Shockwave Medical, Inc.

Patent Trials and Appeals Board

Jul 8, 2020

IPR2019-00409 (P.T.A.B. Jul. 8, 2020)

Trials@uspto.gov Paper 75
Tel: 571-272-7822 Date: July 8, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

CARDIOVASCULAR SYSTEMS, INC.,
Petitioner,
v.
SHOCKWAVE MEDICAL, INC.,
Patent Owner.

IPR2019-00409
Patent 8,728,091 B2

Before MITCHELL G. WEATHERLY, RICHARD H. MARSCHALL, and
AVELYN M. ROSS, Administrative Patent Judges.

ROSS, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
Denying Petitioner’s Motion to Exclude
Denying Patent Owner’s Motion to Exclude
35 U.S.C. § 318(a); 37 C.F.R. § 42.64

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I. INTRODUCTION
We have jurisdiction to hear this inter partes review under 35 U.S.C.
§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a)
and 37 C.F.R. § 42.73. For the reasons discussed herein, we determine that
Cardiovascular Systems, Inc., (“Petitioner”) has shown, by a preponderance
of the evidence, that claims 1–14 (“the challenged claims”) of U.S. Patent
No. 8,728,091 B2 (Ex. 1001, “the ’091 patent”) are unpatentable.
A. Procedural History
Petitioner filed a Petition (Paper 1, “Pet.”) requesting an inter partes
review of claims 1–14 of the ’091 patent. Petitioner relies on the declaration
testimony of Dr. Morten Olgaard Jensen (Ex. 1002) to support its positions.
Shockwave Medical, Inc., (“Patent Owner”) filed a Preliminary Response to
the Petition (Paper 11, “Prelim. Resp.”). Pursuant to 35 U.S.C. § 314(a), on
July 11, 2019, inter partes review was instituted on the following grounds:
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–14 103 Hawkins1 and Li2
1–3, 10 103 Hawkins and Chernenko3
1–14 103 Hawkins, Chernenko and Li
1–14 103 Hawkins and Heeren4

1 Hawkins, et al., US 2009/0312768 A1, published December 17, 2009
(Ex. 1003).
2 US 2006/0221528 A1, published October 5, 2006 (Ex. 1004).
3 US 2003/0176873 A1, published September 18, 2003 (Ex. 1005).
4 US 2013/0041355 A1, published February 14, 2013 (Ex. 1006).
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See Paper 14 (“Inst. Dec.”).
Subsequent to institution, Patent Owner filed a Patent Owner
Response (Paper 34, “PO Resp.”), along with a Declaration of Daniel W.
van der Weide, Ph.D. (Ex. 2100) to support its positions. Petitioner filed a
Reply (Paper 48, “Pet. Reply”) to the Patent Owner Response, along with a
Supplemental Declaration of Dr. Jensen (Ex. 1200), and Patent Owner filed
a Sur-Reply (Paper 55, “Sur-Reply”).
Petitioner filed a Motion to Exclude certain exhibits. Paper 62 (“Pet.
MTE”). Thereafter, Patent Owner filed an Opposition to Petitioner’s Motion
to Exclude (Paper 65, “PO MTE Opp.”).
Patent Owner also filed a Motion to Exclude certain exhibits.
Paper 61 (“PO MTE”). Petitioner filed an Opposition to Patent Owner’s
Motion to Exclude (Paper 63, “Pet. MTE Opp.”).
An oral hearing was held on April 16, 2020. A transcript of the
hearing is included in the record. Paper 74 (“Tr.”).
B. Related Proceedings
Petitioner states that it “is not aware of any judicial or administrative
matter that would affect, or be affected by, a decision in the proceeding.”
Pet. 64. Patent Owner identifies concurrently filed petitions for inter partes
review, IPR2019-00405 and IPR2019-00408, as related proceedings.
Paper 3, 2. In addition, Patent Owner identifies several issued U.S. patents
and applications as related matters. Id. at 2–3.
C. The ’091 Patent
The ’091 patent “relates to a treatment system for percutaneous
coronary angioplasty or peripheral angioplasty in which a dilation catheter is
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used to cross a lesion in order to dilate the lesion and restore normal blood
flow in the artery.” Ex. 1001, 1:15–18. Figure 1 below illustrates a
simplified view of an angioplasty balloon catheter.

Figure 1 shows an angioplasty balloon catheter 20 including hollow
sheath 21, dilating balloon 26, and guidewire 28. Id. at 7:34–40. The
catheter includes shock wave generator 25, i.e., at least one pair of
electrodes 22 and 24, within balloon 26 to generate a high voltage arc across
the electrodes. Id. at 1:45–51. “The arc in turn causes a steam bubble to
form” and “[e]ach steam bubble has the potential of producing two shock
waves, a leading edge shock wave as a result of bubble expansion and a
trailing edge wave as a result of bubble collapse.” Id. at 1:56–62. Through
use of repeated shockwaves, the calcified lesions can be broken up without
damaging the surrounding tissue. Id. at 1:53–54. Because the trailing edge
shock waves exhibit highly variable and greater energy levels, the
’091 patent describes using the leading edge shock waves to create the steam
bubble. Id. at 2:8–10. Even though the leading edge shock waves exhibit
lower energy levels, these shock waves are a more consistent energy level.
Id.
The ’091 patent explains that “it has been learned that to sustain a
leading edge shock wave, it is not necessary to sustain the high voltage
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throughout the shock wave” because it does not produce a shock wave of
greater intensity and the heat produced by the steam bubbles may damage
tissue. Id. at 2:21–29. Therefore, “there is a need to control the applied
energy to assure appropriate bubble and shock wave formation while at the
same time conserving electrode material and assuring tissue safety.” Id.
at 2:49–52. The ’091 patent explains that problems may be avoided and
certain advantages are achieved by including a power source with a current
sensor that sends signals to terminate the high voltage supply when current
flow reaches a predetermined limit. Id. at 3:1–10, 8:20–40.
D. Illustrative Claims
Petitioner challenges claims 1–14 of the ’091 patent. Independent
claims 1 and 10 are illustrative of the challenged claims and are reproduced
below:
1. A balloon catheter for delivering shockwaves to a
calcified lesion comprising:
an elongated carrier;
a flexible balloon mounted on the elongate carrier,
said balloon being fillable with a conductive fluid;
a pair of electrodes on the elongated carrier within the
balloon; and
a power source coupled to the electrodes for supplying
voltage pulses to the electrodes, each voltage pulse generating an
arc in the fluid within the balloon and causing current to flow
between the electrodes and producing a shockwave;
wherein the power source includes a current sensor for
detecting the current flow between the electrodes during each
voltage pulse, and wherein when the current reaches a
predetermined value during each voltage pulse, the sensor
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generates a signal that causes the power source to terminate the
voltage supplied to the electrodes for that pulse.
Ex. 1001, 11:28–46.

10. A method for delivering shockwaves to a calcified
lesion comprising:
advancing a balloon catheter to a calcified lesion wherein
the balloon catheter includes an elongated carrier, a flexible
balloon, and a pair of electrodes on the elongated carrier within
the balloon, wherein the electrodes are connected to a power
source;
activating the power source to supply one or more voltage
pulses to the electrodes such that during each pulse, an arc is
generated in the balloon and a current flows between the
electrodes producing a shockwave;
detecting when the current reaches a predetermined value
during each pulse; and
terminating the voltage supplied to the electrodes after the
current reaches the predetermined value for that pulse.
Id. at 12:19–33. The remaining independent claims, claims 6 and 14, differ
primarily in that each additionally requires termination of the voltage supply
at a predetermined time after the current has reached a predetermined
threshold. Id. at 11:59–12:12, 12:41–61 (claim 14 requiring a “delay timer”
to trigger the timer in response to the current sensor signal).
II. ANALYSIS
A. Applicable Law
To prevail in its challenges to the patentability of the claims,
Petitioner must demonstrate by a preponderance of the evidence that the
challenged claims are unpatentable. 35 U.S.C. § 316(e) (2018). “In an
[inter partes review], the petitioner has the burden from the onset to show
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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 the
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). Furthermore, a petitioner cannot satisfy its burden of
proving obviousness by employing “mere conclusory statements.” In re
Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016).
A claim is unpatentable under 35 U.S.C. § 103 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 of the invention to a
person having ordinary skill in the art. 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).
Consideration of the Graham factors “helps inform the ultimate obviousness
determination.” Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048
(Fed. Cir. 2016) (en banc), cert. denied, 138 S. Ct. 420 (2017).
To prevail in an inter partes review, Petitioner must explain how the
proposed combinations of prior art would have rendered the challenged
claims unpatentable. An obviousness analysis “need not seek out precise
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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; accord In re
Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). However,
Petitioner cannot satisfy its burden of proving obviousness by employing
“mere conclusory statements,” but “must instead articulate specific
reasoning, based on evidence of record” to support an obviousness
determination. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380–81
(Fed. Cir. 2016). Petitioner also must articulate a reason why a person of
ordinary skill in the art would have combined the prior art references. In re
NuVasive, 842 F.3d 1376, 1382 (Fed. Cir. 2016).
At this final stage, we determine whether a preponderance of the
evidence of record shows that the challenged claims would have been
rendered obvious in view of the asserted prior art. We analyze the asserted
grounds of unpatentability in accordance with these principles.
B. Level of Ordinary Skill in the Art and Dr. Jensen’s testimony
1. Level of Ordinary Skill in the Art
We review the grounds of unpatentability in view of the
understanding of a person of ordinary skill in the art at the time of the
invention. Graham, 383 U.S. at 17. Petitioner submits that the ordinarily
skilled artisan would have
knowledge roughly equivalent to the knowledge and/or training
of a person holding the degree of Bachelor of Science in
Mechanical Engineering, Electrical Engineering, Biomedical
Engineering, or equivalent, and between three and five years of
practical experience, including familiarity with the various
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medical devices and techniques for angioplasty lithotripsy,
and/or familiarity with electro-pulsed surgical devices generally.
Pet. 7; see Ex. 1002 ¶¶ 36–37.
Patent Owner disagrees and contends that the level of ordinary skill in
the art requires:
(1) a masters or doctorate degree in electrical engineering or
related field of study or an equivalent understanding of the
relevant aspects of the generation and management of electrical
arcs; and (2) at least two years’ experience in electrohydraulic
shockwave devices or an equivalent understanding of the
relevant aspects of generation and management of shockwaves
and pulsed signals.
PO Resp. 16 (quoting Ex. 2100 ¶ 71).
The parties’ positions primarily differ in that Patent Owner suggests
an advanced degree, i.e., “a masters or doctorate degree in electrical
engineering” and two years of experience in electrohydraulic shockwave
devices is required. Id. Petitioner, instead, explains that a bachelor’s degree
in mechanical engineering, electrical engineering, or biomedical
engineering, with at least three years of experience in angioplasty lithotripsy
or electro-pulsed surgical devices, is required though “[s]pecific study
and/or experience conditions may be met by equivalent experience,
education, or training.” Pet. 7; Ex. 1002 ¶¶ 34–38.
On this record, the parties’ positions are similar. On education,
Petitioner includes other engineering disciplines in addition to electrical
engineering and does not require an advanced degree as a basis for attaining
ordinary skill. However, Petitioner contends that more experience in the
field is needed to attain ordinary skill. Id. Based on the record, we adopt
Patent Owner’s definition of the ordinarily skilled artisan as consistent with
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the level of skill necessary to address the problems encountered in this
field.5 Further, we find that the prior art of record reflects the level of skill
in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d
1350, 1355 (Fed. Cir. 2001).
2. Dr. Jensen’s Testimony
Patent Owner asserts that Dr. Jensen’s testimony should be afforded
little, if any weight. PO Resp. 14. Patent Owner contends that “Dr. Jensen
… does not have this [requisite] level of skill even today.” Id. at 16.
Specifically, Patent Owner contends that Dr. Jensen did not understand the
concepts of inductance and negative resistance nor did he understand certain
figures from the prior art. Id. at 16–17. As a result, Patent Owner contends
that “Dr. Jensen is not skilled in the relevant art [and] his opinions are
entitled to little, if any, weight.” Id. at 18.
Petitioner argues that the concept of negative resistance is not relevant
to the case (Pet. Reply 6–10) and that “Chernenko purposefully did not
disclose the details of various components in Fig. 4b” (id. at 18). Petitioner
further asserts that “Dr. Jensen is qualified as an expert under either party’s
definition of a [person of ordinary skill in the art] [as] established in the
Petition.” Id. at 6.
We agree with Petitioner that Dr. Jensen’s background and experience
meets the level of skill in the art that we adopt in this case. See Ex. 1002

5 Though we adopt Patent Owner’s definition of the level of skill in the art,
the outcome of our Decision would remain the same under Petitioner’s
proposed definition.
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¶¶ 8–13 (statement of qualifications), Appendix A (curriculum vitae) (listing
a bachelor’s degree in electrical engineering, master’s degree in biomedical
engineering, and doctoral degrees in medical science). Furthermore, a
declarant’s expertise and experience need not match perfectly the experience
and education of a person of ordinary skill in the art in order to provide
testimony so long as there is an adequate relationship between the
declarant’s education and experience when compared to the claimed
invention. SEB S.A. v. Montgomery Ward & Co., Inc., 594 F.3d 1360, 1373
(Fed. Cir. 2010). Accordingly, we find that Dr. Jensen is qualified to testify
about the perspective of one of ordinary skill in the art at the time of the
invention.
C. Claim Construction
In an inter partes review filed after November 13, 2018, we construe
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), including
construing the claim in accordance with the ordinary and customary
meaning of such claim as understood by one of ordinary skill in the art and
the prosecution history pertaining to the patent.” See Changes to the Claim
Construction Standard for Interpreting Claims in Trial Proceedings Before
the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340, 51,340, 51,358
(Oct. 11, 2018) (now codified at 37 C.F.R. pt. 42);6 see also Phillips v. AWH
Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).

