Medtronic, Inc. v. Teleflex Innovations S.A.R.L.

Case: 21-2357 Document: 61 Page: 1 Filed: 06/05/2023
United States Court of Appeals
for the Federal Circuit
______________________
MEDTRONIC, INC., MEDTRONIC VASCULAR,
INC.,
Appellants
v.
TELEFLEX INNOVATIONS S.A.R.L.,
Appellee
______________________
2021-2357, 2021-2360, 2021-2364
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2020-
00127, IPR2020-00130, IPR2020-00136.
______________________
Decided: June 5, 2023
______________________
BRITTANY BLUEITT AMADI, Wilmer Cutler Pickering
Hale and Dorr LLP, Washington, DC, argued for appel-
lants. Also represented by JENNIFER L GRABER; TASHA JOY
BAHAL, MARK CHRISTOPHER FLEMING, HANNAH ELISE GEL-
BORT, MADELEINE C. LAUPHEIMER, Boston, MA.
SANJIV P. LAUD, McCurdy LLC, Minneapolis, MN, ar-
gued for appellee. Also represented by PETER M. KOHL-
HEPP, TARA CATHERINE NORGARD, J. DEREK VANDENBURGH,
JOSEPH W. WINKELS, Carlson, Caspers, Vandenburgh &
Lindquist PA, Minneapolis, MN.
Case: 21-2357 Document: 61 Page: 2 Filed: 06/05/2023
2 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
______________________
Before MOORE, Chief Judge, LOURIE and DYK, Circuit
Judges.
MOORE, Chief Judge.
Medtronic, Inc. and Medtronic Vascular, Inc. (collec-
tively, Medtronic) appeal inter partes review decisions of
the Patent Trial and Appeal Board holding Medtronic
failed to establish the unpatentability of various claims of
U.S. Patent Nos. 8,048,032; RE45,380; and RE45,776 (the
patents-in-suit). Medtronic also appeals the Board’s deci-
sions granting Teleflex Innovation S.à.r.l’s (Teleflex) mo-
tions to amend certain claims of the ’032 and ’380 patents.
For the following reasons, we affirm.
BACKGROUND
Coronary artery disease, in which plaque buildup nar-
rows the lumen (i.e., the tubular cavity) of a patient’s ar-
tery and obstructs blood flow, affects millions of Americans.
Cardiologists refer to this narrowing of a patient’s artery
as stenosis. See ’032 patent at 1:25–26. 1 For decades, car-
diologists have used devices known as guide catheters to
deliver interventional cardiology devices (e.g., guidewires,
stents, balloon catheters) designed to alleviate stenoses.
Id. at 1:15–29. Treatment typically involves inserting the
guide catheter into the patient’s femoral or radial artery
and guiding the catheter to the patient’s aorta until the dis-
tal tip of the catheter reaches the ostium (i.e., opening) of
the coronary artery. Id. at 1:30–36. Interventional devices
can then be inserted into the proximal opening of the
1 The patents-in-suit share a common specification.
For simplicity, all citations to the written description will
refer to the ’032 patent.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 3
catheter, advanced through the lumen of the catheter using
a guidewire, and delivered past the stenosis. 2 Id.
These procedures involved certain challenges and
risks. For example, “[c]rossing tough lesions can create
enough backward force to dislodge the guide catheter from
the ostium of the artery being treated,” disrupting the pro-
cedure and potentially harming the patient. Id. at 1:36–
40, 4:40–46. This problem drove practitioners to seek new
catheter designs and methods with increased “back-up sup-
port” that would prevent backward dislodgment of the
catheter. Id. at 1:36–44. For example, one method dis-
closed in a prior art journal article (Takahashi) involves a
“mother-and-child” technique in which a standard 5
French guide catheter is inserted into a 6 French guide
catheter and advanced until its distal tip is deep within the
patient’s ostium, a technique known as deep seating. 3 Id.
at 2:17–29; see J.A. 2172–76 (Takahashi). However, deep
seating using standard guide catheters in the mother-and-
child technique also involved risks, including that the stiff
distal end of the inner catheter could damage the coronary
artery when deeply embedded. ’032 patent at 2:28–44.
The patents-in-suit, owned by Teleflex, sought to ad-
dress these problems by using a coaxial extension catheter
insertable into standard guide catheters that offered in-
creased back-up support and the ability to deep seat with-
out the attendant drawbacks of traditional mother-and-
child systems. See id. at 2:53–3:4, 4:33–5:3. In a preferred
embodiment, the disclosed extension catheter includes
three parts: (1) a proximal substantially rigid portion 20
2 The proximal and distal ends of a catheter respec-
tively refer to the ends nearest to and farthest from the
treating physician.
3 One French is the standard unit of measurement
for catheter diameters. One French equals one third of a
millimeter. See J.A. 1886 ¶ 46.
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4 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
(yellow); (2) a reinforced portion 18 (blue); and (3) a distal
flexible tip 16 (pink). See id. at 6:9–54; see also id. at Fig.
4 (reproduced below as annotated by Medtronic’s expert).
The proximal end of the guide extension catheter includes
a “side opening,” i.e., a partially cylindrical region (red cir-
cle), which permits the extension catheter to receive and
deliver interventional cardiological devices while it is
within the guide catheter. Id. at 9:44–63. As depicted in
Figure 4, the side opening may include multiple inclined
regions separated by a non-inclined region, a structure re-
ferred to herein as a double-inclined side opening. The pa-
tents-in-suit also disclose and claim embodiments in which
the diameter of the extension catheter is no more than one
French smaller than the diameter of the guide catheter,
thereby preserving maximal volume within the coaxial lu-
men for receiving interventional devices. See id. at 3:5–20.
In 2009, Teleflex introduced a series of guide extension
catheters embodying claims of the patents-in-suit and mar-
keted as the GuideLiner V1, GuideLiner V2, and Guide-
Liner V3 (collectively, the GuideLiner). Those products
enjoyed undisputed commercial success and industry
praise and were eventually followed by multiple, competing
guide extension catheters, including Medtronic’s Telescope
product, introduced in 2019.
PROCEDURAL HISTORY
In November of 2019, Medtronic petitioned for inter
partes review of the patents-in-suit, alleging the challenged
claims would have been obvious over U.S. Patent No.
5,439,445 (Kontos), which discloses a support catheter for
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 5
delivering angioplasty balloons, in view of various combi-
nations of secondary references. The secondary references
included: (1) U.S. Patent Application Publication No.
2004/0010280 (Adams), disclosing a catheter assembly
with a distal side opening for removing embolic debris
while occluding blood flow during treatment; (2) U.S. Pa-
tent No. 7,604,612 (Ressemann), disclosing an evacuation
sheath assembly with a distal side opening used to remove
embolic material while occluding blood flow using sealing
balloons; (3) U.S. Patent Application Publication No.
2005/0015073 (Kataishi), disclosing a suction catheter de-
signed to remove thrombi in blood vessels; and (4)
Takahashi.
The Board instituted each petition and issued final
written decisions holding some claims unpatentable and
others not. See Medtronic, Inc. v. Teleflex Innovations
S.à.r.l., No. IPR2020-00127, 2021 WL 2518685 (P.T.A.B.
June 7, 2021) (’032 Decision); Medtronic, Inc. v. Teleflex In-
novations S.à.r.l., No. IPR2020-00130, 2021 WL 2524006(P.T.A.B. June 17, 2021) (’380 Decision); Medtronic, Inc. v.
