Shockwave Medical, Inc.

Patent Trials and Appeals Board

Jul 8, 2020

IPR2019-00405 (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.

IPR2019-00405
Patent 8,956,371 B2

Before MITCHELL G. WEATHERLY, RICHARD H. MARSCHALL, and
AVELYN M. ROSS, Administrative Patent Judges.
WEATHERLY, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining Some Challenged Claims Unpatentable
Denying Petitioner’s Motion to Exclude
35 U.S.C. § 318(a), 37 C.F.R. § 42.64
I. INTRODUCTION
A. BACKGROUND
Cardiovascular Systems, Inc. (“Petitioner”) filed a petition (Paper 1,
“Pet.”) to institute an inter partes review of claims 1–17 (the “challenged
claims”) of U.S. Patent No. 8,956,371 B2 (Ex. 1001, “the ’371 patent”).
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35 U.S.C. § 311. Shockwave Medical, Inc. (“Patent Owner”) timely filed a
Preliminary Response. Paper 11 (“Prelim. Resp.”). On July 9, 2019, based
on the record before us at the time, we instituted an inter partes review of all
challenged claims on all grounds set forth by Petitioner. Paper 19
(“Institution Decision” or “Dec.”). We instituted the review on the
following challenges to the claims:
Claim(s)
Challenged
35
U.S.C. § Reference(s)/Basis
1–6, 11,
14–16
103 Levy,1 AAPA,2 and Mantell,3 Uchiyama,4 or
Willneff5
7, 12 103 Levy, AAPA, and Mantell, Uchiyama, or
Willneff, in further view of Hayes6
8, 12 103 Levy, AAPA, and Mantell, Uchiyama, or
Willneff, in further view of Duchamp7
9 103 Levy, AAPA, and Mantell, Uchiyama, or
Willneff, in further view of Naimark8

1 European Patent Application EP 0571306 A1 (Ex. 1003, “Levy”).
2 Applicant Admitted Prior Art (“AAPA”).
3 U.S. Published Patent App. 2010/0036294 A1 (Ex. 1004, “Mantell”).
4 Japanese Laid Open Application No. JP 62-275446 A (Ex. 1005,
“Uchiyama”).
5 German Patent Application No. DE 3038445 A1 (Ex. 1006, “Willneff”).
6 U.S. Patent No. 7,309,324 B2 (Ex. 1007, “Hayes”).
7 U.S. Published Patent App. 2002/0082553 A1 (Ex. 1008, “Duchamp”).
8 U.S. Patent No. 7,569,032 B2 (Ex. 1009, “Naimark”).
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Claim(s)
Challenged
35
U.S.C. § Reference(s)/Basis
10 103 Levy, AAPA, and Mantell, Uchiyama, or
Willneff, in further view of Beyer9
13 103 Levy, AAPA, and Mantell, Uchiyama, or
Willneff, in further view of Bhatta10
17 103 Levy, AAPA, and Mantell, Uchiyama, or
Willneff, in further view of Schultheiss11
1–4, 6, 11,
15, 16
103 Willneff, AAPA, and Levy or Mantell
5, 14 103 Willneff, AAPA, and Levy or Mantell in
further view of Uchiyama
7, 12 103 Willneff, AAPA, and Levy or Mantell in
further view of Hayes
8, 12 103 Willneff, AAPA, and Levy or Mantell in
further view of Duchamp
9 103 Willneff, AAPA, and Levy or Mantell in
further view of Naimark
10 103 Willneff, AAPA, and Levy or Mantell in
further view of Beyar
13 103 Willneff, AAPA, and Levy or Mantell in
further view of Bhatta
17 103 Willneff, AAPA, and Levy or Mantell in
further view of Schultheiss

9 U.S. Published Patent App. 2006/0190022 A1 (Ex. 1010, “Beyar”).
10 U.S. Patent No. 5,152,768 (Ex. 1012, “Bhatta”).
11 U.S. Published Patent App. 2007/0239082 A1 (Ex. 1011, “Schultheiss”).
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After we instituted this review, Patent Owner filed a Patent Owner
Response in opposition to the Petition (Paper 39, “PO Resp.”). Petitioner
filed a Reply in support of the Petition (Paper 56, “Reply”). Patent Owner
filed a Sur-reply responding to the Reply (Paper 64, “Sur-reply”). Patent
Owner did not move to amend any claim of the ’371 patent.
We heard oral argument on April 15, 2020. A transcript of the
argument has been entered in the record (Paper 74, “Tr.”).
We have jurisdiction under 35 U.S.C. § 6. The evidentiary standard is
a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R.
§ 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C.
§ 318(a) and 37 C.F.R. § 42.73.
For the reasons expressed below, we conclude that Petitioner has
demonstrated by a preponderance of evidence that claims 1–4 and 6–17 are
unpatentable, but it has failed to do so for claim 5.
B. RELATED PROCEEDINGS
Petitioner identified no related matters. Pet. 2. Patent Owner has
identified the following petitions for inter partes review and patents or
patent applications as related matters:
 Petition for Inter Partes Review of U.S. Patent No. 9,642,673,
IPR2019-00408 (filed December 7, 2018);
 Petition for Inter Partes Review of U.S. Patent No. 8,728,091,
IPR2019-00409 (filed December 7, 2018);
 U.S. Patent Application No. 13/646,570 filed on October 5, 2012,
and issued as U.S. Patent No. 9,011,462;
 U.S. Patent Application No. 14/660,539 filed on March 17, 2015,
and issued as U.S. Patent No. 10,039,561;
 U.S. Patent Application No. 16/028,225 filed on July 5, 2018;
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 U.S. Patent Application No. 13/049,199 filed on March 16, 2011,
and issued as U.S. Patent No. 8,956,374;
 U.S. Patent Application No. 13/465,264 filed on May 7, 2012, and
issued as U.S. Patent No. 9,072,534; and
 U.S. Patent Application No. 13/646,583 filed on October 5, 2012.
Paper 3, 1–2.
C. THE ’371 PATENT
The ’371 patent is directed to “a treatment system for percutaneous
coronary angioplasty or peripheral angioplasty in which a dilation catheter is
used to cross a lesion in order to dilate the lesion and restore normal blood
flow in the artery.” Ex. 1001, 1:13–16. The patent purports to improve
upon the prior art angioplasty balloon catheter 10 illustrated in Figure 1
(reproduced below left) by adding electrodes 22, 24 as shown in Figure 2
(reproduced below right), which generate arcs that create shock waves
within balloon 26 to break up calcified lesions in a blood vessel.

FIG. 1 is a view of the therapeutic
end of a typical prior art over-the-
wire angioplasty balloon catheter.
Id. at 3:7–8.
FIG. 2 is a side view of a dilating
angioplasty balloon catheter with two
electrodes within the balloon. Id.
at 3:9–10.
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Balloon 26 may be filled with water or saline to gently fix balloon 26
against the walls of an artery in direct proximity to a calcified lesion. Id.
at 4:27–29. Carrier 21 includes lumen 29
through which a physician inserts a guide
wire (not shown) to guide catheter 20 to
the desired location in a patient’s body.
Id. at 4:31–33. Electrical arcs between
electrodes 22, 24 generate shock waves in
the fluid. Id. at 4:16–17. Figure 11,
reproduced in pertinent part at right, “is a
pressure volume curve showing the
various stages in the breaking of a
calcified lesion with shock waves.” Id.
at 3:45–46.
Figures 11A and 11B, reproduced below left and right respectively,
are cross-sectional views illustrating a vessel before and after treatment.
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Figure 11A illustrates a compliant
balloon expanded snugly against the
vessel wall. Id. at 3:48, 5:31–32.
Figure 11B illustrates pulverized,
calcified plaque “on a vessel wall.”
Id. at 3:50–51.
The Specification explains that: “As the High Voltage pulses generate
shock waves (Region B and C) extremely high pressures, extremely short in
duration will chip away the calcified lesion slowly and controllably
expanding the opening in the vessel to allow blood to flow un-obstructed
(FIG. 11B).” Id. at 5:33–38.
Claims 1 and 15 are the independent claims among the challenged
claims. Id. at 6:21–8:16. Illustrative claim 1 recites:
1. An angioplasty catheter comprising:
[a] an elongated carrier sized to fit within a blood vessel, said
carrier having a guide wire lumen extending therethrough;
[b] an angioplasty balloon located near a distal end of the carrier
with a distal end of the balloon being sealed to the carrier near
the distal end of the carrier and with a proximal end of the
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balloon defining an annular channel arranged to receive a
fluid therein that inflates the balloon; and
[c] an arc generator including a pair of electrodes,
[d] said electrodes being positioned within and in non-touching
relation to the balloon,
[e] said arc generator generating a high voltage pulse sufficient
to create a plasma arc between the electrodes resulting in a
mechanical shock wave within the balloon that is conducted
through the fluid and through the balloon and wherein the
balloon is arranged to remain intact during the formation of
the shock wave.
Id. at 6:21–39 (with third and fourth line breaks and letter designations
[a]–[e] added to aid discussion).
II. ANALYSIS
A. CLAIM INTERPRETATION
For petitions such as this one that are filed after November 13, 2018,
we interpret claims in the same manner used 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.”
37 C.F.R. § 42.100(b) (2019).12 When applying that standard, we interpret
the claim language as it would be understood by one of ordinary skill in the
art in light of the specification. In re Suitco Surface, Inc., 603 F.3d 1255,

