Filed: May 29, 2020
Latest Update: May 29, 2020
Summary: Case: 19-1582 Document: 91 Page: 1 Filed: 05/29/2020 NOTE: This disposition is nonprecedential. United States Court of Appeals for the Federal Circuit _ BOSTON SCIENTIFIC NEUROMODULATION CORPORATION, Appellant v. NEVRO CORP., Cross-Appellant ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor _ 2019-1582, 2019-1635 _ Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board i
Summary: Case: 19-1582 Document: 91 Page: 1 Filed: 05/29/2020 NOTE: This disposition is nonprecedential. United States Court of Appeals for the Federal Circuit _ BOSTON SCIENTIFIC NEUROMODULATION CORPORATION, Appellant v. NEVRO CORP., Cross-Appellant ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor _ 2019-1582, 2019-1635 _ Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in..
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Case: 19-1582 Document: 91 Page: 1 Filed: 05/29/2020
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
BOSTON SCIENTIFIC NEUROMODULATION
CORPORATION,
Appellant
v.
NEVRO CORP.,
Cross-Appellant
ANDREI IANCU, UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
AND DIRECTOR OF THE UNITED STATES
PATENT AND TRADEMARK OFFICE,
Intervenor
______________________
2019-1582, 2019-1635
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2017-
01812, IPR2017-01920.
______________________
Decided: May 29, 2020
______________________
MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP,
Washington, DC, for appellant. Also represented by
ANDREW TUTT; DAVID A. CAINE, Palo Alto, CA.
Case: 19-1582 Document: 91 Page: 2 Filed: 05/29/2020
2 BOSTON SCIENTIFIC v. NEVRO CORP.
CHING-LEE FUKUDA, Sidley Austin LLP, New York, NY,
for cross-appellant. Also represented by SHARON LEE;
RYAN C. MORRIS, Washington, DC; JON WRIGHT, Sterne
Kessler Goldstein & Fox, PLLC, Washington, DC.
MAI-TRANG DUC DANG, Office of the Solicitor, United
States Patent and Trademark Office, Alexandria, VA, for
intervenor. Also represented by THOMAS W. KRAUSE,
FARHEENA YASMEEN RASHEED.
______________________
Before LOURIE, MOORE, and O’MALLEY, Circuit Judges.
O’MALLEY, Circuit Judge.
This is an appeal from a consolidated inter partes re-
view proceeding requested by Nevro Corp. (“Nevro”). The
U.S. Patent Trial and Appeal Board (the “Board”) con-
cluded that certain claims of U.S. Patent No. 6,895,280
(“the ’280 patent”), claims 8, 18, 22–24, and 27, are un-
patentable as obvious. J.A. 39–66, 73–97,103–151. The
Board concluded that claims 26 and 28–30 are not un-
patentable as obvious. Patent Owner Boston Scientific
Neuromodulation Corp. (“Boston Scientific”) appeals the
Board’s invalidity findings. Nevro cross-appeals the
Board’s conclusion that claims 26 and 28–30 are not un-
patentable as obvious. Because we agree with the Board’s
claim constructions and conclude that substantial evidence
supports the Board’s underlying factual findings, we affirm
the Board’s conclusions as to all challenged claims.
I. BACKGROUND
Resolution of this appeal does not require a detailed
recitation of the various prior art references and grounds
of unpatentability addressed in the Board’s decisions. Ac-
cordingly, only the facts relevant to this appeal are dis-
cussed below.
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BOSTON SCIENTIFIC v. NEVRO CORP. 3
A. The ’280 Patent
The ’280 patent, entitled, “Rechargeable Spinal Cord
Stimulator System,” relates to the use of a spinal cord stim-
ulation (“SCS”) system to reduce a patient’s chronic pain.
’280 patent, col. 1 ll. 13–17. The ’280 patent states that
prior art SCS systems struggled with a host of problems,
such as internal power storage and memory issues, large
physical size, and the need to utilize unwieldy surgical
techniques and tools. Id., col. 2 ll. 10–24. The inventors of
the ’280 patent developed a SCS system with “(1) a recharg-
ing system, (2) a system for mapping current fields, (3) op-
tional pulse ramping control, and (4) electrode impedance
measurements.”
Id., col. 1 ll. 19–22. The disclosed system
also “offers a simple connection scheme for detachably con-
necting a lead system thereto.”
