Boston Scientific Neuromodulation Corporationv.Nevro Corp.

Patent Trial and Appeal Board

Nov 30, 2015

13446970 (P.T.A.B. Nov. 30, 2015)

Trials@uspto.gov Paper 10
Tel: 571-272-7822 Entered: November 30, 2015
UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION,
Petitioner,
v.
NEVRO CORPORATION,
Patent Owner.

Case IPR2015-01204
Patent 8,359,102 B2

Before BARRY L. GROSSMAN, MITCHELL G. WEATHERLY, and
JAMES A. WORTH, Administrative Patent Judges.
WORTH, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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I. INTRODUCTION
Petitioner, Boston Scientific Neuromodulation Corporation
(“BSNC”), filed a Petition (Paper 1, “Pet.”) requesting inter partes review of
claims 1, 2, 11–15, 17–23, 25, and 26 of U.S. Patent 8,359,102 B2 (“the
’102 patent,” Ex. 1101). Patent Owner, Nevro Corporation (“Nevro”), filed
a Preliminary Response (Paper 9, “Prelim. Resp.”).
Institution of an inter partes review is authorized by statute when “the
information presented in the petition filed under section 311 and any
response filed under section 313 shows that there is a reasonable likelihood
that the petitioner would prevail with respect to at least 1 of the claims
challenged in the petition.” 35 U.S.C. § 314(a); 37 C.F.R. § 42.108. For the
reasons set forth below, we conclude that the information presented in the
Petition does not establish a reasonable likelihood that BSNC would prevail
in showing that claims 1, 2, 11–15, 17–23, 25, and 26 of the ’102 patent are
unpatentable.
Accordingly, we do not institute an inter partes review for any of
these challenged claims.
A. Related Matters
The parties state that there is no related litigation or related matters
other than a co-pending petition for inter partes review (Case IPR2015-
01203).
B. The ’102 Patent (Ex. 1101)
The ’102 patent is titled “Selective High Frequency Spinal Cord
Modulation For Inhibiting Pain with Reduced Side Effects, and Associated
Systems and Methods,” and relates to a method for applying selective high
frequency modulation to the dorsal column, dorsal horn, dorsal root, dorsal
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root entry zone, and/or other regions of the spinal column to control pain
while reducing or eliminating side effects. Ex. 1101, 1:1–4, 1:21–24, 3:1–6.
Such side effects include unwanted motor stimulation or blocking, and/ or
interference with sensory functions other than the targeted pain. Id. at 2:57–
60. The ’102 patent describes that a problem existed in the art where
electrical pulses generated sensations that masked or otherwise altered the
patient’s pain and created tingling or paraesthesia. Id. at 1:47–52.
The ’102 patent addresses these problems with electrical signals
possessing waveforms with high frequency elements or components (e.g.,
portions having high fundamental frequencies). Id. at 2:55–57; 4:54–60.
One embodiment employed therapeutic signals of about 3 kHz to about 10
kHz, and generally from about 1.5 kHz to about 100 kHz, with the width of
the applied pulses about 30–35 µsec, and the amplitude generally from about
1mA to about 4 mA. Id. at 6:60–7:8.
Several embodiments of the ’102 patent use electrical signal delivery
element with leads implanted in the spinal region on either side of the
midline. Id. at 5:11–34, 6:12–37. Figure 1B is reproduced below:

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Figure 1B, above, depicts the placement of lead 110, according to one
embodiment, at spinal level T7–T8. Id. at 6:39–40.
C. Illustrative Claims
Claims 1 and 26 are independent claims. Claim 1, reproduced below,
is illustrative of the subject matter at issue.
1. A method for treating a patient, comprising: delivering
or instructing delivery of an electrical signal to the patient’s
spinal cord via at least one implantable signal delivery device;
and wherein the electrical signal has a frequency of from about
1.5 kHz to about 50 kHz and does not create paresthesia in the
patient.
Ex. 1101, 26:2–9.
D. The Alleged Grounds of Unpatentability
Petitioner contends that claims 1, 2, 11–15, 17–23, 25 and 26 are
unpatentable on the following grounds:
References Basis Claims challenged
Knudson1 § 102 1, 2, 17–22, 25, and 26
Knudson, either alone or in view of De
Ridder2 and/or MacDonald3 § 103
1, 2, 11–15, 17–23,
25, and 26