12 On October 11, 2018, the USPTO revised its rules to harmonize the
Board’s claim construction standard with that used in federal district court.
Changes to the Claim Construction Standard for Interpreting Claims in Trial
Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340
(Oct. 11, 2018) (now codified at 37 C.F.R. § 42.100(b) (2019)). This rule
change applies to petitions filed on or after November 13, 2018. Id.
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1260 (Fed. Cir. 2010). Thus, we give claim terms their ordinary and
customary meaning as understood by an ordinarily skilled artisan. See In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (“The ordinary
and customary meaning ‘is the meaning that the term would have to a person
of ordinary skill in the art in question.’” (quoting Phillips v. AWH Corp., 415
F.3d 1303, 1313 (Fed. Cir. 2005) (en banc))). Only terms that are in
controversy need to be construed, and then only to the extent necessary to
resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean
Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).
1. “angioplasty balloon”
Petitioner and Patent Owner disagree about the meaning of
“angioplasty balloon” as used in the challenged claims. Petitioner contends
that “angioplasty balloon” means “an inflatable sac that is configured to be
inserted into a blood vessel for use in a medical procedure to widen
narrowed or obstructed blood vessels.” Pet. 12. Patent Owner argues that
“angioplasty balloon” refers to “a balloon that displaces the plaque into the
vessel wall to expand the lumen of the vessel.” PO Resp. 5.
a. Intrinsic Evidence
The plain language of the claim does not refer to any limitation on the
type of “angioplasty” for which the “balloon” is designed. Rather, the claim
merely recites an “angioplasty balloon.” Dependent claims 7 and 8 limit the
balloon to being formed of “compliant” or “non-compliant” material
respectively. Ex. 1001, 6:51–54. Thus, the plain language of the claims
does not reflect a requirement that the claimed “angioplasty balloon” must
displace plaque “into the vessel wall.”
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The Specification states that the “present invention relates to a
treatment system for percutaneous coronary angioplasty or peripheral
angioplasty in which a dilation catheter is used to cross a lesion in order to
dilate the lesion and restore normal blood flow in the artery.” Id. at 1:13–18.
This passage implies that an “angioplasty balloon” is used “to dilate the
lesion and restore normal blood flow in the artery” without specifying or
limiting how the dilation is achieved.
The Specification later illustrates the use of two types of “angioplasty
balloons,” a prior art balloon that does not employ shockwaves, Ex. 1001,
Figs. 10A–C, and the claimed balloon that does employ shockwaves, id.
Figs. 11A, 11B, 12, 13. When describing an embodiment of the claimed
balloon in Figure 11A, the Specification indicates that the balloon is
“expanded to fit snugly to the vessel wall . . . but this is not a requirement.”
Id. at 5:32–33. When describing Figure 11B, the Specification states that
shockwaves will cause “extremely high pressures, extremely short in
duration [that] will chip away the calcified lesion slowly and controllably
expanding the opening in the vessel.” Id. at 5:33–37. Figures 12 and 13 of
the ’371 patent illustrate calcified plaque that is “pulverized by the shock
waves” and “reshaped” by “the expanded balloon.” Id. at 5:39–48, Figs. 12,
13. In all instances, the Specification illustrates and describes breaking and
redistributing plaque within a vessel wall without ever explicitly referring to
displacing plaque “into the vessel wall” from outside the wall. Accordingly,
we find that the Specification alone does not resolve whether “angioplasty
balloon” refers to a balloon that must dilate a blood vessel, at least in part,
by displacing “the plaque into the vessel wall.”
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Patent Owner argues, based on testimony from Dr. Berger, that
intrinsic evidence in the form of two prior art patents submitted during
prosecution of the ’371 patent use “‘angioplasty balloon’ in a manner
consistent with the plain meaning of that term as used in the ’371 patent.”
PO Resp. 10–11 (citing Ex. 2109 (“O’Boyle”), 1:33–37 (angioplasty balloon
used to “stretch and compact the stenosis material against the wall of the
artery”); Ex. 2110 (“O’Connor”), 3:8–12 (angioplasty balloon that “opens
the occluded part of the artery by pressing the thrombus against the internal
wall of the artery”)). Neither quoted passage from O’Boyle and O’Connor
supports Patent Owner’s argument that an “angioplasty balloon” must
displace plaque “into the vessel.” Petitioner correctly points out that the
passages more strongly support its argument for a broader definition because
both passages merely describe compacting or pressing material “against”
rather than “into” the wall of the vessel. Reply 11.
Even more importantly, O’Boyle and O’Connor each describe
angioplasty as a procedure that can result in the removal of material from the
vessel wall via ultrasonic ablation, without displacing material “into the
vessel wall.” For example, O’Boyle’s device, which is described as an
“angioplasty catheter,” Ex. 2109, 3:20–21, performs angioplasty through
ultrasonic ablation of stenosis material without significant “crushing of the
material of the stenosis against the vessel wall,” id. at 3:53–62. O’Connor
describes angioplasty as being performed by ablating a thrombus and
softening calcified plaque within a vessel. Ex. 2110, 3:23–57. O’Connor’s
angioplasty balloon includes an ultrasound transducer and is inflated with
saline to only 1–3 atmospheres. Id. at 3:36–41. The low-pressure saline
ensures that the balloon presses against the thrombus to transmit and focus
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ultrasonic energy to break the thrombus into “microparticulate matter” (i.e,
ablation) while also creating “microfractures within the calcified plaque 12
which is embedded in the wall” of the artery. Id. at 3:41–57. O’Boyle and
O’Connor thus support Petitioner’s broader definition of “angioplasty
balloon” as not requiring that the balloon displace plaque “into the vessel
wall” but merely requiring that the balloon widens a narrowed or obstructed
vessel.
b. Extrinsic Evidence
We do not consider it necessary to rely upon extrinsic evidence to
support our conclusion that an “angioplasty balloon” is not limited to those
balloons that displace material “into the vessel wall.” Nevertheless, the
balance of such evidence of record supports our conclusion that Patent
Owner’s definition of “angioplasty balloon” is unduly narrow.
Patent Owner contends that medical and lay dictionaries and
testimony from Dr. Berger and Dr. Jensen that establish that an “angioplasty
balloon” must displace plaque “into the vessel wall.” PO Resp. 11–12
(citing Ex. 2100 ¶¶ 86–88; Ex. 2111, 126:8–16; Ex. 2018; Ex. 2020). Five
of the six definitions of “angioplasty” proffered by Patent Owner as
establishing that angioplasty refers to displacing plaque “into the vessel
wall” fail to go so far. Rather, Petitioner persuasively points out that five of
the six definitions refer to angioplasty more generally as merely referring to
surgical repair of a blood vessel, sometimes by compressing deposits of fatty
substances or plaque blocking the vessel, and other times by using a laser
beam or replacing part of the vessel. Ex. 2019, 1–3; Ex. 2020, 1. One of
Patent Owner’s dictionaries states that an angioplasty is a procedure in
which a “balloon is inflated to compress the fatty matter into the artery
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wall,” which supports Patent Owner’s argument. Ex. 2018, 1. However, we
find that the group of definitions proffered by Patent Owner as a whole
demonstrate that angioplasty refers more broadly to procedures that repair
blood vessels and do not necessarily involve displacing material “into the
vessel wall.”
Patent Owner also relies upon Dr. Berger, who opines that, based on
definitions in a lay dictionary for “angio-,“ “plasty,” “plastic,” and “elastic
deformation,” an ordinarily skilled artisan understands “angioplasty” to refer
to a procedure that “involves the plastic or permanent deformation or
molding of blood vessels.” Ex. 2100 ¶ 86 (citing Exs. 2166–2169, 2190).
Based on his etymological analysis of “angioplasty,” and without further
evidentiary support, he extends his opinion by concluding that “the plastic
molding of the vessel takes place by the displacement of plaque into the
vessel wall to expand the lumen.”
We heavily discount Dr. Berger’s conclusion about angioplasty
requiring “displacement . . . into the vessel wall” as a non sequitur. At most,
the evidence upon which he bases his opinion establishes only that
angioplasty involves the permanent deformation of a vessel. Additionally,
his testimony on cross-examination that “angioplasty” cannot refer to merely
pressing plaque or a thrombus against the vessel wall, Ex. 1204, 13:7–13,
13:23–14:24, is irreconcilably inconsistent with prior art that was before the
Examiner, O’Boyle and O’Connor. As discussed above, O’Boyle and
O’Connor both describe angioplasty as pressing material against the vessel
wall. Ex. 2109, 1:33–37, 3:53–62; Ex. 2110, 3:8–12. We simply do not
consider Dr. Berger’s opinion that angioplasty must involve displacing
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plaque “into the vessel wall” is credible when considered against objective
evidence that he cites.
Petitioner cites another patent, which was not before the Examiner
that further establishes that an ordinarily skilled artisan would understand
“angioplasty” as referring more broadly to both recanalization and dilation
of a blood vessel. Reply 11 (citing Ex. 1041, 2).
c. Conclusion
For the reasons expressed above, we conclude that “angioplasty
balloon” refers to “an inflatable sac that is configured to be inserted into a
blood vessel for use in a medical procedure to widen narrowed or obstructed
blood vessels.”
2. Other Disputed Terms
The parties expressly address and disagree about the meaning of two
other phrases appearing in claim 1. Namely, “distal end of the balloon
sealed to the carrier near the distal end of the carrier” and “carrier having a
guidewire lumen extending therethrough.” Compare Reply 12–13, with PO
Resp. 16–18 and Sur-Reply 10–13. We adopt Patent Owner’s
interpretations of both terms for the reasons expressed in its briefing and
because Patent Owner’s interpretations comport more closely with the plain
language of the phrases. PO Resp. 16–18; Sur-Reply 10–13. However,
Petitioner establishes that the combined teachings of Levy and AAPA
describe an angioplasty balloon sealed near the distal end of a carrier having
a guidewire extending through the carrier as recited in these two phrases.
See Part II.F.1.d.iii below.
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B. THE PARTIES’ POST-INSTITUTION ARGUMENTS
In our Institution Decision, we concluded that the argument and
evidence adduced by Petitioner demonstrated a reasonable likelihood that at
least one claim was unpatentable, and we instituted review of all challenges
to claims 1–17 as identified in the table in Part I.A above. Dec. 26–27. We
must now determine whether Petitioner has established by a preponderance
of the evidence that the specified claims are unpatentable over the cited prior
art. 35 U.S.C. § 316(e) (2018). We previously instructed Patent Owner that
“any arguments for patentability not raised in the [Patent Owner Response]
may be deemed waived.” Paper 20, 7; see also In re Nuvasive, Inc., 842
F.3d 1376, 1381 (Fed. Cir. 2016) (holding that patent owner’s failure to
proffer argument at trial as instructed in scheduling order constitutes
waiver). Additionally, the Board’s Trial Practice Guide states that the Patent
Owner Response “should identify all the involved claims that are believed to
be patentable and state the basis for that belief.” Office Patent Trial Practice
Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012).
C. LEGAL STANDARDS
Petitioner challenges the patentability of claims 1–17 on the grounds
that the claims are obvious. To prevail in its challenges to the patentability
of the claims, Petitioner must establish unpatentability by a preponderance
of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d) (2018). “In an
[inter partes review], the petitioner has the burden from the onset to show
with particularity why the patent it challenges is unpatentable.” Harmonic
Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing
35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify
“with particularity . . . the evidence that supports the grounds for the
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challenge to each claim”)). This burden never shifts to Patent Owner. See
Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
(Fed. Cir. 2015) (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d
1316, 1326–27 (Fed. Cir. 2008)) (discussing the burden of proof in inter
partes review).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550
U.S. 398 (2007), reaffirmed the framework for determining obviousness as
set forth in Graham v. John Deere Co., 383 U.S. 1 (1966). The KSR Court
summarized the four factual inquiries set forth in Graham that we apply in
determining whether a claim is unpatentable as obvious under 35 U.S.C.
§ 103(a) as follows: (1) determining the scope and content of the prior art,
(2) ascertaining the differences between the prior art and the claims at issue,
(3) resolving the level of ordinary skill in the pertinent art, and
(4) considering objective evidence indicating obviousness or
nonobviousness. KSR, 550 U.S. at 406 (citing Graham, 383 U.S. at 17–18).
In an inter partes review, 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).
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
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
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“mere conclusory statements,” but “must instead articulate specific
reasoning, based on evidence of record” to support an obviousness
determination. Magnum Oil, 829 F.3d at 1380–81. Petitioner also must
articulate a reason why a person of ordinary skill in the art would have
combined the prior art references. NuVasive, 842 F.3d at 1382.
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.
D. 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, Biomedical Engineering or equivalent,
and at least three to five years of practical experience (or
comparable and/or equivalent education or training), including
familiarity with the various medical devices and techniques for
treating plaque buildup in blood vessel or body passages, such as
balloon angioplasty, ablation, rotational atherectomy, lithotripsy.
Pet. 11; Ex. 1002 ¶¶ 63–66.
Patent Owner disagrees and contends that the level of ordinary skill in
the art would have been a “multidisciplinary individual or team that
included”
i) at least one person with a medical degree and relevant clinical
experience concerning the management of patients with vascular
disease, and ii) at least one person with an electrical engineering,
biomedical engineering or equivalent degree and at least two
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years of experience in the engineering, design, testing or
development of catheter-based medical devices.
PO Resp. 4 (citing Ex. 2100 ¶ 3–14).
The parties’ positions primarily differ in that Patent Owner suggests
that a medical degree is required along with an engineering degree.
Petitioner notes that none of the inventors of the ’371 patent, a great
majority of the inventors listed on the prior art asserted here or applied by
the Examiner during prosecution, and Patent Owner’s Vice President of
Research and Development has a medical degree. Reply 5 (citing Ex. 1200
¶¶ 12–15; Ex. 1216, 6:15–7:1, 10:10–13:18). However, Petitioner contends
that three to five years of practical experience with medical devices and
techniques for treating plaque buildup is needed. Pet. 11; Ex. 1002
¶¶ 65–66. We consider Petitioner’s stated level of experience to supply
similar relevant knowledge to the medical degree that Patent Owner
contends to be needed to attain a level of ordinary skill in the art.
For purposes of this Decision, and based on the record, we consider an
ordinarily skilled artisan to possess skill attained by education via a
bachelor’s degree in mechanical, electrical, or biomedical engineering
combined with knowledge of medical devices and techniques for treating
plaque buildup in blood vessels that is attained either by education (a
medical degree) or three to five years of practical experience. 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).
Patent Owner contends, however, that “Dr. Jensen [ ] lacks a medical
degree and relevant clinical experience and would not qualify as one skilled
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in the art.” PO Resp. 4–5. Patent Owner also criticizes Dr. Jensen for
failing to understand certain concepts and figures in the prior art. Id.
We disagree with Patent Owner’s contentions about Dr. Jensen’s
qualifications. Dr. Jensen holds a bachelor’s degree in electrical
engineering, master’s degree in biomedical engineering, doctorates in
medical science and medicine. Ex. 1002 ¶¶ 8–13, Appendix A (curriculum
vitae). His doctorate of medicine (Dr.Med.) was awarded by the University
of Aarhus School of Medicine in Denmark in 2008, and this degree is
typically given only to medical doctors. Ex. 1200 ¶ 21. 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.
E. OVERVIEW OF THE ASSERTED PRIOR ART
1. Levy
Levy describes a device for removing “deposits which form on the
interior walls of passages, and in particular the removal, by disintegration, of
plaque deposits, or atheromas, which form on the inner walls of the blood
vessels.” Ex. 1003, 1.13 Levy’s device is shown in Figure 1 (substantively
reproduced below).

13 We, like Petitioner, refer to the page numbering of the translation of the
Levy reference itself rather than exhibit page numbers.
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Levy’s Figure 1 is a cross-sectional view of an embodiment of
Levy’s device for removing deposits from blood vessel walls.
Levy’s devices includes balloon 10 protruding from distal end 6 of
catheter 8. Id. at 3. Convergent lens 16 on optical fiber 12 protrudes into
balloon 10 from distal end 6 of catheter 8. Balloon 10 is inflated with, e.g.,
saline, supplied by liquid source 22 through a suitable liquid coupling within
the bore of catheter 8. Id. Laser source 20 emits light energy that is carried
into the saline within balloon 10 by optical fiber 12. Id.
A user of Levy’s device inserts catheter 8 into vessel 2 next to
deposit 4 with balloon 10 deflated and then inflates balloon 10 with saline
until it contacts deposit 4. Id. Laser energy is pulsed into the liquid within
balloon 10 to create cavitation as gas bubbles which implode and agitate the
fluid to disintegrate deposit 4. Id. at 4. According to Dr. Jensen, an
ordinarily skilled artisan understands that Levy’s laser pulses create
shockwaves that cause the disintegration of deposit 4. Ex. 1002 ¶ 116.
2. AAPA
Figure 1 of the ’371 patent (reproduced
right) is labeled and described as “PRIOR
ART.” Ex. 1001, Figure 1. The
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Specification describes Figure 1 as “a view of the therapeutic end of a
typical prior art over-the-wire angioplasty balloon catheter 10. Such
catheters are usually non-complaint with a fixed maximum dimension when
expanded with a fluid such as saline.” Id. at 3:66–4:2 (emphasis added).
Although Figure 1 does not illustrate a guidewire, the Specification implies
its presence when describing catheter 10 as being “over-the-wire.”
Figure 2, which illustrates the
claimed catheter 20, also fails to illustrate a
guidewire. Id. at Figure 2, 3:9–12. The
Specification indicates that the guidewire is
not shown but inserted through lumen 29 in
carrier 21. Id. at 4:31–33. Although a carrier and lumen are not enumerated
on Figure 1, similarities between Figures 1 and 2 imply, and we conclude,
that Figure 1 illustrates a carrier and lumen that are essentially the same as
carrier 21 and lumen 29 of Figure 2.
Accordingly, we understand that the AAPA includes the angioplasty
balloon catheter comprising a carrier with a balloon postioned near the distal
end and a guidewire lumen extending through the carrier and protruding
from the distal end of the balloon as illustrated in Figure 1.
3. Mantell
Mantell is directed to “an invasive radially-firing electrohydraulic
lithotripsy probe that creates a substantially annular shockwave for uses such
as breaking up concretions that are at least semi-annular.” Ex. 1004 ¶ 20.
In one implementation, the EHL probes described below
may be delivered to a proper channel of a heart by threading (or
pre-loading) an EHL probe through a center lumen of a catheter
or balloon device. The catheter may be threaded through
appropriate veins or arteries to address concretions either
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forming in vessels or even in the valves of the heart or other
organs.
Id. ¶ 21. One embodiment of Mantell’s device is illustrated below.

Figure 2 is a cross-sectional side view of an embodiment of
Mantell’s electrohydraulic lithotripsy probe. Id. ¶ 4.
Distal portion 101 of probe 100 includes insulating body 102
surrounding electrodes 104, 106, which are positioned within balloon 118.
Id. ¶¶ 23–29. Balloon 118 “encapsulates a liquid such as saline” and an arc
between electrodes 104, 106 “causes a steam bubble in the liquid [that] . . .
rapidly expands and contracts back on itself” to generate “a shockwave.” Id.
¶ 29. That shockwave “radiates away from the lithotripsy tip 101 in a
substantially radial manner such that the shockwave is at least semi-
annular.” Id.
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4. Uchiyama
Uchiyama describes an arc-based shockwave generator within an
inflated balloon as illustrated in Figures 1–7. Ex. 1005, 298–99.14 We
reproduce Figures 1 and 3(a)–(d) below from the translation of Uchiyama.

Figure 1 is a cross section view
illustrating the balloon inflated and
some of the internal elements of the
lithotripsy probe. Id. at 300.
Figures 3(a)–(d) are cross section
views illustrating the process of
using the probe of Figure 1 in the
urinary duct. Id.
Electrodes 3 are positioned near the distal end of tube 1 that includes
tube 6 for inflating balloon 7 with fluid through opening 5. Id. at 298.
Figures 3(a)–(d) illustrate advancing the probe in a urinary duct N to a
position close to calculus S (Figure 3(a)), inflating balloon 7 so that it
contacts calculus S (Figure 3(b)), and using arcs between electrodes 3 to
generate shockwaves that break up calculus S (Figures 3(c) and (d)). Id.
at 298–99. The optimal gap between electrodes 3 and calculus S for making
the shockwaves most effective at breaking up calculus S is managed by
controlling the degree to which balloon 7 is inflated. Id.; see also id.
Figures 3(b) and (c). Uchiyama indicates that arcs are generated within

14 We, like Petitioner, refer to the page numbering of the translation of the
Uchiyama reference itself rather than exhibit page numbers.
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balloon 7 “so that there is no risk that the electric discharge sparks hit a
human tissue directly.” Id. at 299. Uchiyama notes that arcs directly
contacting human tissue may damage the tissue. Id. at 297.
5. Willneff
Willneff describes a “shock wave generator for medical
applications with a spark gap located within a housing.”
Ex. 1006, 2.15 We reproduce Willneff’s Figure 1 at
right, which is a schematic illustration of
Willneff’s catheter with a partial cross section
view showing the configuration of tip 22. Id.
at 9. Supply tube 8, return tube 10, and current
feed 6 pass through sheath 12. Id. Balloon 18
is inflated and deflated with fluid supplied and
controlled via tubes 8, 10. Id. A mechanical
connection 20 between tip 22 and balloon 18
holds spark gap 16 in a fixed relationship
with balloon 18. Id. Spark gap 16 is centered to avoid unintended tissue
damage or burns. Id. at 5. The shock waves generated by arcs across spark
gap 16 can remove concretions from the urinary tract. Id. at 4–5.
F. CLAIMS 1–17: OBVIOUSNESS IN VIEW OF LEVY, AAPA, AND ONE OF
MANTELL, UCHIYAMA, OR WILLNEFF, AND IN FURTHER VIEW OF VARIOUS
OTHER REFERENCES FOR CERTAIN CLAIMS
Petitioner argues that claims 1–6, 11, 14–16 are unpatentable as
obvious in view of the combined teachings of Levy, the AAPA, and any one

