Boston Scientific Neuromodulation Corp.

Patent Trials and Appeals Board

Jan 19, 2021

IPR2019-01340 (P.T.A.B. Jan. 19, 2021)

Trials@uspto.gov Paper 43
571-272-7822 Entered: January 19, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

NEVRO CORP.,
Petitioner

v.

BOSTON SCIENTIFIC NEUROMODULATION CORP.,
Patent Owner.

IPR2019-01340
Patent 6,381,496 B1

Before MICHAEL W. KIM, Vice Chief Administrative Patent Judge,
ROBERT A. POLLOCK, and
JASON W. MELVIN, Administrative Patent Judges.

POLLOCK, Administrative Patent Judge.

FINAL WRITTEN DECISION
Determining All Challenged Claims Unpatentable
35 U.S.C. § 318(a)
Entering Stipulated Protective Order and
Granting Patent Owner’s Motion to Seal
37 C.F.R. §§ 42.1 and 42.54

IPR2019-01340
Patent 6,381,496 B1
2

I. INTRODUCTION
This is a Final Written Decision in an inter partes review challenging
the patentability of claims 1–18 of U.S. Patent No. 6,381,496 B2 (“the ’496
patent,” Ex. 1001). We have jurisdiction under 35 U.S.C. § 6.
Petitioner has the burden of proving unpatentability of a claim by a
preponderance of the evidence. 35 U.S.C. § 316(e) (2018). Having reviewed
the arguments of the parties and the supporting evidence, we determine that
Petitioner has demonstrated by a preponderance of the evidence that the
challenged claims are unpatentable.
A. Procedural Background
Nevro Corp. (“Petitioner”) filed a Petition for an inter partes review
of claims 1–18 of the ’496 patent. Paper 2 (“Pet.”). Boston Scientific
Neuromodulation Corp. (“Patent Owner”) timely filed a Preliminary
Response. Paper 6 (“Prelim. Resp.”). In view of the then-available,
preliminary record, we concluded that Petitioner satisfied the burden, under
35 U.S.C. § 314(a), to show that there was a reasonable likelihood that
Petitioner would prevail with respect to at least one of the challenged claims.
Accordingly, on behalf of the Director (37 C.F.R. § 42.4(a) (2018)), and in
accordance with SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1353 (2018) and
the Office’s Guidance on the Impact of SAS on AIA Trial Proceedings
(Apr. 26, 2018),1 we instituted an inter partes review of claims 1–18 of the
’496 patent on all the asserted grounds. Paper 7 (“Inst. Dec.”), 41.
After institution, Patent Owner filed a Response. Paper 23 (“PO
Resp.”). Petitioner filed a Reply. Paper 33 (“Reply”). Patent Owner filed an

1 https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-
board/trials/guidance-impact-sas-aia-trial.
IPR2019-01340
Patent 6,381,496 B1
3

authorized Sur-reply. Paper 35 (“Sur-reply”). Patent Owner also filed a
motion to seal and for entry of stipulated protective order. Paper 22.
On November 10, 2020, the parties presented arguments at oral
hearing, the transcript of which is of record. Paper 42 (“Tr.”).
B. Real Parties-in-Interest
Petitioner identifies itself, Nevro Corp., as the real party-in-interest.
Pet. 77. According to Patent Owner, its real parties-in-interest are Boston
Scientific Neuromodulation Corp. and Boston Scientific Corp. Paper 4, 2.
C. Related Proceedings
The ’496 patent is at issue in Boston Scientific Corp. et al. v. Nevro
Corp., Civil Action No. 1:18-cv-00644 (D. Del.). See Pet. 77; Paper 4, 2.
D. Asserted Grounds of Unpatentability
The Petition sets forth seven grounds of unpatentability. (Pet. 3–4):
Ground Claims Basis Asserted References
1 1–3, 6 103(a)2 Shelton,3 Nappholz4
2 4, 5 103(a) Shelton, Nappholz, Mumford5
3 7 103(a) Shelton, Nappholz, Barreras ’887
(Barreras II)6

2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the
challenged claims of the ’496 patent have an effective filing date before the
effective date of the applicable AIA amendments, we refer to the pre-AIA
versions of 35 U.S.C. § 103 throughout this Decision.
3 U.S. Patent No. 5,387,228, issued Feb. 7, 1995. Ex. 1005.
4 U.S. Patent No. 5,720,770, issued Feb. 24, 1998. Ex. 1006.
5 U.S. Patent No. 4,432,360, issued Feb. 21, 1984. Ex. 1009.
6 U.S. Patent No. 5,735,887, issued Apr. 7, 1998. Ex. 1008.
IPR2019-01340
Patent 6,381,496 B1
4

Ground Claims Basis Asserted References
4 8–13 103(a) Nappholz
5 14 103(a) Barreras ’217 (Barreras I)7
6 15, 16 103(a) Barreras ’217 (Barreras I), Nappholz
7 17, 18 103(a) Barreras ’217 (Barreras I), Nappholz,
Mumford
In support of its patentability challenges, Petitioner relies on, inter
alia, the Declaration of Mark W. Kroll, Ph.D. Ex. 1003. Patent Owner relies,
inter alia, the Declaration of Alois A. Langer, Ph.D. Ex. 2006.
E. The ’496 Patent and Relevant Background
1. Specification
The ’496 patent is directed to “parameter context switching, i.e.,
defining and/or selecting different operational parameter sets for use by an
implant device.” Ex. 1001, 5:44–62; see id. at Abstract, Title. Elsewhere, the
specification expressly defines “context switching” as “changing one set of
operational parameters to another.” Id. at 3:8–10 “[B]y providing an implant
device having the ability to perform context switching . . . . the patient may
advantageously swap the current set of operational parameters with another
set of operational parameters” thereby controlling the implant device. Id. at
3:6–15.
The ’496 patent further states that, “[t]he present invention relates to
an implant device, e.g., a spinal cord stimulation (SCS) system or other
programmable implant device,” and emphasizes the “broad applicability” of
the invention to “any other programmable implant system” “including all

7 U.S. Patent No. 5,591,217, issued Jan. 7, 1997. Ex. 1007.
IPR2019-01340
Patent 6,381,496 B1
5

types of neural stimulators and sensors, deep brain stimulators, cochlear
stimulators, drug delivery systems, muscle tissue stimulators, and the like.”
Id. at 1:9–11, 1:16–19, 1:37–45, 5:55–62. The Specification exemplifies the
use of context switching “with reference to the implanted pulse generator
(IPG) and hand-held programmer (HHP) of a spinal cord stimulation (SCS)
system. Id. at 5:47–65.
According to the Specification, “[a] spinal cord stimulation (SCS)
system treats chronic pain by providing electrical stimulation pulses from an
electrode array placed epidurally near a patient’s spinal cord.” Ex. 1001,
1:9–14. “The operation of an implanted device depends upon the storage and
use of certain operational parameters.” Id. at 1:21–22. “[T]hese parameters
might include: stimulation pulse amplitudes, pulse durations, channel
frequencies, electrode configurations, ramp rates and treatment times, and
the like.” Id. at 1:23–26. The Specification states that known SCS systems
“use different approaches for modifying or changing the operational
parameters that control operation of the device,” generally requiring an
appointment with a medical professional. Id. at 2:48–55. The Specification
states that “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 2:64–3:1.
The SCS system may include an implanted pulse generator (IPG) and
hand-held programmer (HHP). Id. at 5:47–50. The IPG is shown in Figure 4
of the ’496 patent, reproduced below.
IPR2019-01340
Patent 6,381,496 B1
6

Figure 4 depicts a block diagram of the main components of IPG 100. Id. at
5:5–8.
The ’496 patent’s Specification describes IPG 100 including
microcontroller 160 connected to memory circuit 162. Id. at 9:7–11.
Microcontroller 160 controls “the operation of the IPG in accordance with a
selected operating program and operational parameter set (OPS).” Id. at
9:15–17. “The operating program and OPS are programably stored within
different locations of [] memory 162 by transmitting an appropriate
modulated carrier signal through [] receiving coil 170 and forward/back
telemetry circuitry 172 from an external programing unit, e.g., [HHP] 202
and/or [] clinician programmer 204.” Id. at 9:22–27.
Figure 6 of the ’496 patent is reproduced below.
IPR2019-01340
Patent 6,381,496 B1
7

Figure 6 depicts a functional block diagram of the IPG of Figure 4, and
functionally illustrates a method for selecting different operational
parameters sets. Id. at 5:14–18.
The ’496 patent’s Specification describes memory 162 storing
memory table 165 which “includes individual addressable locations wherein
various operational parameters may be stored.” Id. at 17:2–4. The
Specification explains:
A first operational parameter, for example, may comprise data
that defines the pulse width (PW) of a stimulation pulse. Yet
other operational parameter data may define the pulse rate (PR),
pulse amplitude (PA), electrode configuration (EC), ramp rate
(RR), treatment times (TI), a first other parameter (P1), and a
second other parameter (P2), and the like, associated with a
stimulation pulse sequence. All such data, when combined, thus
define an operational parameter set (OPS) that may be used by
the implant device 100 or 100' as it provides stimulation pulses
through selected electrodes E1, E2, . . . En of the electrode array
110.
IPR2019-01340
Patent 6,381,496 B1
8