6 On October 11, 2018, the USPTO revised its rules to harmonize the
Board’s claim construction standard with that used in federal district court.
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1. “predetermined value” and “predetermined delay time”
Petitioner provides proposed constructions for the terms
“predetermined value” (Pet. 8) and “predetermined delay time” (id. at 9).
Petitioner asserts “predetermined value” means “a value set in advance” and
“predetermined delay time” means “an amount of delay time set in
advance.” Id. at 9– 10. Patent Owner does not propose any express
construction for any claim language. See generally PO Resp. Neither party
argues that the construction of either term is dispositive of any issue
presented in this inter partes review. Accordingly, we need not resolve the
meaning of terms “predetermined value” or “predetermined delay time.”
See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d
1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g,
Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be
construed that are in controversy, and only to the extent necessary to resolve
the controversy.”)).
2. “terminate the voltage supplied to the electrodes for that pulse”
The relevant claim language is reproduced below:
wherein the power source includes a current sensor for detecting
the current flow between the electrodes during each voltage
pulse, and wherein when the current reaches a predetermined
value during each voltage pulse, the sensor generates a signal that
causes the power source to terminate the voltage supplied to the
electrodes for that pulse.

This rule change applies to petitions filed on or after November 13, 2018.
Id.
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Ex. 1001, 11:40–46 (emphasis added). Though neither party requested in
their briefing that we construe the phrase “terminate the voltage supplied to
the electrode for that pulse” (see generally Pet., PO Resp.; Tr. 71:17–72:4),
the issue arises in Petitioner’s reply brief where it addresses the relevance of
“inductance and negative resistance” raised by Patent Owner in its Patent
Owner Response.
According to Patent Owner, “[a] phenomenon known as ‘negative
resistance’ is inherent in electric arc generation [and] . . . provides that at
ambient pressure or above, when extinguishing a pulse the voltage must
increase before current may decrease.” PO Resp. 10 (citing Ex. 2100
¶¶ 38–50, 151). Patent Owner explains that the “negative resistance
phenomenon (and the associated delay) poses a significant hurdle in arc
termination in the context of the device claimed in the ’091 patent.” Id.
at 13 (citing Ex. 2100 ¶¶ 43, 45). Inductance similarly results in a delay that
“prohibit[s] rapid and reliable termination of a voltage pulse,” which “would
also generally defeat any attempt to prematurely terminate a pulse that is
generally 3 s or less.” Id. at 15 (citing Ex. 2100 ¶¶ 37, 45, 50, 52). Patent
Owner alleges that the delay caused by inductance together with negative
resistance “pose[s] a significant challenge with respect to early termination
of an arc-generating high voltage pulse in the context of the device claimed
in the ‘091 patent.” Id. (citing Ex. 2100 ¶ 50).
It its Reply, Petitioner explained that both inductance and negative
resistance are not relevant because “element 1[e] states that the ‘power
source terminates the voltage supplied to the electrodes for that pulse,’ not
the voltage ‘at’ the electrodes (i.e., not the voltage pulse, the current, or the
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resulting arc).” Pet. Reply 6–7. According to Petitioner, its understanding
of the claim language is supported by the Specification. Id. at 7 (citing
Ex. 1001, 7:50–51, 9:11–18, Figs. 2, 6). Petitioner asserts that the
’091 patent Specification fails to discuss negative resistance or inductance or
offer any solution for its effects. Id. at 8.
Patent Owner in its Sur-Reply contends that Petitioner “contrive[s] a
new Reply claim construction under which the ‘voltage pulse’ need not be
terminated” and is in conflict with positions taken in the Petition. Sur-
Reply 2. According to Patent Owner, Petitioner originally took the position
that the “claims are obvious because the prior art allegedly taught
termination of voltage pulses,” but now asserts that “the ‘voltage pulse’ need
not be terminated” because “the claim requires terminating the ‘voltage
supplied to the electrodes.’” Id. at 2–3. Patent Owner contends that
Petitioner’s new argument “runs counter to the claim language,
specification, file history, expert testimony, and the immutable scientific
principles underlying the operation of the devices in question.” Id. at 3.
Patent Owner explains that according to the claims and the Specification,
“[t]here is no difference between the ‘voltage pulse supplied to the
electrodes’ and the ‘voltage supplied to the electrodes for that pulse.’ In
other words, the ‘voltage supplied to the electrodes for that pulse’ is the
voltage pulse.” Id. at 4. Patent Owner further asserts that claim
amendments during prosecution confirm this understanding. Claim 1 was
amended as follows:
a power source coupled to the electrodes for supplying [[a]]
voltage pulses to the electrodes, to generate each voltage pulse
generating an arc . . .
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wherein the power sources includes a current sensor for detecting
the current flow between the electrodes during each voltage
pulse, and wherein the current reaches a predetermined value
during each voltage pulse, the sensor generates a signal that
causes the power source to terminate the voltage supply supplied
to the electrodes for that pulse.
Ex. 1010A, 32. Therefore, Patent Owner contends that it is the voltage pulse
itself that is terminated. Sur-Reply 5.
Any claim construction analysis must begin with the words of the
claim as the claim defines the scope of the invention. See Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The claim,
however, is not read in isolation but rather in view of the specification.
Phillips, 415 F.3d 1315; Vitronics, 90 F.3d at 1582 (characterizing the
specification as “the single best guide to the meaning of a disputed claim”).
In addition, the prosecution history should be examined because it “provides
evidence of how the PTO and the inventor understood the patent.” Phillips,
415 F.3d at 1317. Applying these principles, we agree with Petitioner that a
current sensor that “generates a signal that causes the power source to
terminate the voltage supplied to the electrodes for that pulse” means that
the power source terminates the voltage supplied to the electrodes and not,
as Patent Owner suggests, a signal that instantaneously terminates the
voltage pulse across or at the electrode. Sur-Reply 5–6. The plain language
of the claim is consistent with the Specification, which repeatedly describes
application and termination of the voltage supplied to the electrodes. See,
e.g., Ex. 1001, 2:47–49; 2:67–3:4, 6:5–9, 9:18–23, 10:47–49. The
prosecution history does not compel a different reading.
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Patent Owner does not propose any express construction but
nevertheless invites us to construe “terminate the voltage supplied to the
electrodes for that pulse” as terminating the voltage pulse across (or at) the
electrodes for that pulse. According to Patent Owner, such an understanding
is the only way to achieve the intended purpose of the ’091 patent, i.e.,
“termination of the voltage pulse during that pulse and that allows the
benefits of electrode there and heat reduction to be controlled – to be
achieved.” Tr. 77:20–78:7; Sur-Reply 4 (“That benefit occurs only if the
voltage pulse across the electrodes is actually shortened which is
synonymous with terminating the voltage pulse.” (emphasis added)). While
claims are generally interpreted in light of the purpose of the invention, the
purpose of the invention cannot be used to rewrite the claims or displace the
plain, unambiguous meaning of the words. Innova/Pure Water, Inc. v.
Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004)
(explaining that claims are interpreted in light of the specification but
caution must be taken to avoid reading limitations into the claims); Teleflex
Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1326 (Fed. Cir. 2002) (“[T]he
claims must be read in view of the specification, but limitations from the
specification are not read into the claims.” (citation omitted)). Despite the
opportunity to amend, Patent Owner did not amend its claim to state that the
voltage pulse itself was terminated.7 Innova/Pure Water, 381 F.3d at 1119

7 Patent Owner amended claim 1 to add “pulse” or “voltage pulse” five times
(see Ex. 1010A, 32) yet did not amend the language to state that the “voltage
pulse” was terminated.
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(“[W]hen an applicant uses different terms in a claim it is permissible to
infer that he intended his choice of different terms to reflect a differentiation
in the meaning of those terms.”). As written, the signal causes the power
source to terminate the voltage supplied to the electrodes—without express
limitations on the timing or effect on the voltage pulse across the electrodes;
we will not discount the differences in Patent Owner’s choice of words. In
re Hiniker Co., 150 F.3d 1362, 1368–69 (Fed. Cir. 1998) (“The invention
disclosed in . . . [the] written description may be outstanding in its field, but
the name of the game is the claim.”).
D. Obviousness in view of Hawkins and Li
Petitioner contends the subject matter of claims 1–14 would have been
obvious over the combined disclosures of Hawkins and Li. Pet. 12–35.
1. Hawkins
Hawkins discloses a treatment system for the dilation of calcified
lesions or plaque in an artery wall. Ex. 1003 ¶ 2. According to Hawkins,
the invention includes a catheter comprising an elongated carrier, a dilating
balloon, and an arc generator comprising at least one electrode pair within
the balloon. Id. ¶ 3. The arc generator is connected to a power source and
arcs across the electrodes to form shockwaves within the balloon that are
used to break up the calcified lesion. Id. ¶¶ 10, 51. One exemplary
embodiment is shown below in Figure 15.

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Figure 15 illustrates a dilation catheter 110 with a balloon 116. Id. ¶ 64.
The catheter includes a parabolic reflector 114, which acts as an electrode,
and electrode 112 between which an arc is formed that generates a
shockwave focused on the calcified lesion. Id. The catheter may be
equipped with a sensor, located on the distal end on one electrode, to sense
reflected energy. Id. ¶¶ 6, 58.
2. Li
Li discloses a system and method for “providing over-current
protection in a switching power supply.” Ex. 1004 ¶ 2. According to Li, the
switching power supply may include a current sense circuit and a shut-off
circuit. Id. ¶ 5. For example, when the over-current protection circuit
receives a measured current value from the current sense circuit, the “over-
current detector 50 determines that the measured current is between a first
predetermined over-current threshold and a second predetermined over-
current threshold, then the level 1 over-current detector 50 activates the
level 1 cycle pulse adjust circuit 54.” Id. ¶ 24. The gate logic controller
then begins “narrowing pulses or deactivating pulses.” Id. The cycle pulse
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adjust circuit may also be connected to a shut-off circuit where “[t]he level 1
shut-off circuit 58 monitors the activity of the level 1 cycle pulse adjust
circuit 54 and issues a shut-off command . . . upon the occurrence of a
level 1 predetermined threshold condition.” Id. ¶ 25. The shut-off circuit
may include a timer where “[u]pon the timer reaching a predetermined time,
the level 1 shut-off circuit 58 could issue the shut-off command.” Id.
3. Analysis of Claim 1
Petitioner argues that “Hawkins discloses all the features of claim 1,
except it may not expressly disclose directly sensing current to control
voltage pulses.” Pet. 12. Petitioner asserts that Hawkins describes a balloon
catheter that includes an elongated carrier, a flexible balloon, a pair of
electrodes within the balloon, and a power source to generate current arcs
within the fluid to produce shockwaves. Id. at 12–14 (citing Ex. 1003 ¶¶ 2,
3, 10, 14, 19, 38, 42, 45, 46, 49–55, 56–62, 64 and Figs. 2–15; Ex. 1002
¶¶ 79–83). Relevant to the claimed current sensor, Petitioner argues that
Hawkins describes a sensor located on the distal end of one electrode to
detect reflected energy signals. Id. at 15 (citing Ex. 1003 ¶¶ 6, 15, 22, 37,
57–58, Fig. 9; Ex. 1002 ¶ 85). In particular, Dr. Jensen testifies that,
because the reflected energy indicates effectiveness of the shockwave
resultant from the current flow, it is analogous to current sensing. Id.; see
also Ex. 1002 ¶ 84 (same).
Additionally, Petitioner asserts that Li describes a current sense circuit
that detects current levels and provides the measured current to the over-
current protection circuit. Pet. 16. “When the sensor detects the threshold
current level, Li narrows (terminates) the voltage pulse to limit the amount
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of current applied” for each pulse. Id. at 16–17 (citing Ex. 1004 ¶¶ 24).
Petitioner reasons that the person of ordinary skill in the art would have
reason to combine Hawkins and Li to “reduce the risk of shock to the user
and the subject, as well as the device itself.” Id. at 17–18 (citing Ex. 1002
¶¶ 95–96). Dr. Jensen testifies that, in addition to the practical advantage of
avoiding electric shock, reducing shock risk provides advantages such as
enhanced device lifetime, enhanced device reliability, and reduced warranty
issues. Ex. 1002 ¶¶ 95–98; see also Pet. 18–19 (same).
Petitioner also argues that Li’s level 1 shut-off circuit independently
meets the current sensing requirements of claim 1 alone or together with Li’s
current sense circuit. Pet. 20. Petitioner explains that the shut-off circuit
initiates a delay timer once a threshold current is sensed. Id. When the
delay timer reaches a predetermined time, the shut-off circuit issues a shut-
off command to terminate the pulse. Id. Petitioner reasons that when
applied individually, the shut-off circuit “reduce[s] processing requirements,
avoid[s] response lag-time, and provide[s] reliably-timed voltage
termination.” Id. at 20–21; see Ex. 1002 ¶¶ 103–104. When applied in
combination with the current sense circuit, Petitioner asserts “Li’s overriding
protection provides an additional layer of reliability in current protection.”
Pet. 21 (citing Ex. 1002 ¶¶ 103–105).
Petitioner asserts that “Li is from the same field of control
arrangements for electrically pulsed devices” and is “reasonably pertinent to
EHL [electrohydraulic lithotripsy] devices.” Pet. 22–23. In particular,
Petitioner states that the ’091 patent describes problems with controlling the
energy levels of its pulses, which is not unique to surgical environments. Id.
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at 23. Therefore, “[t]he ordinary artisan, having recognized that the amount
of applied current is an important aspect of EHL, would look to solutions of
others facing high current problems.” Id.
Patent Owner does not dispute Petitioner’s allegations regarding the
teachings of Hawkins, but instead focuses its argument on whether Petitioner
has shown the modification of Hawkins to include Li’s current sensor would
have been obvious to one of skill in the art. PO Resp. 18–32. We
determine, Petitioner’s argument and evidence establish by a preponderance
of the evidence that all elements of claim 1 of the ’091 patent, except for the
claimed current sensor, are present in Hawkins. See In re NuVasive, 841
F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make
specific findings as to claim limitations that Patent Owner does not dispute
are disclosed in the prior art). Below, we address whether the ordinarily
skilled artisan would have reason to make the combination as claimed.
a. whether Li is capable of controlling the current in Hawkins
Patent Owner contends a person skilled in the art “would understand
that the device of Li would not be able to be used in the lithotripter of
Hawkins” because Hawkins8, like known lithotripsy devices, operates at
voltages of 5kV–30kV where “Li operates at voltages on the order of 70V
and uses MOSFETs (metal-oxide semiconductor field-effect transistors)
that, even in the best of circumstances could not tolerate voltages in excess

