Teleflex Medical Devices S.A.R.L.

Patent Trials and Appeals Board

Jun 17, 2021

IPR2020-00136 (P.T.A.B. Jun. 17, 2021)

PUBLIC VERSION
Trials@uspto.gov Paper
104 571-272-7822 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.
IPR2020-00136
Patent RE45,776 E
Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
PAULRAJ, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining No Challenged Claims Unpatentable
Not Deciding Patent Owner’s Motion to Amend
35 U.S.C. § 318(a)
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I. INTRODUCTION
This is our Final Written Decision entered pursuant to 35 U.S.C.
§ 318(a) and 37 C.F.R. § 42.73. For the reasons explained in our analysis
below, we determine that Petitioner has not demonstrated that any of the
challenged claims are unpatentable in this proceeding.
On November 14, 2019, Medtronic, Inc. and Medtronic Vascular, Inc.
(collectively, “Petitioner”) filed a Petition requesting an inter partes review
of claims 25–27, 29–33, 35–39, 41–49, and 52–56 of U.S. Patent No.
RE45,776 E (“the ’776 patent,” Ex. 1401). Paper 1 (“Pet.”). Teleflex
Innovations S.À.R.L. (“Patent Owner”)1 filed a Preliminary Response.
Papers 9 (confidential version), 10 (redacted version) (“Prelim. Resp.”). In
our Institution Decision, we determined that there was a reasonable
likelihood that Petitioner would prevail with respect to at least one
challenged claim and accordingly, instituted an inter partes review pursuant
to 35 U.S.C. § 314 based on all challenges presented in the Petition. Paper
20 (“Institution Decision” or “Inst. Dec.”).
Following institution, Patent Owner filed a post-institution Response
(Papers 39 (confidential), 40 (redacted), “PO Resp.”) and Petitioner filed a
Reply (Papers 69 (redacted), 70 (confidential), “Reply”). Patent Owner then
filed a Sur-reply. Papers 85 (confidential), 86 (redacted) (“PO Sur-Reply”).
Patent Owner also filed a Contingent Motion to Amend. Paper 35 (original),
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 ’776 patent] to Teleflex Life Sciences Limited.” Paper 7,
2
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Paper 81 (corrected) (“Motion”).2 The Motion requests that if any of claims
27, 33, 37, 42, 43, 45, 47, or 56 is found unpatentable, they should be
replaced by proposed substitute claims 58–65. Motion 1. Petitioner filed
Oppositions to the original and corrected Motions to Amend. Papers 72, 84
(“Opp.”). Patent Owner filed a Reply in Support of the Corrected Motion to
Amend (Paper 88), and Petitioner filed a Sur-Reply (Paper 94).
An oral hearing was held on March 8, 2021, and a transcript of the
hearing is included in the record. Papers 102 (redacted version), 103
(confidential version).
A. Real Parties-in-Interest
Petitioner identifies Medtronic, Inc. and Medtronic Vascular, Inc. as
the real parties-in-interest, and notes that “Medtronic plc is the ultimate
parent of both entities.” Pet. 5. Patent Owner identifies the real parties-in-
interest for itself as Teleflex Medical Devices S.A.R.L., Vascular Solutions
LLC, Arrow International, Inc., Teleflex LLC, and Teleflex Life Sciences
Limited and notes that “Teleflex Incorporated is the ultimate parent of the
entities listed above.” Paper 4, 2; Paper 7, 2.
B. Related Matters
Patent Owner is asserting the ’776 patent against Petitioner in the
United States District Court for the District of Minnesota in Vascular
Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760. Pet. 5–6;
2 Pursuant to a stipulation by the parties, we authorized the filing of the
corrected Motion to Amend in order to clarify certain antecedent bases and
thereby simplify the issues.
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Paper 4, 2. The ’776 patent is also the subject of a declaratory judgement
action also in the United States District Court for the District of Minnesota
filed by another party, QXMedical, LLC v. Vascular Solutions, LLC, No. 17-
cv-01969, which was stayed pending our Institution Decision. Paper 17;
Paper 18. Petitioner further notes that the ’776 patent is a reissue of U.S.
Patent No. 8,292,850 (“’850 patent”, which was the subject of a prior district
court action and inter partes reviews in IPR2014-00762 and IPR2014-00763
filed by a different petitioner. Pet. 6.
Petitioner has also filed another petition challenging the ’776 patent
based on different prior art, and we instituted inter partes review based on
that petition on June 8, 2020. IPR2020-00135, Paper 22. In addition,
Petitioner filed concurrent petitions challenging other related patents: U.S.
Patent No. 8,048,032 (IPR2020-00126; IPR2020-00127), RE45,380
(IPR2020-00128; IPR2020-00129; IPR2020-00130; IPR2020-00131), RE
45,760 (IPR2020-00132; IPR2020-00133; IPR2020-00134), and RE47,379
(IPR2020-00137; IPR2020-00138).
C. The ’776 Patent
The ’776 patent, entitled “Coaxial Guide Catheter for Interventional
Cardiology Procedures,” issued on October 27, 2015, as a re-issue of the
’850 patent, which claims priority to a non-provisional application filed May
3, 2006. Ex. 1401, codes (45), (60), (64).3
3 We consider May 3, 2006 to be the effective filing date for purposes of our
analysis here, but note that we determined in IPR2020-00135 that Patent
Owner demonstrated an earlier conception and reduction to practice in order
to antedate the prior art reference at issue in that proceeding. The priority
date for the ’776 patent is not contested in this proceeding.
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The ’776 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
’776 patent, interventional cardiology procedures often include inserting
guidewires or other instruments through catheters into coronary arteries that
branch off from the aorta. Id. at 1:45–47. 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 1:50–55. 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 1:59–65. 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 1:65–67.
To solve this problem, the ’776 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 3:15–18. The ’776 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
after the coaxial guide catheter is in place. Id. at 3:24–27. Figures 1 and 2,
reproduced below, show a coaxial guide catheter and a tapered inner catheter
in accordance with the invention described in the ’776 patent:
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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 5:47–52, Figs. 1, 2. As shown above, coaxial guide catheter
assembly 10 includes coaxial guide catheter 12 and tapered inner catheter
14. Id. at 6:37–39. Coaxial guide catheter 12 includes tip portion 16,
reinforced portion 18, and rigid portion 20. Id. at 6:40–41. Tip portion 16
generally includes bump tip 22 and marker band 24. Id. at 6:44–45. Bump
tip 22 includes taper 26 and is relatively flexible. Id. at 6:45–46. Marker
band 24 is formed of a radiopaque material such as platinum/iridium alloy.