15 We, like Petitioner, refer to the page numbering of the translation of the
Willneff reference itself rather than exhibit page numbers.
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of Mantell, Uchiyama, or Willneff. Pet. 13–42. Petitioner relies on one or
more of the same references or additional references to argue that dependent
claims 7–10, 12, 13, and 17 are also obvious. Id. at 34–43. For the reasons
expressed below, Petitioner has demonstrated by a preponderance of
evidence that claims 1–4 and 6–17 are obvious in view of the teachings of
the asserted combinations of prior art. However, Petitioner has failed to
demonstrate by a preponderance of evidence that claim 5 is obvious.
1. Independent Claim 1
a. Summary of Petitioner’s Argument and Evidence
Petitioner relies upon Levy as describing most of the physical
elements of the catheter of claim 1 (carrier 1a, balloon 1b, and shockwave
generator 1c–e) except that Levy uses a laser to generate shockwaves instead
of an electrical arc. Pet. 23–31 (citing Ex. 1003, 1, 3, Figure 1; Ex. 1002
¶¶ 109–123). Petitioner also relies upon AAPA as teaching the carrier with
a guidewire lumen (element 1a) and balloon (element 1b). Id. at 23–25
(citing Ex. 1001, 3:65–4:2, Figure 1; Ex. 1002 ¶¶ 109, 113). Petitioner
argues that an ordinarily skilled artisan would have been motivated to
substitute any one of the arc-based shockwave generators described by
Mantell, Uchiyama, or Willneff for Levy’s laser-based shockwave generator
to save cost, reduce complexity, and reduce overheating risks. Id. at 28–29
(citing Ex. 1002 ¶ 120). Petitioner contends that an ordinarily skilled artisan
would have considered arc generators and lasers to be interchangeable
devices for generating shockwaves to disintegrate unwanted deposits within
blood vessels. Id. (citing Ex. 1002 ¶ 120); see also id. at 19–21 (citing
Ex. 1002 ¶ 98; Ex. 1012, 1:5–10; Ex. 1006, 3) (discussing similarity of laser-
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and arc-based methods for generating shockwaves to remove unwanted
deposits within the body).
Petitioner persuades us by preponderance of evidence that the
combined teachings of Levy, AAPA, and one of Mantell, Uchiyama, and
Willneff describe all limitations of claim 1 and that an ordinarily skilled
artisan would have combined those teachings to arrive at the angioplasty
catheter of claim 1. We address Patent Owner’s arguments otherwise below.
b. Whether Levy’s Balloon Is an Angioplasty Balloon
Petitioner relies upon Levy as describing an angioplasty balloon near
a distal end of the carrier and AAPA as describing the distal end of the
balloon being sealed to the carrier. Pet. 25–26 (citing Ex. 1001, 3:65–4:2,
Fig. 1; Ex. 1003, 4, Fig. 1; Ex. 1002 ¶¶ 113, 114). Patent Owner argues that
Levy fails to describe an angioplasty balloon because Levy’s balloon “does
not displace plaque into the vessel wall in order to widen the lumen of the
vessel.” PO Resp. 20 (citing Ex. 2100 ¶¶ 55–58, 163–170). Rather, Patent
Owner contends that Levy “removes” plaque through “erosion” and
“disintegration.” Id. (citing Ex. 1003, 3, 6; Ex. 2100 ¶¶ 163–170).
Patent Owner’s argument is unpersuasive in rebutting Petitioner’s
showing that the prior art describes the claimed angioplasty balloon for two
reasons. First, even accepting Patent Owner’s description of Levy as using
“erosion” and “disintegration” to remove plaque from the wall of an artery,
such processes still widen a narrowed or obstructed blood vessel by
removing “plaque deposits, or atheromas, which form on the inner walls of
the blood vessels.” Ex. 1003, 1. Such widening through ablation is within
the scope of “angioplasty balloon” as we have interpreted the term. See Part
II.A.1 above. Second, Patent Owner’s argument fails to address Petitioner’s
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showing, Pet. 25, that the AAPA describes an angioplasty balloon. See PO
Resp. 20–22 (addressing only whether Levy describes claimed “angioplasty
balloon”).
Based on our review of the record, Petitioner persuades us by a
preponderance of evidence that Levy and the AAPA each describe the
claimed angioplasty balloon.
c. Whether Levy’s Balloon Includes a Shockwave Generator
Petitioner contends that Levy’s laser-based device generates
shockwaves inside the balloon without touching the balloon, which remains
intact during formation of the shockwaves. Pet. 26–30 (citing Ex. 1003, 3,
Fig. 1; Ex. 1021 (“Levy ’227”),16 3:58–61; Ex. 1002 ¶¶ 116, 121, 122).
Patent Owner contends that Levy fails to describe a “shockwave generator”
because Levy refers only to “cavitation bubbles” that lead to “vigorous
agitation” that causes disintegration of the plaque deposits. PO Resp. 22.
Patent Owner concedes that Levy ’227 refers to shockwaves, but argues that
Levy ’227 describes using shockwaves only within a tooth canal and not
within a blood vessel. Id. at 22–24 (citing Ex. 2100 ¶¶ 55–58). We
disagree.
Levy indisputably incorporates Levy ’227 by reference as describing
the laser used within Levy’s balloon (Ex. 1003, 3, 5), and we, therefore,
consider Levy ’227 to be part of Levy for our analysis. Levy ’227 first
describes that its laser generates an “implosion” of gas bubbles within a
tooth canal that results in “shockwaves” that detach debris from the walls of
the canal. Ex. 1021, 3:39–42. Levy ’227 later indicates that the same

16 Exhibit 1021 is U.S. Patent 5,116,227, also to Levy, which is incorporated
by reference into Levy. Ex. 1003, 3.
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technique can clean blood vessels by removing “plaque deposits, or
atheromas.” Id. at 4:37–5:2; see also 2:12–33 (describing cavitation-based
implosions as cleaning tooth canals and blood vessels among other body
passages).
Patent Owner also argues that Levy’s description of cavitation
bubbles refers to the generation of “hydraulic or acoustic” waves rather than
shockwaves. PO Resp. 23–24 (citing Ex. 2105 (“de la Torre”), 3:25–52;
Ex. 2100 ¶¶ 55–58). Patent Owner supports its argument with Dr. Berger’s
analysis of de la Torre’s description of the manner in which it uses a laser to
create cavitation bubbles that avoid creating shockwaves. Id. (citing
Ex. 2105, 3:25–52). We discount Dr. Berger’s testimony and de la Torre’s
disclosure because they are inconsistent with Levy’s express description of
using its laser to generate cavitation bubbles within a balloon to create
shockwaves as we find immediately above. See Ex. 1003, 3, 5
(incorporating description of the laser of Levy ’227 as laser used in its
balloon); Ex. 1021, 2:12–33, 3:39–42, 4:37–5:2 (expressly describing using
laser to generate cavitation bubbles leading to shockwaves).
Petitioner also relies upon each of Mantell, Uchiyama, and Willneff as
describing an arc generator that creates shockwaves between electrodes
positioned within a balloon as claimed. Pet. 26–30 (citing Ex. 1004 ¶¶ 21,
24, 29, Figs. 1, 2, 5–7; Ex. 1005, 298, Figs. 1–7; Ex. 1006, 5, 10, Figs. 1–3;
Ex. 1002 ¶¶ 117–119). Patent Owner does not respond to Petitioner’s
showing that each of these three references describes using arcs between
electrodes within a balloon to generate shockwaves. PO Resp. 20–24
(arguing only that Levy does not describe generating shockwaves inside a
balloon).
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For the reasons above, Petitioner persuasively demonstrates by a
preponderance of evidence that each of Levy, Mantell, Uchiyama, and
Willneff describes generating shockwaves within a balloon, with Levy using
a laser and the other references using electrical arcs between electrodes to do
so.
d. Motive to Combine Teachings of the Prior Art
i. Whether EHL Probes17 Would Have Been Considered Too
Dangerous to Use in Blood Vessels
Patent Owner argues that danger to healthy tissue stemming from
using EHL-generated shockwaves within blood vessels would have
prevented an ordinarily skilled artisan from being motivated to incorporate
the EHL probes of Mantell, Uchiyama, or Willneff into Levy’s balloon. PO
Resp. 24–44.
Patent Owner relies primarily upon Chernenko (Ex. 2046) as proving
that EHL-generated shockwaves cannot be used safely within 5 mm of “soft
tissues” such as the walls of a blood vessel. Id. at 24–25 (citing Ex. 2046
¶ 11). Chernenko relates to a lithotripsy device for breaking calcified stones
in the urinary system. Ex. 2046 ¶ 1. Chernenko’s admonition against using
EHL devices within 5 mm of soft tissue appears in its description of known
devices. See id. ¶ 11 (in Background of the Invention section). Chernenko
indicates that at least one prior art device includes a nozzle to direct
shockwaves to a focal point. Id. ¶ 13. Dr. Berger relies heavily upon
Chernenko’s broad statements about other prior art that 5 mm is as close as
an EHL probe can be located to soft tissue without damaging it and that

17 Mantell and the parties refer to electrohydraulic lithotripsy probes as
“EHL probes.” Ex. 1004 ¶ 21; Pet. 1; PO Resp. 1.
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shielding is necessary to focus shockwave energy. Ex. 2100 ¶¶ 32–38
(citing Ex. 2046 ¶¶ 11, 13, 88, Fig. 6).
We discount Dr. Berger’s conclusions about the minimum safe
distance between EHL probes and healthy tissue for two reasons. First,
Chernenko advises that its EHL probe should be moved closer to its target
such that at least one and preferably both electrodes directly contact the
stone to be broken to ensure that arcing passes through the target stone. Id.
¶¶ 89–91, 105, Figs. 6b, 6c, 7a–d, 8a. Second, none of the other prior art
summarized by Chernenko places an EHL probe inside a balloon or forms
part of Petitioner’s proposed combination. Chernenko and the prior art that
it discusses relates to intracorporeal EHL probes that are not placed within
balloons. Id. ¶¶ 1–13. Although Chernenko claims that its device can be
used for “fragmentation of any foreign object[], which might appear in other
locations of the body, e.g. in blood vessels etc.,” id. ¶ 3, Chernenko never
provides any further details on how so, see generally id.
Petitioner persuasively argues that:
The prior art must be considered as a whole for what it teaches.”
Medichem, S.A. v. Rolabo, 437 F.3d 1157, 1166 (Fed. Cir. 2006);
In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991). Although a
reference teaches away from the claimed invention when it
“suggests that the line of development flowing from the
reference’s disclosure is unlikely to be productive of the result
sought by the applicant” (id., at 1165 (citing In re Gurley, 27 F.3d
551, 553 (Fed. Cir. 1994)), there is no rule “that a single
reference that teaches away will mandate a finding of
nonobviousness” (Medichem, 437 F.3d at 1165; In re Dome
Patent, 799 F.3d 1372, 1381 (Fed. Cir. 2015)).
Reply 19. Each of Mantell, Uchiyama, and Willneff generates shockwaves
within a balloon that are used to erode an unwanted deposit within a cavity
of the body. Pet. 26–30 (citing Ex. 1004 ¶¶ 21, 24, 29, Figs. 1, 2, 5–7;
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Ex. 1005, 298, Figs. 1–7; Ex. 1006, 5, 10, Figs. 1–3; Ex. 1002 ¶¶ 117–119).
Furthermore, Petitioner establishes that Levy generates shockwaves within
an angioplasty balloon using a laser rather than electrodes. See Parts
II.F.1.b–c above.
At most, Chernenko is relevant through its summary that the Canadian
counterpart (Ex. 2102) to Bhatta (Ex. 1012) describes focusing shockwaves
emanating from an EHL probe to increase the effectiveness of the device.
Regarding safety, Bhatta suggests that damage to healthy tissue may result
from direct impact of plasma generated by an EHL spark or laser or
inadvertent puncturing by sharply pointed laser delivery fiber. Ex. 1012,
1:46–51. Bhatta comments that its nozzle 30 shapes shockwaves toward a
focal point while also protecting surrounding tissue from problems
associated with tip impacts and damaging effects of plasma. Id. at 3:22–25,
3:48–4:6. On balance, we find Patent Owner’s argument that Chernenko
forecloses any motivation to incorporate the EHL probes of Mantell,
Uchiyama, or Willneff into Levy’s angioplasty balloon unpersuasive.
ii. Petitioner’s Alleged Motives to Replace Levy’s Laser with
an EHL Probe from Mantell, Uchiyama, or Willneff
Petitioner, through Dr. Jensen’s testimony, contends that an ordinarily
skilled artisan would have been motivated to substitute an EHL shockwave
generator such as those described in Mantell, Uchiyama, or Willneff for
Levy’s laser-based shockwave generator for three reasons, including:
(1) reducing complexity, (2) reducing cost and (2) generating less heat,
which Levy recognized as an issue with its laser-based shockwave generator.
Pet. 28 (citing Ex. 1002 ¶ 120). We analyze each reason below and
conclude that Petitioner has proven by a preponderance of evidence that an
ordinarily skilled artisan would have been motivated for at least two reasons
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(reducing cost and complexity) to substitute an EHL shockwave generator
for Levy’s.
a) Complexity
Patent Owner argues that we should disregard Dr. Jensen’s testimony
that EHL systems are less complex than laser-based systems because he fails
to cite objective evidence in support. PO Resp. 53. Patent Owner also
argues, based on testimony from Dr. Berger and Dr. Jensen, that creating
shockwaves using the sparks of EHL devices is “complicated” and not well
understood. PO Resp. 54 (citing Ex. 2100 ¶¶ 138–139; Ex. 2156, 70:4–6,
83:13–14). Patent Owner, based on testimony from Dr. Berger, further
argues that “electrical connections” of EHL systems are “more complex than
the simple optical fiber technology of Levy.” PO Resp. 54 (citing Ex. 2100
¶ 140). The cited testimony from Dr. Berger fails to support the proposition
for which Patent Owner cites it because it wholly fails to express any
opinion about the circuitry that drives EHL or laser-based shockwave
generators. Petitioner responds that the physics of spark formation are not
claimed and that circuits for reliably creating sparks are well known.
Reply 32 (citing Ex. 1200 ¶ 138).
Based on our review of the record, we determine that Petitioner has
proven by a preponderance of evidence that an ordinarily skilled artisan
would have been motivated to substitute an EHL probe for a laser lithotripsy
probe to reduce complexity.
b) Cost
Petitioner contends that using a “laser to generate shockwave energy
is well known to be expensive — approximately 10 times more expensive
than a system employing electrohydraulic (i.e., pair of electrodes) system to
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generate shockwaves.” Ex. 1002 ¶ 95. During his deposition, Dr. Jensen
stated that his opinion was based upon a journal article. Ex. 2111, 61:8–17
(identifying Huang article (Ex. 2157)).
Patent Owner does not dispute that Huang concludes that laser-based
lithotripsy systems are greater than ten times more expensive to use than
EHL systems, but rather argues that Huang’s conclusion is improperly based
upon total system costs including capital and maintenance costs. PO
Resp. 56. Patent Owner argues, based on Dr. Berger’s testimony, that
comparing cost “at a catheter level” (i.e., the cost of the catheter alone) is
more appropriate. Id. (citing Ex. 2100 ¶ 144). Dr. Berger fails to cite
evidence to support his opinion or state how much more expensive and EHL
catheter would be than a laser lithotripsy catheter. Ex. 2100 ¶ 144.
By contrast, Huang explains the basis of its cost analysis to conclude
that the cost per case of using EHL is $336 versus $4,220 for laser-based
lithotripsy. Huang explains:
The large discrepancy in costs can be ascribed not only to the
large initial capital outlay for the Candela LaserTripter, but also
to the substantial amount that must be spent yearly on
maintenance and supplies. Indeed, this yearly cost of the
LaserTripter is more than the capital cost of the EHL machine.
In effect, a new EHL machine could be purchased each year we
operate the LaserTripter.
Ex. 2157, 238.18 Huang also includes a table summarizing the costs by
category that reflects the amortized costs of the probes (i.e., “fibers”) per
case that reveals that laser probes are almost five times more expensive per
case than EHL probes. Id. at 239. Based on our review of Huang, we find