Teleflex Innovations S.à.r.l., No. IPR2020-00136, 2021 WL
2524191 (P.T.A.B. June 17, 2021) (’776 Decision). In addi-
tion, the Board granted Teleflex’s contingent motions to
amend certain claims of the ’032 and ’380 patents and de-
termined the amended claims were not unpatentable.
The parties organize the claims determined not un-
patentable into four (overlapping) sets, a categorization we
adopt for our analysis. The Side Opening Claims are
claims 3, 4, 9, 13, and 18 of the ’032 patent; claims 3, 4, 9,
14, and 19 of the ’380 patent; and claims 25–27, 29, 33, 35–
37, 39, 41–49, and 52 of the ’776 patent. The One-French
Claims are claims 8 and 17 of the ’032 patent; claims 8 and
18 of the ’380 patent; and claims 30–32 and 53–56 of the
’776 patent. The Double-Incline Claims are claims 52–56
of the ’776 patent. Lastly, the Substitute Claims are claims
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6 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
23–25 of the ’032 patent and claims 43 and 44 of the ’380
patent. 4
DISCUSSION
Medtronic appeals the Board’s determination that
Medtronic failed to prove the Side Opening, One-French,
and Double-Incline Claims would have been obvious. It
also challenges the Board’s decision granting Teleflex’s mo-
tion to introduce substitute claims. We address each issue
in turn.
I
We first address Medtronic’s arguments that the Board
erred in determining the Side Opening, Double-Incline,
and One-French Claims are not unpatentable as obvious. 5
Obviousness is a question of law based on underlying facts.
WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1326 (Fed. Cir.
2016). We review the Board’s ultimate determination of
4 Though delineated separately, the One-French and
Double-Incline Claims of the ’776 patent, as well as the
Substitute Claims, also recite a side opening.
5 Teleflex contends Medtronic forfeited various argu-
ments by failing to raise them in its Requests for Director
Rehearing made pursuant to 37 C.F.R. § 42.71(d), which
requires the petitioning party to “specifically identify all
matters the party believes the Board misapprehended or
overlooked.” Specifically, Teleflex argues Medtronic’s al-
leged failure to comply with § 42.71(d), while not a jurisdic-
tional bar to our review, grants us discretion to find
unraised issues forfeited. We need not resolve this ques-
tion. Even if Medtronic forfeited these arguments, an issue
we do not decide, we have the discretion to reach them on
appeal. Ciena Corp. v. Oyster Optics, LLC, 958 F.3d 1157,
1161 (Fed. Cir. 2020) (“[I]t is a discretionary decision to for-
give waivers of non-jurisdictional challenges . . . .”).
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 7
obviousness de novo and its underlying findings of fact for
substantial evidence. Id.A. SIDE OPENING CLAIMS
Claim 3 of the ’032 patent is representative of the Side
Opening Claims. It recites:
3. The device of claim 2 wherein the proxi-
mal 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 an interven-
tional cardiology device into the coaxial lu-
men while the proximal portion remains
within the lumen of the guide catheter.
’032 patent at claim 3 (emphasis added).
As relevant here, Medtronic’s petitions asserted two
obviousness grounds against the Side Opening Claims: (1)
Kontos in view of Adams, asserted against the claims of the
’032 and ’380 patents, and (2) Kontos in view of
Ressemann, asserted against the claims of the ’776 patent.
See ’032 Decision, at *4; ’380 Decision, at *3; ’776 Decision,
at *3. Each ground relied on modifying Kontos’ extension
catheter by removing a funnel portion at the proximal end
of the catheter and replacing it with the distal side open-
ings disclosed in either Adams or Ressemann. Medtronic
contended a skilled artisan would be motivated to make its
proposed modifications for four separate reasons related to
alleged improvements in the ease and scope of use of Kon-
tos’ modified device.
In response, Teleflex argued Medtronic’s proposed
modifications were unsupported by evidence, based on
hindsight, and/or would not achieve the benefits Medtronic
alleged without additional modifications not disclosed in
Medtronic’s petition. In addition, Teleflex introduced
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8 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
evidence of objective indicia of nonobviousness tied to its
GuideLiner products, which are undisputedly embodi-
ments of the Side Opening Claims. This included evidence
that the GuideLiner was commercially successful, solved
long-felt but unsolved needs, garnered industry praise, and
was copied by competitors, including Medtronic.
Medtronic’s reply acknowledged additional modifica-
tions were necessary to achieve some of the alleged benefits
but argued these modifications would not have deterred a
skilled artisan because each was within the level of ordi-
nary skill. It also disputed Teleflex’s evidence of objective
indicia, arguing the evidence lacked a nexus with the Side
Opening Claims and denying it had copied the GuideLiner
in developing the Telescope.
In its final written decisions, the Board held Medtronic
failed to establish the Side Opening Claims would have
been obvious. See ’032 Decision, at *21; ’380 Decision, at
*21; ’776 Decision, at *16. The Board first determined the
parties’ arguments regarding the references’ disclosures
and motivations to combine presented a “close case.” ’032
Decision, at *20; ’380 Decision, at *14; ’776 Decision, at *9.
To resolve that close prima facie case, the Board then
turned to Teleflex’s objective evidence, which it found had
a nexus with the Side Opening Claims. Weighing these
competing considerations, the Board ultimately deter-
mined Teleflex’s “strong objective evidence of nonobvious-
ness” overcame the close prima facie case and that
Medtronic had failed to prove the Side Opening Claims un-
patentable. ’032 Decision, at *21; ’380 Decision, at *21; ’776
Decision, at *16.
On appeal, Medtronic contends the Board committed a
host of legal errors in its analysis of Teleflex’s objective ev-
idence and the parties’ prima facie arguments. For the rea-
sons given below, we conclude that the Board did not err in
its analysis and that its findings are supported by substan-
tial evidence. We therefore affirm the Board’s
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 9
determination that Medtronic failed to establish the Side
Opening Claims would have been obvious.
1. NEXUS
Medtronic first argues the Board committed legal error
when it found a nexus between Teleflex’s objective evidence
and the Side Opening Claims. Specifically, it contends the
Board erred by finding nexus based on “three specific fea-
tures [of the GuideLiner]—(1) rapid exchange functional-
ity, i.e.¸ having a relatively short lumen at the distal end of
the catheter; (2) increased back-up support; and (3) a side
opening”—that were collectively disclosed in a single prior
art reference, namely Ressemann, and therefore are not in-
dicative of nonobviousness. Appellant’s Opening Br. at 68.
We do not agree.
As an initial matter, it is undisputed that a presump-
tion of nexus applies in this case because Teleflex’s “as-
serted objective evidence is tied to a specific product [i.e.,
the GuideLiner] and that product is the invention disclosed
and claimed” by the patents-in-suit. See, e.g., ’032 Deci-
sion, at *19 (internal quotation marks omitted) (quoting
WBIP, 829 F.3d at 1329). As the Board explained, Med-
tronic could rebut this presumption by showing Teleflex’s
objective evidence resulted from features that were known,
as a combination, in the prior art rather than the claimed
invention as a whole. Id. The Board did not err in finding
Medtronic failed to make such a showing here.
The Board acknowledged Medtronic showed every ele-
ment of the Side Opening Claims was individually known
in the prior art but correctly concluded this did not pre-
clude nexus where the evidence was “tied to the combina-
tion of features as a whole” and the combination was not
previously known. Id. (citing WBIP, 829 F.3d at 1331–32).