1 Knudson, U.S. Patent Application Pub. No. US 2007/0073354 A1, pub.
Mar. 29, 2007 (Ex. 1102).
2 De Ridder, U.S. Patent Application Pub. No. 2011/0184488 A1, pub. July
28, 2011 (Ex. 1103).
3 MacDonald, U.S. Patent No. 5,776,170, iss. July 7, 1998 (Ex. 1104).
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II. ANALYSIS
A. Claim Construction
In an inter partes review, the Board interprets claim terms in an
unexpired patent according to the broadest reasonable construction in light
of the specification of the patent in which they appear. 37 C.F.R.
§ 42.100(b); see In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79
(Fed. Cir. 2015). Under that standard, and absent any special definitions, we
give claim terms their ordinary and customary meaning, as would be
understood by one of ordinary skill in the art at the time of the invention.
See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any
special definitions for claim terms must be set forth with reasonable clarity,
deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed.
Cir. 1994).
Petitioner proposes constructions of “implantable signal delivery
device,” “paresthesia,” “spinal cord,” and “nociceptive pain.” Pet. 11–15.
Patent Owner disputes the construction of these terms. Prelim. Resp. 20–25.
We construe only claim terms relevant to issues in dispute and only to
the extent necessary to resolve the issues presented by the Petition. See
Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
1999). For purposes of this Decision, we provide an express construction
for the term “paresthesia.” Paresthesia occurs in the phrase “wherein the
electrical signal has a frequency of from about 1.5 kHz to about 50 kHz and
does not create paresthesia,” as recited by claims 1 and 26.
Petitioner asserts that “paresthesia” refers to a sensation perceived as
tingling or prickling, and proposes a construction for “paresthesia” as “a
tingling sensation induced by spinal cord stimulation.” Pet. 11. Petitioner
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relies on a statement in the Specification’s description of the prior art that
“patients report a tingling or paresthesia that is perceived as more pleasant
and/or less uncomfortable than the underlying pain sensation.” Pet. 11
(quoting Ex. 1101, 1:50–52; citing also Ex. 1115 (McIntyre Decl.) ¶ 14).
Patent Owner requests that “paresthesia” not be limited to “tingling”
and instead proposes that “paresthesia” be construed as follows: “Any
abnormal sensation with no apparent cause from a corresponding physical
condition. Examples of paresthesia include burning, pricking, pressure,
formication, tickling, numbness, tingling, a ‘pins and needles’ feeling, or
creeping on the skin.” Prelim. Resp. 15–16. Patent Owner relies for its
construction on definitions of “paresthesia” from two medical dictionaries
and one general dictionary as follows: (a) DORLAND’S ILLUSTRATED
MEDICAL DICTIONARY (Ex. 2011, 0004) (“morbid or perverted sensation; an
abnormal sensation, as burning, prickling, formication, etc.”); (b) MOSBY’S
MEDICAL DICTIONARY (Ex. 2012, 0003) (“any subjective sensation,
experienced as numbness, tingling, or a ‘pins and needles’ feeling”);
(c) WEBSTER’S THIRD INTERNATIONAL DICTIONARY (Ex. 2013, 0003) (“a
sensation of pricking, tingling, or creeping on the skin having no objective
cause and usu. associated with injury or irritation of a sensory nerve or nerve
root.”). Prelim. Resp. 22.
All of the evidence presented supports an understanding that
paresthesia includes various manifestations of a “pins and needles” feeling,
often described as “tingling.” Patent Owner’s dictionaries also refer to
“pricking,” “formication,” and “creeping on the skin,” which is consistent
with Petitioner’s Declarant’s observation the same sensation may manifest
itself as “prickling.” See Ex. 1115 ¶ 14. Although we recognize that Patent
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Owner has not had the opportunity to submit any “new testimonial
evidence” at this stage of the proceeding, see 37 C.F.R. § 42.107(c), Patent
Owner does not here provide support for “pressure” as it might be
