Teleflex Medical Devices S.A.R.L.

Patent Trials and Appeals Board

Jun 17, 2021

IPR2020-00127 (P.T.A.B. Jun. 17, 2021)

PUBLIC VERSION
Trials@uspto.gov
571-272-7822
Paper
Date:
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
MEDTRONIC, INC., and MEDTRONIC VASCULAR, INC.,
Petitioner,
v.
TELEFLEX INNOVATIONS S.À.R.L.,
Patent Owner.
IPR2020-00127
Patent 8,048,032 B2
Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
SNEDDEN, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining Some Challenged Claims Unpatentable
Granting Patent Owner’s Contingent Motion to Amend
35 U.S.C. § 318(a)
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I. INTRODUCTION
Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a
Petition for inter partes review of claims 1–9 and 11–20 of U.S. Patent No.
8,048,032 (“the ’032 patent,” Ex. 1401). Paper 3 (“Pet.”). Teleflex
Innovations S.À.R.L. (“Patent Owner”)1 filed a Preliminary Response.
Paper 10 (“Prelim. Resp.”). Upon review of the parties’ arguments and
supporting evidence, we instituted an inter partes review of all claims and
grounds asserted in the Petition. Paper 20 (“Inst. Dec.”).
Patent Owner subsequently filed a Patent Owner Response (Paper 40,
“PO Resp.”) (redacted version available at Paper 41), Petitioner filed a
Reply (Paper 71, “Pet. Reply”) (redacted version available at Paper 70), and
Patent Owner filed a Sur-Reply (Paper 86, “Sur-Reply”) (redacted version
available at Paper 87).
Patent Owner also filed a Contingent Motion to Amend. Paper 82
(“MTA”). The Motion requests that if claims 1 or 12 of the ’032 patent are
determined to be unpatentable, they should be replaced by proposed
substitute claims 23–25 (“proposed substitute claims” or “proposed claims”).
MTA 1. Petitioner filed an Opposition to the Motion to Amend (Paper 85,
“Pet. MTA Opp.”), to which Patent Owner filed a reply (Paper 89,
“PO MTA Reply”), and Petitioner filed a sur-reply (Paper 95, “Pet. MTA
Sur-reply”).

1 Patent Owner represents that “Teleflex Innovations S.A.R.L. merged into
Teleflex Medical Devices S.A.R.L,” which subsequently “transferred
ownership of [the ’032 patent] to Teleflex Life Sciences Limited.” Paper 7,
2.
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An oral hearing was held on March 8, 2021, and a transcript of the
hearing is included in the record. Paper 104 (“Tr.”) (redacted version
available at Paper 103).
A. Real Parties in Interest
Petitioner identifies its real parties-in-interest as Medtronic, Inc. and
Medtronic Vascular, Inc., and notes that “Medtronic plc is the ultimate
parent of both entities.” Pet. 4.
Patent Owner identifies its real parties-in-interest as Teleflex Medical
Devices S.À.R.L.; Vascular Solutions LLC; Arrow International, Inc.; and
Teleflex LLC. Paper 4, 2. Patent Owner also notes that “Teleflex
Incorporated is the ultimate parent of the entities listed above.”
B. Related Matters
The parties indicate that the ’032 patent is the subject of litigation in
Vascular Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760 (D.
Minn. filed July 2, 2019) (“Medtronic”) and QXMedical, LLC v. Vascular
Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017). Pet. 4–5;
Paper 4, 2.
The ’032 patent was the subject of two previous inter partes reviews:
IPR2014-00760, filed May 16, 2014 and terminated August 11, 2014 by way
of joint motion to terminate, and IPR2014-00761, filed May 16, 2014 and
terminated August 11, 2014 by way of joint motion to terminate. Paper 4,
2–3.
Petitioner has filed a separate Petition for inter partes review of
claims 1–20 and 22 of the ’032 patent as IPR2020-00126.
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C. The ’032 Patent
1. Specification
The ’032 patent, entitled “Coaxial Guide Catheter for Interventional
Cardiology Procedures,” issued on November 1, 2011, from a non-
provisional application filed May 3, 2006. Ex. 1401, codes (45), (54), (22).
The ’032 patent relates generally to a coaxial guide catheter for use
with interventional cardiology devices that are insertable into a branch artery
that branches off from a main artery. Ex. 1401, Abstract. According to the
’032 patent, interventional cardiology procedures often include inserting
guidewires or other instruments through catheters into coronary arteries that
branch off from the aorta. Id. at 1:15–17. In coronary artery disease, the
coronary arteries may be narrowed or occluded by atherosclerotic plaques or
other lesions in a phenomenon known as stenosis. Id. at 1:20–26. In
treating the stenosis, a guide catheter is inserted through the aorta and into
the ostium of the coronary artery, sometimes with the aid of a guidewire, and
is passed beyond the occlusion or stenosis. Id. at 1:30–36. However,
crossing tough lesions can create enough backward force to dislodge the
guide catheter from the ostium of the artery being treated, which can make it
difficult or impossible for the interventional cardiologist to treat certain
forms of coronary artery disease. Id. at 1:36–40.
To solve this problem, the ’032 patent describes a coaxial guide
catheter that is deliverable through standard guidewires by utilizing a
guidewire rail segment to permit delivery without blocking use of the guide
catheter. Id. at 2:53–56. The ’032 patent teaches that the coaxial guide
catheter preferably includes a tapered inner catheter that runs over a standard
0.014 inch coronary guidewire to allow atraumatic placement within the
coronary artery, and this feature allows removal of the tapered inner catheter
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after the coaxial guide catheter is in place. Id. at 2:57–61. Figures 1 and 2,
reproduced below, show a coaxial guide catheter and a tapered inner catheter
in accordance with the invention described in the ’032 patent:

Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
inner catheter separately, and Figure 2 depicts those two elements assembled
together. Id. at 5:15–21; Figs. 1 and 2. As shown above, coaxial guide
catheter assembly 10 includes coaxial guide catheter 12 and tapered inner
catheter 14. Id. at 6:6–8. Coaxial guide catheter 12 includes tip portion 16,
reinforced portion 18, and rigid portion 20. Id. at 6:9–10. Tip portion 16
generally includes bump tip 22 and marker band 24. Id. at 6:13–14. Bump
tip 22 includes taper 26 and is relatively flexible. Id. at 6:14–15. Marker
band 24 is formed of a radiopaque material such as platinum/iridium alloy.
Id. at 6:19–20. Tapered inner catheter tip 42 includes tapered portion 46 at a
distal end thereof, and straight portion 48. Id. at 6:59–60. Both tapered
portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
figures above). Id. at 6:60–61. Tapered inner catheter 14 may also include
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clip 54 at a proximal end thereof to releasably join tapered inner catheter 14
to coaxial guide catheter 12. Id. at 6:64–67.
In operation, the tapered inner catheter is inserted inside and through
the coaxial guide catheter. Id. at 4:12–13. The coaxial guide catheter/
tapered inner catheter combination may then be inserted into a blood vessel
that communicates with the aorta, and advanced until the tapered inner
catheter is passed into the ostium of a coronary artery over the guidewire.
Id. at 4:15–23. The tapered inner catheter may be removed once the coaxial
guide catheter tapered inner catheter combination has been inserted
sufficiently into the ostium of the coronary artery to achieve deep seating.
Id. at 4:23–26. Once the tapered inner catheter is removed, a cardiac
treatment device, such as a guidewire, balloon, or stent, may be passed
through the coaxial guide catheter within the guide catheter and into the
coronary artery. Id. at 4:30–33. The presence of the coaxial guide catheter
provides additional backup support to make it less likely that the coaxial
guide catheter/guide catheter combination will be dislodged from the ostium
of the coronary artery while directing the coronary therapeutic device past a
tough lesion. Id. at 4:33–39.
2. Illustrative Claims
Independent claims 1 and 11, reproduced below, are illustrative of the
challenged claims.
1. A device for use with a standard guide catheter, the standard
guide catheter having a continuous lumen extending for a
predefined length from a proximal end at a hemostatic valve to a
distal end adapted to be placed in a branch artery, the continuous
lumen of the guide catheter having a circular cross-sectional
inner diameter sized such that interventional cardiology devices
are insertable into and through the lumen to the branch artery, the
device comprising:
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a flexible tip portion defining a tubular structure having a
circular cross-section and a length that is shorter than the
predefined length of the continuous lumen of the guide catheter,
the tubular structure having a cross-sectional outer diameter
sized to be insertable through the cross-sectional inner diameter
of the continuous lumen of the guide catheter and defining a
coaxial lumen having a cross-sectional inner diameter through
which interventional cardiology devices are insertable; and
a substantially rigid portion proximal of and operably
connected to, and more rigid along a longitudinal axis than, the
flexible tip portion and defining a rail structure without a lumen
and having a maximal cross-sectional dimension at a proximal
portion that is smaller than the cross-sectional outer diameter of
the flexible tip portion and having a length that, when combined
with the length of the flexible distal tip portion, defines a total
length of the device along the longitudinal axis that is longer than
the length of the continuous lumen of the guide catheter,
such that when at least a distal portion of the flexible tip
portion is extended distally of the distal end of the guide catheter,
at least a portion of the proximal portion of the substantially rigid
portion extends proximally through the hemostatic valve in
common with interventional cardiology devices that are
insertable into the guide catheter.
11. A device for use with a standard guide catheter, the standard
guide catheter having a continuous lumen extending for a
predefined length from a proximal end at a hemostatic valve to a
distal end adapted to be placed in a branch artery, the continuous
lumen of the guide catheter having a circular cross-section and a
cross-sectional inner diameter sized such that interventional
cardiology devices are insertable into and through the lumen to
the branch artery, the device comprising:
an elongate structure having an overall length that is
longer than the predefined length of the continuous lumen of the
guide catheter, the elongate structure including:
a flexible tip portion defining a tubular structure having a
circular cross-section that is smaller than the circular cross-
section of the continuous lumen of the guide catheter and a length
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that is shorter than the predefined length of the continuous lumen
of the guide catheter, the flexible tip portion being sized having
a cross-sectional outer diameter sized to be insertable through the
cross-sectional inner diameter of the continuous lumen of the
guide catheter and defining a coaxial lumen having a cross-
sectional inner diameter through which interventional cardiology
devices are insertable;
a reinforced portion proximal to the flexible tip portion;
and
a substantially rigid portion proximal of and connected to,
and more rigid along a longitudinal axis than, the flexible tip
portion and defining a rail structure without a lumen and having
a maximal cross-sectional dimension at a proximal portion that
is smaller than the cross-sectional outer diameter of the flexible
tip portion,
such that when at least a distal portion of the flexible tip
portion is extended distally of the distal end of the guide catheter
with at least proximal portion of the reinforced portion remaining
within the continuous lumen of the guide catheter, at least a
portion of the proximal portion of the substantially rigid portion
extends proximally through the hemostatic valve in common
with interventional cardiology devices that are insertable into the
guide catheter.
Ex. 1401, 10:21–54, 11:28–12:4.
D. Evidence
Petitioner relies upon the following prior art references.
Ex. 1409, S. B. Kontos, U.S. Patent No. 5,439,445 (issued Aug. 8,
1995) (“Kontos”).
Ex. 1410, New Method to Increase a Backup Support of a 6 French Guiding
Coronary Catheter, Catheterization and Cardiovascular Interventions 63:
452-456 (2004) (“Takahashi”).
Ex. 1435, D. O. Adams et al., U.S. Patent Application Publication No.
2004/0010280 A1 (published Jan. 15, 2004) (“Adams”).
Ex. 1451, T. A. Berg et al., U.S. Patent No. 5,911,715 (issued Jun. 15,
1999) (“Berg”).
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In support of its arguments, Petitioner relies on the expert declarations
of Dr. Stephen Jon David Brecker (Exs. 1405, 1806, 1902), Dr. Richard A.
Hillstead (Exs. 1442, 1905, 1907), Mr. Michael Jones (Ex. 1807), and Dr.
Paul Zalesky (Exs. 1755, 1830, 1919). Patent Owner relies on the
declarations of Ms. Amy Welch (Ex. 2044) (redacted), Ms. Deborah
Schmalz (Ex. 2039), Mr. Howard Root (Ex. 2118), Mr. Gregg Sutton (Ex.
2119), Mr. Mark Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr.
Steve Erb (Ex. 2122), Mr. Peter T. Keith (Ex. 2123, 2124, 2138, 2243), Dr.
John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Mr. Steve
Jagodzinkski (Ex. 2152 (redacted), 2153 (confidential)), Ms. Heather S.
Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
E. Asserted Grounds of Unpatentability
Petitioner asserts that claims 1–9 and 11–20 would have been
unpatentable on the following grounds.
Ground Claim(s) 35 U.S.C. §2 References/Basis
1 1–7, 9, 11–16, 18, 19 103(a) Kontos, Adams
2 8, 17 103(a) Kontos, Adams
3 20 103(a) Kontos, Adams, Berg

2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the
challenged claims of the ’032 patent have an effective filing date before the
effective date of the applicable AIA amendments, we refer to the pre-AIA
versions of 35 U.S.C. § 103 throughout this Decision.

