Boston Scientific Corporationv.UAB Research Foundation

Patent Trial and Appeal Board

Sep 24, 2015

09391026 (P.T.A.B. Sep. 24, 2015)

Trials@uspto.gov Paper 10
Tel: 571-272-7822 Entered: September 24, 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 IPR2015-00918
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 9,
“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: (1) 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. Related Applications
The ’563 patent issued on July 24, 2001 from Application No.
09/391,026 (filed Sept. 7, 1999), which is a continuation-in-part of
Application No. 09/039,143, now U.S. Patent No. 5,978,705 (“the ’705
patent”), which in turn is a continuation-in-part of Application No.
08/818,261 (filed Mar. 14, 1997) (“the ’261 Application,” Ex. 1002), now
abandoned. Ex. 1001, at [63].
E. The Alleged Grounds of Unpatentability
Petitioner contends that claims 1–20 are unpatentable on the following
grounds:
Reference Basis Claims challenged
KenKnight ’9671 § 102(b) 1–20

II. ANALYSIS
A. Claim Construction
We determine that none of the terms in the challenged claims requires
express construction at this time, as neither of the parties has requested
construction of claim language for institution.

1 KenKnight, U.S. Patent No. 5,797,967, iss. Aug. 25, 1998 (Ex. 1008).
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B. Anticipation over KenKnight ’967 (Ex. 1008)
Relying on the Declaration of David G. Benditt (Ex. 1006), Petitioner
contends that KenKnight ’967 anticipates claims 1–20. Pet. 25–58.
Petitioner contends that KenKnight ’967 is prior art to the ’563 patent based
on Petitioner’s argument that the ’563 patent does not derive priority from
the ’261 Application. Id. at 14–19. Patent Owner disagrees. Prelim. Resp.
11–37.
For the reasons that follow, we determine that KenKnight ’967 is not
prior art to the ’563 patent, and therefore does not anticipate the claims of
the ’563 patent.
1. Overview of KenKnight ’967
KenKnight ’967 discloses a hybrid antitacharrhythmia therapy of
pacing therapy (optionally followed by reduced-strength defibrillation) and
defibrillation therapy. Ex. 1008, at [57]. The two therapies are applied in
either a temporally coincident, or an immediately sequential fashion. Id.
According to KenKnight ’967, “slow, monomorphic, hemodynamically
stable ventricular tachyarrhythmia (VT) may be treated with pacing (~40
microjoule) therapies, e.g., antitachyarrhythmia pacing (ATP), while fast,
polymorphic, hemodynamically unstable rhythms may be treated with low
strength (0.05–2 Joules) shocks followed by higher strength (2–40 Joules)
shocks if earlier interventions fail.” Id. at 1:54–60.
2. The ’261 Application
As with the ’563 patent, the ’261 Application contains the following
statement of use:
The present invention may be used to treat all forms of
cardiac tachyarrythmias, including ventricular fibrillation, with
defibrillation (including cardioversion) shocks or pulses. The
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treatment of polymorphic ventricular tachycardia and
ventricular fibrillation are particularly preferred.

Ex. 1002, 7:4–9; accord Ex. 1001, 1:14–16. As with the ’563 patent, the
’261 Application sets forth the positioning of the electrodes as follows:
As illustrated in Figure 1, the system includes an
electrode A; 50 that resides in the superior vena cava or
innominate vein, an electrode B; 51 positioned in the right
ventricle, and an electrode C; 52 positioned within a vein on the
postero lateral surface of the left ventricle. The active external
portion of the housing 16 serves as a fourth electrode D.

