Case: 21-2359 Document: 59 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
______________________
2021-2359, 2021-2362, 2021-2366
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2020-
00129, IPR2020-00134, IPR2020-00138.
______________________
Decided: June 5, 2023
______________________
JENNIFER L. GRABER, Wilmer Cutler Pickering Hale
and Dorr LLP, Washington, DC, argued for appellants.
Also represented by BRITTANY BLUEITT AMADI; TASHA JOY
BAHAL, MARK CHRISTOPHER FLEMING, HANNAH ELISE
GELBORT, MADELEINE C. LAUPHEIMER, Boston, MA.
JOSEPH W. WINKELS, Carlson, Caspers, Vandenburgh
& Lindquist PA, Minneapolis, MN, argued for appellee.
Also represented by PETER M. KOHLHEPP, TARA CATHERINE
NORGARD, J. DEREK VANDENBURGH.
______________________
Case: 21-2359 Document: 59 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. RE45,380; RE45,760; and RE47,379 (the
patents-in-suit). Medtronic also appeals the Board’s deci-
sions granting Teleflex Innovation S.à.r.l’s (Teleflex) mo-
tion to amend certain claims of the ’379 patent. 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 ’380 patent at 1:48–49. 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 1:39–52. 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 1:53–59. Interventional devices
can then be inserted into the proximal opening of the cath-
eter, advanced through the lumen of the catheter using a
1 The patents-in-suit share a common specification.
For simplicity, all citations to the written description will
refer to the ’380 patent.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 3
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 1:59–
63, 4:56–62. 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 1:59–67. 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 2:40–51; see J.A. 2276–80 (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. ’380 patent at 2:51–56.
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 2:9–27, 4:56–5:27. In a preferred
embodiment, the disclosed extension catheter includes
three parts: (1) a proximal substantially rigid portion 20
(yellow); (2) a reinforced portion 18 (blue); and (3) a distal
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. 1952 ¶ 50.
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4 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
flexible tip 16 (pink). See id. at 6:31–7:15; see also id. at
Fig. 4 (reproduced below as annotated by Medtronic’s ex-
pert). The proximal end of the guide extension catheter in-
cludes a “side opening,” i.e., a partially cylindrical region
(red circle), which permits the extension catheter to receive
and deliver interventional cardiological devices while it is
within the guide catheter. Id. at 10:1–20. 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 3:28–
49.
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.
7,604,612 (Ressemann), which discloses an evacuation
sheath assembly with a distal side opening used to aspirate
embolic material while occluding blood flow using sealing
balloons, in view of various combinations of secondary ref-
erences. The secondary references included: (1) U.S. Pa-
tent No. 5,439,445 (Kontos), which discloses a support
catheter for delivering angioplasty balloons; (2) U.S. Patent
Application Publication No. 2005/0015073 (Kataishi),
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 5
disclosing a suction catheter designed to remove thrombi
in blood vessels; and (3) Takahashi.
The Board instituted each petition and issued final
written decisions holding some claims unpatentable and
others not. Medtronic, Inc. v. Teleflex Innovations S.à.r.l.,
No. IPR2020-00129,
2021 WL 2524890 (P.T.A.B. June 17,
2021) (’380 Decision); Medtronic, Inc. v. Teleflex Innova-
tions S.à.r.l., No. IPR2020-00134, Paper No. 122 (P.T.A.B.
June 7, 2021) (’760 Decision); Medtronic, Inc. v. Teleflex In-
novations S.à.r.l., IPR2020-00138, Paper No. 104 (P.T.A.B.
June 7, 2021) (’379 Decision). 4,5 In addition, the Board
granted Teleflex’s contingent motion to amend certain
claims of the ’379 patent and determined the amended
claims were not unpatentable. ’379 Decision, at J.A. 133–
64.
The parties organize the claims determined not un-
patentable into three (overlapping) sets, a categorization
we adopt for our analysis. The One-French Claims are
claims 32 and 33 of the ’380 patent; claims 48 and 51–53 of
the ’760 patent; and claims 46–51 of the ’379 patent. The
Double-Incline Claims are claim 27 of the ’380 patent and
claims 44, 46–48, and 51 of the ’379 patent. Lastly, the
Substitute Claims are claims 46, 47, and 49–51 of the ’379
patent.
DISCUSSION
Medtronic appeals the Board’s determination that
Medtronic failed to prove the One-French and Double-In-
cline Claims would have been obvious. It also challenges
the Board’s decision granting Teleflex’s motion to introduce
4 The ’760 Decision is included in the Joint Appendix
at J.A. 53–77.