8 Patent Owner argues that Hawkins’ disclosure of between 100 and 3000
volts is a typographical error which should be read as requiring a voltage of
between 1,000 and 30,000 volts. PO Resp. 19–20 & n.2.
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of hundreds of volts.” PO Resp. 19–20 (citing Ex. 2100 ¶¶ 77–78, 81–84;
Ex. 2033, 1 (article on transient cavitation bubbles in lithotripsy); Ex. 1005
¶ 84; Ex. 1006 ¶ 20; Ex. 2103, 14 (shockwave handbook)). Patent Owner,
through the testimony of Dr. van der Weide, explains that “Li is assigned to
Texas Instruments . . . [and that the] Texas Instruments data sheet [“the TI
data sheet”] . . . represents the commercial embodiment of the device
disclosed in Li.” Id. at 20 (noting that both Li and the data sheet describe a
“two-stage thermal protection”) (citing Ex. 2100 ¶¶ 81, 83, 84; Ex. 1004,
code (73)). Patent Owner asserts that the “data sheet discloses that the
device operates at a maximum voltage of 70V” and even if “the Hawkins
device operated at just 1kV, Li could not terminate its voltage [as] [t]hat
voltage is far beyond Li’s operational range.” Id. at 20–21 (citing Ex. 2100
¶¶ 82, 84). Patent Owner further relies on the testimony of Dr. Jensen,
Petitioner’s expert, who explains that the ordinarily skilled artisan would
have known that operating circuitry at a higher level than its design point
can cause damage. Id. at 21 (citing Ex. 1002 ¶ 94).
Petitioner responds that “Hawkins teaches a voltage between 100 and
3000 volts” and that Patent Owner’s “‘error’ explanation seems unlikely,
however, because numerous, related patents all recite the same 100 to 3000
volt range.” Pet. Reply 10 (citing Ex. 1003 ¶ 52; Ex. 1200 ¶ 52). In
addition, Petitioner notes that the ’091 patent itself teaches that voltages as
low as 500 volts can be used which contradicts Patent Owner’s position that
a minimum of 1000 volts is required. Id. (citing Ex. 1001, 7:64–66).
Furthermore, Petitioner explains that Li discloses use of power field-effect
transistors (“FETs”) and the skilled artisan “would have understood that
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power FETs can operate at voltages over 1000 volts.” Id. at 11 (citing
Ex. 1004 ¶ 15; Ex. 1200 ¶ 53–55; Exs. 1208–1210; Ex. 2100 ¶ 81).
On this record, we disagree with Patent Owner because its argument is
premised on Patent Owner’s position that Hawkins involves high voltage
applications and Li involves low voltage applications. To reach its
conclusion, Patent Owner must establish two points—(1) that a
typographical error exists in the Hawkins disclosure and (2) that Li is limited
to voltages less than 1,000V. Neither argument is supported in the record.
First, Patent Owner argues that Hawkins, which expressly discloses a
voltage of 100 to 3,000 volts (Ex. 1003 ¶ 52), includes a typographical error
and should be written as 1,000 to 30,000 volts. PO Resp. 19–20 & n.2.
According to Patent Owner, such a reading is reasonable given that
lithotripsy devices are known to operate in the range of 5kV to about 30kV.
Id. at 19. However, the ’091 patent itself describes voltages applicable for
lithotripsy devices “as low as 500 volts” (Ex. 1001, 7:64–66) and the
purported error in Hawkins was carried forward into numerous applications
(some still pending) and at least four additional patents without correction or
amendment. Ex. 1200 ¶ 52; Exs. 1205–1206; see also U.S. Patent Nos.
9,072,534, 10,039,561, 8,956,374; U.S. Patent Application Nos. 16/028,225,
16/544,516.
Second, Patent Owner argues that despite no express description of
voltage levels, Li is limited to only low voltage applications and specifically,
applications below about 1,000V. PO Resp. 20–21. However, the elicited
testimony of Dr. van der Weide that the TI datasheet is the commercial
embodiment of Li amounts to little more than speculation. See, e.g., Ex.
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2100 ¶¶ 82–83. The only identified commonality is the “two-stage thermal
protection” system; without more, such testimony is unpersuasive.
Furthermore, the evidence of record suggests that power FETs, like those
described in Li, can operate at voltages between 600–4,500 volts. Ex. 1207
(describing power MOSFET operating ranges up to 4,500V); Ex. 1208
(identifying a power MOSFET operating up to 600V); Ex. 1209
(exemplifying a power MOSFET operating at 1,500V); Ex. 1210
(explanation of voltage ratings); Ex. 2100 ¶ 81; Ex. 2108 (MOSFET basics);
Ex. 1200 ¶¶ 53–55. Thus, even if Hawkins was limited to an operating
range of 1,000–30,000 volts, that range overlaps with the operating range of
power FETs used in Li from 1,000–4,500V. Based on the foregoing, we are
not persuaded by Patent Owner’s argument that one of ordinary skill in the
art would not have found it obvious to combine Li with Hawkins because Li
discloses a low voltage and Hawkins discloses a high voltage device.
b. whether the skilled artisan would have had reason to
combine Hawkins and Li
Patent Owner alleges that the skilled artisan would not have had
reason to combine the teachings of Hawkins and Li to arrive at the subject
matter of the invention because (1) “Hawkins already isolates the patient
from the risk of electric shock” (PO Resp. 21–22), (2) only through
improper hindsight would the skilled artisan overlook application of Level 2
protection in favor of Level 1 protection (id. at 24–27), and (3) the skilled
artisan would not have understood Level 1 protection to be successful in
early pulse termination because of negative resistance and inductance (id.
at 27–30).
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Patent Owner’s first argument is that there is no reason to combine
Hawkins and Li because Hawkins itself provides adequate protections. Id.
at 21. According to Dr. van der Weide, Hawkins “provid[es] a balloon
around the arc source and compl[ies] with FDA requirements that any
medical device delivering electrical energy to a patient must be electrically
isolated from the patient.” Ex. 2100 ¶ 91; see also PO Resp. 22 (citing
Ex. 2100 ¶¶ 91–95; Ex. 2111 § 8.1–8.2; Ex. 1003 ¶ 50). Further, Patent
Owner argues that “[c]urrent control alone will not meaningfully reduce any
purported risk . . . [because] [t]he risk of shock would stem from voltage and
Li does little to control voltage in the context of Hawkins.” PO Resp. 23
(citing Ex. 2100 ¶ 96).
We agree with Petitioner (see Pet. Reply 13) that even though
Hawkins’ balloon provides some protection against electric shock, the
ordinarily skilled artisan would have investigated other options to provide
added protection to a patient. DyStar Textilfarben GmbH & Co.
Deutschland KG v. C.H. Patrick Co., 464 F.3d 1353, 1368 (Fed. Cir. 2006)
(explaining that the motivating benefit may be based in making a product
“that is more desirable, for example because it is stronger, cheaper, cleaner,
faster, lighter, smaller, more durable, or more efficient”). Furthermore, we
observe that protecting the patient against the risk of shock is not the only
advantage advanced by Petitioner. For example, Petitioner explains that
reducing excessive current leads to improved device life and enhanced
reliability. Id. at 18 (citing Ex. 1002 ¶¶ 94–97). Thus, even if the patient is
adequately protected against shock by the balloon, reducing current has
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added benefits to the electrodes themselves. These advantages were not
addressed by Patent Owner. See generally PO Resp. 21–23.
Next, Patent Owner contends that Petitioner relies on improper
hindsight by focusing on Level 1 protection to terminate voltage. PO
Resp. 24. According to Patent Owner, “Level 1 is intended for ‘overload
conditions,’ and Level 2 is intended for ‘short circuit’ (i.e., arcing)
conditions.” Id. (citing Ex. 1004 ¶ 20). Patent Owner asserts that
Dr. Jensen’s hindsight reconstruction is apparent as he considered only
Level 1 protections in his analysis because “Level 2 does not terminate an
existing pulse,” and therefore, would not meet the claim. Id. (citing
Ex. 1004 ¶¶ 20, 25–26; Ex. 2105, 65:11–68:22, 92:25–93:2).
Petitioner argues that Dr. Jensen did not employ improper hindsight
reconstruction in forming his opinions relating to Li. Pet. Reply 13–14.
Petitioner explains that Dr. Jensen did consider both levels of protection
offered by Li and relied on Li’s teachings that the two modes were
“mutually exclusive” and “independent” of one another. Id. at 13 (citing
Ex. 1002 ¶ 87; 1200 ¶¶ 15, 60–66; Ex. 1004 ¶¶ 20, 27, Fig. 1; Ex. 2105,
7:11–72:14).
We are not persuaded by Patent Owner’s position that Petitioner,
through the testimony of Dr. Jensen, engaged in improper hindsight by
focusing on Level 1 shut-off circuit protection as opposed to Level 2.
Dr. Jensen testifies that he considered the entirety of the references
(Ex. 2105, 7:11–72:14) and that his focus on Level 1 circuit protection was
due to the fact that Li describes Level 1 and Level 2 protections as being
used independently of one another. Ex. 2105, 35:13–25, 67:9–13
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(explaining that Dr. Jensen is “familiar with Level 2, but [he] just d[i]dn’t
find it relevant because Level 1 and Level 2 could be looked at completely
separately.”). For example, Li explains that
[i]t is understood that the operation of the level 1 shut-off circuit
58 and the level 2 shut-off circuit 60 can be independent of each
other. [Ex. 1004 ¶ 27].
Furthermore, the overcurrent protection circuit 26 may not
include both the level 1 shut-off circuit and the level 2 shut-off
circuit 60, but instead could include only one or neither, as
dictated by the application or the circuit design requirements.
[id.].
Li broadly describes “that any of a variety of ways of monitoring the over-
current condition and compensation can be implemented.” Id. Furthermore,
as we discussed above in Section II.C.2, the claims of the ’091 patent are not
limited to terminating an existing pulse at the electrodes but rather to
terminating the voltage supplied to the electrodes.
Lastly, Patent Owner argues that the person of ordinary skill in the art
would not apply the Level 1 shut-off control of Li for early pulse termination
because other known methods of controlling heat in the device exist. PO
Resp. 28–29. Patent Owner explains that “[a]ny skilled artisan . . . would
readily recognize that early pulse termination would be unpredictable and
potentially impossible in the context of the Hawkins device with pulses
widths in the nanosecond to microsecond range.” Id. (citing Ex. 2100
¶¶ 115, 117, 157, 158). Specifically, Patent Owner asserts that, because of
negative resistance and inductance, “a skilled artisan would not expect the
Level 1 pulse termination of Li to be successful in terminating the arc-
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generating high voltage pulse in Hawkins.” Id.; see also id. at 20 (citing
Ex. 2100 ¶ 37).
Petitioner argues that “[w]hile a [person of ordinary skill in the art]
could have reduced heat in this way, a [person of ordinary skill in the art]
would have understood that reducing heat could also have been
accomplished by early termination of the pulse/arc.” Pet. Reply 14 (citing
Ex. 1002 ¶ 94; Ex. 1200 ¶¶ 69–70). We agree with Petitioner, because the
existence of an alternative means of accomplishing the same result does not
diminish the fact that terminating the voltage reduces heat in the circuit. In
re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012) (“[J]ust because better
alternatives exist in the prior art does not mean that an inferior combination
is inapt for obviousness purposes.”). We credit Dr. Jensen’s testimony that
“[a] [person of ordinary skill in the art] would further have understood while
he or she could have used Hawkins’ mechanisms to control the magnitude of
the shockwave to reduce heat ([PO] Resp., at 29–30), reducing heat could
also have been accomplished by early termination of the pulse/arc.”
Ex. 1200 ¶ 70; Ex. 1002 ¶ 94.
c. whether Li is analogous art
Patent Owner argues that the skilled artisan would not have had
reason to combine Hawkins and Li because Li is nonanalogous art. PO
Resp. 30. According to Patent Owner, because Li is designed to work at low
voltages and “[l]ithotripsy devices are high voltage medical devices,” “one
looking to terminate the high voltage pulses of Hawkins would not be
inclined to look to art relating to low voltage devices.” Id. at 30–31 (citing
Ex. 2100 ¶¶ 85–90). Patent Owner further asserts that Dr. Jensen’s “broad
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view of analogousness is inconsistent with the law requiring the reference to
be ‘reasonably pertinent.’” Id. at 31.
Petitioner argues that “[t]he ’091 patent addresses the problem of
controlling the energy applied from its voltage pulses” and its field of
endeavor, as described by Dr. van der Weide, is “concerned with voltage
pulse production and control.” Pet. Reply 11–12 (citing Ex. 1001, 2:30–53;
Ex. 1203, 112:5–19 (van der Weide deposition)). Petitioner reasons that
because “Li’s ‘over-current protection in a switching power supply’ circuitry
directly addresses this problem/endeavor by teaching a mechanism and
method to detect, control, and protect against over-current through circuitry
arrangements for providing controlled voltage pulses in high current
conditions,” Li is analogous art. Id. (citing Ex. 1004 ¶¶ 13, 19–21, 24–27;
Ex. 1200 ¶¶ 56–57; Ex. 1002 ¶ 85).
We are unpersuaded by Patent Owner’s argument that Li is
nonanalogous. Analogous art is either (1) art from the same field of
endeavor, regardless of the problem addressed or (2) art that is reasonably
pertinent to the particular problem with which the inventor is involved.
Airbus S.A.S. v. Firepass Corp., 941 F.3d 1374, 1379 (Fed. Cir. 2019). As
explained above, we reject Patent Owner’s contentions that Hawkins is
limited to high voltage pulses and that Li is limited to low voltage devices.
See supra Section II.D.1. Further, that Li is analogous to the ’091 patent—
describing the field of endeavor as addressing the “need in the art to be able
to control the energy applied to the electrodes of an electrical arc shock
wave generator”—is supported by the evidentiary record. Ex. 1001, 2:30–
53; see also Ex. 1203, 112:5–19 (testimony of Dr. van der Weide explaining
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that “the ’091 [is] concerned with voltage pulse production and control”).
Li, by way of example, describes circuitry to address this very problem. In
particular, Li explains that “[t]he present invention relates to electronic
circuits, and more specifically to . . . systems and methods for providing
over-current protection in a switching power supply.” Ex. 1004 ¶ 13; see
also id. ¶¶ 2, 5–6, 19–21, 24–27; Ex. 1002 ¶ 85. Thus, we find that Li is
analogous art to the ’091 patent.
Based on the foregoing, Petitioner has established, by a
preponderance of the evidence, that the combination of Hawkins and Li
discloses all of the limitations of claim 1 and that one of ordinary skill in the
art would have been motivated to combine Hawkins with Li. As a result,
when weighed with the evidence of secondary indicia of nonobviousness
(see infra Sections II.H. and II.I.), Petitioner has established by a
preponderance of the evidence claim 1 would have been obvious based on
Hawkins and Li.
4. Analysis of the Remaining Claims (2–14)
Patent Owner does not challenge Petitioner’s allegations as to
independent claims 6, 10, and 14 or dependent claims 2–5, 7–9, and 11–13
separate from the arguments considered above for claim 1. Based on our
independent review of the Petition and cited evidence, we determine that
Petitioner has established by a preponderance of the evidence that the
subject matter of claims 2–14 was suggested by the combined teachings of
Hawkins and Li. For example, claims 2, 7, and 11 additionally require that
the “predetermined value” for the current is 50 amps. Ex. 1001, 11:47–48,
12:13–14, 12:33–34. Petitioner explains that the selection of the
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predetermined current threshold involves optimization of a result effective
variable and is merely a design choice. Pet. 24. According to Petitioner, the
ordinarily skilled “artisan would have understood current as an important
variable in shockwave generation of lithotripsy devices” and that the
treatment of calculi with at least fifty amps was known in the art. Id. (citing
Ex. 1002 ¶ 109; Ex. 1003 ¶ 50 (explaining that “[t]he magnitude of the
shock waves can be controlled by controlling the magnitude of the pulsed
voltage, the current, the duration and repetition rate”); Ex. 1005, claim 2; Ex.
1010A, 50). Hawkins further discloses a guidewire lumen as claimed by
claims 3 and 8. Id. at 25 (citing Ex. 1003 ¶¶ 9, 18, 23, 51, claims 8, 13, 18;
Ex. 1002 ¶ 110). Furthermore, Li describes use of a delay timer (claims 4,
12, and 14) and, according to Petitioner, delaying termination of the voltage
supply for 100 nanoseconds or more (claims 5, 6, 9, and 13) involves
optimization of a result effective variable, was a design choice based on
component selection, and was well known in the art. Id. at 26–29 (citing Ex.
1002 ¶¶ 112, 114–115, 117; Ex. 1004 ¶¶ 13, 21, 25), 29–31 (citing Ex. 1001,
10:60–11:9 (explaining that delay time is dependent on the natural response
delay of the circuitry); Ex. 1002 ¶¶ 120–121; Ex. 1005 ¶ 59). Lastly, claim
10 recites a method which incorporates each of the limitations of claim 1.
Compare Ex. 1001, 11:28–46, with id. at 12:18–32. As a result, Petitioner
has established by a preponderance of the evidence that the subject matter of
claim 10 was suggested by the combined teachings of Hawkins and Li for
the same reasons discussed above for claim 1.
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E. Obviousness in view of Hawkins and Chernenko
Petitioner contends the subject matter of claims 1–3 and 10 would
have been obvious over the combined disclosures of Hawkins and
Chernenko. Pet. 36–43.
1. Chernenko
Chernenko is directed to systems and methods of intracorporeal
lithotripsy using electro-hydraulic destruction or electro-impulse destruction
to disintegrate or destroy stones and other calculi. Ex. 1005 ¶¶ 1, 55–58.
Chernenko explains that “[i]t has been found, that by virtue of the present
invention that even after applying of a single impulse or a few impulses it is
possible to destroy efficiently various calculi.” Id. ¶ 62. Chernenko’s
system includes current sensors “connected to the control circuit, which
controls operation of the charging means and terminates it as soon as either a
preset amount of pulses has been generated or the breakdown occurs,
whatever comes first.” Id. ¶ 72.
2. Analysis of Claim 1
Petitioner argues that “Hawkins discloses all features of claim 1,
except [Hawkins] may not expressly disclose sensing current to control
voltage pulses. However, Chernenko teaches using current sensors in
lithotripsy devices to terminate voltage pulses at threshold current levels.”
Pet. 36. Petitioner asserts that Chernenko describes spark generation
through the application of “either as onetime impulses or as repeating
impulses.” Id. at 37 (citing Ex. 1005, ¶¶ 60, 62). According to Petitioner,
Chernenko’s sensor “terminates voltage upon either of two different
operating scenarios: (i) reaching a numerical limit of voltage pulses, and
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(ii) sensing current of any pulse sufficient to provide dielectric breakdown
forming a spark.” Id. at 38–39 (citing Ex. 1005 ¶ 72; Ex. 1002, 148).
Petitioner contends that the skilled artisan would have had reason to modify
Hawkins to include Chernenko’s current sensors “to provide tight control of
intensely pulsed shockwaves to increase the probability of spark formation
for each pulse, to reduce trauma from unnecessarily high current, to enable
control of fragments, to increase patient safety, [and] to increase treatment
reliability.” Id. at 42 (citing Ex. 1002 ¶ 159); see also id. at 39–41 (citing
Ex. 1005 ¶¶ 20, 37–39, 59; Ex. 1002 ¶¶ 151–158).
Consistent with Patent Owner’s practice in addressing the
combination of Hawkins and Li (above), Patent Owner here does not dispute
Petitioner’s allegations regarding the teachings of Hawkins, but rather
focuses its argument on whether Petitioner has shown that the modification
of Hawkins to include Chernenko’s current sensor would have been obvious.
See generally PO Resp. 32–43. After reviewing the parties’ briefing and
evidence of record, we are persuaded by Petitioner’s arguments and
supporting evidence that Hawkins describes each of the limitations of
claim 1 identified by Petitioner, which is not challenged Patent Owner. We
address Patent Owner’s arguments relating to the deficiencies of Chernenko
and whether the ordinarily skilled artisan would have reason to combine the
teachings of Hawkins and Chernenko.
a. whether Chernenko teaches early termination of voltage
pulses
Patent Owner argues that Chernenko does not teach early termination
of a voltage pulse but rather, “Chernenko teaches only termination of
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subsequent pulses.” PO Resp. 32. Patent Owner explains that the object of
Chernenko is to “detect the onset of the fragmentation process and to
terminate further generation of high voltage impulses.” Id. at 33 (citing
Ex. 1005 ¶ 38; Ex. 2100 ¶ 120). According to Patent Owner, the two
portions of Chernenko—paragraph 69 and claim 8—relied on by Dr. Jensen
during his deposition do not “provide[] that a pulse can be terminated early
in Chernenko.” Id. at 33. Patent Owner contends that paragraph 69, for
example, does not include an embodiment that senses current and even
Dr. Jensen stated that he cannot rely on paragraph 69 entirely. Id. (citing
Ex. 2105, 121:5–16; 122:9–18; Ex. 2100 ¶ 121). And, according to Patent
Owner, “[c]laim 8, if anything, actually demonstrates that Chernenko does
not have the ability to terminate pulses early.” Id. In particular, claim 8
relates to terminating the “generation” of the impulses and does not recite
“that a single arc-generating voltage pulse is terminated early.” Id. at 33–34
(Ex. 2100 ¶ 122; Ex. 1005 ¶ 38). Patent Owner further asserts that “there is
no evidence to suggest that a skilled artisan would understand that such early
termination of an arc-generating voltage pulse would not impact the efficacy
of the shockwave.” Id. at 34 (citing Ex. 2100 ¶ 143). Patent Owner, in its
Sur-Reply, further contends that “[t]he charging means 210 does not supply
any voltage directly to the electrodes” and that “terminating the charging
means would not terminate the voltage pulse even if the charging means
somehow was found to supply voltage to the electrodes,” because charging
means 210 charges the capacitors. Sur-Reply 14 (citing Ex. 2100 ¶¶ 70,
123–142).
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Petitioner first argues that the claims do not require “terminating the
pulse, the current/arc, or the time required to do so,” as Patent Owner
alleges. Pet. Reply 17. Petitioner also contends that Chernenko’s teaching
that “the generation of impulses is terminated” is not limited to terminating
the subsequent pulse, but rather, a person ordinarily skilled in the art would
have understood the disclosure to mean terminating the voltage during any
particular pulse. Id. (citing Ex. 1005 ¶¶ 72, 83; Ex. 1002 ¶¶ 144–155;
Ex. 1200 ¶¶ 89–92).
We find Petitioner’s arguments and evidence persuasive. In
particular, we construe the claimed current sensor according to its plain
meaning, i.e., that the sensor generates a signal that causes the power source
to terminate the voltage supplied to the electrodes. See Section II.C.2.
Accordingly, the claim does not require early termination of the voltage
pulse itself as Patent Owner suggests. With respect to Patent Owner’s
argument that the charging means of Chernenko does not directly supply
voltage to the electrodes and therefore, terminating the voltage would not
terminate the voltage supplied to the electrodes, we observe that the claims
do not require that voltage be directly supplied to the electrodes.
b. whether Figures 4a and 4b of Chernenko disclose a system
capable of early termination of an arc-generating voltage
pulse
Patent Owner also asserts that Figure 4a does not illustrate “a circuit
capable of terminating an arc-generating high voltage pulse early,” a fact
Dr. Jensen admitted during his deposition. PO Resp. 35 (citing Ex. 1002
¶ 147; Ex. 2105, 129:22–130:18; Ex. 2100 ¶ 123). Patent Owner explains
that Figure 4a should be read in conjunction with Figure 4b, as it provides
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more detailed schematics for Figure 4a. Id. (citing Ex. 1005 ¶¶ 50–51). But,
“Dr. Jensen admitted that he did not understand the operation of the circuit
disclosed in 4b” or other aspects of Chernenko. Id. at 35–38 (citing
Ex. 1002 ¶ 149; Ex. 2105, 110, 123, 129:22–130:18; Ex. 2043, 69 (showing
Jensen’s edits to ¶ 149 of Ex. 1002); Ex. 1005 ¶¶ 77–78, Figs. 4a, 4b; 2100
¶ 141). Patent Owner relies on the testimony of Dr. van der Weide who
explains that “the circuit depicted in Figs. 4a and 4b cannot terminate a pulse
that is already underway.” Id. at 38 (citing Ex. 2100 ¶¶ 126, 132–138).
Rather, sensors 490 and 491 control operation of the charging means and
terminates the charging means when either a present number of pulses has
been generated or when a breakdown occurs, but “cannot terminate a pulse
that is already underway.” Id. at 38–39 (citing Ex. 1005 ¶ 72; quoting
Ex. 2100 ¶ 126). Dr. van der Weide explains that because Figure 4a
includes a capacitor bank, charge will flow and continue until the capacitor
bank is discharged. Id. at 39–40 (citing Ex. 2100 ¶¶ 134–137).
Petitioner argues that Patent Owner’s arguments impermissibly limit
Chernenko to the embodiment described in Figure 4b and the use of gas
discharge tubes. Pet. Reply 18 (citing Ex. 2105, 100:13–101:10, 110:4–13,
122:19–125:2, 130:19–132:18, 160:17–161:22; Ex. 1200 ¶¶ 93–100).
According to Petitioner, Chernenko is not limited to particular components.
Id. (citing Ex. 1005 ¶ 113).
Having rejected Patent Owner’s arguments (above Section II.C.2) that
the claims require early termination of an existing voltage pulse and
therefore Chernenko is not applicable, we similarly reject Patent Owner’s
arguments here for the same reasons.
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c. whether negative resistance or inductance would prevent
early pulse termination in Chernenko
Patent Owner further contends “negative resistance and inductance
each pose a significant challenge with respect to early termination of a
pulse.” PO Resp. 43 (citing Ex. 2100 ¶¶ 146–159). As a result, “[a person
of ordinary skill in the art] would have understood that the combined effect
of negative resistance and inductance would make it nearly impossible to
reliably terminate Hawkins’ or Chernenko’s lithotripsy pulse in the middle
of an existing pulse.” Id.
Petitioner argues that the plain language of the claim requires only
that the voltage supplied to the electrodes is terminated and not that the
existing pulse itself is terminated. As a result, concepts of negative
resistance or inductance are irrelevant. Pet. Reply 6–10, 17.
As we discuss above, as properly construed, the claims do not require
termination of the pulse mid-stream. Rather, the claims require only
“terminat[ing] the voltage supplied to the electrodes for that pulse,” so the
delay associated with negative resistance and inductance is not relevant to
the claims at issue.
Based on the foregoing, Petitioner has established, by a
preponderance of the evidence, that the combination of Hawkins and
Chernenko discloses all of the limitations of claim 1 and that one of ordinary
skill in the art would have been motivated to combine Hawkins with
Chernenko. As a result, when weighed with the evidence of secondary
indicia of nonobviousness (see infra Sections II.H. and II.I.), Petitioner has
established by a preponderance of the evidence claim 1 would have been
obvious based on Hawkins and Chernenko.
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3. Analysis of the Remaining Claims (2, 3, 10)
Patent Owner does not present additional argument for claims 2, 3,
and 10 separate from that argued for independent claim 1. See generally PO
Resp. 32–43. Based on our independent review of the Petition, the cited
evidence, and for the reasons discussed above in Section II.D., we determine
that Petitioner has shown by a preponderance of the evidence that the
additional limitations of claims 2, 3, and 10 were suggested by Hawkins.
Therefore, we determine that Petitioner has shown by a preponderance of the
evidence that subject matter of claims 2, 3, and 10 would have been obvious
based on the combined teachings of Hawkins and Chernenko.
F. Obviousness in view of Hawkins, Chernenko, and Li
Petitioner contends the subject matter of claims 1–14 would have been
obvious over the combined disclosures of Hawkins, Chernenko, and Li.
Pet. 44–52. Petitioner argues that “Hawkins discloses all features of claim 1,
except [that Hawkins] may not expressly disclose current sensing to provide
voltage control, which Chernenko discloses to tightly control voltage pulses”
and that “Li provides more specific control implementations, further
motivating modification of Hawkins to include a current sensor providing
voltage control as a practical implementation of active control feedback in
its current protection.” Id. at 44. Petitioner relies on the same arguments
advanced in promoting the combination of Hawkins and Li and the
combination of Hawkins and Chernenko when presenting its arguments for
the combination of Hawkins, Chernenko, and Li. Compare id. at 12–44,
with id. at 44–52.
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Patent Owner argues only that “Petitioner fails to carry its burden to
show that Ground 3 renders the claims of the ’091 patent obvious for the
reasons set forth above with respect to Grounds 1 and 2. Patent Owner
incorporates herein its explanation as to Grounds 1 and 2.” PO Resp. 43.
For the same reasons discussed above in addressing the combinations
of Hawkins with Li and Hawkins with Chernenko, we determine that
Petitioner has shown by a preponderance of the evidence that the subject
matter of claims 1–14 would have been obvious based on the combined
teachings of Hawkins, Chernenko, and Li.
G. Obviousness in view of Hawkins and Heeren
Petitioner asserts the subject matter of claims 1–14 would have been
obvious over the combined disclosures of Hawkins and Heeren. Pet. 52–63.
1. Heeren
Heeren is directed to “[a] pulsed-electric field (PEF) surgical device
that can prevent or reduce damages caused by a dielectric breakdown.”
Ex. 1006 ¶ 5. The device includes “one or more sensors to detect an
attribute characteristic of a dielectric breakdown.” Id. ¶ 6. For example,
“[a] current sensor at the tip of probe 114 can measure the strength of the
electric current passing through probe 114 to detect a sudden increase of
electric current,” which may indicate dielectric breakdown. Id. ¶ 27. The
sensor readings are fed to a transducer monitor which “is configured to
compare the data collected by sensors 126 to a threshold to determine
whether a dielectric breakdown is imminent or whether a dielectric
breakdown has occurred.” Id. ¶ 30. “Based on the sensor data and/or the
result of the comparison between the sensor data and one or more
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predetermined thresholds, transducer monitor 155 instructs pulse generator
170 to adjust the properties of the electrical pulses.” Id. ¶ 31. Operational
parameters such as pulse duration may be adjusted or the electric pulses may
be turned off. Id. ¶ 33.
2. Analysis of Claim 1
Petitioner argues “Hawkins discloses all features of claim 1, except
[that Hawkins] may not expressly disclose sensing current to control voltage
pulses.” Pet. 52. But, Petitioner alleges Heeren discloses “a current
sensor 126 to detect the onset of dielectric breakdown at the electrodes
which causes sparking.” Id. (citing Ex. 1006 ¶¶ 17–18, 25–27; Ex. 1002
¶ 188). Petitioner explains that Heeren compares current sensor data to a
threshold value to determine whether a dielectric breakdown has occurred
and dynamically adjusts the pulse duration when the threshold is met. Id.
at 53 (citing Ex. 1006 ¶¶ 27, 30–32; Ex. 1002 ¶¶ 188, 190). Relying on the
testimony of Dr. Jensen, Petitioner explains that “setting the pulse duration
necessarily sets the pulse termination.” Id. (citing Ex. 1002 ¶ 190).
Petitioner also contends that Heeren describes “reduc[ing] pulse duration on
a pulse-by-pulse basis” and that pulses may be adjusted mid-pulse. Id. at 54
(citing Ex. 1006 ¶¶ 32–33; Ex. 1002 ¶¶ 192–193). Petitioner explains that
Heeren’s dynamic pulse control “reduce[s] damage to the patient from
electrical pulsed surgical devices, such as from excess heat, burns, or the
like.” Id. (citing Ex. 1006 ¶¶ 4, 14, 24, 33, 26). Petitioner reasons a person
skilled in the art would have realized Heeren’s dynamic pulse control would
reduce excessive current flows from shockwave devices like Hawkins. Id.
at 54–55 (citing Ex. 1002 ¶ 194). Therefore, the skilled artisan would have
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modified Hawkins in view of Heeren to increase electrical efficiency, which
decreases component wear. Id. (citing Ex. 1002 ¶¶ 193–197).
Patent Owner does not dispute Petitioner’s allegations related to
Hawkins and instead raises two principal arguments related to the
combination with Heeren—the combination does not disclose all elements of
the claim and no reason exists to combine Hawkins and Heeren. See PO
Resp. 43–50. As discussed above, we determine Petitioner’s argument and
evidence establish by a preponderance of the evidence that Hawkins
describes each limitation of claim 1 that Petitioner identifies. See In re
NuVasive, 841 F.3d at 974 (Fed. Cir. 2016). Below, we address whether
Heeren teaches the requisite current sensor, which Patent Owner disputes, as
well as whether the ordinarily skilled artisan would have had reason to
combine Heeren with Hawkins as argued.
a. whether Heeren describes early termination of a pulse based
on a current threshold value
Patent Owner contends that “Heeren teaches sensing a rate of change
in the current, not a value of the current[, and] [a]s such, Heeren does not
disclose the ‘current sensing’ limitation of claim 1.” PO Resp. 47 (citing
Ex. 2100 ¶ 169). Patent Owner explains that Heeren measures the “sudden
increase of electric current” and that “Heeren is monitoring the rate of
change of the current because a rapid increase in current would indicate a
dielectric breakdown.” Id. (citing Ex. 1006 ¶ 27; Ex. 2100 ¶¶ 168–171).
Dr. van der Weide testifies that “it would make little sense for Heeren to
monitor whether the current has crossed a certain threshold because Heeren
is interested in detecting the onset of dielectric breakdown, i.e., the moment
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just before or as dielectric breakdown occurs” and a determination of the
rate of change of current is a better indication of dielectric breakdown. Id.
at 47–48 (citing Ex. 2100 ¶¶ 168, 170, 172).
Petitioner argues that the current sensor of Heeren “measures the
strength of the current” and that the “sensor is connected to a transducer
monitor configured to compare a signal collected from the sensor to a
predetermined threshold.” Pet. Reply 15 (citing Ex. 1006 ¶¶ 15, 18–19, 27,
30). Petitioner explains that simply the threshold, which relates to an
increase in current, is “[b]ased on a result of the comparison between the
sensor data and the ‘predetermined threshold.” Id. at 15–16 (citing Ex. 1006
¶¶ 30–33). Petitioner, through the testimony of Dr. Jensen, explains that a
person skilled in the art would have understood that the threshold could have
been set to a known current value indicative of a breakdown. Id. at 16
(citing Ex. 1200 ¶¶ 73–81). Further, Petitioner asserts that “Heeren does not
sense rate of change; Heeren’s current sensor measures electric current.” Id.
(citing Ex. 1006 ¶ 27). And, Petitioner alleges that even if Heeren measures
the rate of change in current, “that specific delta of the rate of change is still
a predetermined threshold and thus would meet element 1[e].” Id. (citing
Ex. 1200 ¶¶ 82–83).
After reviewing the parties’ briefing and evidence of record, we are
persuaded by Petitioner’s arguments and supporting evidence. In particular,
we are persuaded by Petitioner that Heeren, in fact, measures current and
generates a signal when a predetermined value is reached. Pet. 52–53; Pet.
Reply 15–16. For example, Heeren explains that its surgical device includes
at least one sensor to detect characteristics of dielectric breakdown.
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Ex. 1006 ¶ 6. These sensors may include various sensor types including “a
photon sensor, a pressure sensor, and/or a thermal sensor, or various meters
for measuring voltage or current, etc.” Id. ¶ 15; see also id. ¶¶ 18
(describing “a flow rate sensor, a photon sensor, a pressure sensor, a thermal
sensor, a current sensor, a volt meter, a bubble formation detector, and so
on”), 25 (explaining that “[a] dielectric breakdown is generally accompanied
by a flash, a burst of pressure wave, and/or changes in current or voltage.”).
Heeren’s current sensors “measure the strength of the electric current
passing through probe 114 to detect a sudden increase of electric current.”
Id. ¶ 27. Therefore, Heeren detects “current flow” as claimed. Furthermore,
embodiments of Heeren are broadly described as being “configured to
compare a reading collected by sensors 126 to a predetermined threshold and
obtain a comparison result. Based on the comparison result from transducer
monitor 155, control circuit 150 in FIG. 3 controls pulse generator 170.” Id.
¶ 19; see also id. ¶¶ 30–31. Accordingly, the detected current is compared
to a predetermined value to determine whether the sensor generates a signal
like that of claim 1. Though certain of Heeren’s claims state that “the
threshold corresponds to an increase of current predetermined to the cause
dielectric breakdown” (id. at claim 6) these claims cannot limit the scope of
Heeren’s broad disclosure that data collected by current sensors is compared
to threshold values, that is, a predetermined current value. Furthermore,
even accepting Patent Owner’s contention that the term “predetermined
value” necessarily “refer[s] to a specific number” (Sur-Reply 18), the rate of
change of a value is a specific number—in this case, current over time.
Ex. 1200 ¶¶ 81–82.
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b. whether Heeren teaches early termination of a pulse
Patent Owner also argues that Heeren does not teach early termination
of a pulse, but rather, “teaches that certain parameters of a pulse (e.g.
voltage) can be adjusted after pulse termination.” PO Resp. 48–49 (citing
Ex. 1006 ¶ 33, Fig. 7, Diagram 702; Ex. 2100 ¶ 174). Furthermore, Patent
Owner contends that “[i]n order for the current . . . to stop, the dielectric
must reestablish, which as discussed herein will not happen
instantaneously.” Id. at 49 (citing Ex. 2100 ¶ 175). Dr. van der Weide
testifies that because “Heeren’s pulses are about a million times faster than
the dielectric relaxation time [of the protein complexes being treated] (1 ms
v. 1 ns), a skilled artisan would understand that Heeren simply could not
immediately cut off the current in the middle of a pulse.” Id. at 49–50
(citing Ex. 2045 ¶ 70 (Kovalcheck patent application for removing
proteinaceous tissue); Ex. 1006 ¶ 22; Ex. 2100 ¶ 176). And, as asserted
above, Patent Owner argues that “the combined effects of negative
resistance and inductance would make it nearly impossible to terminate the
voltage pulse in Heeren.” Id. at 50 (citing Ex. 2100 ¶¶ 178–191).
Petitioner argues that Patent Owner’s “arguments ignore
element 1[e]’s language [which] says nothing about terminating the pulse,
current/arc, or the time required to do so.” Pet. Reply 15. Rather, the claims
require only that the voltage supplied to the electrodes be terminated. Id.
at 6–10, 15. Furthermore, Petitioner argues that Heeren does teach
terminating the pulse where Heeren describes that its system can “(i)
‘reduc[e] the strength, duration, and/or shape of the pulses,’ (ii) adjust
‘operational parameters’ (e.g., such as ‘voltage’) ‘in the middle of the pulse,’
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(iii) turn the pulses off completely, and (iv) make the adjustments
‘dynamically.’” Id. at 16 (citing Ex. 1006 ¶¶ 32–33).
As we explain above, we do not construe claim 1 to require early
termination of the voltage pulse itself, rather, the plain language of the claim
requires only that “the power source terminate the voltage supplied to the
electrodes for that pulse.” Accordingly, we are not persuaded by Patent
Owner’s arguments based on the purported failure of Heeren to describe
early pulse termination.
Furthermore, Heeren’s disclosure expressly contradicts Patent
Owner’s assertions in this regard. For example, Heeren explains that
The operational parameters, such as the voltage of the pulses,
may be adjusted in the middle of an electric pulse, as shown in
diagram 702 in FIG. 7. Alternatively, the operational
parameters, such as the duration and voltage of the pulses, may
be adjusted in between two electric pulses (diagram 704). The
electric pulses may be turned off completely as well (diagram
706).
Id. ¶ 33 (italics emphasis added); see also id. ¶¶ 4 (same), 21 (explaining
that control circuit 150 controls pulse amplitude, pulse duration, repetition
rate, pulse pattern, and pulse train length based on sensor data). Figure 7,
reproduced below, exemplifies adjusting the operational parameters
according to Heeren.
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Figure 7 “illustrates series of electric pulses with parameters adjusted during
a dielectric breakdown.” Ex. 1006 ¶ 13. Heeren further explains that “[b]y
dynamically adjusting the operational parameters of pulse generator 170 in
response to an imminent dielectric breakdown or a dielectric breakdown,
PEF device 200 can prevent or reduce damage[] caused by a dielectric
breakdown.” Id. ¶ 33. And, as Dr. Jensen testifies, adjusting or reducing the
pulse duration “necessarily sets the pulse termination as the end of the given
pulse.” Ex. 1002 ¶ 189.
Based on the foregoing, Petitioner has established, by a
preponderance of the evidence, that the combination of Hawkins and Heeren
discloses all of the limitations of claim 1 and that one of ordinary skill in the
art would have been motivated to combine Hawkins with Heeren. As a
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result, when weighed with the evidence of secondary indicia of
nonobviousness (see infra Sections II.H. and II.I.), Petitioner has established
by a preponderance of the evidence claim 1 would have been obvious based
on Hawkins and Heeren.
3. Analysis of the Remaining Claims (2–14)
Patent Owner does not challenge Petitioner’s allegations as to
independent claims 6, 10, and 14 or dependent claims 2–5, 7–9, and 11–13
separate from the arguments considered above for claim 1. Based on our
independent review of the Petition and cited evidence, we determine that
Petitioner has established by a preponderance of the evidence that the
subject matter of claims 2–14 would have been obvious based on the
combined teachings of Hawkins and Heeren. For the reasons discussed
above, the additional limitations claims 2, 3, 7, 8, 10, and 11 would have
been suggested by Hawkins and understanding of the skilled artisan in the
art. See Section II.D.4. And, the additional limitation of claims 4, 12, and
14, i.e., a delay timer, are suggested by Heeren’s dynamic control which sets
the pulse duration. Pet. 58–59 (citing Ex. 1006 ¶¶ 32–33; Ex. 1002
¶¶ 203–204). Furthermore, the duration of the delay, relevant for claims 5,
6, 9, and 13, involves optimization of a result effective variable, is a matter
of design choice based on component selection, and was well known in the
art. Id. at 60–62 (citing Ex. 1001, 10:60–11:9 (explaining that delay time is
dependent on the natural response delay of the circuitry); Ex. 1002
¶¶ 207–211; Ex. 1010, Fig. 4; Ex. 1005 ¶ 59).
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H. Objective Indicia of Nonobviousness
The fourth Graham factor instructs that we must consider—apart from
what the prior art itself would have suggested— whether objective evidence
of nonobviousness (i.e., secondary considerations) may lead to a conclusion
that the challenged claims would not have been obvious. See, e.g.,
Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983)
(instructing that evidence of secondary considerations, when present, must
always be considered in determining obviousness). Objective evidence of
nonobviousness may include evidence of commercial success, licensing,
copying, praise by others, longfelt but unresolved need, and failure or
skepticism of others. Graham, 383 U.S. at 17–18. But, secondary
considerations are only a part of the “totality of the evidence”; its mere
existence does not control the conclusion of obviousness. See Richardson-
Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997) (citations
omitted). Objective evidence of nonobviousness “may often be the most
probative and cogent evidence in the record” and “may often establish that
an invention appearing to have been obvious in light of the prior art was
not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling
USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012).
Objective evidence of nonobviousness “is only relevant to the
obviousness inquiry ‘if there is a nexus between the claimed invention and
the [objective indicia of nonobviousness].’” In re Affinity Labs of Tex., LLC,
856 F.3d 883, 901 (Fed. Cir. 2017) (quoting Ormco Corp. v. Align Tech.,
Inc., 463 F.3d 1299, 1312 (2006)). A “nexus” is a legally and factually
sufficient connection between the objective evidence and the claimed
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invention such that the objective evidence should be considered in the
determination of obviousness. Henny Penny Corp. v. Frymaster LLC, 938
F.3d 1324, 1332 (Fed. Cir. 2019); In re Paulsen, 30 F.3d 1475, 1482 (Fed.
Cir. 1994). A presumption of nexus arises where “the patentee shows that
the asserted objective evidence is tied to a specific product and that product
‘embodies the claimed features, and is coextensive with them.’” Fox
Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting
Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018)
(quoting Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229
F.3d 1120, 1130 (Fed. Cir. 2000))); see also Teva Pharms. USA, Inc. v.
Sandoz, Inc., 723 F.3d 1363, 1372 (Fed. Cir. 2013) (explaining that a
“presumption of a nexus” exists where a product is “coextensive” with a
patent claim). If, however, the patented invention is only a component of
the commercial embodiment, the patentee is not entitled to a presumption of
nexus. Fox Factory, 994 F.3d at 1374. “A patent is not coextensive with a
product that includes a ‘critical’ unclaimed feature that is claimed by a
different patent and that materially impacts the products’ functionality.” Id.
at 1375. But, “[a] finding that a presumption of nexus is inappropriate does
not end the inquiry into secondary considerations”; rather, “the patent owner
is still afforded an opportunity to prove nexus by showing that the evidence
of secondary considerations is ‘the direct result of the unique characteristics
of the claimed invention.’” Id. at 1374 (quoting In re Huang, 100 F.3d 125,
140 (Fed. Cir. 1996). Patent Owner bears the burden of establishing that a
nexus exists between the evidence of secondary considerations and the
patented invention. Id. at 1373.
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Patent Owner argues that there exists substantial evidence of
nonobviousness in the form of industry acclaim, skepticism of others, and
commercial success. See PO. Resp. 50–59. In particular, Patent Owner
contends that “[t]he claims of the ’091 patent are directed to an important
aspect of the Shockwave device that contributes substantially to patient
safety.” Id. at 51 (citing Ex. 2100 ¶ 196). Patent Owner attributes patient
safety to the ability of its “improved shockwave catheter [to] deliver[] ‘a
maximum intensity shockwave . . . formed without wasting energy, without
unduly eroding the electrodes, and without generating unnecessary heat.’”
Id. (citing Ex. 1001, 11:14–16). Patent Owner further explains that its
current monitoring sensor and pulse termination ensures that the Shockwave
device “generates less heat in the balloon” as too much heat may damage
tissue. Id. According to Patent Owner, the safety of the Shockwave IVL is
evidenced by industry praise, skepticism in the art, and commercial success.
See generally PO Resp. 50–59. Through the testimony of Dr. van der
Weide, Patent Owner contends “that the Shockwave IVL device includes
each feature recited in the claims of the ’091 patent.” Id. (citing Ex. 2100 ¶
195; Exs. 2178–2180 (claim charts)). Patent Owner, however, does not
argue that the Shockwave IVL device is coextensive with any of the
challenged claims or address whether a presumption of nexus is appropriate
in this case.9 Id. Therefore, we assume for purposes of our analysis that all

