardia pacing.” Pet. 28
(citing Ex. 1006 ¶ 246).
We agree with the Patent Owner that Petitioner does not explain why
a person of ordinary skill in the art would have looked to the atrial
defibrillator of Adams for placement of leads for antitachycardia pacing to
the left ventricle. Although Adams discloses pacing to the right ventricle in
the context of bradycardia, and discloses sense electrodes on the left
ventricle, that does not necessarily suggest the placement of leads for
delivery of energy to the left ventricle. The fact that sense electrodes were
known in the art does not explain why a person of ordinary skill in the art
would have performed the combination of electrodes in this manner for the
delivery of energy to the left ventricle, or would have looked to Adams for
the placement of leads to deliver energy to that location.
Relying on the Declaration of Dr. Benditt, Petitioner contends that
Nickolls would have informed the placement of electrodes for the delivery
of energy to the left ventricle (Pet. 28 (citing Ex. 1006 ¶¶ 201–216, 245–
47)), but that again begs the question as to why a person of ordinary skill
would then have looked to Adams for the placement of electrodes for
delivering energy. Further, Petitioner does not present sufficient evidence
that it would have been predictable to substitute the transvenously-placed
lead and electrode of Adams for the lead and patch electrode of Nickolls.
See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (“a court must
ask whether the improvement is more than the predictable use of prior art
elements according to their established functions.”). Having reviewed the
Declaration, we agree with Patent Owner that Petitioner’s reasoning for the
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combination of references is conclusory and does not state a reasonable
likelihood of prevailing on its assertion of obviousness.

III. CONCLUSION
We determine that Petitioner has not established a reasonable
likelihood of prevailing on its assertion with respect to claims 1–20.
IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
review is not instituted.

PETITIONER:

Jason Kraus
Brian Oberst
FAEGRE BAKER DANIELS LLP
jason.kraus@faegrebd.com
brian.oberst@faegrebd.com

PATENT OWNER:
Peter D. Siddoway
Lance A. Lawson
Lynne A. Borchers
Anthony P. DeRosa
MYERS BIGEL SIBLEY & SAJOVEC, P.A.
psiddoway@myersbigel.com
llawson@myersbigel.com
jsteen@myersbigel.com