Citing testimony from three of Teleflex’s experts, the Board
found “it was the GuideLiner devices as a whole that re-
sulted in the evidence of secondary considerations, not any
individual feature in isolation.” Id. (emphasis added); see
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10 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
’380 Decision, at *20; ’776 Decision, at *15. The Board cred-
ited this testimony as showing that “[w]hen the various
features of the prior art were combined to form the Guide-
Liner device . . . the result was a new, market-making, com-
mercially successful product that provided significant
benefits over prior art devices, received praise in the art,
and was copied by competitors.” ’032 Decision, at *19 (em-
phasis added). The Board thus explicitly grounded its
nexus finding on a combination of GuideLiner features it
found were not disclosed, at least as a combination, in the
prior art. We detect no legal error in this analysis.
Medtronic accuses the Board of legal error because, in
its view, Ressemann discloses the combination of features
upon which Teleflex and the Board relied in its nexus anal-
ysis. While styled as a dispute of law, Medtronic’s argu-
ment is merely disagreement with the Board’s fact
findings. See, e.g., Med. Instrumentation & Diagnostics
Corp. v. Elekta AB, 344 F.3d 1205, 1221 (Fed. Cir. 2003)
(“The question of what a reference teaches and whether it
describes every element of a claim is a question for the
finder of fact.”); WBIP, 829 F.3d at 1331 (“Questions of
nexus are highly fact-dependent . . . .”). Medtronic asserts
Teleflex attributed the GuideLiner’s success to its combi-
nation of rapid exchange functionality, increased back-up
support, and “a side opening.” This is a mischaracteriza-
tion. Teleflex and its experts did not attribute the Guide-
Liner’s success to a side opening in combination with the
improved functionalities. Rather, Teleflex argued the
GuideLiner was successful because, in addition to offering
increased back-up support and rapid exchange functional-
ity, it could advantageously “receive the full array of inter-
ventional cardiology devices,” an ability it grounded in “the
claimed requirement that the tubular structure have a ‘co-
axial lumen’ (which facilitates maximizing ‘real estate’) . . .
combined with a side opening that facilitates entry of . . .
[an] interventional cardiology device into the tubular por-
tion.” J.A. 17611 (emphasis added); see also J.A. 23676–67
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 11
(explaining the ability to receive the full array of cardiolog-
ical devices is “reflected in the claimed requirement for a
single lumen, as well as [a side opening]” (emphasis
added)).
Teleflex, and the Board, thus clearly relied not just on
the presence of a side opening, as Medtronic contends, but
on a side opening together with coaxial lumens. Indeed,
Teleflex’s expert Dr. Graham clearly explained that both
the coaxial lumen and proximal side opening are critical to
the GuideLiner’s ability to receive the full array of inter-
ventional cardiology devices. The proximal side opening
allows the GuideLiner to “receive interventional cardiology
devices . . . while the proximal opening was deep inside the
guide catheter,” and the coaxial lumen “allow[s] the usable
real estate inside the guide extension catheter to be max-
imized.” J.A. 10302 ¶ 81. Thus, even if Medtronic’s allega-
tion that Ressemann discloses a device with a side opening,
rapid exchange functionality, and increased back-up sup-
port were true, it does not show the features driving the
GuideLiner’s success were disclosed in the prior art.
Medtronic contends the Board’s reliance on the coaxial
lumens touted by Teleflex’s experts is irrelevant because
“the Board never made any finding distinguishing the
claimed side opening from Ressemann.” Appellant’s Reply
Br. at 27. Medtronic misunderstands the applicable bur-
dens. In an inter partes review, “the petitioner shall have
the burden of proving a proposition of unpatentability by a
preponderance of the evidence.” 35 U.S.C. § 316(e). The
absence of a finding that Ressemann does not have a coax-
ial lumen therefore cannot establish Ressemann in fact has
those features. 6 Medtronic also points to the Board’s
6 Medtronic’s assertion that the Board did not make
any findings distinguishing the claimed side opening from
Ressemann is also incorrect. In discussing Teleflex’s evi-
dence of copying, the Board rejected Medtronic’s argument
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12 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
finding in a related proceeding that Ressemann anticipates
claims 25, 26, 28–31, 34–37, and 39 of the ’380 patent. See
Medtronic, Inc. v. Teleflex Innovations S.à.r.l., No.
IPR2020-00129, 2021 WL 2524890, at *11 (P.T.A.B. June
17, 2021). However, as the Board noted in that decision,
those claims do not recite coaxial lumens. Id. at *7 n.9.
The Board’s finding that Ressemann anticipates those
claims therefore implies nothing about whether
Ressemann discloses the coaxial lumens recited by the Side
Opening Claims.
We conclude the Board did not err in finding a nexus
between Teleflex’s objective evidence and the Side Opening
Claims. Medtronic does not otherwise argue that the
Board’s finding, if legally proper, is not supported by sub-
stantial evidence. Accordingly, we affirm the Board’s find-
ing of nexus.
2. COPYING
Medtronic next challenges the Board’s finding that
Medtronic copied the GuideLiner in developing its own
guide extension catheter, the Telescope. See ’032 Decision,
at *20; ’380 Decision, at *21; ’776 Decision, at *16. The
Board found Medtronic copied the GuideLiner based on its
findings that (1) Medtronic had access to the GuideLiner
that Teleflex could not show copying of the GuideLiner, as
opposed to the prior art, because Ressemann is also “a
rapid exchange device and has a side opening.” ’032 Deci-
sion, at *21. The Board found this argument unavailing
because the copying product “did not merely apply the idea
of rapid exchange or the use of a side opening,” as taught
by Ressemann, but instead “reproduce[d] the entire combi-
nation of features that were assembled for the first time by
the GuideLiner products.” Id. The Board thus rejected any
contention that Ressemann disclosed the full combination
of features utilized by the GuideLiner.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 13
while it was developing the Telescope and the products
have substantially similar designs, and (2) there was “di-
rect evidence” Teleflex had copied “at least a portion of the
GuideLiner device.” See, e.g., ’032 Decision, at *20. Med-
tronic argues the Board’s reliance on substantial similarity
between the GuideLiner and Telescope products to infer
copying evinces legal error. In Medtronic’s view, evidence
of substantial similarity is “irrelevant” because it does not
show that Medtronic “actually copied” the GuideLiner
when developing the Telescope. Appellant’s Opening Br.
at 64. Under a correct view of the law, Medtronic argues,
the Board “identified no evidence of actual copying efforts”
and therefore its finding of copying must be reversed. Id.“It is well established that copying by a competitor is a
relevant consideration in the objective indicia analysis”
and therefore “may be evidence that the patented invention
is nonobvious.” Liqwd, Inc. v. L’Oreal USA, Inc., 941 F.3d
1133, 1137 (Fed. Cir. 2019). The fact that a competitor cop-
ied the patentee’s invention, rather than one within the
public domain, is probative of nonobviousness because it
suggests the competitor saw value in the invention that he
could not achieve without copying. See, e.g., Diamond Rub-
ber Co. of N.Y. v. Consol. Rubber Tire Co., 220 U.S. 428, 441
(1911). “Copying may indeed be another form of flattering
praise for inventive features” of a patented product, Crocs,
Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1311 (Fed. Cir.
2010), but one undertaken at the risk of infringement.
