Case: 18-2220 Document: 69 Page: 1 Filed: 04/09/2020
United States Court of Appeals
for the Federal Circuit
______________________
NEVRO CORP.,
Plaintiff-Appellant
v.
BOSTON SCIENTIFIC CORPORATION, BOSTON
SCIENTIFIC NEUROMODULATION
CORPORATION,
Defendants-Cross-Appellants
______________________
2018-2220, 2018-2349
______________________
Appeals from the United States District Court for the
Northern District of California in No. 3:16-cv-06830-VC,
Judge Vince Chhabria.
______________________
Decided: April 9, 2020
______________________
DEANNE MAYNARD, Morrison & Foerster LLP, Wash-
ington, DC, argued for plaintiff-appellant. Also repre-
sented by SETH W. LLOYD, BRIAN ROBERT MATSUI; BITA
RAHEBI, Los Angeles, CA; KENNETH ALEXANDER KUWAYTI,
ERIC C. PAI, Palo Alto, CA; MICHAEL ALLEN JACOBS, San
Francisco, CA; BRADFORD J. BADKE, CHING-LEE FUKUDA,
Sidley Austin LLP, New York, NY; RYAN C. MORRIS,
CARTER GLASGOW PHILLIPS, Washington, DC.
MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP,
Case: 18-2220 Document: 69 Page: 2 Filed: 04/09/2020
2 NEVRO CORP. v. BOSTON SCIENTIFIC CORP.
Washington, DC, argued for defendants-cross-appellants.
Also represented by MARC A. COHN, EDWARD HAN; THOMAS
T. CARMACK, KRISTA MARIE CARTER, Palo Alto, CA.
______________________
Before MOORE, TARANTO, and CHEN, Circuit Judges.
MOORE, Circuit Judge.
Nevro Corporation sued Boston Scientific Corporation
and Boston Scientific Neuromodulation Corporation (col-
lectively, Boston Scientific) in the Northern District of Cal-
ifornia, alleging infringement of eighteen claims across
seven patents: U.S. Patent Nos. 8,359,102; 8,712,533;
8,768,472; 8,792,988; 9,327,125; 9,333,357; and 9,480,842. 1
The asserted patents are directed to high-frequency spinal
cord stimulation therapy for inhibiting an individual’s
pain. 2 According to the specification, conventional spinal
cord stimulation systems deliver electrical pulses to the
spinal cord to generate sensations, such as tingling or par-
esthesia, that mask or otherwise alter the patient’s pain.
’533 patent at 1:31–49. The claimed invention purportedly
improves conventional spinal cord stimulation therapy by
using waveforms with high frequency elements or
1 Nevro alleged infringement of claims 11, 21 and 23
of the ’102 patent; claims 7, 12, 35, 37 and 58 of the ’533
patent; claims 1 and 5 of the ’472 patent; claim 18 of the
’988 patent; claims 18, 34 and 55 of the ’125 patent; claims
5 and 34 of the ’357 patent; and claims 1 and 22 of the ’842
patent.
2 The ’102, ’533, ’988, ’125, ’357 and ’842 (collectively,
the Alataris patents) belong to the same patent family and
share a specification. The ’472 patent shares common in-
ventors with the Alataris patents and is likewise directed
to high-frequency, paresthesia-free spinal cord stimulation
therapy.
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NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 3
components, which are intended to reduce or eliminate side
effects. Id. at 2:49–56.
In July 2018, the district court issued a joint claim con-
struction and summary judgment order. The district court
held invalid as indefinite claims 7, 12, 35, 37 and 58 of the
’533 patent, claims 18, 34 and 55 of the ’125 patent, claims
5 and 34 of the ’357 patent and claims 1 and 22 of the ’842
patent. J.A. 5–11. As to the remaining six asserted claims,
which the district court held were not indefinite, the dis-
trict court granted Boston Scientific summary judgment of
noninfringement. J.A. 12–13. Nevro appeals the district
court’s judgment of invalidity. Boston Scientific cross-ap-
peals the district court’s determination that the remaining
six asserted claims are not indefinite. We have jurisdiction
under 28 U.S.C. § 1295(a)(1).
