Opinion

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

  • 69 F.4th 1341
Court
Court of Appeals for the Federal Circuit
Filed
Jun 5, 2023
Status
Published
Cited by
5 cases
Authority
More cited than 62.3%

ex- plaining that even “[i]f the evidence will support several reasonable but contradictory conclusions, we will not find [a tribunal]’s decision unsupported by substantial evidence simply because [it] chose one conclusion over another plau- sible alternative.” (citation omitted)

How later courts described this case

  • ex- plaining that even “[i]f the evidence will support several reasonable but contradictory conclusions, we will not find [a tribunal]’s decision unsupported by substantial evidence simply because [it] chose one conclusion over another plau- sible alternative.” (citation omitted)
  • “If the evidence will support several reasonable but contradictory conclusions, we will not find the Board’s decision unsupported by substantial evidence simply because the Board chose one conclusion over an- other plausible alternative.” (quoting Velander v. Garner, 348 F.3d 1359, 1378 (Fed. Cir. 2003))
  • collectively, “the previous Med- tronic decisions”

Written by the judges who cited it.

The opinion

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.

Case: 21-2359 Document: 59 Page: 3 Filed: 06/05/2023

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.

Case: 21-2359 Document: 59 Page: 4 Filed: 06/05/2023

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),

Case: 21-2359 Document: 59 Page: 5 Filed: 06/05/2023

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.

Case: 21-2359 Document: 59 Page: 6 Filed: 06/05/2023

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 . . . .”).

Case: 21-2359 Document: 59 Page: 7 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 8 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 9 Filed: 06/05/2023

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.

Case: 21-2359 Document: 59 Page: 10 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 11 Filed: 06/05/2023

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.

Case: 21-2359 Document: 59 Page: 12 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 13 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 14 Filed: 06/05/2023

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.

Case: 21-2359 Document: 59 Page: 15 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 16 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 17 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 18 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 19 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 20 Filed: 06/05/2023

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.

Case: 21-2359 Document: 59 Page: 21 Filed: 06/05/2023

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

Case: 21-2359 Document: 59 Page: 22 Filed: 06/05/2023

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.

Case: 21-2359 Document: 59 Page: 23 Filed: 06/05/2023

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.

Case: 21-2359 Document: 59 Page: 24 Filed: 06/05/2023

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

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

A word about cookies

We need a few to keep you signed in and the library working. The rest help us see which pages people use and where they get stuck. They stay off unless you say yes.