Aortic Innovations LLC v. Edwards Lifesciences Corporation, Edwards Lifesciences LLC, Edwards Lifesciences…

United States Court of Appeals
for the Federal Circuit
______________________
AORTIC INNOVATIONS LLC,
Plaintiff-Appellant
v.
EDWARDS LIFESCIENCES CORPORATION,
EDWARDS LIFESCIENCES LLC, EDWARDS
LIFESCIENCES (U.S.), INC.,
Defendants-Appellees
______________________
2024-1145
______________________
Appeal from the United States District Court for the
District of Delaware in No. 1:21-cv-01377-JPM, Judge Jon
P. McCalla.
______________________
Decided: October 27, 2025
______________________
J OHN BRUCE CAMPBELL , McKool Smith, P.C., Austin,
TX, argued for plaintiff-appellant. Also represented by
G EOFFREY SMITH , J OEL L ANCE T HOLLANDER .
MARK A NDREW P ERRY , Weil, Gotshal & Manges LLP,
Washington, DC, argued for defendants-appellees. Also
represented by BRIAN C. BARNES , CHRISTY G. L EA , J OSHUA
STOWELL , Knobbe, Martens, Olson & Bear, LLP, Irvine,
CA; BRIAN CHRISTOPHER HORNE, Los Angeles, CA.
______________________
Case: 24-1145 Document: 45 Page: 1 Filed: 10/27/2025

-- 1 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
2
Before P ROST , REYNA, and CHEN, Circuit Judges.
REYNA, Circuit Judge.
This appeal concerns devices for transcatheter aortic
valve replacement, a procedure in which a prosthetic heart
valve replaces a diseased aortic valve. Aortic Innovations
LLC appeals from a stipulated judgment of non-infringe-
ment of four asserted patents from the U.S. District Court
for the District of Delaware. Aortic argues that the district
court’s construction of “outer frame,” on which the stipu-
lated judgment of non-infringement was based, was erro-
neous. We agree with the district court’s construction and
affirm the judgment as to three of the asserted patents at
issue. As to the fourth asserted patent, we dismiss the ap-
peal for lack of jurisdiction.
BACKGROUND
I.
It was known in the art that a transcatheter aortic
valve replacement device collapses down to a narrow diam-
eter and is delivered to the site of the patient’s diseased
aortic valve via a delivery catheter. Once at the site, the
device is removed from the catheter sheath and expanded
in one of the following two ways, anchoring the device in
place. First, it can expand via a balloon-expandable frame.
This is a frame that requires a balloon inflating at the cen-
ter of the device to expand from the collapsed state to the
deployed state. Second, it can expand via a self-expanding
frame, which expands due to its shape-memory material
that springs back to an expanded shape after being re-
leased from the delivery catheter. The two types of frames
are displayed below:
Case: 24-1145 Document: 45 Page: 2 Filed: 10/27/2025

-- 2 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
3
J.A. 3680.1
II.
Appellant Aortic Innovations LLC (“Aortic”) owns the
four asserted patents in this case, which are U.S. Patent
Nos. 10,881,538 (“’538 patent”), 10,966,846 (“’846 patent”),
10,987,236 (“’236 patent”), and 11,129,735 (“’735 patent”)
(collectively, the “Asserted Patents”). The Asserted Pa-
tents derive from the same predecessor application and
claim priority to the same provisional applications.
J.A. 41–42. They also share a common specification.
The specification discloses two types of devices.2 The
first is an “endograft device” for endovascular repair of as-
cending aortic aneurysms, directed primarily to treatment
of aortic diseases. J.A. 173, 2:53–55; J.A. 175, 6:36–49.
The second is a “transcatheter valve.” J.A. 174, 3:61–62.
The claims of the Asserted Patents are directed to the
transcatheter valve. J.A. 183; J.A. 150; J.A. 118;
J.A. 85–86. According to the summary section of the spec-
ification, a “transcatheter valve” “includes a frame compo-
nent having a balloon-expandable frame extending distally
1 Appellee included the red text displayed in the im-
age above. See Response Br. 13.
2 For the remainder of this opinion, we cite to the
specification of the ’735 patent when discussing the As-
serted Patents’ common specification.
Case: 24-1145 Document: 45 Page: 3 Filed: 10/27/2025