DISCUSSION
We review a district court’s grant of summary judg-
ment according to the law of the regional circuit, here the
Ninth Circuit. Kaneka Corp. v. Xiamen Kingdomway Grp.
Co., 790 F.3d 1298, 1303 (Fed. Cir. 2015). In the Ninth
Circuit, summary judgment is reviewed de novo. Brunozzi
v. Cable Commc’ns, Inc., 851 F.3d 990, 995 (9th Cir. 2017).
We review indefiniteness determinations de novo, except
for necessary subsidiary fact findings, which we review for
clear error. Cox Commc'ns v. Sprint Commc'n Co., 838
F.3d 1224, 1228 (Fed. Cir. 2016).
I. “paresthesia-free”
Several of the asserted claims are directed to embodi-
ments of the claimed invention in which “therapy-induced
paresthesia is not a prerequisite to achieving pain reduc-
tion.” ’533 patent at 3:16–19. Specifically, claims 18, 34
and 55 of the ’125 patent, claims 5 and 34 of the ’357 patent
and claims 7, 12, 35, 37, and 58 of the ’533 patent recite
systems or devices comprising a means for generating
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4 NEVRO CORP. v. BOSTON SCIENTIFIC CORP.
therapy signals that are “paresthesia-free.” 3 Claims 11, 21
and 23 of the ’102 patent, claims 1 and 5 of the ’472 patent
and claim 18 of the ’988 patent are method claims reciting
similar limitations. Claim 18 of the ’125 patent is illustra-
tive of the asserted system and device claims and recites:
18. A spinal cord modulation system for reducing
or eliminating pain in a patient, the system com-
prising:
means for generating a paresthesia-free therapy
signal with a signal frequency in a range from 1.5
kHz to 100 kHz; and
means for delivering the therapy signal to the pa-
tient’s spinal cord at a vertebral level of from T9 to
T12, wherein the means for delivering the therapy
signal is at least partially implantable.
(emphasis added). Claim 1 of the ’472 patent is illustrative
of the asserted method claims and recites:
1. A method for alleviating patient pain or discom-
fort, without relying on paresthesia or tingling to
mask the patient’s sensation of the pain, compris-
ing:
implanting a percutaneous lead in the patient’s
epidural space, wherein the percutaneous lead in-
cludes at least one electrode, and wherein implant-
ing the percutaneous lead includes positioning the
at least one electrode proximate to a target location
in the patient’s spinal cord region and outside the
sacral region;
3 As used in this opinion the term “paresthesia-free”
refers to “paresthesia-free,” “non-paresthesia-producing”
and similar phrases used to express the idea that a claimed
therapy or therapy signal does not produce paresthesia.
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NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 5
implanting a signal generator in the patient;
electrically coupling the percutaneous lead to the
signal generator; and
programming the signal generator to generate and
deliver an electrical therapy signal to the spinal
cord region, via the at least one electrode, wherein
at least a portion of the electrical therapy signal is
at a frequency in a frequency range of from about
2,500 Hz to about 100,000 Hz.
(emphasis added).
The district court determined that “paresthesia-free”
has a “clear meaning,” namely that the therapy or therapy
signal “does not produce a sensation usually described as
tingling, pins and needles, or numbness.” J.A. 9. It found,
based on extrinsic evidence, that “[a]lthough the parame-
ters that would result in a signal that does not create par-
esthesia may vary between patients, a skilled artisan
would be able to quickly determine whether a signal cre-
ates paresthesia for any given patient.” J.A. 11. The dis-
trict court therefore held that the term “paresthesia-free”
does not render the asserted method claims indefinite. Id.
The district court held indefinite, however, the asserted
“paresthesia-free” system and device claims. It held that
infringement of these claims depended upon the effect of
the system on a patient, and not a parameter of the system
or device itself and therefore, “a skilled artisan cannot
identify the bounds of these claims with reasonable cer-
tainty.” J.A. 10. Nevro appeals, arguing that the district
court erred in holding indefinite the asserted “paresthesia-
free” system and device claims. Boston Scientific cross-ap-
peals, arguing that the district court erred in holding that
the “paresthesia-free” method claims are not indefinite.
