Neuro and Cardiac Technologies, LLC

Patent Trials and Appeals Board

May 18, 2020

IPR2019-00264 (P.T.A.B. May. 18, 2020)

Trials@uspto.gov Paper 32
Tel: 571-272-7822 Date: May 18, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

LIVANOVA, INC., and LIVANOVA USA, INC.,
Petitioner,

v.

NEURO AND CARDIAC TECHNOLOGIES, LLC,
Patent Owner.
_______________

IPR2019-00264
Patent 7,076,307 B2
_______________

Before GRACE KARAFFA OBERMANN, SHERIDAN K. SNEDDEN,
and ELIZABETH M. ROESEL, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
35 U.S.C. § 328(a)

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I. INTRODUCTION
This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a)
and 37 C.F.R. § 42.73. Petitioner bears the burden of proving
unpatentability of the challenged claims, and that burden of persuasion never
shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
800 F.3d 1375, 1378 (Fed. Cir. 2015). The evidentiary standard is a
preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
For the reasons that follow, we determine that Petitioner has
established by a preponderance of the evidence that claims 1–12 and 18–28
of Patent No. 7,076,307 B2 (Ex. 1001, “the ’307 patent”) are unpatentable.
A. Procedural Background
Petitioner filed a Petition requesting inter partes review of claims 1–
12 and 18–28 (“the challenged claims”) of the ’307 patent. Paper 1 (“Pet.”).
Patent Owner filed a Patent Owner Preliminary Response. Paper 6. Upon
consideration of the information presented in the Petition and the
Preliminary Response, we instituted an inter partes review of claims 1–12
and 18–28 of the ’307 patent on each ground of unpatentability set forth in
the Petition.
Subsequently, Patent Owner filed a Patent Owner Response
(Paper 15; “PO Resp.”), Petitioner filed a Reply (Paper 20; “Reply”), and
Patent Owner filed a Sur-Reply (Paper 25; “Sur-Reply”).
The Petition is supported by the Declaration of Richard T. Mihran,
Ph.D. Ex. 1003. Patent Owner relies on the Declaration of Shivanand
(Nandan) Lad, M.D., Ph.D. (Ex. 2021).
Oral argument was conducted on February 25, 2020. A transcript is
entered as Paper 31 (“Tr.”).
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We address herein the arguments and evidence set forth in the Papers
to the extent necessary to resolve the dispute between the parties.
B. The ’307 patent (Ex. 1001)
The ’307 patent discloses a method and system for neuromodulating
vagus nerve(s) to provide therapy for neurological and neuropsychiatric
disorders, which comprises implantable and external components. Ex. 1001,
Abstract. The claimed subject matter relates to a programmable implantable
pulse generator (“IPG”). Id. at 32:63–36:34.
Figure 34 of the ’307 patent is reproduced below:

Figure 34 depicts a “simplified block diagram of the implantable pulse
generator.” Id. at 9:44–45. The ’307 patent discloses that the pulse
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generator “is preferably a microprocessor based device, where the entire
circuitry is encased in a hermetically sealed titanium can.” Id. at 20:46–48.
The system provides “electrical pulses that are delivered to electrodes 61, 62
via a lead 40.” Id. at 20:51–52. The external programmer 85 communicates
with the implanted device via bi-directional inductive telemetry to provide
activation, programming, and selection of predetermined/pre-packaged
programs. Id. at 20:52–57, 25:60–28:23, Figs. 45–52.
The memory contained within the implanted pulse generator stores
“pre-determined/pre-packaged” programs for vagus nerve therapy, which
“comprise unique combinations of pulse amplitude, pulse width, pulse
frequency, ON-time and OFF-time.” Id. at 20:58–64. Table 4 of the ’307
patent is reproduced below.

Id. at 21:1–12. Table 4 provides an example of parameters that may be
included in a predetermined/pre-packaged program, and lists pulse
amplitude, pulse width, frequency, ON-time, and OFF-time as such
parameters.
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Figures 26A and 26B of the ’307 patent are reproduced below.

Figures 26A and 26B illustrate aspects of the pulse characteristics, including
the “on time” and “off time” parameters. Ex. 1001, 9:23–26, 15:13–17,
Figs. 26A, 26B. As discussed in the corresponding text, “on time” and “off
time,” in the context of vagus nerve stimulation (“VNS”) therapy, refer to a
therapy procedure wherein the signal is ramped up and ramped down rather
than abruptly turned on and off. In particular, the ’307 patent provides as
follows:
The pulses delivered to the nerve tissue for stimulation
therapy are shown graphically in FIG. 26A. As shown in FIG
26B, for patient comfort when the electrical stimulation is turned
on, the electrical stimulation is ramped up and ramped down,
instead of abrupt delivery of electrical pulses.
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Id. at 15:13–17; see also id. at 25:15–20 (“The purpose of the ramping-up is
to avoid sudden changes in stimulation, when the pulse train begins.”).
Column 19 of the ’307 patent discloses several tables providing
examples of stimulation parameters used to deliver different stimulation
states to the vagus nerves, such as a low or high stimulation state. One such
table is reproduced below.

Ex. 1001, 19:33–37. The table describes the “on time” and “off time”
parameters in the context of repeating cycles. Id.
C. Illustrative Claim
Independent claims 1 and 18, reproduced below, are illustrative of the
challenged claims:1
[1.0] 1. A method of providing electrical pulses to a vagus
nerve(s) of a patient for treating or alleviating the
symptoms of at least one of neurological,
neuropsychiatric, and obesity disorders, comprising the
steps of:

[1.1] providing a microprocessor based implanted pulse
generator, wherein said pulse generator comprises
microprocessor, circuitry, memory, and power source;

1 In the interest of consistency and clarity, we adopt the Petitioner’s
annotation to refer to the claim elements of the independent claims. Pet. 46–
74.
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[1.2] providing at least two predetermined/pre-packaged
programs of neuromodulation therapy stored in memory
of said implantable pulse generator, wherein said
predetermined/pre-packaged programs define
neuromodulation parameters of pulse amplitude, pulse-
width, pulse frequency, on-time and off-time;

[1.3] providing an implanted lead in electrical contact with
said implanted pulse generator; wherein said implanted
lead comprising at least one electrode adapted to be in
contact with said vagus nerve(s);

[1.4] providing programmer means for activating and/or
programming said implanted pulse generator, wherein
bi-directional inductive telemetry is used to exchange
data with said implanted pulse generator; and

[1.5] selectively choosing between at least two
predetermined/pre-packaged program and activating said
selected program.
[18.0] 18. A system for providing electrical pulses to a vagus
nerve(s) of a patient for treating or alleviating the
symptoms of at least one of neurological,
neuropsychiatric, and obesity disorders, comprising:

[18.1] an implantable pulse generator comprising
microprocessor, circuitry, memory, and power source;

[18.2] at least two predetermined/pre-packaged programs of
stimulation therapy stored in said memory to control said
electrical pulses emitted by said implantable pulse
generator, wherein said predetermined/pre-packaged
programs define neuromodulation parameters of pulse
amplitude, pulse-width, pulse frequency, on-time and
off-time;

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[18.3] an implantable lead in electrical contact with said
implantable pulse generator wherein said lead
comprising at least one electrode adapted to be in contact
with said vagus nerve(s); and

[18.4] means for activating and/or programming said
implantable pulse generator, wherein bi-directional
inductive telemetry is used to exchange data with said
implantable pulse generator.