-- 3 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
4
from a proximal end of the frame component and a self-ex-
panding frame secured to the balloon-expandable frame.”
J.A. 174, 3:61–65.
On appeal, the parties dispute the construction of the
claim term “outer frame” in claim 1 of the ’735 patent. This
claim recites:
1. An endovascular transcatheter valve assembly
comprising:
an outer frame,
wherein the outer frame is formed from a metallic
material and defines an open cell configuration
wherein the outer frame includes an inflow end at
a proximal portion thereof and an outflow end at a
distal portion thereof,
wherein the outer frame is formed by a plurality of
struts that adjoin each other at the inflow end to
form apices:
an inner frame that engages a prosthetic heart
valve having prosthetic leaflets, wherein the inner
frame includes a cylindrically extending inner graft
covering extending at least partially radially out-
wardly of the prosthetic heart valve and radially
inwardly of the outer frame for providing sealing to
the prosthetic heart valve,
wherein the outer frame is secured to the inner
graft covering by stitching a proximal portion of the
outer frame;
an outer seal for preventing paravalvular leaks
that at least partially extends over at least two
most proximal rows of cells formed in the outer
frame,
Case: 24-1145 Document: 45 Page: 4 Filed: 10/27/2025

-- 4 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
5
wherein the outer seal is formed of outwardly ex-
tending fibers positioned externally to the outer
frame,
wherein the valve assembly has a radially com-
pressed orientation and a radially expanded orien-
tation,
wherein the valve assembly is configured to press
some of the fibers against native leaflets of the
aorta of the patient
wherein an end of the apices of the outer frame that
are most proximal are covered by the outer seal and
the graft covering,
wherein the end of the most proximal apices of the
outer frame extends more proximally than a proxi-
mal end of the outer seal.
J.A. 183, 21:17–22:11 (emphases added).
The specification discloses two categories of embodi-
ments. It first discloses “serial-frame” embodiments,
where a self-expanding frame and balloon-expandable
frame attach at a meeting point, meaning there is no outer
or inner frame but rather one serial frame. See J.A. 180,
15:23–16:14. The specification also discloses “dual-frame”
embodiments, where an inner frame sits within the outer
one. J.A. 181, 17:47–61.
Turning to the dual-frame embodiments, the specifica-
tion provides for a dual-frame transcatheter valve, as illus-
trated in Figure 20 displayed below:
Case: 24-1145 Document: 45 Page: 5 Filed: 10/27/2025

-- 5 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
6
J.A. 170; see also J.A. 182, 19:19–22.
When discussing Figure 20, the specification refers to
structure 416 as an “outer frame” several times. J.A. 181,
17:64–67 (“It should be appreciated that in other embodi-
ments the outer frame 416 may be formed from a polymeric
material.”); J.A. 181, 18:3–4, 18:22–23, 18:35; J.A. 182,
19:19, 19:36, 19:39, 19:41. It also refers to structure 416 as
a “self-expanding frame” or a “self-expanding outer frame”
several times. J.A. 181, 17:58–61 (“The dual-frame 414 in-
cludes a self-expanding outer frame 416 and a balloon-ex-
pandable inner frame 218 that is secured to the self-
expanding outer frame 416 and houses the valve 32.”); see
also J.A. 181, 17:61–62, 18:43–44, 18:53–54, 18:66–67.
Case: 24-1145 Document: 45 Page: 6 Filed: 10/27/2025