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II. ANALYSIS
A. Priority Date of the ’032 Patent
Petitioner argues that “[t]he ’032 patent is subject to the AIA’s first-
to-file provisions because it contains at least one claim that lacks a written
description, and therefore, pre-AIA priority.” Pet. 14. Petitioner advances
this argument to preclude Patent Owner from swearing behind the Itou
reference based on a showing of prior invention, which could otherwise be
done for a pre-AIA “first-to-invent” application. Id. We are not persuaded
by Petitioner’s argument.
The AIA’s first-to-file provisions apply to patent applications “that
contain[] or contained at any time a claim to a claimed invention that has an
effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
effective filing date is “the actual filing date of the patent or the application
for the patent containing a claim to the invention; or the filing date of the
earliest application for which the patent or application is entitled.” 35
U.S.C. § 100(i)(1). In the present case, the ’032 patent issued from an
application filed May 3, 2006, and does not claim the benefit of any other
filing date. Ex. 1001, code (22). Thus, the only possible effective filing date
of the ’032 patent is May 3, 2006, which thus qualifies it as a pre-AIA
patent.3
B. Level of Ordinary Skill in the Art
We consider the asserted grounds of unpatentability in view of the
understanding of a person of ordinary skill in the art (“POSITA”). Petitioner

3 Petitioner’s priority date argument appear to be a back door attempt to have
us address whether the ’032 patent satisfies the written description
requirement of 35 U.S.C. § 112. But this is a question we may not address
in an IPR. See 35 U.S.C. § 311(b).
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provides two alternatives for a person having ordinary skill in the art. First,
Petitioner asserts that “[i]f a person of ordinary skill in the art (‘POSITA’)
was a medical doctor, s/he would have had (a) a medical degree; (b)
completed a coronary intervention training program, and (c) experience
working as an interventional cardiologist.” Pet. 14. Alternatively, Petitioner
asserts that “if a POSITA was an engineer s/he would have had (a) an
undergraduate degree in engineering, such as mechanical or biomedical
engineering; and (b) at least three years of experience designing medical
devices, including catheters or catheter-deployable devices.” Id. at 14–15.
Additionally, Petitioner contends that “[e]xtensive experience and technical
training might substitute for education, and advanced degrees might
substitute for experience.” Id. at 15.
Patent Owner “does not dispute Petitioner’s proposed definition of a
POSITA.” PO Resp. 8.
On this record, in determining whether the evidence of record
supports institution, we apply both of Petitioner’s definitions for a POSITA,
as they are undisputed at this time and consistent with the level of skill
reflected in the prior art and the Specification of the ’032 patent. See
Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art
itself can reflect the appropriate level of ordinary skill in the art).
C. Claim Construction
We interpret a claim “using the same claim construction standard that
would be used to construe the claim in a civil action under 35 U.S.C.
282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe
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.” Id. Furthermore, at this stage in the
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proceeding, we need only construe the claims to the extent necessary to
determine whether to institute inter partes review. See Nidec Motor Corp. v.
Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
(“[W]e need only construe terms ‘that are in controversy, and only to the
extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v.
Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
Petitioner proposes construction for several claimed terms, including
“standard guide catheter,” “placed in a branch artery,” “flexural modulus,”
“interventional cardiology devices.” Pet. 13–19. For the purpose of this
Decision, we find it helpful to address the term “interventional cardiology
devices.”
1. “interventional cardiology devices”
Independent claims 1 and 11 of the ’032 patent recite a standard guide
catheter having a continuous lumen sized “such that interventional
cardiology devices are insertable into and through the lumen.” Ex. 1401,
10:26–27, 11:34–35. To that point, the Specification expressly defines the
claim term “interventional cardiology devices” as follows:
For the purposes of this application, the term “interventional
cardiology devices” is to be understood to include but not be
limited to guidewires, balloon catheters, stents and stent
catheters.
Id. at 1:17–21.
In view of the express definition provided in the ’032 patent, in the
Institution Decision we construed claims 1 and 11 to require that the coaxial
lumen have a cross-sectional inner diameter through which at least two types
of interventional cardiology devices (including, but not limited to
guidewires, balloon catheters, stents, and stent catheters) are insertable. Inst.
Dec. 19.
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Petitioner contends that claims 1 and 11 require that only one
interventional cardiology device be insertable through the cross-sectional
inner diameter of the coaxial lumen. Pet. 30, 57–58. Patent Owner contends
claims 1 and 11 require that all four of the enumerated classes of devices
identified in the definition of “interventional cardiology devices,” i.e.,
“guidewires, balloon catheters, stents, and stent catheters,” are insertable
through the cross-sectional inner diameter of the coaxial lumen. PO Resp.
9–10. Patent Owner reasons that the use of the conjunctive “and,” rather
than the disjunctive “or,” in the definition indicates that all of the identified
“interventional cardiology devices” must be insertable through the coaxial
lumen of the flexible tip portion. Id. According to Patent Owner, this
conclusion is consistent with the written description of the ’032 patent
because the “Summary of the Invention” section notes that the “invention
has an inner diameter acceptable for delivering standard coronary devices
after it is placed in the blood vessel,” and guidewires, balloon catheters,
stents, and stent catheters are four of the most common coronary devices.
Id. at 11 (citing Ex. 1401, 3:1–4, 5:9–12; Ex. 2145 ¶ 85; Ex. 2138 ¶ 104).
In its Reply, Petitioner reiterates its position that only one
interventional cardiology device need be insertable through the coaxial
lumen of the tip portion, but because resolution of the question of whether
one or two devices must be insertable into the lumen does not impact the
outcome in this case, Petitioner asserts that “the Board can adopt its
preliminary construction of ‘interventional cardiology devices’” in this
proceeding. Pet. Reply 1–2. Responding to Patent Owner’s arguments,
Petitioner contends that because the term “standard coronary devices” is
broader than the specific set of “interventional cardiology devices” identified
in the written description, the intrinsic record does not support limiting the
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scope of claims 1 and 12 to require that the coaxial lumen of the tip portion
have a cross-sectional inner diameter through which all four of the
“interventional cardiology devices” expressly identified in the ’032 patent
are insertable. Id. at 2 (citing Ex 1800, 63:20–64:1).
As both parties agree, the ’032 patent expressly defines the term
“interventional cardiology devices” to include, but not be limited to,
“guidewires, balloon catheters, stents and stent catheters.” We understand
this definition to mean that “guidewires,” “balloon catheters,” “stents,” and
“stent catheters,” are each “interventional cardiology devices.” See Ex.
1401, 4:46–49 (“This discussion will refer to a guide wire but it is to be
understood that similar principles apply to other interventional cardiology
devices including balloon catheters and stent catheters.”). The use of the
conjunctive “and” in the definition is consistent with this understanding, as
all the listed devices are “interventional cardiology devices.” See id.
We further understand that an individual guidewire or stent represents
an “interventional cardiology device.” Pet. 27 (identifying Kontos’s PTCA
catheter as an “interventional cardiology device”); PO Resp. 21 (“Thus, the
PTCA catheter taught by Kontos is one ‘interventional cardiology device,’
not two.”); Ex. 1401, 4:43–46 (describing the forces in play “when a
physician attempts to direct a guidewire or other interventional cardiology
device past an occlusive or stenotic lesion in the branch artery”). And
because a “guidewire” and “balloon catheter” are each an interventional
cardiology device, as a matter of logic and grammar, to the extent both a
“guidewire” and a “balloon catheter” are insertable through the cross-
sectional inner diameter of the coaxial lumen, the lumen is sized to accept
“interventional cardiology devices.”
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As noted by Patent Owner, the ’032 patent indicates in the
“Summary of the Invention” section that the “invention has an inner
diameter that is appropriate for delivering standard coronary treatment
devices after it is placed in the blood vessel.” Ex. 1401, 5:9–12; PO Resp.
11. The same section clarifies, however, that this is only a preference, not a
requirement. Ex. 1401, 3:1–4 (“In addition, the coaxial guide catheter
preferably has an inner diameter that is appropriate for delivering standard
coronary treatment devices after it is placed in the coronary artery.”)
(emphasis added). In addition, Petitioner persuasively explains why the
terms “standard coronary treatment devices” and “interventional cardiology
devices” are not co-extensive in scope. Pet. Reply 2.
In view of the foregoing, we determine that use of the term
“interventional cardiology devices” in claims 1 and 11 requires that the
coaxial lumen of a device has a cross-sectional inner diameter through which
at least two types of the devices selected from the group that includes, but is
not limited to, guidewires, balloon catheters, stents and stent catheters, are
insertable. For example, the cross-sectional diameter of the lumen may be
sized to receive a guidewire and a stent or a balloon. Ex. 1401, 7:36–40
(“Once the guidewire 64 is pushed past stenotic lesion 66 or occlusive lesion
(not shown), a treating catheter including a stent or balloon can be passed
along the guidewire to stenotic lesion 66 or occlusive lesion (not shown).”).4

4 Although we construe claims 1 and 11 to require that the coaxial lumen of
the tip portion is sized such that two different types of “interventional
cardiology devices” are insertable, Petitioner’s construction requiring that
only one type of device (e.g., “stents”) be insertable through the coaxial
lumen is not without support. Ex. 1401, 4:46–49 (“This discussion will refer
to a guide wire but it is to be understood that similar principles apply to
other interventional cardiology devices including balloon catheters and stent
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2. Other Recited Claim Terms/Phrases
We determine that no express construction of any other claim term is
necessary to determine whether to institute inter partes review.
D. Petitioner’s Patentability Challenges
1. Ground 1: Obviousness of claims 1–7, 9, 11–16, 18, and 19 in
view of Kontos and Adams
Petitioner asserts that claims 1–7, 9, 11–16, 18, and 19 are
unpatentable under 35 U.S.C. § 103(a) as obvious over the combination of
Kontos and Adams. Pet. 17–69. For the reasons set forth below, we
determine that Petitioner has not demonstrated by a preponderance of the
evidence that claims 1–7, 9, 11–16, 18, and 19 would have been obvious
over Kontos and Adams.
a) Summary of the References Relied Upon
(1) Kontos (Ex. 1409)
Kontos is directed to a support catheter assembly for facilitating
medical procedures and, in particular, to a catheter assembly that has
“particular utility in facilitating insertion of a PTCA5 balloon into a lesion.”
Ex. 1409, 1:9–13.

catheters.”); Pet. 13, 27–29; Pet. Reply 1. We need not resolve this issue,
however, because we find that at least two different types of interventional
cardiology devices are insertable through the lumen of Kontos’s stent 10,
and therefore Kontos teaches this limitation under Petitioner’s construction
as well.
5 PTCA stands for “percutaneous transluminal coronary angioplasty.”
Ex. 1405 ¶ 37.
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Figure 1 of Kontos is reproduced below:

Figure 1 is a side plan view of a support catheter, “cut-away in part to show
in logitudinal cross-section a tubular body having a soft tip and radiopaque
marker, and a manipulating wire.” Ex. 1409, 2:51–54. As shown in
Figure 1, support catheter assembly 10 is composed of two major elements,
body 12 and insertion/manipulation wire 14. Id. at 3:45–46. Body 12,
“which may be viewed as a mini guide catheter, includes tube 16 having a
base portion 18 at its proximal end 20.” Id. at 3:47–49. “Tube 16 has a
continuous lumen 22 therethrough from proximal end 20 to distal end 24.”
Id. at 3:49–50. Body 12 also include a soft tip 28 disposed at distal end 24
and funnel portion 26 disposed at proximal end 20. Id. at 3:50–52. Wire 14
is attached to body 12 at base portion 18. Id. at 3:52–53. Support assembly
10 may also include distal marker band 30 and proximal marker band 32.
Id. at 3:53–55.
Kontos explains that the size and shape of the various elements of
support assembly 10 “may vary depending on the desired application,” but
in the applications depicted in Figure 1, tube 16 has a 0.055 inch outer
diameter and lumen 22 has a 0.045 inch diameter. Id. at 4:46–50.
According to Kontos, the sizes used in these embodiments “are generally
suitable for existing PTCA catheters.” Id. at 4:61–64.
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Figure 5 of Kontos is reproduced below:

Figure 5 is a side schematic view of a support catheter having a PTCA
catheter disposed therein. Id. at 2:64–66. In this figure, PTCA catheter 40
and its deflated balloon 48 reside in lumen 22 of support assembly 10. Id. at
5:2–5.
Figures 6A–6C of Kontos are reproduced below:

Figures 6A–6C are cross-sectional views showing three stages in a process
for guiding a PTCA catheter to a coronary artery lesion. Id. at 2:67–3:2. In
Figure 6A, the PTCA catheter/support catheter assembly is fed into guide
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catheter 38 and advanced to the distal end of this catheter by simultaneously
exerting axial force on wire 14 and catheter tube 50. Id. at 5:25–30.
In Figure 6B, when the PTCA catheter/support catheter assembly
reaches the distal end of guide catheter 38, “it may be advanced as a unit out
of the distal end of guide catheter 38 and into coronary ostia 39.” Id. at
5:31–35. When extending beyond the distal end of guide catheter 38, body
12 functions as a guide catheter extension protecting fragile balloon 48 and
lessening “considerably the tendency of the PTCA catheter 40 to bend,
buckle or kink.” Id. at 5:49–56.
In Figure 6C, after body 12 has been positioned adjacent the restricted
area, PTCA catheter 40 is advanced so that balloon 48 exits body 12 and is
advanced into the restricted area, e.g., stenosis B. Id. at 6:9–13. Balloon 48
is then inflated, as represented by dotted lines 48, “to effect a well-known
angioplasty procedure.” Id. at 6:13–15. Balloon 48 is then deflated and
PTCA catheter 40, support catheter assembly 10, and guiding catheter 38
may be withdrawn. Id. at 6:15–18.
(2) Adams (Ex. 1435)
Adams discloses a device and method for treating vascular disease.
Ex. 1435 ¶ 1. In particular, Adams discloses “a distal protection device
which is deployed to filter or remove embolic debris” and “creates a seal to
prevent the flow of blood during the treatment of vascular disease.” Id. ¶ 11.
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Figure 1A of Adams is reproduced below:

Figure 1A is a side view in partial cross-section of the device of Adams. Id.
¶ 28. In this figure, Y connector 7 is attached to the proximal end of guide
catheter 10 and control wire 5 passes through Y connector 7. Id. ¶¶ 59–60.
To reduce blood loss, Y connector 7 has hemostasis valve 9 at its proximal
end. Id. ¶ 60. As shown in Figure 1A, distal end 12 of guide catheter 10
may be inserted into the ostium “O” of coronary vessel “V,” which has a
lesion “L.” Id. ¶ 59. Guide seal 20a is then deployed beyond the distal end
of guide catheter 10. Id.
Adams explains that in practice, a physician advances a guidewire
through the femoral artery into the aorta. Id. ¶ 61. “The guide catheter is
then advanced over the guidewire until the distal tip of the guide catheter is
in the ostium of the vessel.” Id. The guide seal is then advanced beyond the
distal tip of the guide catheter and, after some additional steps, an embolic
protection device of choice may be advanced through the lumen of the guide
seal and across the lesion to a point distal to the treatment site. Id.
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b) Discussion
(1) Independent claims 1 and 11
(a) The Parties’ Arguments
Petitioner contends that the combination of Kontos and Adams
teaches each of the limitations of independent claims 1 and 11. Pet. 21–38
(citing Ex. 1405 ¶¶ 167–187). With regard to the “coaxial lumen having a
cross-sectional inner diameter through which interventional cardiology
devices are insertable” limitation of claims 1 and 11, the Petition cites the
balloon catheter 40 of the Kontos device:
Moreover, an interventional cardiological device, such as a
PTCA catheter 40 with balloon 48 is insertable through lumen
22 of tube 16, i.e., through the “cross-sectional inner diameter”
of tube 16 and body 12. Ex. 1405, ¶ 171; Ex. 1409, 4:66–5:2,
Figs. 6A-C.
Pet. 31; see also id. at 55–57; Ex. 1405 ¶ 227–228.
To the extent that Kontos does not expressly teach or suggest both a
support catheter that has a total length (flexible tip and substantially rigid
portion) that is longer than the length of the continuous lumen of the guide
catheter, or a proximal end that extends through a hemostatic valve in
common with interventional cardiology devices, Petitioner asserts that one
of ordinary skill in the art would have found both limitations obvious.
Pet. 31. Petitioner reasons that in order for the physician to treat a stenosis
using the device of Kontos the combined length of the support catheter must
be longer than the length of the guide catheter and the proximal end must
extend through a hemostatic valve. Id. at 34–35, 62 (citing Ex. 1409, 9:62–
10:15, 11:15–43. Specifically, Petitioner contends,
Kontos does not disclose the length of the guide catheter, but a
POSITA would appreciate that the combined length of the
flexible tip portion in combination with the substantially rigid
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portion is longer than the length of the guide catheter. Ex. 1405,
¶ 172 (explaining that the typical guide catheter is 100 cm14 in
length, which is shorter than the combined length of the flexible
tip portion and substantially rigid portion—approximately 62
inches or 157 cm—as taught by Kontos).
Id. at 34.
To the extent these structural limitations would not have been obvious
over Kontos individually, Petitioner contends they would have been obvious
in view of the additional disclosures of Adams, which discloses a device
having a flexible tip portion and substantially rigid portion with a combined
length that is “greater than that of the guide catheter” and that “extend
proximal to the hemostatic valve 9 when the guide seal extends beyond the
distal end of guide catheter 10.” Pet. 36–37, 62–63 (citing Ex. 1435 ¶ 60,
Figs. A–B). Petitioner contends one of ordinary skill in the art would have
sought to use the well-known aspects of interventional cardiology devices
disclosed in Adams, such as relative sizes and designs, because Kontos
teaches that its catheter applies “known medical procedures.” Id. at 37
(citing Ex. 1405 ¶ 175; Ex. 1409, 5:11–15).
Patent Owner does not contest that one of ordinary skill in the art
would have combined the identified disclosures of Kontos and Adams, but
contends that Petitioner’s arguments with respect to claims 1 and 11 still fail
because Petitioner has not demonstrated that at least two devices (or all four
under Patent Owner’s construction of “interventional cardiology devices”)
from the group that includes guidewires, balloon catheters, stents, and stent
catheters are insertable into the lumen of Kontos’s support catheter.
PO Resp. 20–21. Patent Owner reasons that the PTCA catheter is a single
device having an integrated balloon, and not a balloon catheter and a
separable balloon. Id. at 20–21 (Ex. 1409, 5:16–24 (“the relatively fragile
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PTCA catheter balloon 48”), Figs. 8A–B; Ex. 2138 ¶¶ 140–141 (Mr. Keith
testifying, “A balloon catheter cannot be used once the balloon becomes
detached.”).
Patent Owner contends also,
The Petitioner has not even attempted to show that stents or stent
catheters are insertable into the support catheter of Kontos—nor
could it. Indeed, the only times the word “stent” appears in the
Kontos reference is in describing how the support catheter of
Kontos itself can function as a stent. Ex. 1409, 1:13-16, 2:13-14,
6:59-7:5; Ex. 2138, ¶ 142. Moreover, Kontos discloses that its
lumen preferably has an inner diameter of 0.045 inches, while
the evidence submitted by Petitioner shows that even smaller
stents required a minimum guide catheter inner diameter
significantly larger than 0.045 inches. Ex. 1409, 4:48-50; Ex.
1422, 3 (Cypher stent required a guiding catheter minimum inner
diameter of 0.056 inches); Ex. 1423, 11; Ex. 1424, 2 (Taxus stent
required a guide catheter minimum inner diameter of 0.058
inches); Ex. 2145, ¶ 150.
PO Resp. 19.
Petitioner argues in reply that the 0.045 inch inner diameter of support
catheter 10 of Kontos is in fact sized to allow a PTCA catheter, a guidewire,
a stent, and a stent catheter to travel through Kontos’s body 12. Pet. Reply
4–5 (citing Ex. 1409, 5:2–5; Ex. 1806 ¶¶ 153–154; Ex. 2138 ¶ 48; Ex. 1415,
85; Ex. 1802, 6–7, 15, 21, 25; Ex. 2116, 335:18–336:1).
Patent Owner contends Petitioner’s reply arguments regarding
guidewires, stents, and stent catheters are untimely, improper, and prejudice
Patent Owner’s due process rights to fairly respond. Sur-Reply 7–8. Patent
Owner further contends that, in the 2005–2006 timeframe, the stents
identified by Petitioner still required a minimum guiding catheter diameter
of 5 French, which is far larger than the 0.045 inch inner diameter of support
assembly 10. Id. at 8.
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(b) Discussion
Kontos discloses a PTCA catheter that is insertable into the lumen of
tube 16, and the evidence presented by both Petitioner and Patent Owner
persuasively demonstrates that a guidewire will necessarily pass through the
0.045 inch lumen of Kontos’s tube 16. Pet. 31; Pet. Reply 4 (citing Ex. 2138
¶ 48 (Dr. Keith explaining that guidewires are typically 0.014 inches in
diameter); Ex. 1806 ¶¶ 153–155). Thus, Petitioner persuasively
demonstrates that “interventional cardiology devices” are insertable through
the cross-sectional inner diameter of Kontos’s tube 16.
We find that Petitioner’s reply arguments regarding guidewires are
permissible for at least two reasons. First, Petitioner continues to rely on the
same structure of Kontos as meeting the disputed claim limitation, and
simply points to evidence and information that was in the record prior to the
filing of its Reply to show that this structure satisfies the identified claim
language even under the Board’s more restrictive construction of
“interventional cardiology devices.” See Pet. 31; Pet. Reply 4; PO Resp. 13
(Patent Owner explaining that the inner diameter of Kontos’s tube 16 is
0.045 inches), 28 (asserting that the balloon catheter of Kontos has a
“guidewire-like tip”); Ex. 2138 ¶ 48 (Dr. Keith explaining that the diameter
of a typical guidewire used in coronary applications is 0.014 inches); see
also Ex. 1409, 9:47–50 (Kontos explaining that, “[o]f course, the device of
the present invention may be used with almost any type of catheter,
including over-the-wire catheters as well as catheters with captive guide
wires.”). Second, although Patent Owner was given an opportunity in the
Sur-Reply to generally counter Petitioner’s argument that a guidewire is
insertable through the inner diameter of Kontos’s lumen, Patent Owner did
not take advantage of that opportunity. See Genzyme Therapeutic Prods.
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Ltd. P’ship v. Biomarin Pharm. Inc., 825 F.3d 1360, 1367–69 (Fed. Cir.
2016) (explaining that it is sufficient that a Patent Owner is given notice of
reply arguments and an opportunity to respond to them).
(c) Conclusion with Respect to Claims 1 and 11
Petitioner persuasively identifies where every limitation of claims 1
and 11 is disclosed in Kontos and Adams. Petitioner also persuasively
explains why one of ordinary skill in the art would have combined Kontos
and Adams to arrive at the subject matter of claims 1 and 12 with a
reasonable expectation of success. Accordingly, Petitioner demonstrates by
a preponderance of the evidence that claims 1 and 11 would have been
obvious over Kontos and Adams.
(2) Dependent Claims 2 and 12
(a) The Parties’ Arguments
Claims 2 and 12 require that the device include a tubular structure that
will, when its distal portion is extended beyond the distal end of the guide
catheter, “assists in resisting axial and shear forces exerted by the
interventional cardiology device passed through and beyond the coaxial
lumen that would otherwise tend to dislodge the guide catheter from the
branch artery.” Ex. 1401, 10:59–62, 12:8–11.
Petitioner contends that claims 2 and 13 recite an intended use that
should be afforded no patentable weight. Pet. 39 n.15. 64 n.26 (citing In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)). To the extent that the
relevant claim language is limiting, however, Petitioner contends the
extension catheter within the guide catheter provides “stiffer back up
support” than a guide catheter alone, and when both the guide catheter and
the extension catheter are inserted into a coronary ostium this will improve
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distal anchoring of the system. Id. at 39–40, 64 (citing Ex. 1401, 8:18–32;
Ex. 1405 ¶¶ 179, 186–187).
Patent Owner argues that the functional limitations of claims 2 and 13
may not be ignored and that Petitioner fails to demonstrate that Kontos’s
protective extension catheter would necessarily provide the resistance to
axial and shear forces recited in claims 2 and 12. PO Resp. 24–26.
According to Patent Owner, the length and type of materials used in Kontos
make body 12 “more akin to a ‘wet noodle’” that one of ordinary skill in the
art would not expect to provide any reinforcement in the central, narrow
portion of tube 16. Id. at 24–25. Given these characteristics, Patent Owner
posits that if Kontos’s extension catheter were subject to backout force it
may “rotate, bend, or ‘crunch up,’ risking damage to the PTCA balloon
catheter and injury to the patient.” Id. at 25 (citing Ex. 2138 ¶¶ 147–149;
Ex. 2145 ¶ 147).
(b) Discussion
We agree with Patent Owner that the disputed claim language is a
limitation and that this functional language requires a structure that “assists
in resisting axial and shear forces exerted by the interventional cardiology
device passed through and beyond the coaxial lumen that would otherwise
tend to dislodge the guide catheter from the branch artery.” See K-2 Corp. v.
Salomon S.A., 191 F.3d 1356, 1363–64 (Fed. Cir. 1999) (noting that all
limitations of a claim must be given weight and that functional language
may inform as to structural requirements of the claim). Petitioner and
Drs. Jones and Brecker present persuasive evidence, however, that the
device of Kontos will resist axial and shear forces, at least to some extent,
when extended into the ostium of a blood vessel. Pet. 45 (citing Ex. 1405
¶¶ 179, 186–187); Pet. Reply 6–10; Ex. 1806 ¶¶ 159–167; Ex. 1807 ¶¶ 14–
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27, 152–158 (Dr. Jones testifying the structure and method of use of
Kontos’s device would necessarily provide some level of backup support).
As such, Petitioner demonstrates that the subject matter of claim 2 is
disclosed in Kontos.
We have considered Patent Owner’s argument, “[i]f Kontos was
subjected to backout force, it may rotate, bend, or ‘crunch up,’ risking
damage to the PTCA balloon catheter and injury to the patient.” PO Resp.
25 (citing Ex-2138 ¶¶ 147-149; Ex-2145 ¶ 147). Here, we note that claims
do not require a particular amount of “assist[ance],”6 nor do the claims
require the prevention of axial and shear forces from exerting backward
force. Pet. Reply 10; Ex. 1806 ¶ 167. Thus, that Kontos may perform the
“assist” function poorly as compared to the claimed device is not pertinent to
our analysis as to whether Kontos discloses that feature of the claims.
(c) Conclusion with Respect to Claims 2 and 12
In view of the foregoing, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claims 2 and 12
would have been obvious over the combined disclosures of Kontos and
Adams.

6 Claims 2 and 12 state that the device assists in resisting axial and shear
forces that “would otherwise tend to dislodge the guide catheter from the
branch artery.” Patent Owner does not assert in its Response or Sur-Reply
that this portion of the claim requires a particular quantum of assistance in
resisting axial or shear forces. PO Resp. 26; Sur-Reply 11.
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(3) Dependent Claim 6
(a) The Parties’ Arguments
Claim 6 depends from claim 1 and further requires, “the tubular
structure includes a flexible cylindrical distal tip portion and a flexible
cylindrical reinforced portion proximal to the flexible distal tip portion.”
Ex. 1401, 11:10–13.
Figure 1 of Kontos, reproduced below (annotations added by
Petitioner), “is a side plan view of a support catheter of the present
invention, cut-away in part to show in longitudinal cross-section a tubular
body having a soft tip and radiopaque marker, and a manipulating wire.”
Ex. 1409, 2:51–54.

Petitioner contends that body 12 of Kontos constitutes a “flexible tip portion
defining a tubular structure” and, as shown in the figure above, is composed
of a “flexible cylindrical distal tip portion” and a “flexible cylindrical
reinforced portion.” Pet. 49–52. According to Petitioner, the annotated
figure above shows the portions of Kontos that the Petition identifies as the
claimed “flexible cylindrical distal tip portion” and the claimed “flexible
cylindrical reinforced portion.” Id. at 49–50.
With reference to another annotated version of Figure 1, reproduced
below, Petitioner contends also that one of ordinary skill in the art would
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have found it obvious to reinforce tube 16 with metallic braiding/coiling, as
disclosed in Adams, resulting in the following “flexible cylindrical
reinforced portion” (Id. at 50–52).