While the district court made several underlying fac-
tual findings, the parties dispute only the district court’s
legal conclusion of indefiniteness. Accordingly, we review
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6 NEVRO CORP. v. BOSTON SCIENTIFIC CORP.
the district court’s indefiniteness holdings regarding the
“paresthesia-free” claims de novo. BASF Corp. v. Johnson
Matthey, Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017). Under
35 U.S.C. § 112, patent claims must “particularly point[ ]
out and distinctly claim[ ] the subject matter” regarded as
the invention. Claims, viewed in light of the specification
and prosecution history, must “inform those skilled in the
art about the scope of the invention with reasonable cer-
tainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S.
898, 910 (2014); see Interval Licensing LLC v. AOL, Inc.,
766 F.3d 1364, 1371 (Fed. Cir. 2014). This standard “man-
dates clarity, while recognizing that absolute precision is
unattainable.” Nautilus, 572 U.S. at 910. We conclude
that the district court correctly determined that the “par-
esthesia-free” method claims are not indefinite, but that it
erred in holding indefinite the “paresthesia-free” system
and device claims.
It is undisputed that “paresthesia,” as used in the as-
serted patents, means “a sensation usually described as
tingling, pins and needles, and numbness.” See J.A. 6 (cit-
ing e.g., ’472 patent at 1:62–66). It is also undisputed that
“a skilled artisan would be able to quickly determine
whether a signal creates paresthesia for any given pa-
tient.” J.A. 11. In nonetheless holding indefinite the as-
serted “paresthesia-free” system and device claims, the
district court applied the wrong legal standard. The test
for indefiniteness is not whether infringement of the claim
must be determined on a case-by-case basis. Instead, it is
simply whether a claim “inform[s] those skilled in the art
about the scope of the invention with reasonable cer-
tainty.” Nautilus, 572 U.S. at 910. We conclude that both
the “paresthesia-free” method claims and the “paresthesia-
free” system and device claims satisfy this standard.
“Paresthesia-free” is a functional term, defined by what
it does rather than what it is. But that does not inherently
render it indefinite. See Halliburton Energy Servs., Inc. v.
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NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 7
M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008). In fact, we
have held that functional language can “promote[] definite-
ness because it helps bound the scope of the claims by spec-
ifying the operations that the [claimed invention] must
undertake.” Cox Commc’ns, 838 F.3d at 1232. When a
claim limitation is defined in “purely functional terms,” a
determination of whether the limitation is sufficiently def-
inite is “highly dependent on context (e.g., the disclosure in
the specification and the knowledge of a person of ordinary
skill in the relevant art area).” Halliburton, 514 F.3d at
1255. We have held that the ambiguity inherent in func-
tional terms may be resolved where the patent “provides a
general guideline and examples sufficient to enable a per-
son of ordinary skill in the art to determine the scope of the
claims.” Enzo Biochem. Inc. v. Applera Corp., 599 F.3d
1325, 1335 (Fed. Cir. 2010).
Here, the asserted claims recite parameters for a sys-
tem or device configured to generate a “paresthesia-free”
signal. See, e.g., ’125 patent at Claim 34; ’102 patent at
Claim 7. The specification teaches how to generate and
deliver the claimed signals using the recited parameters.
For example, the specifications of the Alataris patents de-
scribe a study comparing the effects of conventional sig-
nals and the effects of the claimed therapy signals. To
achieve paresthesia-free therapy signals, the specifica-
tions teach using “therapeutic signals at a frequency of
from about 3 kHz to about 10 kHz” and amplitudes ranging
“from about 1 mA to about 4 mA (normally about 2.5 mA).”
’533 patent at 6:51–7:5. Accordingly, a person of ordinary
skill would know whether a spinal cord stimulation sys-
tem, device or method is within the claim scope. Thus, the
patents provide reasonable certainty about the claimed in-
ventions’ scope by giving detailed guidance and examples
of systems and devices that generate and deliver paresthe-
sia-free signals with high frequency, low amplitude, and
other parameters. Enzo Biochem., 599 F.3d at 1335. That
Case: 18-2220 Document: 69 Page: 8 Filed: 04/09/2020
8 NEVRO CORP. v. BOSTON SCIENTIFIC CORP.
a given signal will eliminate paresthesia in some patients,
but not others, does not render the claims indefinite. See
id. at 1336 (“[T]he claims are not indefinite simply because
the binding strength of a DNA strand will vary based on
the strand’s length and sequence . . . .”).