Id. at 6:49–50. Tapered inner catheter tip 42 includes tapered portion 46 at a
distal end thereof, and straight portion 48. Id. at 7:22–23. Both tapered
portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
the figures above). Id. at 7:23–24. Tapered inner catheter 14 may also
include clip 54 at a proximal end thereof to releasably join tapered inner
catheter 14 to coaxial guide catheter 12. Id. at 7:27–29.
Figure 4 of the ’776 patent is reproduced below:
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Figure 4 is a sectional view of a coaxial guide catheter. Id. at 5:58–60. As
shown in Figure 4, rigid portion 20 includes first full circumference portion
34, hemicylindrical portion 36, and arcuate portion 38. Id. at 6:64–7:3.
Hemicylindrical portion 36 includes 40% to 70% of the circumference of the
rigid portion tube, and may extend approximately 20 to 75 cm in length. Id.
at 7:7–10. Hemicylindrical portion 36 tapers into arcuate portion 38, which
extends from 25% to 40% of the circumference of the tube. Id. at 7:11–14.
In operation, the tapered inner catheter is inserted inside and through
the coaxial guide catheter. Id. at 4:43–44. 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 4:47–54. The tapered inner catheter may be removed once the coaxial
guide catheter/guide catheter combination has been inserted sufficiently into
the ostium of the coronary artery to achieve deep seating. Id. at 4:54–57.
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 4:61–
64. 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
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directing the coronary therapeutic device past a tough lesion. Id. at 4:64–
5:3.
D. Illustrative Claims
Among the challenged claims, independent claim 25 is representative
and reproduced below:
25. A guide extension catheter for use with a guide
catheter, comprising:
a substantially rigid segment;
a tubular structure defining a lumen and positioned distal
to the substantially rigid segment; and
a segment defining a partially cylindrical opening
positioned between a distal end of the substantially rigid segment
and a proximal end of the tubular structure, the segment defining
the partially cylindrical opening having an angled proximal end,
formed from a material more rigid than a material or material
combination forming the tubular structure, and configured to
receive one or more interventional cardiology devices
therethrough when positioned within the guide catheter,
wherein a cross-section of the guide extension catheter at
the proximal end of the tubular structure defines a single lumen.
Ex. 1401, 13:35–52 (cl. 25).
E. Prior Art and Asserted Grounds
We instituted review of claims 25–27, 29–33, 35–37, 39, 41–49, and
52–56 of the ’776 patent on the following grounds (Inst. Dec. 7–8, 41):
Claim(s) Challenged 35 U.S.C. §4 Reference(s)/Basis
4 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103, effective March 16,
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25–27, 29, 33, 35–37,
39, 41–49, 52
103(a) Kontos,5 Ressemann,6 the
knowledge of a person of
ordinary skill in the art
(“POSITA”)
30–32, 53–56 103(a) Kontos, Ressemann, Takahashi,7
the knowledge of POSITA
52 103(a) Kontos, Ressemann, Kataishi,8
the knowledge of POSITA
53–56 103(a) Kontos, Ressemann, Takahashi,
Kataishi, the knowledge of
POSITA
Petitioner relies on the expert declarations of Dr. Stephen Jon David
Brecker (Ex. 1405, 1806, 1904), Dr. Richard A. Hillstead (Ex. 1442, 1905),
Mr. Michael Jones (Ex. 1807), Dr. Paul Zalesky (Ex. 1830, 1919). Patent
Owner relies on the declarations of Mr. Peter T. Keith (Ex. 2042, 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).
2013. Because the application from which the ’776 patent issued was filed
before this date, the pre-AIA version of § 103 applies.
5 Kontos, US 5,439,445, issued August 8, 1995 (Ex. 1409) (“Kontos”).
6 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1408)
(“Ressemann”).
7 Takahashi, et al., New Method to Increase a Backup Support of a 6 French
Guiding Coronary Catheter, Catheterization and Cardiovascular
Interventions 63:452–456 (2004) (Ex. 1410) (“Takahashi”).
8 Kataishi, US 2005/0015073 A1, published January 20, 2005 (Ex. 1425)
(“Kataishi”).
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II. ANALYSIS
A. Level of Ordinary Skill in the Art
We consider the asserted grounds of unpatentability in view of the
understanding of a POSITA. Petitioner 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. 13. 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. Additionally, Petitioner contends that
“[e]xtensive experience and technical training might substitute for education,
and advanced degrees might substitute for experience.” Id.
Patent Owner “does not dispute Medtronic’s proposed definition of a
POSITA.” PO Resp. 8.
Upon review of the parties’ arguments and supporting evidence, we
adopt Petitioner’s definitions for a POSITA, as they are undisputed and
consistent with the level of skill reflected in the prior art and the
specification of the ’776 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).
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B. 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). This standard requires that we
construe claims “in accordance with the ordinary and customary meaning of
such claim[s] as understood by one of ordinary skill in the art and the
prosecution history pertaining to the patent.” Id.
Petitioner proposes constructions for the claim terms a “concave
track” and “flexural modulus.” Pet. 13–16. Patent Owner does not propose
any claim constructions of its own for these terms, but argues that claim 36
does not require two inclines. PO Resp. 1–2.
Upon review of the parties’ arguments and supporting evidence, we
determine that no terms of the ’776 patent require construction for purposes
of this Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
795, 803 (Fed. Cir. 1999) (holding that “only those terms need to be
construed that are in controversy, and only to the extent necessary to resolve
the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean
Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in
the context of an inter partes review).
C. Ground 1: Obviousness in View of Kontos, Ressemann, and the
Knowledge of a POSITA
Petitioner asserts that claims 25–27, 29, 33, 35–37, 39, 41–49, and 52
are rendered obvious in view of Kontos, Ressemann, and the knowledge of a
POSITA. Pet. 8.