These rationales only apply, of course, if the alleged
copyist has in fact copied the patented product rather than
independently arrived at a similar design. Indeed, a com-
petitor’s independent and contemporaneous development
of a similar product may, in some cases, even suggest the
patented product would have been obvious. Lindemann
Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730
F.2d 1452, 1460 (Fed. Cir. 1984) (“[T]he possibility of near
simultaneous invention by two or more equally talented in-
ventors working independently . . . may or may not be an
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14 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
indication of obviousness when considered in light of all the
circumstances.”). It is also clear that the copying inquiry
involves a comparison of the competitor’s product with the
allegedly copied patented product, rather than the patent’s
claims, lest the “separate infringement and copying inquir-
ies [collapse] into a single analysis.” Liqwd, 941 F.3d at
1137; see also Iron Grip Barbell Co. v. USA Sports, Inc., 392
F.3d 1317, 1325 (Fed. Cir. 2004) (“[C]opying requires the
replication of a specific product.”). To that end, we have
recognized copying must be supported by “actual evidence
of copying efforts as opposed to mere allegations regarding
similarities between the accused product and a patent.”
Liqwd, 941 F.3d at 1337–38.
We have never held, however, that copying cannot be
established through evidence of access to and substantial
similarity with a patented product. Indeed, in Liqwd, the
very case Medtronic cites for the proposition that substan-
tial similarity is irrelevant, we expressly recognized that
“[e]vidence of copying may include . . . access and similarity
to a patented product.” Id. at 1337; see also Cable Elec.
Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1027 (Fed.
Cir. 1985) (“Access in combination with similarity can cre-
ate a strong inference of copying.”), overruled on other
grounds by Midwest Indus., Inc. v. Karavan Trailers, Inc.,
175 F.3d 1356 (Fed. Cir. 1999). That same standard is also
universally applied in the copyright context, which like-
wise requires actual copying of a copyrighted work rather
than similarity by happenstance. See, e.g., Walker v. Time
Life Films, Inc., 784 F.2d 44, 48 (2d Cir. 1986) (“Copying
may be inferred where a plaintiff establishes that the de-
fendant had access to the copyrighted work and that sub-
stantial similarities exist as to protectible material in the
two works.”).
Medtronic’s contention that the Board identified no ev-
idence of actual copying is at odds with this precedent. Ev-
idence of access and substantial similarity is evidence of
copying. Medtronic’s argument is tantamount to requiring
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 15
that copying can be proven only by direct evidence “such as
photos of patented features or disassembly of products,”
Liqwd, 941 F.3d at 1137, rather than circumstantial evi-
dence such as access and similarity. Our case law has
never drawn any such distinction, nor would such a distinc-
tion be consistent with basic principles of evidence and in-
ference. Circumstantial evidence is just that—evidence. It
establishes that a given fact is more likely to be true than
one would otherwise believe in the absence of the evidence.
Nor is circumstantial evidence second-class to direct evi-
dence: “Circumstantial evidence is not only sufficient, but
may also be more certain, satisfying and persuasive than
direct evidence.” Michalic v. Cleveland Tankers, Inc., 364
U.S. 325, 330 (1960) (citation omitted).
Here, there is more than sufficient circumstantial evi-
dence to support the Board’s finding of copying. 7 See
WBIP, 829 F.3d at 1336 (“Copying is a question of fact” re-
viewed for substantial evidence). Teleflex’s experts “per-
suasively demonstrate[d] that the . . . Telescope products,
when considered as a whole, are substantially similar in
design to then-existing GuideLiner products on the mar-
ket, including the combined use of a flexible tip, reinforced
portion, angled opening, pushrod, and rounded push tab.”
’032 Decision, at *20 (citing J.A. 10052–57 ¶¶ 231–39).
Medtronic contends the Board disregarded differences be-
tween the GuideLiner and Telescope in finding substantial
similarity. Not so. The Board acknowledged the Telescope
“differs from the 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.” Id. It simply found,
again crediting Teleflex’s expert, that these differences
7 It is undisputed that the GuideLiner was publicly
available on the market and accessible to Medtronic while
it was developing the Telescope.
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16 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
were not so significant as to preclude substantial similarity
and the corresponding inference that Medtronic copied. Id.Medtronic’s argument that the Board committed legal
error by relying on evidence of substantial similarity is
meritless. 8 Because the Board’s finding that Medtronic
copied is supported by substantial evidence, we affirm its
finding that Medtronic’s copying is indicative of nonobvi-
ousness.
3. ADDITIONAL OBJECTIVE INDICIA
In addition to Medtronic’s copying, the Board relied on
multiple other objective indicia of nonobviousness, includ-
ing evidence the GuideLiner was copied by other competi-
tors, enjoyed “a high level of commercial success,” “received
significant praise in the industry,” and solved long-felt
needs within the medical community for catheters with in-
creased back-up support. 9 See, e.g., ’032 Decision, at *16–
20. Medtronic does not challenge any of these findings on
appeal. Thus, having affirmed the Board’s findings of
nexus and Medtronic’s copying, the Board’s findings re-
lated to objective indicia remain entirely intact.
The Board’s findings related to Teleflex’s objective evi-
dence played a critical role in its determination that the
Side Opening Claims are not unpatentable. The Board ex-
pressly turned to that “strong evidence” in order to resolve
8 Medtronic also disputes the Board’s finding of “di-
rect evidence” of copying on the same grounds that it dis-
putes the Board’s finding of substantial similarity: that the
evidence is insufficient to show actual copying. See, e.g.,
’032 Decision, at *20. We reject those arguments for the
same reasons.
9 The Board also considered Teleflex’s evidence that
competitors licensed the patents-in-suit but found this evi-
dence to have limited probative value. ’032 Decision, at
*17. We therefore do not consider this evidence on appeal.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 17
the parties’ close prima facie arguments and, on that basis,
found Medtronic had failed to establish the obviousness of
the Side Opening Claims. E.g., ’032 Decision, at *21. While
we review the ultimate question of obviousness de novo, the
Board’s finding that the objective evidence carried signifi-
cant weight is entitled to deference. In re Inland Steel Co.,
265 F.3d 1354, 1366 (Fed. Cir. 2001) (“[W]e give the Board
broad deference in its weighing of the [objective] evidence
before it.”); see also Bristol-Myers Squibb Co. v. Teva
Pharms. USA, Inc., 752 F.3d 967, 978 (Fed. Cir. 2014) (“We
give deference to a lower court’s factual findings regarding
evidence of secondary considerations.”).
“Weighing this objective evidence along with all the
other evidence relevant to obviousness,” we agree with the
Board’s determination that Medtronic failed to prove the
Side Opening Claims obvious by a preponderance of the ev-
idence. See Transocean Offshore Deepwater Drilling, Inc.
v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1355 (Fed.
Cir. 2012) (concluding claims were nonobvious despite
prima facie showing of obviousness). Even accepting Med-
tronic’s arguments concerning the prior art’s disclosures
and motivations to combine, the unusually strong objective
evidence in this case strongly supports a determination of
nonobviousness. See Stratoflex, Inc. v. Aeroquip Corp., 713
F.2d 1530, 1538–39 (Fed. Cir. 1983) (“[E]vidence of second-
ary considerations may often be the most probative and co-
gent evidence in the record. It may often establish that an
invention appearing to have been obvious in light of the
prior art was not.”).