5 The ’379 Decision is included in the Joint Appendix
at J.A. 78–167.
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6 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
substitute claims in the ’379 patent. We address each issue
in turn.
I
We first address Medtronic’s arguments that the Board
erred in determining the One-French and Double-Incline
Claims are not unpatentable as obvious. 6 Obviousness is a
question of law based on underlying facts. In re Gartside,
203 F.3d 1305, 1316 (Fed. Cir. 2000). We review the
Board’s ultimate determination of obviousness de novo and
its underlying findings of fact for substantial evidence.
Id.
A. ONE-FRENCH CLAIMS
Claim 48 of the ’760 patent is representative of the
One-French Claims. It recites:
48. A system comprising:
a guide catheter configured to be advance-
able through a main blood vessel to a posi-
tion adjacent to an ostium of a coronary
artery, the guide catheter having a lumen
extending from a hemostatic valve at a
6 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
proximal end of the guide catheter to a dis-
tal end of the guide catheter that is adapted
to be positioned adjacent to the ostium of
the coronary artery;
a guide extension catheter configured to be
partially advanceable through the guide
catheter and into the coronary artery, the
guide extension catheter having a length
such that the distal end of the guide exten-
sion catheter is extendable through the lu-
men and beyond the distal end of the guide
catheter, and a proximal end of the guide
extension catheter is extendable through
the hemostatic valve at the proximal end of
the guide catheter;
the guide extension catheter including, in a
proximal to distal direction, a substantially
rigid segment, a segment defining a side
opening, and a tubular structure defining a
lumen coaxial and in fluid communication
with the lumen of the guide catheter, the
lumen of the tubular structure having a
length that is shorter than the length of the
lumen of the guide catheter and 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, the side
opening extending for a distance along the
longitudinal axis of the segment defining
the side opening and accessible from a lon-
gitudinal side defined transverse to the lon-
gitudinal axis, and the side opening and
the lumen of the tubular structure config-
ured to receive one or more stents or bal-
loon catheters when the segment defining
the side opening and a proximal end
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8 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
portion of the tubular structure are posi-
tioned within the lumen of the guide cath-
eter and the distal end of the guide
extension catheter extends beyond the dis-
tal end of the guide catheter;
wherein the segment defining the side
opening comprises a portion of the guide
extension catheter that is more rigid than
a distal end portion of the tubular struc-
ture.
’760 patent at claim 48 (emphasis added).
As relevant on appeal, Medtronic asserted the One-
French Claims would have been obvious over Ressemann
in view of Takahashi. ’380 Decision, at *3; ’760 Decision,
at J.A. 59; ’379 Decision, at J.A. 88. Medtronic argued a
skilled artisan would have been motivated to modify
Ressemann by removing its sealing balloons and replacing
its inflation lumen with a pushrod or wire so that it could
be used as an extension catheter. See, e.g., ’380 Decision,
at *16. Medtronic alleged a skilled artisan would be moti-
vated to remove the sealing balloons and inflation lumen
used to aspirate emboli because, inter alia, Ressemann
teaches its device can also be used to deliver certain inter-
ventional cardiological devices such as stents or angio-
plasty balloons.
Id. It further alleged a skilled artisan
would be motivated to incorporate Takahashi’s five-in-six
system into Ressemann as modified to achieve the in-
creased back-up support touted by Takahashi.
Id.
Teleflex responded that Medtronic’s modifications
would not have been obvious because they would render
Ressemann inoperable as a catheter capable of providing
embolic protection (i.e., preventing embolic debris from es-
caping down the bloodstream while the embolism is being
removed), which Teleflex alleged was the entire purpose of
Ressemann.
Id. Teleflex further argued the modifications
were based on hindsight and that the alleged benefits could
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 9
not be achieved without further modifications not detailed
in the petitions. See, e.g., ’379 Decision, at J.A. 118–19. In
reply, Medtronic argued removing Ressemann’s sealing
balloons would not render it inoperable for embolic protec-
tion because other non-occlusive, distal protection devices
could be used instead. ’380 Decision, at *16.