Id. at 17:4–15. Memory 162 may store “a plurality of different operational
parameter sets, e.g., OPS0, OPS1, OPS2, . . . OPSn.” Id. at 17:26–32. The
patient user may then manually select a different OPS from each OPS stored
within memory 162. Id. at 17:32–45.
2. Challenged Claims
The ’496 patent includes 18 claims. Claims 1, 8, and 14 are
independent. Claim 1 is illustrative:
1. An implant device comprising:
an implantable case;
electronic circuitry housed within said implantable case for
performing a prescribed function, the electronic circuitry
including
a control register wherein a control set of operational
parameters is stored,
a controller that controls the operation of the implant
device as a function of the control set of operational
parameters stored in the control register, and
a plurality of sets of operational parameters; and
selection means for selecting one of the plurality of sets of
operational parameters as the control set of operational
parameters that is stored in the control register;
whereby the operation of the implant device may be changed
through selection of a different set of operational
parameters.
3. Relevant Prosecution History
The Examiner allowed claims 1–18 without rejection or comment.
Ex. 1002, 40–46. None of the references recited in Petitioner’s Grounds
were before the Examiner. See Ex. 1001, code (56).
IPR2019-01340
Patent 6,381,496 B1
9

II. ANALYSIS
A. Legal Standards
“In an [inter partes review], the petitioner has the burden from the
onset to show with particularity why the patent it challenges is
unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
petitions to identify “with particularity . . . the evidence that supports the
grounds for the challenge to each claim”)). This burden of persuasion never
shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics,
Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in
inter partes review).
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 that
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 ordinary skill in the art; and (4) objective evidence of
nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
In analyzing the obviousness of a combination of prior art elements, it
can be important to identify a reason that would have prompted one of skill
in the art “to combine . . . known elements in the fashion claimed by the
patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the
specific subject matter of a challenged claim is not necessary to establish
obviousness. Id. Rather, “any need or problem known in the field of
IPR2019-01340
Patent 6,381,496 B1
10

endeavor at the time of invention and addressed by the patent can provide a
reason for combining the elements in the manner claimed.” Id. at 420.
Accordingly, a party that petitions the Board for a determination of
unpatentability based on obviousness must show that “a skilled artisan
would have been motivated to combine the teachings of the prior art
references to achieve the claimed invention, and that the skilled artisan
would have had a reasonable expectation of success in doing so.” In re
Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal
quotations and citations omitted).
B. Level of Ordinary Skill in the Art
In determining the level of skill in the art, we consider the type of
problems encountered in the art, the prior art solutions to those problems, the
rapidity with which innovations are made, the sophistication of the
technology, and the educational level of active workers in the field. Custom
Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d 955, 962 (Fed. Cir.
1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed.
Cir. 1983).
Petitioner contends that a person of ordinary skill in the art as of the
relevant date “would have had general knowledge of implantable medical
devices and various related technologies,” as well as “(1) at least a
bachelor’s degree in a relevant life sciences field, mechanical engineering,
electrical engineering, biomedical engineering, or equivalent coursework,
and (2) at least one year of experience researching or developing implantable
medical devices, and/or methods of their manufacture.” Pet. 11 (citing
Ex. 1003 ¶¶ 15–18). We applied this definition in our Institution Decision
and Patent Owner adopts it in this proceeding. Inst. Dec. 10–11; PO Resp.
IPR2019-01340
Patent 6,381,496 B1
11

11. As the above definition is both unopposed and consistent with the cited
prior art, we apply it here. See Okajima v. Bourdeau, 261 F.3d 1350, 1355
(Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill
level are not required “where the prior art itself reflects an appropriate level
and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v.
Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).
C. Claim Construction
We interpret the challenged claims “using the same claim construction
standard that would be used to construe the claim in a civil action under
35 U.S.C. [§] 282(b).” See 37 C.F.R. § 42.100(b) (2019). Under that
standard, we presume that a claim term carries its “ordinary and customary
meaning,” which “is the meaning that the term would have to a person of
ordinary skill in the art in question” at the time of the invention. In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (quoting
Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005)). Any special
definition for a claim term must be set forth in the specification with
reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
1475, 1480 (Fed. Cir. 1994). Limitations, however, may not be read from the
specification into the claims (In re Van Geuns, 988 F.2d 1181, 1184 (Fed.
Cir. 1993)), nor may the Board “construe claims during [an inter partes
review] so broadly that its constructions are unreasonable under general
claim construction principles” (Microsoft Corp. v. Proxyconn, Inc., 789 F.3d
1292, 1298 (Fed. Cir. 2015), overruled on other grounds by Aqua Products,
Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017)); see also, Nidec Motor Corp.
v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir.
2017) (“[W]e need only construe terms ‘that are in controversy, and only to
IPR2019-01340
Patent 6,381,496 B1
12

the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc.
v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
1. “set of operational parameters”
In our Institution Decision, we addressed Patent Owner’s contention
that we should construe a “set of operational parameters” as a “combination
of more than one type of data defining the stimulation pulses provided by the
implant device.” Inst. Dec. 7–12 (citing Prelim. Resp. 7–8; Ex. 1001, 17:2–
15, Figs. 7–8). At that point in the proceedings, and absent input from
Petitioner, we focused primarily on Patent Owner’s reference to “stimulation
pulses,” rather than the number or type of data defining those pulses. Id.
In support of its construction, Patent Owner pointed to Figure 6 of the
’496 patent, reproduced below. Prelim. Resp. 7–8.
Figure 6 shows “a block diagram of a portion of the implant device, or IPG
100 or 100', that functionally illustrates one manner that may be used in
accordance with the present invention to allow the patient user to select one
of a plurality of operational parameter sets (OPSs), for use by the implant
device.” Ex. 1001, 16:44–49.
IPR2019-01340
Patent 6,381,496 B1
13

In the context of a spinal cord stimulation system (SCS), Figure 6
“functionally illustrates one manner in which different operational parameter
sets may be selected for use by the implant device.” Id. at 5:5–17, 5:23–28,
5:46–50. This includes,
data that defines operational parameters that are used within the
implant device 100 or 100' to control its operation in accordance
with an operating program stored in its memory 162. Such data
is forwarded to appropriate locations within a memory 162,
which specified locations may be considered as a memory table
165.
Id. at 16:63–17:1; see also Figs. 7–8 (illustrating memory tables in IPG and
hand held programming device, respectively). “[M]emory table 165 includes
individual addressable locations wherein various operational parameters may
be stored.” Ex. 1001, 17:2–4. In this embodiment:
A first operational parameter may comprise data that defines the
pulse width (PW) of a stimulation pulse. Yet other operational
parameter data may define the pulse rate (PR), pulse amplitude
(PA), electrode configuration (EC), ramp rate (RR), treatment
times (TI), a first other parameter (P1), and a second other
parameter (P2), and the like, associated with a stimulation pulse
sequence. All such data, when combined, thus define an
operational parameter set (OPS) that may be used by the implant
device 100 or 100' as it provides stimulation pulses through
selected electrodes.
Id. at 17:4–14.
In our Institution Decision, we noted that Patent Owner’s first
proposed definition was unduly narrow, as it presupposed control of
stimulation impulses in an implanted SCS, whereas, “none of the challenged
claims recite a spinal cord stimulation system or any other type of implanted
pulse generator that might require a set of operational parameters to direct
the implanted device to deliver “stimulation pulses.” Inst. Dec. 13. We
further noted that the ’496 patent’s emphasis on the “broad applicability” of
IPR2019-01340
Patent 6,381,496 B1
14

the invention to “any other programmable implant system” “including all
types of neural stimulators and sensors, deep brain stimulators, cochlear
stimulators, drug delivery systems, muscle tissue stimulators, and the like.”
Id. at 13–14 (citing 1:16–19, 1:37–45, 5:55–62). Thus, rather than limited to
“defining the stimulation pulses” of an SCS system, as indicated in Patent
Owner’s first proposed construction, we noted that appropriate operational
parameters for a drug delivery system may be “related to the type of drug
delivery, [or] the drug medication rate of delivery.” Id. at 14 (citing
Ex. 1001, 1:20–29).
Considering the breadth of the ’496 disclosure, we found that all of
the recited operational parameters were directed to “control[ing] the
intended function(s) of some implanted device.” Inst. Dec. 14. In particular,
we stated that
irrespective of the type of device or system, the Specification
explains that “[t]he present invention relates to the manner in
which these operational parameters, used by the implant system
as it carries out its intended function, are changed and managed.”
Id. at 1:34–37. “When it is necessary to change the operation of
such an implanted device, it is necessary to modify the
parameters used by the device as it carries out its intended
function, e.g., delivering stimulation pulses, delivering drug
medication, sensing physiological activity, or the like.” Id. at
1:29–34.
Inst. Dec. 14. Accordingly, we rejected Patent Owner’s proposed
construction as overly restrictive and provisionally construed “set of
operational parameters” as “at least two types of data used by a device to
carry out an intended function.” Id.
Patent Owner now argues that we should construe “set of operational
parameters” as “a combination [or collection] of at least two types of data
used by a device to carry out an intended function.” PO Resp. 12–13 (citing
IPR2019-01340
Patent 6,381,496 B1
15