According to Petitioner, the figure above identifies flexible tip portion 28 as
the “flexible cylindrical distal tip portion” and the remaining portion of stent
10 (body 12) as the “flexible reinforced portion.” Id. at 52.
Patent Owner argues that the plain meaning of “cylindrical” is
“shaped like a cylinder,” and what the Petition points to in Kontos “is not a
‘cylindrical’ shape.” PO Resp. 42 (citing Ex. 2138 ¶ 194). Instead,
according to Patent Owner, body 12 of Kontos is irregularly shaped, with
protruding funnel portion 26 and base portion 18 that tapers inward where
the reinforcing pushwire ends. Id.
Petitioner argues in response that nothing in the patent requires perfect
cyclindricality and, as shown in a further annotated version of Figure 1
reproduced below, under either parties’ understanding of this claim term
Kontos teaches two different flexible cylindrical reinforced portions.
Pet. Reply 19–20.
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According to Petitioner, the annotated Figure above shows the identified
“flexible reinforced portions” set forth in the Petition and the Reply. Id. at
20.
Patent Owner argues in its Sur-Reply that although cylindricality need
not be absolute, it does not include a structure with “distinctly asymmetric
and outwardly protruding structures.” Sur-Reply 9. Patent Owner further
argues that Petitioner’s new mapping of the identified claim language to
cover only portions of body 12 of Kontos “is improper and the Board should
disregard it.” Id. at 22–23.
(b) Discussion
Petitioner demonstrates, and Patent Owner does not dispute, that the
portions of Kontos’s body 12 identified in Petitioner’s Reply are proximal to
the flexible cylindrical distal tip portion and represent “cylindrical reinforced
portions” even under Patent Owner’s understanding of claim 1. Sur-Reply
22–23. Accordingly, we determine that Petitioner persuasively demonstrates
that Kontos discloses this claim limitation.
Petitioner’s reply arguments are permissible because they merely note
that under either parties’ understanding of the scope of claim 1, Kontos’s
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body 12—the structure identified in the Petition—meets the claim limitation
in question. See Apple Inc. v. Andrea Elects. Corp., 949 F.3d 697, 706–07
(Fed. Cir. 2020) (rejecting an argument that reply evidence was improper
when the “reply does not cite any new evidence or ‘unidentified portions’ of
the [prior art] reference”).
(c) Conclusion with Respect to Claim 6
In view of the foregoing, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claim 6would have
been obvious over the combined disclosures of Kontos and Adams.
(4) Dependent Claims 3, 4, 9, 13, and 18
(a) The Parties’ Arguments
Claim 3 depends from claim 2 and requires that “the proximal portion
of the tubular structure further comprises structure defining a proximal side
opening extending for a distance along the longitudinal axis, and accessible
from a longitudinal side defined transverse to the longitudinal axis, to
receive the interventional cardiology devices into the coaxial lumen while
the proximal portion remains within the lumen of the guide catheter.”
Ex. 1401, 11:33–40. Claims 4, 9, 13, and 18, likewise require a side opening
(or otherwise recite elements defining a side opening). Id. at 11:4–6, 11:21–
24, 12:12–20, 12:39–42.
Petitioner concedes that Kontos does not teach or suggest a side
opening extending for a distance along the longitudinal axis, but contends
such structures were well known in the art and are disclosed in Adams.
Pet. 42 (citing Ex. 1405 ¶¶ 95–108, 190; Ex. 1442 ¶ 100; Ex 1407, 4:15; Ex
1408, 12:9–13:60, Fig. 6A–6E; Ex 1418, Fig. 7; Ex 1432, 119, Fig. 1; Ex
1433 ¶¶ 35, 49, Fig. 2; Ex 1435 ¶ 66; Ex 1450, Fig.7; Ex 1461, 6:9–11, Fig.
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1B). Petitioner asserts that one of ordinary skill in the art would have sought
to modify Kontos to add a side opening at the proximal end of tube 16, as
taught by Adams, for multiple reasons. First, Petitioner contends use of a
proximal opening would allow for reduction of the outer diameter of the
catheter assembly without a commensurate reduction in the area for the point
of entry of the extension catheter. Pet. 43 (citing Ex. 1405 ¶ 193; Ex. 1442
¶ 100). Second, Petitioner contends a proximal side opening would facilitate
a “smoother” reception of the interventional cardiology device as it enters
the lumen of the child catheter. Id. at 44 (citing Ex. 1408, 6:52–57;
Ex. 1405 ¶¶ 196–198; Ex. 1442 ¶¶ 101–102; Ex. 1426, 3:6–9). Third,
Petitioner contends a person of ordinary skill in the art would understand
that a side opening would reduce the force a physician would need to exert
to advance the catheter through tortuous vasculature. Id. at 45 (citing
Ex. 1408, 6:52–57; Ex. 1405 ¶ 197–199; Ex. 1442 ¶ 103; Ex. 1425, Abstr.,
¶ 34). Fourth, Petitioner contends a person of ordinary skill in the art would
understand that a proximal side opening would permit smooth re-entry if the
proximal end of the extension catheter was extended beyond the distal end
of the guide catheter. Id. at 45–46 (citing Ex. 1405 ¶¶ 200–202; Ex. 1442
¶¶ 97–99).
Patent Owner contends one of ordinary skill in the art would not have
made the proposed modifications to Kontos’s device for multiple reasons.
First, Patent Owner argues that protruding base portion 18 and larger
diameter tip portion 28 create a substantial gap between the device and the
inner wall of the guide catheter, which Kontos addresses by using funnel
portion 26. PO Resp. 26. According to Patent Owner, removing funnel
portion 26 would make the device “worse” by exposing the gap and greatly
increasing the likelihood of catching or hang-up when a device is inserted
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through the catheter. Id. at 27–30 (citing Ex. 2138 ¶¶ 156–162; Ex. 2145 ¶¶
214–217; Ex. 2137, 345:19–346:6).
Second, Patent Owner argues that side openings to receive an
interventional cardiology device when a device is positioned within a guide
catheter were “very rare” in the art and the proximal end of Adams is only
used to facilitate the collapse of the mesh when it is back-loaded into the
distal end of the guide catheter, not to facilitate entry of a device at the
proximal opening. Id. at 32–36 (citing Ex. 1435 ¶61; Ex. 2138 ¶¶ 165–175;
Ex. 2145 ¶¶ 107–109) (asserting that only Ressemann discloses a side
opening to receive an interventional cardiology device). Indeed, Patent
Owner contends Adams teaches removing mesh guide seal 20 prior to
advancing a treatment device to the treatment site. Id. at 32 (citing Ex. 1435
¶ 64).
Third, with respect to the purported benefit of reduced size when the
funnel portion of Kontos is removed, Patent Owner argues that no size
benefit would be obtained from this modification because the distal tip
marker band and protruding base portion 18 would still set the outer
diameter of the device, thereby preventing any decrease in size. PO Resp.
37–38. In addition, Patent Owner notes that Kontos is already sized
consistent with usage in a 6 French guide catheter and, in the relevant time
frame, smaller catheters were not routinely used in the art and offered no
major advantage. Id. at 35–36 (citing Ex. 2167, 33; Ex. 2145 ¶ 220).
Fourth, Patent Owner contends that Petitioner’s argument that a side
opening would allow for smoother passage of the catheter assembly through
tortuous vasculature is simply unsupported by the evidence of record, as it is
the distal end of the catheter that drives the ease of advancement. Id. at 37
(citing Ex. 2138 ¶¶ 185–186; Ex. 2145 ¶ 223).
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Finally, Patent Owner argues that the fourth proposed motivation of
permitting “smooth reentry” if the catheter were pushed entirely out of the
end of the guide catheter is based on hindsight and generally contrary to
what Kontos teaches. Id. at 37–38. According to Patent Owner, Kontos
instructs that it is generally not desirable to extend the proximal end of
body 12 beyond the distal end of the guide catheter, and all experts agree
that a person of ordinary skill in the art would “never” have actually done
this. Id. (citing Ex. 1409, 5:67–6:2, 6:23–28, Fig. 6B; Ex. 2116, 365:14–25,
366:22–367:5; Ex. 2137, 329:4–9; Ex. 2138 ¶¶ 109, 124, 187; Ex. 2145 ¶¶
149, 224).
Petitioner argues in reply that removing the funnel of Kontos and
increasing the diameter of the catheter would maximize real estate within the
catheter, which was universally understood to be advantageous.
Pet. Reply 11–14. Petitioner further argues that raised marker band 30 could
be recessed or embedded in the catheter, obviating the need for a raised
profile. Id. at 14 (citing Ex. 1807 ¶¶ 168–182). With respect to the
argument that removal of the funnel would lead to devices catching during
entry into the catheter, Petitioner argues that the dimensions of Kontos
demonstrate that this concern is incorrect. Id. at 16–18. According to
Petitioner, the gap between the outer diameter of tube 16 and the inner
diameter of the guide catheter would be 0.005 inches, whereas a guidewire,
or “the distal-most wire of a fixed-wire balloon,” is typically 0.014 inches in
diameter. Id. Petitioner contends these size differences demonstrate that a
PTCA catheter would not catch in the gap between tube 16 and the inner
wall of the guide catheter. Id. at 17–18.
Finally, Petitioner argues that Ressemann expressly states that side
openings facilitate smoother passage of interventional cardiology devices
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and that Mr. Keith argued in a prior litigation that the funnel of Kontos
contributes to a “pushability problem.” Id. at 15–16 (citing Ex. 1819 ¶ 112).
In its Sur-Reply, Patent Owner argues that it is now undisputed that
even with its funnel removed, Kontos’s device is still too large to fit in a
5 French guide catheter, a primary reason set forth in the Petition for making
the proposed modification. Sur-Reply 12 (citing Ex. 2241, 107:8–15).
Patent Owner further argues that Petitioner’s argument that removal of
Kontos’s funnel and implementing a side opening would maximize the
usable real estate within the guide catheter is a new argument that should not
be permitted for the first time in reply. Id. at 14.
To the extent Petitioner’s new arguments are considered, Patent
Owner contends they are nonetheless unpersuasive. Patent Owner reasons
that Petitioner provides no explanation as to how the marker bands of
Kontos could be recessed and still allow for attachment of soft tip portion
28, a step which in 2005 there was no obvious way to accomplish. Id. at 14
(citing Ex. 1807 ¶¶ 168–182; Ex. 1800, 194:19–197:24). Petitioner further
reasons that redesigning Kontos’s device to maximize its interior diameter is
contrary to the purpose of the support catheter, which is to protect delicate
fixed-wire balloon catheters and still have a small enough profile to fit inside
a lesion and act as a temporary stent. Id.
(b) Patent Owner’s Evidence of Objective Indicia of
Non-Obviousness
Objective indicia of non-obviousness, or “secondary considerations,”
guard against hindsight reasoning in an obviousness analysis, and are often
“the most probative and cogent evidence in the record.” WBIP, LLC v.
Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir. 2016) (citations omitted). As
such, objective indicia of non-obviousness must be considered in every case
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in which they are presented. Id. (citing Transocean Offshore Deepwater
Drilling Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir.
2012)).
Objective indicia of non-obviousness include: (1) commercial
success; (2) long-felt but unsolved needs; (3) failure of others; (4) copying;
(5) praise in the art; (6) unexpected results; and (7) industry acceptance.
Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120,
1129 (Fed. Cir. 2000) (citing Graham, 383 U.S. at 17; Allen Archery, Inc. v.
Browning Mfg. Co., 819 F.2d 1087, 1092 (Fed. Cir. 1987)).
As objective indicia relevant to the challenged claims, Patent Owner
presents evidence that its GuideLiner products, i.e., GuideLiner V1,
GuideLiner V2, and GuideLiner V3, as a whole, solved a long-felt but
unresolved need in the art, are commercially successful, were repeatedly
copied by competitors, and received industry praise. PO Resp. 49–69.
Patent Owner also presents evidence that the ’032 patent was licensed by a
competitor. Id. at 62. Patent Owner contends this objective evidence of
non-obviousness outweighs any prima facie evidence of obviousness set
forth in the Petition with respect to claims 3, 9, 13, and 18. Id. at 50.
(i) Commercial Success
“Commercial success is relevant because the law presumes an idea
would successfully have been brought to market sooner, in response to
market forces, had the idea been obvious to persons skilled in the art.”
Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1376 (Fed. Cir.
2005). Petitioner’s own internal documents
and Patent Owner presents uncontroverted
evidence that through 2019 it and its licensee (Boston Scientific) “had
essentially 100% of the U.S. guide extension catheter market,” achieving
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nearly in annual revenue. PO Resp. 56–58 (citing Ex. 2153
¶¶ 2–8; Ex. 2154); Ex. 2198, 3.
Petitioner does not generally dispute that Patent Owner’s GuideLiner
products are commercially successful. See generally Pet. Reply 22–29.
Upon review of the arguments and the evidence of record, we find
that the GuideLiner products achieved a high level of commercial success.
(ii) Industry Praise
Evidence that the industry praised a claimed invention weighs against
an assertion that the same claim would have been obvious because industry
participants, especially competitors, are not likely to praise an obvious
advance over the known art. WBIP, 829 F.3d at 1334.
Published scientific journals and text books praise the properties of
the GuideLiner products. For example, a review article in the International
Journal of Cardiology states that the GuideLiner product “provides an
elegant method to overcome” the problem of “severe vessel angulation and
tortuosity” and has “significantly improved procedural outcomes in complex
lesion anatomy and broadened the subset of lesions where PCI can be
successfully performed.” Ex. 2194, 142, 147; PO Resp. 60. A technical
report in EuroIntervention reports that GuideLiner allowed a stent to be
“easily and successfully” deployed in a case where stent delivery was
otherwise “impossible despite the use of a highly supporting guiding
catheter.” Ex. 2180, 279; PO Resp. 60. In addition, a text book on
catheterization procedures notes that “[l]ack of backup support can be easily
overcome by using a guide catheter extension such as a Guideliner,” which
“does not add complexity to the intervention and provides extraordinary
backup support for complex interventions.” Ex. 2167, 182; PO Resp. 60.
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Petitioner does not generally dispute that Patent Owner’s GuideLiner
product was praised in the industry. See generally Pet. Reply 22–29.
Upon review of the parties’ arguments and the evidence of record, we
find that the GuideLiner product received significant praise in the industry.
(iii) Licensing
Evidence that competitors or customers have licensed a patent may
provide probative and cogent evidence of non-obviousness of the claims at
issue. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738
F.3d 1337, 1347 (Fed. Cir. 2013). Patent Owner presents evidence that its
competitor, Boston Scientific, licensed the GuideLiner patents
PO Resp. 62 (citing Ex. 2044 ¶ 34; Ex.
2153 ¶ 8). Patent Owner also asserts that Petitioner sought a license to the
GuideLiner patent portfolio. Id. (citing Ex. 2044 ¶ 21; Ex. 2068 ¶ 26).
Petitioner asserts that Patent Owner’s licensing evidence is not
persuasive because it has not submitted the Boston Scientific license in this
case or provided any context surrounding the license, which was entered into
as part of a settlement agreement. Pet. Reply 27 n.7.
The mere existence of a license, without evidence that the license was
entered into because of the merits of the claimed invention, is of limited
probative value because it is often “cheaper to take a license than to defend
infringement suits.” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d
1317, 1324 (Fed. Cir. 2004); In re Antor Media Corp., 689 F.3d 1282, 1293–
94 (Fed. Cir. 2012) (determining that the existence of licenses was
insufficient because the licenses may have been entered into “as a business
decision to avoid litigation, because of prior business relationships, or for
other economic reasons”). Here, Patent Owner does not explain in any
detail the terms of the Boston Scientific license or the circumstances under
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which the license was granted, except to concede that the license was taken
in settlement of litigation. See PO Resp. 62; Ex. 2044 ¶ 34. Thus, Patent
Owner’s licensing efforts are of limited probative value in this case. See
Iron Grip, 392 F.3d at 1324.
(iv) Copying
Evidence of copying of the claimed invention by a competitor, rather
than one within the public domain, tends to show nonobviousness. WBIP,
829 F.3d at 1336. As discussed below, Petitioner contends its competitors
copied the GuideLiner products, whereas Patent Owner contends the
competing products identified by Patent Owner merely copied what was
known in the prior art.
Patent Owner asserts that after the introduction of the GuideLiner
product “three companies launched products that not only infringed the
GuideLiner patents but were close copies of then-existing versions of the
commercial GuideLiner products.” PO Resp. 63. These products are
Boston Scientific’s “Guidezilla” product, QXMedical’s “Boosting Catheter,”
and Petitioner’s “Telescope” product.
Patent Owner contends that Boston Scientific’s Guidezilla product is
virtually identical to the GuideLiner V1 product. PO Resp. 63. In support
of its arguments, Patent Owner provides the following annotated comparison
of GuideLiner V1 and the Guidezilla product. Id.
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The figure above shows the general structure and length of the GuideLiner
V1 and Guidezilla products. Referencing the above figures, Dr. Keith
testifies that the two devices both have a flexible tube with a lumen, a rigid
collar, a rigid metallic pushrod, and a handle that is marked with the device’s
size. Ex. 2138 ¶¶ 232–237. When all of the elements of the two devices are
considered in combination, Dr. Keith testifies that the two devices are
“virtually identical.” Id. ¶ 238. Dr. Graham likewise testifies that both
products are “substantially similar” and that in his clinical experience
“Guidezilla functions and performs similarly to GuideLiner.” Ex. 2145
¶¶ 261–263.
Patent Owner contends that Boston Scientific confirmed the
substantially similar nature of the two devices in its regulatory filings,
informing regulators that Guidezilla “incorporates substantially equivalent
device materials and design, packaging materials and design, fundamental
technology, manufacturing processes, sterilization process and intended use”
as GuideLiner. PO Resp. 64–65 (citing Ex. 2138 ¶¶ 231–249; Ex. 2145
¶¶ 261–263; Ex. 2151 ¶ 12; Ex. 2046 ¶¶ 68–79; Ex. 2200, 1).
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With respect to the “Boosting Catheter,” Patent Owner contends that
QXMedical had access to the GuideLiner V1 and developed a “substantially
similar” product. Id. at 65 (citing Ex. 2138 ¶¶ 240–249; Ex. 2196, 1).
With respect to Petitioner’s Telescope product, Patent Owner
contends
and, as shown in the annotated figure
below, Petitioner’s Telescope product is a striking copy of Patent Owner’s
GuideLiner V3 product. PO Resp. 65, 69.