18 We cite the native page numbers reflected in Huang rather than the exhibit
page number.
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that the analysis fairly reflects the comparative operating cost per case for
each type of system.
Patent Owner also criticizes Dr. Jensen’s reliance upon Huang’s
analysis because the comparatively poor safety of EHL versus laser
lithotripsy outweighs the cost savings. PO Resp. 57–58. Patent Owner
quotes Huang, id. at 57, which states that “[t]he perforation rates of
lasertripsy are 1% to 12%, whereas that of EHL has been shown to be as
high as 17% to 25%.” Ex. 2157, 237. Huang’s statement describes the
safety of prior versions of EHL, however, not the EHL probe that Huang
analyzed, which Huang described as “similar in freedom from significant
complications” to the laser lithotripsy devices that were studied. Id. at 238.
Huang also concludes that “EHL can be used safely for distal ureteral stones
and is more cost effective than lasertripsy.” Id. at 239. Huang recognized
that the EHL and laser lithotripsy “modalities have inherent advantages and
disadvantages.” Id. However, if a hospital “must choose one lithotripter,”
the “EHL unit with the smaller-caliber probes would be the logical choice,
because this is a safe, effective, and cost effective modality.” Id.
Based on our review of the entire record, Petitioner has proven by a
preponderance of evidence that an ordinarily skilled artisan would have been
motivated to substitute an EHL probe for a laser lithotripsy probe to save
cost.
c) Reduce Heat
Petitioner contends that Levy itself identifies heat generated by its
laser as enough of a concern that its balloon could be cooled by circulating
liquid through the balloon. Pet. 18, 29 (citing Ex. 1002 ¶¶ 96, 120);
Reply 31 (citing Ex. 1003, 3–5). However, Petitioner fails to adduce
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evidence that an EHL shockwave generator produces less heat than a laser-
based shockwave generator such as Levy’s. Accordingly, we determine that
Petitioner has failed to prove by a preponderance of evidence that an
ordinarily skilled artisan would have been motivated to substitute an EHL
probe for Levy’s laser probe to reduce heat generated by the probe.
iii. Motive to Incorporate a AAPA Guidewire and Sealing
Arrangement into Levy
As an initial matter, we address Patent Owner’s argument that we may
not consider AAPA during this proceeding because the AAPA is not a patent
or printed publication under § 311(b). PO Resp. 64–65. We disagree.
The Federal Circuit has affirmed Board decisions in inter partes
review that claims were unpatentable based in part upon admitted prior art
found in the challenged patent. B/E Aerospace, Inc. v. C&D Zodiac, Inc.,
No. 2019-1935, 2020 WL 3478651, at *5 (Fed. Cir. June 26, 2020); Papst
Licensing GMBH & Co. v. Samsung Elecs. Am., Inc., 924 F.3d 1243, 1255
(Fed. Cir. 2019). Additionally, the Board, and our reviewing Court, have
long treated a patentee’s admissions as prior art: “We see no reason why the
patentee’s representations in their application should not be accepted at face
value as admissions that . . . may be considered ‘prior art’ for any purpose,
including use as evidence of obviousness under 35 U.S.C. [§] 103.” In re
Nomiya, 509 F.2d 566, 570–71 (CCPA 1975). This is true, even though the
admissions may not qualify as prior art under 35 U.S.C. § 102:
[A] statement by an applicant, whether in the application or in
other papers submitted during prosecution, that certain matter is
“prior art” to him, is an admission that that matter is prior art for
all purposes, whether or not a basis in [§] 102 can be found for
its use as prior art.
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Id. at 571 n.5. The AAPA upon which Petitioner relies is expressly
characterized as prior art and appears in a patent. We consider the AAPA to
constitute “prior art consisting of patents” as stated in 35 U.S.C. § 311(b).
Accordingly, we find Patent Owner’s argument unpersuasive and consider
the AAPA relied upon by Petitioner.
On the merits, no dispute exists that a guidewire extending through a
carrier to which an angioplasty balloon is sealed near its distal end was well
known. The ’371 patent labels such
an arrangement “PRIOR ART” as
shown in Figure 1, reproduced at
right. Although the guidewire is not
shown in Figure 1 or any figure illustrating the claimed invention, the
Specification describes Figure 1 as illustrating “a typical prior art over-the-
wire angioplasty balloon catheter 10.” Id. at 3:66–67; see also id. 4:31–33
(describing guidewire not shown in Figure 2 illustration of invention).
Petitioner relies upon Figure 1 of the ’371 patent and its
accompanying text as constituting AAPA. Pet. 23–25 (citing Ex. 1001,
3:65–4:2, Fig. 1; Ex. 1002 ¶ 113). Petitioner contends that a similar
arrangement is also shown in other prior art, Healy (Ex. 1047). Id. Prior art
of record confirms that the arrangement of a balloon sealed near the distal
end of a carrier through which a guidewire extends was well known.
Ex. 1008 ¶¶ 21–22, Figs. 1–3; Ex. 1047, Abstract, 3:17–27, Fig. 2; Ex. 1268
(“Lennox”), 4:63–5:8; Figs. 1, 3; Ex. 2110, 3:26–51, Figs. 2, 3. The
prosecution history of the ’371 patent confirms the same. The Examiner
found that the prior art taught the claimed structural arrangement between
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the balloon, carrier, and guidewire, Ex. 1013, 304 (applying Lennox), and
Patent Owner did not contest the Examiner’s finding, id. at 290–297.
Petitioner argues that it was known to an ordinarily skilled artisan to
use a guidewire extending through an elongated bore to assist a physician to
navigate the catheter to reach the area for treatment. Pet. 24 (citing Ex. 1002
¶ 112). Petitioner also argues that it would have been obvious to
“implement the AAPA with the angioplasty balloon described in Levy” as a
“routine design choice” because the arrangement was “the most common
angioplasty catheter and balloon design, with predictable and expected
results.” Pet. 26 (citing Ex. 1002 ¶ 115).
Patent Owner argues that Petitioner did not establish that an ordinarily
skilled artisan would have been motivated to modify Levy by incorporating
the guidewire extending through the carrier as described by the AAPA. PO
Resp. 59–62. Patent Owner also argues that Petitioner failed to establish
that an ordinarily skilled artisan would have been motivated to modify Levy
to seal its balloon near the distal end of Levy’s catheter as described by the
AAPA. Id. at 62–63.
In response to both arguments, Petitioner points out that an ordinarily
skilled artisan would understand Levy to be adapted for angioplasty
procedures. Reply 34 (citing Ex. 1002 ¶¶ 114, 156; Ex. 1003, 5 (“[T]he
balloon may have the shape of a balloon of the kind that is used with
catheters used to perform treatments in [b]lood vessels.”); Ex. 1200 ¶ 142).
Petitioner also contends, based on testimony of Dr. Jensen, that an ordinarily
skilled artisan
looking to adapt Levy’s catheter and/or balloon design to
increase the types of treatments Levy could perform, would have
been motivated to look to other catheters/balloons used to
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perform treatments in blood vessels, including the AAPA—i.e.,
the “most common angioplasty catheter and balloon design” as
Dr. Jensen described in his original declaration.
Reply 34 (citing Ex. 1002 ¶¶ 115, 157). Petitioner also argues that
configuring Levy according to well-known principles reflected by the AAPA
“would have been a routine design choice well within the [artisan’s] skill set
and would have yielded predicable results.” Id. (citing Ex. 1002 ¶¶ 115,
157; KSR, 550 U.S. 398 at 416).
In its Sur-reply, Patent Owner argues that Dr. Jensen’s testimony is
insufficient because he fails to explain how or why an ordinarily skilled
artisan would have modified Levy’s catheter. Sur-reply 31–32. However,
we find this argument unpersuasive because the prior art and prosecution
history of the ’371 patent indisputably establishes that the configuration of
an angioplasty catheter with a balloon sealed to the distal end of a carrier
through which a guidewire extends was so well known. Ex. 1001, 3:65–4:2,
Fig. 1; Ex. 1008 ¶¶ 21–22, Figs. 1–3; Ex. 1047, Abstract, 3:17–27, Fig. 2;
Ex. 1268, 4:63–5:8; Figs. 1, 3; Ex. 2110, 3:26–51, Figs. 2, 3; Ex. 1013, 290–
297, 304.
For all the reasons identified by Petitioner above and the testimony by
Dr. Jensen, we find that Petitioner has proven by a preponderance of
evidence that an ordinarily skilled artisan would have had motive to combine
teachings of Levy and AAPA to arrive at the claimed configuration of the
balloon sealed near the distal end of a carrier through which a guidewire
extends.
e. Reasonable Expectation of Success
Petitioner contends that an ordinarily skilled artisan would have
understood how to substitute an EHL shockwave generator from Mantell,
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Uchiyama, or Willneff for Levy’s laser-based shockwave generator because
electrodes and lasers were known and interchangeable alternative
mechanisms for generating shockwaves. Pet. 1–2 (citing Ex. 1012), 19–20
(citing Ex. 1012, 1:5–10, 1:15–30, Ex. 1002 ¶ 98), 28–29 (citing Ex. 1002
¶ 120). Patent Owner contends that an ordinarily skilled artisan would not
have reasonably expected to successfully substitute electrodes of Mantell,
Uchiyama, or Willneff for Levy’s laser for four reasons. PO Resp. 44–53.
We address each reason below.
i. Whether EHL and Laser Lithotripsy Are Known Alternatives
Patent Owner argues that Dr. Jensen wrongly concludes that Levy’s
laser generate shockwaves in the same manner as electrodes. PO
Resp. 44–45. More specifically, Patent Owner argues that Levy does not
generate shockwaves at all, but merely generates “less powerful and harmful
acoustic waves.” Id. at 45 (citing Ex. 2100 ¶ 131). For the reasons
expressed in Part II.F.1.c above, we disagree and find that Petitioner has
proven by a preponderance of evidence that Levy, Mantell, Uchiyama, and
Willneff all generate shockwaves in the same manner, by creating cavitation
bubbles in the fluid whose collapse creates shockwaves.
Patent Owner also argues that Bhatta does not establish that lasers and
electrodes are known interchangeable alternatives for generating
shockwaves. Id. at 45–46. More specifically, Patent Owner contends that
Bhatta refers to waves generated by lasers as “stress waves” but waves
generated by electrodes as “shockwaves.” Id. (citing Ex. 1012, 1:17–18,
2:5–11; Ex. 2100 ¶¶ 46, 55–58). Patent Owner’s argument is unpersuasive
because we see no meaningful distinction drawn by Bhatta between “stress
waves” and “shockwaves.” Bhatta expressly equates laser and electrodes as
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mechanisms for breaking biliary calculi when it explains that:
“Electrohydraulic lithotripsy and laser lithotripsy systems frequently are
used to fragment urinary and biliary stones. Both systems utilize plasma-
induced stress waves to fragment calculi.” Ex. 1012, 1:16–19. Furthermore,
when Bhatta describes its own electrode-based invention, it sometimes refers
to the electrodes as generating “energy pulse waves,” which Bhatta equates
with “shockwaves.” Id. at 2:5–11, Abstract. Patent Owner’s argument that
Bhatta’s choice of “stress” or “shock” refers to different types of waves is
simply not supported by Bhatta considered as a whole. Bhatta also expressly
states that its device is suited for treating arteriosclerotic plaque. Id.
at 1:5–9. We find that the record establishes that an ordinarily skilled artisan
would have understood lasers and electrodes to be alternative forms of
generating shockwaves for treating plaque in vessels.
ii. Whether an Artisan Would Have Expected Electrodes to
Burst the Angioplasty Balloon
Patent Owner argues that an ordinarily skilled artisan would have
expected an EHL probe placed in an angioplasty balloon to fail by bursting
the balloon. PO Resp. 46–51. Patent Owner relies primarily upon testimony
from Dr. Berger and his review of other evidence including declarations
from other witnesses and objective evidence. Id. (citing Ex. 2100
¶¶ 148–161 (citing Ex. 2033, 319 (“Zhong”); Ex. 2048; Ex. 2111; Ex. 2115;
Ex. 2117; Ex. 2118; Fig. 5; Ex. 2119; Ex. 2170; Ex. 2173; Ex. 2174;
Ex. 2175). Dr. Berger’s opinion rests upon his understanding that EHL
steam bubbles create “peak pressures of 50-250 ATM” (Ex. 2100 ¶ 154

19 Our citations refer to the exhibit page number rather than Zhong’s internal
numbering.
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citing Ex. 2033, 5, Fig. 8), which exceed typical burst pressures of
angioplasty balloons of “around 25–30 ATM” (Ex. 2100 ¶ 153 (citing
Ex. 2048, 2; Ex. 2111, 162:14–163:5; Ex. 2115, 4, Table 2)).
Petitioner responds that Dr. Berger’s testimony is inconsistent with
the teachings of the prior art that Petitioner cites as a basis for its challenge
because each of Mantell, Uchiyama, and Willneff describes using an EHL
probe within a balloon without bursting the balloon. Reply 27. Petitioner
also notes that Willneff explains that steep pressure spikes pass through the
balloon and healthy tissue to act upon target concretions. Id. at 28 (citing
Ex. 1006, 420); see also Ex. 1006, 7. Petitioner also points out that
Dr. Berger’s reliance on testimony from Drs. Soukas, Kereiakes, and
Armstrong expressing skepticism that Patent Owner’s device would work
without bursting the balloon is flawed for three reasons. Reply 28. More
specifically, Petitioner argues that: (1) Drs. Soukas, Kereiakes, and
Armstrong are not proven to be ordinarily skilled artisans, (2) they did not
review the ’371 patent or the asserted prior art, and (3) their skepticism has
not been shown to have existed at the time of invention. Id.
Based on our review of the entire record, Petitioner persuades us that
an ordinarily skilled artisan would have had a reasonable expectation that
substituting an EHL probe as taught by Mantell, Uchiyama, or Willneff for
Levy’s laser probe would not have burst Levy’s balloon.

20 Our citations to Willneff refer to Willneff’s internal numbering rather than
the exhibit page number.
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iii. Whether the Proposed Combination Results in an
Unacceptably Large Balloon Diameter
Patent Owner argues, based on Dr. Berger’s testimony, that an
ordinarily skilled artisan would have expected that adding electrical
components to the interior of the AAPA angioplasty balloon would be
unsuccessful because it would increase the diameter of the balloon. PO
Resp. 51–52 (citing Ex. 2100 ¶¶ 121, 133, 150, 151, 171–173). We discount
Dr. Berger’s testimony because it is: (1) poorly supported by objective
evidence (citing no evidence of the size of EHL, ultrasound, or laser-based
angioplasty devices in the prior art), (2) is inconsistent with the express
teachings of at least Levy (Ex. 1003, Fig. 1), O’Boyle (Ex. 2109, 3:20–21,
3:53–62), O’Connor (Ex. 2110, 3:36–57), and Bhatta (Ex. 1012, 2:52–3:11,
Fig. 1), which all describe devices used to treat blood vessels that include
probes inside a balloon, and (3) based upon a flawed legal premise that
demonstrating obviousness requires proof that one device may be bodily
incorporated into another.
Based on our review of the entire record, Petitioner persuades us that
an ordinarily skilled artisan would have expected to succeed at placing an
EHL probe inside a balloon without resulting in an acceptably large diameter
of the balloon.
iv. Whether the Proposed Combination Would Lead to
Restenosis and Embolism
Patent Owner contends, based on Dr. Berger’s testimony, that an
ordinarily skilled artisan would have feared that placing a shockwave
generator inside an angioplasty balloon would “likely have result[ed] in
embolism” and “lead to restenosis caused by thermal damage.” PO
Resp. 52–53 (citing Ex. 2100 ¶¶ 174–176, 206). Petitioner points out that
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balloon angioplasty without a shockwave generator includes a low risk of
embolism and contends that an ordinarily skilled artisan would expect a
similarly low risk using a balloon with a shockwave generator. Reply 29–30
(citing Ex. 1200 ¶ 133). Petitioner also points out that a saline-filled balloon
would protect the patient from thermal damage. Id. at 30 (citing Ex. 1200
¶ 133).
Both Dr. Berger and Dr. Jensen appear to draw their respective
conclusions without any objective evidence to support them. See Ex. 2100
¶¶ 174–176, 206; Ex. 1200 ¶ 133. O’Boyle and O’Connor from the prior art
also express concerns about embolism associated with balloon angioplasty.
Ex. 2109, 1:32–43; Ex. 2110, 1:14–20. We also note that a risk of embolism
is present even in Patent Owner’s commercial device. See Ex. 2028, 3
(listing “Emboli (air, tissue, thrombus, or atherosclerotic emboli” and stating
that “[p]ossible adverse effects are consistent with standard angioplasty”).
Therefore, because embolism is a generalized concern with all balloon
angioplasty, we fail to see why an ordinarily skilled artisan would have
believed no reasonable chance of success existed if the prior art teachings
were combined as proposed by Petitioner.
Regarding restenosis from thermal damage, Levy refers to the saline
in its balloon as “coolant,” which can be circulated or may be of low enough
temperature or high enough heat absorption capacity to address any concern
about damaging the vessel with excessive heat. Ex. 1003, 4–5. Moreover,
even if we were to credit Patent Owner’s proof, we do not consider the
alleged concern to be of the type that would obviate Petitioner’s motivations
to substitute the EHL devices of Mantell, Uchiyama, or Willneff for Levy’s
laser probe. Our reviewing court has recognized that a given course of
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action often has simultaneous advantages and disadvantages, and this does
not necessarily obviate any or all reasons to combine teachings. See Winner
Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The
fact that the motivating benefit comes at the expense of another benefit,
however, should not nullify its use as a basis to modify the disclosure of one
reference with the teachings of another. Instead, the benefits, both lost and
gained, should be weighed against one another.”).
We determine that Petitioner has demonstrated that an ordinarily
skilled artisan would have reasonably believed that Petitioner’s proposed
combination of teachings from the prior art would be successful.
f. Objective Indicia of Nonobviousness
i. Nexus
Patent Owner argues, based solely upon testimony of Dr. Berger, that
it has proven that it is entitled to a presumption of nexus between the
claimed invention and all objective evidence of non-obviousness because
“the claims” are “essentially coextensive with the Shockwave IVL system.”
PO Resp. 68–69 (citing Ex. 2100 ¶ 201). Dr. Berger’s cited testimony
states:
The claims are also not merely directed to a small
component of a larger system; rather, they are directed to the
essence of the innovation that was identified by analysts as one
of the major drivers of Shockwave’s success. The analysts
identified Shockwave’s “elegant,” “easy-to-use,” “unique” and
“innovative” technology as one of the most important factors in
Shockwave’s stock performance.
Ex. 2100 ¶ 201. Dr. Berger does not link the claims to the structure of
Patent Owner’s commercial device in this testimony. Rather, he links the
claims to “the essence of the innovation” and the “major drivers of [Patent
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Owner’s] success.” Id. Dr. Berger’s immediately preceding paragraph
reflects his comparison of the claims to Patent Owner’s commercial product.
Id. ¶ 200. We interpret Patent Owner to have intended to cite paragraph 200
of Dr. Berger’s testimony.
Petitioner appears to have interpreted Patent Owner’s argument the
same way. See Reply 36 (referring to Dr. Berger’s testimony as ¶ 200 as the
evidence of nexus). Petitioner contends that Dr. Berger cannot render an
opinion that the claims cover Patent Owner’s Shockwave IVL21 product
because he has seen only photos of the Shockwave IVL, does not know who
prepared the claim chart that appears in his Declaration, and merely
reviewed written materials to verify that the words and pictures appearing in
the chart were present in the cited documents. Id.
Patent Owner bears the burden of establishing that a nexus exists
“between the evidence and the patented invention.” Fox Factory, Inc. v.
SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Henny Penny
Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019)). Patent
Owner is entitled to a rebuttable presumption of nexus “when 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.’”
Id. (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072
(Fed. Cir. 2018)); see also Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-
01129, Paper 33 at 32 (PTAB Jan. 24, 2020) (Final Written Decision)
(precedential). “A patent claim is not coextensive with a product that
includes a ‘critical’ unclaimed feature that is claimed by a different patent