9 Patent Owner initially asserted that it was entitled to a presumption of
nexus because the Shockwave product was coextensive with the claimed
features. Prelim. Resp. 56–57. Patent Owner, however, did not reassert this
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of the challenged claims cover the Shockwave IVL device, but do not apply
a presumption of nexus because Patent Owner waived that argument. Below
we consider the parties’ arguments and evidence regarding any purported
industry praise, skepticism in the art, and commercial success in light of any
alleged nexus.
1. Industry Praise
Patent Owner contends that “[t]he Shockwave IVL device has
achieved significant praise from those in the industry for its superior safety,
which derives in substantial part from the claimed invention.” PO Resp. 53.
As evidence of this praise, Patent Owner points to the “Breakthrough
Device” designation awarded to the Shockwave IVL device by the U.S.
Food and Drug Administration (“FDA”). Id. According to Patent Owner,
the “designation is awarded to a device that ‘provides for more effective
treatment’ with ‘no approved or cleared alternatives’ while ‘offer[ing]
significant advantages over existing approved or cleared alternatives . . . .’”
Id. (citing Ex. 2135, 7 (FDA Guidance on Breakthrough Devices Program)).
Dr. van der Weide testifies that “while he ‘understand[s] the Breakthrough
Designation was not awarded solely based on the pulse terminating