The Board found four distinct objective factors support
nonobviousness, the majority of which Medtronic did not
even attempt to dispute below or on appeal. These include
the Board’s finding that the GuideLiner enjoyed a “high
level of commercial success” and that Teleflex’s licensees
“had essentially 100% of the U.S. guide extension catheter
market.” ’032 Decision, at *16 (citing J.A. 10533–40 (con-
fidential documents demonstrating the GuideLiner’s
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18 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
commercial success)). Indeed, Medtronic’s own internal
documents concede the GuideLiner “created the market”
for guide extension catheters and enjoyed substantial mar-
ket share. J.A. 10858. The GuideLiner’s considerable com-
mercial success clearly supports a determination of
nonobviousness. Demaco Corp. v. F. Von Langsdorff Li-
censing Ltd., 851 F.2d 1387, 1391 (Fed. Cir. 1988) (“The
commercial response to an invention is significant to deter-
minations of obviousness, and is entitled to fair weight.”).
The Board also relied on extensive praise within the indus-
try, which touted the GuideLiner as “an elegant method to
overcome” problems the industry previously considered
“impossible despite the use of a highly supporting guiding
catheter.” ’032 Decision, at *17 (citing J.A. 10588–843); see
also ’380 Decision, at *16 (discussing evidence the Guide-
Liner solved the long-felt but unmet need for a catheter
that could avoid backout problems and “allow[ed] physi-
cians to perform previously impossible coronary proce-
dures”). That the GuideLiner solved problems the industry
previously considered “impossible” is also strongly sugges-
tive of nonobviousness. WBIP, 829 F.3d 1335 (“If industry
participants or skilled artisans are skeptical about whether
or how a problem could be solved . . . it favors nonobvious-
ness.”). Teleflex’s experts similarly testified the Guide-
Liner was “a transformational and enabling device” that
provided an “elegant” and “completely new” solution to
problems the industry had attempted to solve for decades
without success. See J.A. 10292 ¶¶ 69, 70 (Dr. Graham);
J.A. 11158–64 ¶¶ 7, 9–20 (Dr. Thompson); J.A. 10487–92
¶¶ 4–10, 12 (Dr. Azzalini).
Additionally, like the Board, we find particularly per-
suasive the Board’s finding that multiple competitors cop-
ied the GuideLiner in developing their own guide extension
catheters. WBIP, 829 F.3d at 1336 (“The fact that a com-
petitor copied technology suggests it would not have been
obvious.”). This finding was based not only on Teleflex’s
expert testimony that the GuideLiner and competing
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 19
products were substantially similar, but also direct evi-
dence showing competitors actively sought to emulate the
GuideLiner. For example, Medtronic’s design documents
demonstrate Medtronic purchased and tested the Guide-
Liner while developing the Telescope, J.A. 10899–90, and
concede it was seeking to “build its own ‘Half Pipe’ design,”
J.A. 10848, “Half Pipe” being a marketing term used by Te-
leflex to describe the GuideLiner’s side opening, J.A.
10565. See also J.A. 11317–33 (confidential documents
comparing the GuideLiner and Telescope). Other docu-
ments and testimony show other competitors likewise
sought to reproduce the claimed beneficial features of the
GuideLiner. See, e.g., J.A. 10887 (Boston Scientific charac-
terizing its GuideZilla product as “incorporate[ing] sub-
stantially equivalent device materials and design . . . [and]
fundamental technology . . . as the GuideLiner V2”); J.A.
10052 ¶¶ 232–39 (Teleflex expert opining the GuideZilla
and GuideLiner are substantially similar).
The Board’s findings support the conclusion that Med-
tronic failed to carry its burden to show obviousness. We
see no legal error in the Board’s conclusion that Medtronic
failed to prove the Side Opening Claims would have been
obvious by a preponderance of the evidence. While we have
acknowledged “[a] strong case of prima facie obviousness .
. . cannot be overcome by a far weaker showing of objective
indicia of nonobviousness,” Tokai Corp. v. Easton Enters.,
Inc., 632 F.3d 1358, 1371 (Fed. Cir. 2011), this case pre-
sents the opposite scenario. The Board found Medtronic
presented a “close” prima facie case, but that this showing
was overcome by Teleflex’s “strong” objective evidence. We
agree.
4. THE BOARD’S PRIMA FACIE ANALYSIS
Medtronic’s remaining arguments regarding the Side
Opening Claims take issue with the Board’s exemplary rea-
sons for finding the parties’ prima facie arguments
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20 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
presented a close case. Medtronic argues these reasons re-
flect legal errors in the Board’s analysis. We are not per-
suaded.
Medtronic first contends the Board erred by allegedly
ignoring two of Medtronic’s proposed motivations to com-
bine. Medtronic’s petition contended a skilled artisan
would be motivated to make its proposed modifications for
four reasons, namely to (1) allow the outer diameter of Kon-
tos’ assembly to be reduced without reducing entry area;
(2) facilitate smoother insertion of interventional cardiol-
ogy devices into the extension catheter; (3) reduce the force
necessary to advance the extension catheter through the
guide catheter while in tortuous vasculature; and (4) per-
mit smoother reentry of the proximal end of the extension
catheter into the guide catheter if it was extended beyond
the distal tip of the guide catheter. Medtronic asserts the
Board legally erred by failing to consider the latter two rea-
sons in its decisions.
Contrary to Medtronic’s arguments, the Board’s deci-
sions do not suggest the Board ignored any proposed moti-
vations to combine. The Board expressly and accurately
recounted each of Medtronic’s proposed motivations and
Teleflex’s responses before concluding that “upon review of
the . . . arguments and supporting evidence,” the parties
had presented a close case. ’032 Decision, at *20; ’380 De-
cision, at *14; ’776 Decision, at *9. The Board’s express
statement that it “review[ed]” and weighed the arguments
it had just recounted belies Medtronic’s contention that
those arguments were simply ignored.
Medtronic infers the Board ignored these motivations
because they do not appear in the Board’s exemplary rea-
sons for finding the parties’ arguments presented a close
prima facie case. See ’032 Decision, at *20 (providing “ex-
ample[s]” of deficiencies in Medtronic’s arguments); ’380
Decision, at *14 (same); ’776 Decision, at *9 (same). Med-
tronic’s inference is not warranted. That the Board did not
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 21
explicitly address some of Medtronic’s proposed motiva-
tions in its exemplary reasons does not imply the Board ig-
nored those motivations, especially where, as here, the
Board had just enumerated the arguments. Nothing in the
Board’s decisions suggests its examples were intended as
an exhaustive list of arguments the Board considered or
rejected. Indeed, if any inference is to be drawn from the
absence of the allegedly ignored motivations in the Board’s
exemplary criticisms, it is that the Board considered those
motivations and found them more persuasive than those it
explicitly decried—precisely the opposite of what Med-
tronic suggests.