D. Asserted Prior Art
The Petition identifies the following references as prior art in the
grounds of unpatentability:
Ex. 1011, John G. Webster, Design of Cardiac Pacemakers, IEEE
Press (1995) (selected pages) (“Webster”).
Ex. 1013, Michael T. Lee, U.S. Patent No. 6,442,432 B2, issued Aug.
27, 2002 (“Lee”).
Ex. 1016, P. Meadows et al., U.S. Patent No. 6,381,496 B1, issued
Apr. 30, 2002 (“Meadows”).
Ex. 1046, P. Rutecki et al., U.S. Patent No. 5,330,515, issued July 19,
1994 (“Rutecki”).
Ex. 1051, Salmons, S. et al., ASIC or PIC? Implantable stimulators
based on semi-custom CMOS technology or low-power
microcontroller architecture, 23 MEDICAL ENGINEERING & PHYSICS
37–43 (2001) (“Salmons”).
E. Asserted Grounds of Unpatentability
We instituted review of claims 1–12 and 18–28 of the ’307 patent as
follows.
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Claims 35 U.S.C. §2 Reference(s)/Basis
1–5, 7–12, and 18–28 103(a) Meadows, Rutecki, and Webster
6 103(a) Meadows, Rutecki, Webster, and Lee
1–5, 7–12, and 18–28 103(a) Meadows, Rutecki, Webster, and Salmons
6 103(a) Meadows, Rutecki, Webster, Salmons, and Lee

II. ANALYSIS
A. Person of Ordinary Skill in the Art
Petitioner asserts that a person of ordinary skill in the art
would have had a bachelor’s degree in electrical engineering,
biomedical engineering, or similar field, and two to three years
of experience in devices and systems utilized for neuro- and/or
neuromuscular stimulation, or equivalent. Furthermore, a person
with more technical education but less experience could also
meet the relevant standard for POSITAs.
Pet. 7.
Patent Owner asserts that a person of ordinary skill in the art
would have had a bachelor’s degree in electrical engineering,
biomedical engineering, or a similar field, and two or three years
of experience in devices and systems utilized for
neuromodulation, or equivalent. Additionally, a person with
more technical education but less experience could also meet the
relevant standard.

2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
Stat. 284, 287–88 (2011), amended 35 U.S.C. §§ 102 and 103. Because the
’307 patent was filed before March 16, 2013 (the effective date of the
relevant amendment), the pre-AIA version of § 103 applies.
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PO Resp. 28–29 (citing Ex. 2021 ¶ 169). Patent Owner contends that its
proposed “definition is similar to Petitioner’s definition but omits the
specific reference to ‘neuromuscular’ experience.” Id. at 29.
Having considered the parties’ positions and evidence of record,
summarized above, we agree with Patent Owner that the claims are directed
to methods of neuromodulation and agree that the definition of a person of
ordinary skill in the art is likewise appropriately limited to those persons
having the relevant education and expertise in devices and systems utilized
for neuromodulation, or equivalent. Accordingly, we adopt Patent Owner’s
definition of a POSA for the purposes of this decision. That said, we discern
no appreciable difference in the respective definitions of a POSA as that
definition relates to the dispositive issues of this case, discussed below.
Furthermore, in view of the above definition, and based on their
statements of experience and qualifications, we find that Dr. Mihran and
Dr. Lad both are qualified to opine about the perspective of a person of
ordinary skill in the art at the time of the invention. See Ex. 1004
(Dr. Mihran’s curriculum vitae); Ex. 2022 (Dr. Lad’s curriculum vitae).
B. Claim Construction
For petitions filed before November 13, 2018, such as the case here,3
we interpret the claims of an unexpired patent that will not expire before