Ex. 1002 at 9:3–9; accord Ex. 1001, 6:62–7:2. As with the ’563 patent, the
’261 Application discloses that “[t]he energy of the auxiliary pulse may be
from .01 or .05 to 1 or 2 Joules. The energy of the defibrillation pulse may
be from 5 or 10 Joules to 30, 40 or 50 Joules.” Ex. 1002, 12:30–32; accord
Ex. 1001, 4:21–23, 6:5–15, 8:57–60, 13:51–60.
3. Analysis
A patent that arises from an application that is a continuation-in-part
of a parent application may benefit from the filing date of the earlier
application so long as the disclosure of the earlier application meets the
requirements of 35 U.S.C. § 112, ¶ 1, including the written description
requirement. Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1326
(Fed. Cir. 2008). To meet the requirements thereof, the disclosure of the
earlier application must convey with reasonable clarity to those skilled in the
art that the inventor was in possession of the invention, as of the filing date
sought. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir.
1991). “[W]hile the description requirement does not demand any particular
form of disclosure, or that the specification recite the claimed invention in
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haec verba, a description that merely renders the invention obvious does not
satisfy the requirement.” Ariad Pharma., Inc. v. Eli Lilly and Co., 598 F.3d
1336, 1352 (Fed. Cir. 2010) (en banc) (internal citations omitted).
Petitioner argues that the ’563 patent added new subject matter
directed to antitachycardia pacing and is not entitled to a filing date earlier
than its September 7, 1999 filing date. Pet. 14–19. In support thereof,
Petitioner includes a chart setting forth certain differences between the ’705
patent (which issued from the ’261 Application) and the ’563 patent. Id. at
14–18. Petitioner also relies on the Declaration of Dr. Benditt in support of
its assertion that the ’563 patent “constituted the first time the inventors
described and disclosed using antitachycardia pacing, including a control
circuit configured for delivering antitachycardia pacing.” Id. at 17–18
(citing Ex. 1006 ¶¶ 178–185). Petitioner does not add further argument with
respect thereto.
Patent Owner asserts that “[a]s a whole, the ’261 application discloses
a device for the treatment of cardiac tachyarrhythmias via multiple therapies,
including defibrillation, auxiliary pulsing, and pacing.” Prelim. Resp. 13.
Patent Owner further asserts that by treating tachyarrhythmias, the device
disclosed in the ’261 Application “by definition could treat both tachycardia
and fibrillation.” Id. Patent Owner relates that it was understood such an
implantable device would provide “tiered therapy,” and that the “use of
these ‘tiered therapy’ devices was well known in the art.” Id. (citing Ex.
2004; Ex. 1006 ¶ 46; Ex. 2002, 2038).
We agree with Patent Owner, and we determine that the ’261
Application sets forth a device “configured for” “delivering antitachycardia
pacing to said heart,” as recited by independent claims 1, 7, and 14.
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Petitioner has not persuaded us that the ’261 Application fails to disclose the
claimed structure. Indeed, the ’261 Application discloses the same
configuration of electrodes that deliver electrical impulses of the same
energy and characteristics as the ’563 patent. Ex. 1002, 9:3–9, 12:30–32,
Fig. 1. As noted by Patent Owner, the ’261 Application makes plain that it
is directed to the treatment of “all forms of cardiac tachyarrythmias,”
including “ventricular tachycardia.” See id. at 7:4–9.2
Petitioner further observes that the ’563 patent contains additional
language, not contained in the ’261 Application, which states 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 [sic] to an additional
electrode, such as an electrode positioned in the right ventricle.” Pet. 17–18
and Table (quoting Ex. 1001, 6:5–15). However, written description support
need not be in haec verba. As set forth above, the examples provided in the
’261 Application and ’563 patent describe primary and auxiliary pulses,
where the energy of the auxiliary pulse may be from .01 or .05 to 1 or 2
Joules. Ex. 1001, 12:30–32. As explained by Petitioner’s declarant, it was
understood in 1996 that a typical pacing pulse would have been .025 Joules
(25 µJ), whereas cardioversion pulses would be 1–15 Joules, and
defibrillation pulses would be even higher energies. Ex. 1006 (Benditt
Decl.) ¶¶ 66–67 (citing Ex. 1011; Ex. 1015). Thus, the auxiliary pulses of
the ’261 Application have the same energy as pacing pulses (.01 or .05

2 Page 11 (original page number) of the ’261 Application appears to be
missing from Ex. 1002.
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Joules) or cardioversion pulses (1 or 2 Joules), and the device is configured
to deliver either.3
The claims at issue recite “a plurality of primary stimulation
electrodes,” and do not differentiate among those electrodes as to the
delivery of primary pulses or auxiliary pulses. Indeed, as explained above,
the same electrodes (A, B, C, or D) may be used to deliver auxiliary or
primary pulses depending on the instance. See Ex. 1002, Tables 1–4;
Ex. 1001, Tables 1–4. In this connection, the ’261 Application describes “a
plurality of primary stimulation electrodes” that are configured to deliver
pulses having the same energy as antitachycardia pacing pulses, as recited
by claims 1–20 of the ’563 patent.
Further, we agree with Patent Owner (Prelim. Resp. 14) that the ’261
Application also discloses the use of “pace/sense” electrode 54, which can
be located proximal or distal to primary electrode 53 on lead 23. See
Ex. 1002, 15:17–20, 27–29, Fig. 6. The ’261 Application describes the
placement of electrode 53 [electrode E] as follows:
the beneficial effects are augmented by placing an additional
electrode E; 53 on endocardial transvenous elongate lead 23 in
the area of the heart experiencing the weakest electric field
when electrode C; 52 is present. The weak field area in this
location is in the region of the right ventricular conus.

3 We note, in this regard, the 1990 scientific article relied on by Patent
Owner for the knowledge of a person of ordinary skill in the art at the time
of the invention (see Prelim. Resp. 13), which explains that “[t]he ideal
implantable antitachycardia device should be capable of several modes of
therapy including antitachycardia pacing, low-energy cardioversion, and
high-energy defibrillation,” and that the device would deliver a particular
therapy based upon the device’s ability to detect and differentiate ventricular
tachycardia from ventricular fibrillation. Ex. 2002, 2038–39.
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Specifically, the electrode E can be located within the right
atrial appendage or the right ventricular outflow track.

Ex. 1002, 15:1–9. Thus, the ’261 Application uses the term “pace” with
respect to electrode E, indicating that the disclosed system was intended to
provide “[p]acing and sensing capability” when the system is “configured to
monitor electrical rhythm activity in both atrial and ventricular chambers.”
Id. at 16:1–5. For all of these reasons, we determine that Petitioner has not
demonstrated that it is reasonably likely to prevail in showing that the ’261
Application fails to provide adequate written-description support for the
’563 patent claims.
III. CONCLUSION
We determine that the ’563 patent may benefit from the filing date of
the ’261 Application, and that KenKnight ’967 is not prior art to the ’563
patent.
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.

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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