Medtronic also suggests that, even if the Board in fact
considered each motivation in reaching its determination,
its failure to explicitly address every motivation in its writ-
ten decisions is inconsistent with its obligations under the
Administrative Procedure Act. We do not agree. While we
have acknowledged “it is not adequate [for the Board] to
summarize and reject arguments without explaining why
[it] accepts the prevailing argument,” In re Nuvasive, Inc.,
842 F.3d 1376, 1383 (Fed. Cir. 2016), we have also repeat-
edly explained “the Board is not require[d] . . . to address
every argument raised by a party or explain every possible
reason supporting its conclusion,” Yeda Rsch. v. Mylan
Pharms. Inc., 906 F.3d 1031, 1046 (Fed. Cir. 2018). The
central inquiry is whether we can “reasonably discern that
[the Board] followed a proper path, even if that path is less
than perfectly clear.” Ariosa Diagnostics v. Verinata
Health, Inc., 805 F.3d 1359, 1365 (Fed. Cir. 2015) (citing
Bowman Transp., Inc. v. Arkansas-Best Freight Sys., Inc.,
419 U.S. 281, 285–86 (1974)).
The Board’s path in this case is discernible. The Board
accurately recounted the parties’ prima facie arguments
and evidence and noted those arguments made for a close
case, suggesting it considered and weighed all of the argu-
ments it had just recounted. The Board then went on to
expressly identify the prevailing argument driving its
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22 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
decision, namely the strong objective evidence of nonobvi-
ousness, which it turned to “in order to resolve this close
case of obviousness.” ’032 Decision, at *20; see also ’380
Decision, at *14; ’776 Decision, at *10. While the Board’s
decision could have been more detailed, “we do not require
perfect explanations.” In re Nuvasive, 842 F.3d at 1382.
Certainly, nothing suggests the Board “entirely failed to
consider an important aspect of the problem” before it. Mo-
tor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut.
Auto. Ins. Co., 463 U.S. 29, 43 (1983). Accordingly, we con-
clude the Board adequately explained the grounds for its
decisions. See SEC v. Chenery Corp., 318 U.S. 80, 94 (1932)
(“[T]he orderly functioning of the process of review requires
that the grounds upon which the administrative agency
acted [are] clearly disclosed and adequately sustained.”).
Medtronic also argues the Board erred in its analysis
of the motivations. In each decision, the Board noted that
replacing Kontos’ funnel to reduce the diameter of the cath-
eter and increase the interior volume would require several
additional modifications absent from Medtronic’s petition,
including at least one modification that the Board found
“may not have been possible in the relevant time period.”
’032 Decision, at *20; ’380 Decision, at *14; ’776 Decision,
at *9. 10 Although the Board did not indicate it gave these
observations particular weight in its analysis or that they
led it to ultimately find a skilled artisan would not have
had a reasonable expectation of success, Medtronic con-
tends the Board erred in “doubting” that success. Appel-
lant’s Opening Br. at 40–45. Specifically, Medtronic argues
the Board’s supposed finding that a skilled artisan would
not have had a reasonable expectation of success is not
10The Board’s observation that one modification may
have been impossible was not included in the ’776 Decision,
although Medtronic relied on the same modification in that
proceeding.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 23
supported by substantial evidence because each modifica-
tion would have been routine and within the level of ordi-
nary skill.
The Board’s “doubts” regarding Medtronic’s proposed
modifications do not indicate the Board found a skilled ar-
tisan would not have had a reasonable expectation of suc-
cess. Indeed, had the Board made such a finding, there
would have been no need for it to rely on Teleflex’s objective
evidence to resolve the case because the absence of a rea-
sonable expectation of success defeats obviousness. Re-
gents of Univ. of Cal. v. Broad Inst., Inc., 903 F.3d 1286,
1291 (Fed. Cir. 2018) (“An obviousness determination re-
quires finding that a person of ordinary skill in the art
would have been motivated to combine or modify the . . .
prior art and would have had a reasonable expectation of
success in doing so.” (emphasis added and citation omit-
ted)). We understand the Board’s decision as concluding
that, even if a skilled artisan would have been motivated to
make and reasonably expected success in making the pro-
posed modifications, Medtronic had not established obvi-
ousness in view of Teleflex’s strong objective evidence. 11
Medtronic’s assertion that the Board’s doubts demonstrate
legal error or constitute unsupported findings is thus un-
persuasive.
Next, Medtronic argues the Board erred as a matter of
law by discounting prior art side openings intended to re-
ceive interventional cardiological devices as rare. See, e.g.,
’032 Decision, at *20 (noting in its exemplary criticisms
that side openings used to receive interventional devices
while the catheter was still in vasculature were “rare” in
the prior art). We do not agree. In the circumstances of
11 To the extent the Board did make such a finding, it
is supported by substantial evidence for the same reasons
discussed below with respect to the One-French Claims.
See infra Section I.B.
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24 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
this case, the Board, as the trier of fact, could consider a
feature’s rarity in finding whether there was a motivation
to combine the prior art, itself a factual inquiry. 12 See, e.g.,
WBIP, 829 F.3d at 1327.
Medtronic contends our decision in Cree precludes the
Board from “dismiss[ing]” prior art disclosures because of
their rarity. Appellant’s Opening Br. at 36–37 (citing In re
Cree, Inc., 818 F.3d 694, 700–01 (Fed. Cir. 2016)). As an
initial matter, the Board’s decisions do not suggest they
“dismissed” the prior art disclosures. Rather, those deci-
sions prove the Board considered the disclosures but found,
as a factual matter, that their relative rarity weighed
against a motivation to combine. See, e.g., ’032 Decision, at
*20. In any event, the Board’s analysis is consistent with
Cree. There, Cree argued the Board erred by relying on
expert testimony to support a finding that a process was
known in the prior art because the experts had also testi-
fied the process was disfavored. 818 F.3d at 700. We re-
jected that argument because the testimony plainly cut
against Cree’s contention that the process was “unknown”
and instead supported the Board’s finding that the process
was known, even if disfavored. Id. This case presents the
inverse scenario, but the Board’s reliance on Teleflex’s ex-
pert testimony was no less proper. Medtronic’s petition
contended that side openings were “well known” in the
prior art and identified several purported examples. J.A.
17064. Teleflex responded with expert testimony explain-
ing why Medtronic’s cited examples did not in fact use side
openings in the manner claimed and opining such side
12 Medtronic did not raise any argument, below or on
appeal, that rarity was not probative because it was due to
factors unrelated to potential motivations to combine. In-
stead, it argued only that the rarity of a feature is categor-
ically irrelevant to whether a skilled artisan would have
been motivated to incorporate it into a new design.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 25
openings were “not well-known.” The Board did not err in
taking this testimony into account when assessing the
strength of Medtronic’s evidence. Testimony that a prior
art feature was rare is plainly relevant to whether it was
in fact well known, as Medtronic contended. Thus, the
Board did not “dismiss explicit prior art” disclosures be-
cause of their rarity. Appellant’s Opening Br. at 36. In-
stead, it reasonably discounted Medtronic’s argument that
the prevalence of side openings in prior art interventional
cardiology devices contributed to a motivation to combine.
See, e.g., ’032 Decision, at *15, *20.
Finally, with respect to the Side Opening Claims of the
’776 patent, Medtronic contends the Board legally erred by
crediting Teleflex’s expert testimony that a skilled artisan
would not be motivated to replace Kontos’ funnel with
Ressemann’s side opening because of significant problems
it would create. See ’776 Decision, at *9. Medtronic’s accu-
sation of legal error is yet again mere disagreement with
the Board’s fact finding. Teleflex’s expert explained that
simply slicing off Kontos’ funnel, as proposed, would intro-
duce a gap between Kontos’ support catheter and the inner
wall of the guide catheter, exposing an interior spring coil
and significantly increasing the likelihood of the device
catching. J.A. 10009–11 ¶¶ 157–59. This is consistent with
Ressemann’s own disclosure that “[s]tent delivery cathe-
ters . . . are particularly subject to hanging-up on the prox-
imal end” of the disclosed side opening, a problem
Ressemann addresses in other embodiments. See J.A. 2145
at 25:17–29. Medtronic ignores the Board’s express reli-
ance on Teleflex’s expert and asserts the Board instead
came to its conclusion by erroneously focusing on
Ressemann’s hang-up-mitigating embodiments to the det-
riment of the side opening embodiment. The Board did not
ignore Ressemann’s side opening embodiment; it merely
found Teleflex’s expert testimony more persuasive than
Medtronic’s. That is not legal error.