21 IVL refers to intravascular lithotripsy. Ex. 2100 ¶ 190.
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and that materially impacts the product’s functionality . . . .” Fox Factory,
944 F.3d at 1375. Nevertheless, even if a patentee fails to demonstrate a
presumption of nexus, it may directly establish a nexus between the claimed
invention and the objective evidence of non-obviousness. Id. at 1378. The
patentee bears the burden of directly proving such a nexus. Id.
Based on our review of Dr. Berger’s testimony about the “claim
chart” appearing in his Declaration, we find that Patent Owner fails to prove
by a preponderance of evidence that “the Shockwave IVL devices include
each feature recited in the claims” as Dr. Berger opines. Ex. 2100 ¶ 200.
First, the claim chart does not include any claim language at all. Id. Rather,
it merely refers to claim language using shorthand [1a]–[1e], which the
parties use in their briefing. Id. However, Dr. Berger never explains his
understanding of what that shorthand means. See generally, Ex. 2100.
More importantly, based on our own review of the chart, many details
of the claimed invention are left unaddressed. For example, the chart fails to
address expressly whether the Shockwave IVL devices include:
a “distal end of the balloon being sealed to the carrier near the
distal end,”
a “proximal end of the balloon defining an annular channel
arranged to receive a fluid therein that inflates the balloon,”
a “pair of electrodes,” or
the “arc generator generating a high voltage pulse sufficient to
create a plasma arc between the electrodes resulting in a
mechanical shock wave within the balloon.”
Compare Ex. 2100 ¶ 200 (descriptions in claim chart), with Ex. 1001,
6:21–39 (claim 1). We have reviewed the entirety of the evidence cited in
the chart and found that none of it ever refers to “electrodes,” “arc,” or
“plasma.” The evidence adduced by Patent Owner simply fails to carry its
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burden of persuasion that the claims cover its product, much less that the
two are sufficiently coextensive to be entitled to a presumption of nexus.
Nevertheless, for purposes of the analysis below, we will assume that Patent
Owner has demonstrated that the claims cover its commercial product and
some degree of nexus between its objective evidence of nonobviousness and
the claimed features.
ii. Long Felt Need
Patent Owner contends that its device, Shockwave IVL, filled a long
felt need for a device that could effectively treat medial calcified lesions.
PO Resp. 69–75. Patent Owner supports its argument with testimony from
Dr. Berger (Ex. 2100 ¶¶ 190–203) and testimony from clinicians,
Drs. Kereiakes (Ex. 2174), Lyden (Ex. 2171), Hill (Ex. 2172), Soukas
(Ex. 2170), and Armstrong (Ex. 2173), and statements appearing in
documents distributed by financial analysts at Wells Fargo (Exs. 2003, 2004,
2016, 2017). PO Resp. 69–75. Dr. Berger relies on many of the same items
of evidence but also considers journal articles. We analyze each type of
evidence below.
a) Clinicians’ Testimony
Dr. Kereiakes explains that medial plaque occurs within the walls of
arteries and can “cause narrowing of the lumen of the artery” and opines that
“there has been no known way to treat a medial calcified lesion.” Ex. 2174
¶ 9. Dr. Lyden testifies that “medial calcified lesions” prevented angioplasty
balloons from expanding a vessel sufficiently to enable the placement of a
stent to hold the vessel open. Ex. 2171 ¶ 15. Dr. Hill testifies that “the
community struggled to achieve full lesion expansion that would allow the
lumen of the artery to be expanded to the desired diameter” often because of
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“medial calcified lesions.” Ex. 2172 ¶ 7. Dr. Soukas testifies that
“Shockwave IVL was the first, and remains the only, effective treatment for
medial calcified lesions. . . . [N]either atherectomy nor an angioplasty
balloon are effective at breaking up medial plaque.” Ex. 2170 ¶ 15.
We note that none of the Patent Owner’s clinicians support any of
their testimony about the benefits of Shockwave IVL over competitive
devices with citations to objective evidence. See Exs. 2170–2174 (citing no
outside evidence objective or otherwise). We consider this fact to slightly
reduce the weight of the testimony from these clinicians, but we also
recognize them as having firsthand knowledge of outcomes in certain cases
involving the use of Patent Owner’s Shockwave IVL device. Those
experiences, however, are merely ad hoc examples of success that we do not
consider to definitively prove that the Shockwave IVL is the first and only
way to treat occluded vessels that also exhibit medial calcification.
Accordingly, we consider the testimony from clinicians to be of modest, but
meaningful, probative value on whether IVL is more effective than pre-
existing options for treating calcified plaque that includes plaque within the
medial tissues of arteries.
Petitioner argues that no “unmet need to effectively treat medial
calcified lesions” exists because medial calcium rarely obstructs blood
vessels and rarely causes symptoms that require medical treatment.
Reply 37. Petitioner supports its argument with deposition testimony of
Drs. Soukas, Hill, and Kereiakes (clinicians proffered by Patent Owner) and
declarations from Drs. Chambers and Finn (clinicians proffered by
Petitioner). Id. at 37–38 (citing Ex. 1212, 34:8–14, 37:24–39:5; Ex. 1211,
86:19–87:19, Ex. 1213, 38:12–23; Ex. 1350 ¶¶ 8–9; Ex. 1362 ¶¶ 9–15). We
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find that this cited testimony establishes that all five clinicians agree that the
presence of medial calcium alone does not call for treatment by
cardiovascular intervention. We have carefully reviewed Petitioner’s cited
evidence and find it persuasive on this point.
Patent Owner attempts to rebut Petitioner’s cited evidence by citing
deposition testimony from Dr. Finn for the proposition that he defined
“medial calcification” as a condition not associated with atherosclerotic
plaque that obstructs blood vessels. Sur-reply 41 (citing Ex. 2253,
25:13–25, 26:5–29:16). Based on our review of this cited testimony from
Dr. Finn, we find that it fails to support Patent Owner’s position. Rather, the
testimony reveals that Dr. Finn uniformly distinguishes “medial
calcification” from atherosclerotic plaque, which occurs in the intimal layer
of a vessel and is a different form of calcification. Ex. 2253, 25:13–25,
26:5–16. The objective evidence about which Patent Owner questioned Dr.
Finn, which relates to the progression of calcification in arteries, similarly
distinguishes between medial calcification and atherosclerotic plaque. See,
e.g., Ex. 2247 (“atherosclerotic intimal calcification is different from medial
Monckeberg calcification, and the latter occurs independently from intimal
calcification”).
Patent Owner also argues that Dr. Chambers uses “medial
calcification” to refer to “deep atherosclerotic plaque that occludes the
vessel and requires treatment by angioplasty or otherwise.” Sur-reply 41–42
(citing Ex. 2251, 39:2–19, 40:2–4, 132:6–11). However, we find that
Dr. Chambers’ cited testimony merely confirms his originally stated view
that “medial calcium” alone does not require treatment unless calcium is also
present in the intima. Ex. 2251, 39:2–40:22. Petitioner contends, based
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upon Dr. Chambers’ testimony, that orbital atherectomy was a successful
method of treating heavily calcified plaque that included medial plaque.
Reply 38 (citing Ex. 1350 ¶ 9–21). Dr. Chambers’ testimony is supported
by citations to objective evidence. Ex. 1350 ¶¶ 16–19 (citing
Exs. 1351–1353). His testimony is also consistent with the conclusions
about the efficacy of rotational atherectomy reflected in the Dill paper
discussed in Part II.F.1.f.ii.b) below, which we consider to be highly
probative evidence on this point.
b) Articles Cited by Dr. Berger
Dr. Berger relies, in part, upon reports from financial analysts and
three journal articles for his opinion that Shockwave IVL was more effective
at treating vessels that included medial calcified lesions than either
traditional balloon angioplasty or rotational atherectomy. Ex. 2100
¶¶ 193–196 (citing Ex. 2126;22 Ex. 2127; Ex. 2128). Exhibit 2126 (“Dill”) is
a paper reporting results of a randomized study of about 500 total patients on
the comparative efficacy of using either a rotational atherectomy device or
traditional angioplasty balloons for treating “complex, calcified, and long
lesions” in small coronary arteries. Ex. 2126, 1. Dill concludes that both
treatment methods were relatively successful in treating the “difficult
morphologies” of the studied complex lesions with success rates of 78%
(angioplasty) and 85% (atherectomy). Id. at 6–7. Dill concluded that
rotational atherectomy may be required to treat lesions “resistant to high
balloon pressures.” Id. at 7.