Ex. 2006 ¶¶ 38–39); Sur-reply 3. Somewhat at odds with its position that the
phrase requires “at least two types of data,” Patent Owner argues that the
claim term “‘set’ means ‘a number of things of the same kind that belong or
are used together.’” PO Resp. 15–16 (emphasis added) (citing Ex. 2016, 4;
2017, 4; Ex. 2018, 6; Ex. 2019, 7; Ex. 2006 ¶40). In this respect, Petitioner
points out that even applying the “colloquial definition of ‘set’” referenced
by Patent Owner, “a ‘set’ does not need to have two types of data,
irrespective of what ‘type of data’ means.” Reply 4 (citing e.g., Ex. 2016, 4).
As noted by Dr. Kroll in the context of claim 8, “each set could have one
element.” Ex. 2005, 70:16–71:11.
With respect to intrinsic evidence, Patent Owner points to the memory
tables in Figures 6–8 of the ’496 patent where “OPSs are stored in ‘memory
tables’” that “include individual addressable locations wherein various
operational parameters may be stored.” PO Resp. 13–14 (citing Ex. 1001,
17:2–4, 17:38–43, 18:14–17, 19:4–7, 19:20–21, Figs, 6–8, Ex. 2006 ¶¶ 40–
42). Patent Owner argues that the figures and related text “make clear . . .
that each OPS is a combination of stored data for each of several operational
parameters.” Id. at 14–15 (citing Ex. 1001, 17:4–15, 17:25–32; Ex. 2006
¶ 40) (emphasis omitted). In particular, “[e]ach operational parameter (or
type of data) is found in one column of each row” and, as recited at column
17, lines 4–11 of the ’496 patent, may define “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),
and the like, associated with a stimulation pulse sequence.” Id. at 14–15
(citing Ex. 1001, 17:4–15, 17:25–32; Ex. 2006 ¶ 40. Patent Owner
emphasizes the ’496 Patent’s assertion that “[a]ll such data, when combined,
thus define an operational parameter set (OPS) that may be used by the
IPR2019-01340
Patent 6,381,496 B1
16

implant device.” Id. at 15 (quoting Ex. 1001, 17:4–15) (emphasis added by
Patent Owner).
Petitioner, by contrast, proposes that we construe “set of operational
parameters” as “the set of data used by a device to carry out an intended
function.” Reply 2–8. Petitioner contends that, whereas dictionary
definitions of “set” (including those submitted by Patent Owner) encompass
a wide variety of meanings, in the context of the ’496 patent we should look
to its technical or mathematical meaning of a collection of objects
encompassing any number of members, including one and zero, i.e., a “null
set.” Reply 3–5 (citing Ex. 1024, 155 (defining “empty set” as having zero
elements), 334 (defining “null set” as an empty set), 432 (defining set as,
inter alia, “[a] well-defined collection of objects.”), 441 (defining
“singleton” as “[a] set containing just one element”); Ex. 1022, 88:14–89:6;
Ex. 2016–2019); see PO Resp. 15–16; Reply 3–4 (addressing dictionary
definitions).
Patent Owner responds that “Petitioner’s reliance on the ‘technical
(i.e., mathematical)’ definition of ‘set’ to include zero and single member
sets . . . ignores the context of the ’496 patent––which is directed to medical
devices, not mathematics.” Sur-reply 3. In this respect, we cannot agree with
Patent Owner. Of course, the ’496 patent generally, and the disputed claim
term in particular, are directed to the electronic control of medical devices.
Indeed, Figures 6–8 and the related text upon which Patent Owner relies,
feature a block diagram of circuitry including memory for controlling a
representative device. See, e.g., Ex. 1001, 17:14–24 (describing circuitry and
control logic for generating stimulation impulses). Such technical pursuits,
however, inescapably embody the application of mathematical principles
and, as the ’496 patent does not expressly define this term to the contrary,
IPR2019-01340
Patent 6,381,496 B1
17

we agree with Petitioner that one of ordinary skill in the art (as defined in
section II.F, above) would have understood it in the mathematical/technical
sense.
We also, however, note Patent Owner’s salient observation that
“Petitioner never explains how a device can use a set of data having zero
members to carry out an intended function.” Sur-reply 3. Petitioner neither
points to, nor do we discern, any evidence that “set” in the context of the
’496 patent describes or suggests the execution of any intended function
based on a null set. Absent such explanation or evidence, we determine that
any definition for “set of operational parameters” must include at least one
operational parameter.8
Petitioner also argues that the ’496 patent does not “require at least
two types of data.” And although Patent Owner’s arguments rely on the SCS
embodiment, the ’496 patent itself asserts “broad applicability,” and may be
used with many other types of implant devices and/or systems. Reply 5
(citing Ex. 1001, 5:55–62). Petitioner argues, for example, that the ’496
patent is applicable to controlling an implant device such as an insulin pump
described by Irsigler9 where the single parameter is flow rate. Id. (citing
Ex. 1023, 1072, Fig. 1; Ex. 1001, 1:38–45 (asserting applicability to “drug

8 We view the plural “parameters” in this phrase as merely a linguistic
convention encompassing sets having more than one parameter (as shown,
for example, in the SCS-based examples of the ’496 patent).
9 Irsigler, K., et al., “Long Term Continuous Intraperitoneal Insulin Infusion
with an Implanted Remote-Controlled Insulin Infusion Device,” Diabetes,
30(12):1072-1075, (December 1981), Ex. 1023.
IPR2019-01340
Patent 6,381,496 B1
18

delivery systems”); Ex. 1022, 91:17–92:12 (Patent Owner’s expert noting
that early pacemakers used a single operational parameter)).10
Patent Owner contends that the insulin pump Petitioner refers to is
irrelevant as outmoded technology. Sur-reply 4. We are unpersuaded by
Patent Owner’s attorney argument in light of the ’496 patent’s asserted
“broad applicably” to SCS systems “or any other programmable implant
system,” “including all types of . . . drug delivery systems. . . regardless of
whether such systems incorporate implantable or external components.”
Ex. 1001, 1:16–19, 1:34–45, 5:55–62.
In sum, we agree with Petitioner, that “set of operational parameters”
does not require at least two types of data. And to the extent Patent Owner’s
reference to “a combination,” or even “a collection,” might be read to infer
such a requirement, we are unpersuaded they should be included in the
construction for the reasons stated. Accordingly, we modify our initial
construction as Petitioner proposes, and construe “set of operational
parameters” as “set of data used by a device to carry out an intended
function.”
2. “parameter context switching.” (Claim 14)
The preamble to claim 14 recites: “An implant system that permits
parameter context switching.” In our Institution Decision, we noted that the
Specification provides an express definition of “parameter context
switching” as “defining and/or selecting different operational parameter sets

10 Patent Owner’s counsel also contends that the Irsigler insulin pump “uses
at least three types of data.” Sur-reply 4 (citing Ex. 1023, 1072). But as we
understand the reference, Irsigler indicates that although the pump may be
programmed to respond to different biological conditions, this reduces to
different levels for a single parameter—flow rate.
IPR2019-01340
Patent 6,381,496 B1
19

for use by an implant device,” and provisionally adopted that term to the
extent construction was required. Inst. Dec. 15–16 (citing Ex. 1001, 5:44–
47). To the extent necessary, we apply that definition here.
The parties presently agree that the express definition of the
“parameter context switching” applies, but disagree as to whether the
preamble is limiting and, thus, whether the term should be accorded
patentable weight. PO Resp. 17, 56–60; Reply 8, 22; Sur-reply 23.
Patent Owner contends that, despite its sole recitation in the preamble,
“‘parameter context switching’ is a substantive limitation of claim 14 and its
dependents,” because it is “a focus” of the ’496 patent highlighted in the
title, abstract, and specification, and because it discloses steps that are
essential to the invention. PO Resp. 56–60 (citations omitted). Patent Owner
points to On Demand Mach. Corp. v. Ingram Indus., Inc., 442 F.3d 1331,
1343–44 (Fed. Cir. 2006), as instructive, where recitation of “high speed
manufacture” in the preamble was “limiting because this concept was
‘fundamental’ to the invention and the ‘entirety of the claim implements the
preamble’s high speed manufacture of a single copy’ of a book.” Id. at 59–
60. Patent Owner argues that, as in On Demand,
the entirety of claim 14 implements the ’496 patent’s
fundamental concept of parameter context switching, yet the
concept is only stated in the preamble. Without its preamble,
claim 14 recites only standard features of implantable devices—
e.g., “a first memory element” for storing a “set of operational
parameters” and “control data” that defines a single “set of
operational parameters.” (EX1001 at 20:65-21:21.) Only with
the framework provided by the preamble’s “parameter context
switching” does claim 14 align with the stated purpose and
invention of the ’496 patent.
Id. at 60.
IPR2019-01340
Patent 6,381,496 B1
20

Patent Owner’s argument has some merit. It is not, however,
dispositive because we are not guided solely by the specification. “Whether
to treat a preamble as a limitation is determined on the facts of each case in
light of the overall form of the claim, and the invention as described in the
specification.” Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1357 (Fed.
Cir. 2012) (internal quotation marks omitted). Although we agree with
Patent Owner that the Specification of the ’496 patent highlights context
switching as an important aspect, Patent Owner does not cite any case law
requiring the Applicant to seek protection for a highlighted element in every
claim. Nor does Patent Owner argue that the case law requires that any
element highlighted in the specification must be read into every claim where
it is not recited.
We also take particular note of the overall form of the claim. “If the
claim preamble, when read in the context of the entire claim, recites
limitations of the claim, or, if the claim preamble is ‘necessary to give life,
meaning, and vitality’ to the claim, then the claim preamble should be
construed as if in the balance of the claim.” Pitney Bowes, Inc. v. Hewlett
Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (citations omitted). Here,
the preamble to claim 14 recites “[a]n implant system that permits parameter
context switching.” As Petitioner points out, the “permits” element of the
preamble indicates the permissive nature of claim 14 and describes a
purpose of the implant system to permit parameter context switching. Reply
22. The body of the claim, however, neither references nor describes the
concept of parameter context switching.11 Rather, it describes a structurally