The Board agreed with Teleflex and held Medtronic
failed to establish the One-French Claims would have been
obvious. ’380 Decision, at *16–17; ’760 Decision, at J.A. 71–
72; ’379 Decision, at J.A. 119–21. Contrary to Medtronic’s
position that Ressemann is a multi-purpose device, the
Board found Ressemann’s “entire premise” was to provide
embolic protection using sealing balloons and that Med-
tronic’s “extensive” modifications would eliminate “the ca-
pability of Ressemann’s aspiration catheter to act as an
aspiration catheter.” ’379 Decision, at J.A. 120; ’380 Deci-
sion, at *16 (finding Medtronic’s “intended-purpose-de-
stroying modification counsels strongly against an
obviousness determination”); ’760 Decision, at J.A. 71–72
(same). The Board rejected Medtronic’s argument that em-
bolic protection could be preserved through other means,
noting Medtronic did not raise these arguments in its peti-
tions and that the additional extensive modifications were
further evidence of hindsight bias. E.g., ’380 Decision, at
*17.
On appeal, Medtronic argues the Board legally erred
by focusing on the detrimental effects of Medtronic’s modi-
fications to one of Ressemann’s intended purposes (embolic
protection) to the neglect of Ressemann’s other purpose of
delivering interventional cardiological devices. According
to Medtronic, the Board’s reasoning conflicts with our deci-
sion in Intel Corp. v. Qualcomm Inc., in which we held the
“intended purpose of [a reference] does not control” the ob-
viousness inquiry.
21 F.4th 784, 800–01 (Fed. Cir. 2021).
We do not agree.
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10 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
Medtronic’s argument, although styled as a legal chal-
lenge, is premised on an assertion of fact contrary to the
Board’s findings, namely that Ressemann is suitable for
procedures that do not employ occlusive sealing balloons.
The Board did not find that Ressemann’s device was in-
tended to function for any purpose, including delivering in-
terventional devices, in the absence of sealing balloons.
Rather, it found Ressemann’s “entire premise” was to use
sealing balloons to prevent embolic flow and that removing
the balloons would “render Ressemann completely inopera-
ble for its stated purpose of embolic protection.” ’379 Deci-
sion, at J.A. 120 (emphasis added) (adopting Teleflex’s
positions). That finding is supported by substantial evi-
dence, including Teleflex’s expert testimony that
“Ressemann’s sealing balloons are critical to [its] goal of al-
lowing a lesion to be treated without embolic debris being
carried downstream” and Ressemann’s own disclosures
emphasizing the role of sealing balloons for embolic protec-
tion.
Id. (citing J.A. 20596–97 ¶ 148; J.A. 2240–43
(Ressemann) at 8:12–15, 12:31–53, 13:15–14:39). Med-
tronic’s experts also acknowledged Ressemann is “directed
to an embolic protection device” and that Ressemann’s
sealing balloons were a “necessary part” of that function.
J.A. 12192 at 396:20–397:20; see also ’379 Decision, at J.A.
118 (citing Medtronic’s expert testimony that “[i]f a
POSITA desired to only use Ressemann for delivering ther-
apy devices, . . . Ressemann’s device would be simplified to
eliminate the features necessary for evacuating emboli,” in-
cluding sealing balloons).
Medtronic contends this finding is inconsistent with
Ressemann’s disclosures that its device can be used in
other surgical procedures, including to deliver interven-
tional devices. See J.A. 2239 at 6:25–34 (describing
Ressemann’s device “is contemplated for use . . . in other
procedures . . . where reduction or removal of a blockage in
a blood vessel is beneficial”); J.A. 2248 at 23:8–20 (disclos-
ing Ressemann’s evacuation sheath is “designed to allow
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 11
for the passage of interventional devices”). Teleflex’s ex-
perts, however, explained that sealing balloons would still
be used during such procedures to occlude blood flow. J.A.
20597 ¶ 148; see also J.A. 2243 (Ressemann) at 13:15–14:39
(discussing the use of sealing balloons to occlude blood flow
during stent delivery). Medtronic relies on other disclo-
sures indicating an elastomeric tube could be used in lieu
of sealing balloons, see J.A. 2240 at 8:41–44, but this does
not lead to a conclusion that the Board’s finding is not sup-
ported by substantial evidence. 7 Consolo v. Fed. Mar.
Comm’n,
383 U.S. 607, 620 (1966) (“[T]he possibility of
drawing two inconsistent conclusions from the evidence
does not prevent an administrative agency’s finding from
being supported by substantial evidence.”); Velander v.
Garner,
348 F.3d 1359, 1378 (Fed. Cir. 2003) (“If the evi-
dence will support several reasonable but contradictory
conclusions, we will not find the Board’s decision unsup-
ported by substantial evidence simply because the Board
chose one conclusion over another plausible alternative.”).