Id., col. 2 ll. 62–64. Alt-
hough “the lead system [(comprising lead extension 120
and electrode array 110)] is intended to be permanent, the
IPG may be replaced should its power source fail, or for
other reasons.”
Id., col. 27 ll. 26–38.
As relevant to this appeal, claims 8, 22, 26, and 27 re-
cite an SCS system and method for implanting an SCS sys-
tem with the above-recited features. Independent claim 8
recites:
8. A spinal cord stimulation system comprising:
a multi-channel implantable pulse generator (IPG)
having a replenishable power source, the IPG hav-
ing a housing which contains IPG processing cir-
cuitry;
an implantable electrode array detachably con-
nected to the IPG, the electrode array having a
multiplicity of n electrodes (En) thereon;
a multiplicity of m stimulation channels provided
by the IPG, wherein each stimulation channel is in-
dependently programmable with different stimula-
tion parameters,
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4 BOSTON SCIENTIFIC v. NEVRO CORP.
wherein m is equal to or less than n, and m is 2 or
greater;
an external trial stimulator (ETS); and
a percutaneous extension which temporarily cou-
ples the ETS with the implantable electrode array.
’280 patent, col. 53 ll. 3–18. Independent claim 22 recites:
22. A spinal cord stimulation system comprising:
an implantable, multi-channel implantable pulse
generator (IPG) having a replenishable power
source;
an implantable electrode array detachably con-
nected to the IPG, the electrode array having a
multiplicity of n electrodes (En) thereon;
a secondary, implanted coil coupled electrically to
the replenishable power source;
an external battery charger including:
a primary coil;
a rechargeable battery contained in the
charger, electrically coupled to the primary
coil; and
a power amplifier for applying alternating
current derived from the rechargeable bat-
tery in the charger to the primary coil,
whereby the alternating current in the primary coil
is transcutaneously transferred to the secondary
implanted coil to the replenishable power source
contained in the IPG; and
alignment circuitry for detecting alignment be-
tween the primary and secondary coils, the align-
ment circuitry including a back telemetry receiver
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BOSTON SCIENTIFIC v. NEVRO CORP. 5
for monitoring the magnitude of the ac voltage at
the primary coil as applied by the power amplifier,
wherein reflected impedance associated with en-
ergy magnetically coupled through the primary coil
is monitored.
’280 patent, col. 55 l. 62–col. 56 l. 21. Independent claim
26 recites:
26. A method for implanting a spinal cord stimula-
tor system into a patient for stimulation therapy,
the method comprising:
(a) implanting a nerve stimulation lead
with a distally located, multi-electrode ar-
ray placed near target tissue, said lead hav-
ing a lead connector on the proximal end;
(b) connecting the lead connector to a per-
cutaneous extension;
(c) externalizing the percutaneous exten-
sion through the skin;
(d) connecting an external trial stimulator
(ETS) to the externalized lead extension;
(e) programming the stimulation parame-
ters at first optimal values;
(f) waiting a specified period of time and re-
programming the stimulation parameters
to second optimal values;
(g) disconnecting the percutaneous exten-
sion from the lead connector;
(h) connecting a multi-channel, implanta-
ble pulse generator to the lead connector;
(i) implanting the implantable pulse gener-
ator, while programmed to the second, op-
timal stimulation parameters.
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6 BOSTON SCIENTIFIC v. NEVRO CORP.
’280 patent, col. 57 ll. 13–36. Independent claim 27 recites:
27. A method of charging a rechargeable battery
contained within an implantable pulse generator
(IPG), which IPG is connected to an implanted, sec-
ondary coil antenna, the method employing an ex-
ternal battery charger, which charger contains a
rechargeable battery electrically connected to an
external, primary antenna coil, the method com-
prising:
(a) charging the rechargeable battery in the
eternal battery charger using an external
power source;
(b) aligning the primary antenna coil with
the implanted secondary coil;
(c) broadcasting electromagnetic energy
through the primary antenna coil;
(d) receiving the broadcast electromagnetic
energy through the secondary antenna coil,
whereby an alternating current is produced
in the secondary coil;
(e) rectifying the induced, alternating cur-
rent received by the secondary coil;
(f) charging the rechargeable battery car-
ried within the IPG, while monitoring the
charging current or voltage across the bat-
tery as the battery is being charged to pre-
vent overcharging; and
(g) stopping the charging at the battery
charger when the current or voltage at the
battery in the IPG reaches a prescribed
level.
’280 patent, col. 57 l. 37–col. 58 l. 20.