11 In this respect, we decline to read the word “permit” in the preamble as
“describ[ing] a device that practices parameter context switching,” as Patent
Owner proposes. See Sur-reply 24; SuperGuide Corp. v. DirecTV Enters.,
IPR2019-01340
Patent 6,381,496 B1
21

complete invention comprising an implant device, an external control
device, and an external charging device. Ex. 1001, 20:65–21:22. Because
“the body of the claim fully and intrinsically sets forth the complete
invention, including all of its limitations, and the preamble offers no distinct
definition of any of the claimed invention’s limitations, but rather merely
states, for example, the purpose or intended use of the invention, [] the
preamble is of no significance to claim construction because it cannot be
said to constitute or explain a claim limitation.” Pitney Bowes at 1305.
Accordingly, we are persuaded that the preamble to claim 14 should
not be read as limiting.
D. Overview of Asserted References
1. Shelton (Ex. 1005)
Shelton is directed to “implantable medical devices capable of
generating output stimulating pulses at selectable energy levels” and more
specifically, implantable cardiac pacemakers having programmable
stimulating pulse amplitudes selectable by means of an external
programming unit. Ex. 1005, code (57), 1:6–9. Shelton discloses that “state-
of-the-art implantable medical devices are vastly more sophisticated and
complex than early pacemakers, and are capable of performing significantly
more complex functions.” Id. at 1:20–23. For example, incorporating digital
circuits in implantable devices allows for programming and reprogramming
to alter one or more operating parameters. Id. at 3:13–24. Shelton discloses

Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). (“Though understanding the claim
language may be aided by the explanations contained in the written
description, it is important not to import into a claim limitations that are not
a part of the claim.”)
IPR2019-01340
Patent 6,381,496 B1
22

that because “digital technology has made it possible to program numerous
non-invasively programmable parameters in implantable devices, it is now
relatively common for pacemakers to provide for a plurality of different
stimulating pulse amplitude settings.” Id. at 3:32–36.
Shelton discloses an implantable pacemaker that may be non-
invasively programmed via telemetry using a commercially available
external programming unit such as the Medtronic Model 9760 programmer.
Id. at 8:22–43. An embodiment of Shelton’s pacemaker is shown in Figure
1, reproduced below.

Figure 1 depicts a block diagram of implantable pacemaker 10. Id. at 7:21–
22.
Implantable pacemaker 10 includes “activity sensor 50 [] bonded to
the inside of the pacemaker’s outer, protective shield.” Id. at 9:12–15.
Activity sensor 50 is coupled to input/output circuit 22, which includes
microcomputer circuit 24. Id. at 15–23. Microcomputer circuit 24 includes
microprocessor 25, on-board random access memory (“RAM”) 27, and read
IPR2019-01340
Patent 6,381,496 B1
23

only memory (“ROM”) 28, which are each coupled to digital
controller/timer circuit 31. Id. at 9:24–34. Input/output circuit 22 is also
connected to antenna 23 through radio frequency (“RF”) telemetry circuit
33, which may be coupled directly to microcomputer circuit 24. Id. at 9:46–
54.
Digital controller/timer circuit 31 “includes certain registers for
storing digital data used in the control of pacemaker functions.” Id. at 12:6–
8. For programmable functions, “the digital data representing selected values
for programmable parameters are downloaded from an external
programming device to pacemaker 10 via the telemetry link.” Id. at 12:9–12.
Figure 2, reproduced below, shows a diagram of an eight-bit atrial output
control register.

Figure 2 depicts the format of an eight-bit atrial control register in the digital
controller/timer circuit from Figure 1. Id. at 7:23–25. The register includes
several bit positions, including AUNB, which identifies unipolar or bipolar
atrial pacing; ACPD, which enables and disables the atrial portion of charge
pump circuit 44; AREG, which enables and disables charge pump
comparator 46, and AAS3–AAS0, which determine the amplitude of atrial
stimulating pulses. See id. at 12:25–67, 13–15, Tables 1, 2. Figure 3 depicts
a similar ventricular output control register. Id. at 13:50–52.
Shelton discloses that “for each chamber there are sixteen possible
amplitude settings.” Id. at 15:29–32. “[D]igital controller/timer circuit 31
implements a pacing algorithm and at various times takes steps to initiate
IPR2019-01340
Patent 6,381,496 B1
24

delivery of atrial and/or ventricular stimulating pulses.” Id. at 15:54–57. The
resulting operation of pacemaker 10 “offers ten programmable pacing pulse
amplitude settings.” Id. at 23:33–36. Shelton discloses “some of the
programmable amplitudes are implemented as ‘regulated’ settings for which
charge pump comparator 46 is used to ensure that output pulses are
generated at the desired amplitude.” Id. at 23:39–42.
2. Nappholz (Ex. 1006)
Nappholz is directed to cardiac stimulation system including an
implanted device in communication with an external device. Ex. 1006, code
(57). The implantable device may be a cardiac monitoring and/or stimulation
device, and the external device may be a repeater, programmer and
telephone (“RPP”). Id. at 3:61–65. The system including implantable cardiac
device (“ICD”) 12 and RPP 14 is shown in Figure 2, reproduced below.

Figure 2 depicts a block diagram of an implantable cardiac device.
The implantable cardiac device 12 may include microprocessor 46
connected to RAM/ROM unit 49. Id. at 4:30–52. The external device, e.g.,
IPR2019-01340
Patent 6,381,496 B1
25

RPP 14, may also include a microprocessor connected to an external
memory used to store programming data. Id. at 5:56–60; see Figure 3. The
programming data may include “a complete set of operational parameters,
and allowable ranges for these parameters and other programmable options.”
See id. at 6:64–67. RPP 14 may further communicate with a remote control
console located in a physician’s office. Id. at 4:11–13.
Nappholz discloses remotely modifying operation of the implantable
cardiac device in Figure 6, reproduced below:

Figure 6 depicts a flow chart for remotely changing the operational
parameters of an implantable cardiac device via the RPP. Id. at 3:35–37.
IPR2019-01340
Patent 6,381,496 B1
26

“At implantation, [] device 12 is programmed in a conventional
manner.” Id. at 7:8–9. To remotely modify operation of the implantable
device, “the physician enters instructions for the initializing or changing of
the functional parameters.” Id. at 7:59–60. The functional parameters are
then downloaded from the remote console to the RPP and then to the
implantable cardiac device. Id. at 7:60–65.
Nappholz discloses that “the cardiac stimulation device must be
adaptable to various physiological or pathological conditions and to vary the
therapy applied to the patient accordingly.” Id. at 8:60–66. A method for
varying therapy is shown in Figure 7, reproduced below:

IPR2019-01340
Patent 6,381,496 B1
27

Figure 7 depicts a flow chart for changing the operation of the device by the
patient. Id. at 3:38–39.
The implantable cardiac device communicates with the external
device to request information from the patient when it “detects a change
which may require a different mode of operation.” Id. at 9:19–24. The
patient may then select a response from a menu of activities displayed by the
external device. Id. at 9:24–29. Based on that selection, the implantable
cardiac device “reconfigures or modifies its operational parameters, in Step
306.” Id. Upon this modification, the implantable cardiac device may also
alert the patient of a change in its mode of operation. Id. at 9:39–40.
3. Mumford (Ex. 1009)
Mumford is directed to a computer-controlled programmer designed
to control the parameters of a wide variety of implantable devices, e.g.,
cardiac pacers and neural stimulators, with different programming
requirements. Ex. 1009, code (57), 1:30–38. Mumford discloses “[t]he
programmer automatically changes programming options in response to . . .
selection of certain modes and lead configurations. The programmer
software is designed to limit access to certain ranges of values of parameters
and certain parameters themselves, which require the attendance of an
authorized physician.” Id. at 2:66–3:5. Mumford teaches an access control
digital lock used to control the level of access to the programmer. Id. at
5:55–56. Entering the correct combination permits full access mode to the
programmer, as opposed to the limited access mode. Id. at 5:59–66.
4. Barreras ’217 (Barreras I, Ex. 1007)
Barreras I is generally directed to implantable devices and, in
particular, to an implantable stimulator that delivers electrical stimulation
IPR2019-01340
Patent 6,381,496 B1
28

pulses to a targeted tissue. Ex. 1007, code (57).12 With respect to such
devices, Barreras I states that, “it is important that the physician or medical
technician be permitted to change the pulse current frequency, pulse width
and ON time of the electric stimulation impulses.” Id. at 7:51–54.
Accordingly, Barreras I discloses “[a] system for delivering electric
stimulation pulses . . .comprising an implantable stimulator . . . [and] means
for programming said implantable stimulator such that said stimulator
delivers electric stimulation pulses to [a] targeted tissue in a manner
dependent upon the stimulation program.” See id. at 14:14–19 (claim 25 as it
depends from claim 16).
One embodiment of the Barreras I’s implantable stimulator system is
illustrated in Figure 1, reproduced below.