Boston Scientific contends that the asserted “paresthe-
sia-free” claims are indefinite because infringement can
only be determined after using the device or performing the
method. Appellees’ Br. 44–46, 55–56 (citing Halliburton,
514 F.3d at 1254–55; Geneva Pharm., Inc. v. Glax-
oSmithKline PLC, 349 F.3d 1373, 1384 (Fed. Cir. 2003)).
We do not agree. Definiteness does not require that a po-
tential infringer be able to determine ex ante if a particular
act infringes the claims. See, e.g., Star Sci., Inc. v. R.J.
Reynolds Tobacco Co., 537 F.3d 1357, 1372–73 (Fed. Cir.
2008); Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d
1374, 1384 (Fed. Cir. 2005). Our decisions in Halliburton
and Geneva do not hold otherwise. In Halliburton, we held
claims reciting the term “fragile gel” indefinite not because
infringement could only be determined after use, but be-
cause infringement could not be determined at any time.
514 F.3d at 1254–56. That is not the case here, as “a skilled
artisan would be able to quickly determine whether a sig-
nal creates paresthesia for any given patient.” J.A. 11.
And in Geneva, we held that “[t]he fact that the same dos-
age amount does not yield synergy under other circum-
stances is irrelevant” and does not alone render the term
“synergistically effective amount” indefinite. 349 F.3d at
1384.
Accordingly, we hold the district court erred in holding
invalid as indefinite the “paresthesia-free” system and de-
vice terms, and we construe “paresthesia-free” in accord-
ance with the plain language of the claims and
specification to mean that the therapy or therapy signal
“does not produce a sensation usually described as
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NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 9
tingling, pins and needles, or numbness.” See, e.g., ’472
patent at 1:62–66.
II. “configured to”
Claims 1 and 22 of the ’842 patent and claims 7, 12, 35
and 37 of the ’533 patent recite “a signal generator config-
ured to generate” a therapy signal with set parameters and
functions. Claim 1 of the ’842 patent is illustrative and re-
cites:
1. A spinal cord modulation system comprising:
a signal generator configured to generate a therapy
signal having a frequency of 10 kHz, an amplitude
up to 6 mA, and pluses having a pulse width be-
tween 30 microseconds and 35 microseconds; and
an implantable signal delivery device electrically
coupleable to the signal generator and configured
to be implanted within a patient’s epidural space to
deliver the therapy signal from the signal genera-
tor the patient’s spinal cord.
(emphasis added).
Nevro argued before the district court that the term
“configured to” means “designed to.” Boston Scientific dis-
agreed, arguing that if a construction is necessary, “config-
ured to” should be construed as “requir[ing] no further
configuration to.” At the Markman hearing, the district
court sua sponte suggested that “‘configure[d] to’ maybe is
indefinite.” J.A. 12506. After the parties filed supple-
mental briefing on the district court’s newly raised indefi-
niteness theory, the district court concluded that
“configured to” could be “reasonably construed . . . to mean
one of two things: (1) the signal generator, as a matter of
hardware and firmware, has the capacity to generate the
described electrical signals (either without further pro-
graming or after further programming by the clinical pro-
gramming software); or (2) the signal generator has been
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10 NEVRO CORP. v. BOSTON SCIENTIFIC CORP.
programmed by the clinical programmer to generate the
described electrical signals.” J.A. 6. Because the district
court determined that “configured to” is susceptible to dif-
fering constructions, it held the term renders indefinite
claims 1 and 22 of the ’842 patent and claims 7, 12, 35 and
37 of the ’533 patent.