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BOSTON SCIENTIFIC v. NEVRO CORP. 7
B. Asserted Prior Art References
i. Holsheimer
Holsheimer is a U.S. patent entitled, “Multichannel
Apparatus for Epidural Spinal Cord Stimulation,” and dis-
closes a pulse generator that drives a plurality of electrodes
implanted near a patient’s spinal cord. J.A. 2136–37. The
implanted apparatus uses a “multi-channel neurological
pulse generator which provides independently controlled
voltage or current pulses.” J.A. 2156, col. 2 ll. 21–26; J.A.
2157, col. 3 ll. 56–59. The pulse generator is connected to
a lead with electrodes at the distal end, corresponding to
the number of channels. J.A. 2156, col. 2 ll. 26–29.
ii. Schulman
Schulman is a U.S. patent entitled, “Battery-Powered
Patient Implantable Device,” and discloses a device that
may be implanted under the skin of a patient for nerve or
muscle stimulation. J.A. 2293. An embodiment of the in-
vention includes a charging circuit that is capable of pro-
ducing a “charging current in response to an externally
produced AC magnetic field.” J.A. 2307, col. 2 ll. 1–3.
iii. Loeb
Loeb is a U.S. patent entitled, “Implantable Multichan-
nel Stimulator.” Loeb discloses an implantable multichan-
nel stimulator that includes a microstimulator array and
an electrode array “sealed or molded in a body compatible
material” to form an “integral implantable multichannel
stimulator unit.” J.A. 2621; J.A. 2636–37, col. 8 l. 66–col.
9 l. 3. The microstimulator array 45 is powered through
inductive coupling with an external power source. J.A.
2637, col. 9 ll. 33–58. Loeb discloses that the stimulator 50
includes “alignment means, such as a magnet or marker
48, that helps align the implanted microstimulator array
45, and more particularly the coils 30 . . . of the implanted
microstimulator arrays, with an external coil . . . connected
Case: 19-1582 Document: 91 Page: 8 Filed: 05/29/2020
8 BOSTON SCIENTIFIC v. NEVRO CORP.
to an external source that generates the modulated power
signal.” Id., col. 9 ll. 20–27.
iv. Alo
Alo is an article entitled, “Computer Assisted and Pa-
tient Interactive Programming of Dual Octrode Spinal
Cord stimulation in the Treatment of Chronic Pain.” J.A.
2221. Also discloses a study comparing two types of multi-
electrode stimulation systems with continuous stimulation
(“C-stim”): “patient controlled SCS” (“PC-stim”) and “multi-
stim SCS” (“M-stim”). J.A. 2223. The study involved pa-
tients with low-back pain, wherein electrodes were placed
at the T9 and T10 intervertebral disc spaces. J.A. 2224.
Patients tried different C-stim programs over a five- to
seven-day trial period. J.A. 2224–25.
C. The Board Proceedings
After Boston Scientific sued Nevro for patent infringe-
ment in the District of Delaware, Nevro filed two separate
petitions, requesting inter partes review of claims 8, 18,
22–24, and 26–30 of the ’280 patent. J.A. 2. On February
5, 2018, the Board instituted review on the grounds chal-
lenging claim 27 in both petitions and consolidated the two
proceedings. Id. The Board,
however, denied institution
on the grounds challenging claims 8, 18, 22–24, 26, and 28–
30. J.A. 2–3. After the Supreme Court issued its decision
in SAS Institute Inc. v. Iancu,
138 S. Ct. 1348 (2018), the
Board modified its institution decisions to review all chal-
lenged claims, on all grounds presented in the petitions.
J.A. 3.
On February 1, 2019, the Board issued its Final Writ-
ten Decision in the consolidated action. J.A. 1. The Board
concluded that Nevro had established, by a preponderance
of evidence, that challenged claims 8, 18, 22–24, and 27 of
the ’280 patent are unpatentable as obvious. J.A. 39–66,
73–97, 103–151. The Board did not find claims 26 and 28–
30 unpatentable, however. J.A. 66–72, 97–103.
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BOSTON SCIENTIFIC v. NEVRO CORP. 9
Boston Scientific timely appeals the Board’s final writ-
ten decision, challenging its obviousness determinations on
claims 8, 18, 22–24, and 27 of the ’280 patent. Nevro cross
appeals, challenging its non-obviousness determinations
on claims 26 and 28–30. We have jurisdiction under 28
U.S.C. § 1295(a)(4)(A).