-- 6 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
7
The specification also provides for a dual-frame endo-
graft device, as illustrated in Figure 9 displayed below:
When discussing Figure 9, the specification refers to struc-
ture 216 as an “outer frame” several times. See, e.g.,
J.A. 178, 12:20–23 (“The outer frame 216 includes an elon-
gated proximal section 220 . . . .”). It also refers to structure
216 as a “self-expanding frame” or “self-expanding outer
frame” several times. See, e.g., J.A. 178, 12:14–18 (“Refer-
ring now to FIG. 9, the self-expanding outer frame 216 has
a generally hourglass shape . . . .”); J.A. 178, 12:64–67 (“The
outwardly tapered middle section 62 of the self-expanding
frame 216 has . . . .”).
III.
Aortic sued appellees Edwards Lifesciences Corpora-
tion, Edwards Lifesciences LLC, and Edwards Lifesciences
Case: 24-1145 Document: 45 Page: 7 Filed: 10/27/2025

-- 7 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
8
(U.S.), Inc. (collectively, “Edwards”) in the U.S. District
Court for the District of Delaware. J.A. 194. Aortic alleged
that Edwards’ SAPIEN 3 Ultra valve, a single, balloon-ex-
pandable frame, infringed Aortic’s Asserted Patents.
Edwards then filed petitions for inter partes review be-
fore the Patent Trial and Appeal Board (“Board”).
J.A. 1830. The Board instituted review as to three of the
Asserted Patents, denying institution only as to the ’735
patent. Edwards then moved the district court to stay the
litigation, which the district court did except for the ’735
patent.
Before the district court, the parties disputed the
meaning of the term “outer frame” in claim 1 of the ’735
patent. Aortic argued that this term should be given its
plain and ordinary meaning. Edwards argued that “outer
frame” should be construed as “[a] self-expanding frame
having a generally hourglass shape that is positioned out-
side the inner frame.” J.A. 3619.
The district court determined that the patentee acted
as his own lexicographer and redefined the term “outer
frame” to be “a self-expanding frame.” J.A. 14; J.A. 19–20;
J.A. 40.3 The district court grounded this redefinition on
the point that the terms “outer frame,” “self-expanding
frame,” and “self-expanding outer frame” interchangeably
refer to the same structure in two embodiments, i.e., struc-
tures 216 and 416. J.A. 19–20. The district court also clar-
ified that its construction of “outer frame” in claim 1 of the
3 The district court rejected Edwards’ argument that
an “outer frame” also has a “generally hourglass shape.”
J.A. 20–21. No party challenges this determination on ap-
peal.
Case: 24-1145 Document: 45 Page: 8 Filed: 10/27/2025

-- 8 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
9
’735 patent applied to each of the Asserted Patents.
J.A. 39.4
The district court also concluded that the patentee, act-
ing as a lexicographer, redefined “inner frame” of claim 1
as a “balloon-expandable frame” by using these terms in-
terchangeably. J.A. 22–24. No party disputes this con-
struction on appeal.
Following claim construction, the parties jointly stipu-
lated to non-infringement of the Asserted Patents because
Edwards’ accused product does not have a self-expanding
frame. J.A. 2. The district court lifted the stay as to the
’846, ’538, and ’236 patents and entered a final judgment of
non-infringement as to the Asserted Patents. J.A. 2.
Aortic appeals the judgment of non-infringement, chal-
lenging the district court’s construction of “outer frame.”
J.A. 2.
J URISDICTION
We have jurisdiction under 28 U.S.C. § 1295(a)(1) as to
Aortic’s appeal of the judgment concerning the ’735, ’846,
’236 patents. We dismiss Aortic’s appeal as to the ’538 pa-
tent for lack of subject matter jurisdiction. On December
1, 2023, the U.S. Patent and Trademark Office issued a cer-
tificate cancelling the asserted claims of the ’538 patent.
Thus, there is no actual case or controversy between the
parties concerning the ’538 patent, mooting Aortic’s appeal
as to this patent. Fresenius USA, Inc. v. Baxter Int’l, Inc.,
721 F.3d 1330, 1340 (Fed. Cir. 2013).
4 The district court determined that there was no
clear disavowal made in the specification of outer frames
that are not self-expanding. J.A. 17–18.
Case: 24-1145 Document: 45 Page: 9 Filed: 10/27/2025