position in its Response and as a result, Patent Owner has waived this
argument. Unified Patents Inc. v. Nonend Inventions N.V., IPR2016-00174,
Paper 28, 3–4 (PTAB July 25, 2017) (arguments raised in a patent owner
preliminary response but not reasserted in a patent owner response are
waived); see also Paper 15, 7–8 (“Patent Owner is cautioned that any
arguments for patentability not raised in the response may be deemed
waived.”).
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innovation disclosed and claimed in the ’091 patent, that innovation does
contribute to the safety profile of the Shockwave IVL device.’” Id. (quoting
Ex. 2100 ¶ 202).
Patent Owner also relies on the testimony of clinicians who “regularly
use the Shockwave IVL device and have praised its safety.” Id. at 53 (citing
Ex. 2100 ¶ 203). For example, Dr. Kereiakes testifies that the “Shockwave
IVL has generated excitement in the community due to its ease of use and
safety profile” and that he tells his colleagues that “they should expect ‘zero’
complications of the procedure with Shockwave IVL.” Id. at 53–54 (quoting
Ex. 2174 ¶¶ 17–18). Dr. Soukas testifies that the Shockwave IVL is
“extremely safe” and that he has “never encountered an issue with . . . the
energy creating an unacceptable amount of heat in the hundreds of times
[he] ha[s] used Shockwave IVL.” Id. at 54 (first alteration in the original).
Dr. Soukas explains that “Shockwave IVL includes controls that limit the
duration of energy, which creates shockwaves to prevent too much heat from
being generated.” Id. (quoting Ex. 2170 ¶ 20). Dr. Armstrong attests that
the “Shockwave device has an amazing safety profile” and that it is “much
safer than traditional angioplasty balloons and atherectomy devices.” Id.
(quoting Ex. 2173 ¶ 22). And, Dr. Lyden affirms that “[t]he device is also
extremely safe with no adverse events from shockwaves” and identifies
“[o]ne of the safety feature[s] is the result of a sensor that allows the electric
charge to be terminated before it generates too much heat.” Id. at 55
(quoting Ex. 2171 ¶ 20) (alterations in original).
Lastly, Patent Owner contends that financial analyst reporting and
industry articles reflect industry praise. Id. at 55–56. In particular, these
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articles characterize the Shockwave IVL device and accompanying
technology as “innovative, potentially paradigm-changing” and “disruptive”
(id. (quoting Ex. 2132, 3, 52, 59; quoting Ex. 2133, 14)), “elegant” and
“easy to use” (id. at 56 (quoting Ex. 2016, 1)), “revolutionary” (id. (quoting
Ex. 2003, 1)), “amazing” and “actually space-age technology” (id. (quoting
Ex. 2002, 2)), and “‘safer’ than other devices” (id. (quoting Ex. 2114, 11)).
Much of Patent Owner’s evidence—the Breakthrough Device
designation, analyst reports, and articles—is “generalized praise”
unattributed to any claimed feature (or combination of features) of the ’091
patent. Similarly, much of the clinician testimony is largely unrelated to
claimed features of the ’091 patent, much less the current monitoring sensor
purportedly responsible for improved safety due to the generation of less
heat within the balloon. See Ex. 2174 ¶ 18 (testimony of Dr. Kereiakes that
“[t]here have not been any reported arterial ruptures or perforations caused
by the angioplasty balloon” or “reported incidents of atheroembolization”);
Ex. 2170 ¶ 20; Ex. 1212, 148:20–149:19 (testimony of Dr. Soukas crediting
the button delivering energy as responsible for preventing too much heat
from being generated); Ex. 2173 ¶ 22 (failing to tie reduction in excessive
heat to any feature of the Shockwave device). Only the testimony of
Dr. Lyden provides any nexus to the safety feature claimed by the ’091
patent. Ex. 2171 ¶ 20 (“One of the safety feature[s] is the result of a sensor
that allows the electric charge to be terminated before it generates too much
heat.”). Dr. Lyden has received between $5,000–$10,000 in consulting fees
from Shockwave separate from the consulting work performed in connection
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with this matter which, as of January 2020, has not been billed. Ex. 1214, 2
(questions regarding Lyden and Armstrong).
Therefore, having considered the record evidence, we find that some
evidence of industry praise with a nexus to the ’091 patent, namely the
testimony of Dr. Lyden, exists in the record. We also do not view such
“financial interest” to be noteworthy or find other evidence of bias on the
part of Dr. Lyden. On balance, we accord moderate weight to Patent
Owner’s evidence of industry praise as significant industry praise tied to the
claimed features has not been shown.
2. Skepticism in the Art
Patent Owner asserts that “clinicians that regularly use the device
expressed skepticism as to whether the Shockwave IVL would generate an
unsafe amount of heat that could result in tissue damage.” PO Resp. 56
(citing Ex. 2100 ¶ 216). For example, Dr. Soukas explained that he had
concerns about the device creating an unacceptable amount of heat that
could cause damage to the arterial wall, but “that his concern ‘proved to be
unwarranted as the device is extremely safe.’” Id. at 56–57 (quoting
Ex. 2170 ¶¶ 19–20). Further, Dr. Armstrong testifies that “when [he] first
learned of the technology [his concern] was whether it would generate too
much heat” because “[i]t is well known in this field that heating the blood
vessel by more than about two degrees Celsius could damage the vessel
wall, which would almost certainly lead to restenosis.” Id. at 57 (quoting
Ex. 2173 ¶ 21) (second quote alteration in original). But, Dr. Armstrong
“testifies that his safety concerns were ‘allayed by the Shockwave clinical
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studies and the clinical experience of physicians.’” Id. (quoting Ex. 2173
¶ 21).
The testimony of Drs. Soukas and Armstrong provide some evidence
of skepticism. Specifically, Dr. Armstrong was skeptical about: (1) the
ability of the Shockwave IVL device to pass through heavily calcified
lesions, especially in light of the additional components included in the
device (Ex. 2173 ¶¶ 15–17), (2) the risk of embolism (id. ¶¶ 18–19), (3)
whether the “balloon could survive the pressure generated by the
shockwave” and rupture (id. ¶ 20), and (4) whether the Shockwave IVL
would generate too much heat and cause restenosis (id. ¶ 21). Similarly,
Dr. Soukas expressed skepticism that a balloon could be used to treat heavily
calcified lesions (Ex. 2170 ¶¶ 10, 19), concern that the angioplasty balloon
would rupture (id. ¶ 19), worry that “the generation of energy in the form of
a shockwave would create an unacceptable amount of heat” (id.), and
concern over the potential for embolism (id. ¶ 21). Only Dr. Soukas tied his
concern of overheating to a feature of the Shockwave IVL—specifically that
the “Shockwave IVL includes controls that limit the duration of energy,
which creates the shockwaves to prevent too much heat from being
generated.” Id. ¶ 20. When questioned about this statement, however,
Dr. Soukas testified that he was referring the ability to deliver voltage using
a button control.
Q.· What artery is -- never mind.··You answered that.··So,
you make a statement, Shockwave IVL includes controls that
limit the duration of·energy.··What were you referring to with
respect to those controls?
A.· The fact that you have to keep your finger on the
button in order to deliver the spark.
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Q.· Okay.··So, you can't -- as soon as your finger comes
off, the sparks stop; is that fair?
A.· That's correct.
Q.· Yeah, can you -- so, let me ask this. So, to deliver the
30 pulses maximum in -- in one button press if you will, how
long does that take?
A.· 30 seconds.
Q.· One per second?
A.· (Witness nodding.)
Q.· So, you can -- can you precise -- so, can you just
deliver 10 by looking at your watch and counting 10 seconds?
A.· Sure.
Q.· Okay.··When you're using the Shockwave device is
that typical, or do you either use one pulse or the full 30?
A.· Most of the time I use the full 30.
Ex. 1212, 148:20–149:19. Thus, the skepticism expressed by Dr. Soukas—
and tied to features of the Shockwave IVL—are not attributed to the
advantages of the claimed invention because none of the claims recites use
of a control button to control the delivery of energy. Rather, the evidence of
nonobviousness expressed here is due to “additional unclaimed features.”
Polaris, 882 F.3d at 1072. As such, we assign little weight to Patent
Owner’s evidence of skepticism as Patent Owner failed to adequately link
the record evidence to the claimed features of the ’091 patent.
3. Commercial Success
Patent Owner states that “Shockwave IVL sales have skyrocketed due,
in part, to the safety profile of the device discussed above. Because the
invention claimed in the ‘091 patent makes a substantial contribution to the
safety of the device, it follows that the innovation has made a substantial
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contribution to the success of the Shockwave IVL device.” PO Resp. 57.
Patent Owner explains that Shockwave “sells only one product with
different model numbers used for different indications.” Id. at 58 (citing
Ex. 2100 ¶ 219; Ex. 2141, 10 (SEC Form 10-Q, consolidated financial
statements)). As evidence of commercial success, Patent Owner explains
that “Shockwave’s current market capitalization is about $1 billion”
(Ex. 2122 (Yahoo Finance data)), projected revenue for 2019 “range from
$38 million to $40 million, which represents 210% to 226% growth over the
company’s prior year revenue” (Ex. 2176, 1 (Shockwave 2d Quarter
Financial Results); Ex. 2175 ¶ 8 (Stephens declaration)), and “second
quarter revenue of 2019 was $10.0 million, an increase of $7.7 million, or
339%, compared to the second quarter of 2018” (PO Resp. 58).
Dr. Kereiakes also testifies that the Shockwave IVL effectiveness, ease of
use, and safety profile are responsible for its success. Id. at 58 (citing
Ex. 2174 ¶ 19). Further, Dr. Kereiakes “recounts that ‘[u]pon seeing or
using Shockwave IVL, seasoned interventional cardiologists often ask how
they can invest in the technology, which in ‘estimation [] is a ringing
endorsement of the technology that is traced directly to the effectiveness,
ease of use, and safety profile of Shockwave IVL.’” Id. (quoting Ex. 2174
¶ 19) (alterations in original).
While we agree, in view of the evidence and supporting testimony,
that the Shockwave IVL device is commercially successful and has resulted
in significant sales, Patent Owner does little, if anything, to tie that
commercial success to any patented features of the ’091 patent, much less
safety in general. The record lacks evidence as to whether the Shockwave
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device sales are the result of the unique characteristics of the claimed
invention as opposed to other economic or commercial factors unrelated to
the safety of the invention, such as successful marketing and promotion. See
Ex. 1216, 30:20–37:7 (testimony by Mr. Stephens that the sales force has
“gone up meaningfully” since 2018); Ex. 2141, 4, 20–23 (Patent Owner’s
10-Q detailing a 59% increase in its sales and marketing expenses from
2018-2019). And though Dr. Kereiakes credits the Shockwave safety profile
as a partial contributor to its commercial success, his testimony is based on
the fact that “[t]here have not been any reported arterial ruptures or
perforations caused by the angioplasty balloon” or “reported incidents of
atheroembolization (plaque particles being dislodged and going
‘downstream’ to cause distal vessel occlusion).” Ex. 2174 ¶ 18; see also id.
¶ 14 (explaining that known angioplasty balloons rupture 1–2% of the time).
Accordingly, we accord only moderate weight to Patent Owner’s evidence
of commercial success in the absence of a more substantial nexus to the
claims.
I. Conclusion as to Obviousness
Petitioner persuasively explains where Hawkins in combination with
either of Li, Chernenko, Chernenko and Li, or Heeren discloses the
limitations of the challenged claims. See generally Pet. Petitioner also
persuasively explains why one of ordinary skill in the art would have had
reason to modify Hawkins in view of the secondary references to achieve the
invention as claimed. Id. When this evidence of obviousness is considered
in combination with Patent Owner’s evidence of objective indicia of
nonobviousness, we determine that Petitioner has demonstrated by a
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preponderance of the evidence that claims 1–14 of the ’091 patent would
have been obvious over the combined disclosures (1) Hawkins and Li
(claims 1–14), Hawkins and Chernenko (claims 1–3 and 10), Hawkins,
Chernenko and Li (claims 1–14), and Hawkins and Heeren (claims 1–14).
III. MOTIONS TO EXCLUDE
A. Petitioner’s Motion to Exclude
Petitioner filed a Motion to Exclude Exhibits 2002–2004, 2006, 2008,
2048, 2015–2018, 2025, 2026, 2100, 2106, 2107, 2111, 2114, 2116–2122,
2132–2138, 2141, 2143, 2153, 2154, 2159-–2163, 2170, 2172, 2173, and
2175–2180. Pet. MTE 1.
1. Hearsay Objections
Petitioner moves to exclude Exhibits 2002, 2003, 2006, 2016, 2017,
2114, 2117, 2119, 2122, 2132, 2133, 2134, 2135, 2141, and 2175–2177 as
inadmissible hearsay under Federal Rules of Evidence 801, 802, and 805.
Pet. MTE, 1–2.10 The objected to exhibits include news articles (Exs. 2002,
2003, 2114), analyst materials (Exs. 2006, 2007, 2016, 2017, 2132, 2133),
partial transcripts of a Shockwave roundtable discussion (Exs. 2117, 2119),
Yahoo Finance data (Ex. 2122), FDA Breakthrough letter and Guidance
paper (Exs. 2134, 2135), Shockwave 10-Q (Ex. 2141), and the Stephens’
Declaration and supporting documents (Exs. 2175–2177). Id.