II. DISCUSSION
Boston Scientific appeals: (1) the Board’s findings that
the prior art discloses “detachable leads”; (2) the Board’s
claim construction of “aligning” and “alignment”; (3) the
Board’s claim construction of “back telemetry receiver”;
(4) the Board’s finding that a person of ordinary skill in the
art (“POSA”) would have been motivated to combine the
Schulman and Loeb references; and (5) the Board’s refusal
to consider Exhibit C of Dr. Lipson’s declaration. Appellant
Br. 29–32. Nevro cross-appeals the Board’s construction of
“waiting” and its factual findings with respect to the Alo
reference. Appellee Br. 87. We address each issue in turn.
A. Substantial Evidence Supports
the Board’s Factual Findings
Regarding “Detachable Leads”
We review the Board’s legal determination of obvious-
ness de novo, and its underlying factual findings for sub-
stantial evidence. PPC Broadband, Inc. v. Corning Optical
Commc’ns RF, LLC, 815 F.3d 747, 751 (Fed. Cir. 2016).
Substantial evidence is “such relevant evidence as a rea-
sonable mind might accept as adequate to support a con-
clusion.” In re Gartside,
203 F.3d 1305, 1312 (Fed. Cir.
2000).
In holding that claims 8, 18, and 22–24 would have
been obvious over a combination of Holsheimer, Schulman,
and Loeb, prior art U.S. patents, the Board concluded that
both Holsheimer and the combination of Schulman and
Loeb disclose “detachable leads.” Boston Scientific argues
that the Board’s factual findings are erroneous because
Case: 19-1582 Document: 91 Page: 10 Filed: 05/29/2020
10 BOSTON SCIENTIFIC v. NEVRO CORP.
they are unsupported by substantial evidence. We disa-
gree.
The Board reasoned that Holsheimer discloses “detach-
able leads” based on its findings that: (1) Holsheimer dis-
closes an SCS system; and (2) “all known SCS systems at
the time of the ’280 patent used detachable leads.” J.A. 79–
80. Substantial evidence supports both findings. The
claimed invention in Holsheimer “provides a number of su-
perimposed current generated electrical fields for epidural
spinal cord stimulation.” J.A. 2156 at col. 2 ll. 21–23; J.A.
2157 at col. 3 ll. 54–55 (“a neurological stimulation system
employing the present invention to stimulate spinal cord
12 of the patient”). Four inventors of the ’280 patent testi-
fied, moreover, that prior to the critical date, “all SCS sys-
tems known to them employed detachable leads.” J.A. 80;
J.A. 3127; J.A. 3318; J.A. 3679–3680; J.A. 3899. And Bos-
ton Scientific’s expert, Dr. Lipson, testified that he is not
aware of any SCS systems that do not utilize detachable
leads, and that he had never implanted an SCS lead while
it was attached to an implantable pulse generator (“IPG”).
J.A. 81; J.A. 6506.
The Board further explained why, at the time of the in-
vention, all SCS systems required detachable leads. Rely-
ing on Dr. Lipson’s testimony, the Board explained that,
during the SCS system implantation process for percuta-
neous leads, “the lead is not attached to the IPG and, in
fact, could not be so attached, because the lead’s distal end
must remain free so that the needle can be removed by slid-
ing it back and over the free distal end of the lead.” J.A. 82
(citing J.A. 2960–61). Dr. Lipson also testified that even
implantation of SCS systems with paddle electrodes—like
those described in Holsheimer—required the use of detach-
able leads. J.A. 82–83 (citing 2961–62 at col. 30 ll. 2–7, col.