Even if Ressemann contemplates use cases without
sealing balloons, the Board’s reasoning does not constitute
legal error. Medtronic contends the Board’s finding is in-
consistent with our holding in Intel that the intended pur-
pose of a prior art device is not dispositive of whether a
skilled artisan would have been motivated to modify it. See
21 F.4th at 800–01.
7 Teleflex argues Medtronic forfeited its argument
that sealing balloons are not mandatory because they could
be replaced by an elastomeric tube. It also disputes, as a
factual matter, whether inflatable elastomeric tubes are
meaningfully distinct from sealing balloons. We will not
resolve this factual dispute on appeal. Even if Medtronic’s
argument is not forfeited and has a reasonable basis in fact,
it does not compel reversal of the Board’s finding.
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12 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
But there is no conflict. We read the Board as finding
that Ressemann teaches against using its device without
sealing balloons because doing so while advancing inter-
ventional cardiac devices like those contemplated for use
with the challenged claims might produce safety concerns.
See, e.g., ’380 Decision, at *8, *16 (finding that removing
sealing balloons would undermine Ressemann’s ability to
“capture particulate matter during a procedure,” for exam-
ple “positioning and placing [a] stent”); J.A. 20565 ¶ 103,
20597 ¶ 148 (Teleflex expert asserting that a person of or-
dinary skill in the art would not “insert and deploy a bal-
loon or stent catheter through the Ressemann device
without first using the balloons to occlude blood flow”); ’380
patent at abstract & 1:42–44 (invention directed at exten-
sion catheter for use with interventional devices such as
stents and balloon catheters).
In other words, the Board found that removing
Ressemann’s sealing balloons would undermine a goal it
shares with the challenged claims—safely advancing inter-
ventional devices to treat cardiac lesions. See ’380 Deci-
sion, at *2 (finding that the ’380 patent is directed at guide
catheters for advancing “a stent or balloon catheter” to
treat a cardiac lesion); id. at *9 (finding that Ressemann
allows surgeons to advance a “therapeutic device, such as
a stent” to treat a cardiac lesion while collecting “dislodged
material”); J.A. 2237 (Ressemann) (noting that procedures
such as stent placement carry the risk “that some of the
treated plaque will be disrupted,” and “if allowed to flow
through the vascular system, may cause subsequent infarc-
tions or ischemia”). Medtronic did not argue that the pro-
cedures contemplated in the challenged claims were free
from such risks. See, e.g., J.A. 28399–400 (arguing instead
that Ressemann could retain the ability to catch loose
plaque even if modified); J.A. 22129–130 (same). The
Board reasonably recognized that modifying a device in a
manner that would undermine a purpose it shares with the
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 13
challenged claims counsels against a motivation to make
such modifications.
Intel is both consistent with the Board’s analysis and
distinguishable from the facts at hand. In Intel, we re-
jected the Board’s reasoning that a proposed rationale for
modifying a circuit was insufficient because it “would have
resulted in the circuit not being suitable for its intended
purpose.” 21 F.4th at 800. We explained this reasoning—
in which the intended purpose of the device was given con-
trolling weight—was inconsistent with the Supreme
Court’s recognition that “common sense teaches . . . that fa-
miliar items may have obvious uses beyond their primary
purposes,” and with the reference’s express recognition of
use cases compatible with the proposed modification to the
circuit. Id. at 801 (quoting KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 420 (2007)). We did not hold, however, that
a proposed modification’s destruction of a device’s primary
purpose is always legally irrelevant to obviousness. Such
a conclusion is equally at odds with common sense and
gives in to the very hindsight bias the obviousness inquiry
is designed to avoid. Indeed, we have held it was error for
the Board to ignore evidence that a proposed modification
would interfere with a reference’s stated purpose. See Po-
laris Indus. v. Arctic Cat, Inc.,
882 F.3d 1056, 1061, 1067–
69 (Fed. Cir. 2018) (vacating Board decision that failed to
consider whether modifying prior art reference would un-
dermine its goal, shared with the challenged claims, of con-
structing stable all-terrain vehicles).
The Board’s analysis was consistent with these princi-
ples. The Board found, in the context of these patents, that
the destruction of Ressemann’s “entire premise” “coun-
sel[ed] strongly against” obviousness, not that it was deter-
minative. See, e.g., ’032 Decision, at *16. The Board went
on to consider Medtronic’s argument that embolic protec-
tion could be achieved without sealing balloons but found
that argument unpersuasive because it was not presented
in Medtronic’s petition and the extensive nature of the
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14 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
additional proposed modifications was suggestive of hind-
sight. 8
Id. Further, unlike in Intel, in which the reference
contemplated use cases beyond the “intended purpose,” 21
F.4th at 801, the Board found Ressemann’s “entire prem-
ise” was founded on the sealing devices Medtronic’s pro-
posed modifications would remove. We conclude the Board
did not err in determining the destruction of Ressemann’s
entire purpose, shared with the challenged claims, was pro-
bative of whether Medtronic’s modifications would have
been obvious.