10 Though Petitioner objected to Exhibits 2004, 2008, 2015, 2025, and 2026
as inadmissible hearsay (see Paper 17), Petitioner does not move to exclude
these exhibits as improper hearsay, but rather, as uncited exhibits. Pet. MTE
7.
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Patent Owner argues that “laudatory statements” are not offered for
the truth of the matter but rather to show that the statements were made. PO
MTE Opp. 1–2. Patent Owner further contends that the exhibits Petitioner
seeks to exclude “are relied upon by an expert, who is entitled to rely on
hearsay materials to support his or her opinions.” Id. at 2. Lastly, Patent
Owner argues that the exhibits are sufficiently trustworthy in light of the
totality of the circumstances. Id. at 3.
We are not persuaded that Exhibits 2002, 2003, 2006, 2016, 2017,
2114, 2117, 2119, 2122, 2132, 2133, 2134, 2135, 2141, and 2175–2177
should be excluded. These exhibits are, for the most part, offered in support
of Patent Owner’s argument that objective evidence of nonobviousness
exists, i.e., industry praise, skepticism, and commercial success. See
generally PO Resp. 50–59. Patent Owner does not rely on statements made
in these exhibits for the truth of the matter asserted, for example, that the
Shockwave device “has an amazing safety profile [Ex. 2173 ¶ 22]” or that it
is “space-age technology [Ex. 2002, 1].” Rather, Patent Owner relies upon
these statements to show that industry actors took notice of and commented
on the Shockwave device. Quanergy Sys., Inc. v. Velodyne Lidar, Inc.,
IPR2018-00256, Paper 66 at 5–6 (PTAB May 21, 2020) (“[S]tatements
offered solely for the purpose of showing they were made are admissible.”);
Fox Factory, Inc. v. SRAM, LLC, IPR2016-01876, Paper 59 at 59 (PTAB
Apr. 2, 2018). To the extent the evidence may have served a hearsay
purpose, we assign it little, if any, weight. Further, experts like Dr. van der
Weide are permitted to rely on hearsay if experts in the same field would
reasonably rely on such materials in forming opinions and inferences based
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on the subject. See Fed. R. Evid. 703. To the extent that Dr. van der Weide
relies on evidence that is not of the type which “experts in the field would
reasonably rely,” we have assigned very little weight to such evidence.11
Therefore, we deny Petitioner’s motion to exclude these Exhibits 2002,
2003, 2006, 2016, 2017, 2114, 2122, 2132, 2133, 2134, 2135, 2141, and
2175–2177.
Exhibits 2117 and 2119, though considered by Dr. van der Weide in
forming his opinions, are not relied upon by Patent Owner in advancing its
positions. Accordingly, we deny Petitioner’s motion to exclude Exhibits
2117 and 2119 as moot.
2. Uncited Exhibits
Petitioner moves to exclude exhibits 2004, 2008, 2015, 2025, 2026,
2048, 2106, 2107, 2116, 2118, 2120, 2121, 2136–2138, 2143, 2153, 2154,
2159–2163, and 2173 as irrelevant under Federal Rules of Evidence 401 and
402. Pet. MTE 7. Petitioner argues that because Patent Owner did not cite
to these exhibits in any of its pleadings and declarations, “the exhibits
‘ha[ve] no bearing on any fact that is of consequence in determining the
outcome of the proceeding’ and should be excluded under FRE 401 and
402.” Id. at 8 (quoting One World Technologies, Inc. v. The Chamberlain