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1. Overview of Kontos (Ex. 1409)
Kontos is a U.S. patent that issued from an application filed on June
27, 1994. Ex. 1409. Thus, on its face, Kontos qualifies as prior art under
pre-AIA 35 U.S.C. § 102(b).
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 PTCA9 balloon into a lesion.”
Id. at 1:9–13.
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 longitudinal cross-section a tubular body having a soft tip and radiopaque
marker, and a manipulating wire.” Id. at 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 a tube 16 having a base portion
18 at its proximal end 20.” Id. at 3:47–49. “Tube 16 has a continuous
lumen 22 there through 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.
9 PTCA stands for “percutaneous transluminal coronary angioplasty.”
Ex. 1405 ¶ 37.
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Insertion/manipulation 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 “generally are
suitable for existing PTCA catheters.” Id. at 4:61–64.
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.
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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
catheter 38 and advanced to the distal end of this catheter by exerting axial
force on wire 14 and catheter tube 50 simultaneously. 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, into the 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 5:52–56. “To help ensure that proximal end 20 does
not unintentionally exit from the guide catheter,” guide catheter 38 may be
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provided with “a radially inwardly formed annular ridge 44 for impeding
further axial movement of funnel 26 beyond the distal end of guide catheter
38.” Id. at 5:59–6:2.
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.
Although the Figures depict the use of a PTCA catheter, Kontos
discloses 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.” Id. at 9:47–50.
2. Overview of Ressemann (Ex. 1408)
Ressemann is a U.S. patent that issued on October 20, 2009 from an
application filed on August 9, 2002. Ex. 1408. Thus, on its face,
Ressemann qualifies as prior art under pre-AIA 35 U.S.C. § 102(e).
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.” Id. at 1:13–16.
Figures 1A and 1B of Ressemann are reproduced below:
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Figure 1A is a cross-sectional view of a partial length evacuation sheath
assembly 100. Id. at 3:16–18. 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 1A 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 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, which preferably is
made of a relatively flexible polymer, as well as evacuation lumen 140 and
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inflation lumen 142. 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. 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 1B shows inflation lumen 142, a “second and preferably
smaller lumen of the multi-lumen tube 138.” Id. at 6:61–62. Inflation
lumen 142, having open proximal end 142a and closed distal end 142b, is
designed to provide fluid to inflate balloons on evacuation head 132. Id. at
6:61–64. Evacuation sheath assembly 100 has a shaft that includes proximal
shaft portion 110, intermediate shaft portion 120, and distal shaft portion 130
(not shown in Figure 1A). Id. at 10:30–35. 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. Inflation lumen 142, having open proximal end 142a and closed distal
end 142b, is designed to provide fluid to inflate balloons on evacuation head
132. Id. at 6:61–64.
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
then advanced over the guide wire and positioned within the blood vessel.
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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. Id. at 13:35–41.
According to Ressemann, “[t]his retrograde flow will carry any dislodged
material out of the patient and into a collection chamber.” Id. at 13:43–44.
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3. The Parties’ Arguments
Petitioner contends that the combination of Kontos and Ressemann, as
set forth above, teaches each of the claim limitations. Petitioner identifies
where each limitation of independent claim 25 is taught or suggested by
Kontos and Ressemann. Pet. 21–38. Petitioner relies upon the same
teachings and assertions with regard to independent claim 52. Id. at 53–56.
We focus on the parties’ arguments with regard to independent claim 25 as it
is dispositive to our conclusion for all the claims challenged under Ground 1.
With regard to independent claim 25, Petitioner asserts the following:
With respect to the requirement for “[a] guide extension catheter for
use with a guide catheter,” Petitioner contends that, to the extent the
preamble is limiting, 10 Kontos’s support catheter assembly 10 meets this
limitation. Pet. 21–22 (citing Ex. 1405 ¶ 154; Ex. 1409, 2:16–22, 3:45–46,
5:49–52, Fig. 1, Fig. 6B).
With respect to the requirement for “a substantially rigid segment.”
Petitioner contends that the insertion/manipulation wire 14 that is proximal
of tube 16 in Kontos’s support catheter 10 meets this limitation. Id. at 22–24
(citing Ex. 1405 ¶ 155; Ex. 1409, Abstract, 5:25–30, Fig. 1). Petitioner
notes that the ’776 patent precludes the substantially rigid segment from
overlapping with the tubular structure, and has applied the claims as recited
in the ’776 patent and as interpreted by Patent Owner in the district court.
Id. at 23 n.6 (citing Ex. 1477, 127:24–128:14, 144:9–22, 145:9–17).
10 We need not determine at this time whether the preamble of claim 25 is
limiting because Petitioner shows sufficiently for purposes of institution that
the recitation in the preamble is disclosed in Kontos.
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With respect to the requirement for “a tubular structure defining a
lumen and positioned distal to the substantially rigid segment,” Petitioner
identifies the tube 16 in Kontos’s support catheter as meeting this limitation.
Id. at 24–25 (citing Ex. 1405 ¶ 156; Ex. 1409, 3:49–50, 3:56–57, Figs. 1,
6C).
With respect to the requirements for “a segment defining a partially
cylindrical opening positioned between a distal end of the substantially rigid
segment and a proximal end of the tubular structure” and the “segment
defining the partially cylindrical opening having an angled proximal end,”
Petitioner relies upon the combination of Kontos with Ressemann and/or the
knowledge of a POSITA as meeting these requirements. Id. at 25–34.
Petitioner acknowledges that Kontos does not teach a partially cylindrical
opening, but contends that such partially cylindrical openings were well-
known in the art. Id. at 27 (citing Ex. 1405 ¶¶ 90–108, 158–59; Ex. 1442 ¶¶
73-78; Ex. 1407, 4:11; Ex. 1408, 12:9–13:60, Figs. 6A–6E; Ex. 1418, Fig. 7;
Ex. 1432, 119, Fig. 1; Ex. 1433 ¶¶ 035, 49, Fig. 2; Ex. 1435 ¶ 66; Ex. 1450,
Fig. 7; Ex. 1461, 6:9–11, Fig. 1B). As one such example, Petitioner
contends that Ressemann teaches an evacuation assembly 100/2100
(“extension catheter”) where the entry to the evacuation lumen 140a/2140 is
“preferably angled.” Id. (citing Ex. 1405 ¶¶ 160–161; Ex. 1408, 6:52–60
(100 embodiment), 24:33–38 (2100 embodiment)).