3 The Petition was filed on November 12, 2018. The Final Rule changing
the claim construction standard does not apply here, as the Petition was filed
before the effective date of the Final Rule, November 13, 2018. See
Changes to the Claim Construction Standard for Interpreting Claims in Trial
Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340,
51,340, 51,344 (Oct. 11, 2018).
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issuance of a final written decision using the broadest reasonable
interpretation in light of the specification. See 37 C.F.R. § 42.100(b) (2018);
Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under
the broadest reasonable construction standard, claim terms are presumed to
have their ordinary and customary meaning, as would be understood by one
of ordinary skill in the art in the context of the entire disclosure. In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special
definitions for claim terms must be set forth with reasonable clarity,
deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
1994).
Only terms that are in controversy need to be construed, and then only
to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am.
Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); Nidec Motor Corp. v.
Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
(applying Vivid Techs. in the context of an inter partes review).
1. “on-time and off-time”
Each of independent claims 1 and 18 recite “at least two
predetermined/pre-packaged programs” and provide that the
“predetermined/pre-packaged programs define neuromodulation parameters
of pulse amplitude, pulse-width, pulse frequency, on-time and off-time.” In
the Petition, Petitioner does not offer a construction for “on-time and off-
time.” Pet. 18–29.
In its Response, Patent Owner contends that, “when properly
construed, the meaning of ‘on-time and off-time’ in the challenged claims is
critical to a full understanding of the invention and helps explain why a
POSITA would not combine Meadows and Rutecki as Petitioner proposes.”
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PO Resp. 27. To that point, Patent Owner contends that the Specification
discloses that “‘on-time and off-time’ in the context of VNS therapy refer to
a duty cycle within a prolonged, intermittent therapy procedure, wherein the
signal is ramped up and ramped down rather than abruptly turned on and
off.” Id. To support that contention, Patent Owner directs us to the
following disclosure in the Specification:
The pulses delivered to the nerve tissue for stimulation therapy
are shown graphically in FIG. 26A. As shown in FIG 26B, for
patient comfort when the electrical stimulation is turned on, the
electrical stimulation is ramped up and ramped down, instead of
abrupt delivery of electrical pulses.
Id. (quoting Ex. 1001, 15:13–17). Thus, according to Patent Owner, “the
plain and ordinary meaning of ‘on-time and off-time’ in the challenged
claims is a duty cycle within a prolonged, intermittent therapy procedure,
wherein the signal is ramped up and ramped down rather than abruptly
turned on and off.” Id. at 28.
In its Reply, Petitioner responds that “there is a relevant embodiment
in the ’307 Patent that differentiates a ramping parameter from ‘on-time’ and
‘off-time’ and illustrates ramping as a programmable variable that can be set
to ‘off,’ or no ramping.” Reply 5 (citing Ex. 1001, 21:1–13 (Table 4)).
Table 4 is reproduced (with highlighting added) below:
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Table 4 is entitled “Programmable Implantable Pulse Generator (IPG)” and
is described in the Specification as follows:
These pre-packaged/pre-determined programs comprise unique
combinations of pulse amplitude, pulse width, pulse frequency,
ON-time and OFF-time.
. . . The range of programmable electrical stimulation
parameters are shown in table 4 below.”
Ex. 1001, 20:62–67. Thus, according to Petitioner, the Specification
discloses “On-time” and “Off-time” parameters and, additionally, an
optional independent “Ramp” parameter that may be set to “ON/OFF.”
Reply 6–7 (citing Ex. 1055, 223:23–224:23).
Furthermore, Petitioner contends that the claims do not require a
“duty cycle” because
the claim terms “on-time and off-time” refer to parameters in a
“program,” and ranges of those parameters are illustrated in
Table 4 as having values up to 24 hours each. “On-time” and
“off-time” refer to no more than time intervals in a given
measurement period (e.g., one day) and do not impliedly require
a repeating cycle within a 24-hour period.
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Id. at 9. Thus, according to Petitioner, the terms “on-time and off-time” do
not require “a duty cycle within a prolonged, intermittent therapy
procedure.” Id. at 7.
In its Sur-Reply, Patent Owner contends as follows with regard to the
meaning of “on-time and off-time” in the context of the ’307 patent:
[W]hile the specification suggests a limited situation where
ramping might optionally be turned off, the testimony of Dr. Lad
was that a POSITA would understand that the “on-time and off-
time” of the ’307 Patent claims would typically include the
ramping functionality. See Exhibit 2021 at ¶¶ 88–93, 115–16,
136–44.
Sur-Reply 4.
Patent Owner acknowledges that the term “duty cycle” is not used in
the Specification, but contends that:
Regardless of the specific terminology used in the ’307 Patent
specification, the concept of repeating cycles of on-time and off-
time within a treatment session, which is what duty cycle is, is
certainly taught in the ’307 Patent. See, e.g., ’307 Patent at
19:30–65, Figures 26A and 42. . . . Petitioner’s argument that
the claims do not literally recite a “duty cycle” is unavailing, as
the therapy procedures disclosed in the specification are recited
as VNS therapy procedures, which operate according to a duty
cycle (as described in the ’307 Patent).
Sur-Reply 4 (citing Exhibit 2021 ¶¶ 89–90, 136–44).
Having considered the parties positions and evidence of record,
summarized above, we determine as follows. First, we agree with Petitioner
that the Specification does not support Patent Owner’s contention that the
terms “on-time” and “off-time” encompass the concept of a ramp, wherein
“the signal is ramped up and ramped down rather than abruptly turned on
and off.” PO Resp. 27. The Specification expressly discloses a “ramp” as a
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parameter that is distinct from on-time and off-time parameters. Reply 5
(citing Ex. 1001, 21:1–13 (Table 4)).
Second, we determine that the recited “on-time” and “off-time”
parameters, together, may define a repeatable treatment period within a
prolonged, intermittent therapy procedure, or, in other words, a “duty cycle.”
PO Resp. 27–28. That is, in the context of the ’307 patent, “on-time” and
“off-time” refer to time intervals within a given treatment period, and the
presence of both an “on-time” and “off-time” implies a repeatable cycle
within any given therapy procedure. In this regard, we note that the
Specification describes various parameters, such as on-time and off-time, for
VNS therapy for the treatment of neurological and neuropsychiatric
disorders. Ex. 1001, 20:58–64, Figures 26A–26B. For example, Table 4
shows that the “on-time” and “off-time” parameters can take values between
5 seconds and 24 hours, thereby describing VNS treatments as including
repeating cycles of on-time and off-time. Ex. 1001, 21:1–13 (Table 4); see
also, Ex. 1001, 19:30–39 (“20 sec. on-time and 2.0 min. off-time in
repeating cycles.”), 19:40–47 (“1.5 min. on-time and 20.0 min. off-time in
repeating cycles.”), 19:48–56 (“1.5 min. on-time and 20.0 min. off-time in
repeating cycles.”), 19:58–65 (“2.0 min. on-time and 20.0 min. off-time in
repeating cycles.”).
The preambles of claims 1 and 18 recite “providing electrical pulses
to a vagus nerve(s) of a patient for treating or alleviating the symptoms of at
least one of neurological, neuropsychiatric, and obesity disorders,”
demonstrating that VNS therapy is the appropriate context for defining “on-
time and off-time.” Ex. 1001, 32:64–67, 35:6–9. On this point, we credit
Dr. Lad’s testimony that the concept of duty cycle is important in VNS
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therapy, the focus of the ’307 patent, because it provides “a cumulative
therapy whose effects are felt over time rather than immediately, and
because prolonged excitation of the vagus nerve without an off time will
damage the nerve.” Ex. 2021 ¶¶ 88–89.
Thus, the evidence of record supports a determination that “on-time”
and “off-time” are expressly recited parameters that require a non-zero value
to ensure the effective delivery of VNS therapy and, therefore, together,
define a duty cycle. To the extent further discussion of the meaning of this
term is necessary to our decision, we provide that discussion below in our
analysis of the asserted grounds of unpatentability.
2. Other Recited Claim Terms/Phrases
Petitioner advances proposed constructions for the following phrases
recited in the claims: “providing programmer means for activating and/or
programming said implanted pulse generator, wherein bi-directional
inductive telemetry is used to exchange data with said implanted pulse
generator” (claim 1); “means for activating and/or programming said
implantable pulse generator, wherein bi-directional inductive telemetry is
used to exchange data with said implantable pulse generator” (claim 18);
“telemetry means for remote device interrogation and/or programming over
a wide area network” (claim 6); and “telemetry means to remotely control
said predetermined program(s)” (claim 21). Pet. 19–29.
Patent Owner does not challenge those proposed constructions in its
Preliminary Response. See PO Resp. 26 (“Patent Owner agrees to the claim
constructions for those four terms proposed in the Petition.”).
For the purposes of this decision, we adopt Petitioner’s claim
constructions for the above-mentioned phrases recited in the challenged
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claims because those constructions are not disputed and are supported by the
Specification as well as the plain language of the claims.
C. Petitioner’s Patentability Challenges
A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations, including: (1) the scope and content of the prior art;
(2) any differences between the claimed subject matter and the prior art; (3)
the level of skill in the art; and (4) objective evidence of nonobviousness,
i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1,
17–18 (1966).
We analyze the instituted grounds of unpatentability in accordance
with the above-stated principles.
1. Ground 1: Obviousness of Claims 1–5, 7–12, and 18–28 over
the Combination of Meadows, Rutecki, and Webster
a. Summary of References Relied Upon
i. Meadows
Meadows discloses a spinal cord stimulation (“SCS”) system or other
programmable implant device. Ex. 1016, 1:12–15. The SCS of Meadows
“includes several components, ranging from implantable and external
components, surgical tools, and software.” Id. at 1:14–16.
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Figure 1 of Meadows is reproduced below.

Ex. 1016, Fig. 1. Figure 1 is a block diagram that illustrates the various
implantable, external, and surgical components of a representative SCS
system of Meadows. Id. at 4:60–65. In that embodiment, the components of
the invention are subdivided into three broad categories: “(1) implantable
components 10, (2) external components 20, and (3) surgical components
30.” Id. at 6:2–4 (emphasis omitted). The implantable components 10
include implantable pulse generator (IPG) 100, electrode array 110, and
extension 120. Id. at 6:5–8. Extension 120 is used to electrically connect
electrode array 110 to IPG 100. Id.
Meadows discloses that the SCS “treats chronic pain by providing
electrical stimulation pulses from an electrode array placed epidurally near a
patient’s spinal cord.” Ex. 1016, 1:12–15. The “electrode array” is
described as a series of up to sixteen separate electrodes for connection to
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various locations along the spinal cord. Id. at 6:31–62. The separate
electrodes provide simultaneous treatment to a number of locations along the
spinal cord. Id. at 17:11–15. Meadows discloses that “providing multiple
stimulation channels” allows the system “to address variable stimulation
parameter requirements and multiple sites of electrical stimulation signal
delivery.” Id. at 2:25–28. In contrast, Meadows discloses that existing SCS
systems had “only a single stimulation channel, which must be multiplexed
in a fixed pattern to up to four electrode contacts,” or had “only one voltage
source, and hence only a single stimulation channel, for delivery of the
current stimulus to multiple electrodes through a multiplexer.” Id. at 2:35–
37, 2:41–44.
Meadows also discusses the need “for the patient to readily make
appropriate changes to the operating parameters of an implant device so long
as such operating parameter changes maintain the device operation within
safe operating limits.” Ex. 1016, 2:65–3:1. In that regard, Meadows
discloses that the SCS system has the ability to perform “context switching,”
which is defined in Meadows as “changing one set of operational parameters
to another” for the multiple spinal cord electrodes. Id. at 3:8–10. Moreover,
Meadows discloses that the operational parameter sets (OPSs) may be
selected by a patient. Id. at 1:9–20; see also id. at Abstract (“The patient
may swap the current set of operational parameters with another set of
operational parameters.”). The ability to change the operational parameter
set may be achieved by including memory circuitry within the implant
device wherein a plurality of OPSs are stored. Id. at Abstract. Meadows
discloses that “[w]hen the patient wishes to change the OPS, he manually
activates the appropriate controls on the hand-held programming device, and
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such activation causes the new OPS to be telemetered to the implant device,
where it replaces the current OPS.” Id.
Figure 6 of Meadows is reproduced below:

Figure 6 “depicts a functional block diagram of a portion of an implant
device . . . and functionally illustrates one manner in which different
operational parameter sets may be selected for use by the implant device.”
Id. at 5:16–18. As shown in Figure 6, the “operational parameters” of
Meadows may include “pulse width (PW) . . . pulse rate (PR), pulse
amplitude (PA), electrode configuration (EC), ramp rate (RR), treatment
times (TT), a first other parameter (P1), and a second other parameter (P2).”
Id. at 17:6–10.
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ii. Rutecki
Rutecki is directed to “techniques for treating painful syndromes in
patients by selective electrical stimulation of vagus nerve afferent fiber
activity with an implanted neurostimulating device.” Ex. 1046, 1:11–15; see
also id. at 6:26–29 (The neurostimulator is “preferably but not necessarily
implantable in the patient.”). Specifically, Rutecki discloses as follows:
Selective stimulation of the vagal afferents for treating and
controlling pain according to the invention is performed using a
neurostimulator, which is preferably but not necessarily
implantable in the patient. The therapy is delivered from a pulse
generator of the neurostimulator to a nerve electrode array
implanted on the patient’s vagus nerve to appropriately modulate
the electrical activity of the nerve. The neurostimulator is
programmed by the attending physician to provide the desired
therapeutic modality for that purpose.
Id. at 6:26–35. Stimulation is delivered to the vagus nerve “above the point
where the pain sensation is most pronounced to the patient.” Id. at 7:1–5. In
particular, treatment is performed “by selectively applying a pulse wave
form to a lead/electrode implanted on the patient’s cervical vagus nerve or
other site preferably above the location of the pain to stimulate afferent
fibers for activating a descending anti-nociceptive pathway and thereby
blocking incoming pain signals.” Id. at Abstract.
Rutecki discloses that the pulse waveform has programmable
functions, which include “output current or voltage, output signal frequency,
output signal pulse width, output signal on-time, output signal off-time,
daily treatment time for continuous or periodic modulation of vagal activity,
and output signal-start delay time.” Id. at Abstract, 10:32–38. “The
programmed pulse sequences are applied to the implanted electrode either
on a continuous basis, or only during the period the patient is normally
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awake, or is initiated by the patient or automatically in response to the onset
of pain.” Id. at Abstract.
iii. Webster
Webster, a textbook, is relied on by Petitioner for general teachings
related to the implementation of programmable pacemakers. Ex. 1011, 33.
Webster describes a “programmer” as “an external device which
communicates programming and telemetry information with the
pacemaker.” Id. Webster further discloses that
a bidirectional communications link can . . . be used to
relay data collected from sensors in the patient or pacemaker.
This process is called telemetry. Although programming and
telemetry are different pacemaker functions—putting data in
versus getting data out—they share much of their hardware and
theory of operation.
Id.
b. Petitioner’s Challenge
Petitioner asserts that claims 1–5, 7–12, and 18–28 are unpatentable
under 35 U.S.C. § 103 as obvious over the combination of Meadows,
Rutecki, and Webster. Pet. 32–74. In support of its assertion that the
combination of Meadows, Rutecki, and Webster renders those challenged
claims obvious, Petitioner provides a detailed discussion explaining how
each claim limitation is disclosed in the combination of Meadows, Rutecki,
and Webster. Id. As for the recitation of “on-time and off-time,” Petitioner
identifies Meadows’ disclosure of “treatment times (TT)” and “treatment
(stimulation) time, and the like” and “auto-run time.” Id. at 51. Petitioner
further contends that, “to the extent that it is argued that Meadows does not
explicitly disclose the operational parameters of on-time and off-time, a
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POSITA would look to Rutecki for other applicable parameters (e.g., that
would fall under the category of “and the like” contemplated by Meadows)
when using the IPG of Meadows for VNS.” Id. at 52.
In combining Meadows and Rutecki, Petitioner contends that the
“IPGs used in the neurostimulation systems of Rutecki and Meadows each
utilize neuromodulation to address the same problem of chronic neuropathic
pain, i.e., the same neurological disorder.” Id. at 38 (citing Ex. 1003
¶¶ 279–81). Petitioner contends that Meadows discloses that the use of
multiple unique OSPs is applicable to “numerous different types of implant
devices and systems, including all types of neural stimulators and sensors,
deep brain stimulators, cochlear stimulators, drug delivery systems, muscle
tissue stimulators, and the like.” Id. at 37 (quoting Ex. 1016, 1:41–45)
(emphasis omitted). Petitioner further contends that the IPG of Rutecki was
one of the well-known “types of neural stimulators” and that a person of
ordinary skill in the art would have recognized that the improvements
disclosed in Meadows directed to storing multiple parameter sets in the
memory of an IPG and making these selectable by a patient would have
benefited the systems of Rutecki. Id. (citing Ex. 1003 ¶ 265). In particular,
Petitioner contends that Meadows explains the desirability of providing
patients a convenient way to change operating parameters, e.g., to avoid
having to “schedule an appointment” to see a physician. Id. at 36 (citing Ex.
1016, 2:48–3:1). In this regard, Petitioner directs our attention to the
following disclosure in Meadows:
Often, the changes needed by the patient are relatively
benign (insofar as the safety of the altered treatment is
concerned), and could easily be made by the patient himself or
herself if only the implant device provided such capability. . . .
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Thus, what is needed is a way for the patient to readily make
appropriate changes to the operating parameters of an implant
device so long as such operating parameter changes maintain the
device operation within safe operating limits.
Id. at 36 (citing Ex. 1016, 2:55–3:1). Thus, according to Petitioner, a person
of ordinary skill in the art would have been “motivated to apply the broad
teachings of Meadows for managing multiple sets of unique programmable
therapy parameters in implantable neurostimulators to the application of
stimulation of the vagus nerve to alleviate pain, as disclosed in Rutecki, to
yield the predictable and beneficial result of giving patients some limited
control to choose different stimulation parameter sets without having to visit
a physician or other clinician each time a change is desirable.” Id. at 39
(citing Ex. 1003 ¶ 275).
With regard to whether, and why, an ordinarily skilled artisan would
have combined Meadows and Rutecki with Webster, Petitioner contends
that:
While the Webster programming system is described in
the context of a bidirectional telemetry of an IPG used for
stimulating cardiac tissue, i.e., a pacemaker, IPGs used for VNS
(e.g., Meadows as modified by Rutecki) are physically and
functionally very similar to a traditional programmable
pacemaker, and in each case, external programmers are used to
modify programmable stimulation parameters in the IPG along
with receiving status and diagnostic information from the IPG.
[Ex. 1003] ¶ 299.
Id. at 44.
c. Patent Owner’s Response
Patent Owner sets forth several arguments to support its position that
Petitioner fails to establish that claims 1–5, 7–12, and 18–28 of the ’307
patent would have been obvious over the combination of Meadows, Rutecki,
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and Webster. PO Resp. 41–54. First, Patent Owner contends that Petitioner
failed to establish a motivation to combine Meadows and Rutecki. Id. at 41–
46. Patent Owner contends that “Petitioner’s suggestion that SCS and VNS
systems are interchangeable and can be combined with each other for the
purpose of rendering the claims obvious is an improper use of hindsight.”
Id. at 45. According to Patent Owner, Meadows discloses an SCS device
that relies on electrode arrays to deliver pulses along the spinal column for
treatment of pain, which “is a vastly different system than afferent VNS
therapy for neurological and neuropsychiatric disorders.” Id. at 41.
Second, Patent Owner contends that the combined disclosure of
Meadows and Rutecki fails to disclose elements [1.2] and [18.2]. Id. at 46–
51. In particular, Patent Owner contends that the OPSs of Meadows are not
“predetermined/pre-packaged programs of neuromodulation therapy” as
described in the ’307 patent because they are designed for spinal cord
stimulation and do not define neuromodulation parameters such as on-time
and off-time. Id. at 47. Patent Owner contends that the treatment times and
auto-run times in Meadows are not the same as the recited on-time and off-
time parameters, which, according to Patent Owner, refer to the duty cycle
within an intermittent therapy program. Id.
Third, Patent Owner contends that “Rutecki distinguishes itself from
dorsal column stimulation systems (like Meadows), thus expressly teaching
away from such a combination.” Id. at 42 (citing Ex. 1046, 8:9–27).
Fourth, Patent Owner contends that “nothing in Meadows teaches or
suggests the concept of a duty cycle (as the ’307 Patent and VNS therapy in
general), rendering its teachings (and SCS) not only unsuitable for
application to VNS therapy but dangerous, as well.” Id. at 42. According to
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Patent Owner, the multiple electrodes of Meadows are not suitable for VNS
therapy because the OPSs of Meadows manage direct therapy applied to
different locations of the spinal cord, and not different stimulation programs
to a single area as required by the VNS system recited in the claims. Id.
at 50 (Ex. 2021 ¶¶ 194, 212). Patent Owner acknowledges that Rutecki
discloses a VNS system, but contends that Rutecki expressly distinguishes
itself from dorsal column stimulation systems (like Meadows), and
therefore, for the reasons discussed by Rutecki, the systems are not
interchangeable. Id. at 45–46 (citing Ex. 2021 ¶¶ 181–83). In particular,
Rutecki discloses as follows:
The [disclosed VNS systems are] distinguished from the
pain suppression performed by the prior art [transcutaneous
electrical nerve stimulation (TENS)] and dorsal column
stimulation techniques. Vagal stimulation performed according
to the invention is stimulation of the nerve itself, in contrast to
the activation of receptors by TENS units. Dorsal column
stimulation is also at the cord level, and, like TENS therapy, is
thought to work in accordance with the gate theory of pain
described earlier herein. In fact, the pain associated with many
neuropathies may result from loss of large fiber function and
consequent inability of the large fiber sensory pathways to inhibit
the incoming pain signals from small diameter pain fibers. With
vagal stimulation, it does not appear to be an activation of
somatic large fiber sensory nerves, but rather, an activation of
brain stem centers which in turn activate a descending pathway
to inhibit incoming pain signals. Thus, vagal stimulation is more
akin to brain stem stimulation for pain control, but is much less
invasive.
Ex. 1046, 8:9–27 (emphasis added). Thus, according to Patent Owner,
combining the teachings of Meadows and Rutecki would require
modifications of one or both references that would not only
change their fundamental operation but render them unsuitable
for their intended purposes. See MPEP § 2143.01 (citing In re
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Ratti, 270 F.2d 810, 813 (C.C.P.A. 1959)). Neither Petitioner
nor Dr. Mihran explains how combining Meadows and Rutecki
would preserve the operation of either one, maintaining its
suitability for its intended purpose. In contrast, as Dr. Lad
explains, combining the VNS therapy procedures of Rutecki with
the SCS procedure of Meadows would endanger the patient and
would require a change in the principle operation of one or both
references. See [Ex. 2021] ¶¶ 100–01, 181–83.
PO Resp. 45–46.
With regard to Webster, Patent Owner contends that nothing in
Webster cures the deficiencies related to the improper combination of
Meadows and Rutecki. Id. at 52.
Patent Owner further contends that the nonobviousness of the subject
matter of the challenged claims is supported by “the long-felt need for and
failure of others to realize the inventions claimed in the ’307 Patent counsel
against a finding of obviousness.” Id. at 62. In particular, Patent Owner
contends as follows:
Cyberonics—predecessor in interest to Petitioner and the
applicant and owner of Rutecki—filed the Rutecki application on
June 17, 1992. See [Ex. 1046] at [22]. Cyberonics filed Baker
on November 18, 1991. See [Ex. 1012] at [22]. But Petitioner
did not introduce the first implantable VNS device incorporating
multiple predetermined/pre-packaged programs until 2017. And
Petitioner’s first patents describing multiple therapy programs in
an implanted pulse generator were filed in 2005. See Exhibit
2019 (filing date October 27, 2005). Thus, it took Petitioner
years to realize the benefit of combining implantable VNS
technology with multiple programs. Moreover, Petitioner’s use
of the technology claimed in the ’307 Patent has resulted in
overwhelming commercial success.
Id. at 63.
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d. Petitioner’s Reply
In its Reply, Petitioner contends that
Even under PO’s proposed construction, Meadows
discloses parameters that define “on-time and off-time.” For
example, regarding the “duty cycle” aspect, Meadows discloses
that “the patient can schedule auto-run times for IPG operation
at certain times of the day . . . . The auto-run time continues
for a set time period, e.g., several hours, or for only a few
minutes.” Ex. 1016 at 12:45–52 (emphases added). Thus,
Meadows discloses this as an example of a duty cycle by
scheduling IPG auto-run times to deliver therapy (signal “on-
time”) at “certain times of the day” (intermittent therapy) thereby
defining sequences of “on-time” and “off-time” throughout the
day (a prolonged procedure). See e.g. Ex. 1003 ¶ 177, 327-333,
374.
Reply 12–13. Furthermore, according to Petitioner, Meadows has the
necessary hardware features to accept vagal nerve programming parameters
identified in Rutecki. Id. at 15 (citing Pet. 40–41; Ex. 1054, 48:13–23; Ex.
1003 ¶¶ 284–87). Thus, according to Petitioner, “Meadows discloses the
ability to be programmed with parameters, such as those in Rutecki, defining
‘on-time and off-time’ under [Patent Owner’s] more narrow interpretation.”
Id. at 13–14 (citing Ex. 1003 ¶¶ 264–69, 276–87). Moreover, Petitioner
contends that “[a] POSITA, utilizing ordinary creativity and the teachings of
the references, would readily program the parameters of the Meadows IPG
to define safe stimulation on-times and stimulation off-time times.” Id. at 17
(citing Ex. 1003 ¶¶ 328–29; Pet. at 51).
Regarding Patent Owner’s teaching away and motivation to combine
arguments, Petitioner contends that “Rutecki does not disparage storing
multiple therapy programs,” but rather “contribut[es] to the motivation to
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utilize Meadows’ teachings with Rutecki’s VNS application.” Id. at 19. In
particular, Petitioner contends as follows:
Rutecki’s disclosure of an alternative to the more convenient
storage of multiple therapy programs to provide some control by
the patient (per Meadows) does not constitute a teaching
away . . . . Instead, Rutecki recognizes the benefit of having an
additional program available for patient activation as an
alternative to an initial program stored in memory. [Ex. 1016,]
13:4–9. The device of Meadows provides the benefit of allowing
the additional program of Rutecki to be programmed in memory
as an alternative OPS, rather than requiring the patient to return
to a physician for re-programming of the device.