12 Barreras I makes clear that the disclosed invention is not limited to an
implantable stimulator, but encompasses other devices, such as implantable
drug delivery systems, pacemakers, and diagnostic units. See id. at 4:20–23,
6:22–28, 10:51–59.
IPR2019-01340
Patent 6,381,496 B1
29

Figure 1 depicts an implantable stimulator 10, hand held magnet 14,
programmer unit 16, and refresh-recharge transmitter unit 20. Id. at 4:61–64.
Implantable stimulator 10 includes modulator/demodulator and
decoder circuit 44 and memory unit 48. Id. at 6:12–14. Memory 48 “stores
information regarding the pulse width, pulse amplitude and stimulating
frequency, for the delivery of substantially continual stimulation pulses. Id.
at 7:42–46. Implantable stimulator 10 also includes capacitive energy power
supply and source 36 to provide source power for stimulating electronic
module 38. Id. at 6:7–11. Barreras I discloses implantable stimulator 10
includes antenna 11 for receiving RF telemetric data from programmer unit
16 and refresh-recharge transmitter 20. Id. at 5:56–6:2.
Programmer unit 16 includes programming circuit 92 and antenna 17.
Id. at 8:3–11. A physician or medical technician programs programming unit
16 with frequency, pulse width, and ON time, etc. via keyboard 90, and the
resulting program data is stored programming circuit 92. Id. Programmer
unit 16 “transfer[s] the commands and programming information from
antenna 17 to antenna 11. Upon receipt of this programming data,
modulator/demodulator and decoder 44 decodes and conditions these signals
and the digital programming information is captured by memory 48.” Id. at
8:8–15.
Refresh-recharge transmitter unit 20 includes primary battery 70 and
inductor coil 82 that emits RF waves which are received by inductor 30 of
the implantable stimulator. Id. at 6:34–46. Transmitter electronic module 76
sends out command signals via antenna 21 to antenna 11 in the implanted
stimulator. Id. at 6:47–54. “These received command signals are
demodulated by decoder 44 and replied and responded to based on a
program in memory 48. Memory 48 then activates the proper control and the
IPR2019-01340
Patent 6,381,496 B1
30

inductor receiver coil 30 [accepts] the RF coupled power from inductor 82.”
Id.
5. Barreras ’887 (Barreras II, Ex. 1008)
Barreras II is directed to a RF coupled neural stimulator system
including a subcutaneous receiver. Ex. 1008, 8:48–64. Barreras ’887
discloses the subcutaneous receiver is capable of: 1) memorizing data
defining all stimulation values in a non-volatile memory, 2) using the
memorized values to autonomously regulate “all stimulation functions such
as amplitude, rate, pulse width, amplitude ramp-up time at the start of
stimulation, amplitude ramp-down time when stimulation ceases, and
electrode polarity.” Id. at 8:53–56. The stimulation values are stored in
appropriate memory locations. Id. at 8:60–61.
Barreras II further discloses that a microcontroller associated with the
subcutaneous receiver receives specific data definition stimulation values,
electrode selection and polarity, all of which are programmed into an
erasable/reprogrammable non-volatile memory. Id. at 11:34–40. The device
then regulates the output voltage and on/off duration of a D/A converter. Id.
at 11:40–42.
E. Obviousness in view of Shelton and Nappholz (Ground 1)
As Ground 1, Petitioner challenges claims 1–3 and 6 as obvious over
Shelton and Nappholz. Pet. 20–37. Petitioner’s challenge includes a detailed
mapping of the teachings of these references to each limitation of the claims.
See id. In opposing the Petition, Patent Owner contends that the Petition fails
to establish that the following language from claim 1 is rendered obvious
under Ground 1: “a plurality of sets of operational parameters,” “selection
means for selecting one of the plurality of sets of operational parameters as
IPR2019-01340
Patent 6,381,496 B1
31

the control set of operational parameters that is stored in the control
register,” and “whereby the operation of the implant device may be changed
through selection of a different set of operational parameters.” PO Resp. 25–
50; Sur-reply 5–23. Patent Owner further challenges Petitioner’s assertions
with respect to the “memory circuity” and “memory means external to the
implant device wherein the plurality of sets of operational parameters are
stored” recited in claims 2 and 3, respectively. PO Resp. 47–50; Sur-reply
22.
We have reviewed Petitioner’s contentions regarding Ground 1 and
conclude that Petitioner has established by a preponderance of the evidence
that the undisputed limitations are taught or suggested by the prior art for the
reasons disclosed in the Petition. We address the disputed elements below.
1. Petitioner’s contentions regarding disputed elements of Claim 1
Claim 1 recites “electronic circuitry including a control register
wherein a control set of operational parameters is stored.” As stated on page
24 of the Petition, “Shelton discloses loading data to control the implanted
pacemaker into an eight-bit atrial output control register that resides in
digital controller/timer circuit,” illustrated in Figure 2, reproduced below.
Pet. 24.

Figure 2 shows the eight-bit atrial control register referenced by Petitioner.
Ex. 1005, 7:23–25. The register includes several bit positions, including
AUNB, which identifies unipolar or bipolar atrial pacing; ACPD, which
enables and disables the atrial portion of charge pump circuit 44; AREG,
IPR2019-01340
Patent 6,381,496 B1
32

which enables and disables charge pump comparator 46, and AAS3–AAS0,
which determine the amplitude of atrial stimulating pulses. See id. at 12:25–
67. According to Petitioner, “Shelton also loads data to control the implanted
pacemaker into a ventricular output control register.” Pet. 24 (citing
Ex. 1005, 14:1–10. The controller retrieves the data from the control register
to control the operation of the pacemaker. Id. (citing Ex. 1005, 12:6-24;
Ex. 1003 ¶ 66).
Claim 1 further recites “a controller that controls the operation of the
implant device as a function of the control set of operational parameters
stored in the control register.” With respect to this element, Petitioner relies
on Shelton’s teaching that “digital controller/timer circuit 31 uses the data in
the atrial output control register to control various aspects of atrial pacing by
pacemaker 10.” (Pet. 25 (citing Ex. 1005, 12:20–23; Ex. 1003 ¶ 74)).
Petitioner points to the data in the atrial output register, for example, as a
control set of operating parameters. Id. (citing Ex. 1005, 12:20-23; Ex. 1003
¶¶ 74–75).
With respect to “a plurality of sets of operational parameters,”
Petitioner states that “[w]hile Shelton discloses a pacemaker having a
selectable output amplitudes . . . it may not expressly disclose a plurality of
sets of operational control parameters.” Pet. 25 (citing Ex. 1005, 23:33–42,
24:28–32). Petitioner, however, argues that this element is disclosed by
Nappholz. Id. (citing Ex. 1003 ¶ 76). In particular, Petitioner asserts that
Nappholz discloses different modes of operation corresponding to different
levels of activity for a patient, e.g., sleep/rest, getting up, exercise, and
taking medication. Id. at 25; see id. at 45–48. Petitioner asserts that when the
patient selects a new mode of operation, Nappholz’s device reconfigures or
modifies the operation parameters, wherein each mode of operation
IPR2019-01340
Patent 6,381,496 B1
33

corresponds to a different set of operational parameters. Id. (citing Ex. 1006,
9:17–29, Fig. 7; Ex. 1003 ¶¶ 76–78) Accordingly, Petitioner contends, “it
would have been obvious to a POSA that a physician or a patient should
have the capability to define respective characteristics associated with the
operation of the implant device.” Id. at 26 (citing ¶¶ 76–79); see also id. at
49 (“it would have been obvious to a POSA that if a user selects a different
level of activity the user is selecting one of the stored sets of operational
parameters as a control set”) (citing e.g., Ex. 1003 166–168).
Petitioner relies on Nappholz and Shelton with respect to the means
plus function limitation, “selection means for selecting one of the plurality
of sets of operational parameters as the control set of operational parameters
that is stored in the control register.” Referencing the action of
microcontroller 160 of the ’496 patent, Petitioner contends that Shelton’s
Figure 1 illustrates a similar structure performing the same function. Pet. 26–
28 (citations omitted); Ex. 1003 ¶¶ 81–90.
Petitioner further relies on Nappholz as disclosing selection means,
stating that with Nappholz’s RPP, “a user can change the mode of operation
of Nappholz’s implant device by making a selection of a new level of
activity” where “each mode of operation corresponds with a different set of
operational parameters.” Id. at 28 (citing Ex 1006, 9:17–29, Fig 7; Ex. 1003
¶ 91).
Petitioner concludes that one of skill in the art reading Shelton in view
of Nappholz,
would have appreciated that Nappholz’s operational parameter
sets for controlling the pacemaker (e.g., from Nappholz’s RPP)
would be downloaded by the implanted device (e.g., Shelton’s
pacemaker) using Shelton’s telemetry circuit and communicated
to Shelton’s RAM unit. In response to a selection of an activity
IPR2019-01340
Patent 6,381,496 B1
34

level using Nappholz’s RPP, a control set of operating
parameters are transferred from Shelton’s RAM unit to Shelton’s
control registers, via the data and control bus.
Pet. 28–29 (citing Ex. 1003 ¶¶ 81-92).
Further addressing the “selection means,” Petitioner points to
Shelton’s description of external programming devices, such as the
Medtronic Model 9760, that can communicate with an implanted device and
select a set of operational parameters for controlling an implanted device. Id.
at 29 (citing Ex. 1005, 8:14–50; Ex. 1010 ¶¶ 83–86). Petitioner further
contends that Nappholz’s RPP 14 could also perform this function. Id.
(citing Ex. 1006, Fig. 7, 9:17–29; Ex. 1003 ¶ 93). Petitioner concludes that,
in light of Shelton and Nappholz, one of ordinary skill in the art would have
known that “that an external programming unit such as Nappholz’s RPP can
transmit sets of operational parameters to be stored in memory of an implant
device using a telemetry circuit.” Id. (citing Ex. 1003 ¶ 94).
Petitioner similarly addresses the claim language, “whereby the
operation of the implant device may be changed through selection of a
different set of operational parameters,” asserting that “Nappholz describes
changing the operation of the implant device by selecting a new level of
activity using Nappholz’s RPP, which can select a set of operational
parameters for controlling an implanted device.” Pet. 30 (citing Ex. 1006,
9:17–29). Accordingly, Petitioner contends, “Shelton in view of
Nappholz . . . describes changing the operation of the implant device through
selection of a different set of operational parameters.” Id. (citing Ex. 1003 ¶¶
96–97).
IPR2019-01340
Patent 6,381,496 B1
35