30 l. 24–col. 31 l. 10, col. 32 l. 3–col. 33 l. 9). The Board
properly relied on this substantial evidence to conclude
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BOSTON SCIENTIFIC v. NEVRO CORP. 11
that Holsheimer’s SCS system discloses “detachable
leads.” 1
Similarly, substantial evidence supports the Board’s
finding that a POSA “would have found it obvious” to com-
bine Schulman and Loeb into an SCS system that uses de-
tachable leads. In determining that a POSA would have
been motivated to combine the disclosures of both patents,
the Board relied on evidence that it had discussed in its
findings regarding Holsheimer. J.A. 113 (“Much of the ev-
idence considered in Section V.C.3.iii., above, is relevant
here.”). For example, the Board cited to the testimony from
four inventors of the ’280 patent that, prior to the critical
date, “all SCS systems known to them employed detacha-
ble leads.” J.A. 113 (emphasis included). The Board ex-
plained that this evidence “documents the knowledge a
POSITA would bring to bear in evaluating the appropriate
lead arrangement for an SCS system, e.g., that rendered
obvious by Schulman.” Id. The Board again considered the
testimony of Boston Scientific’s expert, Dr. Lipson, who tes-
tified that he was not aware of any SCS systems that do
1 Appellant argues that the Board’s finding is “le-
gally erroneous” because it “rests on a conclusion that Hol-
sheimer inherently discloses detachable leads.” Appellant
Br. 37. But the Board made no such finding. The Board
concluded that a POSA, at the time of the invention, would
have concluded that Holsheimer’s SCS system discloses
“detachable leads”—its conclusion did not rely on our in-
herency precedent. J.A. 79–83. In any event, even if the
Board concluded that Holsheimer discloses detachable
leads inherently (as opposed to expressly), for the reasons
stated above, we conclude that substantial evidence sup-
ports such a finding. See Finnigan Corp. v. Int’l Trade
Comm’n, 180 F.3d 1354, 1362 (Fed. Cir. 1999) (“Whether a
claim limitation is inherent in a prior art reference for pur-
poses of anticipation is . . . a question of fact.”).
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12 BOSTON SCIENTIFIC v. NEVRO CORP.
not utilize detachable leads, and that “the process by which
an SCS system is implanted requires a detachable connec-
tion to the IPG.”
Id. (citing J.A. 6506). And, the Board
considered the testimony of Nevro’s expert, Dr. Kroll, who
also testified that a POSA would have found it obvious to
use detachable leads. J.A. 114–115 (“We also do not agree
with Patent Owner’s argument that Dr. Kroll’s analysis in-
volves hindsight reasoning . . . record evidence also demon-
strates that, in an SCS system, detachability is required
and expected by those skilled in the art.”).
Accordingly, we conclude that the Board’s findings
with respect to the prior art’s disclosures of “detachable
leads” are supported by substantial evidence.
B. The Board’s Construction of
“Aligning” and “Alignment” is Not Erroneous
This court reviews the Board’s ultimate construction of
a claim de novo, with subsidiary factual findings involving
extrinsic evidence reviewed for substantial evidence.
Knowles Elecs. LLC v. Cirrus Logic, Inc., 883 F.3d 1358,
1361–62 (Fed. Cir. 2018). The broadest reasonable inter-
pretation standard applies in this IPR proceeding. Person-
alized Media Commc’ns., LLC v. Apple, Inc.,
952 F.3d 1336,
1340 (Fed. Cir. 2020). See also Changes to the Claim Con-
struction Standard for Interpreting Claims in Trial Pro-
ceedings Before the Patent Trial and Appeal Board, 83 Fed.
Reg. 51,340 (Oct. 11, 2018) (codified at 37 C.F.R. §
42.100(b)). Thus, the Board’s interpretation must be rea-
sonable in light of the specification, prosecution history,
and the understanding of one skilled in the art. See Mi-
crosoft Corp. v. Proxyconn, Inc.,
789 F.3d 1292, 1298 (Fed.
Cir. 2015), overruled on other grounds by Aqua Prods., Inc.
v. Matal,
872 F.3d 1290 (Fed. Cir. 2017) (en banc).
Claims 22 and 27 recite an “alignment circuitry for de-
tecting alignment between the primary and secondary
coils” and “aligning the primary antenna coil with the im-
planted secondary coil.” J.A. 12–13. In the underlying
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BOSTON SCIENTIFIC v. NEVRO CORP. 13
proceedings, Boston Scientific proposed construing these
“alignment” and “aligning” limitations as: “achieving a spa-
tial arrangement of the primary and secondary coils such
that charging efficiency is optimized based on measure-
ment of an electrical parameter.” J.A. 12. The Board re-
jected this construction and instead construed the terms to
mean “achieving a relative position between the primary
and secondary coils to permit energy transfer.” J.A. 12–13.
We find no error in the Board’s construction.
Intrinsic evidence supports the Board’s construction.