Petitioner contends that a POSITA would have been motivated, with a
reasonable expectation of success, to add Ressemann’s partially cylindrical
opening to Kontos’s structure as shown in the annotated figure below:
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Id. at 28–29 (citing Ex. 1405 ¶¶ 161–174; Ex. 1442 ¶¶ 91–100; Ex. 1409,
Fig. 1). The annotated figure above shows a magnified version of Kontos’s
Figure 1 modified to include Ressemann’s support collar (labeled the
“partially cylindrical opening”) in between the wire 14 (labeled the
“substantially rigid segment”) and tube 16 (labeled the “tubular structure”).
Petitioner contends that the result of the combination would necessarily
include a segment with an angled proximal end. Id. at 35 (citing Ex. 1405 ¶
175).
Petitioner identifies multiple reasons as to why a POSITA would have
been motivated to modify Kontos to add a partially cylindrical opening
proximal of the tubular structure, as taught by Ressemann. Id. at 29 (citing
Ex. 1405 ¶¶ 162–72; Ex. 1442 ¶¶ 91–99). Petitioner contends that the use of
a partially cylindrical opening could permit a reduction of the outer diameter
of the catheter assembly without resulting in a commensurate reduction in
the area of the point of entry to the extension catheter, and this would have
been beneficial for the small diameter (6 French) guiding catheters that were
commonly used as of the priority date of the ’776 patent. Id. at 29–31
(citing Ex. 1405 ¶¶ 163–165; Ex. 1406, Fig. 6B; Ex. 1442 ¶ 96). Petitioner
further contends that a POSITA would have been motivated to use a
partially cylindrical opening in order to facilitate “smoother” reception,
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passage, and reentry of the device as it enters the lumen of the child catheter
and navigates winding vasculature. Id. at 31–32 (citing Ex. 1405 ¶ 166–173;
Ex. 1442 ¶¶ 80, 89–95, 98–100). Petitioner also contends that employing
Ressemann’s partially cylindrical opening (as opposed to an opening
perpendicular to the longitudinal axis) with Kontos’s device would have
amounted to a simple substitution of a known element to obtain predictable
results. Id. at 33–34 (citing KSR Int’l co. v. Teleflex Inc., 550 U.S. 398, 417
(2007)).
With respect to the requirement that the segment is “formed from a
material more rigid than a material or material combination forming the
tubular structure,” Petitioner contends that the incorporation of Ressemann’s
support collar 2141 to Kontos’s structure would meet this requirement. Id.
at 35–36 (citing Ex. 1405 ¶¶ 176–177; 1442 ¶¶101–105). Petitioner points
out that Ressemann’s support collar is preferably “a metallic material” with
“suitable rigidity to prevent kinking,” while Kontos’s tube 16 includes “any
pliable material,” but preferably is composed of a molded plastic material,
such as polyethylene. Id at 36 (citing Ex. 1408, 24:47–55, 24:62–67, 25:13–
16; Ex. 1409, 4:1–4).
With respect to the requirement that the segment is “configured to
receive one or more interventional cardiology devices therethrough when
positioned within the guide catheter,” Petitioner contends that Kontos
teaches that the extension catheter (support catheter 10) is positioned within
the guide catheter when it receives the interventional cardiology device. Id.
at 37 (citing Ex. 1409, 4:66–5:2, 5:16–18, 7:45–52, Figs. 6A–C; Ex. 1405
¶ 178). Petitioner also argues that the “configured to” language recites an
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intended use, to which no patentable weight should be given. Id. (citing In
re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)).
Finally, with respect to the requirement “wherein a cross-section of
the guide extension catheter at the proximal end of the tubular structure
defines a single lumen,” Petitioner contends that Kontos discloses an
extension catheter (support catheter 10) where a cross-section at the
proximal end of the tubular structure defines a single lumen, and further
contends that the addition of Ressemann’s support collar 2141 would not
result in more than one lumen. Id. at 37–38 (citing Ex. 1405 ¶ 179; Ex. 1442
¶ 107).
Patent Owner argues that Petitioner has not shown, for several
reasons, that the claimed guide extension catheter, including a “partially
cylindrical opening,” would have been obvious based on Kontos and
Ressemann. PO Resp. 9–29. Patent Owner contends that a POSITA would
have expected that the removal of Kontos’s funnel in favor of Ressemann’s
support collar would make the device less effective because it would expose
the gap that the funnel was intended to bridge, and greatly increase the
likelihood of catching or hang-up. Id. at 19. Patent Owner further contends
that removing Kontos’s funnel would also be counter-productive for the
purpose of that device because it would reduce the target area of the
proximal opening for fixed-wire balloon catheters. Id. at 20–21. Patent
Owner also argues that Petitioner’s purported motivations for replacing
Kontos’s funnel portion with Ressemann’s support collar are based on
hindsight and unsupported by the evidence. Id. at 22–29. Patent Owner also
argues that there are additional reasons why the Petition fails to show that
claims 52, 36–37, and 49 would have been obvious based on Kontos and
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Ressemann, including with respect to the requirement for “two inclined
regions.” Id. at 29–43. Patent Owner also presents objective indicia
evidence in support of the non-obviousness of the challenged claims. Id. at
53–73. Patent Owner contends that a nexus exists between the inventions of
independent claims 25, 52, and 53 and the objective evidence of non-
obviousness. Id. at 73–80.
4. Analysis of Prior Art Arguments
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 a partially cylindrical opening proximal of the tubular structure,
as taught by Ressemann. Patent Owner provides several arguments in
response as to why the modifications suggested by Petitioner are grounded
in hindsight.
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,11
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. We further note that the funnel portion
of Kontos appears to be crucial to the device’s ability to receive and
facilitate exchange of balloon catheters: “Because of flared funnel portion
11 The parties refers to the limitations reciting a “partially cylindrical
opening” in the ’776 patent claims as the “side opening” limitations. PO
Resp. 1; Reply 1.
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26, the second catheter can negotiate the transition from guide catheter 38
into body 12.” Ex. 1409, 7:20-22; Ex-2138, ¶ 143; Ex-2145, ¶ 148.