The figure above is annotated by Patent Owner to identify the alleged
similarities between GuideLiner V3 and Petitioner’s Telescope product,
including a flexible tip, reinforced portion, angled opening, Half-pipe,
pushrod, and rounded push tab. Id. at 66.
Addressing the product’s “Half-pipe” feature, Patent Owner provides
the following annotated figure showing the similarities between the half-pipe
of GuideLiner V3 and the Telescope product (id. at 68).
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The figure above is an annotated, side-by-side comparison of the “Half-
pipe” of Patent Owner’s GuideLiner V3 product and Petitioner’s Telescope
product. Id. Patent Owner contends
and
comparison of the two devices demonstrates that “Petitioner succeeded in its
efforts to copy” this feature into its Telescope product. Id. at 67–68 (Patent
Owner asserting that the two products have very similar side openings and,
while not quite as long, Petitioner’s half-pipe is “nonetheless quite long and
(like GuideLiner V3) includes two inclined regions with a non-inclined
region in between”); Ex. 2197, 1
; Ex. 2138 ¶ 256.
Petitioner argues that the elements identified by Patent Owner to
establish copying of Guidezilla and the Boosting Catheter are all found in
the prior art. Pet. Reply 27. In particular, Petitioner asserts that Guidezilla
and the Boosting Catheter are similar to Itou and Ressemann in that they are
rapid exchange devices that are “configured to deliver a wide variety of
IVCDs and provide increased backup support when extended partially past a
[guide catheter].” Id. Petitioner further asserts that, “[l]ike Itou and
Ressemann, Guidezilla also had a side opening.” Id.
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With respect to its Telescope product, Petitioner contends this product
simply “practices the prior art” and “[n]one of the claims for which [Patent
Owner] claims nexus in this IPR pertain to its ‘half-pipe.’” Pet. Reply 28.
In addition, Petitioner contends that Patent Owner “ignores the numerous
unclaimed but important differences between GuideLiner and Telescope,
including Telescope’s hydrophilic coating and round pushwire,” differences
Patent Owner “itself emphasizes . . . as core distinguishing features”
between the two products. Id. at 29 (citing Ex. 1824, 4:22–5:10).
(v) Nexus
To be relevant, a nexus must be established between the evidence of
secondary considerations and the merits of the claimed invention. Liqwd,
941 F.3d at 1138. A presumption of nexus exists “when the patentee shows
that the asserted objective evidence is tied to a specific product and that
product ‘is the invention disclosed and claimed in the patent.’” WBIP, 829
F.3d at 1329 (quoting J.T. Eaton & Co. v. ATl. Paste & Glue Co., 106 F.3d
1563, 1571 (Fed. Cir. 1997)).
Dr. Keith provides unrebutted claim charts demonstrating that the
GuideLiner V1, V2, and V3 products read on every limitation of claims 1, 2,
3, 9, 12, 13, and 18 of the ’032 patent. Ex. 2138, Appendix B at 1–37
(Declaration of Peter Keith). Patent Owner also persuasively ties its
evidence of long-felt need, commercial success, industry praise, and copying
to one or more of the GuideLiner V1, V2, and V3 products. PO Resp. 49–
68. Accordingly, a presumption of nexus applies in this case. Id. at 68–70;
Ex. 2138 ¶¶ 211–212, 263, Appendix B; WBIP, 829 F.3d at 1329–30.
The presumption of nexus may be rebutted by showing that the
proffered objective evidence was due to extraneous factors other than the
patented invention, such as additional unclaimed features or improvements
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in marketing, etc. WBIP, 829 F.3d at 1329. The presumption of nexus may
also be rebutted by showing that the objective evidence results from a
feature that was known in the prior art. Id.; In re Kao, 639 F.3d 1057, 1068
(Fed. Cir. 2011) (“where the offered secondary considerations actually
results from something other than what is both claimed and novel in the
claim, there is no nexus to the merits of the claimed invention.”).
Petitioner argues that other than “the side opening,” which was
generally known in the art, “Kontos discloses the structure of” claims 3, 9,
14, and 19. Pet. Reply 23. Petitioner further argues that all that is necessary
to apply the benefits of modern guide extension catheters is rapid exchange,
a side opening, and a lumen relatively close to the size of the guide catheter,
and Kontos, Itou, and Ressemann all disclose rapid exchange and a lumen
close in size to the guide catheter (providing backup support), and Itou and
Ressemann have side openings. Id. at 24–27.
As noted by Petitioner, every element of the disputed claims was
individually known in the prior art. But evidence of secondary
considerations may be tied to the combination of features as a whole, as
opposed to one or more “novel” elements of a claimed invention. See WBIP,
829 F.3d at 1331–32. In line with this precedent, Drs. Graham, Thompson,
and Azzalini persuasively testify that it was the GuideLiner devices as a
whole that resulted in the evidence of secondary considerations, not any
individual feature in isolation. Ex. 2138 ¶ 215; Ex. 2145 ¶¶ 71, 82, 238–241
(Dr. Graham); Ex. 2215 ¶ 22 (Dr. Thompson); see generally Ex. 2151 ¶¶ 5–
15 (Dr. Azzalini). According to these declarants, despite the fact that the
individual features of the GuideLiner device were known in the prior art,
including mother-and-child catheters and catheters with a side opening,
devices prior to GuideLiner did not provide an effective, reliable solution to
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the long standing problem of lack of backup support. Ex. 2145 ¶¶ 62–67,
82. When the various features of the prior art were combined to form the
GuideLiner device, however, the result was a new, market-making,
commercially successful product that provided significant benefits over prior
art devices, received praise in the art, and was copied by competitors. Id.
¶¶ 76, 82; Ex. 2198, 3; Ex. 2215 ¶¶ 21–23 (Dr. Thompson testifying that the
GuideLiner products “fundamentally changed the way patients were treated”
and allowed him “to treat patients who otherwise would have been
untreatable with a catheter procedure”); Ex. 2151 ¶ 15 (Dr. Azzalini
testifying that “GuideLiner made cases possible that were previously
impossible, and made cases faster, safer, and more reliable”).
In view of the foregoing, we find that there is a nexus between the
invention recited in claims 3, 9, 14, and 19 of the ’032 patent and Patent
Owner’s evidence of long-felt but unmet need, industry praise, and
commercial success. With respect to copying, we find a nexus exists for this
evidence because (1) competitors had access to the GuideLiner products and
produced substantially similar designs, and (2) there is direct evidence of
copying of at least a portion of the GuideLiner device by Petitioner. See
Liqwd, 941 F.3d at 1138 (“But where there is evidence of actual copying
efforts, that evidence is always relevant.”).
(c) Discussion
As set forth above, the Petition provides multiple reasons why one of
ordinary skill in the art would have wanted to remove the funnel of Kontos
and provide an angled side opening. Patent Owner provides several
arguments in response as to why the modifications suggested by Petitioner
are grounded in hindsight, including the required, but previously-
undescribed, recessing of raised marker band 30.
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Upon review of the parties’ arguments and supporting evidence, we
find the parties’ arguments present a close case on the question of
obviousness. For example, while side openings were known in the art, they
were rare in devices intended to receive an interventional cardiology device
when positioned within a guide catheter. Moreover, switching to a side
opening in Kontos to beneficially increase the available real estate within the
catheter or to reduce the size of the guide catheter would require several
modifications to the device, at least one of which was not mentioned in the
Petition and may not have been possible in the relevant time period
(recessing marker band 30).
In order to resolve this close case of obviousness, we look, as we
always must, to Patent Owner’s evidence of objective indicia of non-
obviousness. Patent Owner presents persuasive evidence that its GuideLiner
products resolved a long-felt but unmet need in the art, are commercially
successful, received significant praise in the industry, and were copied by
competitors. Patent Owner also persuasively demonstrates a nexus between
this evidence and the inventions recited in claims 3, 9, 14, and 19.
Accordingly, Patent Owner’s secondary considerations evidence points
strongly to the nonobviousness of claims 3, 9, 14, and 19 of the ’032 patent.
In particular, we are persuaded by Patent Owner’s evidence and
argument with regard to copying. Evidence of copying may take the form of
“internal documents, direct evidence such as photos or patented features, or
disassembly of products, or access and similarity to a patented product.”
Liqwd, Inc. v. L’Oreal USA, Inc., 941 F.3d 1133, 1137 (Fed. Cir. 2019). In
this case, Patent Owner persuasively demonstrates that Guidezilla, the
Boosting Catheter, and Petitioner’s Telescope product were launched into
the market after the relevant GuideLiner products. Thus, each competitor
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had access to the GuildeLiner products. See Ex. 2200, 1; Ex. 2138 ¶ 247;
Ex. 2196, 1; Ex. 2202, 1–2. Patent Owner and Dr. Keith also persuasively
demonstrate that the Guidezilla and Telescope products,7 when considered
as a whole, are substantially similar in design to the then-existing
GuideLiner products on the market, including the combined use of a flexible
tip, reinforced portion, angled opening, pushrod, and rounded push tab.8
PO Resp. 63–68; Ex. 2138 ¶¶ 231–239.
As Petitioner notes, Ressemann is a rapid exchange device and has a
side opening. But Guidezilla did not merely apply the idea of rapid
exchange or the use of a side opening, as the device reproduces the entire
combination of features that were assembled for the first time by the
GuideLiner products. As such, we do not find persuasive Petitioner’s
argument that Guidezilla merely copied the prior art, as opposed to the
relevant GuideLiner products.
Petitioner’s Telescope product differs from GuideLiner V3 in its use
of a hydrophilic coating and a round pushwire, and the “half-pipe” design of
the two products is not identical. Pet. Reply 28–29. We credit the testimony
of Dr. Keith, however, that the overall design of the two products is