. . . Moreover, with respect to the technical aspects of an
SCS IPG, PO’s expert agrees with Dr. Mihran that internal
components of VNS IPGs and SCS IPGs have the same
components and include overlapping parameters. E.g., Ex. 1055
at 110:15–129:17. Thus, PO fails to establish that Rutecki
teaches away from a combination with the IPG of Meadows.
Id. at 19–20.
Petitioner also contends that Patent Owner’s secondary considerations
arguments are conclusory and insufficient to demonstrate the requisite nexus
between the claimed invention and secondary considerations of non-
obviousness. Id. at 21–24.
e. Patent Owner’s Sur-Reply
In its Sur-Reply, Patent Owner argues that the argument that “there is
no support in the references for combining them in this way, and nothing in
the references overcomes Dr. Lad’s opinion that a POSITA would not
combine the therapies discussed in Meadows and Rutecki as Petitioner has
done.” Sur-Reply 10. In particular, Patent Owner contends as follows:
Although Rutecki discloses on-times and off-times of 1 minute
and 59 minutes, respectively, there is nothing in Meadows that
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suggests such a repeating pattern of treatment times. In fact, Dr.
Lad testified at his deposition that repeating patter[n]s (or what
he referred to as “bursts”) were not explored in the context of
SCS therapy until just recently—years after the invention date of
the ’307 Patent—further confirming the non-obviousness of
Petitioner’s proposed combination. See, e.g., Exhibit 1055 at
125:13–126:21, 183:8–24.
Id. at 10–11.
Patent Owner contends that the claims are directed to VNS treatments
requiring repeating cycles of on-time and off-time, or duty cycles. In
particular, Patent Owner contends as follows:
Petitioner also argues that the ’307 Patent discloses tonic
stimulation (like Meadows) because Table 4 shows that the “on-
time” and “off-time” parameters can take values between 5
seconds and 24 hours. See Reply at 24. But Table 4 merely
shows the “range of programmable electrical stimulation
parameters.” See ’307 Patent at 20:65–67, Table 4. Thus, it
shows the technical “programming” capability of the IPG. But
the technical capability of the described IPG must be read in the
context of the specification, which describes VNS treatments as
including repeating cycles of on-time and off-time. Nothing in
the specification states that any particular combination of the
values shown in Table 4 constitutes a specific (or appropriate)
therapy program for VNS therapy—and certainly not a 24-hour
on-time and 24-hour off-time treatment. On the contrary, the
more relevant examples of predetermined/prepackaged program
parameter values are shown in the ’307 Patent specification in
Column 19. See, e.g., ’307 Patent at 19:30–39 (“20 sec. on-time
and 2.0 min. off-time in repeating cycles.”), 19:40–47 (“1.5 min.
on-time and 20.0 min. off-time in repeating cycles.”), 19:48–56
(“1.5 min. on-time and 20.0 min. off-time in repeating cycles.”),
19:58–65 (“2.0 min. on-time and 20.0 min. off-time in repeating
cycles.”).
Id. at 13. Here, Patent Owner directs our attention to Dr. Lad’s declaration
explaining why the types and manner of therapy procedures are different
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between SCS and VNS systems, regardless of the fact that the hardware
components are similar. Id. at 12 (citing Ex. 2021 ¶ 191 (“The cumulative
therapy system of the ’307 Patent relies on multiple, selectable, and
complete therapy programs[, which] differs from the conventional
wisdom at the time, which was vagal tuning . . . .”)).
Patent Owner contends that Petitioner failed to successfully rebut
Patent Owner’s evidence of teaching away. Id. at 14–17 (citing Reply 20).
In particular, Patent Owner argues that
Rutecki teaches away from multiple programs because it
explicitly says that the parameters are applied until
reprogrammed. See Response at 51 (quoting Rutecki at 10:67–
11:4). Petitioner argues that Meadows improves on this point, so
Rutecki does not teach away. But, as Patent Owner has pointed
out, Meadows’s operational parameter sets are not
“predetermined/prepackaged programs” as defined in the claims.
See, e.g., Response at 46–51; Exhibit 2021 at ¶¶ 189–212.
Petitioner’s argument that Rutecki merely discloses an
“alternative to the more convenient storage of multiple therapy
programs” is misplaced and finds no support in Rutecki. That
argument trivializes the inventive aspect of using multiple
predetermine/prepackaged programs rather than tuning the
system for each patient at a particular time.
Id. at 14.
f. Analysis
i. Whether the Combination of Meadows and Rutecki
Teach or Suggest the Claimed “at least two
predetermined/pre-packaged programs” having the
recited “on-time” and “off-time” parameters
As noted by Patent Owner, there are certain differences between the
scope and content of the prior art that a person of ordinary skill in the art
would have to contemplate prior to combining the teachings to arrive at the
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claimed subject matter, such as differences between SCS therapy and VNS
therapy. PO Resp. 25, 39–41. In this regard, the dispute between the parties
concerns whether the combination of Meadows and Rutecki teaches or
suggests an IPG having “at least two predetermined/pre-packaged programs”
of neuromodulation therapy as required by the claims, and, in particular, the
on-time and off-time parameters of elements [1.2] and [18.2]. Pet. 35–39,
49–52, 67; PO Resp. 47–51. Having considered the parties’ positions and
evidence of record, summarized above, we determine that Petitioner has
established that Meadows combined with Rutecki suggests the elements of
[1.2] and [18.2]. Pet. 49–52.
To begin, Meadows discloses an implantable pulse generator
(Ex. 1016, 9:7–18) that is programmed with a “plurality” of OPSs (id.
at 3:54–58). Each OPS “includes parameter values that define, e.g., pulse
amplitude, pulse width (duration), channel frequency, electrode
configuration, ramp rate, treatment (stimulation) time, and the like” (id. at
9:18–22) and, additionally, “treatment times” (id. at 17:2–13) and “auto-run
times” (id. at 12:41–56). The parties dispute whether the disclosed treatment
times and auto-run times in Meadows are the same as the recited “on-time”
and “off-time” parameters.
In that regard, Meadows discloses that the patient can schedule auto-
run times for the disclosed IPG at certain times of day, meaning the time that
therapy automatically turns on and runs for a specified period of time.
Specifically, Meadows discloses as follows:
[T]he patient can schedule auto-run times for IPG operation at
certain times of the day. . . . The auto-run time continues for a
set time period, e.g., several hours, or for only a few minutes.
Advantageously, the auto-run time is defined by the current OPS.
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Ex. 1016, 12:41–56; see also, (Ex. 1016) at 17:2-13 (“operational parameter
data may define . . . treatment times (TT)”); Pet. 51; Ex. 1003 ¶¶ 327, 329.
Having considered the parties positions and evidence of record, however, we
do not understand the parameters defining “treatment times (TT)” and “auto-
run time” as necessarily disclosing both on-time and off-time parameters.
While an “auto-run time” may result in the same practical effect, a period of
on-time and a period of off-time, we find insufficient evidence supporting a
determination that the OPSs disclosed in Meadows include an off-time
parameter. Rather, the off-time in Meadows is merely determined as a
consequence of the device not having an on-time. Consequently, we agree
with Patent Owner that Petitioner fails to establish that Meadows discloses
the recited off-time parameter.
There is no dispute, however, that Rutecki discloses an implanted
neurostimulating device that may be programed with each of the claimed
parameters, including “output signal on-time, [and] output signal and off-
time,” which have the same meaning of the recited on-time and off-time
parameters. Pet. 52; Ex. 1046, 1:11–15, 10:32–38; Ex. 1003 ¶¶ 309–333;
PO Resp. 50–51. Thus, the evidence of record supports the conclusion that
Rutecki discloses on-time and off-time parameters as recited in the
challenged claims. Ex. 1046, 1:11–15, 10:32–38; Ex. 1003 ¶¶ 309–333;
Pet. 52; PO Resp. 50–51. Accordingly, taken together, we determine that
the combination of Meadows and Rutecki discloses the disputed elements of
the recited predetermined/pre-packaged programs of neuromodulation
therapy as required by the challenged claims. See In re Merck & Co. Inc.,
800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be
established by attacking references individually where the rejection is based
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upon the teachings of a combination of references. . . . [The reference] must
be read, not in isolation, but for what it fairly teaches in combination with
the prior art as a whole.”).
ii. Whether a Person of Ordinary Skill in the Art Would
Have Had Reason to Combine the SCS System of
Meadows with the VNS System of Rutecki
A critical issue in this case is whether a person of ordinary skill in the
art would have had reason to combine the SCS system of Meadows with the
VNS system of Rutecki to achieve a system or method of providing
electrical pulses to a vagus nerve using an IPG having “at least two
predetermined/pre-packaged programs” of neuromodulation therapy stored
in its memory. Whether there was a motivation to combine prior art
references is a question of fact. Arctic Cat Inc. v. Bombardier Recreational
Prods. Inc., 876 F.3d 1350, 1359 (Fed. Cir. 2017). An invention is not
obvious simply because all of the claimed limitations were known in the
prior art at the time of the invention. Instead, we ask “whether there is a
reason, suggestion, or motivation in the prior art that would lead one of
ordinary skill in the art to combine the references, and that would also
suggest a reasonable likelihood of success.” Smiths Indus. Med. Sys., Inc. v.
Vital Signs, Inc., 183 F.3d 1347, 1356 (Fed. Cir. 1999). The motivation
“can be found explicitly or implicitly in the prior art references themselves,
in market forces, in design incentives, or in ‘any need or problem known in
the field of endeavor at the time of invention and addressed by the patent.’”
Arctic Cat, 876 F.3d at 1359 (quoting KSR, 550 U.S. at 420–21). Having
considered the parties’ positions and evidence of record, summarized above,
we determine that a preponderance of evidence supports a determination that
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a person of ordinary skill in the art would have been motivated to combine
the disclosures of Meadows, Rutecki, and Webster to achieve an implantable
VNS device according to the challenged claims.
To begin, we note that both Meadows and Rutecki are related to using
neuromodulation to treat “the same neurological disorder” (Ex. 1003
¶ 278)—that is, chronic neuropathic pain (Ex. 1016, 1:12–15; Ex. 1046,
Abstract). Pet. 37. Rutecki, in particular, “relates generally to methods and
apparatus for treating . . . neurological disorders by application of
modulating electrical signals to a selected nerve or nerve bundle of the
patient” (Ex. 1046, 1:6–10), such as “the vagus nerve . . . to inhibit the