Ressemann, however, explains that the angled proximal opening on its 2100
embodiment creates potential issues with intravascular device catching or
hang-up, and proposes a different structure (“reverse bevel 2125”) to try to
mitigate this. Ex. 1408, 25:17-29; Ex. 2138 ¶ 148. In contrast, Ressemann’s
Figure 11 embodiment has a “flare 131” similar to Kontos’s funnel, and
Ressemann does not identify any catching or hang-up issues created by the
flare. Ex. 1408, 7:40-47, Fig. 11A; Ex. 2138 ¶ 148. We credit the testimony
of Patent Owner’s expert Mr. Keith that a POSITA would not have been
motivated to slice off the funnel of Kontos as the Petitioner advocates, in
view of the significant catching/hang-up problems it would create. Ex.
2138, ¶¶ 148-49.
Ultimately, we determine that Petitioner has not met its burden for
these claims, particularly in view of the objective indicia evidence provided
by Patent Owner, as discussed below.
5. Analysis of Objective Indicia Arguments
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.
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
in which they are presented. Id. (citing Transocean Offshore Deepwater
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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. 53–73.
Patent Owner also presents evidence that the ’776 patent was licensed by a
competitor. Id. at 65. Patent Owner contends this objective evidence of
non-obviousness precludes a determination of obviousness with respect to
independent claims 25 and 52, and 53. Id. at 73–80.
a) Long-Felt Need
“Evidence of long felt but unresolved need tends to show non-
obviousness because it is reasonable to infer that the need would not have
persisted had the solution been obvious.” WBIP, 829 F.3d at 1332. Patent
Owner contends that in the late 1980s and early 1990s it was recognized in
the interventional cardiology field that there was a tendency for a guide
catheter to back out of the ostium if a stent or balloon encountered
significant resistance within the coronary vasculature. PO Resp. 52–53.
This problem often prevented successful procedures due to the inability to
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advance the stent or balloon into the lesion needing treatment. Ex. 2145
¶¶ 41–42; Ex. 2215 ¶¶ 10–19; Ex. 2138 ¶¶ 213–214.
The long-felt need for a product that would not back out of the ostium
when a stent or balloon encountered significant resistance is supported by
the testimony of Dr. John Graham (Ex. 2145), Dr. Lorenzo Azzalini
(Ex. 2151), and Dr. Craig Thompson (Ex. 2215). Each of these doctors has
performed thousands of percutaneous coronary interventions, including
complex percutaneous coronary interventions, and they unanimously agree
that since at least the early 1990s the field struggled with the problem of
insufficient guide catheter backup support when seeking to navigate difficult
anatomy or crossing difficult lesions. Ex. 2145 ¶¶ 10, 42; Ex. 2215 ¶¶ 2–6;
Ex. 2151 ¶¶ 2, 4.
Dr. Graham explains that in this time period there were at least four
approaches a physician could use in an attempt to overcome the lack of
backup support: a physician could attempt to “deep seat” the guide catheter
in the ostium; “upsize” the catheter or change to a stiffer catheter; thread a
second guidewire, or “buddy” wire; or use a mother-and-child approach,
inserting a smaller, full-length guide catheter into the already-in-place guide
catheter. Ex. 2145 ¶ 50. Drs. Graham, Azzalini, and Thompson testifiy that
each of these approaches presented significant difficulties related to time,
expense, and potential injury to the patient. Id. ¶¶ 51–66; Ex. 2215 ¶¶ 9–19;
Ex. 2151 ¶¶ 9–14. For example, Dr. Graham testifies that switching to a
mother-and-child approach required a longer 300 cm “exchange length”
guidewire that is more difficult to manage than the typical 180-200 cm
guidewire and requires the assistance of a second operator. Ex. 2145 ¶¶ 62–
63. The mother-and-child approach also required “re-crossing a lesion a
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second time,” which Dr. Graham explains is “highly undesirable and
potentially dangerous.” Id. ¶ 63.
Dr. Graham, Dr. Thompson, and Dr. Azzalini agree that the
GuideLiner products, with their pushrod structure, distal tubular structure,
and side opening located at the junction of the pushrod and tubular structure,
overcame the backout problem, allowing for stents and balloons to be
delivered deep into the coronary vasculature and allowing physicians to treat
patients “who otherwise would have been untreatable with a catheter
procedure.” Ex. 2215 ¶¶ 22–23; Ex. 2145 ¶ 67 (Dr. Graham testifying that
the GuideLiner product “provided a highly effective, reliable solution to the
longstanding problem of lack of backup support.”); Ex. 2151 ¶ 9
(Dr. Azzalini testifying that the GuideLiner product “changed the field of
interventional cardiology” and gave cardiologists a device “that finally
solved the long-existing guide catheter backout problem.”).
Petitioner does not generally dispute the impact the GuideLiner
products had on the field of interventional cardiology, but contends that
prior art devices, including those taught by Kontos and Ressemann,12
provided backup support, and it was understood in the art that full-length,
mother-and-child devices “provide guide extension and additional backup
support.” Pet. Reply 25–31 (citing Ex. 1800, 26:10–27:8; Ex. 1817, 25:20–
26:9, 37:8–38:6). The evidence of record persuasively demonstrates,
12 For the reasons discussed in IPR2020-00135, we find that Itou is not prior
art to the ’776 patent. See IPR2020-00135, Paper 126. As such, we do not
consider Petitioner’s arguments with respect to Itou in our analysis of
secondary considerations. Even if we were to consider Itou, however, it
would not change our analysis with respect to secondary considerations.
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however, that the long-felt need for improved backup support was
unresolved in the art prior to introduction of the GuideLiner devices. As
noted by Petitioner, Kontos and Ressemann both provide some level of
backup support, but there is no persuasive evidence that either of these
products resolved the long-felt need in the art for a device that would avoid
backout problems when difficult lesions are encountered during a procedure.
See Ex. 2151 ¶¶ 8–9. And although mother-and-child devices were known
to provide additional backup support, Patent Owner’s declarants
persuasively demonstrate that a mother-and-child approach was not a safe or
time- and cost-effective solution to the backout problem addressed by the
GuideLiner products. PO Resp. 56–58; Ex. 2151 ¶¶ 6–8; Ex. 2145 ¶¶ 60–
66; Ex. 2215 ¶¶ 16–19 (Dr. Thompson testifying that the problems related to
the mother-and-child approach led to very limited use of this technique).