Nevro argues that that the district court applied the
wrong legal standard in holding the claims indefinite. We
agree. The test for indefiniteness is whether the claims,
viewed in light of the specification and prosecution history,
“inform those skilled in the art about the scope of the in-
vention with reasonable certainty.” Nautilus, 572 U.S. at
910. The test is not merely whether a claim is susceptible
to differing interpretations. Such a test would render
nearly every claim term indefinite so long as a party could
manufacture a plausible construction. In fact, the Su-
preme Court declined to adopt such a rule in Nautilus. Id.
at 909 (declining to adopt a test rendering a patent invalid
“when a claim is ‘ambiguous, such that readers could rea-
sonably interpret the claim’s scope differently’”). Under
the proper standard, we hold that the claim term “config-
ured to” does not render the asserted claims indefinite.
A person of ordinary skill would be reasonably certain
that “a signal generator configured to generate” means “a
signal generator programmed to generate.” The asserted
claims contemplate that “configured to” requires program-
ming the signal generator (i.e., setting parameters) to gen-
erate the claimed signals. For example, claim 37 of the ’533
patent recites a “signal generator configured to gener-
ate . . . wherein at least a portion of the therapy signal is
at a frequency of 10 kHz, and at a current amplitude in a
current amplitude range from 0.1 mA to 20 mA.” ’533 pa-
tent at Claim 37; see also ’125 patent at Claim 1 (reciting
“a step for configuring the signal generator, including pro-
gramming”). The specifications of the asserted patents
confirm that “configured to” requires setting parameters.
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NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 11
Indeed, the focus of the specifications is on setting the sig-
nal generator’s parameters; they are silent as to any other
steps the inventors took to configure the signal generator.
See, e.g., ’533 patent at 6:34–7:5 (distinguishing the
claimed spinal cord stimulation systems from conventional
systems based on the parameters used to generate the
therapy signals). Moreover, in prosecuting a related patent
application, U.S. Pat. App. 14/522,405, Nevro agreed with
the examiner that “configured” means “programmed” as
opposed to “programmable.” J.A. 12929. This is consistent
with the prosecution history of the asserted ’842 patent,
during which Nevro consistently distinguished the claimed
invention from the prior art on the basis that the prior art
did not disclose specific parameters for a signal generator.
J.A. 12938–39 (distinguishing a prior art reference on the
basis that it does not teach “the specific combination of
therapy signal parameters in the claimed ranges”); see also
J.A. 12947.
Nevro contends that “configured to” should instead be
construed as “designed to.” It argues that this construction
is consistent with the specifications, which use the terms
“configured” and “programmed” separately in the same
sentence. See ’533 patent at 24:18. It also argues that its
construction is consistent with our precedent, which it con-
tends equates “adapted to” with “configured to,” “designed
to” and “made to.” Appellant’s Br. 37 (citing, e.g., Aspex
Eyewear, Inc., v. Marchon Eyewear, Inc., 672 F.3d 1335,
1348–49 (Fed. Cir. 2012)). Nevro’s contentions are unavail-
ing. The sentence from the specifications that Nevro relies
upon merely states that “the patient will typically not feel
a paresthesia, unless the system is configured and pro-
grammed to deliberately produce paresthesia in addition to
the therapy signal.” ’533 patent at 24:15–20. The refer-
enced programming and configuring relates only to the sys-
tem; the sentence is silent regarding configuring the signal
generator. And our construction of different claims in
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12 NEVRO CORP. v. BOSTON SCIENTIFIC CORP.
different patents is insufficient to overcome the plain lan-
guage of the claims and the specification here. See Medrad,
Inc. v. MRI Devices Corp., 401 F.3d 1313, 1318 (Fed. Cir.
2005) (holding that a particular term, even the same term,
“need not have the same meaning when used in an entirely
separate patent, particularly one involving different tech-
nology”). Accordingly, we conclude the district court erred
in holding indefinite the claims reciting the term “config-
ured to” and we construe “configured to” to mean “pro-
grammed to.”
III. “means for generating”
Asserted claims 18, 34 and 55 of the ’125 patent recite
“a means for generating” a paresthesia-free or non-pares-
thesia-producing therapy signal. Claim 18 of the ’125 pa-
tent is illustrative and recites:
18. A spinal cord modulation system for reducing
or eliminating pain in a patient, the system com-
prising:
means for generating a paresthesia-free therapy sig-
nal with a signal frequency in a range from 1.5 kHz
to 100 kHz; and
means for delivering the therapy signal to the pa-
tient’s spinal cord at a vertebral level of from T9 to
T12, wherein the means for delivering the therapy
signal is at least partially implantable.