2. Patent Owner’s Response
Patent Owner contends that Shelton alone does not disclose a plurality
of sets of operational control parameters, pointing out that even Petitioner
admits that this element is not expressly disclosed in Shelton. PO Resp. 26
(citing Pet. 20, 25; Ex. 1003 ¶¶ 60, 76). Rather, Patent Owner contends
Shelton’s Figure 2 illustrates the disclosure of “at best, only a singular
‘control set of operational parameter’—an additional limitation of the ’496
patent that is separate and distinct from a ‘plurality of operational parameter
sets.’” Id. at 27–28 (citing Ex. 1005, 12:20–24). As we understand this
argument, Patent Owner contends that although Shelton discloses ten pulse
amplitude settings programmable with an external controller, these settings
are not concurrently stored in memory. See PO Resp. 29 (citing Ex. 2005,
71:20–72:3, 72:5–73:3, 77:23–78:23). Thus, according to Patent Owner’s
expert, “Shelton discloses a plurality of programmable—not selectable—
settings for a single parameter—i.e., a single type of data for example pulse
amplitude . . . . . Shelton does not even hint at defining, storing, or selecting
from a ‘plurality of operational parameter sets’ . . . .” Id. (citing Ex. 2006 ¶¶
3–9, 48). We are persuaded that Petitioner’s position is correct.
As construed in section II.C.1, above, “set of operational parameters”
means “set of data used by a device to carry out an intended function.”
Shelton Figure 2 shows eight bit positions, four of which (AAS3, AAS2,
AAS1, and AAS0) determine the amplitude of atrial stimulating pulses.
Ex. 1005, 12:25–67, 13–15 Tables 1, 2. Data at these positions comprise a
set of operational parameters and, in particular, “the control set of
operational parameters that is stored in the control register,” set forth in
claim 1. Shelton discloses a “selection means,” i.e., an external programmer
like the Medtronic Model 9760, which can be used to select pulse amplitude
IPR2019-01340
Patent 6,381,496 B1
36

settings and communicate them to the implanted device. Patent Owner’s
expert states that, “Shelton discloses a plurality of programmable—not
selectable—settings for a single parameter—i.e., a single type of data for
example pulse amplitude.” Ex. 2006, ¶48; Reply 9. But Petitioner points out
that the Medtronic Model 9760 allows a user to save at least one set of
operational parameters and to later select that saved set of operational
parameters. Reply 9–10 (citing Ex. 1022, 111:18–112:7). In this light, we
agree with Petitioner that “Shelton alone discloses a plurality of selectable
sets of operational parameters that govern stimulation amplitudes” and,
therefore, satisfies the disputed claim elements under our construction. See
Reply 10 (citing Ex. 1005, 13–15, Tables 1, 2).
Patent Owner also argues that Shelton fails to disclose “set[s] of
operational parameters” because cardiac stimulation devices employ
sophisticated algorithms to dynamically adjust therapy incrementally, or not
at all. PO Resp. 30. But to the extent the pulse amplitude selected in Shelton
is fed into an algorithm, it nevertheless, is still a “set of data used by the
device to carry out an intended function.” See section II.C.1, above.
Patent Owner further argues that Sheldon fails to disclose “set[s] of
operational parameters” because its device cannot be programmed by a
patient, but requires physician input to change amplitude settings. PO Resp.
5–9, 31–24; Sur-reply 8–10. We are persuaded Petitioner is correct for the
reasons set forth on pages 10–11 of the Reply. In short, although patient
accessibility is one of the benefits touted in the specification of the ’496
patent, this is not an element of claim 1. To the contrary, claim 1 is agnostic
as to the user, if any. See Ex. 1022, 72:3–14 (Dr. Langer admitting that claim
1 does not require a patient to manually select an operational parameter nor
preclude selection by clinician or physician users).
IPR2019-01340
Patent 6,381,496 B1
37

We further note that the only reference to patient control of operating
parameters is found in claim 17 (not challenged under Ground 1), which
includes “a manual patient selection circuit that allows a patient user of the
external control device to selectively alter the selected plurality of individual
operating parameters.” In this respect, claim differentiation suggests that the
remaining claims do not require a means for patient user control.
Accordingly, the claims encompass physician-only programming and,
indeed, automatic adjustments based on the patient’s physiology or behavior.
To the extent Shelton alone does not satisfy the disputed elements,
Petitioner further relies on Nappholz. Patent Owner contends “[l]ike Shelton,
Nappholz also fails to disclose a plurality of ‘sets of operational parameters
under any claim construction.” PO Resp. 35 (emphasis omitted). In
particular, Patent Owner points to Nappholz as describing an operational
program “including a complete set of operational parameters, and allowable
ranges for these parameters and other programmable options [] stored in the
external console 27 or RPP.” Id. at 35–36 (citing Ex. 1006, 6:64:67, 7:8–9,
7:50–8:2; Ex. 2006 ¶¶ 52, 53, 64). Accordingly, Patent Owner argues,
Nappholz’s device is implanted with “a single set of operational parameters
that will allow it to operate properly under all possible conditions.” Id.
(citing, e.g., Ex. 2006 ¶¶ 53, 64).
We are persuaded that Petitioner’s position is correct. Indeed, in this
respect, the arrangement Patent Owner describes in Nappholz is comparable
to memory table 165 of the ’496 patent, which comprises “individual
addressable locations wherein various operational parameters may be
stored,” and where “most of these operational parameters, if not all, are
initially defined by the clinician using the clinician programmer.” Ex. 1001,
17:2–4, 17:45–55; see also id. at 17:25–45 (describing retrieval of
IPR2019-01340
Patent 6,381,496 B1
38

operational parameters stored in memory). Consistent with Patent Owner’s
description, Nappholz describes that a physician can preprogram the entirety
of this information into the device at the time of implantation, such that it
contains all possible sets of operational parameters available to a particular
patient. Ex. 1006, 6:64–67 (operating program having “a complete set of
operational parameters, and allowable ranges for these parameters and other
programmable options is stored in the external console 27 or RPP 14), see
also Reply 12–13 (discussing additional evidence that Nappholz’s
operational parameters are preprogrammed for a particular patient and
selectable as illustrated in Figure 7).
Moreover, and illustrative of “selection means for switching between
multiple operational parameters,” Nappholz’s claim 27 recites, “means for
generating first and second electrical stimulation signals for said heart to
provide selectively one of a corresponding first therapy and a second
therapy, means for switching between said first and second therapies in
response to data from said patient indicative of a change in a condition of the
patient.” Ex. 1006, 17:12–22. Accordingly, Patent Owner’s distinction
between the multiple operational parameters of claim 1 exemplified in
memory table 165 of the ’496 patent, and Nappholz’s description of the
entirety of its programming options as a complete set of operational
parameters (i.e., comprising all sets of operational parameters that can be
deployed as control sets), is a matter of semantics with no patentable
significance.13 Both systems comprise a defined number of operational

13 Accordingly, we see no contradiction in Dr. Kroll’s testimony that “if
we’re going to make a selection between multiple choices [i.e., between
more than one operational parameter], those choices have to exist
somewhere” because Nappholz’s device is pre-programmed with all of the
IPR2019-01340
Patent 6,381,496 B1
39

parameters, albeit accessed in different manners. Those of memory table 165
are addressable by the location of the group, whereas those in Nappholz are
addressable by the location of individual elements comprising the group.
Irrespective of how their data are structured and accessed, they are both a
“set of operational parameters,” in that each is a “set of data used by a
device to carry out an intended function.”
As set forth in the Petition and illustrated in Figure 7, Nappholz
discloses that, in response to a query from the device, a patient may change
the mode of operation using a remote communication console. For example,
when the device 12 detects a change which may require a
different mode of operation, it establishes communication via a
routine handshake. The device 14 then requests information from
the pat[i]ent about his level of activity. Various levels of activity
are displayed, as shown in Step 302. This is accomplished by
showing a menu of 2S activities on display (Step 302). In Step
304, the patient selects a key on unit 14 corresponding to his level
of activity, the device 12 then reconfigures or modifies its
operational parameters.
Ex. 1006, 9:17–29; see also claim 27. Patent Owner contends that Nappholz
fails to satisfy the disputed claim elements because the above “passage
makes clear that the device—not the patient. . . initiates the selection process
when it ‘detects a change which may require a different mode of operation.’”
PO Resp. 37.
Patent Owner’s position does not prevail for at least the reasons set
forth on pages 11–13 of the Reply, which we adopt. As discussed above, we
emphasize that claim 1 does not require that the patient select a different
operational parameter set and, accordingly, the claim is met from selection

sets of operational parameters available for treating a particular patient. See
Ex. 2005, 67:4 –76:4.
IPR2019-01340
Patent 6,381,496 B1
40

by a physician, the device itself, or a digital algorithm. Indeed, even Patent
Owner’s expert conceded “that the selection means in Claim 1, in addition to
the hand-held programmer, would enable automatic selection of an
operational parameter set without the intervention of either a patient user or
a physician user or a clinician user.” Ex. 1022, 71:4–12, 72:3–8.
Moreover, and contrary to Patent Owner’s interpretation, Nappholz
does discloses patient selection of operational parameters, as is illustrated in
Nappholz’s Figure 7. That a patient’s input may be prompted by Nappholz’s
system, and that the precise set of operational parameters selected may be
interpreted and refined by the system’s algorithm is not contrary to the
challenged claims. See Sur-reply 19–20 (distinguishing use of algorithm to
provide incremental changes and as-need “dynamic” therapy from
“swap[ping] one entire set of operational parameters for another.”).
We are similarly persuaded that the modes of operation disclosed in
Nappholz are operational parameter sets. PO Resp. 40–44. Although Patent
Owner argues that “‘mode’ has a very specific meaning in the pacemaker art
. . . . [that] does not carry over to spinal stimulators,” the claims at issue are
not limited to spinal simulators. See id. at 41–42; Ex. 1022, 72:17–20.
Patent Owner further argues that “Nappholz does not perform a
context switch as defined in the ’496 patent” because it “‘reconfigures or
modifies its operational parameters’ rather than swapping in a complete new
set.” PO Resp. 42–44. As an initial matter, we note that “parameter context
switching” is specific to the preamble of claim 14. See section II.C.2, above.
We, nevertheless, credit Petitioner’s argument that Nappholz’s device is
configured to change the set of operational parameters within a given mode.
Reply 15–16 (citing, e.g., Ex. 2006 ¶¶ 63–64; Ex. 1006 (based on patient
input, “device 12 reconfigures or modifies its operational parameters”)).
IPR2019-01340
Patent 6,381,496 B1
41