understood apart from “pricking,” “formication,” and “creeping on the skin.”
For purposes of this Decision on Institution, we determine that the
broadest reasonable construction consistent with the Specification of “does
not create paresthesia” is “does not create tingling.” We are guided by the
submitted dictionaries as well as the Specification which criticizes prior art
techniques for causing “tingling or paresthesia.” Ex. 1101, 1:50–52. We
credit the statement of Petitioner’s Declarant that the same sensation may be
variously perceived. However, we do not include “pressure” itself within
that construction.
B. Principles of Law
To establish anticipation, each limitation in a claim must be found in a
single prior art reference, arranged as recited in the claim. Net MoneyIN,
Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). While the
limitations must be arranged or combined in the same way as in the claim,
identity of terminology is not required. In re Gleave, 560 F.3d 1331, 1334
(Fed. Cir. 2009); In re Bond, 910 F.2d 831, 832 (Fed. Cir. 1990). Moreover,
a reference anticipates a claim “if it discloses the claimed invention such that
a skilled artisan could take its teachings in combination with his own
knowledge of the particular art and be in possession of the invention.” In re
Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995) (emphasis omitted). Thus, “it
is proper to take into account not only specific teachings of the reference but
also the inferences which one skilled in the art would reasonably be
expected to draw therefrom.” In re Preda, 401 F.2d 825, 826 (CCPA 1968).
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A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
differences between the claimed subject matter and the prior art are such that
the subject matter, as a whole, would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations, including: (1) the scope and content of the prior art;
(2) any differences between the claimed subject matter and the prior art; (3)
the level of skill in the art; and (4) objective evidence of nonobviousness.
Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).
In that regard, an obviousness analysis “need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR, 550 U.S. at 418; see also
Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). A prima facie
case of obviousness is established when the prior art itself would appear to
have suggested the claimed subject matter to a person of ordinary skill in the
art. In re Rinehart, 531 F.2d 1048, 1051 (CCPA 1976). The level of
ordinary skill in the art may be reflected by the prior art of record. See
Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC
Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91
(CCPA 1978).
C. Anticipation by Knudson (Ex. 1102)
Relying on the Declaration of Cameron C. McIntyre, Ph.D. (Ex.
1115), Petitioner contends that Knudson anticipates claims 1, 2, 17–22, 25,
and 26. Pet. 16–27. Patent Owner disagrees. Prelim. Resp. 26–32. We
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determine, on the current record, that Petitioner has not established a
reasonable likelihood of prevailing on its assertion.
Overview of Knudson 1.
Knudson discloses a neural blocking therapy for treating a tissue
sensation or for treating a condition associated with neural activity of a
spinal cord by placing an electrode near the target area to at least partially
block neural activity. Ex. 1102, at [54], [57], ¶ 36. In particular, Knudson
discloses that application of a blocking signal to the electrode blocks signals
such as pain signals from the dorsal root of the spinal cord. Id. ¶ 83.
Knudson discloses the use of frequencies in excess of 3,000 Hz and more
preferably about 5,000 Hz or more. Id.
2. Analysis
Petitioner sets forth in the Petition how each limitation of claims 1, 2,
17–22, 25, and 26 would be understood to be disclosed by Knudson.
Pet. 16–27. Petitioner states that the mechanism of action of Knudson’s
nerve block is to “block the propagation of action potentials along the nerve”
(id. at 20 citing Ex. 1102 ¶ 11), and relies on the Declaration of Dr.
McIntyre for the understanding that if no action potentials are traveling