-- 9 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
10
STANDARD OF REVIEW
We review a district court’s claim construction and its
interpretations of intrinsic evidence de novo. Apple Inc. v.
Wi-LAN Inc., 25 F.4th 960, 967 (Fed. Cir. 2022). We review
any subsidiary fact findings based on extrinsic evidence for
clear error. Id.
D ISCUSSION
I.
The parties dispute the construction of “outer frame” in
claim 1 of the ’735 patent. Aortic argues that the claim
term “outer frame” should be given its plain and ordinary
meaning of “positioned outside,” a meaning that is “readily
apparent” to the parties and to the court. Appellant Br. 26.
Aortic also argues that the specification does not support a
determination that “outer” is interchangeable with “self-
expanding,” which are two separate and distinct concepts.
Appellant Br. 24–41, 32–36. Thus, Aortic argues, the dis-
trict court erroneously read out “outer” and read in a “self-
expanding” limitation. See Appellant Br. 42–52. For the
following reasons, we agree with the district court’s con-
struction that the “outer frame” is a “self-expanding
frame.”5 We affirm the judgment of non-infringement.
5 At oral argument, the parties discussed an alterna-
tive construction as a “self-expanding outer frame,” a con-
struction which would not affect the stipulation to a
judgment of non-infringement. See Oral Arg. at 18:37–58,
19:30–35, 20:16–20, 28:28–50, available at
https://www.cafc.uscourts.gov/oral-arguments/24-1145_06
022025.mp3. We see little difference between a “self-ex-
panding outer frame” and a “self-expanding frame” for pur-
poses of this claim construction. We, however, leave
untouched the district court’s construction, which parallels
Case: 24-1145 Document: 45 Page: 10 Filed: 10/27/2025

-- 10 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
11
The claims define the metes and bounds of the pa-
tentee’s invention. Phillips v. AWH Corp., 415 F.3d 1303,
1312 (Fed. Cir. 2005) (en banc). The patentee is free to
choose a broad term and expect to obtain the full scope of
its plain and ordinary meaning unless the patentee clearly
redefines the term (lexicography) or disavows claim scope
(claim disavowal). Thorner v. Sony Comput. Ent. Am. LLC,
669 F.3d 1362, 1367 (Fed. Cir. 2012). The standard for
these two exceptions is exacting. Id. at 1366.
To act as his own lexicographer, “a patentee must
clearly set forth a definition of the disputed claim term
other than its plain and ordinary meaning.” Id. at 1365
(citation modified). Thus, the patentee’s written descrip-
tion of the invention is relevant and controlling “insofar as
it provides clear lexicography . . . [.]” Id. at 1366 (citation
modified) (emphasis in original).
An explicit redefinition is not required for a patentee to
act as a lexicographer. “[T]he specification may define
claim terms by implication such that the meaning may be
found in or ascertained by a reading of the patent docu-
ments.” Bell Atl. Network Servs., Inc. v. Covad Commc’ns
Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001) (citation
modified). But “implied redefinition must be so clear” that
a skilled artisan would understand “that it equates to an
explicit one.” Thorner, 669 F.3d at 1368 (citation modified).
“Simply referring to two terms as alternatives or disclosing
embodiments that all use the term[s] the same way is not
sufficient to redefine a claim term.” Id.
A patent’s consistent and clear interchangeable use of
two terms can result in a definition equating the two terms.
See Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322,
1329 (Fed. Cir. 2009); Wasica Fin. GmbH v. Cont’l Auto.
the district court’s construction of claim 1’s “inner frame”
as a “balloon-expandable frame.”
Case: 24-1145 Document: 45 Page: 11 Filed: 10/27/2025