7 Patent Owner provides no figures or description comparing the Guideliner
product to the Boosting Catheter. Although Dr. Keith does provide such a
comparison, Patent Owner may not incorporate these materials by reference
into its Response. 37 C.F.R. § 42.6(a)(3). As such, we make no findings
with respect to the similarity of GuideLiner and the Boosting Catheter in this
proceeding.
8 We note that Boston Scientific has not had the opportunity to refute Patent
Owner’s “substantial similarity” arguments. We find only that, on this
record, Petitioner has not refuted Mr. Keith’s testimony that the Guidezilla
product, when considered as a whole, is substantially similar to the relevant
GuideLiner V1 product. Ex. 2138 ¶¶ 240–249.
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substantially similar (Ex. 2138 ¶¶ 250–262), and there is little doubt that
Petitioner had access to GuideLiner products and

Ex. 2235, 5

, 15–17
; Ex. 2198, 3 ; Ex. 2197,
1
; Ex. 2069, 5. As such, the evidence of copying by Petitioner is
relevant in this case and favors, at least to some extent, a conclusion of non-
obviousness of the claims at issue. See Liqwd, 941 F.3d at 1138–39.
(d) Conclusion with Respect to Claims 3, 4, 9, 13, and
18
Considering the close case of obviousness presented by Petitioner
along with the strong objective evidence of nonobviousness presented by
Patent Owner, we determine that Petitioner has not demonstrated by a
preponderance of the evidence that claims 3, 9, 14, and 19 would have been
obvious over Kontos and Adams. See Transocean, 699 F.3d at 1354–55.
Because claim 4 depends from claim 3, and because Petitioner’s arguments
with respect to this claim do not overcome the issues addressed above with
respect to claim 3, we also determine that Petitioner has not demonstrated by
a preponderance of the evidence that claim 4 would have been obvious over
Kontos and Adams.
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(5) Dependent Claims 5, 7, 9, 14–16, and 19
Petitioner identifies where it contends Kontos and Adams disclose
every limitation of dependent claims 5, 7, 9, 14–16, and 19. Pet. 48–49, 52–
54, 66–69. In support of these arguments, Petitioner provides a detailed
analysis of the disclosures of Kontos and Adams, as well the supporting
testimony of Dr. Brecker and Dr. Hillstead. Id. (citing generally Exs. 1405
and 1442).
Patent Owner does not address Petitioner’s specific arguments with
respect to claims 5, 7, 9, 14–16, and 19.
Upon review of Petitioner’s arguments, as well as Dr. Brecker’s and
Dr. Hillstead’s supporting testimony, we determine that Petitioner has
sufficiently identified where each limitation of the challenged dependent
claims are disclosed in Kontos and Adams. Accordingly, Petitioner has
demonstrated a reasonable likelihood that claims 5, 7, 9, 14–16, and 19
would have been obvious over Kontos and Adams.
2. Ground 2: Obviousness of claims 8 and 17 in view of Kontos,
Adams, and Takahashi
Claims 8 and 17 depend from claims 1 and 11, respectively, and
further require that the cross-sectional inner diameter of the coaxial lumen is
not more than one French smaller than the cross-sectional inner diameter of
the guide catheter. Ex. 1401, 11:54–57, 13:14–17. Petitioner contends these
claims would have been obvious over the combined disclosures of Kontos,
Adams, and Takahashi. Pet. 69–72. For the reasons set forth below, we
determine that Petitioner has not demonstrated by a preponderance of the
evidence that claims 8 and 17 would have been obvious over the
combination of Kontos, Adams, and Takahashi.
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a) Summary of Takahashi
Takahashi is a journal article entitled “New Method to Increase a
Backup Support of a 6 French Guiding Coronary Catheter.” Ex. 1410. It
bears a copyright date of 2004. Id. at 5. Takahashi discloses a “five-in-six”
system wherein a 5 French guiding catheter is inserted into a 6 French
guiding catheter to provide increased backup support. Id. at 452. In this
system, the 5 French catheter is 120 cm in length, whereas the 6 French
catheter is 100 cm in length. Id. According to Takahashi, the soft end
portion of the 5 French catheter “can easily negotiate the tortuous coronary
artery with minimal damage and then it can be inserted more deeply into the
artery.” Id.
b) Discussion
Claim 8 depends from claim 1 and claim 17 depends from claim 11.
Ex. 1401, 11:54, 12:35. Both claims require that “the cross-sectional inner
diameter of the coaxial lumen of the tubular structure is not more than one
French smaller than the cross-sectional inner diameter of the guide catheter.”
Id. at 11:17–20, 12:35–38.
Petitioner contends one of ordinary skill in the art would have sought
to implement Takahashi’s five-in-six system in the device of Kontos and
Adams because of the increased support provided by the “not-more-than-
one-French differential” taught by Takahashi. Pet. 69–72. Petitioner
concedes that this modification would increase the diameter of Kontos’s
body, but contends this modification was well within the skill in the art, “as
appropriately sized catheters were ubiquitous in the art.” Id. at 72 (citing
Ex. 1442 ¶¶ 109–110; Ex. 1409, 4:64–65 (Kontos noting that “[o]f course,
other sizes may be used for other applications”); Ex. 1410, 452).
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Petitioner further contends that, for the reasons discussed for claim 3,
one of ordinary skill in the art would have had a reasonable expectation of
success when removing Kontos’s funnel in favor of a proximal side opening.
Id. at 71–72.
Patent Owner argues that merely removing the funnel of Kontos and
“making it bigger” is not enough to meet the “one French” limitation of
claims 8 and 18 because Kontos’s device would still have protruding marker
band structure 30 and protruding base portion 18, which would result in a
greater than 1 French differential between the inner diameter of the lumen
and the inner diameter of the guide catheter. PO Resp. 44.
Petitioner argues in reply that one of ordinary skill in the art could
simply recess Kontos’s distal marker bands and taper its pushrod for
attachment onto the “Kontos-Ressemann combination,”9 which Petitioner
contends would allow the diameter of tube 16 to be increased and permit
Kontos to achieve the not-more-than-one-French differential of claims 8 and
18. Pet. Reply 21.
Petitioner’s arguments with respect to claims 8 and 18 are premised
on one of ordinary skill in the art removing Kontos’s funnel in favor of a
side opening. Pet. 71–72. As discussed above with respect to claim 3, we
are not persuaded that this modification to Kontos would have been obvious.
Moreover, as noted by Patent Owner, the argument that one of ordinary skill
in the art would recess the marker bands and modify the pushrod structure of
Kontos requires significant modifications of Kontos’s device, modifications
that were not proposed in the Petition. Sur-Reply 23–24; Pet. 71–72. The

9 We understand the reference to the Kontos-Ressemann combination to be a
typographical error that was intended to refer to the Kontos-Adams
combination.
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extensive need to modify Kontos’s device in a way not suggested in the
Petition supports Patent Owner’s argument that the proposed modifications
are based on a hindsight desire to recreate the claimed invention, as opposed
to a known need in the art for such a device. Sur-Reply 23–24; Pet. 71–72.
Accordingly, we determine that Petitioner has not demonstrated by a
preponderance of the evidence that claims 8 and 17 would have been
obvious over Kontos, Adams, and Takahashi.
3. Ground 3: Obviousness of Claim 20 in view of Kontos, Adams,
and Berg
Claim 20 depends from claim 19 (which depends from claim 11) and
further requires that “the first flexural modulus is about 13,000 PSI plus or
minus 5000 PSI, the second flexural modulus is about 29,000 PSI plus or
minus 10,000 PSI, and the third portion flexural modulus is about 49,000
PSI plus or minus 10,000 PSI.” Ex. 1401, 13:29–33. Petitioner contends the
subject matter of claim 20 would have been obvious over the combined
disclosures of Kontos, Adams, and Berg. Pet. 73–75. For the reasons set
forth below, we determine that Petitioner has demonstrated by a
preponderance of the evidence that claim 20 would have been obvious over
the combination of Kontos, Adams, and Berg.
a) Summary of Berg
Berg discloses a “guiding catheter for use in coronary angioplasty and
other cardiovascular interventions.” Ex. 1451, Abstract. In particular, Berg
discloses a guide catheter “having a transition zone with a different
flexibility than adjacent portions of the catheter shaft for improved catheter
performance.” Id. at 1:21–25.
Berg notes that in order for a physician to place a catheter at the
correct location in a blood vessel, the physician must apply longitudinal and
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rotational forces. Id. at 1:49–51. Thus, the catheter must be rigid enough to
push through the blood vessel and torsionally rigid enough to transmit the
applied torque, but flexible enough to navigate the bends in the blood vessel.
Id. at 1:49–56. Berg also notes that “it is preferable to have a soft tip or
flexible section engage the ostium,” which provides a less traumatic section
to the blood vessel. Id. at 1:63–2:4. A problem that occurs, however, is that
more flexible tips may increase the incidence of guide catheter back-out,
when the guide disengages from its preferred positioning in the coronary
ostium. Id. at 2:11–15.
Berg overcomes the deficiencies of the prior art “by providing a
transition element in the material,” which “allows for flexibility of a guiding
catheter to be increased, while maintaining its ability to prevent catheter
back-out.” Id. at 2:35–39. Figure 19 of Berg is reproduced below:

Figure 19 is a partial cross-sectional view of a distal portion of a
catheter tube or guide catheter. Id. at 5:49–51. The guide catheter of Figure
19 has a plurality of discrete outer tubular member segments 140, 142, 144,
146, 148, and 150. Id. at 13:53–55. Soft tip zone 140 has a flexural
modulus of “about 1 to about 15 Kpsi”; distal section zone outer tubular
segment 142 has a flexural modulus of “between about 2 and about 49
Kpsi”; transition zone outer tubular segment 144 has a flexural modulus of
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“between about 13 and about 49 Kpsi”; secondary curve zone outer tubular
segment 146 has a flexural modulus of “greater than 49 Kpsi”; mid-shaft
zone outer tubular segment 148 has a flexural modulus of “about 29 to about
67 Kpsi”; and proximal shaft zone outer tubular segment 150 has a flexural
modulus of “greater than 49 Kpsi to provide maximum stiffness for push and
control.” Id. at 13:66–15:6.
b) Discussion
Petitioner contends Berg discloses using a guide catheter having
varying degrees of stiffness and that the flexural modulus for the first,
second, and third portions of Berg’s catheter overlap the ranges recited in
claim 20. Pet. 73–75. Petitioner further contends that one of ordinary skill
in the art would have used the flexural moduli disclosed in Berg for the
catheter of Kontos because Berg instructs that the disclosed combination of
flexibilities allows the “flexibility of a guiding catheter to be increased,
while maintaining its ability to prevent guide catheter back-out.” Id. at 74–
75 (quoting Ex. 1444, 1:36–38; Ex. 1451, 2:37–39; Ex. 1442 ¶ 118).
Patent Owner argues that one of ordinary skill in the art would not
have looked to the disclosures of Berg because it is directed to a guide
catheter, as opposed to an extension catheter, and emphasizes that its
discrete segments should be “matched to its clinical role and function.”
PO Resp. 49–50 (citing Ex. 1451, 2:56–60). According to Patent Owner,
these disclosures caution against importing a “one-size-fits-all” approach
into different devices with different purposes and functions. Id. at 48–49
(citing Ex. 2138 ¶ 208).
Petitioner argues in reply that a person of ordinary skill in the art
would look to the disclosure of Berg because Kontos’s assembly and the
guide catheter of Berg must navigate the same vasculature, which is the
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same general “clinical role and function” of the prior art combination.
Pet. Reply 22.
Patent Owner does not address the combination of Kontos, Adams,
and Berg in its Sur-Reply.
Although the devices are not identical, we find Petitioner’s
explanation persuasive as to why one of ordinary skill in the art would apply
Berg’s teachings of the specific flexular modulus for each portion of the
device of Kontos and Adams, i.e., because the devices must navigate the
same vasculature. We are also persuaded that the flexural moduli of Berg
overlap the claimed flexural moduli. See In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003); (“[E]ven a slight overlap in range establishes a prima
facie case of obviousness.”). Accordingly, Petitioner has demonstrated by a
preponderance of the evidence that claim 20 would have been obvious over
Kontos, Adams, and Berg.
III. CONTINGENT MOTION TO AMEND
Having determined that claims 1, 11, and 16 of the ’032 patent are
unpatentable, we address the request to add proposed substitute claims 23–
25 as set forth in Patent Owner’s Motion to Amend.
A. Legal Standard
In an inter partes review, amended claims are not added to a patent as
a matter of right; rather, they must be proposed as a part of a motion to
amend. 35 U.S.C. § 316(d). In reviewing a motion to amend, the Board
assesses the patentability of the proposed substitute claims “without placing
the burden of persuasion on the patent owner.” Aqua Prods., Inc. v. Matal,
872 F.3d 1290, 1328 (Fed. Cir. 2017) (en banc); see Lectrosonics, Inc. v.
Zaxcom, Inc., IPR2018-01129, Paper 15 at 3‒4 (PTAB Feb. 25, 2019)
(precedential).
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Notwithstanding the foregoing, a patent owner’s proposed substitute
claims must meet the statutory requirements of 35 U.S.C. § 316(d) and the
procedural requirements of 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4–
8. In particular, a patent owner must demonstrate: (1) the amendment
proposes a reasonable number of substitute claims; (2) the proposed claims
are supported in the original disclosure (and any earlier filed disclosure for
which the benefit of a filing date is sought); (3) the amendment responds to a
ground of unpatentability involved in the trial; and (4) the amendment does
not seek to enlarge the scope of the claims of the patent or introduce new
subject matter. See 35 U.S.C. § 316(d); 37 C.F.R. § 42.121.
B. Proposed Substitute Claims
In its Contingent Motion to Amend, Patent Owner seeks to add
proposed substitute claims 23–25 in place of original claims 1, 11, or 16,
respectively. MTA 1. Proposed substitute claims 23–25 are reproduced
below, with underlining indicating text added and brackets indicating text
deleted from a claim.
23. A device for use with a standard 6 French guide
catheter, the standard guide catheter having a continuous lumen
extending for a predefined length from a proximal end at a
hemostatic valve to a distal end adapted to be placed in a branch
artery, the continuous lumen of the guide catheter having a
circular cross-sectional inner diameter sized such that
interventional cardiology devices are insertable into and through
the lumen to the branch artery, the device comprising, in a distal-
to-proximal direction:
a flexible tip portion defining a tubular structure having a
circular cross-section and a length that is shorter than the
predefined length of the continuous lumen of the standard
6 French guide catheter, the tubular structure having a cross-
sectional outer diameter sized to be insertable through the cross-
sectional inner diameter of the continuous lumen of the guide
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catheter and defining a coaxial lumen having a cross-sectional
inner diameter of at least 0.056 inches through which
interventional cardiology devices are insertable;
a substantially rigid side opening that includes a first
inclined region, a second inclined region, and a non-inclined
concave track between the first and second inclined regions; and
a substantially rigid portion proximal of and operably
connected to, and more rigid along a longitudinal axis than, the
flexible tip portion and defining a rail structure without a lumen
and having a maximal cross-sectional dimension at a proximal
portion that is smaller than the cross-sectional outer diameter of
the flexible tip portion and having a length that, when combined
with the length of the flexible distal tip portion, defines a total
length of the device along the longitudinal axis that is longer than
the length of the continuous lumen of the guide catheter,
such that when at least a distal portion of the flexible tip
portion is extended distally of the distal end of the guide catheter,
at least a portion of the proximal portion of the substantially rigid
portion extends proximally through the hemostatic valve in
common with interventional cardiology devices that are
insertable into the guide catheter.
24. A device for use with a standard guide catheter, the
standard guide catheter having a continuous lumen extending for
a predefined length from a proximal end at a hemostatic valve to
a distal end adapted to be placed in a branch artery, the
continuous lumen of the guide catheter having a circular cross-
section and a cross-sectional inner diameter sized such that
interventional cardiology devices are insertable into and through
the lumen to the branch artery, the device comprising:
an elongate structure having an overall length that is
longer than the predefined length of the continuous lumen of the
guide catheter, the elongate structure including:
a flexible tip portion defining a tubular structure having a
circular cross-section that is smaller than the circular cross-
section of the continuous lumen of the guide catheter and a length
that is shorter than the predefined length of the continuous lumen
of the guide catheter, the flexible tip portion being sized having
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a cross-sectional outer diameter sized to be insertable through the
cross-sectional inner diameter of the continuous lumen of the
guide catheter and defining a coaxial lumen having a cross-
sectional inner diameter through which interventional cardiology
devices are insertable;
a reinforced portion having a uniform, fixed cross-
sectional outer diameter proximal to the flexible tip portion;
[and]
a substantially rigid portion proximal of and connected to,
and more rigid along a longitudinal axis than, the flexible tip
portion and defining a rail structure without a lumen and having
a maximal cross-sectional dimension at a proximal portion that
is smaller than the cross-sectional outer diameter of the flexible
tip portion,
such that when at least a distal portion of the flexible tip
portion is extended distally of the distal end of the guide catheter
with at least proximal portion of the reinforced portion remaining
within the continuous lumen of the guide catheter, at least a
portion of the proximal portion of the substantially rigid portion
extends proximally through the hemostatic valve in common
with interventional cardiology devices that are insertable into the
guide catheter; and
a side opening positioned between a proximal end of the
reinforced portion and a distal end of the substantially rigid
portion, the side opening having a first inclined sidewall that
tapers into a non-inclined concave track that is proximate a
second inclined sidewall;
wherein the device is configured so that, when the
reinforced portion extends into the branch artery, the reinforced
portion and the substantially rigid portion assist in resisting
forces exerted by the interventional cardiology devices passed
through and beyond the coaxial lumen that would otherwise tend
to dislodge the guide catheter from the artery.
25. The device of claim 24 [[11]], wherein the
reinforced portion is reinforced with metallic elements in a
braided or coiled pattern, wherein the standard guide catheter is
a standard 6 French guide catheter, and wherein each of the
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flexible tip portion and reinforced portion has a crosssectional
inner diameter greater than or equal to 0.056 inches through
which the interventional cardiology devices are insertable.
MTA A3–5.
C. Statutory and Procedural Requirements
1. Reasonable Number of Substitute Claims
A patent owner may only request substitution of a reasonable number
of claims. 35 U.S.C. § 316(d)(1)(B); 37 C.F.R. § 42.121(a)(3). Patent
Owner presents two substitute claims, each corresponding to one original
claim. MTA A1–5. We find this one-for-one substitution is reasonable, and
Petitioner does not assert otherwise. 37 C.F.R. § 42.121(a)(3) (“The
presumption is that only one substitute claim would be needed to replace
each challenged claim . . . .”).
2. Whether Proposed Substitute Claims 23–25 Enlarge Claim Scope or
Add New Matter
A proposed amendment may not seek to enlarge the scope of the
claims or introduce new subject matter. 35 U.S.C. § 316(d)(3); see
37 C.F.R. § 42.121(a)(2)(ii); TurboCare Div. of Demag Delaval Turbomach.
Corp. v. Gen. Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001) (“When the
applicant adds a claim . . . , the new claims . . . must find support in the
original specification.”). Proposed substitute claims 23–25 seek to add or
reorder limitations, and do not remove any limitations. See, e.g., MTA A1–
5. Accordingly, we are persuaded that proposed substitute claims 23–25 do
not enlarge the scope of the claims they replace.
In its Motion to Amend, Patent Owner identifies citations in the
original disclosure of Application Serial No. 11/416,629 (Ex. 1403, “the
’629 application”) that it asserts provide support for the proposed
amendment of each claim. MTA 3–8 (citations omitted). Petitioner does
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not argue that the substitute claims introduce new matter. See generally Pet.
MTA Opp. Upon review of the citations identified by Patent Owner, we are
persuaded that proposed substitute claims 23–25 are supported by the
original disclosure of the ’629 application.
3. Responsive to a Ground of Unpatentability
A motion to amend may be denied where it “does not respond to a
ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i).
Patent Owner contends that the additional limitations included in proposed
substitute claims 23–25 seek to further distinguish the prior art advanced in
the Petition. MTA 9–20. Petitioner does not argue otherwise. See generally
Pet. MTA Opp.
Upon review of Patent Owner’s proposed amendments, we agree that
proposed substitute claims 23–25 respond to a ground of unpatentability
involved in the trial.
4. Conclusion
On this record, we determine that Patent Owner’s Contingent Motion
to Amend meets the statutory and regulatory requirements set forth in
35 U.S.C. § 316(d) and 37 C.F.R. § 42.121 with respect to proposed
substitute claims 23–25.
D. Patentability Analysis of the Proposed Substitute Claims
Petitioner challenges the patentability of proposed substitute claims
23–25 on the grounds that claims 23–25 are invalid as indefinite and also
would have been obvious over the prior art of record. Pet. MTA Opp. 11–
35. We address these challenges below.
1. Indefiniteness of Proposed Substitute Claim 23–25
To satisfy the definiteness requirement of § 112, a patent’s claims
must, when “viewed in light of the specification and prosecution history,
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inform those skilled in the art about the scope of the invention with
reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S.
898, 910 (2014).
Petitioner contends proposed substitute claims 24 and 25 are
indefinite because the claims recite “‘a substantially rigid portion . . .
connected to . . . the flexible tip portion,’ even though the claim recites an
intervening ‘reinforced portion.’” PO MTA Opp. 1 (citing MTA A3–5).
Patent Owner contends Petitioner misreads claim 23, claiming it
“recites a ‘substantially rigid side opening’ that is outside of both the
‘flexible tip portion’ and the ‘substantially rigid portion.’” PO MTA
Reply. 11. As noted by Patent Owner, however, “the claim does not recite a
separate side opening ‘segment,’ and there is no basis for requiring the side
opening to be positioned outside of the substantially rigid segment.” Id. at 8
(citing Ex. 2243 ¶ 45).
Regarding proposed substitute claims 24 and 25, Patent Owner
responds that the term “connected to” includes both direct and indirect
connections, and Petitioner’s expert “confirms ‘the specification teaches an
indirect connection, such that the flexible tip portion is connected to the
reinforced portion, which is connected to the substantially rigid portion.’”
PO MTA Reply 8–9 (citing Dynamics, LLC v. Buyers Prods. Co., 717 F.3d
1336, 1342 (Fed. Cir. 2013)). As noted by Patent Owner, however, we are
directed to no disclosure or limitation in the ’032 patent that would require a
direct connection, as opposed to an indirect or operable one, between the
substantially rigid portion and the flexible tip portion. Indeed, the ’032
patent includes embodiments that appear to require that the flexible tip
portion be indirectly connected to the substantially rigid portion and not
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directly connected. PO MTA Reply 2 (citing Ex. 2243 ¶ 46; Ex. 1003, 14:7–
9, 16:12–19); Ex. 1401, 11:1–18.
Accordingly, in view of the above, we do not find persuasive
Petitioner’s argument that proposed substitute claims 23–25 are indefinite
due to its recitation of a connection between two elements that are not
physically in contact.
2. Challenges to the Proposed Claims under 35 U.S.C. § 103(a)
Petitioner asserts in its Opposition that the proposed substitute claims
are unpatentable on the following grounds:
Claims 35 U.S.C. §10 References/Basis
23–25 103(a) Itou,
11 Ressemann,12
Kataishi13
23–25 103(a) Kontos, Ressemann, Takahashi
23–25 103(a) Kontos, Kataishi

a) Obviousness of Proposed Substitute claims 23–25 over Kontos
in view of Ressemann and Takahashi
Petitioner contends that proposed substitute claims 23–25 would have
been obvious over the combined disclosures of Kontos, Ressemann, and
Takahashi. Pet. MTA Opp. 25–35.

10 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the
challenged claims of the ’032 patent have an effective filing date before the
effective date of the applicable AIA amendments, we refer to the pre-AIA
versions of 35 U.S.C. § 103 throughout this Decision.
11 Itou et al., US 7,736,355, issued June 15, 2010 (Ex. 1407) (“Itou”).
12 Ressemann et al., US 7,604,612, issued October 20, 2009 (Ex. 1408)
(“Ressemann”).
13 Kataishi et al., US 2005/0015073, published January 20, 2005 (Ex. 1425)
(“Kataishi”).
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(1) Ressemann
Ressemann is directed to an apparatus “used to prevent the
introduction of emboli into the bloodstream during and after surgery
performed to reduce or remove blockage in blood vessels.” Ex. 1408, 1:13–
16. Figure 1A of Ressemann, reproduced below, illustrates a first
embodiment of a system for evacuating emboli from a blood vessel:

Figure 1A is a cross-sectional view of a partial length evacuation sheath and
depicts evacuation sheath assembly 100, which “is sized to fit inside a guide
catheter” and be advanced “into a blood vessel to treat a stenosis.” Id. at
3:16–18, 6:18–24, Fig. 5A.
Evacuation sheath assembly 100 includes a shaft having proximal
shaft portion 110, intermediate shaft portion 120, and distal shaft portion 130
(not shown in Figure 1A). Id. at 10:30–35. Evacuation head 132 includes
multi-lumen tube 138 having evacuation lumen 140 and inflation lumen 142
and is preferably made of a relatively flexible polymer. Id. at 6:35–64.
Evacuation lumen 140 is preferably larger than inflation lumen 142 and “is
designed to allow for the passage of interventional devices such as, but not
limited to, stent delivery systems and angioplasty catheters.” Id. at 6:44–47.
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Proximal and distal ends of evacuation lumen 140 are angled to allow for
smoother passage of evacuation sheath assembly 100 through a guide
catheter and to facilitate smoother passage of other therapeutic devices
through evacuation lumen 140. Id. at 6:52–57. According to Ressemann,
“[t]he larger area of the angled open ends also allows for larger deformable
particulate matter to pass through the lumen more smoothly.” Id. at 6:58–
60.
Figure 1 B of Ressemann is reproduced below:

Figure 1B is a cross-sectional view of the partial length evacuation sheath of
Figure 1A, taken along line 1B-1B of Figure 1A. Id. at 3:19–20. Figure 1B
shows inflation lumen 142, which has open proximal end 142a and closed
distal end 142b (shown in Figure 1A) and is designed to provide fluid to
inflate balloons on evacuation head 132. Id. at 6:61–64. Stiffness transition
member 135 is attached to the distal end of proximal shaft portion 110, “is
located co-axially in the inflation lumen 142,” and extends to soft tip 144.
Id. at 11:30–39.
In use, a guiding catheter is directed to a blood vessel and then a
coronary guide wire is advanced to a location just proximal to the distal tip
of the guiding catheter. Id. at 12:9–14. Evacuation sheath assembly 100 is
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then advanced over the guide wire and positioned within the blood vessel.
Id. at 12:19–21. In this process, evacuation head 132 is positioned with its
distal end within the blood vessel while its proximal end remains in the
guiding catheter. Id. at 12:37–39. Sealing balloons 136 and 134 are then
inflated to provide a fluid seal between the sealing balloons and the blood
vessel. Id. at 12:40–45.
Figure 6D of Ressemann is reproduced below:

Figure 6D is a cross-sectional view of the partial length evacuation sheath of
Figures 1A and 1B deployed within a blood vessel. Id. at 3:59–61. As
shown in Figure 6D, guidewire 170 may be advanced beyond stenosis 180 in
blood vessel 150. Id. at 13:3–16. A therapeutic device, such as a stent, may
then be advanced over guide wire 170 and across stenosis 180. Id. at 13:57–
60. As indicated by arrows 195, blood flow within the blood vessel is
directed towards evacuation sheath 100, which “will carry any dislodged
material out of the patient and into a collection chamber.” Id. at 13:35–44.
Ressemann also discloses another embodiment where the “multi-
lumen tube forming the evacuation head may include three lumens,” which
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is illustrated in Figures 16A–16J. Id. at 22:29–33. Figure 16A, reproduced
below, is a side view of a full-length evacuation sheath assembly 2100. Id.
at 5:21–23.