11 Even if we accorded the identified exhibits and testimony substantial
weight, it would not alter our ultimate decision finding the claims obvious as
Patent Owner’s showing of nexus between the objective indicia of
nonobviousness and the claims is inadequate.
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Group, Inc., IPR2017-00126, paper 56 at 16 (PTAB October 24, 2018))
(alteration in original).
Patent Owner contends that the uncited exhibits should not be
excluded because “the better course is to preserve them in the record.” PO
MTE Opp. 6–7.
We are not persuaded by Petitioner’s arguments that the evidence on
which Patent Owner relies must be excluded from the record. Patent Owner
does not rely on Exhibits 2004, 2008, 2015, 2025, 2026, 2048, 2106, 2107,
2116, 2118, 2120, 2121, 2136–2138, 2143, 2153, 2154, 2159–2163, and
2173 to support its arguments. See generally PO Resp., Sur-Reply. Because
Petitioner does not rely on Exhibits 2004, 2008, 2015, 2025, 2026, 2048,
2106, 2107, 2116, 2118, 2120, 2121, 2136–2138, 2143, 2153, 2154,
2159–2163, and 2173, we do not consider these exhibits in rendering our
Decision. Accordingly, we deny Petitioner’s motion to exclude these
Exhibits as moot.
3. Deposition Exhibits
Petitioner moves to exclude Exhibits 2178–2180, that is, claim charts
mapping certain claims to the Shockwave devices. Pet. MTE 8–9.
According to Petitioner, “Mr. Stephens and Dr. van der Weide lack[]
personal knowledge of the information recited in the exhibits.” Id. at 9.
Patent Owner argues that Petitioner failed to make a timely objection
to Exhibits 2178–2180 and therefore such objection is waived. PO MTE
Opp. 7. Patent Owner further explains that Exhibits 2178–2180 are relied
upon by Dr. van der Weide, not Mr. Stephens, and further that there is no
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requirement that an expert have personal knowledge about the facts and data
upon which he relies. Id. at 8.
Our rules require that “[a] party wishing to challenge the admissibility
of deposition evidence must make an objection during the deposition [and,
a] party wishing to challenge evidence other than deposition evidence, must
file any objections within five business days of service of evidence.”
37 C.F.R. §§ 42.64(a); Patent Trial and Appeal Board Consolidated Trial
Practice Guide 78–79 (Nov. 2019) (“Consolidated TPG”).12 Any such
“[o]bjections may be preserved by filing a motion to exclude the evidence.”
37 C.F.R. §§ 42.64(c); Consolidated TPG 78–79. The failure to raise an
objection at the appropriate time, results in a waiver of the objection. As a
result, we advise parties that “[a] motion to exclude evidence should . . .
[i]dentify where in the record the objection was originally made.”
Consolidated TPG 79. Here, Petitioner does not identify the portion of the
record where its objection to Exhibits 2178–2180 were originally made (see
Pet. MTE 8–9) and our review of the Petitioner’s Objections (Papers 17, 37),
as well as the deposition testimony of Mr. Stephens and Dr. van der Weide,
show that Petitioner failed to object to Exhibits 2178–2180. Therefore, we
deny Petitioner’s Motion to Exclude Exhibits 2178–2180.