sensation of pain” (id. at 4:55–62). The therapy described by Rutecki “is
delivered from a pulse generator of the neurostimulator to a nerve electrode
array implanted on the patient’s vagus nerve to appropriately modulate the
electrical activity of the nerve.” Id. at 6:29–3. An implantable version of
the device is disclosed (id. at 9:55–58), and Rutecki expressly teaches that
the device may be programmed with each of the claimed parameters of
elements [1.b] and [18.b], including “output signal on-time [and] output
signal off-time” (id. at 10:32-38, 12:24–59), as discussed above.
For its part, Meadows discloses an IPG having the elements of [1.1]
and [18.1]. Pet. 47–48 (citing Ex. 1016, 9:7-18, 9:49-51, Fig. 4; Ex. 1003 ¶¶
309–15). Although Meadows does not explicitly disclose stimulating a
vagus nerve, Meadows is widely applicable to “all types of neural
stimulators.” Ex. 1016, 1:38–45. Additionally, Meadows discloses a
similar, and, as discussed above, functionally equivalent set of stimulation
parameters within the disclosed OPSs that are used to define stimulation
therapy programs. See id. at 9:18–22 (“The operational parameter set for an
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IPG 100 . . . includes parameter values that define, e.g., pulse amplitude,
pulse width (duration), channel frequency, electrode configuration, ramp
rate, treatment (stimulation) time, and the like.”). Regarding elements [1.2]
and [18.2], Meadows discloses that a plurality of predetermined OPSs
(example “programs” of “neuromodulation therapy,” as recited in elements
[1.2] and [18.2]) are stored in the memory of the IPG. Ex. 1016, 3:11–15,
3:54–58 (disclosing a plurality of OPSs programably stored in memory
circuitry of implant device). Given the strong similarities of the devices and
methods disclosed in Meadows and Rutecki, we agree with Petitioner that a
person of ordinary skill in the art would have been motivated to combine the
advances in IPG technology disclosed in Meadows and Webster (providing
general guidance on the advances of IPG technology, summarized above) to
the VNS stimulation methods and parameter sets disclosed by Rutecki (e.g.,
to avoid having to go to see a physician each time the parameter set is
desired to be changed), thereby achieving the subject matter of the
challenged claims. Pet. 35–45.
We have considered Patent Owner’s contentions that combining the
SCS system of Meadows with the VNS system of Rutecki would render the
neurostimulation system of Meadows unsatisfactory for the disclosed
intended purposes, but we are instead persuaded by Petitioner’s arguments
and evidence. In this regard, we note that combinations that change the
“basic principles under which the [prior art] was designed to operate,” In re
Ratti, 270 F.2d 810, 813 (CCPA 1959), or that render the prior art
“inoperable for its intended purpose,” In re Gordon, 733 F.2d 900, 902 (Fed.
Cir. 1984), may fail to support a conclusion of obviousness. However, the
preponderance of evidence on this record does not support a conclusion that
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the systems of Meadows and Rutecki are incompatible. Rather, a
preponderance of the evidence supports a determination that the system of
Meadows could have been used to run the stimulation programs of Rutecki
with few modifications. For example, the VNS stimulator disclosed in
Rutecki requires only a single pair of bipolar electrodes, representing a
single channel, which is contemplated by Meadows. Ex. 1016, 7:56–57
(“[T]he present invention may also be used in single-channel systems. . . .”);
see also, Ex. 1003 ¶ 285 (“The requirement of only a single channel of
stimulation for VNS simplifies the combination and decreases demands on
IPG memory, since the multiple sets of operating parameters need only be
stored with respect to one channel of stimulation, rather than multiple
discrete channels, as is common in SCS.”). Pet. 52–53.
Furthermore, we credit Dr. Mihran’s testimony that Meadow’s leads
require only routine modification to apply Meadow’s device to VNS:
And as I testified earlier, really the only thing that would
require any modification whatsoever or particular form would be
just having a correct lead that was appropriate for the particular
morphology or anatomy of the vagus nerve itself as compared to
other possible targeted nerve structures. And beyond that, all of
the parameter values, all of the parameter ranges, and all of the
programmability that is part of the IPG of Meadows would serve
to function as the vagus nerve stimulator with the appropriate
electrode attached.
Ex. 1054, 48:13–23; see also Ex. 1003 ¶¶ 284–87 (“IPGs used for VNS are
physically and functionally very similar to IPGs used for SCS, both of which
had in turn, commonly evolved from programmable cardiac pacemaker
technologies”) (citing Ex. 1046, 11:26–12:2, Figs. 2–3; Ex. 1016, 7:56–57).
Dr. Lad’s testimony is consistent with Dr. Mihran’s on this point.
Specifically, Dr. Lad testified that the components of many IPGs share
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common components and each could be programmed with stimulation
therapy parameters. Ex. 1055, 116:16–120:12, 128:7–129:17. Dr. Lad also
testified that IPGs for VNS and SCS have similar abilities in terms of
delivering packets of energy (id. at 127:16–128:5) and that the leads tend to
be interoperable between the IPGs (id. at 129:5–17). Dr. Lad testified that
electrode arrays of SCS IPGs evolved from monopolar and bi-polar arrays
and that it would have been technically possible to reduce the number of
electrodes on a SCS IPG to a number suitable for VNS therapy. Id.
at 231:14–17. Thus, while we understand that the SCS therapy programs of
Meadows, or the use of a multitude of leads as in Meadows, may endanger a
patient receiving VNS therapy, a preponderance of the evidence of record
supports a conclusion that a POSA could have modified the IPG hardware of
Meadows to make use of a single lead and programmed with the VNS
treatment programs disclosed by Rutecki and would have been motivated to
do so to obtain the benefit of patient control, as disclosed in Meadows. Pet.
35–41; Ex. 1003 ¶¶ 264–287.
We have also considered Patent Owner’s arguments that Rutecki
teaches away from the use of “at least two predetermined/pre-packaged
neuromodulation therapy programs” (elements [1.2], [18.2]) and/or
“selectively choosing between” at least two programs parameters (element
[1.5]). PO Resp. 41, 46, 51, 52. We recognize that one “may rebut a prima
facie case of obviousness by showing that the prior art teaches away from
the claimed invention in any material respect.” In re Peterson, 315 F.3d
1325, 1331 (Fed. Cir. 2003); citing In re Geisler, 116 F.3d 1465, 1469 (Fed.
Cir. 1997). However, for a reference to teach away, it must state more than
a general preference for an alternative invention. It must “criticize,
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discredit, or otherwise discourage” investigation into the invention claimed.
DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327
(Fed. Cir. 2009) (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004)). The most that can be said about Rutecki is that it discloses certain
VNS devices and methods that are distinguishable from other known
neurostimulators and methods involving, for example, direct brain
stimulation or dorsal column stimulation. Ex. 1046, 8:9–27. We discern no
disclosure in Rutecki that rises to the level of criticism guiding a person of
ordinary skill in the art away from combining, for example, SCS or other
IPG hardware components and the systems disclosed by Rutecki and,
therefore, we are persuaded that Petitioner has established a motivation to
combine, notwithstanding Patent Owner’s arguments to the contrary.
As to the dependent claims, the dispute between the parties similarly
concerns whether the combination of Meadows and Rutecki fails to disclose
an “on-time and off-time” parameters as set forth in the challenged claims.
PO Resp. 53–54. For the reasons set forth above, we resolve that dispute in
favor of Petitioner.
iii. Secondary Considerations
Before we can determine that Petitioner demonstrates the obviousness
of the challenged claims, we must consider the evidence of obviousness
anew in light of any evidence of secondary considerations of
nonobviousness presented by Patent Owner. See Graham, 383 U.S. at 17-18
(“Such secondary considerations as commercial success, long felt but
unsolved needs, failure of others, etc., might be utilized to give light to the
circumstances surrounding the origin of the subject matter sought to be
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patented. As indicia of obviousness or nonobviousness, these inquiries may
have relevancy.”); Transocean Offshore Deepwater Drilling, Inc. v. Maersk
Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012) (“This objective
evidence must be “considered as part of all the evidence, not just when the
decision maker remains in doubt after reviewing the art.” (quoting
Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538-39 (Fed. Cir.
1983))).
Among the secondary considerations that must be considered is the
existence of a long-felt but unsolved need. Graham, 383 U.S. at 17–18.
Patent Owner, however, does not present any actual evidence of long-felt
need, only argument, which we find insufficient to rebut evidence of record
establishing a motivation to apply the advances in IPG technology disclosed
in Meadows and Webster to the VNS stimulation methods disclosed by
Rutecki so as to avoid having to go to see a physician each time the
parameter set is desired to be changed, as discussed above. PO Resp. 62–65.
As such, Patent Owner has failed, on the current record, to establish a long-
felt need. See Tex. Instruments v. U.S. Int’l Trade Comm’n, 988 F.2d 1165,
1178 (Fed. Cir. 1993) (“[L]ong-felt need is analyzed as of the date of an
articulated identified problem and evidence of efforts to solve that
problem.”); Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317,
1325 (Fed. Cir. 2004)(“Absent a showing of long-felt need or the failure of
others, the mere passage of time without the claimed invention is not
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evidence of nonobviousness.”); accord In re Wright, 569 F.2d 1124, 1127
(CCPA 1977).4
g. Conclusion
In conclusion, we are persuaded by Petitioner’s arguments, as they are
supported by the cited evidence, notwithstanding Patent Owner’s arguments,
addressed above. Accordingly, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claims 1–5, 7–12, and
18–28 of the ’307 patent are unpatentable under 35 U.S.C. § 103(a) as
obvious over the combination of Meadows, Rutecki, and Webster.
2. Ground 2: Obviousness of Claim 6 over the Combination of
Meadows, Rutecki, Webster, and Lee
Petitioner contends that Claim 6 is unpatentable under 35 U.S.C.
§ 103 over the combination of Meadows, Rutecki and Webster further in
view of Lee. Pet. 75–79. Claim 6 depends from claim 1 and further requires
“wherein said implanted pulse generator may further comprise a telemetry
means for remote device interrogation and/or programming over a wide area
network.” Ex. 1001, 33:37–40. For that element, Petitioner relies on Lee,
which is generally directed to “providing real-time communication between
the [implantable medical devices (“IMDs”)], medical instruments associated