Indeed, in view of its inherent limitations, the mother-and-child approach
was rarely, if ever, used by interventional cardiologists. Ex. 2145 ¶ 66 (Dr.
Graham testifying that the mother-and-child approach “had many significant
drawbacks” and he was “not aware of any instances in which a mother-and-
child system was successfully marketed.”); Ex. 2215 ¶ 16 (“The mother-and-
child approach was rarely, if ever, used by interventional cardiologist for a
number of reasons.”).
In view of the foregoing, we credit the testimony of Drs. Graham,
Thompson, and Azzalini and find that the GuideLiner products solved a
long-felt but unmet need in the art, allowing physicians to perform
previously impossible coronary procedures.
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b) 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
nearly in annual revenue. PO Resp. 58–62 (citing Ex. 2153
¶¶ 2–8; Ex. 2154); Ex. 2198, 3.
Petitioner does not dispute that Patent Owner’s GuideLiner products
are commercially successful. See generally Pet. Reply 25–32.
Upon review of the arguments and the evidence of record, we find
that the GuideLiner products achieved a high level of commercial success.
c) 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
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successfully performed.” Ex. 2194, 142, 147; PO Resp. 64. 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. 63. 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. 64.
Petitioner does not generally dispute that Patent Owner’s GuideLiner
product was praised in the industry. See generally Pet. Reply 25–32.
Upon review of the parties’ arguments and the evidence of record, we
find that the GuideLiner product received significant praise in the industry.
d) 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. 65 (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 30 n.7.
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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
which the license was granted, except to concede that the license was taken
in settlement of litigation. See PO Resp. 65; 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.
e) 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, Patent Owner contends its
competitors copied the GuideLiner products, whereas Petitioner contends the
competing products identified by Patent Owner merely copied what was
known in the prior art.
i. The Parties’ Arguments for Copying
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. 66. These products are
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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. Id. In support of its
arguments, Patent Owner provides the following annotated comparison of
GuideLiner V1 and the Guidezilla product. Id.
The figure above shows the general structure and length of the GuideLiner
V1 and Guidezilla products. Referencing the above figures, Mr. 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, Mr. 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.
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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. 68 (citing Ex. 2138 ¶¶ 231–249; Ex. 2145 ¶¶ 261–
263; Ex. 2151 ¶ 12; Ex. 2046 ¶¶ 68–79; Ex. 2200, 1).
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 69 (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. 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.
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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 71).
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 71–72 (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 27–32. In particular, Petitioner asserts that
Guidezilla and the Boosting Catheter are similar to Ressemann in that they
are rapid exchange devices that are “configured to deliver a wide variety of
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IVCDs and provide increased backup support when extended partially past a
[guide catheter].” Id. at 30. Petitioner further asserts that “Guidezilla and
Boosting Catheter, like Ressemann’s collar, have a side opening with more
than one inclineGuidezilla also had a side opening.” Id.
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.’” Id. at 30–31. In
addition, Petitioner contends that Patent Owner “ignores other important
differences between GuideLiner and Telescope . . . including Telescope’s
hydrophilic coating and round pushwire,” which are differences Patent
Owner “itself emphasizes . . . as core distinguishing features” between the
two products. Id. at 31–32 (citing Ex. 1824, 4:22–5:10).
ii. Analysis for 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).
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 had access to
the GuildeLiner products. See Ex. 2200, 1; Ex. 2138 ¶ 247; Ex. 2196, 1; Ex.
2202, 1–2. Patent Owner and Mr. Keith also persuasively demonstrate that
the Guidezilla and Telescope products,13 when considered as a whole, are
13 Patent Owner provides no figures or description comparing the
GuideLiner product to the Boosting Catheter. Although Mr. Keith does
provide such a comparison, Patent Owner may not incorporate these
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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.14 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 Mr. Keith, however, that the overall design of the two products is
substantially similar (Ex. 2138 ¶¶ 250–262), and there is little doubt that
Petitioner had access to GuideLiner products and
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.
14 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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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.
f) 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)).
Mr. Keith provides unrebutted claim charts demonstrating that the
GuideLiner V1, V2, and V3 products read on every limitation of claims 25,
52, and 53 of the ’776 patent. Ex. 2138, Appendix B at 1–27 (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. 73–80. Accordingly, a
presumption of nexus applies in this case. Id.; 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
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patented invention, such as additional unclaimed features or improvements
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 the “side opening” was generally known in the
art, and there is no evidence that the presence of such a side opening drove
sales of the GuideLiner. Pet. Reply 26–27. 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 the prior art including Kontos and Ressemann all
disclose rapid exchange and a lumen close in size to the guide catheter
(providing backup support), while Ressemann included side openings. Id. at
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
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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
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 25, 52, and 53 of the ’776 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.”).
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6. Conclusion with Respect to Claims 25–27, 29, 33, 35–37, 39, 41–49,
52 (Ground 1)
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 independent claims 25 and 52.
Accordingly, Patent Owner’s secondary considerations evidence points
strongly to the nonobviousness of claims 25 and 52 of the ’776 patent.
Weighing all the evidence presented by the parties, we determine that
Petitioner has not demonstrated by a preponderance of the evidence that
claims 25 and 52 would have been obvious over Kontos and Ressemann.
See Transocean, 699 F.3d at 1354–55. Because claims 26, 27, 29, 33, 35–
37, 39, and 41–49 depend from claim 25, and because Petitioner’s
arguments with respect to these claims do not overcome the issues addressed
above with respect to claim 25 or the objective indicia of unpatentability, we
also determine that Petitioner has not demonstrated by a preponderance of
the evidence that these dependent claims would have been obvious over
Kontos and Ressemann.
D. Ground 2: Obviousness in view of Kontos, Ressemann, Takahashi,
and the Knowledge of a POSITA
For its Ground 2 challenge, Petitioner asserts that claims 30–32 and
53–56 would have been obvious in view of Kontos, Ressemann, Takahashi,
and the knowledge of a POSITA. Pet. 56–66.
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42
1. Overview of Takahashi (Ex. 1410)
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 publication date of December 2004 and a copyright date of 2004. Id.