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26 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
For the reasons given, we affirm the Board’s holding
that Medtronic failed to establish that the Side Opening
Claims are unpatentable as obvious.
B. ONE-FRENCH CLAIMS
Claim 8 of the ’032 patent is representative of the One-
French Claims. It recites:
8. The device of claim 1 wherein the cross-
sectional inner diameter of the coaxial lu-
men of the tubular structure is not more
than one French smaller than the cross-sec-
tional inner diameter of the guide catheter.
’032 patent at claim 8 (emphasis added).
Medtronic asserted two obviousness grounds against
the One-French Claims: (1) Kontos in view of Adams and
Takahashi, asserted against the claims of the ’032 and ’380
patents, and (2) Kontos in view of Ressemann and
Takahashi, asserted against the claims of the ’776 patent.
’032 Decision, at *21; ’380 Decision, at *21; ’776 Decision,
at *16. As it did for the Side Opening Claims, Medtronic
posited the desire for increased back-up support would mo-
tivate a skilled artisan to replace Kontos’ proximal funnel
with the distal side openings of Adams and Ressemann.
Medtronic reasoned this modification would allow a skilled
artisan to incorporate Takahashi’s five-in-six system, in
which a 5-French inner catheter is inserted into a 6-French
guide catheter. Teleflex opposed on the same grounds it
opposed Medtronic’s arguments concerning the Side Open-
ing Claims, including by identifying objective evidence of
the nonobviousness of the ’776 patent One-French Claims,
which also recite a side opening. It also argued removing
Kontos’ funnel would result in a greater than one-French
gap between the inner extension catheter and guide cathe-
ter because of Kontos’ protruding marker band and base.
See, e.g., ’032 Decision, at *22. In reply, Medtronic argued
a skilled artisan could account for that gap by making
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 27
additional modifications not proposed in its petition, in-
cluding by recessing Kontos’ marker band. Id.The Board held Medtronic failed to establish the One-
French Claims would have been obvious. E.g., ’032 Deci-
sion, at *22. In doing so, the Board invoked the same rea-
sons it gave for concluding the Side Opening Claims were
not unpatentable, namely that Medtronic failed to estab-
lish it would have been obvious to replace Kontos’ proximal
funnel with a side opening and that Medtronic’s reliance on
new, extensive modifications in reply was more suggestive
of hindsight than obviousness. Id. Additionally, with re-
spect to the One-French Claims of the ’776 patent, the
Board found Teleflex’s objective evidence was indicative of
nonobviousness. ’776 Decision, at *18.
On appeal, Medtronic argues the Board’s decision must
be reversed for the same reasons it contends the Board’s
analysis of the Side Opening Claims was legally erroneous.
We reject those arguments for the reasons already given.
Additionally, we hold the Board’s finding that Med-
tronic failed to establish a reasonable expectation of suc-
cess to modify Kontos to achieve the One-French Claims
was neither legally erroneous nor unsupported by substan-
tial evidence. See PAR Pharm., Inc. v. TWI Pharms., Inc.,
773 F.3d 1186, 1196 (Fed. Cir. 2014) (“The presence or ab-
sence of a reasonable expectation of success is . . . a ques-
tion of fact,” reviewed for substantial evidence). The Board
observed that replacing Kontos’ funnel with a side opening
would “require[] significant modifications to Kontos’ de-
vice, modifications that were not proposed in the Petition.”
’032 Decision, at *22; ’380 Decision, at *22; ’776 Decision,
at *20. The Board explained “[t]he extensive need to mod-
ify Kontos’ device in a way not suggested in the Petition
supports [Teleflex’s] argument that the proposed modifica-
tions 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. The Board did not err in discounting
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28 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
modifications not presented in Medtronic’s petition as in-
dicative of hindsight. It was within the Board’s discretion
not to consider these untimely raised modifications. See
Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821
F.3d 1359, 1369 (Fed. Cir. 2016) (“Once the Board identi-
fies new issues presented for the first time in reply, neither
this court nor the Board must parse the reply brief to de-
termine which, if any, parts of that brief are responsive and
which are improper.”).
Further, the Board explained one of the modifications
not raised in Medtronic’s petition (recessing Kontos’
marker band) “may not have been possible in the relevant
time period.” See, e.g., ’032 Decision, at *20. That is con-
sistent with Teleflex’s expert testimony explaining recess-
ing the marker band as proposed was not a realistic option
as of the patents’ priority date because it would reduce the
mechanical integrity of Kontos’ device and weaken the at-
tachment of Kontos’ distal tip. See J.A. 5318. This is sub-
stantial evidence supporting the Board’s finding. We
therefore affirm the Board’s determination that Medtronic
failed to prove the One-French Claims would have been ob-
vious by a preponderance of the evidence.
C. DOUBLE-INCLINE CLAIMS
Claim 52 of the ’776 patent is representative of the
Double-Incline Claims. It recites:
52. 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
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 29
proximal end of the tubular structure, the
segment defining the partially cylindrical
opening having an angled proximal end,
formed from a material having a greater
flexural modulus than a flexural modulus
of the tubular structure, and configured to
receive one or more interventional cardiol-
ogy devices therethrough when positioned
within the guide catheter,
wherein a cross section of the guide exten-
sion catheter at the proximal end of the
tubular structure defines a single lumen;
wherein the segment defining the angled
proximal end of the partially cylindrical
opening includes at least two inclined re-
gions.
’776 patent at claim 52 (emphasis added).
Medtronic asserted the Double-Incline Claims would
have been obvious over Kontos and Ressemann, which it
argued together would have taught a catheter with a prox-
imal side opening in view of Kataishi, which discloses a
suction catheter with a distal tip with two inclined regions.
’776 Decision, at *18. Medtronic argued a skilled artisan
would have been motivated to include Kataishi’s double-
inclined opening to improve crossability and reduce
kinking and because the double incline would increase the
entry area of the side opening for receiving interventional
devices. Id. Teleflex argued the combination would not
have been obvious for the same reasons it opposed Med-
tronic’s Side Opening Claims grounds. Id. Teleflex further
contended a skilled artisan would not have been motivated
to substitute Kataishi’s distal tip, designed to flexibly con-
form to and remove thrombi, with the proximal side open-
ing of the proposed Kontos-Ressemann combination,
designed to receive interventional cardiological devices.
Amongst other things, Teleflex submitted expert testimony
Case: 21-2357 Document: 61 Page: 30 Filed: 06/05/2023
30 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
explaining such a substitution would increase kinking, not
improve crossability, and have no impact on entry area,
contrary to Medtronic’s proposed motivations. See, e.g.,
J.A. 12021 ¶ 81; J.A. 16668–72 ¶¶ 212–17.