4 We acknowledge Patent Owner’s assertion that “Petitioner’s use of the
technology claimed in the ’307 Patent has resulted in overwhelming
commercial success,” but note that such attorney argument is not the
equivalent of evidence of commercial success. PO Resp. 63. Thus, even
assuming a nexus between the Patent Owner’s assertion of commercial
success and a patent claim, we determine that the record lacks sufficient
evidence to support a finding of commercial success sufficient to overcome
the evidence of obviousness set forth in the Petition.
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with or compatible with the IMDs, and a specialized remote expert data
center, a central IMD support information network, or other remote
collaborators.” Ex. 1013, 1:13-18; Ex. 1003 ¶ 425. Lee also discloses that
its implantable medical device may be “a pacemaker, defibrillator, drug
pump, [or] neurological stimulator.” Ex. 1013, 10:46-50.
Patent Owner’s arguments, as to this ground, for the most part refer
back to the discussion with respect to ground 1, which we discuss above.
PO Resp. 54–68.
Having considered the parties’ positions and evidence of record, we
agree, for the reasons set forth in the Petition, which we adopt (Pet. 75–79;
Ex. 1003, ¶¶ 426, 437–40), that Lee discloses the element of claim 6 and that
a person of ordinary skill in the art would have been motivated to apply the
general technological advances disclosed in Lee to the neurostimulators of
Meadows and Rutecki. Accordingly, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claim 6 of the ’307
patent is unpatentable under 35 U.S.C. § 103(a) as obvious over the
combination of Meadows, Rutecki, Webster, and Lee.
3. Grounds 3 and 4
Because the obviousness grounds over the combination of Meadows,
Rutecki, Webster, and Lee are dispositive as to claims 1–12 and 18–28, we
need not reach the obviousness grounds over the combination of Meadows,
Rutecki, Salmons, and Webster (ground 3) and combination of Meadows,
Rutecki, Salmons, Webster, and Lee (ground 4). See SAS Inst. Inc. v. Iancu,
138 S. Ct. 1348, 1359 (2018) (holding a petitioner “is entitled to a final
written decision addressing all of the claims it has challenged”).
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III. CONCLUSION
In summary, we make the following conclusions.5
Claims 35 U.S.C. § Reference(s)/Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
1–5, 7–12,
18–28 103(a)
Meadows,
Rutecki,
Webster
1–5, 7–12,
18–28
6 103(a)
Meadows,
Rutecki,
Webster, Lee
6
1–5, 7–12,
18–28 103(a)
6
Meadows,
Rutecki,
Salmons,
Webster