To establish the public accessibility of Takahashi, Petitioner relies upon the
declaration of Dr. Sylvia D. Hall-Ellis, who attests that “[i]n view of the
MARC record for Exhibit 1410, the Takahashi article was publicly available
no later than December 17, 2004, because the serial title had been cataloged
and indexed at the National Library of Medicine and made part of its online
catalog database.” Ex. 1478 ¶ 47. Based on this evidence, we are persuaded
that Petitioner has established a reasonable likelihood that Takahashi
qualifies as a prior art printed publication under 35 U.S.C. § 102(b). See
Hulu, LLC v. Sound View Innovations, LLC, Case IPR2018-01039 (PTAB
Dec. 20, 2019) (Paper 29) (precedential).
Takahashi discusses the use of a guiding catheter in percutaneous
coronary intervention (PCI). See generally Ex. 1410. 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 the minimal damage and then it can be inserted more deeply into
the artery.” Id.
2. Analysis for Claims 30–32 and 53–56 (Ground 2)
Claim 30 depends from claim 25, and recites:
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wherein the guide catheter includes a lumen having a cross-
sectional inner diameter of six French, seven French or eight
French and wherein a cross-sectional inner diameter of the
lumen of the tubular structure is not more than one French size
smaller than a cross-sectional inner diameter of a lumen of the
guide catheter.
Ex. 1401, 13:66–14:5. Claim 53 is written in independent form, and recites
“the lumen having a uniform cross-sectional inner diameter that is not more
than one French size smaller than the cross-sectional inner diameter of the
lumen of the guide catheter.” Id. at 16:2–5.
For these claims, and their respective dependent claims (claims 31, 32
and 54–56), Petitioner relies upon the teachings of Kontos and Ressemann,
as discussed above, and further relies upon Takahashi’s disclosure of a
“five-in-six” system wherein the inner diameter of the 5 French catheter is
not more than one French smaller than the cross–sectional inner diameter of
the 6 French guide catheter. Pet. 59–60 (citing Ex. 1405 ¶¶ 233–235; Ex.
1442 ¶¶ 138–38, 142–145; Ex. 1410, 452). Petitioner contends it would
have been obvious to modify Kontos in light of Ressemann and Takahashi to
achieve the not-more-than-one French differential in order to improve
backup support, and a POSITA would have had a reasonable expectation of
success in removing Kontos’s funnel in favor of a proximal side opening,
which would result in a uniform diameter of the lumen and permit
achievement of the not-more-than-one French differential. Id. at 60.
With respect to Ground 2, Patent Owner contends that Kontos teaches
away from using a 5 French catheter as taught by Takahashi insofar as the
primary purpose of Kontos’s catheter is to “ptotect[] the fragile balloon” of
the balloon catheter by providing a smaller central tube 16 that provides a
snug fit around the balloon catheter. PO Resp. 44 (citing Ex. 2138 ¶ 204;
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Ex. 1409, 5:18–24). Patent Owner further argues that the secondary purpose
is to serve as a “stent” to prop open an artery and promote blood flow in
preparation for surgery, which requires that the support catheter be small
enough to pass all the way into the stenotic area deep within the coronary
vasculature. Id. at 44–45 (citing Ex. 1409, 2:16–32; 6:48–7:5; Figs. 8A–C;
Ex. 2138, ¶ 204). Patent Owner additionally contends that removing
Kontos’s funnel still would not allow Kontos to meet the “one French size”
limitation because the device still has raised-profile protrusions at “base
portion 18” and “distal marker band/tip” 28. Id. at 45–46 (citing Ex. 2138
¶¶ 205–07; Ex. 1405 ¶ 156). Patent Owner also contends that Takahashi
only looked at the prior art mother-and-child systems despite being aware of
rapid exchange devices. Id. at 47 (citing Ex. 2138 ¶ 208).
Petitioner argues in reply that a POSITA knew how to (i) replace the
proximal funnel with a side opening and (ii) recess Kontos’s distal marker
bands, and that because Kontos explicitly teaches that “tube 16 may be
molded directly only application wire 14” (Ex. 1409, 4:31–32), the POSITA
would taper the pushrod for attachment onto the Kontos-Ressemann
combination. Pet. Reply 20–21 (citing Ex. 1807 ¶¶ 183–195). According to
Petitioner, these modifications allow the diameter of tube 16 to be increased,
and Kontos would achieve the not-more-than-one-French differential. Id. at
21 (citing Ex. 1806, ¶¶ 190, 192). Id. at 21.
Petitioner’s arguments with respect to claims 30–32 and 53–56 are
premised on one of ordinary skill in the art removing Kontos’s funnel in
favor of a side opening. Pet. 56–66. As discussed above with respect to
independent claims 25 and 52, we are not persuaded that this modification to
Kontos would have been obvious. Moreover, as noted by Patent Owner, the
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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, and these modifications were not
proposed in the Petition. PO Sur-Reply 4. The 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. Id. Furthermore, we have taken into account the
objective indicia evidence presented by Patent Owner (as discussed above),
and find that evidence also supports the non-obviousness of claims 30–32
and 53–56.
E. Ground 3: Obviousness in view of Kontos, Ressemann, Kataishi, and
the Knowledge of a POSITA
For its Ground 3 challenge, Petitioner asserts that claim 52 would
have been obvious in view of Kontos, Ressemann, Kataishi, and the
knowledge of a POSITA. Pet. 66–72.
1. Overview of Kataishi (Ex. 1425)
Kataishi is a publication of a U.S. patent application that was filed on
January 22, 2004, and published on January 20, 2005. Ex. 1425. Thus, on
its face, Kataishi qualifies as prior art under pre-AIA 35 U.S.C. § 102(b).
Kataishi teaches “a thrombus suction catheter with improved suction
and crossing having a small pressure loss, which is a tube having a lumen
passing through from a proximal end to a distal end, a distal end opening
having an angled cut surface.” Ex. 1425, ¶ 10. Figure 1 of Kataishi,
reproduced below, is a front view of a thrombus suction catheter.
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As shown in Figure 1, a thrombus suction catheter includes a catheter body
1, a connector 2 provided at a proximal end of the catheter body 1, a distal
end opening 12 formed by an angled cut surface, and a guide wire insertion
port 13. Id. at ¶¶ 27, 29.