(emphasis added). The parties agreed before the district
court that these claim terms are means-plus-function
terms under 35 U.S.C. § 112 ¶ 6, having a function of “gen-
erating” the claimed paresthesia-free therapy signal.
Nevro identified the corresponding structure as a pulse
generator and Boston Scientific identified the structure as
“a signal generator configured to generate.” The district
court nonetheless determined that there was “not an ade-
quate disclosure of a corresponding structure in the patent
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NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 13
specification” and sua sponte held indefinite claims 18, 34,
and 55 of the ’125 patent J.A. 11. It held that the patents’
disclosures of a “generic signal generator” as the corre-
sponding structure” was “not sufficient” because signal
generators were “already known in the prior art.” Id.
Because the district court relied only on the intrinsic
record, we review the district court’s indefiniteness deter-
mination de novo. BASF, 875 F.3d at 1365. Pre-AIA sec-
tion 112 ¶ 6 allows a patentee to express an element of a
claim as a means for performing a specified function. 35
U.S.C. § 112 ¶ 6 (2006). In exchange for using this form of
claiming, the patent specification must disclose with suffi-
cient particularity the corresponding structure for per-
forming the claimed function and clearly link that
structure to the function. See Ibormeith IP, LLC v. Mer-
cedes–Benz USA, LLC, 732 F.3d 1376, 1379 (Fed. Cir.
2013). If the function is performed by a general-purpose
computer or microprocessor, then the specification must
also disclose the algorithm that the computer performs to
accomplish that function. Aristocrat Techs. Australia Pty.
Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir.
2008).
Nevro argues that the asserted patent specifications’
disclosure of a signal generator as the structure for this
limitation should end the inquiry. We agree. The only case
the district court cites in holding to the contrary, Aristocrat
Techs., 521 F.3d at 1333, addresses only whether a general-
purpose computer or processor, without a corresponding al-
gorithm, can provide structure for computer-implemented
inventions. It does not require a specific algorithm when
the identified structure is not a general-purpose computer
or processor. Here, the specification clearly recites a signal
or pulse generator, not a general-purpose computer or pro-
cessor, as the structure for the claimed “generating” func-
tion. See, e.g., ’125 patent at 3:54–5:45. The specification
teaches further how to configure the signal generators to
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14 NEVRO CORP. v. BOSTON SCIENTIFIC CORP.
generate and deliver the claimed signals using the recited
parameters, clearly linking the structure to the recited
function. See, e.g., ’125 patent at 6:56–7:10.
Boston Scientific does not dispute that the correspond-
ing structure is a signal/pulse generator configured to gen-
erate. Instead, it argues that this term renders the claims
indefinite for the same reasons it contends “configured to”
render the asserted claims indefinite. Appellees’ Br. 38–
39. For the reasons discussed above, this contention is un-
availing. We hold that the district court erred in holding
indefinite claims 18, 34 and 55 of the ’125 patent. We con-
strue the claim term “means for generating” as a means-
plus-function term, having a function of “generating” and a
structure of “a signal/pulse generator configured to gener-
ate” the claimed signals.
IV. “therapy signal”
All but four of Nevro’s asserted claims recite a “therapy
signal,” 4 which the district court construed as an “electrical
impulse” or “electrical signal.” J.A. 5. In reaching its con-
struction, the district court relied on a passage from the
’472 patent specification, which it contends “defined” the
term “therapy signal.” On appeal, Nevro challenges the
court’s construction. It argues that “therapy signal” should
instead be construed as “a spinal cord stimulation or mod-
ulation signal to treat pain.” Appellant’s Br. 63–64. Boston
Scientific contends that the district court erred in holding
that “therapy signal” does not render the asserted claims
indefinite.
We review a district court’s claim construction de novo
except for underlying fact findings related to extrinsic evi-
dence, which we review for clear error. Teva Pharm. USA,
Inc. v. Sandoz, Inc., 135 S. Ct. 831, 835 (2015). “The words
4 Claims 11, 21 and 23 of the ’102 patent and claim
58 of the ’533 patent do not recite a “therapy signal.”