5 Should Patent Owner wish to pursue amendment of the challenged
claims in a reissue or reexamination proceeding subsequent to the
issuance of this decision, we draw Patent Owner’s attention to the April
2019 Notice Regarding Options for Amendments by Patent Owner
Through Reissue or Reexamination During a Pending AIA Trial
Proceeding, 84 Fed. Reg. 16,654 (Apr. 22, 2019). If Patent Owner
chooses to file a reissue application or a request for reexamination of the
challenged patent, we remind Patent Owner of its continuing obligation to
notify the Board of any such related matters in updated mandatory
notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
6 As explained above in Section II.C.3, we do not reach Petitioner’s
challenge to claims 1–5, 7–12, and 18–28 as obvious over the combination
of Meadows, Rutecki, Salmons, and Webster.
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Claims 35 U.S.C. § Reference(s)/Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
6 103(a)7
Meadows,
Rutecki,
Salmons,
Webster, Lee

IV. ORDER
Accordingly, it is
ORDERED that claims 1–12 and 18–28 of the ’307 patent are
unpatentable; and
FURTHER ORDERED that, because this is a Final Written Decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

7 As explained above in Section II.C.3, we do not reach Petitioner’s
challenge to claim 6 as obvious over the combination of Meadows, Rutecki,
Salmons, Webster, and Lee.
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FOR PETITIONER:
Andrew Lowes
Clint Wilkins
Jamie McDole
Michael D. Karson
HAYNES & BOONE LLP
andrew.lowes.ipr@haynesboone.com
clint.wilkins.ipr@haynesboone.com
jamie.mcdole@haynesboone.com
Michael.Karson@haynesboone.com

For PATENT OWNER:

Andrew Wright
Brent Bumgardner
Brian P. Herrmann
NELSON BUMGARDNER ALBRITTON P.C.
andrew@nbafirm.com
brent@nbafirm.com
brian@nbafirm.com