along a nerve, the patient will not feel paresthesia. Pet. 20 (citing Ex. 1115 ¶
45).
Petitioner further points to two scientific publications (discussed
during the prosecution of a related application) for evidence that Knudson’s
disclosure of “blocking” peripheral nerves is consistent with, and inherently
means, “without causing paresthesia.” See Pet. 20–23 (citing K. Kilgore et
al., Reversible Nerve Conduction Block Using Kilohertz Frequency
Alternating Current, 17 NEUROMODULATION: TECHNOLOGY AT THE NEURAL
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INTERFACE 242–255 (International Neuromodulation Society, 2013–14) (Ex.
1116) and C. Perruchoud et al., Analgesic Efficacy of High-Frequency
Spinal Cord Stimulation: A Randomized Double-Blind Placebo-Controlled
Study, 16 NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE
363–369 (International Neuromodulation Society, 2013) (Ex. 1117)). In this
connection, Petitioner, inter alia, quotes Kilgore as explaining that “[i]n true
nerve conduction block, action potentials are arrested as they pass under the
blocking electrode.” Pet. 21 (discussing Ex. 1116). Petitioner asserts that
Perruchoud utilizes a 5kHz signal but does not refer to blocking. See Pet. 23
(discussing Ex. 1117).
We are persuaded by Patent Owner that Knudson does not disclose a
paresthesia-free therapy, either explicitly or inherently. Prelim. Resp. 10–
13. We have reviewed Kilgore and Perruchoud and do not find that they
support a reading that Knudson’s nerve blocking necessarily resulted in the
patient feeling no paresthesia. The Petition relies primarily on the testimony
of Dr. McIntyre for the proposition that Knudson’s method of nerve
blocking inherently discloses an application “without causing paresthesia in
the patient.” See Pet. 16–24. However, Dr. McIntyre offers no support for
the proffered testimony that “one of ordinary skill would have understood
that by describing his therapy signal as applying a ‘blocking’ signal,
Knudson was teaching application of a signal that would not cause the
patient to perceive paresthesia.” Ex. 1115 ¶ 44. To the extent that Petitioner
and Petitioner’s Declarant rely on a mechanism of nerve block as blocking a
nerve action potential, Petitioner has not adduced persuasive evidence as to
what a patient would necessarily have perceived or sensed in the Knudson
experiment. See 37 C.F.R. § 42.65 (“Expert testimony that does not
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disclose the underlying facts or data on which the opinion is based is entitled
to little or no weight.”).
We conclude that Petitioner has not adequately shown that Knudson
discloses application of electricity “without causing paresthesia in the
patient,” as required by independent claims 1 and 26. See In re Robertson,
169 F.3d 743 (Fed. Cir. 1999) (“Inherency, however, may not be established
by probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.”). We, therefore,
determine that Petitioner has not established a reasonable likelihood of
prevailing on its assertion with respect to claims 1, 2, 17–22, 25, and 26.
D. Obviousness over Knudson, either alone or in view of De
Ridder (Ex. 1103) and/or MacDonald (Ex. 1104)
Petitioner contends the combination of Knudson, either alone or in
view of De Ridder and/or MacDonald renders obvious claims 1, 2, 11–15,
17–23, 25, and 26. Pet. 27–35. Patent Owner disagrees. Prelim. Resp. 33–
52. We determine, on the basis of the record before us, that Petitioner has
not established a reasonable likelihood of prevailing on its assertion.
Overview of De Ridder 1.
De Ridder discloses a system and method for treating pain without
paresthesia by spinal cord stimulation. Ex. 1103, at [54], [57]. De Ridder
discloses paresthesia as a side effect of high frequency electrode stimulation.
Id. ¶ 4. De Ridder discloses that treatment with “burst stimulation” resulted
in “complete pain suppression” and that one patient experienced a “complete
suppression of both pain and paresthesia with burst [spinal cord stimulation]
treatment.” Id. ¶ 44. De Ridder performed experiments with an “inter-