Figure 16A depicts evacuation sheath assembly 2100 having evacuation
head 2132, which includes multi-lumen tube 2138 and two expandable
sealing surfaces. Id. at 22:32–33, 22:40–41. Evacuation sheath assembly
2100 includes a shaft having two sections, a proximal shaft portion 2110 and
an intermediate shaft portion 2120, each having distinct diameters. Id. at
27:22–36. “The proximal shaft portion 2110 provides fluid communication
between an inflation apparatus (see FIG. 16I) and the intermediate shaft
portion 2120.” Id. at 27:37–38. “The intermediate shaft portion 2120
includes a tapered metallic core wire 2135 inside a polymer tube 2122.” Id.
at 27:51–53.
Evacuation head 2132 may include a structure to reinforce the
proximal opening of multi-lumen tube 2138. Id. at 24:47–49. Figure 16J,
reproduced below, is an isometric view of support collar 2141 used in
evacuation sheath assembly 2100. Id. at 5:46–47.
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Figure 16J illustrates the structure used to reinforce the proximal opening of
multi-lumen tube 2138. Id. at 24:47–49. Support collar 2141 includes
cylindrical portion 2141a that fits into the proximal opening of evacuation
lumen 2140 allowing support collar 2141 to reinforce the proximal opening
of evacuation lumen 2140 “in the presence of deforming forces, particularly
torsional stresses that may be created unintentionally by rotation of the
catheter shaft near its proximal end.” Id. at 24:49–58.
Support collar cylindrical portion 2141a tapers into tab portion 2141b
that extends proximally and in a direction parallel to a longitudinal axis of
evacuation lumen 2140 to provide a flexibility transition between the
proximal end of evacuation head 2131 and the shaft of evacuation sheath
assembly 2100. Id. at 24:58–67. Preferably, support collar 2141 is
fabricated from a thin walled metallic tube with a series of windows 2141c
that “allow for some flexibility and also allow for better adhesion of the
encapsulation material 2133, which covers the support collar 2141, while the
cylindrical portion 2141a maintains hoop support to the proximal opening of
the evacuation lumen 2140.” Id. at 25:1–8 (emphasis added).
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Figure 16D, reproduced below, is an enlarged cross-sectional side
view of the proximal end of evacuation sheath assembly 2100 and shows the
placement of support collar 2141within the structure as a whole. Id. at 5:29–
31.

To facilitate attachment between evacuation head 2132 and intermediate
shaft portion 2120, a distal portion of polymer tube 2122 is flared and
flattened by heating with an appropriately formed mandrel. Id. at 27:59–63.
As shown in Figure 16D, the “flared section is overlapped over the walls of
the multi-lumen tube 2138, which define the core wire lumen 2143 and the
inflation lumen 2142, as well as over the tab portion 2141b of the support
collar 2141.” Id. at 27:63–67.
(2) Analysis
Petitioner contends that one of ordinary skill in the art would have
modified Kontos’s device to include various features disclosed in
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Ressemann and Takahashi to arrive at the subject matter recited in proposed
substitute claims 23–25. In particular, Petitioner contends one of ordinary
skill in the art would have added reinforcing metallic braiding to tube 16 of
Kontos, as is disclosed in Ressemann, in order to promote pushability and
prevent kinking during advancement of the catheter. Pet. MTA Opp. 32.
Petitioner further contends that a person of ordinary skill in the art “would
have been motivated to modify Kontos to add Ressemann’s support collar
2141” in order to optimize the inner diameter of tube 16, facilitate smooth
reception of an interventional cardiology device as it enters the lumen,
promote smoother passage of the catheter assembly, and permit smooth re-
entry if the proximal end of the extension catheter was extended beyond the
distal end of the guide catheter. Id. at 26. With respect to the relative sizes
of the guiding catheter and support catheter of Kontos, Petitioner contends
that a person of ordinary skill in the art would have sought to resize
Kontos’s device in order to implement Takahashi’s 5-in-6 system, because
Takahashi “teaches that using a catheter-in-catheter assembly—in particular,
an assembly that achieves 1 French differential between the inner and outer
catheters—can improve back-up support.” Id. at 29 (citing Ex. 1902 ¶ 151;
Ex. 1905 ¶¶ 138–41).
Petitioner contends that there would have been a reasonable
expectation of success in making the proposed combination of Kontos,
Ressemann, and Takahashi because a person of ordinary skill in the art
“knew how to (i) replace the proximal funnel with a side opening, as
discussed above, and (ii) recess Kontos’s distal marker bands.” Id. (citing
Ex. 1902 ¶ 154).
Petitioner’s proposed combination expressly requires modifying
Kontos by: (1) removing Kontos’s funnel and replacing it with the side
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opening of Ressemann (Pet. MTA Opp. 26); (2) adding metallic braiding or
coiling to reinforce tube 16 of Kontos (id. at 32); (3) increasing the inner
diameter of Kontos’s tube 16 from 0.045 inches to 0.059 inches (5 French)
(id. at 29); (4) recessing Kontos’s distal marker bands (id.); and (5) tapering
Kontos’s pushrod (id. at 30). Dr. Brecker testifies that these expressly
identified modifications would also require: (1) reconfiguring Kontos’s
distal soft tip 28 so that it no longer overlaps Kontos’s tube 16 (Ex. 2240,
130:19–131:2); (2) potentially resizing Kontos’s distal marker bands (id. at
131:3–134–9); (3) removing Kontos’s base portion 18 (id. at 134:24–25,
94:14–18); (4) securing Ressemann’s support collar tab 2141b on top of
Kontos’s pushwire, as opposed to embedding it within the structure of the
catheter (id. at 147:9–149:21); and (5) covering the “windows” in
Ressemann’s collar 2141 (id. at 39:1–18, 137:5–13).
The sheer number of required modifications strongly suggests that
Petitioner’s proposed combination is based on hindsight, using the ’032
patent as a roadmap. Moreover, Petitioner’s proposed modifications require
using Ressemann’s collar in a manner that is not disclosed in Ressemann or
any other recited prior art reference, i.e., resting the tab portion of
Ressemann’s collar on top of the catheter structure as opposed to embedding
it within. Compare Ex. 1902 ¶ 193, with Ex. 1408, at 27:63–67, Fig. 16D;
Ex. 2243 ¶ 97. Petitioner provides no persuasive explanation as to why one
of ordinary skill in the art would have ignored Ressemann’s express
teachings of embedding the tab portion of support collar 2141 within the
structure of the catheter and instead redesigned (filled in Ressemann’s
“windows”) and reoriented the tab portion to rest on the top of Kontos’s
pushwire in the open space within the guide catheter. Ex. 2243 ¶¶ 97, 107
(Dr. Keith noting the lack of explanation for the unique application of the
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tab portion of Ressemann’s support collar in the proposed combined device).
Accordingly, we do not find Petitioner’s arguments with respect to proposed
substitute claims 23–25 persuasive.
In view of the foregoing, we agree with Patent Owner that Petitioner
fails to adequately explain why one of ordinary skill in the art would have
made the proposed combination of Kontos, Ressemann, and Takahashi.
Accordingly, Petitioner has not demonstrated by a preponderance of the
evidence that proposed substitute claims 23–25 would have been obvious
over Kontos, Ressemann, and Takahashi.
b) Obviousness of Proposed Substitute Claims 23–25 over Kontos
in view of Kataishi
Petitioner contends that Kataishi also discloses a “complex side
opening limitation” and, “[f]or reasons similar to those discussed above . . . a
POSITA would have found it obvious to replace Kontos’s flared opening
with a double-inclined opening like in Kataishi.” Pet. MTA Opp. 35 (citing
Ex. 1902 ¶¶ 211–217).
Kataishi’s complex side opening is located at its distal tip and is used
to improve suction in Kataishi’s device. Ex. 1425 ¶ 1, Fig. 10. In its single
paragraph addressing this proposed ground, Petitioner provides no reasoned
explanation as to why one of ordinary skill in the art would have sought to
implement such a suction-improving distal tip at the proximal opening of
Kontos, and Petitioner’s arguments related to Kontos and Ressemann do not
address this issue. Nor does Petitioner persuasively explain why its
motivations related to Itou (referenced in its Kontos-Kataishi ground) would
necessarily translate to the distal opening of Kontos.
In any event, Dr. Keith persuasively testifies that the distal tip of
Kataishi would increase flexibility at the proximal opening of Kontos,
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creating a kink point. Ex. 2243 ¶ 131 (“While increased flexibility at the
distal end provides increased suction, flexibility at the proximal opening of
the catheter would increase the risk of kinking.”); see also id. ¶¶ 119–132
(generally refuting Petitioner’s reasons for combining Kontos and Kataishi).
We credit this testimony and, given the negative effects resulting from the
importation of Kataishi’s distal opening at Kontos’s proximal opening, we
find that Petitioner’s unpatentability arguments based on Kontos and
Kataishi are unpersuasive.
c) Obviousness of Proposed Substitute Claims 23–25 over Itou in view of
Ressemann or Kataishi
Petitioner contends that proposed substitute claims 23–25 would have
been obvious over Itou in view of Ressemann and Kataishi. Pet. MTA Opp.
12–25. In this ground, Petitioner contends that one of ordinary skill in the
art would have implemented Ressemann’s support collar at the proximal
opening of Itou’s catheter. Id. at 17. Petitioner provides an annotated figure
showing its proposed combination of Itou and Ressemann

The figure reproduced above shows Petitioner’s proposed combination of
Itou and Ressemann. Id.
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As shown in Petitioner’s annotated figure, Petitioner proposes to use
Ressemann’s support collar 2141 in Itou in a tab-on-top configuration, with
the tab portion resting on Itou’s metal pushwire. Id.; PO MTA Reply 11–12.
But Petitioner again fails to explain why one of ordinary skill in the art
would have ignored Ressemann’s express teachings of embedding the tab
portion of support collar 2141 deep within the structure of the catheter, and
instead laid the tab portion on top of Itou’s metal pushwire. See PO MTA
Reply 11–12; see also id. at 13 (noting that Petitioner’s proposed
combination would require at least six different modifications to the
combined device). Thus, we do not find Petitioner’s reasons for combining
Itou and Ressemann persuasive.
Accordingly, Petitioner’s arguments with respect to the combination
of Itou, Ressemann, and Kataishi are not persuasive.
3. Conclusions with Respect to Obviousness of Proposed
Substitute Claims 23–25
For the reasons discussed above, we determine that Petitioner has not
demonstrated by a preponderance of the evidence that proposed substitute
claims 23–25 would have been obvious over Itou in view of Ressemann or
Kataishi, over Kontos in view of Ressemann and Takahashi, or over Kontos
in view of Kataishi. Accordingly, we grant Patent Owner’s Contingent
Motion to Amend.
IV. CONSTITUTIONAL CHALLENGE
Patent Owner argues that the Petition should be denied because “the
manner in which administrative law judges are appointed is
unconstitutional.” PO Resp. 75 (citing Arthrex, Inc. v. Smith & Nephew,
Inc., 941 F.3d 1320, 1325 (Fed. Cir. 2019)). Patent Owner further argues
that the remedy in the Arthrex decision “severing certain removal
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protections, is insufficient to cure the constitutional defect, because, e.g., it
still does not give a properly appointed principle office the power to review
administrative law judge decisions.” Id. (citing Lucia v. SEC, 138 S. Ct.
2044, 2055 (2018)). We decline to consider Patent Owner’s constitutional
argument because the Federal Circuit addressed this issue in
Arthrex. Arthrex, 941 F.3d at 1328.
V. CONCLUSION14
For the foregoing reasons, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claims 1, 2, 5–7, 11,
12, 14–16, 19, and 20 are unpatentable as having been obvious over
Petitioner’s Kontos-based grounds. Petitioner has not shown by a
preponderance of the evidence, however, that claims 3, 4, 8, 9, 14, 17, and
18 are unpatentable.
With respect to Patent Owner’s Contingent Motion to Amend, we
determine that Petitioner has not demonstrated by a preponderance of the
evidence that proposed substitute claims 23–25 would have been
unpatentable as having been obvious over Itou in view of Ressemann or
Kataishi, Kontos in view of Ressemann and Takahashi, or Kontos in view of
Kataishi. Accordingly, Patent Owner Contingent Motion to Amend is
granted.

14 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
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In summary:

The table below summarizes our conclusions as to Patent Owner’s
Revised Motion to Amend the claims.
Motion to Amend Outcome Claim(s)
Original Claims Cancelled by Amendment
Substitute Claims Proposed in the Amendment 23–25
Substitute Claims: Motion to Amend Granted 23–25
Substitute Claims: Motion to Amend Denied
Substitute Claims: Not Reached

VI. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that Petitioner demonstrates by a preponderance of the
evidence that claims 1, 2, 5–7, 11, 12, 14–16, 19, and 20 of U.S. Patent No.
8,048,032 are unpatentable;
FURTHER ORDERED that Petitioner has not demonstrated by a
preponderance of the evidence that claims 3, 4, 8, 9, 13, 17, and 18 are
unpatentable;
Claims

35
U.S.C. §
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1–7, 9,
11–16,
18, 19
103 Kontos, Adams 1, 2, 5–7, 11,
12, 14–16, 19
3, 4, 9, 13, 18
8, 17 103 Kontos, Adams, Takahashi
8, 17
20 103 Kontos, Adams, Berg
20
Outcome 1, 2, 5–7, 11,
12, 14–16, 19,
20
3, 4, 8, 9, 13,
17, 18
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FURTHER ORDERED that Patent Owner’s Contingent Motion to
Amend U.S. Patent No. 8,048,032 to add proposed substitute claim 43 and
44 is granted; and
FURTHER ORDERED that, because this is a final written decision,
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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FOR PETITIONER:

Cyrus Morton
Sharon Roberg-Perez
Christopher Pinahs
William E. Manske
Emily J. Tremblay
ROBINS KAPLAN LLP
cmorton@robinskaplan.com
sroberg-perez@robinskaplan.com
cpinahs@robinskaplan.com
wmanske@robinskaplan.com
etremblay@robinskaplan.com

FOR PATENT OWNER:

Derek Vandenburgh
Dennis Bremer
CARLSON, CASPERS, VANDENBURGH & LINDQUIST, P.A.
dvandenburgh@carlsoncaspers.com
dbremer@carlsoncaspers.com

PUBLIC VERSION