2. Analysis for Claim 52 (Ground 3)
Independent claim 52 recites a guide extension catheter similar to
claim 25, except it requires that the segment is “formed from a material
having a greater flexural modulus than a flexural modulus of the tubular
structure,” and further requires that “the segment defining the angled
proximal end of the partially cylindrical opening includes at least two
inclined regions.” Ex. 1401, 15:15–34.
As noted above, we have determined that Petitioner has not
demonstrated by a preponderance of the evidence that claim 52 would have
been obvious based on the combination of Kontos and Ressemann as set
forth in Ground 1. To the extent that the Kontos-Ressemann combination
fails to teach the requirement of “at least two inclined regions,” Petitioner
relies upon Kataishi as teaching this limitation. Pet. 68–72. Petitioner
contends that a POSITA had motivation to modify the Ressemann’s support
collar 2141 to include Kataishi’s two inclined, partially cylindrical opening
because “Kataishi teaches a suction catheter with a distal end designed to do
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two things: (i) improve crossability of the catheter; and (ii) provide superior
loading of matter (thrombus) into the distal end of the suction catheter,” and
“[t]hese advantages are accomplished by the shape of Kataishi’s distal end.”
Id. at 70 (citing Ex. 1405 ¶¶ 247–249; Ex. 1442 ¶¶ 152–158). Petitioner
contends that adding a second, inclined slope to support collar 2141 would
have increased the area of entry for the stent or balloon, without increasing
the catheter’s outer diameter. Id. at 70–71. Additionally, Petitioner contends
that locating the two-incline opening on the proximal side would minimize
kinking, thereby improving the crossability of the device by avoiding drag
on the inside of the guide catheter. Id. at 71.
With respect to Ground 3, Patent Owner additionally argues that the
Petition fails to explain why a POSITA would have been motivated to
modify the proximal end of Kontos’ guide catheter body based on the distal
end of Kataishi’s suction catheter. PO Resp. 47–53. According to Patent
Owner, the distal end of Kataishi’s suction catheter is designed to suction a
thrombus from the side of the distal end by being flexible and shaped to
conform about the thrombus and against a vessel wall, and Petitioner has not
shown how this relates to introducing interventional cardiology devices into
the proximal end of a suction catheter. Id. at 49–53.
We agree with Patent Owner’s contentions regarding Kataishi. In
particular, 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.
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. Petitioner’s arguments related to
Kontos and Ressemann do not address this issue.
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In any event, Mr. Keith persuasively testifies that the distal tip of
Kataishi would increase flexibility at the proximal opening of Kontos,
creating a kink point. Ex. 2243 ¶ 81 (“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 Ex. 2138 ¶¶ 210–
17 (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. Furthermore, we have taken into
account the objective indicia evidence presented by Patent Owner (as
discussed above), and find that evidence also supports the non-obviousness
of claim 52 with respect to this ground.
F. Ground 4: Obviousness in view of Kontos, Ressemann, Takahashi,
Kataishi, and the Knowledge of a POSITA
For its Ground 4 challenge, Petitioner asserts that claims 53–56 would
have been obvious in view of Kontos, Ressemann, Takahashi, Kataishi, and
the knowledge of a POSITA. Pet. 72–73. Petitioner relies upon each of the
references the manner discussed above for similar claim limitations. Patent
Owner also relies upon the same arguments presented with respect to the
other grounds. PO Resp. 53.
For the reasons discussed above, we determine that Petitioner has not
demonstrated the obviousness of claims 53–56 by a preponderance of the
evidence based on its Ground 4 contentions.
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III. MOTION TO AMEND
Patent Owner presents a Contingent Motion to Amend in the event
that the Board finds any of issued claims 27, 33, 37, 42, 43, 45, 47, or 56 of
the ’776 unpatentable. Motion, 1. Having determined that Petitioner has not
demonstrated that any of the challenged claims are unpatentable in this
proceeding, we do not reach the merits of the 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. 80 (citing Arthrex, Inc. v. Smith & Nephew,
Inc., 941 F.3d 1320, 1325 (Fed. Cir. 2019)). 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. CONCLUSION
After reviewing the arguments and evidence of record, we determine
that Petitioner has not demonstrated by a preponderance of the evidence that
25–27, 29–33, 35–39, 41–49, and 52–56 of the ’776 patent are unpatentable.
In view of this conclusion with regard to the original claims, we do not reach
Patent Owner’s contingent Motion to Amend.
In summary:
Claims 35
U.S.C. §
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
25–27,
29, 33,
35–37,
103(a) Kontos,
Ressemann,
knowledge of
POSITA
25–27, 29, 33,
35–37, 39,
41–49, 52
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The table below summarizes our conclusions as to Patent Owner’s
Motion to Amend the claims.
Motion to Amend Outcome Claim(s)
Original Claims Cancelled by Amendment
Substitute Claims Proposed in the Amendment
Substitute Claims: Motion to Amend Granted
Substitute Claims: Motion to Amend Denied
Substitute Claims: Not Reached 58–65
39, 41–
49, 52
30–32,
53–56
103(a) Kontos,
Ressemann,
Takahashi,
knowledge of
POSITA
30–32, 53–56
52 103(a) Kontos,
Ressemann,
Kataishi,
knowledge of
POSITA
52
53–56 103(a) Kontos,
Ressemann,
Takahashi,
Kataishi,
knowledge of
POSITA
53–56
Outcome 25–27, 29–33,
35–39, 41–49,
and 52–56
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VI. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that Petitioner has not demonstrated by a preponderance
of the evidence that claims 125–27, 29–33, 35–39, 41–49, and 52–56 of U.S.
Patent No. RE45,776 E are unpatentable;
FURTHER ORDERED that we do not reach Patent Owner’s
Contingent Motion to Amend U.S. Patent No. RE45,776 E; 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
ROBINS KAPLAN LLP
cmorton@robinskaplan.com
sroberg-perez@robinskaplan.com
cpinahs@robinskaplan.com
wmanske@robinskaplan.com
FOR PATENT OWNER:
Derek Vandenburgh
Dennis Bremer
CARLSON, CASPERS, VANDENBURGH & LINDQUIST, P.A.
dvandenburgh@carlsoncaspers.com
dbremer@carlsoncaspers.com
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