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burst” frequency of 40 Hz and an “intra-burst” frequency of 500 Hz. Id.
¶ 41–42; Table 1.
2. Overview of MacDonald
MacDonald discloses an electrotherapeutic apparatus “for producing
analgesia through electrical stimulation wherein the apparatus comprises two
or more electrodes adapted to supply electrical signals to two or more
locations on the surface of a body overlying the central nervous system.”
Ex. 1104, at [54], [57], 2:22–26. MacDonald proceeds to disclose an
experiment in which “[s]urface electrodes were attached to the stimulator
that produced a square wave pulse of 4–8 μs duration, at a rate of 100 pulses
per second, at various amplitudes (voltages) to see whether the phenomenon
of spatial summation could be produced in the spinal cord.” Id. at 5:33–37.
MacDonald reports that “if the electrodes were separated by a distance of 10
cms or so the levels between T1 and T12 could be perceived and described
by the trained observer at a lower threshold than the tingling. It was a
continuous feeling of warmth and painless, light pressure.” Id. at 5:48–63.
3. Analysis
Petitioner contends the combination of Knudson, either alone or in
view of De Ridder and/or MacDonald renders obvious claims 1, 2, 11–15,
17–23, 25, and 26. Pet. 27–36. Petitioner asserts that it would have been an
obvious design choice for one of ordinary skill in the art to implement
Knudson’s therapy in a way that does not cause paresthesia, and that De
Ridder and MacDonald disclose treatment of pain without causing
paresthesia. Pet. 27–30 (citing Ex. 1103 ¶¶ 41–44; Ex. 1104, 6:33–48, 7:65–
8:35; Ex. 1115 ¶¶ 67–71; KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 420
(2007) (“When there is a design need or market pressure to solve a problem
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and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp.”)). Petitioner also reasons that De Ridder teaches
paresthesia was undesirable. Pet. 28–29.
However, we agree with Patent Owner that De Ridder discloses that
high frequency stimulation causes, rather than avoids, paresthesia. Prelim.
Resp. 37–39 (citing Ex. 1103 ¶ 4). Further, De Ridder’s data reporting
suppression of paresthesia was conducted at an “inter-burst” frequency of 40
Hz and an “intra-burst” frequency of 500 Hz, rather than the recited
frequencies. Id. ¶ 41–42; Table 1.
With respect to MacDonald, we determine that Petitioner has not
established that MacDonald indicates how a person of ordinary skill would
deliver an electric signal, without causing paresthesia, at the frequencies of
about 1.5 kHz to about 50 kHz, as recited by claims 1 and 26. See Pet. 27–
36.
We also agree with Patent Owner that the Petition does not articulate
the obviousness ground inasmuch as the Petition does not explain which
aspects of Knudson would have been retained and which aspects of
De Ridder or MacDonald would have been the basis for a modification, and
the rationale for the choice of any such elements. See Prelim. Resp. 39–42;
Pet. 27–36; 37 C.F.R. § 42.104(b)(4), (b)(5); KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007).
We determine that Petitioner has not established a reasonable
likelihood of prevailing on its assertion that claims 1, 2, 11–15, 17–23, 25,
and 26 are rendered obvious by the combination of Knudson, either alone or
in view of De Ridder and/or MacDonald.
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III. CONCLUSION
We conclude that Petitioner has not demonstrated a reasonable
likelihood of prevailing on its assertion that claims 1, 2, 11–15, 17–23, 25,
and 26 of the ’102 patent are unpatentable.
IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
review is not instituted.

PETITIONER:

J. Derek Vandenburgh
dvandenburgh@carlsoncaspers.com
Iain A. Mcintyre
imcintyre@carlsoncaspers.com
CARLSON CASPERS
225 South Sixth Street, Suite 4200
Minneapolis, MN 55402

Jon E. Wright
jwright@skgf.com
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
1100 New York Avenue, N.W.
Washington, D.C. 20005-3934

J. Steven Baughman
steven.baughman@ropesgray.com
ROPES & GRAY LLP
One Metro Center, 700 12th St. – Ste. 900
Washington, DC 2005-3948