22 Dr. Berger erroneously cites Exhibit 2136, but context makes clear that he
intended to cite Exhibit 2126. Ex. 2100 ¶ 194.
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We view Dill to be among the most probative evidence on the issue of
whether rotational atherectomy was effective for treating complex calcified
lesions in coronary arteries. Dill establishes that rotational atherectomy was
more effective than traditional angioplasty balloons for such lesions and
undermines Patent Owner’s contention that Shockwave IVL was the only
treatment available for such lesions.
Exhibits 2127 and 2128 (“CAD I” and “CAD II” respectively, and
collectively, the “CAD Studies”) reflect results of tests focusing solely upon
whether the Shockwave IVL device is safe and effective at treating “heavily
calcified atherosclerotic plaques,” Ex. 2127, 1, or “severe CAC [coronary
artery calcification],” Ex. 2128, 2. CAD I involved treatment of 60 patients.
Ex. 2127, 2. CAD II involved treatment of 120 patients. Ex. 2128, 4. The
CAD Studies conclude that Shockwave IVL was “a feasible frontline tool
for CAC plaque modification.” Ex. 2128, 6. The CAD II study indicates
that using Shockwave IVL resulted in “intraplaque calcium fracture, thereby
modifying vascular compliance and facilitating stent expansion.” Id. The
success rates of IVL determined in CAD I and CAD II were 95% and 94.2%
respectively with very few side effects noted during each 30-day study
period. Ex. 2127, 2; Ex. 2128, 5, Table 4. Neither of the CAD Studies
presented detailed information of the precise radial depth of calcification
within the tissues of the arteries that were treated (i.e., whether the
calcification was in the intimal or medial tissues), but CAD II indicated that
maximum calcium fracture depth of 0.6±0.3 mm and maximum calcium
thickness at fracture site of 0.8±0.3 mm was observed in the 37 patients for
whom such data was gathered. Ex. 2128, 7, Table 7.
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We similarly view the CAD Studies as objective and reliable evidence
of the potential efficacy of using IVL to treat severe coronary artery
calcification. However, one limitation that we note is that neither of the
CAD Studies reflect whether IVL had detrimental side effects after the 30-
day study period.
Petitioner contends, based on testimony by Dr. Chambers, that IVL
has been shown to have a primary patency rate (i.e., the rate at which a
treated vessel remains open) that is lower than that expected for balloon
angioplasty and drug eluting angioplasty. Reply 39 (citing Ex. 1350
¶¶ 25–26). Dr. Chambers relies upon articles that reported 12-month
patency rates for patients treated with IVL in peripheral arteries (in the
“PAD II” trial) was 54% while patients in a different study that were treated
with balloon angioplasty or drug eluting balloons exhibited patency rates of
75% and 94.7% respectively. Ex. 1350 ¶¶ 25–26 (Ex. 1355; Ex. 1356). We
consider Dr. Berger’s testimony on this point to be credible.
c) Statements by Financial Analysts
Patent Owner and Dr. Berger rely upon unsupported statements in
documents written by unidentified employees of various financial advisers
describing the Shockwave IVL was more effective than “[a]therectomy and
other plaque modification devices” at treating medial calcium. See, e.g.,
Ex. 2100 ¶ 193 (quoting Ex. 2006, 17).
We discount the probative weight of all the statements from financial
analysts as being from authors who have not been established to either have
relevant medical or scientific training or may have biases based on financial
interest. For example, Wells Fargo warns readers of its “analysis” of Patent
Owner’s stock that: “investors should be aware that the firm may have a
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conflict of interest that could affect the objectivity of the report and investors
should consider this report as only a single factor in making their investment
decision.” Ex. 2006, 1. Wells Fargo also refers readers of the report to
“page 31 for . . . important disclosures” that reflect five different ways in
which Wells Fargo has financial interests in or received compensation from
Patent Owner in the past or going into the future. Id. at 1, 31–32. The
probative weight of such evidence is not increased merely by having
Dr. Berger read it and recount the conclusions drawn by such analysts.
Accordingly, we ascribe little weight to statements by the financial analysts
or Dr. Berger’s testimony that relies upon such statements.
d) FDA Breakthrough Designation
Patent Owner argues, based on testimony from Dr. Berger, that the
designation of the Shockwave IVL as a “breakthrough device” by the FDA
establishes that its device treats a condition for which “no approved or
cleared alternatives exist.” PO Resp. 73–74 (citing Ex. 2100 ¶¶ 197–199).
The documents upon which Dr. Berger bases his testimony are the letter
from the FDA informing Patent Owner of its designation (Ex. 2124) and
“Guidance for Industry” from the FDA on the “Breakthrough Devices
Program” (Ex. 2125). Ex. 2100 ¶¶ 197–199 (citing Ex. 2124; Ex. 2125).
A “breakthrough device” designation as defined in section 515B(b) of
the FD&C Act refers to devices:
(1) that provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating human disease or
conditions; and
(2)(A) that represent breakthrough technologies;
(B) for which no approved or cleared alternatives exist;
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(C) that offer significant advantages over existing
approved or cleared alternatives, including the potential,
compared to existing approved alternatives, to reduce or
eliminate the need for hospitalization, improve patient quality of
life, facilitate patients’ ability to manage their own care (such as
through self-directed personal assistance), or establish long-term
clinical efficiencies; or
(D) the availability of which is in the best interest of
patients.
Ex. 2125, 8.
FDA guidance explains that a breakthrough designation may be
granted for devices that meet the requirement of section (1) and one of the
four subparagraphs listed in section (2) (i.e., one of (2)(A)–(D)). Meeting
section (1) requirement can occur when the manufacturer shows “a
reasonable expectation that the device could provide for more effective
treatment or diagnosis of the disease or condition identified in the proposed
indications for use.” Id. at 9. This showing may be made based upon
“literature or preliminary data.” Id.
Without further explanation or identifying specific evidence,
Dr. Berger concludes that “[b]ased on the evidence discussed above, I
believe that the Shockwave IVL meets each of the criteria 2(A) through
2(D).” Ex. 2100 ¶ 199. Petitioner correctly notes that Patent Owner has
submitted no evidence revealing the content of its request for a breakthrough
designation or any correspondence with the FDA relating to its application
for the designation other than the FDA’s letter granting the breakthrough
designation. Reply 40. Petitioner also contends that the FDA grants
breakthrough designations about 71% of the time. Id.
Based on FDA guidance discussed immediately above, we conclude
that Patent Owner could have obtained the designation by merely
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demonstrating a “reasonable expectation” based on “literature or preliminary
data” that the Shockwave IVL is more effective at treating a life threatening
or debilitating condition. We discern no reliable basis for Dr. Berger to have
concluded that the Shockwave IVL met all four of the section (2) criteria for
devices that are “breakthrough devices” because none of the items upon
which Dr. Berger relies reflects personal knowledge of underlying facts
needed to draw such a conclusion. Accordingly, we ascribe little probative
weight to the FDA’s “breakthrough device” designation because: (i) Patent
Owner failed to supply evidence of the precise basis for its request for
designation or the FDA’s precise basis for granting it, (ii) manufacturers
need only demonstrate a “reasonable expectation” of meeting the criterion of
section (1) based on “literature or preliminary data,” and (iii) about 71% of
those seeking the designation get it.
e) Evidence First Introduced with the Sur-Reply
Patent Owner presents Exhibit 2131 (“Kassimis”) for the first time
with its Sur-reply. Sur-reply 42 (citing Ex. 2131). Patent Owner argues that
Kassimis reports a head-to-head comparison of orbital atherectomy and IVL
treatments and concludes that IVL is superior based on the following quote:
Moreover, shock-wave pulses affect calcium sheets located
within the target field regardless of their depth in the vessel
wall, which contrasts with inefficacy of PTRA or OA
[rotational or orbital atherectomy] to modify deep-seated
calcium. . .
IVL is unique among all technologies in its ability to modify
calcium circumferentially and transmurally thus, modifying
transmural conduit compliance. [. . .] We believe that IVL
balloon is going to transform the market, as it is easy to use,
with predictable results and in most centers will replace cutting
and scoring balloons for the treatment of calcific disease.
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Id. (quoting and emphasizing text of Ex. 2131, 11).
This passage speaks glowingly about IVL, but the statement is
prospective and not definitive, which is apparent from the following section
of Kassimis, labeled “Conclusion,” which reads:
The optimal therapy for calcified CAD [coronary artery
disease] is multi-adjunctive and several strategies should always
be available in the catheter laboratory (Fig. 10). The outcome
is less favourable compared to non-calcified lesions, but with
increased understanding of calcification, more sophisticated,
individualized treatment regiments will likely evolve to make
optimal use of the variety of dedicated technologies and success.
The advent of the IVL balloon may revolutionise this indication
but cost-effectiveess of these advanced technologies will need to
be considered.
Ex. 2131, 11 (emphasis added). The “several strategies” of “Fig. 10”
includes orbital atherectomy. Id. at 10, Fig. 10. Thus, Kassimis recognizes
that IVL is not yet proven to be a superior treatment for calcified coronary
artery disease, but is likely to be an important option added to existing
options for treating the entire population of potential patients. On balance,
Kassimis supports Patent Owner’s argument that IVL has promise to be an
improved mode of treating certain types of coronary artery disease.
f) Conclusion
Based on our analysis of the evidence adduced by both parties, we
conclude that Patent Owner has demonstrated that IVL is a promising
treatment for stenoses in arteries with complex coronary artery calcification.
However, Petitioner has also established that previous methods for treating
the same type of stenoses, e.g., rotational and orbital atherectomy, remain
viable treatment options that may have advantages in certain circumstances.
We also conclude that the medical community at large has recognized that
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severe calcification of arteries makes successful short and long term
treatment more difficult to attain. We also find that neither party has
provided conclusive evidence of what, if any, long term detrimental side
effects result from treatment with IVL, but Petitioner has submitted credible
evidence that IVL does or is likely to lead to long term side effects.
Accordingly, whether IVL is more meaningfully effective than prior
methods of treating arteries with complex coronary artery calcification
remains an open question.
iii. Failure of Others
Patent Owner’s argument that all other treatments for coronary artery
disease accompanied by complex calcification have failed is based upon the
same testimony that we have reviewed in detail in Part II.F.1.f.ii above. PO
Resp. 74–79. We are not persuaded by Patent Owner’s evidence because
Petitioner has adduced persuasive evidence that prior treatments have been
used with an acceptable level of success. The evidence supporting our
conclusion is also described and analyzed in Part II.F.1.f.ii above. Although
IVL may show signs of being able to treat certain types of coronary artery
disease in a measurably more effective manner than prior techniques, Patent
Owner does not persuade us that those prior techniques are failures.
iv. Skepticism
The parties’ arguments and evidence relating to skepticism closely
follow their argument and evidence on the issue of whether an ordinarily
skilled artisan would not have had a reasonable expectation of succeeding in
substituting an EHL probe for Levy’s laser probe because of risks of the
balloon bursting and embolism. Compare PO Resp. 79–82 (citing Ex. 2100
¶¶ 205–212; Ex. 2170; Ex. 2171; Ex. 2173; Ex. 2174), with PO Resp. 46–51
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(citing Ex. 2100 ¶¶ 148–161 (citing Ex. 2170; Ex. 2173; Ex. 2174;
Ex. 2175)). For the reasons expressed in Part II.F.1.e above, we found that
an ordinarily skilled artisan would have had a reasonable expectation of
successfully making a working device according to claim 1 that would not
burst or result in unwarranted risks of embolism. Accordingly, we find that
Patent Owner’s evidence of skepticism is a weak indicator of non-
obviousness.
v. Industry Praise
Patent Owner argues “first and foremost” that the FDA’s designation
of Shockwave IVL as a “breakthrough device” is “significant praise” from
those in the industry. We have explained in detail why we do not consider
the evidence adduced by Patent Owner to establish that the FDA’s
designation proves that Shockwave IVL was a breakthrough, or
praiseworthy as a more effective treatment than existing options. See
Part II.F.1.f.ii.d) above. For those same reasons, we do not consider the
FDA’s designation to demonstrate praise by the industry.
Patent Owner also relies upon testimony from the clinicians,
Drs. Kereiakes, Hill, and Lyden. PO Resp. 83 (citing Ex. 2171 ¶ 12;
Ex. 2172 ¶ 10; Ex. 2174 ¶¶ 10, 16). This testimony reflects unsubstantiated
speculation about better efficacy, which has yet to be supported by objective
evidence. See Part II.F.1.f.ii above. We do not, however, entirely discount
what appears to be genuine excitement by clinicians about IVL.
We cannot draw the same conclusion regarding Patent Owner’s
evidence of “praise,” introduced by Dr. Berger, because it merely recounts
unsubstantiated and often forward-looking statements from financial
analysts or hopeful statements from the Kassimis article. PO Resp. 83–84
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(citing Ex. 2100 ¶¶ 216–223 (citing Ex. 2131; Ex. 2132; Ex. 2133, Ex. 2135;
Ex. 2139)). We have explained why we consider statements of financial
analysts to be of little probative value and the weight we accord the cited
portion of Kassimis article, which does not reflect the conclusion drawn in
Kassimis above. See Parts II.F.1.f.ii.c) and II.F.1.f.ii.e).
For all these reasons, we ascribe some, but not great, weight to Patent
Owner’s evidence of industry praise.
vi. Commercial Success
Patent Owner contends that its Shockwave IVL devices, Patent
Owner’s only commercial products, are commercially successful because
Patent Owner: (1) “projects revenue for the full year 2019 to range from
$38 million to $40 million, which represents 210% to 226% growth over the
company’s prior year revenue”; (2) realized a 339% increase (of $7.7
million) in revenue for the second quarter of 2019 over the second quarter of
2018; and (3) has a current market capitalization of “about $1 billion.” PO
Resp. 85–86 (citing Ex. 2100 ¶¶ 224–225; Ex. 2175 ¶ 8; Ex. 2164).
Petitioner responds that Patent Owner’s evidence fails to establish
commercial success because it fails to reflect the market share achieved by
Patent Owner’s devices. Reply 44. Patent Owner does not cure this
deficiency in its evidentiary showing despite having an opportunity to do so.
See Sur-reply 38–39 (arguing that it need not provide evidence of market
share).
Petitioner also points out that, based on testimony from Mr. Stephens
and Patent Owner’s 10-Q, Patent Owner increased its spending on its sales
and marketing forces by 59% from 2018 to 2019, which at least partially
accounts for the increase in revenue that Patent Owner alleges. Reply 45
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(citing Ex. 1216, 30:20–37:7; Ex. 2141, 4, 20–23). Patent Owner does not
contest that the increase of 59% in sales and marketing expenses did not
occur, but rather argues that its expenditures were “relatively low” and not a
“primary driver of the device’s success.” Sur-reply 40 (citing Ex. 2252,
256:11–259:3). We are persuaded that Patent Owner’s increased spending
on sales and marketing at least partially explains the increase in its revenues.
More importantly, however, “the more probative evidence of
commercial success relates to whether the sales represent a substantial
quantity in the market.” In re Applied Materials, Inc., 692 F.3d 1289, 1300
(Fed. Cir. 2012) (internal quotations omitted) (quoting In re Huang, 100
F.3d 135 140 (Fed. Cir. 1996)). Patent Owner’s evidence of revenue
increases wholly fails to establish the amount of market share attained by
Patent Owner’s devices. Just as important, however, is that Patent Owner’s
“evidence” of revenue increases does not pass muster. Patent Owner relies
upon testimony from Dr. Berger and Mr. Stephens. PO Resp. 85–86 (citing
Ex. 2100 ¶ 225; Ex. 2175 ¶ 8). The cited testimony from both witnesses
relies upon the same document, a press release by Patent Owner reporting
financial results and projected revenue increases for 2019 over 2018.
Ex. 2100 ¶ 225 (citing Ex. 2176); Ex. 2175 ¶ 8 (citing Ex. 2176). The press
release rightly points out that “forward looking statements” such as revenue
projections “are uncertain” and thus “actual results may differ materially
from those projected.” Ex. 2176, 1. The press release also reports a net loss
of $10.6 million for Q2, 2019, which was $0.5 million higher than the loss
reported for Q2, 2018. Id. Patent Owner’s evidence of its market
capitalization is an undated printout of Yahoo’s stock quote page. Ex. 2164.
Patent Owner fails to explain how its market capitalization meaningfully
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reflects commercial success, and we discern no reason to find it probative of
commercial success.
Patent Owner also contends, based on testimony of Drs. Berger and
Armstrong, that its success is more noteworthy because doctors have “a
strong financial disincentive” to use Shockwave IVL devices. PO Resp. 86
(citing Ex. 2100 ¶ 227; Ex. 2173 ¶ 29). First, Dr. Berger’s testimony simply
quotes and relies upon the cited testimony of Dr. Armstrong; so, ultimately,
Dr. Armstrong’s testimony is the only evidence that might be probative.
Ex. 2100 ¶ 227 (citing Ex. 2173 ¶¶ 28–29). Dr. Armstrong cites no evidence
underlying his testimony, which limits its probative value. Second, even if
we were to accept Dr. Armstrong’s testimony as true, his cited testimony
provides no evidence of market share or the quantitative effect of the
“disincentive” that he describes. Ex. 2173 ¶¶ 28–29. However, he does
testify that he has performed over 2,000 vascular interventions and about
300 such procedures per year with 200 being atherectomy procedures, but he
has only performed “over 100” IVL procedures. Id. ¶ 5. This testimony
implies that he uses directly competing atherectomy devices far more often
than Shockwave IVL devices. Id. In any event, this testimony does not
establish that doctors perform IVL procedures at an abnormally high rate
despite financial disincentives.
Even if we were to conclude that Patent Owner’s increases in revenue
are tied to the claimed features, we find Patent Owner’s showing of
commercial success to be weak.
g. Weighing of Evidence of Obviousness and Conclusion
We conclude that Petitioner has proven that Guy Levy, a dentist,
described a laser-based shockwave generator in an angioplasty balloon to
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treat atheromas in blood vessels before Patent Owner conceived its claimed
invention. We also conclude that Petitioner has persuasively proven that an
ordinarily skilled artisan would have been motivated to modifying Levy’s
device by substituting a known EHL shockwave generator for the laser and
adapting Levy’s balloon and carrier to use a well-known configuration of a
guidewire to place the balloon. We consider Petitioner’s showing of
obviousness to be rather straightforward and well supported.
Patent Owner’s objective evidence of non-obviousness is voluminous,
but largely weak for all the reasons that we express above even crediting
Patent Owner for having established some nexus. Ultimately, we find that
excitement about the potential efficacy of the Shockwave IVL or its
potential commercial success simply does not warrant a conclusion that
claim 1 remains patentable. When we consider all the evidence and
arguments adduced by the parties, we conclude that Petitioner has proven by
a preponderance of evidence that the combined teachings of Levy, AAPA,
and any one of Mantell, Uchiyama, or Willneff render claim 1 unpatentable
as obvious.
2. Dependent Claims 2–14
Petitioner contends that the limitations introduced in each of
dependent claims 2–6, 11, and 14, all of which ultimately depend from
claim 1, are described by one or more of Mantell, Uchiyama, or Willneff or
are simply well known by an ordinarily skilled artisan. Pet. 31–39. Except
for dependent claim 5, Patent Owner does not distinguish the limitations
introduced in these dependent claims from the teachings of the prior art or
knowledge of an ordinarily skilled artisan that Petitioner identifies. See PO
Resp. 18–65 (presenting arguments only for claims 1, 5, and 15). For the
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reasons expressed below, we conclude that Petitioner has proven by a
preponderance of evidence that dependent claims 2–4 and 6–14 are
unpatentable as obvious, but has failed to do so for claim 5.
a. Claim 2
Claim 2 depends from claim 1 and further recites: “wherein the pair
of electrodes includes a pair of metallic electrodes.” Ex. 1001, 6:40–41.
Petitioner argues that Mantell describes that the electrodes of its probe may
be metallic. Pet. 31 (citing Ex. 1004 ¶ 23). Petitioner also contends, based
on testimony by Dr. Jensen, that an ordinarily skilled artisan would have
considered electrodes made of metallic material to have been an obvious
design choice because electrodes must be conductive. Id. (citing Ex. 1002
¶ 126). Patent Owner does not respond to Petitioner’s showing. See PO
Resp. 18–65 (presenting arguments only for claims 1, 5, and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
Mantell or the background knowledge of an ordinarily skilled artisan render
claim 2 unpatentable as obvious.
b. Claim 3
Claim 3 depends from claim 2 and further recites: “wherein the
electrodes are radially displaced from each other.” Ex. 1001, 6:42–43.
Petitioner argues that Mantell describes electrodes that are radially displaced
from each other. Pet. 31–32 (citing Ex. 1004, Figs. 2, 7; Ex. 1002 ¶ 128).
Patent Owner does not respond to Petitioner’s showing. See PO
Resp. 18–65 (presenting arguments only for claims 1, 5, and 15).
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Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
Mantell render claim 3 unpatentable as obvious.
c. Claim 4
Claim 4 depends from claim 2 and further recites: “wherein the
electrodes are longitudinally displaced from each other.” Ex. 1001, 6:44–45.
Petitioner argues that Willneff describes electrodes that are longitudinally
displaced from each other. Pet. 31–32 (citing Ex. 1006, Fig. 1 (spark gap 16
between two longitudinally displaced electrodes); Ex. 1002 ¶ 130). Patent
Owner does not respond to Petitioner’s showing. See PO Resp. 18–65
(presenting arguments only for claims 1, 5, and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA,
Mantell or the background knowledge of an ordinarily skilled artisan, and
Willneff render claim 4 unpatentable as obvious.
d. Claim 5
Claim 5 depends from claim 2 and further recites: “wherein the pair
of electrodes is disposed adjacent to and outside of the guide wire lumen.”
Ex. 1001, 6:46–47. Petitioner argues that Uchiyama describes “a shockwave
generator including a pair of electrodes (3) that are disposed radially spaced
away from the lumen of tube (8).” Pet. 32 (citing Ex. 1005, Figs. 1, 3, 4, 6,
7; Ex. 1002 ¶ 132). Petitioner also contends, based on testimony by Dr.
Jensen, that an ordinarily skilled artisan would have found it obvious to
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implement the routine design choice of configuring electrodes as described
by Uchiyama. Id. at 33 (citing Ex. 1002 ¶ 133).
Patent Owner argues, based upon testimony by Dr. Berger, that an
ordinarily skilled artisan would not have radially spaced electrodes from the
longitudinal center of an EHL probe because doing so would unacceptably
increase the risk of damaging healthy tissue by placing the electrodes too
close to such tissue. PO Resp. 65 (citing Ex. 2100 ¶¶ 33–60, 169, 170, 178).
Petitioner responds that Uchiyama expressly describes that electrodes
need not be radially centered within its balloon but could be spaced from the
longitudinal center of the balloon. Reply 35 (citing Ex. 1200 ¶ 144).
Petitioner also contends that an ordinarily skilled artisan would have
understood from Uchiyama that placing the electrodes radially off-center
would permit shockwaves to attain greater lateral coverage to reach
calcifications that are not uniformly distributed around the circumference of
a vessel. Id. (citing Ex. 1200 ¶ 144 (cross-referencing id. ¶¶ 32–34);
Ex. 1204, 175:19–177:3). Petitioner also argues that an ordinarily skilled
artisan would not have been dissuaded from placing the electrodes off center
as shown in Uchiyama because Uchiyama teaches that placing the electrodes
within a balloon would avoid undesirable tissue damage. Id. (citing
Ex. 1200 ¶ 144 (cross-referencing id. ¶¶ 32–34)).
In its Sur-reply, Patent Owner argues that Dr. Jensen testifies that
Uchiyama’s electrodes are not disposed radially away from the lumen of
tube 8. Sur-reply 36 (citing Ex. 2249, 38:4–40:15). Patent Owner also
points out that Uchiyama’s tube 8 is not a guidewire lumen as recited in the
claim.
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Based on our review of Uchiyama, we agree with Patent Owner that
Uchiyama fails to describe “the pair of electrodes is disposed adjacent to and
outside of the guide wire lumen” as recited in claim 5. The position of
Uchiyama’s pair of electrodes 3 is illustrated in the version of Figure 1 about
which Dr. Jensen testified, which we reproduce below. Ex. 2240.