The Board did not err in determining Medtronic failed
to carry its burden to show the One-French Claims would
have been obvious, and substantial evidence supports its
underlying findings of fact. Accordingly, we affirm the
Board’s holding that Medtronic failed to establish the One-
French Claims are unpatentable.
B. DOUBLE-INCLINE CLAIMS
Claim 27 of the ’380 patent is representative of the
Double-Incline Claims. It recites:
8 Medtronic argues the Board legally erred and
abused its discretion by “refusing to consider” these argu-
ments because Medtronic properly raised them in reply to
rebut Teleflex’s arguments. Appellant’s Opening Br. 39.
The Board’s decisions make plain, however, that it consid-
ered Medtronic’s arguments. See ’032 Decision, at *17 (re-
counting and rejecting Medtronic’s reply arguments); ’760
Decision, at J.A. 72 (same); ’379 Decision, at J.A. 121
(same). It simply found them unpersuasive because they
relied on extensive modifications not discussed in the peti-
tion, suggesting they were “improperly based on a hind-
sight desire to recreate the inventions . . . and not a known
need in the art for such a device.” ’379 Decision, at J.A.
121.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 15
27. The system of claim 26, wherein the
side opening includes at least two different
inclined slopes.
’380 patent at claim 27 (emphasis added).
Medtronic asserted the Double-Incline Claims would
have been obvious over Ressemann and Kataishi. It ar-
gued a skilled artisan would have been motivated to incor-
porate the double-inclined shape of Kataishi’s distal tip
into Ressemann’s proximal side opening because doing so
would increase entry area (i.e., the area in which to insert
interventional devices into the extension catheter) and im-
prove crossability (i.e., the ability to advance the extension
catheter through the guide catheter and into vasculature).
See ’032 Decision, at *13–14; ’379 Decision, at J.A. 124–26.
The Board found neither motivation persuasive and ac-
cordingly held Medtronic failed to prove the Double-Incline
Claims are unpatentable. ’380 Decision, at *14–15; ’379
Decision, at J.A. 127–29. Specifically, crediting Teleflex’s
expert testimony, the Board found Medtronic failed to show
a skilled artisan would be motivated to use the shape of
Kataishi’s distal tip for Ressemann’s proximal side opening
because opening area does not depend on having a double-
inclined opening and because using the shape of Kataishi’s
distal tip in lieu of Ressemann’s proximal side opening may
actually impair crossability by increasing the risk of
kinking. ’380 Decision, at *14–15; ’379 Decision, at J.A.
127–29.
On appeal, Medtronic argues the Board’s findings rest
on legal error. In particular, it asserts the Board erred by
(1) concluding an alternative design choice to increase en-
try area negated its proposed motivation to combine, (2)
reasoning the location of Kataishi’s tip vis-à-vis Ress-
mann’s side opening (i.e., distal vs. proximal) weighed
against a motivation to combine, and (3) effectively requir-
ing physical incorporation of Kataishi into Ressemann
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16 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
when it credited Teleflex’s expert that using Kataishi’s
double-inclined tip would increase the risk of kinking.
Medtronic’s arguments are unavailing. First, the
Board did not find a lack of motivation to use Kataishi’s
double-inclined shape merely because entry area could be
increased in other ways. The Board expressly found the
use of a double-inclined opening is irrelevant to entry area
because, as Teleflex’s expert testified, entry area depends
only on the angle of the opening. See ’380 Decision, at *14
(crediting expert testimony that “increased area is a func-
tion of how sharp one chooses to angle the opening and does
not depend on having a complex, multi-angle shape like
that of Kataishi”); ’379 Decision, at J.A. 128 (same). While
Medtronic may be correct that the entry area of Kataishi’s
double-inclined tip is larger than Ressemann’s side open-
ing, the Board found this is not due to Kataishi’s tip being
doubly-inclined and that Medtronic therefore failed to
show increasing entry area would have motivated a skilled
artisan to incorporate this feature into Ressemann.
The Board’s reasoning does not rest upon the existence
of alternative designs to achieve the same ends. It rests on
the idea that the design feature Medtronic sought to incor-
porate—a double-inclined opening—does not achieve that
end. Something else does, namely a sharper opening angle.
This was not legal error. Indeed, to hold otherwise would
countenance motivation arguments based on functionally
irrelevant features of references that happen to exhibit a
benefit for altogether different reasons, a recipe that would
be ripe for hindsight abuse.