-- 11 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
12
Sys., Inc., 853 F.3d 1272, 1282 n.6 (Fed. Cir. 2017) (high-
lighting interchangeable use within the claims and within
the written description); Bid for Position, LLC v. AOL,
LLC, 601 F.3d 1311, 1317–18 (Fed. Cir. 2010) (highlighting
interchangeable use within a claim and within certain em-
bodiments); Bell Atl., 262 F.3d at 1274–75 (highlighting in-
terchangeable use within the written description and
within the prosecution history); Tate Access Floors, Inc. v.
Maxcess Techs., Inc., 222 F.3d 958, 968 (Fed. Cir. 2000)
(highlighting interchangeable use throughout the abstract
and summary of invention).
For example, in Edwards, the “specification consist-
ently use[d] the words ‘graft’ and ‘intraluminal graft’ inter-
changeably.” Edwards, 582 F.3d at 1329. Specifically, the
court noted the interchangeable use of the claimed term
“graft” and the narrowed term “intraluminal graft” in the
disclosure of the invention of U.S. Patent 6,582,458 at
1:57–59 and in the “preferred embodiment” at columns 5
and 6. Id. The court then concluded that the interchange-
able use of the two terms was “akin to a definition equating
the two.” Id.
Here, a skilled artisan would understand that the
claimed term “outer frame” is a “self-expanding frame.”
First, when discussing structure 416 in the dual-frame
transcatheter valve embodiment and structure 216 in the
dual-frame endograft device embodiment, the specification
refers to these structures as an “outer frame,” a “self-ex-
panding frame,” and a “self-expanding outer frame” several
times. J.A. 178, 12:20–23, 12:14–18, 12:64–67; J.A. 181,
17:65–67, 17:58–62, 18:3–4, 18:22–23, 18:35, 18:43–44,
18:53–54, 18:66–67; J.A. 182, 19:19, 19:36, 19:39, 19:41.
Thus, this disclosure clearly indicates that structures 216
and 416 are outer frames that must self-expand.
Second, beyond the discussion of structures 416 and
216, the specification consistently indicates that claim 1’s
“outer frame” is a “self-expanding frame.” The summary
Case: 24-1145 Document: 45 Page: 12 Filed: 10/27/2025

-- 12 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
13
section of the specification provides that “[a]ccording to an-
other aspect [of the disclosure], a transcatheter valve is dis-
closed.” J.A. 174, 3:61–62. It then says that “[t]he
transcatheter valve includes a frame component having a
balloon-expandable frame . . . and a self-expanding frame
secured to the balloon expandable frame.” J.A. 174,
3:62–65. In the paragraphs immediately following this
statement, the specification notes that “[i]n some embodi-
ments,” other features may be present, but it never limits
the presence of a self-expanding frame to only “some em-
bodiments.” See J.A. 174, 4:5–35. The contrast in the lan-
guage indicates that a transcatheter valve must have a
self-expanding frame and a balloon-expanding frame,
whether it be configured as a serial-frame or a dual-frame.6
Claim 1 is undisputedly directed to a dual-frame transcath-
eter valve, i.e., a device with an inner frame that sits within
the outer frame. See J.A. 183, 21:16–41. Given that the
district court construed claim 1’s “inner frame” to be bal-
loon-expandable, a construction no party disputes on ap-
peal, then claim 1’s “outer frame” must be self-expanding.
This conclusion, that a transcatheter valve must have
a balloon-expandable frame and a self-expanding frame, is
supported by the dual-frame embodiments. When discuss-
ing structures 216 and 416, the specification notes several
times that “in other embodiments,” these self-expanding
structures (216/416) may have different features, such as
being covered by a hydrogel. See J.A. 181, 18:14–16; J.A.
181, 18:29–31. However, the specification never indicates
6 Contrary to Aortic’s position, we do not read this
disclosure as limited to a serial-frame transcatheter valve.
Reply Br. 17–18. There is no indication from this disclo-
sure that it excludes dual-frame transcatheter valves and
includes only serial-frame transcatheter valves. To the
contrary, it broadly states that a “transcatheter valve is
disclosed.” J.A. 174, 3:61–62.
Case: 24-1145 Document: 45 Page: 13 Filed: 10/27/2025