12 The Consolidated TPG is available at
https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf).
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4. Objections under Federal Rule of Evidence 401, 402, and 403
Petitioner moves to exclude exhibits 2002, 2003, 2006, 2016, 2018,
2111, 2122, 2132–2135, 2141, 2171, and 2173 as irrelevant under Federal
Rules of Evidence 401, 402, and 403. Pet. MTE 9. The exhibits identified
as objectionable include news articles (Exs. 2002, 2003), analyst materials
(Exs. 2006, 2016, 2132, 2133), the Motisan reference (Ex. 2018),
international standard documentation (Ex. 2111), Yahoo Finance data
(Ex. 2122), FDA Breakthrough letter and Guidance paper (Exs. 2134, 2135),
Shockwave 10-Q (Ex. 2141), and the declaration testimony of Drs. Lyden
and Armstrong (Exs. 2171, 2173). Id. Petitioner contends the identified
exhibits provide scant, cumulative, and unhelpful information that should be
excluded. See generally id. at 9–13.
Patent Owner argues that, instead of excluding evidence deemed to be
irrelevant, little weight should be accorded such evidence. PO MTE
Opp. 8–9. Patent Owner explains that each of Petitioner’s arguments go to
the weight of the evidence as opposed to admissibility. See generally id.
at 8–15. Patent Owner also contends that the declarations of Drs. Lyden and
Armstrong (Exs. 2171, 2173) each “bring[] a different perspective and
emphasize[] different aspects of the Shockwave device,” and therefore are
not cumulative. Id. at 11. Further, according to Patent Owner, “[t]he
declarations also corroborate one another in various respects, which is
another important aspect of the declarations.” Id. at 11–12.
We are not persuaded by Petitioner’s arguments that Exhibits 2002,
2003, 2006, 2016, 2018, 2111, 2122, 2132–2135, 2141, 2171, and 2173
must be excluded from the record. The evidence Petitioner seeks to exclude
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supports Patent Owner’s argument that the claims of the ’091 patent are
nonobviousness; specifically, the exhibits relate to objective indicia of
nonobviousness. Therefore, the exhibits are relevant as having a “tendency
to make a fact more or less probable.” Fed. R. Evid. 401. Further, because
the decision here is rendered by the panel, as opposed to a jury, there is little
risk that the purported “scant, cumulative, and unhelpful information” will
confuse or mislead the panel such that the probative value is outweighed by
the danger of unfair prejudice. Id. at 403; see Corning Inc. v. DSM IP Assets
B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“Similar to a
district court in a bench trial, the Board, sitting as a non-jury tribunal with
administrative expertise, is well-positioned to determine and assign
appropriate weight to the evidence presented.”). For the above reasons, we
are not persuaded that the testimony at issue should be excluded and, thus,
we deny Patent Owner’s Motion to Exclude Exhibits 2002, 2003, 2006,
2016, 2018, 2111, 2122, 2132–2135, 2141, 2171, and 2173.
5. Testimony of Dr. van der Weide
Petitioner moves to exclude portions of the declaration testimony of
Dr. van der Weide under Federal Rules of Evidence 702 and 703. Pet.
MTE 14. In particular, Petitioner seeks to exclude certain paragraphs of Dr.
van der Weide’s declaration (Ex. 2100), including:
paragraphs 68, 70, 78 (testimony not based on sufficient facts or
data), 83 (unfounded conclusion; testimony not based on
sufficient facts or data that the TI data sheet represents the
commercial embodiment of the Li reference, Ex. 1004); 91, 92,
94, 95 (prior art never address FDA requirements; testimony not
based on sufficient facts or data), 127–131 (testimony not based
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on sufficient facts or data), and 172 (mischaracterizes Heeren;
testimony not based on sufficient facts or data).
Id.
Patent Owner argues that Petitioner’s basis for excluding certain
paragraphs of Dr. van der Weide’s declaration are conclusory and that
Petitioner “does not explain how the testimony is not based on sufficient
facts or data, what alternative facts or data could or should instead have been
considered, or how the prior art is mischaracterized.” PO MTE Opp. 15.
Whether Dr. van der Weide’s opinions are conclusory,
mischaracterizes evidence, or not adequately based on record evidence, in
this case, goes to the weight we should give to his testimony. Thus, we deny
Petitioner’s motion to exclude the identified paragraphs of Dr. van der
Weide’s second declaration (Ex. 2100).
B. Patent Owner’s Motion to Exclude
Patent Owner filed a Motion to Exclude Exhibits 1002 and 1200, i.e.,
the expert opinion testimony offered by Dr. Morten Jensen. PO MTE 1.
According to Patent Owner, “Dr. Jensen is not qualified to testify either as a
person of ordinary skill in the art or as an expert in this proceeding.” Id.
Patent Owner objected to Exhibit 1002 under Federal Rule of Evidence 703,
i.e., including statements that are unsupported by facts, data or other
evidence, and Exhibit 1200 under Rule 702, that is, Dr. Jensen’s opinions
are unreliable because he is not qualified as an expert. Id. Patent Owner
argues Exhibits 1002 and 1200 should be excluded for the same reasons—
Dr. Jensen is not qualified, as established by the facts that Dr. Jensen:
(1) did not understand the concept of negative resistance (id. at 3); (2) “did
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not consider the impact inductance would have had on any attempt to
terminate an arc-generating voltage pulse early” (id. at 4); (3) “does not
understand the prior art references on which he relied” (id. at 5); and
(4) admitted “he had only a ‘general understanding’ of the preferred
embodiment of the ’091 patent (Fig. 6) and ‘didn’t dive into great detail’”
(id. at 7). Therefore, Patent Owner contends that, because Dr. Jensen’s
testimony is based on a misunderstanding of the technology, it is unreliable,
unhelpful, and prejudicial to Patent Owner. Id. at 8.
Regarding Exhibit 1200, Petitioner argues that Patent Owner did not
timely object or respond to Petitioner’s supplemental evidence. Pet. MTE
Opp. 1. Therefore, Petitioner reasons that Patent Owner did not preserve its
objections. Id. at 2.13
We are not persuaded we should exclude Dr. Jensen’s declaration
testimony (Ex. 1200) as an unqualified expert under Rule 702.14 Dr. Jensen
holds an undergraduate degree in electrical and computer engineering with

13 Petitioner’s argument that Patent Owner did not timely object is without
merit. Petitioner complains that Patent Owner filed its objections six days
and not the requisite five days after Petitioner served Exhibit 1200. Pet.
MTE Opp. 1. But, February 17, 2020 fell on the third Monday in February,
i.e., Presidents’ Day, a federal holiday. Therefore, Patent Owner’s
objections are not tardy.
14 Patent Owner did not originally object to Exhibit 1002 on the grounds that
Dr. Jensen was unqualified to testify as an expert under Rule 702. Rather,
Patent Owner only objected to certain paragraphs under Rules 703 and 403.
See Paper 16, 2. Thus, we observe Patent Owner also failed to preserve any
objection to 1002 on the ground that Dr. Jensen is unqualified, as alleged in
Patent Owner’s Motion to Exclude.
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an emphasis on biomedical engineering, a master’s degree in biomedical
engineering, and a doctorate in both medicine (Ph.D.) and medical science
(Dr.Med.). Ex. 1002 ¶ 8. Dr. Jensen indicates that he is currently employed
as a professor of biomedical engineering and the University of Arkansas and
is an adjunct professor in the Department of Cardiothoracic Surgery at the
University Hospital of Aarhus where he teaches biomedical engineering. Id.
¶ 9. Dr. Jensen has “published numerous articles relating to aspects of
device interactions with cardiovascular tissues, including device design,
performance and specific features that allow these devices to function
optimally.” Id. ¶ 10. Dr. Jensen has observed and participated in hundreds
of heart surgeries on large animals, in particular porcine models—“well-
known model[s] for the human heart and cardiovascular system”—as part of
his research efforts. Id. ¶¶ 11–12. Therefore, at the time of invention for the
’091 patent, Dr. Jensen had the requisite academic training and sufficient
experience necessary to provide expert testimony regarding the technology
embodied in the ’091 patent. Though his experience may not specifically
relate to arcs, arc formation, or the generation and management of
shockwaves, complete overlap between an expert’s technical qualifications
and the field of invention is not required. SEB, 594 F.3d at 1373 (stating
that there is no requirement that of a perfect match between the expert’s
experience and the field of invention so long as there is “sufficient relevant
technical expertise.”). At a minimum, there exists “an adequate relationship
between [Dr. Jensen’s] experience and the claimed invention” sufficient to
provide testimony as to what a person of ordinary skill in the art would have
understood at the time of invention. Id. at 1372–1373.
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With respect to Patent Owner’s objections to Exhibit 1002 under
Rule 703, Petitioner argues that Patent Owner did not preserve its objection
to the entirety of Exhibit 1002, but rather, objected only to twelve
paragraphs. Pet. MTE Opp. 2. Petitioner also asserts that the portions of
Dr. Jensen’s testimony Patent Owner objects to have been taken in isolation
and not considered as a whole. Id. 5–8.
We agree with Petitioner that Patent Owner originally objected only to
paragraphs 55, 56, 60–63, 74, 75, 97, 102, 192, and 203 of Exhibit 1002
under Rule 703. See Paper 16, 2. And, regarding Exhibit 1200, Patent
Owner specifically objected to paragraphs 32–33, 36, 37, 40–70, 73–88,
90–101, 103, and 106. Paper 52, 2. Our rules instruct that a motion to
exclude evidence should:
(a) Identify where in the record the objection originally was made;
(b) Identify where in the record the evidence sought to be excluded
was relied upon by an opponent;
(c) Address objections to exhibits in numerical order; and
(d) Explain the basis and grounds for each objection.
37 C.F.R. §§ 42.64(c); Consolidated TPG 79. Here, Patent Owner fails to
identify where Petitioner relies on the evidence to be excluded and does not
explain the substance of its objections for each paragraph. Id. Accordingly,
Patent Owner’s Motion to Exclude is procedurally deficient.
Furthermore, Patent Owner’s objections go to the weight and
sufficiency of the testimony, rather than its admissibility. PO MTE 5–8.
Whether Dr. Jensen may not understand certain concepts or may have failed
to consider certain evidence in the manner Patent Owner prefers does not
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warrant exclusion of his testimony in this case. Patent Owner had the
opportunity to, and in fact did, thoroughly cross examine Dr. Jensen about
the purported deficiencies in his declaration testimony. See, e.g., Ex. 2105,
122:19–123:17; Ex. 2205, 7:20–46:19, 174:7–180:16. “Vigorous cross-
examination [and] presentation of contrary evidence . . . are the traditional
and appropriate means of attacking shaky but admissible evidence.”
Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 595 (1993). And,
because the panel, not a jury, will assess the evidence, the risk of prejudice is
mitigated. Corning, IPR2013-00053, Paper 66 at 19.
Thus, we deny Patent Owner’s motion seeking to exclude the
testimony of Dr. Jensen in this proceeding.
IV. CONCLUSION15
For the reasons set forth above, we determine that Petitioner has
established by a preponderance of the evidence that claims 1–14 of the ’091
patent are unpatentable.

15 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
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Claims
35
U.S.C. §
Reference(s)/
Basis
Claims Shown
Unpatentable
Claims Not
Shown
Unpatentable
1–14 103 Hawkins, Li 1–14
1–3, 10 103 Hawkins,
Chernenko
1–3, 10
1–14 103 Hawkins,
Chernenko, Li
1–14
1–14 103 Hawkins,
Heeren
1–14
Overall
Outcome
1–14

V. ORDER
Accordingly, it is
ORDERED that claims 1–14 of U.S. Patent No. 8,728,091 B2 have
been shown to be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude Exhibits
2002–2004, 2006, 2008, 2048, 2015–2018, 2025, 2026, 2100, 2106, 2107,
2111, 2114, 2116–2122, 2132–2138, 2141, 2143, 2153, 2154, 2159–2163,
2170, 2172, 2173, and 2175–2180 is denied;
FURTHER ORDERED that Patent Owner’s Motion to Exclude
Exhibits 1002 and 1200 is denied; and
FURTHER ORDERED that, because this is a final 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.
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PETITIONER:

Mark C. Nelson
Jeffrey Stone
BARNES & THORNBURG LLP
mnelson@btlaw.com
jstone@btlaw.com

PATENT OWNER:

Greg H. Gardella
Michael Stallman
W. Cook Alciati
Natalie J. Grace
Ruth G. Davilla
GARDELLA GRACE P.A.
ggardella@gardellagrace.com
calciati@gardellagrace.com
ngrace@gardellagrace.com
rdavila@gardellagrace.com

Michael Stallman
MORRISON & FOERSTER LLP
mstallman@mofo.com