Although the ’496 patent discloses embodiments in which a first set of
operational parameters stored in first location is replaced with a second set
stored in a second location, we do not read this as a requirement of the
challenged claims. We find it sufficient that Nappholz discloses modifying a
set of operational parameters to create a second set of operational
parameters. Once modified, the new set of operational parameters serve as
the control set of operational parameters, irrespective of whether the
modification involved replacing a single parameter or the entirety of the
original set, and irrespective of how, or how often, that process occurs.
Patent Owner further argues that Nappholz fails to disclose selecting
from a plurality of sets of operational parameters, and that Petitioner
improperly relies on the same feature to satisfy both the “defining” element
of claim 12, and “selecting” elements of claims 1 and 8. PO Resp. 44–45.
Petitioner’s position is more persuasive. As we understand the reference, the
parameters programmed into Nappholz’s device by a physician define the
universe of possible sets of operational parameters available to the device,
individual sets of which may be selected as the control set of operational
parameters by the algorithm, and with input from the patient. We
additionally credit Petitioner’s argument that the defining and selecting
elements are satisfied because Nappholz’s external console or RPP includes
a complete set of operational parameters, and because the physician must
customize the implanted device for the particular patient and the patient’s
condition. Reply 18 (citing Ex. 1006, 6:56–67). Accordingly, “the physician
. . . enters instructions for initializing or changing the functional parameters
of the implant device.” Id. (citing Pet., 54).
Patent Owner further argues that one of ordinary skill in the art would
not have understood Nappholz or Shelton to disclose defining, storing, or
IPR2019-01340
Patent 6,381,496 B1
42

selecting from a plurality of sets of operational parameters, because they
“would not consider it necessary or safe to allow a patient the ability to
make wholesale changes to the operational parameters of such a system.”
PO Resp. 46; Sur-reply 21–22. We disagree with Patent Owner for the
reasons set forth at pages 18–20 of the Reply, which we adopt. See also id at
45–49 (similar arguments in context of Claim 8). In short, we do not read the
challenged claims to require a patient unfettered access to a device’s
operational parameters. Yet, as Petitioner points out, “Nappholz’s express
disclosure belies the safety argument because it unambiguously allows a
user to select an activity level, and thus”—with the assistance of the devices
internal programming—a set of operational parameters. Reply 19.
3. Disputed elements of claims 2 and 3
With respect to claim 2, Petitioner points to Shelton’s RAM/ROM
unit 29 within microcomputer circuit 24, and/or Nappholz’s RAM 49 as
“electronic circuitry . . . includ[ing] memory circuitry wherein the plurality
of sets of operational parameters are stored.” Pet. 30 (citing Ex. 1005, 9:27–
34, 9:24–34; Ex. 1006, Fig. 2; Ex. 1003 ¶¶ 100–101). With respect to claim
3, Petitioner points to memory 106 in Nappholz’s RPP/external console as
disclosing “memory means external to the implant device wherein the
plurality of sets of operational parameters are stored.” Pet. 34 (citing
Ex. 1006, 3:1–10, 5:57–60, 7:59–64; Ex. 1003 ¶¶ 113–117. As summarized
in Patent Owner’s Sur-reply, Patent Owner argues that claims 2 and 3 refer
to where “the plurality of sets of operational parameters are stored,” but
[t]he passages of Nappholz on which Petitioner relies do not
disclose the storage of a plurality of OPSs; they disclose only that
the initial “functional parameters are downloaded to external
RPP 14” (EX1006 at 7:61-62) and then “are downloaded from
IPR2019-01340
Patent 6,381,496 B1
43

RPP 14 to the cardiac stimulating device 12.” (EX1006 at 7:63-
64.) These passages thus relate to the initial programming of one
set of operational parameters—not to the storage of a plurality
of sets of operational parameters. (EX2006 ¶¶ 52-53, 74, 77-78.)
Sur-reply 21–22; see PO Resp. 47–50.
We agree with Petitioner here, at least with respect to Nappholz.
Nappholz discloses an operational program having “a complete set of
operational parameters, and allowable ranges for these parameters and other
programmable options [] stored in the external console 27 or RPP,” which
we equate to the memory table 165 of the ’496 patent (comprising
“individual addressable locations wherein various operational parameters
may be stored”) and, the storage location for a plurality of sets of operational
parameters. See section II.D.2, above; Ex. 1001, 17:2–4. Ex. 1006, 6:64–67.
In addition, Petitioner points to Nappholz’s Figure 6 and corresponding text
stating that: “In step 250 the functional parameters are downloaded to
external RPP 14. In step 252, the functional parameters are downloaded
from RPP 14 to the cardiac stimulating device 12.” Reply 20 (quoting
Ex. 1006, 7:59–64). Petitioner, thus, reasons that Step 252 stores the
operational parameters on Nappholz’s implant device, and that the
operational parameters are also loaded on Nappholz’s implant device using
Nappholz’s external programming device. Id. Petitioner notes, as do we, that
the operational parameters loaded onto the Nappholz’s implant device
include a plurality of sets of operational parameters that correspond to the
patient’s selection of an activity level. Id. at 20–21.
4. Weight of Expert Opinions
Patent Owner contends that we should accord little or no weight to
Dr. Kroll’s opinions. PO Resp. 21–25; Sur-reply 25–26. Patent Owner,
IPR2019-01340
Patent 6,381,496 B1
44

however, neither challenges Dr. Kroll’s credentials nor moves to exclude his
testimony. Patent Owner’s primary complaint appears to be that more than
140 paragraphs of Dr. Kroll’s 265-paragraph declaration are essentially
identical to the Petition such that it “merely repeats arguments from the
Petitioner verbatim.” PO Resp. 22–23. Patent Owner also points to three
instances at Dr. Kroll’s deposition ( Ex. 2005, 71:7–11, 101:11–102:5,
105:22–106:9) and two in his declaration ( Ex. 1003 ¶¶ 76, 167) where it
contends Dr. Kroll provided opinions unsupported by credible evidence. PO
Resp. 24; Sur-reply 26.
Although it is often helpful to the Board for an expert declaration to
further explicate or support a party’s assertions, we have not been apprised
of requirement that they do so. Irrespective of the precise relationship
between the declaration and a party’s assertions, we consider the clarity of
the expert’s opinions, whether those opinions are supported in the record, the
expert’s experience and qualifications, and the reputation the witness puts on
the line with every submission to, and deposition before, this body. In the
present case, we do not find Dr. Kroll’s testimony as a whole so wanting as
to be given little or no weight. We, nevertheless, take Patent Owner’s
arguments into account in considering Dr. Kroll’s testimony, and draw our
conclusions based on the entirety of the record.
5. Conclusion as to Ground 1
Patent Owner makes no additional arguments with respect to claim 6,
relying instead on its arguments with respect to claim 1. PO Resp. 23. For
the reasons set forth above, Petitioner has established by a preponderance of
the evidence that claims 1–3, and 6 are obvious in view of Shelton and
Nappholz.
IPR2019-01340
Patent 6,381,496 B1
45

F. Grounds 2–4: Obviousness over one or more of Shelton, Nappholz,
Mumford, and Barreras ’887
As Ground 2, Petitioner challenges claims 4 and 5 as obvious over
Shelton, Nappholz, and Mumford. Pet. 37–42. As Ground 3, Petitioner
challenges claim 7 as obvious over Shelton, Nappholz, and Barreras ’887
(Barreras II). Pet. 42–44. As Ground 4, Petitioner challenges claims 8–13 as
obvious over Nappholz. Pet. 44–57. For each ground, Petitioner challenge
includes a detailed mapping of the teachings of these references to each
limitation of the claims.
For each of Grounds 2–4, Patent Owner relies solely on its arguments
with respect to Ground 1. PO Resp. 50–51 (arguing that “Mumford does not
disclose ‘a plurality of sets of operational parameters’ and Petitioner does
not suggest that it does”), 52–53 (arguing that “Barreras II does not disclose
‘a plurality of sets of operational parameters’ or selecting from such a
plurality and Petitioner does not suggest that it does”), 53–55 (restating prior
argument that although Nappholz discloses “an initial set of operational
parameters, this does not amount to a plurality of combinations of
operational parameters”); Sur-reply 23 (referencing “the same reasons
discussed above in regards to Ground 1”). We have addressed Petitioner’s
arguments regarding Ground 1 in section II.E, above. We have reviewed
Petitioner’s contentions regarding Grounds 2–4 and conclude that Petitioner
has established by a preponderance of the evidence that claims 4, 5, and 7–
13 are obvious over the combinations set forth in Grounds 2–4.
G. Ground 5: Obviousness over Barreras ’217 (Barreras I)
As Ground 5, Petitioner challenges claim 14 as obvious over
Barreras ’217 (Barreras I). Pet. 57–62; Reply 23. Petitioner’s challenge
includes a detailed mapping of the teachings of that reference to each
IPR2019-01340
Patent 6,381,496 B1
46