Second, the Board did not err in finding that the al-
leged benefits associated with Kataishi’s distal tip would
not translate to Ressemann’s proximal opening. The Board
relied on substantial evidence, including Teleflex’s expert
testimony explaining that the ability of Kataishi’s tip to
“cross tortuous vasculature is almost entirely driven by the
design of its distal end, as that is the portion that interacts
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 17
with vasculature as it is being advanced” and that “[c]on-
siderations for suctioning a thrombus into the distal open-
ing of Kataishi, in a distal-to-proximal direction, would not
apply to inserting interventional devices, in a proximal-to-
distal direction, into Ressemann’s proximal opening.” ’379
Decision, at J.A. 127 (citing J.A. 20600 ¶ 153, J.A. 12931 ¶
193, and J.A. 12470 at 385:1–23). Given its finding that
the benefits of Kataishi’s distal tip were tied to its distal
location and the “lack of any teaching suggesting any inter-
ventional devices being passed through Kataishi’s suction
catheter,” the Board reasonably found Medtronic failed to
carry its burden to establish a motivation to combine. Med-
tronic again points to its contrary expert testimony that
Kataishi teaches its shape would improve crossability even
if applied to a proximal opening because it would improve
the proximal opening’s ability to smoothly navigate
through the guide catheter (as opposed to vasculature).
But the Board’s decision to credit Teleflex’s experts over
Medtronic’s does not render its finding unsupported by
substantial evidence. In re Jolley,
308 F.3d 1317, 1329
(Fed. Cir. 2002).
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 decisions make no reference
to Kataishi’s materials. Instead, the Board credited Tele-
flex’s expert testimony explaining that, because
Ressemann’s device already has an angled side opening, no
further benefits to crossability would accrue from using a
double-inclined opening. ’380 Decision, at *15. The Board’s
reasoning was thus explicitly focused on the shape of Ka-
taishi’s distal tip, not its materials. The Board further
found that utilizing that shape would disadvantageously
increase flexibility at Ressemann’s proximal end, “thereby
increasing the risk of kinking.”
Id. (citing J.A. 12933
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18 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
¶ 197). As Kataishi’s shape is the very feature Medtronic
sought to incorporate into Ressemann, the Board’s deci-
sions do not demonstrate that it improperly required phys-
ical incorporation of the references beyond that proposed
by Medtronic.
We conclude the Board did not err in its analysis and
that substantial evidence supports its findings. We there-
fore affirm its determination that Medtronic failed to carry
its burden to prove the Double-Incline Claims would have
been obvious.
C. SUBSTITUTE CLAIMS
During the inter partes review proceedings for the ’379
patent, Teleflex filed a contingent motion to amend propos-
ing certain substitute claims. Proposed substitute claim
49, which amends claim 38, is representative of the Substi-
tute Claims:
49. A method of forming a device adapted for use
with a standard guide catheter having a continu-
ous lumen extending for a predefined length, the
method comprising:
providing a flexible tip segment having a lu-
men therethrough;
providing a reinforced segment including
one or more metallic elements covered with
a polymer and having a uniform, fixed
outer diameter and a lumen for coaxial
alignment a lumen for coaxial alignment
with the lumen of the flexible tip segment,
said flexible tip segment and reinforced
segment defining a tubular structure with
a single lumen that is configured to be co-
axial with the continuous lumen of the
guide catheter when positioned therein,
wherein said tubular structure has an in-
ner diameter that is not more than about
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 19
one French smaller than the continuous in-
ner lumen of the guide catheter;
providing a substantially rigid segment de-
fining a rail structure without a lumen ex-
tending from a proximal end portion to a
distal end portion, wherein the substan-
tially rigid segment is more rigid along a
longitudinal axis than the flexible tip seg-
ment;
defining a side opening portion, including
forming, in a proximal to distal direction,
an arcuate cross-sectional shape and hemi-
cylindrical cross-sectional shape, the side
opening portion extending for a distance
along a longitudinal axis of the device such
that the side opening is accessible from a
longitudinal side, defined transverse to the
longitudinal axis, to receive a balloon cath-
eter and stent; and
arranging, in a proximal to distal direction,
the substantially rigid segment, the side
opening portion, the reinforced segment,
and the flexible tip segment such that when
the flexible tip segment is extended distally
of a distal end of the guide catheter, the
proximal end portion of the substantially
rigid segment extends proximally of a prox-
imal end of the guide catheter and the side
opening portion is positioned within the
continuous lumen of the guide catheter,
whereby the reinforced segment and sub-
stantially rigid segment are configured to
resist forces exerted by the balloon catheter
and stent that are passed through and be-
yond the coaxial lumen that would other-
wise tend to dislodge the guide catheter
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20 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
from a branch artery into which the rein-
forced segment has been advanced.