The Board held Medtronic failed to prove the Double-
Incline Claims unpatentable. ’776 Decision, at *19. The
Board first found Medtronic failed to provide a reasoned
explanation for substituting Kataishi’s suction-improving
distal tip at the proximal opening of Kontos. Id. Even
granting such a reason, however, the Board found Tele-
flex’s expert testimony regarding the increased chance of
kinking, together with Teleflex’s objective evidence, de-
feated Medtronic’s obviousness arguments. Id.On appeal, Medtronic argues the Board’s findings rest
on legal error. In particular, it asserts the Board erred by
(1) failing to address its argument that using Kataishi’s
double incline would increase the entry area for receiving
interventional devices, (2) reasoning the location of Ka-
taishi’s tip vis-à-vis Kontos and Ressmann’s proposed side
opening (i.e., distal vs. proximal) weighed against a moti-
vation to combine, and (3) effectively requiring physical in-
corporation of Kataishi into Kontos when it credited
Teleflex’s expert that using Kataishi’s double-inclined tip
would increase the risk of kinking.
Medtronic’s arguments are unavailing. Even accepting
Medtronic’s arguments concerning motivations to combine,
we conclude, as above, that Teleflex’s objective evidence is
sufficient to uphold the Board’s determination that Med-
tronic failed to prove the Double-Incline Claims unpatent-
able.
We see no error in the Board’s prima facie analysis.
First, with respect to Medtronic’s increased-area argu-
ment, the Board’s failure to explicitly address that argu-
ment does not show the Board failed to consider it. See
Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328
(Fed. Cir. 2017) (“[T]his court has said on multiple
Case: 21-2357 Document: 61 Page: 31 Filed: 06/05/2023
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 31
occasions that failure to explicitly discuss every issue or
every piece of evidence does not alone establish that the
tribunal did not consider it.”). The Board’s alleged errors
in failing to address that argument and doubting whether
a skilled artisan would use Kataishi’s distal tip for a prox-
imal side opening are immaterial. The Board expressly
found, in the alternative, that Teleflex’s expert persua-
sively testified that using Kataishi’s distal tip would in-
crease the risk of kinking and that a skilled artisan
therefore would not have been motivated to use that struc-
ture. See ’776 Decision, at *19. Medtronic contends its ex-
pert testified otherwise, but the presence of conflicting
evidence does not render the Board’s finding unsupported
by substantial evidence. Consolo v. Fed. Mar. Comm’n, 383
U.S. 607, 620 (1966) (“[T]he possibility of drawing two in-
consistent conclusions from the evidence does not prevent
an administrative agency’s finding from being supported
by substantial evidence.”).
Lastly, Medtronic’s contention that the Board required
physical incorporation of the references is without merit.
Medtronic argues the Board’s finding that kinking would
discourage skilled artisans from using Kataishi’s distal tip
was improperly predicated on using the materials disclosed
in Kataishi. Yet, the Board’s decision makes no reference
to Kataishi’s materials. Instead, the Board credited Tele-
flex’s expert testimony explaining Kataishi’s tip is designed
to be “highly flexible” and that high degree of flexibility
“would increase the risk of kinking.” ’776 Decision, at *19
(citing J.A. 12021 ¶ 81). The Board’s decision does not
demonstrate that it improperly required physical incorpo-
ration.
We conclude the Board did not err in its analysis and
that substantial evidence supports its findings. We there-
fore affirm the Board’s determination that Medtronic failed
to carry its burden to prove the Double-Incline Claims
would have been obvious.
Case: 21-2357 Document: 61 Page: 32 Filed: 06/05/2023
32 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
D. SUBSTITUTE CLAIMS
During the inter partes review proceedings for the ’032
and ’380 patents, Teleflex filed contingent motions to
amend proposing certain substitute independent claims.
Proposed substitute claim 23 of the ’032 patent is repre-
sentative of the Substitute Claims:
23. A device for use with a standard 6
French guide catheter, the standard guide
catheter having a continuous lumen ex-
tending for a predefined length from a
proximal end at a hemostatic valve to a dis-
tal end adapted to be placed in a branch ar-
tery, the continuous lumen of the guide
catheter having a circular cross-sectional
inner diameter sized such that interven-
tional cardiology devices are insertable into
and through the lumen to the branch ar-
tery, 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 prede-
fined length of the continuous lumen of the
standard 6 French guide catheter, the tub-
ular structure having a cross-sectional
outer diameter sized to be insertable
through the cross-sectional inner diameter
of the continuous lumen of the guide cathe-
ter 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 in-
cludes a first inclined region, a second in-
clined region, and a non-inclined concave
Case: 21-2357 Document: 61 Page: 33 Filed: 06/05/2023
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 33
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-sec-
tional outer diameter of the flexible tip por-
tion and having a length that, when
combined with the length of the flexible dis-
tal tip portion, defines a total length of the
device along the longitudinal axis that is
longer than the length of the continuous lu-
men of the guide catheter,
such that when at least a distal portion of
the flexible tip is extended distally of the
distal end of the guide catheter, at least a
portion of the proximal portion of the sub-
stantially rigid portion extends proximally
through the hemostatic valve in common
with interventional cardiology devices that
are insertable into the guide catheter.
See ’032 Decision, at *24–25 (emphases added).
In each proceeding, Medtronic argued the proposed
substitute claims lacked adequate written description in
the original application to which the ’032 and ’380 patents
claim priority. In particular, Medtronic contended the sub-
stitute claims encompass catheters with side openings
physically separate from the substantially rigid portion,
whereas the written description only describes side open-
ings that were part of the substantially rigid portion. In
addition, Medtronic argued the substitute claims would
have been obvious over Kontos, Kataishi, and Takahashi
Case: 21-2357 Document: 61 Page: 34 Filed: 06/05/2023
34 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
on the same bases it argued the Double-Incline Claims
would have been obvious. 13
The Board determined the substitute claims had ade-
quate written description support and would not have been
obvious over Medtronic’s asserted grounds. ’032 Decision,
at *26, 30–32; ’380 Decision, at *26, *30–32. On appeal,
Medtronic argues the Board erred by failing to adequately
address its written description arguments and by commit-
ting the same legal mistakes it allegedly made in analyzing
the patentability of the Double-Incline Claims.
We reject Medtronic’s arguments concerning alleged
errors in the Board’s analysis of Medtronic’s obviousness
grounds for the same reasons we conclude the Board did
not err in its analysis of the Double-Incline Claims. We
further reject Medtronic’s arguments regarding lack of
written description. In a parallel inter partes review pro-
ceeding against related U.S. Patent RE47,379, which
claims priority to the same original application at issue
here, Medtronic raised identical written description argu-
ments. We today affirmed the Board’s written description
finding in that appeal, which resolves this issue. See
13 Medtronic also argued the substitute claims would
have been obvious over U.S. Patent No. 7,736,355 (Itou) in
view of Ressemann or Kataishi. On appeal, Medtronic ar-
gues the Board erred by failing to address the Itou-Ka-
taishi grounds. In a separate decision, we affirmed the
Board’s finding in a parallel proceeding that Itou post-
dates May 3, 2006, the priority date of the patents-in-suit,
and consequently is not prior art. See Medtronic, Inc. v.
Teleflex Innovations S.À.R.L., No. 2021-2356, 2023 WL
3606143, at *1 (Fed. Cir. May 24, 2023). We therefore need
not address the Board’s alleged failure to address this
ground.
Case: 21-2357 Document: 61 Page: 35 Filed: 06/05/2023
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 35
Medtronic, Inc. v. Teleflex Innovations S.à.r.l., Nos. 21-
2359, 21-2362, 21-2366 (Fed. Cir. June 5, 2023).
CONCLUSION
We have considered the parties’ other arguments and
find them unpersuasive. For the reasons given, we affirm
the Board’s decisions holding the Side Opening, Double-In-
cline, and One-French Claims not unpatentable and grant-
ing issuance of the Substitute Claims.
AFFIRMED