The plain language of the claims does not require position-
ing that achieves optimal charging efficiency. ’280 patent,
col. 55 l. 62–col. 56 l. 21; col. 57 l. 37–col. 58 l. 20. Rather,
the claim language simply identifies that the primary and
secondary coils must be aligned. Id. 2 The ’280 patent spec-
ification, moreover, uses the phrase “in terms of a relative
position between two elements, for example between elec-
trodes or between inductive coils.” J.A. 14 (citing ’280 pa-
tent, col. 1 ll. 51–55, col. 10 ll. 58–61, col. 41 ll. 12–17). And
although the specification addresses “efficient” charging or
“maximum power transfer,” it discusses this optimized
charging efficiency in the context of proper alignment, as
opposed to alignment generally. See J.A. 14–15 (citing ’280
patent, col. 5 ll. 6–9, col. 41, ll. 14–17, col. 44 ll. 27–28).
Thus, the ’280 patent supports the Board’s determination
that “alignment” only requires a relative position between
the two coils to allow some energy transfer.
2 We do not agree, however, that the Board’s con-
struction of “alignment” and “aligning” is broad enough to
include “misalign[ment].” See J.A. 14. After all, misalign-
ment suggests that the coils have not achieved a “relative
position . . . to permit energy transfer.” J.A. 12. That being
said, we agree with the Board that the proper construction
of the limitation covers concepts that fall short of “perfect”
or “optimized” alignment.
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14 BOSTON SCIENTIFIC v. NEVRO CORP.
Beyond the intrinsic evidence, the Board also cited to
dictionary definitions that are consistent with its construc-
tion of the “alignment” and “aligning” limitations. J.A. 16.
Thus, extrinsic evidence further supports the Board’s con-
struction that “align” requires coil placement in “relative
position” to permit energy transfer. J.A. 16 (citing J.A.
4572).
Accordingly, we agree with the Board that the broadest
reasonable interpretation of the “alignment” and “aligning”
limitations is “achieving a relative position between the
primary and secondary coils to permit energy transfer.”
C. The Board’s Construction of
“Back Telemetry Receiver” is Not Erroneous
Claim 22 recites “alignment circuitry” that includes a
“back telemetry receiver for monitoring the magnitude of
the ac voltage” and “reflected impedance.” ’280 patent, col.
56 ll. 15–21. In its Final Written Decision, the Board did
not explicitly construe the “back telemetry receiver” limi-
tation, but it rejected Boston Scientific’s argument that the
receiver “must, at a minimum, receive transmitted data or
information.” J.A. 17, 20–21. The Board’s determination
that a “back telemetry receiver” need not receive transmit-
ted data or information—only that it must monitor voltage
or impedance, or transmitting power—is not erroneous.
First, the claim language supports the Board’s con-
struction. Claim 22 recites that a “back telemetry receiver”
is part of the “alignment circuitry,” and its role is “monitor-
ing the magnitude of the ac voltage at the primary coils as
applied by the power amplifier.” ’280 patent, col. 56 ll. 14–
18. Therefore, “claim 22 already specifies what the ‘back
telemetry receiver’ is and what it does—it is circuitry that
monitors voltage and impedance.” J.A. 18 (emphasis in-
cluded). We agree with the Board that the claim does not
require the “back telemetry receiver” to additionally “re-
ceive transmitted data or information.” J.A. 18 (“[E]ven if
we agree that ‘back telemetry receiver . . . must, at a
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BOSTON SCIENTIFIC v. NEVRO CORP. 15
minimum, receive transmitted data or information,’ we dis-
agree in light of Patent Owner’s argument that monitoring
voltage or impedance, or transmitting power, is not ‘re-
ceiv[ing] transmitted data or information.’”).
Second, the ’280 patent specification supports the
Board’s construction. Like the claim language, the specifi-
cation states that the “back telemetry receiver” “monitor[s]
the magnitude of the ac power . . . thereby monitoring re-
flected impedance.” ’280 patent, col. 4 l. 64–col. 5 l.1, col.
42 ll. 36–43. Boston Scientific cites to portions of the ’280
patent that allegedly compel a different conclusion. Appel-
lant Br. 51, 53–54. But these portions describe the back
telemetry transmitter, not the back telemetry receiver. For
example, the specification explains that the back telemetry
transmitter 690 transmits information regarding changes
in rectification, while the back telemetry receiver 692 mon-
itors voltage and reflected impedance. ’280 patent, col. 42
ll. 33–43. None of these passages suggest that the “back
telemetry receiver” must receive transmitted data or infor-
mation, other than monitoring voltage or impedance, or
transmitting power.