See ’379 Decision, at J.A. 137–38 (emphases added).
Before the Board, Medtronic argued the Substitute
Claims lacked adequate written description in the original
application to which the ’379 patent claims priority,
namely Application Serial No. 11/416,629. See J.A. 30456–
97 (’629 application). In particular, Medtronic contended
the Substitute Claims encompass catheters with side open-
ings separate from the substantially rigid segment,
whereas the written description only describes side open-
ings that were part of the substantially rigid segment. In
addition, as relevant on appeal, Medtronic argued the Sub-
stitute Claims would have been obvious over
U.S. Patent
No. 5,439, 445 (Kontos) in view of, inter alia, Kataishi and
Takahashi. 9
The Board determined the Substitute Claims had ade-
quate written description support and would not have been
obvious over Medtronic’s asserted grounds. ’379 Decision,
at J.A. 139–47, J.A. 162–64. On appeal, Medtronic argues
the Board erred by finding written description support
based on the absence of any disclosure that the location of
the side opening was critical to the invention and by
9 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, Med-
tronic argues the Board erred by failing to address the Itou-
Kataishi 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 ’379 patent, 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.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 21
deferring to the examiner’s interpretation of the prosecu-
tion history. It also argues the Board committed legal error
when it determined Medtronic failed to show the Substi-
tute Claims would have been obvious. We are not per-
suaded.
Medtronic contends the Board failed to assess whether
the disclosures of the ’629 application would have reasona-
bly conveyed to a skilled artisan that the applicant pos-
sessed a catheter with a side opening separate from the
substantially rigid segment, but this is precisely the in-
quiry the Board undertook. The Board acknowledged writ-
ten description requires “the patent specification [to]
describe an invention in sufficient detail that one skilled in
the art can clearly conclude that the inventor invented
what is claimed” and found, after “[h]aving reviewed the
portions of the [s]pecification referenced by [Teleflex],” that
the specification provided adequate support. ’379 Decision,
at J.A. 145 (quoting Cordis Corp. v. Medtronic AVE, Inc.,
339 F.3d 1352, 1364 (Fed. Cir. 2003)). It then identified
written disclosures and figures it found provided the nec-
essary support, including the patent’s description that
“[t]he rigid portion may include a cutout portion [i.e., a side
opening] and a full circumference portion.”
Id. (emphasis
added) (quoting ’629 application at 8:18–21).
The Board further supported its finding by noting that
the ’629 application’s specification “does not indicate that
putting the side opening specifically in the substantially
rigid portion is critical to the invention” and that the appli-
cant never asserted the location of the side opening was a
point of novelty during prosecution. J.A. 146. Applying our
holding in Ethicon Endo-Surgery, Inc. v. U.S. Surgical
Corp., the Board correctly determined the absence of em-
bodiments in the ’629 application with a side opening sep-
arate from the rigid segment did not preclude written
description. J.A. 146–47 (citing
93 F.3d 1572, 1582 n.7
(Fed. Cir. 1997) (“If [the inventor] did not consider the pre-
cise location of the [feature] to be an element of his
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22 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
invention, he was free to draft [the claims] broadly (within
the limits imposed by the prior art) to exclude the lockout’s
exact location as a limitation of the claimed invention.”)).
As we explained in Ethicon, if the precise location of the
side opening was not an element of the invention, claims
that do not recite the location as a limitation are not “un-
supported by the specification even though [they] would be
literally infringed by undisclosed embodiments.” 93 F.3d
at 1582 n.7; see In re Rasmussen,
650 F.2d 1212, 1215
(CCPA 1981) (“[T]hat a claim may be broader than the spe-
cific embodiment disclosed in a specification is in itself of
no moment. Indeed, the statutory provision for broadened
claims in reissue applications is intended to meet precisely
the situation in which a patentee has claimed ‘less’ than he
had a right to claim.”). As the Board acknowledged, writ-
ten description requires only that a skilled artisan would
reasonably conclude, based on the patent’s disclosures and
the knowledge of a person skilled in the art, that the appli-
cant possessed catheters in which the side opening could be
located outside the rigid segment. Ariad Pharms., Inc. v.
Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc) (“[T]he test for sufficiency is whether the disclosure
of the application relied upon reasonably conveys to those
skilled in the art that the inventor had possession of the
claimed subject matter as of the filing date.”). Medtronic
has not demonstrated the Board’s findings in this regard
constitute legal error. 10
10 Medtronic’s argument that the Board erroneously
deferred to the examiner’s acceptance of amendments di-
rected to this issue, see J.A. 18718–19050, is without merit.
The Board recounted, but did not rely, on the examiner’s
allowance of the claim to find written description. ’379 De-
cision, at J.A. 143–44. Instead, it expressly based its find-
ing on “portions of the specification . . . [that] adequately
support[] the proposed substitute claims.”
Id. at J.A. 145.
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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. 23
Finally, Medtronic argues the Board erred in determin-
ing the Substitute Claims are not unpatentable because it
made two findings that are inconsistent with other findings
made in this and other inter partes reviews of related pa-
tents. First, Medtronic contends the Board contradicted its
finding in this proceeding that Kataishi discloses a double-
inclined side opening. Compare ’379 Decision, at J.A. 162
(“Kataishi fails to disclose the recited Complex Side Open-
ing feature of the proposed substitute claims”), with
id. at
J.A. 128 (“Kataishi discloses . . . [a] mutli-angled distal
tip”). Read in context, the Board’s statements do not evince
legal error. The Board’s full statement is as follows: “As
discussed hereinabove in our analysis of [Medtronic’s] chal-
lenges to original claim 44, however, we determine Ka-
taishi fails to disclose the recited Complex Side Opening
feature of the proposed substitute claims.”
Id. at J.A. 162.
The Board’s “finding” must therefore be read in view of its
discussion of claim 44, which it expressly incorporated in
the very same sentence. Critically, in analyzing claim 44,
the Board did not rely on Kataishi’s lack of disclosure to
hold the claim not unpatentable, 11 but instead relied on
Medtronic’s failure to establish a motivation to incorporate
Kataishi’s distal tip into Ressemann’s proximal side open-
ing. See Section I.B supra. Understood in this context, the
Board’s statement regarding Kataishi’s disclosure is best
read to refer to the underlying lack of motivation to com-
bine Kataishi with Kontos. We acknowledge the Board’s
statement in this regard is imprecise. But, as we have ex-
plained many times, “we do not require perfect explana-
tions” of the Board, In re Nuvasive, Inc.,
842 F.3d 1376,
1382 (Fed. Cir. 2016); rather, we only require that its path
be reasonably discernible, Ariosa Diagnostics v. Verinata
Health, Inc.,
805 F.3d 1359, 1365 (Fed. Cir. 2015). That
11 Indeed, in analyzing claim 44, the Board recog-
nized Kataishi discloses a double-inclined distal tip. See
J.A. 122–23.
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24 MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
standard is satisfied here, where the allegedly contradic-
tory phrase is prefaced by thorough analysis (incorporated
by reference) elucidating the basis for the Board’s decision.
Second, Medtronic contends the Board contradicted its
findings in other proceedings involving related patents
that Kontos discloses a reinforced segment. Compare ’379
Decision, at J.A. 163 (finding Medtronic’s Kontos/Kataishi
combination “requires modifying Kontos to achieve . . . sub-
stitute claim 49’s limitation of ‘a reinforced segment’”),
with Medtronic, Inc. v. Teleflex Innovations S.à.r.l., No.
IPR2020-00127,
2021 WL 2518685, at *14 (P.T.A.B. June
7, 2021) (finding “Kontos’s body 12 identified in Petitioner’s
Reply are proximal to the flexible cylindrical distal tip por-
tion and represent ‘cylindrical reinforced portions’”). This
argument is similarly unavailing. Even if true, this would
not require vacatur because the Board provided an alter-
native ground for its determination that Medtronic failed
to establish the unpatentability of proposed substitute
claim 49, namely a lack of motivation to combine. The
Board found Medtronic failed to establish a skilled artisan
would have been motivated to combine Kataishi and Kon-
tos because they disclose “different devices, used in differ-
ent procedures, and directed to different problems that
might be encountered during an interventional procedure.”
‘379 Decision, at J.A. 163 (quoting J.A. 20749 ¶ 121). Med-
tronic does not challenge the factual bases for these find-
ings. Accordingly, we affirm on this ground without
deciding whether and to what effect the Board may have
reached inconsistent findings.
CONCLUSION
We have considered the parties’ other arguments and
find them unpersuasive. For the reasons given, we affirm
the Board’s decisions holding the Double-Incline and One-
French Claims not unpatentable and granting issuance of
the Substitute Claims.
AFFIRMED