-- 13 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
14
that the self-expanding nature of structures 216 and 416 is
absent or modified in other embodiments. Thus, the spec-
ification clearly and consistently conveys that the self-ex-
panding nature of structures 216 and 416 is present in all
embodiments of those devices. See GPNE Corp. v. Apple
Inc., 830 F.3d 1365, 1370 (Fed. Cir. 2016) (“[W]hen a patent
repeatedly and consistently characterizes a claim term in
a particular way, it is proper to construe the claim term in
accordance with that characterization.” (citation modi-
fied)).
In sum, a skilled artisan, when reading the patent,
would understand that the “very character of the invention
[of a transcatheter valve] requires the [self-expanding] lim-
itation be a part of every embodiment.” Alloc, Inc. v. Int’l
Trade Comm’n, 342 F.3d 1361, 1370 (Fed. Cir. 2003). Thus,
the district court correctly construed the claim term “outer
frame” as a “self-expanding frame.”
II.
Aortic alternatively argues that Edwards should be ju-
dicially estopped from arguing that the claim term “outer
frame” should be construed as having a meaning other
than its plain and ordinary one. According to Aortic, Ed-
wards argued before the Board that “outer frame” carried
its plain and ordinary meaning but argued to the district
court that “outer frame” only means a “self-expanding
frame.” Appellant Br. 53–55. Thus, according to Aortic,
Edwards should be judicially estopped here from arguing
the latter position. Id.
Edwards responds, and we agree, that Aortic forfeited
its judicial estoppel argument by not raising it before the
district court.
Aortic’s responsive claim construction brief at the dis-
trict court noted the position Edwards took at the Board
and maintained that “Edwards should not be heard to ar-
gue differently here.” J.A. 5050. However, that brief did
Case: 24-1145 Document: 45 Page: 14 Filed: 10/27/2025

-- 14 of 15 --

AORTIC INNOVATIONS LLC v.
EDWARDS LIFESCIENCES CORPORATION
15
not otherwise develop any argument for application of ju-
dicial estoppel. Further, at the claim construction hearing,
after Edwards’s counsel preemptively addressed the pro-
spect of an estoppel-based argument on this issue and ob-
served that “Aortic hasn’t argued or cited any law” that
would support estoppel, see J.A. 6500, Aortic’s counsel re-
sponded: “I think there’s some confusion, it seems, as to the
point here. The propriety of taking different positions in
front of different forums, I’ll leave for the [c]ourt . . . . [T]he
point here is that we know what the plain and ordinary
meaning is.” J.A. 6511–12 (emphasis added). Under these
circumstances, we deem Aortic’s judicial-estoppel argu-
ment as not having been raised before the district court and
thus forfeited in this appeal.
“We have regularly stated and applied the important
principle that a position not presented in the tribunal un-
der review will not be considered on appeal in the absence
of exceptional circumstances.” In re Google Tech. Holdings
LLC, 980 F.3d 858, 863 (Fed. Cir. 2020). Here, we see no
exceptional circumstances that would justify departing
from that principle. We therefore do not consider Aortic’s
judicial estoppel argument.
CONCLUSION
We have considered the parties’ remaining arguments
and find them unpersuasive. For the reasons discussed, we
affirm the district court’s judgment as to the ’735, ’846, ’236
patents and dismiss the appeal for lack of jurisdiction as to
the ’538 patent.
AFFIRMED-IN-PART AND DISMISSED-IN-PART
COSTS
Costs to Edwards.
Case: 24-1145 Document: 45 Page: 15 Filed: 10/27/2025

-- 15 of 15 --