Accordingly, we agree with the Board that the broadest
reasonable interpretation of “back telemetry receiver” does
not require that the element “receive transmitted data or
information,” other than monitoring voltage or impedance,
or transmitting power.
D. Substantial Evidence Supports the
Board’s Factual Findings
that a POSA Would Have Been
Motivated to Combine Schulman and Loeb
In its obviousness determination for claims 8, 18, 22–
24, and 27, the Board found that a POSA would have been
motivated to combine Schulman and Loeb to create an SCS
system. J.A. 108–09. Substantial evidence supports the
Board’s factual findings.
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16 BOSTON SCIENTIFIC v. NEVRO CORP.
The Board first relied on Schulman’s teachings that its
tissue stimulation system may be used for stimulating
nerves and neural pathways to relieve pain. J.A. 107 (cit-
ing J.A. 2293 (Abstract). It then credited Dr. Kroll’s unre-
butted testimony that SCS systems fall into the category of
systems described in Schulman, and that “it would have
been obvious to a POSA that Schulman’s system could be
used for SCS.” J.A. 107 (citing 2450 ¶ 22, J.A. 2476 ¶ 73).
The Board concluded that a POSA would have been mo-
tivated to combine the teachings of Schulman and Loeb
based on the disclosures in those references, and Dr. Kroll’s
testimony. J.A. 108–110. Schulman and Loeb are both di-
rected to tissue stimulation systems, J.A. 109 (citing J.A.
2293 (Abstract), J.A. 2636), and Schulman expressly incor-
porates Loeb, describing it as a known “[i]mplantable de-
vice for tissue stimulation.” J.A. 110 (citing J.A. 2307, col.
1, ll. 15–19.). And while Loeb discloses an “exemplary”
cochlear electrode array, the reference clarifies that this is
“one of many possible types of implantable electrode arrays
that may be used with the invention.” J.A. 2636, col. 8 ll.
1–6. Dr. Kroll, moreover, testified that a POSA would have
found it obvious to arrange Schulman’s microstimulators
in Loeb’s array configuration because: “(1) the array is less
likely to migrate from its implantation site, which provides
better control in stimulating a targeted area, and (2) the
array allows for better alignment of the charging coils of
the implanted and external components of the system, thus
allowing more efficient charging of the rechargeable power
sources.” J.A. 109 (citing J.A. 2472–73). We conclude that
substantial evidence supports the Board’s factual findings
regarding a POSA’s motivation to combine.
E. The Board Did Not Abuse its
Discretion When it Excluded
Exhibit C of Dr. Lipson’s Declaration
37 C.F.R. § 42.6(a)(3) provides that “[a]rguments must
not be incorporated by reference from one document into
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BOSTON SCIENTIFIC v. NEVRO CORP. 17
another document.” The Board’s determination that a
party improperly incorporated arguments by reference
from another document in violation of 37 C.F.R. § 42.6(a)(3)
is reviewed for an abuse of discretion. Intelligent Bio-Sys.,
Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed.
Cir. 2016).
Boston Scientific argues that the Board’s decision to ex-
clude Exhibit C of Dr. Lipson’s declaration was an abuse of
discretion because the excluded document was allegedly
“evidence not argument.” Appellant Br. 63. Boston Scien-
tific alleges that the Board “faulted Boston Scientific for
not putting more words in its brief (which is not evidence)
rather than simply citing to testimony from an expert di-
rectly showing why its argument is correct.” Id. We disa-
gree with Boston Scientific’s characterization of the
Board’s determination.
In the “Objective Indicia of Non-Obviousness” section
of its Patent Owner Response, Boston Scientific alleged
that certain products practice claim 27 of the ’280 patent.
J.A. 601–604. In support of these assertions, Boston Sci-
entific cited to Dr. Lipson’s declaration. Id. As the Board
noted, however, the Patent Owner Response failed to ad-
dress “certain elements of claims 8, 18, and 22–24 that are
not present in exemplary claim 27.” J.A. 56. For example:
[W]ith respect to claim 8, the Response does not ad-
dress “a multi-channel implantable pulse genera-
tor having a replenishable power source, the IPG
having a housing which contains IPG processing
circuitry,” “wherein m is equal to or less than n,
and m is 2 or greater,” or “a percutaneous exten-
sion.” With respect to claim 18, the Response does
not address the “soft ramping circuit” limitation.
And with respect to claim 22–24, the Response does
not address the “alignment circuitry” limitation.