Uchiyama’s Figure 1 is a cross-sectional view of Uchiyama’s
lithotripter with the balloon 7 inflated. Ex. 1005, 299.
Electrodes 3 (blue) are shown offset downward from the longitudinal
center of the device as it is shown in the figure. Ex. 2240. Uchiyama states:
“The electrodes3 are electrically connected with a pair of electric cables4
inserted into the tube1 above.” Ex. 1005, 298. Uchiyama also describes
fluid channel 6 through which fluid is injected to inflate balloon 7 or
removed to deflate balloon 7. Id. Regarding “tube (8),” which Petitioner
identifies as corresponding to the claimed lumen through the carrier,
Uchiyama states: “The duct end of the balloon7 is air-tightly fixed by a
removable stopper ring8 attached on the putter [sic, outer] circumference of
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the tip part of the tube1.” Id. Thus, “tube (8)” is not a lumen for a
guidewire or even a lumen in a “carrier.” Rather, stopper ring 8 is the device
for holding balloon 7 to tube 1. Id. In addition, Petitioner has not
established that electrodes 3 are disposed both adjacent to and radially
“outside” stopper ring 8, as Uchiyama describes them as connected to
electric cables 4 radially inside both tube 1 and stopper ring 8. Id.; Pet. 32
(arguing that electrodes 3 are radially spaced away from stopper ring 8).
Based on our review of Uchiyama, we find that Petitioner has failed to
prove that Uchiyama describes a pair of electrodes that are both “adjacent to
and outside of the guidewire lumen” as required in claim 5. Petitioner
identifies no other prior art that meets these limitations. Accordingly, we
conclude that Petitioner has failed to demonstrate by a preponderance of
evidence that claim 5 is unpatentable as obvious in view of the combined
teachings of Levy, AAPA, Mantell, and Uchiyama or the combined
teachings of Levy, AAPA, Uchiyama, and the background knowledge of an
ordinarily skilled artisan.
e. Claim 6
Claim 6 depends from claim 2 and further recites: “wherein the
catheter has a distal end and wherein the pair of electrodes is disposed
proximal to the distal end of the catheter.” Ex. 1001, 6:48–50. Petitioner
argues that Willneff describes electrodes that are disposed proximal to the
distal end of the catheter. Pet. 33 (citing Ex. 1006,23 Fig. 1 (spark gap 16
formed between two electrodes disposed proximal to distal end of

23 Petitioner mistakenly cites Ex. 1005 as is made clear by the context (spark
gap 16) and as is consistent with the cited testimony from Dr. Jensen. See
Ex. 1002 ¶ 135 (correctly citing Ex. 1006, Fig. 1).
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catheter 22); Ex. 1002 ¶ 135). Patent Owner does not respond to Petitioner’s
showing. See PO Resp. 18–65 (presenting arguments only for claims 1, 5,
and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA,
Mantell or the background knowledge of an ordinarily skilled artisan, and in
further view of Willneff render claim 6 unpatentable as obvious.
f. Claim 7
Claim 7 depends from claim 1 and further recites: “wherein the
balloon is formed of non-compliant material.” Ex. 1001, 6:51–52.
Petitioner correctly notes that the ’371 patent acknowledges that prior art
angioplasty balloons are typically made of non-compliant material to fix the
maximum dimension of the balloon. Pet. 34 (citing Ex. 1001, 3:65–4:2).
Petitioner argues that Hayes describes non-compliant angioplasty balloons.
Id. (citing Ex. 1007, 1:5–10). Based on Dr. Jensen’s testimony, Petitioner
argues that an ordinarily skilled artisan would readily recognize that Levy as
modified by AAPA includes a non-compliant balloon and that using a non-
compliant balloon would have been easily implemented. Id. (citing
Ex. 1002 ¶ 137). Patent Owner does not respond to Petitioner’s showing.
See PO Resp. 18–65 (presenting arguments only for claims 1, 5, and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
one of Mantell, Uchiyama, or Willneff and in further view of Hayes, render
claim 7 unpatentable as obvious.
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g. Claim 8
Claim 8 depends from claim 1 and further recites: “wherein the
balloon is formed of compliant material.” Ex. 1001, 6:53–54. Petitioner
argues that compliant angioplasty balloons were well known as evidenced
by Duchamp. Pet. 34–35 (citing Ex. 1008 ¶ 40; Ex. 1002 ¶ 138). Based on
Dr. Jensen’s testimony, Petitioner argues that an ordinarily skilled artisan
would readily recognize that a compliant balloon could be readily and
successfully substituted for the angioplasty balloon of Levy as modified by
AAPA. Id. at 35 (citing Ex. 1008 ¶ 40). Patent Owner does not respond to
Petitioner’s showing. See PO Resp. 18–65 (presenting arguments only for
claims 1, 5, and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
one of Mantell, Uchiyama, or Willneff and in further view of Duchamp,
render claim 8 unpatentable as obvious.
h. Claim 9
Claim 9 depends from claim 1 and further recites: “wherein the
balloon has a surface, and wherein the catheter further comprises at least one
stress riser carried on the surface of the balloon.” Ex. 1001, 6:55–57.
Petitioner argues that angioplasty balloons with stress risers were well
known as evidenced by Naimark in the form of micro-needles 21, 31 on the
surface of its balloon. Pet. 35–36 (citing Ex. 1009,24 Abstract, Figs. 2, 3
(illustrating micro-needles 21, 31); Ex. 1002 ¶ 140). Based on Dr. Jensen’s

24 Petitioner mistakenly cites Ex. 1008 as is made clear by the context
(microneedles 21, 31). Ex. 1009, Abstract, 4:21–31, 5:18–20, Figs. 2, 3.
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testimony, Petitioner argues that an ordinarily skilled artisan would readily
recognize that a balloon with stress risers could be readily and successfully
substituted for the angioplasty balloon of Levy as modified by AAPA. Id.
at 35 (citing Ex. 1008 ¶ 40). Patent Owner does not respond to Petitioner’s
showing. See PO Resp. 18–65 (presenting arguments only for claims 1, 5,
and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
one of Mantell, Uchiyama, or Willneff and in further view of Naimark,
render claim 9 unpatentable as obvious.
i. Claim 10
Claim 10 depends from claim 1 and further recites: “further
comprising a sensor that senses reflected energy.” Ex. 1001, 6:58–59.
Petitioner argues that sensors used with shockwaves created within a fluid-
filled balloon were well known as evidenced by Beyar. Pet. 36 (citing
Ex. 1010, ¶¶ 192, 243; Ex. 1002 ¶ 142). Patent Owner does not respond to
Petitioner’s showing. See PO Resp. 18–65 (presenting arguments only for
claims 1, 5, and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
one of Mantell, Uchiyama, or Willneff and in further view of Beyar, render
claim 10 unpatentable as obvious.
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j. Claim 11
Claim 11 depends from claim 1 and further recites: “further
comprising a reflector within the balloon that focuses the shock waves.”
Ex. 1001, 6:60–61. Petitioner argues that Willneff describes a wall 34 that
reflects and focuses its shockwave. Pet. 37 (citing Ex. 1006, 10, Fig. 2
(pressure waves reflected by wall 34 toward focal point 36); Ex. 1002
¶ 144). Patent Owner does not respond to Petitioner’s showing. See PO
Resp. 18–65 (presenting arguments only for claims 1, 5, and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA,
Mantell, Uchiyama, or Willneff render claim 11 unpatentable as obvious.
k. Claim 12
Claim 12 depends from claim 1 and further recites: “wherein the
balloon electrically insulates the pair of electrodes from tissue external to the
catheter.” Ex. 1001, 6:62–64. Petitioner argues that balloon material was
well known to generally be non-conductive and insulating to the electrodes
within them. Pet. 37 (citing Ex. 1002 ¶ 146). For example, Uchiyama
teaches that its balloon regulates the force emanating from its spark
generator and prevents its spark from directly hitting human tissue. Id.
(citing Ex. 1005, 298). Additionally, Duchamp and Hayes both describe
non-conductive materials used to insulate the pair of electrodes from tissue.
Id. at 38 (citing Exs. 1007, 1008; Ex. 1002 ¶ 146). Patent Owner does not
respond to Petitioner’s showing. See PO Resp. 18–65 (presenting arguments
only for claims 1, 5, and 15).
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Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
one of Mantell, Uchiyama, or Willneff and in further view of Duchamp or
Hayes render claim 12 unpatentable as obvious.
l. Claim 13
Claim 13 depends from claim 1 and further recites:
wherein the pair of electrodes includes a first electrode and a
second electrode, the second electrode being arranged to form an
electrical arc with the first electrode to generate the mechanical
shock wave and to generator including a pair of electrodes being
positioned reflect the mechanical shock wave in a desired
pattern.
Ex. 1001, 6:65–7:2. Petitioner argues that Bhatta describes a shockwave
generator with a pair of electrodes in which one of the electrodes is a
metallic nozzle that also reflects the shockwave in a desired pattern. Pet. 38
(citing Ex. 1012, 3:17–25). Based on Dr. Jensen’s testimony, Petitioner
argues that an ordinarily skilled artisan would have found it obvious to have
modified Levy in view of Mantell to include Bhatta’s nozzle-shaped
electrode to focus the shockwave being generated. Id. at 38–39 (citing
Ex. 1002 ¶ 148). Patent Owner does not respond to Petitioner’s showing.
See PO Resp. 18–65 (presenting arguments only for claims 1, 5, and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
one of Mantell, Uchiyama, or Willneff and in further view of Bhatta render
claim 13 unpatentable as obvious.
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m. Claim 14
Claim 14 depends from claim 1 and further recites: “wherein the
balloon has a center axis and the guidewire lumen has a center axis in
common with the balloon center axis; and wherein at least one electrode of
the electrode pair is disposed in non-intersecting relation with respect to the
balloon center axis.” Ex. 1001, 7:3–8. Petitioner argues that “Uchiyama
discloses a balloon with a center of axis that is collinear with the guidewire
lumen.” Pet. 39 (cross-referencing argument relating to claim 5). Patent
Owner does not respond to Petitioner’s showing. See PO Resp. 18–65
(presenting arguments only for claims 1, 5, and 15).
As explained in Part II.F.2.d above, we find that Uchiyama fails to
describe a pair of electrodes that are outside of a guidewire lumen.
However, Uchiyama does illustrate a pair of electrodes in which one of the
electrodes is located off the center longitudinal axis of its balloon.
Additionally, the AAPA that forms part of Petitioner’s challenge to claim 1
describes a guidewire lumen that shares a common central longitudinal axis
with the balloon. Ex. 1001, 3:65–4:2, Fig. 1.
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
one of Mantell or Willneff along with Uchiyama or the combined teachings
of Levy, AAPA, and Uchiyama render claim 14 unpatentable as obvious.
3. Independent Claim 15
Independent claim 15 is directed to a system comprising an
angioplasty catheter that is materially the same as the catheter of claim 1 and
a “power source configured to provide a high voltage pulse to the arc
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generator” that is not recited in claim 1. Compare Ex. 1001, 7:9–8:9, with
id. at 6:21–39. Petitioner contends, and we agree, that all the arguments
directed to claim 1 apply to claim 15. Pet. 40. With respect to the “power
source,” Petitioner argues that each of Levy, Mantell, Uchiyama, and
Willneff describe a power source that is configured to provide a high voltage
pulse to their respective arc generators. Id. at 40–41 (citing Ex. 1003, 4,
Fig. 1 (laser light source 20); Ex. 1004 ¶ 24 (Autolith EHL generator);
Ex. 1005, 299 (high voltage supplied to electrodes 3); Ex. 1006, 9 (current
feed 6)). Petitioner argues, based in part on testimony by Dr. Jensen, that an
ordinarily skilled artisan would have included a suitable generator to ensure
that the pair of electrodes generates a spark resulting in the formation of
shockwaves. Id. at 41 (citing Ex. 1002 ¶ 164).
Patent Owner argues, based on testimony by Dr. Berger, that the prior
art cautions against deploying EHL electrodes within an angioplasty balloon.
PO Resp. 65–66 (citing Ex. 2100 ¶ 178). We have fully considered and
found unpersuasive Patent Owner’s argument. See Part II.F.1 above. For
the reasons, expressed in connection with our analysis of claim 1 and
Petitioner’s argument and evidence discussed immediately above, we
conclude that Petitioner has proven by a preponderance of evidence that the
combined teachings of Levy, AAPA, and any one of Mantell, Uchiyama, or
Willneff render claim 15 unpatentable as obvious.
4. Dependent Claims 16 and 17
Petitioner contends that the limitations introduced in each of
dependent claims 16 and 17, both of which directly depend from claim 15,
are described by the prior art. Pet. 42–43. For the reasons expressed below,
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we conclude that Petitioner has proven by a preponderance of evidence that
dependent claims 16 and 17 are unpatentable as obvious.
a. Claim 16
Claim 16 depends from claim 15 and further recites: “wherein the
power source is arranged to provide high voltage pulses having at least one
of selectable pulse durations, selectable voltage amplitudes, and selectable
pulse repetition rates.” Ex. 1001, 9:10–13. Petitioner contends that both
Levy and Mantell describe power sources meeting the requirements of claim
16. Pet. 42 (citing Ex. 1003, 3 (incorporating controllable power source
described in Levy ’227); Ex. 1005 ¶¶ 51, 82 (describing power source with
selectable voltage amplitudes (e.g., power level) and pulse repetition rates
(e.g., number of pulses)); Ex. 1002 ¶¶ 168–169). Patent Owner does not
respond to Petitioner’s showing. See PO Resp. 18–65 (presenting arguments
only for claims 1, 5, and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
any one of Mantell, Uchiyama, or Willneff render claim 16 unpatentable as
obvious.
b. Claim 17
Claim 17 depends from claim 15 and recites: “further comprising an
R wave detector that synchronizes the mechanical shock waves with a
cardiac R waves.” Ex. 1001, 9:14–16. Petitioner contends that Schultheiss
describes “a shockwave applicator and an R wave detector that synchronizes
the mechanical shockwaves with cardiac waves.” Pet. 43 (citing Ex. 1011
¶ 72; Ex. 1002 ¶ 171). Petitioner also contends, based on the same evidence,
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that it would have been obvious to use Schultheiss’ detector to avoid a
fibrillation in the patient. Id. Patent Owner does not respond to Petitioner’s
showing. See PO Resp. 18–65 (presenting arguments only for claims 1, 5,
and 15).
Based on our review of Petitioner’s argument and evidence, which we
adopt as our own findings, we conclude that Petitioner has proven by a
preponderance of evidence that the combined teachings of Levy, AAPA, and
any one of Mantell, Uchiyama, or Willneff along with Schultheiss renders
claim 17 unpatentable as obvious.
5. Conclusion
Based on our review of the entire record and the parties’ arguments,
we conclude that Petitioner has demonstrated by a preponderance of
evidence that claims 1–4 and 6–17 are unpatentable as obvious.
G. CLAIMS 1–17: OBVIOUSNESS IN VIEW OF WILLNEFF, AAPA, AND LEVY OR
MANTELL AND IN FURTHER VIEW OF VARIOUS OTHER REFERENCES FOR
CERTAIN CLAIMS
As an alternative, Petitioner argues that the same prior art applied
above, but with Willneff as a primary reference, renders claims 1–17
obvious. Compare Pet. 13–43 (addressing Levy as primary reference), with
id. at 43–60 (addressing Willneff as primary reference). Because we have
found that the challenges based on Levy as the primary reference render
claims 1–4 and 6–17 unpatentable as obvious, we find the challenges to
these claims based upon Willneff as the primary references moot and do not
address them in this Decision. See Boston Sci. Simed, Inc. v. Cook Grp. Inc.,
No. 2019-1594, 2020 WL 2071962, at *4 (Fed. Cir. Apr. 30, 2020) (holding
that “the Board need not address issues that are not necessary to the
resolution of the proceeding”).
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However, because we have found that Petitioner’s challenge to claim
5 based upon Levy as the primary reference fails, we must determine
whether Petitioner’s challenges to claim 5 based upon Willneff, AAPA,
Levy, and Uchiyama or Willneff, AAPA, Mantell, and Uchiyama render
claim 5 obvious. Petitioner’s challenges to claim 5 based upon Willneff as
the primary reference fail for the same reasons explained in Part II.F.2.d
above, because Petitioner relies on Uchiyama in the manner in this challenge
as in the previous challenge, and Petitioner has not proven that Uchiyama
discloses the limitations of claim 5 for the reasons explained above.
III. PETITIONER’S MOTION TO EXCLUDE
Petitioner moves to exclude Exhibits 2002–2004, 2006, 2008, 2016,
2017, 2124, 2125, 2126, 2132, 2133, 2139, 2141, 2149, 2152, 2161, 2162,
2163, 2164, 2170–2176, 2196 and certain paragraphs from Dr. Berger’s
Declaration for various reasons. Paper 67 (“Motion” or “Mot.”). Patent
Owner opposes the Motion. Paper 68 (“Opposition” or “Opp.”). Petitioner
filed a reply brief in support of the Motion. Paper 70 (“Motion Reply” or
“Mot. Reply”). For the reasons explained below, we deny the Motion as
unpersuasive, moot, or both.
A. HEARSAY
Petitioner moves to exclude Exhibits 2002–2004, 2006, 2008, 2016,
2017, 2124, 2125, 2132, 2133, 2139, 2141, and 2164 as containing
inadmissible hearsay under Federal Rules of Evidence 801, 802, and 805.
Mot. 1–4. These Exhibits include news articles (Exs. 2002–2004), materials
from financial analysts or investment bankers (Exs. 2006, 2008, 2016, 2017,
2132, 2133, 2139), materials received from or authored by the FDA
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(Exs. 2124, 2125), Yahoo Finance data (Ex. 2164), and one of Patent
Owner’s 10-Q submissions (Ex. 2141). Id.
Patent Owner argues that “laudatory statements” are not offered for
the truth of the matter but rather to show that the statements were made.
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.
Petitioner fails to persuade us that we should exclude any of these
exhibits. These exhibits are, for the most part, offered in support of Patent
Owner’s argument that objective evidence of nonobviousness exists, i.e.,
long felt need, failure of others, skepticism, industry praise, and commercial
success. See generally PO. Resp. 69–89. 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 a “unique ability” to treat medial
calcium (Ex. 2017 1) 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 that the evidence
may have served a hearsay purpose, we assign it little if any weight.
Further, experts like Dr. Berger are permitted to rely on hearsay if experts in
the same field would reasonably rely on such materials in forming opinions
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and inferences based on the subject. See Fed. R. Evid. 703. To the extent
that Dr. Berger relies upon evidence that is not of a type upon which
“experts in the field would reasonably rely,” we have assigned very little
weight to such evidence. Therefore, we deny Petitioner’s motion to exclude
these Exhibits 2002–2004, 2006, 2008, 2016, 2017, 2124, 2125, 2132, 2133,
2139, 2141, and 2164 as being unpersuasive, moot, or both.
B. UNCITED EXHIBITS
Petitioner moves to exclude exhibits 2126, 2152, 2161, 2162, and
2163 as being irrelevant under Fed. R. Evid. 401 and 402 because Patent
Owner does not cite them in its briefing. Patent Owner responds that Dr.
Berger cites and relies upon Exhibits 2126 and 2161–2163. Opp. 6 (citing
Ex. 2100 ¶¶ 194 (with a typo mistakenly referring to 2126 as 2136), 224
(referring to Ex. 2196, which cites Exs. 2161–2163)). We deny Petitioner’s
Motion because the exhibits are relied upon by Dr. Berger in offering his
testimony.
However, Patent Owner does not identify where it or any of its
declarants cite or rely upon Ex. 2152, and we find no such citations. Id.
at 6–7. Exhibit 2152 is U.S. Patent 5,454,809 to Janssen, entitled
“Electrosurgical Catheter and Method for Resolving Atherosclerotic Plaque
by Radio Frequency Sparking.” Ex. 2152, Title. We have not considered
Ex. 2152 in rendering our Decision and, therefore, deny Petitioner’s Motion
as being moot.
C. PERSONAL KNOWLEDGE
Petitioner moves to exclude Exhibit 2196, which is a claim chart
mapping certain claims to the Shockwave devices, because Mr. Stephens has
no personal knowledge of who prepared the exhibit. Mot. 5. Patent Owner
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argues that Petitioner failed to timely object to Exhibit 2196 and therefore
waived any objection now raised. Opp. 7. Patent Owner further explains
that Dr. Berger relies upon Exhibit 2196, not Mr. Stephens, and argues that
an expert need not have personal knowledge about the facts and data upon
which he relies. Id. Petitioner does not respond to Patent Owner’s
arguments. See generally, Mot. Reply.
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); Combined Trial Practice Guide, November 2019,
78–79 (“Combined TPG”).25 “A motion to exclude evidence must be filed
to preserve any objection.” 37 C.F.R. § 42.64(c). 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.” Id. at 79.
Here, Petitioner does not identify the portion of the record where its
objection to Exhibits 2178–2180 were originally made. See Mot. 5. Our
review of the Petitioner’s Objections (Papers 22, 43), the testimony of
Mr. Stephens (Ex. 1216), and the testimony of Dr. Berger (Exs. 1126, 1204)
show that Petitioner failed to object to Exhibit 2196. Therefore, we deny
Petitioner’s motion to exclude Exhibit 2196.