limitation of the claim. See id. Claim 14 recites, as preamble, “[a] implant
system that permits parameter context switching.” As discussed in section
II.C.2, above, we do not treat the preamble as limiting. As Patent Owner’s
arguments with respect to Ground 5 are based on this non-limiting language,
we are persuaded Petitioner prevails here. See PO Resp. 56–62; Sur-reply
23–25.
To the extent the preamble is limiting, parameter context switching
means “changing one set of operational parameters to another.” Ex. 1001, 5,
44–47; section II.C.2, above. Pointing to Barreras I’s disclosure of an
implanted stimulator that receives programming information, including
operating parameters such as frequency, pulse, width, and ON time,
Petitioner contends “Barreras’s programming information allows the
stimulating electronic module to change operational parameters,” and, thus,
discloses an implant system that permits parameter context switching. Pet.
57–58 (citing; Ex. 1007, 5:48–49, 8:3–6, 8:11–16, Fig. 1; Ex. 1003 ¶¶ 194–
195).
Patent Owner responds that Barreras I comprises an implantable
stimulator programmed via an external programmer. PO Resp. 60–61.
According to Patent Owner,
Once programmed, the operational parameter values that were
not chosen during programming are not stored in the device’s
memory or selectable by the physician or patient. There is also
no suggestion that any operational parameters are arranged as
combinations—i.e., sets of operational parameters. Thus,
Barreras I does not disclose defining, storing, or selecting from a
plurality of operational parameter sets.
PO Resp. 61 (citing Ex. 2006 ¶ 66); see also id. at 62 (quoting Petitioner’s
acknowledgement that “Barreras I does not specifically disclose transferring
a plurality of sets [of] operational parameters to the implanted device”); Sur-
IPR2019-01340
Patent 6,381,496 B1
47

reply 24–25 (Barreras I . . . discloses transmitting only one OPS––the
control set of operational parameters common to every implantable device—
which does not satisfy the ’496 patent’s limitation s of defining, storing, and
selecting from a plurality of OPSs”).
Patent Owner’s arguments are misplaced. Claim 14 does not recite the
limitations Patent Owner seeks to impose and contains no requirement for
defining or storing multiple sets of operational parameters. To the contrary,
claim 14 refers to only a single defined set of operational parameters stored
in memory. In particular, claim 14 refers to transferred “control data . . . that
defines the set of operational parameters stored in the first memory element
of the implant device,” and which control “electronic circuity that performs
a prescribed function.”
Thus, were we to accord the preamble patentable weight as Patent
Owner urges, claim 14 would instead require “changing one set of
operational parameters to another.” Barreras I satisfies this element. In
particular, Barreras I discloses an implantable stimulator system including a
programmer unit, with which a physician can program a set of operational
parameters (frequency, pulse width, and ON time), the data for which is
stored in memory unit 48. See section II.D.4, above. The programmer unit
transmits this information as command signals to the memory of the
implanted device, which thereby controls its operation. See id. When a
physician reprograms an implanted device to change one or more of the
operational parameters, this changes the set of operational parameters
controlling the device’s intended function. Barreras I claims this process as a
“means for programming [an] implantable stimulator such that said
stimulator delivers electric stimulation pulses to [a] targeted tissue in a
IPR2019-01340
Patent 6,381,496 B1
48

manner dependent upon the stimulation program.” Ex. 1007, 14:14–19.
Thus, as articulated by Petitioner,
Barreras I discloses transmitting at least one set of operational
parameters to the implant device from a programming unit 16 to
the implant device using the programming circuit 92 and antenna
17. EX1007, Barreras I, 8:3-15. Barreras I’s programming unit
may thus be used to define other sets of operational parameters
as well.
Reply 23.
In view of the above, we persuaded that Barreras I discloses means for
“defining and/or selecting different operational parameter sets for use by an
implant device,” and, thus, permits parameter context switching as set forth
in claim 14. Patent Owner does not challenge Ground 5 on any basis not
discussed above. We have reviewed Petitioner’s contentions regarding
Ground 5 and conclude that Petitioner has established by a preponderance of
the evidence that claim 14 is obvious in view Barreras I.
H. Ground 6: Obviousness over the combination of Barreras I and Nappholz
As Ground 6, Petitioner challenges claims 15 and 16 as obvious over
the combination of Barreras I and Nappholz. Pet. 62–69. Petitioner’s
challenge includes a detailed mapping of the teachings of these references to
each limitation of the claims. See id. In disputing Petitioner’s challenge
under Ground 6, Patent Owner relies on its earlier arguments with respect to
Barreras I and Nappholz, which we have discussed above in sections II.G
and II.E, respectively. See PO Resp. 62–63; Sur-reply 25. For the reasons
advanced by Petitioner (see Pet. 62–69), and for the reasons set forth in
sections II(G) and II(E), above, Petitioner has established by a
preponderance of the evidence that claims 15 and 16 are unpatentable over
the combination of Barreras I and Nappholz.
IPR2019-01340
Patent 6,381,496 B1
49

I. Ground 7: Obviousness over the combination of Barreras I, Nappholz,
and Mumford
As Ground 7, Petitioner challenges claims 17 and 18 as obvious over
the combination of Barreras I, Nappholz, and Mumford. Pet. 69–76.
Petitioner’s challenge includes a detailed mapping of the teachings of these
references to each limitation of the claims. See id. In disputing Petitioner’s
challenge under Ground 7, Patent Owner relies on its earlier arguments with
respect to Barreras I and Nappholz, which we address in the previous
section. See PO Resp. 63–64; Sur-reply 25. We have reviewed Petitioner’s
contentions regarding Ground 7 and conclude that Petitioner has established
by a preponderance of the evidence that claims 17 and 18 are unpatentable
under Ground 7.
J. Stipulated Protective Order and Patent Owner’s motion to seal
In Paper 22, Patent Owner submits a Stipulated Protective Order
based on our Default Protective Order but having modifications regarding
in-house counsel access and expert certifications. Petitioner does not oppose
(id. at 1) and we determine the proposed modifications are acceptable.
Accordingly, the Stipulated Protective Order (Attachment A to Paper 22)
shall apply to the confidentiality of documents submitted in this proceeding.
Also in Paper 22, Patent Owner moves to seal Exhibits 2007–2009,
2011, and portions of its Patent Owner Response containing data taken from
those exhibits. Id. at 4. Petitioner does not oppose the motion.
According to Patent Owner, Exhibit 2008 is a confidential physician
survey relating to the SCS market; Exhibit 2009 is confidential internal
presentation relating to SCS devices; and Exhibit 2011 is an internal SCS
market analysis. Id. at 2. According to Patent Owner, public disclosure of
IPR2019-01340
Patent 6,381,496 B1
50

this information would result in competitive harm to Patent Owner. Id. at 2–
4.
“There is a strong public policy for making all information filed in a
quasi-judicial administrative proceeding open to the public, especially in an
inter partes review which determines the patentability of claims in an issued
patent and therefore affects the rights of the public.” Garmin Int’l v. Cuozzo
Speed Techs., LLC, IPR2012-00001, Paper 34 (PTAB Mar. 14, 2013), 1–2.
For this reason, except as otherwise ordered, the record of an inter partes
review shall be made available to the public. 35 U.S.C. § 316(a)(1); 37
C.F.R. § 42.14.
The standard for granting a motion to seal is “for good cause.”
37 C.F.R. § 42.54(a). That standard includes a showing that
(1) the information sought to be sealed is truly confidential, (2) a
concrete harm would result upon public disclosure, (3) there
exists a genuine need to rely in the trial on the specific
information sought to be sealed, and (4) on balance, an interest
in maintaining confidentiality outweighs the strong public
interest in having an open record.
Argentum Pharms. LLC v. Alcon Research, Ltd., IPR2017-01053, Paper 27
(PTAB Jan. 19, 2018) (informative), 3–4. The moving party bears the
burden of showing that the relief requested should be granted. 37 C.F.R. §
42.20(c).
Patent Owner has set forth a reasonable case that good cause exists to
seal the identified information. Because our Decision does not rely on any of
the material sought to be protected we are satisfied that Patent Owner has
provided sufficient justification for keeping this information confidential,
which outweighs the heightened public interest in understanding the basis
IPR2019-01340
Patent 6,381,496 B1
51

for our decision on patentability. Accordingly, we grant Patent Owner’s
motion to seal.
III. CONCLUSION
On the present record, we find Petitioner has established by a
preponderance of the evidence that the cited references would have taught or
suggested each element of claims 1–18 of the ’496 patent, and set forth a
sufficient rationale for why a person of ordinary skill would have been
motivated to combine these teachings and suggestions to arrive at the
invention recited in those claims. Accordingly, and for the foregoing
reasons, Petitioner has met its burden of showing, by a preponderance of the
evidence, that claims 1–18 of the ’496 patent are unpatentable, as
summarized in the following table:
Claims 35 U.S.C §
Reference(s)/
Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
1–3, 6 103(a) Shelton, Nappholz 1–3, 6
4, 5 103(a)
Shelton,
Nappholz,
Mumford
4, 5
7 103(a)
Shelton,
Nappholz,
Barreras ’887
7
8–13 103(a) Nappholz 8–13
IPR2019-01340
Patent 6,381,496 B1
52

14 103(a) Barreras ’217 14
15, 16 Barreras ’217, Nappholz 15, 16
17, 18
Barreras ’217,
Nappholz,
Mumford
17, 18
Overall
Outcome 1–18

IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–18 of U.S. Patent No. 6,381,496 B1 are
determined to be unpatentable;
ORDERED that the Stipulated Protective Order (Attachment A to
Paper 22) applies to this proceeding;
ORDERED that Patent Owner’s Motion to Seal is Granted; 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.

IPR2019-01340
Patent 6,381,496 B1
53

For PETITIONER:
Jon Wright
Ian Soule
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
Jwright-ptab@sternekessler.com
Isoule-ptab@sternekessler.com

Ching-Lee Fukuda
Thomas Broughan
Sharon Lee
SIDLEY AUSTIN
clfukuda@sidley.com
tbroughan@sidley.com
Sharon.lee@sidley.com

For PATENT OWNER:
David Caine
Wallace Wu
ARONLD & PORTER KAYE SCHOLER LLP
David.caine@apks.com
Wallace.wu@apks.com