Case: 19-1582 Document: 91 Page: 18 Filed: 05/29/2020
18 BOSTON SCIENTIFIC v. NEVRO CORP.
J.A. 56 (citations omitted). These missing elements are
only addressed in Exhibit C of the Lipson Declaration. See
J.A. 7062–91.
Boston Scientific’s reliance on Exhibit C for its objec-
tive indicia arguments for claims 8, 18, and 22–24 is clearly
an attempt to incorporate arguments by reference. Thus,
we conclude that the Board did not abuse its discretion in
excluding Exhibit C of Dr. Lipson’s declaration.
F. The Board’s Construction of “Waiting” is
Not Erroneous and Substantial Evidence
Supports the Board’s Factual
Findings Regarding Alo
Having considered the issues Boston Scientific raises
on appeal, we now turn to Nevro’s cross-appeal.
Independent claim 26 recites, inter alia, “(e) program-
ming the stimulation parameters at first optimal values;
(f) waiting a specified period of time and re-programming
the stimulation parameters to second optimal values.” ’280
patent, col. 57 ll. 25–29. In concluding that claim 26 is not
obvious over the combined teachings of Holsheimer and
Alo, the Board concluded that claim 26 requires sequential
steps of “programming,” then “waiting,” and then “re-pro-
gramming,” and that Alo does not disclose these limita-
tions. We conclude that the Board’s construction of the
“waiting” limitation is not erroneous, and that substantial
evidence supports its factual finding regarding the Alo ref-
erence.
The broadest reasonable interpretation of claim 26
supports a construction wherein the steps of “program-
ming,” “waiting,” and “re-programming” must be com-
pleted in that specific order. Claim 26 recites sequential
steps of programming the stimulation parameters, waiting
a specified period of time, and re-programming the param-
eters to “second optimal values.” ’280 patent, col. 57 ll. 25–
29. And as the Board noted, the prefix “re-,” in step (f) of
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BOSTON SCIENTIFIC v. NEVRO CORP. 19
the claim suggests that the recited “re-programming” is a
“new, second occurrence of programming that occurs after
the first ‘programming’ occurrence, recited in step (e).” J.A.
101. Therefore the “waiting” limitation must occur after
the first “programming” step (e) and before the second “re-
programming” step (f). J.A. 100–101. To hold otherwise
would render the “waiting” element superfluous and effec-
tively obviate the need to “re-program” the stimulation pa-
rameters.
Substantial evidence also supports the Board’s conclu-
sion that Alo does not disclose the “waiting” limitation,
much less for a “specified period of time.” Alo discloses a
study in which two electrodes were placed in the epidural
spaces of eighty patients. J.A. 2224. The electrode leads
were connected to a trial stimulator, which was pro-
grammed with various options, to be tested over a five to
seven-day trial period. J.A. 2224–25. In particular,
[t]he patient was sent home for the first 24 hours
of the trial with a simple C-stim program. This al-
lowed the patient to become familiar with the basic
controls of amplitude and the sensation of pares-
thesia. The next day the patient was given up to
24 programs to choose from (PC-stim) . . . . These
24 programs could be activated individually by the
patient at home using the transmitter. The patient
was instructed to try each program one at a time
and to rate each of the programs . . . .
Programs that did not provide effective paresthe-
sias were deleted. Treatment evolved via this di-
rect interactive approach to a set of optimal
programs that were stored in the transmitter.
J.A. 2225. The reference explains that, even on the first
day of the trial period, while in “C-stim” mode, the patient
may immediately re-program stimulation parameters, e.g.,
amplitude and frequency, to second optimal values, with-
out waiting for any period of time. J.A. 2225, 2227
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20 BOSTON SCIENTIFIC v. NEVRO CORP.
(“Patient control is limited to turning the single program
on or off and control of amplitude and frequency”). In the
“PC-stim” mode, moreover, the patient may immediately
re-program stimulation parameters, e.g., amplitude and
frequency, to second optimal values, without waiting for
any period of time. J.A. 2227.
Accordingly, we conclude that the Board’s construction
of the “waiting” limitation in claim 26, and its factual find-
ing that Alo does not disclose the “waiting” limitation, are
not erroneous.
III. CONCLUSION
For the foregoing reasons, the Board’s conclusions that
(1) claims 8, 18, 22–24, and 27 are unpatentable as obvious;
and (2) claims 26 and 28–30 are not unpatentable as obvi-
ous are affirmed.
AFFIRMED
COSTS
No costs.