25 The Combined TPG is available at
https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf).
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D. AUTHENTICATION
Petitioner moves to exclude Exhibit 2149, a Japanese Patent with an
included Abstract in English because Patent Owner failed to provide a
complete certified translation. Mot. 5. Patent Owner served a certified
translation of Exhibit 2149 (Ex. 2222), which it files with its Opposition as
Exhibit 2256. Petitioner does not argue that Patent Owner’s supplemental
evidence failed to cure its objection to Exhibit 2149. See generally, Mot.
Reply. We deny Petitioner’s Motion to exclude Ex. 2149 because the
service of Exhibit 2256 cured Petitioner’s objection.
E. RELEVANCE OR PREJUDICE
Petitioner moves to exclude Exhibits 2003, 2004, 2006, 2125, 2139,
2141, and 2170–2176 as irrelevant or prejudicial under Federal Rules of
Evidence 401, 402, and 403. Mot. 5–9. Petitioner contends the identified
exhibits provide scant, cumulative, and unhelpful information that should be
excluded. See generally id.
Patent Owner argues that instead of excluding evidence deemed to be
irrelevant, little weight should be accorded such evidence. Opp. 8. Patent
Owner explains that each of Petitioner’s arguments go to the weight but not
the admissibility of the evidence. See generally id. at 8–14. Patent Owner
also contends that the declarations of Drs. Lyden, Kereiakes, Hill, Soukas,
and Armstrong (Exs. 2170–2174) 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.
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We are not persuaded by Petitioner’s arguments that Exhibits 2003,
2004, 2006, 2125, 2139, 2141, and 2170–2176 must be excluded from the
record. The evidence Petitioner seeks to exclude support Patent Owner’s
argument that the ’371 patent is nonobviousness; specifically, the exhibits
relate to objective indicia of nonobviousness. Therefore, the objected to
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, unhelpful needlessly cumulative and/or misleading information,”
Mot. 6, will confuse or mislead the panel such that the probative value is
outweighed by the danger of unfair prejudice. Fed. R. Evid. 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.”). As
appropriate, we have explained above the weight that we accord various
aspects of these exhibits. For the reasons above, we are not persuaded that
the testimony or documents at issue should be excluded and, thus, we deny
Patent Owner’s Motion to exclude Exhibits 2003, 2004, 2006, 2125, 2139,
2141, and 2170–2176.
F. PORTIONS OF DR. BERGER’S TESTIMONY
Petitioner moves to exclude portions of the declaration testimony of
Dr. Berger under Federal Rules of Evidence 702 and 703. Mot. 9–10. More
specifically, Petitioner argues:
paragraphs 18, 19, 59, 60, 66, 132 (testimony not based on
sufficient facts or data, patent owner has not shown the ’371
patent is entitled to a June 13, 2008 priority date), 143, 144
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(testimony not based on sufficient facts or data), 165 (testimony
not based on sufficient facts or data), 170 (testimony not based
on sufficient facts or data), 175 (testimony not based on
sufficient facts or data), 199 (not qualified to opine on device
meeting criteria), 201, 205, 205 [sic], 217, 218, 220, 221, 222,
and 229 (testimony not based on sufficient facts or data) are
inadmissible under FRE 702(b) and/or 703.
Id.
Patent Owner argues that Petitioner’s basis for excluding certain
paragraphs of Dr. Berger’s declaration are conclusory and that Petitioner
“does not explain which aspects of the opinions are unsupported or what
facts or data could or should have been considered.” Opp. 14.
Whether Dr. Berger’s opinions are conclusory, mischaracterize
evidence, or are not adequately based on objective evidence goes to the
weight we should accord to his testimony. As appropriate, we have
explained above the weight that we accord the allegedly objectionable
testimony by Dr. Berger. Thus, we deny Petitioner’s motion to exclude the
identified paragraphs of Dr. Berger’s declaration (Ex. 2100).
IV. CONCLUSION26
In summary,
Claim(s)
35
U.S.C.
§ Reference(s)
Claim(s)
Shown
Unpatentable
Claim(s) Not
Shown
Unpatentable
1–3, 15,
16
103 Levy, AAPA,
Mantell
1–3, 15, 16

26 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.
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Claim(s)
35
U.S.C.
§ Reference(s)
Claim(s)
Shown
Unpatentable
Claim(s) Not
Shown
Unpatentable
4, 6, 11 103 Levy, AAPA,
Mantell, Willneff
4, 6, 11
5, 14 103 Levy, AAPA,
Mantell,
Uchiyama
14 5
7, 12 103 Levy, AAPA,
Mantell, Hayes
7, 12
8, 12 103 Levy, AAPA,
Mantell, Duchamp
8, 12
9 103 Levy, AAPA,
Mantell, Naimark
9
10 103 Levy, AAPA,
Mantell, Beyer
10
13 103 Levy, AAPA,
Mantell, Bhatta
13
17 103 Levy, AAPA,
Mantell,
Schultheiss
17
1, 2, 5,
14–16
103 Levy, AAPA,
Uchiyama
1, 2, 14–16 5
4, 6, 11 103 Levy, AAPA,
Uchiyama,
Willneff
4, 6, 11
7, 12 103 Levy, AAPA,
Uchiyama, Hayes
7, 12

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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Claim(s)
35
U.S.C.
§ Reference(s)
Claim(s)
Shown
Unpatentable
Claim(s) Not
Shown
Unpatentable
8, 12 103 Levy, AAPA,
Uchiyama,
Duchamp
8, 12
9 103 Levy, AAPA,
Uchiyama,
Naimark
9
10 103 Levy, AAPA,
Uchiyama, Beyer
10
13 103 Levy, AAPA,
Uchiyama, Bhatta
13
17 103 Levy, AAPA,
Uchiyama,
Schultheiss
17
1, 2, 4, 6,
11, 15, 16
103 Levy, AAPA,
Willneff
1, 2, 4, 6, 11,
15, 16

7, 12 103 Levy, AAPA,
Willneff, Hayes
7, 12
8, 12 103 Levy, AAPA,
Willneff,
Duchamp
8, 12
9 103 Levy, AAPA,
Willneff, Naimark
9
10 103 Levy, AAPA,
Willneff, Beyer
10
13 103 Levy, AAPA,
Willneff, Bhatta
13
17 103 Levy, AAPA,
Willneff,
Schultheiss
17
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Claim(s)
35
U.S.C.
§ Reference(s)
Claim(s)
Shown
Unpatentable
Claim(s) Not
Shown
Unpatentable
1, 2, 4, 6,
11, 15
103 Willneff, AAPA,
Levy27

3, 16 103 Willneff, AAPA,
Levy, Mantell

5, 14 103 Willneff, AAPA,
Levy, Uchiyama
5
7, 12 103 Willneff, AAPA,
Levy, Hayes

8, 12 103 Willneff, AAPA,
Levy, Duchamp

9 103 Willneff, AAPA,
Levy, Naimark

10 103 Willneff, AAPA,
Levy, Beyar

13 103 Willneff, AAPA,
Levy, Bhatta

17 103 Willneff, AAPA,
Levy, Schultheiss

1–3, 15,
16
103 Willneff, AAPA,
Mantell

27 For all challenges to claims 1–4 and 6–17 relying upon Willneff as a
primary prior art reference, we do not reach a decision because those
challenges are moot in view of our ruling on the challenges to these claims
based upon Levy as the primary prior art reference. See Boston Sci. Simed,
Inc. v. Cook Grp. Inc., No. 2019-1594, 2020 WL 2071962, at *4 (Fed. Cir.
Apr. 30, 2020) (holding that “the Board need not address issues that are not
necessary to the resolution of the proceeding”); cf. Ex parte Moncla, Appeal
No. 2009-006448 (PTAB June 22, 2010) (holding that it is premature to
address a provisional rejection) (designated precedential).
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Claim(s)
35
U.S.C.
§ Reference(s)
Claim(s)
Shown
Unpatentable
Claim(s) Not
Shown
Unpatentable
5, 14 103 Willneff, AAPA,
Mantell,
Uchiyama
5
7, 12 103 Willneff, AAPA,
Mantell, Hayes

8, 12 103 Willneff, AAPA,
Mantell, Duchamp

9 103 Willneff, AAPA,
Mantell, Naimark

10 103 Willneff, AAPA,
Mantell, Beyar

13 103 Willneff, AAPA,
Mantell, Bhatta

17 103 Willneff, AAPA,
Levy, Schultheiss

Overall Outcome 1–4, 6–17 5
V. ORDER
For the reasons given, it is:
ORDERED, based on a preponderance of evidence, that claims 1–4
and 6–17 of U.S. Patent 8,956,371 B2 are unpatentable as obvious under
35 U.S.C. § 103;
FURTHER ORDERED that Petitioner has not demonstrated that
claim 5 of U.S. Patent 8,956,371 B2 is unpatentable; and
FURTHER ORDERED that Petitioner’s Motion to Exclude Exhibits
2002–2004, 2006, 2008, 2016, 2017, 2124, 2125, 2126, 2132, 2133, 2139,
2141, 2149, 2152, 2161, 2162, 2163, 2164, 2170–2176, 2196, and 2100
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(¶¶ 18, 19, 59, 60, 66, 132, 143, 144, 165, 170, 175, 199, 201, 205, 217, 218,
220, 221, 222, and 229) is denied;
FURTHER ORDERED because this is a final written decision, the
parties to this proceeding seeking judicial review of our 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
W. Cook Alciati
Natalie J. Grace
Ruth G. Davila
GARDELLA GRACE P.A.
ggardella@gardellagrace.com
calciati@gardellagrace.com
ngrace@gardellagrace.com
rdavila@gardellagrace.com

Michael Stallman
MORRISON & FOERSTER LLP
mstallman@mofo.com