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NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 15
of a claim are generally given their ordinary and customary
meaning as understood by a person of ordinary skill in the
art when read in the context of the specification and pros-
ecution history.” Thorner v. Sony Comput. Entm’t Am.
LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). While the dis-
trict court correctly determined that the claims reciting a
“therapy signal” are not indefinite, we hold that the district
court erred in its construction of the term.
The plain language of the claims makes clear that the
claimed “therapy signal” is for pain-relief spinal cord stim-
ulation therapy. For example, claim 37 of the ’533 patent
recites a “spinal cord stimulation system for reducing or
eliminating pain in a patient, the system comprising: an
implantable signal generator configured to generate a non-
paresthesia-producing therapy signal.” Likewise, claim 1
of the ’472 patent recites “a method for alleviating patient
pain or discomfort” comprising “programming the signal
generator to generate and deliver an electrical therapy sig-
nal to the spinal cord region.” The pain-relief therapy com-
ponent of the claimed “therapy signal” is confirmed by the
specifications of the asserted patents, as they consistently
identify treating pain as the purpose of the claimed inven-
tion. See, e.g., ’533 patent at 3:11–13 (describing embodi-
ments of the claimed invention as “directed to producing a
therapeutic effect that includes pain reduction in pa-
tients”); id. at 3:39–45, 50–56, 5:35–38. In fact, during
prosecution of the ’842 patent, Nevro distinguished the
claimed “therapy signals” from prior art electrical signals
on the basis that the prior art signals were merely “diag-
nostic signals.” J.A.8837, 8814.
The portion of the ’472 patent that the district court
contends “defined” the term “therapy signal” merely states
that “[t]he pulse generator 101 or other controller trans-
mits instructions and power to the electric array 103 via
the lead body 102 to apply therapy signals (e.g., electrical
impulses) to the nerve fibers . . . .” ’472 patent at 5:44–49.
This does not meet the exacting standard for redefining
Case: 18-2220 Document: 69 Page: 16 Filed: 04/09/2020
16 NEVRO CORP. v. BOSTON SCIENTIFIC CORP.
“therapy signal.” See Hill-Rom Servs., Inc. v. Stryker
Corp., 755 F.3d 1367, 1371–73 (Fed Cir. 2014); see also In-
terval Licensing, 766 F.3d at 1373 (“declin[ing] to cull out
a single ‘e.g.’ phrase from a lengthy written description to
serve as the exclusive definition” of a claim term). And the
other passages cited by the district court merely indicate
that electrical signals that stimulate or modulate a spinal
cord to treat pain are examples of “therapy signals.” ’533
patent at 3:45–53, 4:43–50.
Boston Scientific does not dispute that the claimed
“therapy signal” is used to provide pain relief. Instead, it
contends that the asserted claims reciting a “therapy sig-
nal” are indefinite because “the patents do not disclose the
structure or steps which necessarily achieve the claimed
therapeutic signal.” Appellees’ Br. 58. It argues that the
specification fails to inform a person of ordinary skill in the
art how to achieve the claimed therapeutic result with rea-
sonable certainty because “two signals with the same set of
characteristics (e.g., frequency, amplitude, and pulse
width) may result in therapy in one patient and no therapy
in another.” Id. But, as discussed above, the fact that a
signal does not provide pain relief in all circumstances does
not render the claims indefinite. Geneva, 349 F.3d at 1384.
Accordingly, we hold that the district court correctly
determined that the term “therapy signal” does not render
the asserted claims indefinite. We also hold that the dis-
trict court erred in its construction of the term. A “therapy
signal” is “a spinal cord stimulation or modulation signal
to treat pain.”
CONCLUSION
We have considered the parties remaining arguments
and find them unpersuasive. For the foregoing reasons, we
vacate and remand the district court’s judgment of invalid-
ity as to claims 7, 12, 35, 37 and 58 of the ’533 patent,
Case: 18-2220 Document: 69 Page: 17 Filed: 04/09/2020
NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 17
claims 18, 34 and 55 of the ’125 patent, claims 5 and 34 of
the ’357 patent and claims 1 and 22 of the ’842 patent.
VACATED AND REMANDED
COSTS
Costs to Appellant.