Bardy Diagnostics, Inc. v. iRhythm Technologies, Inc.

OCR transcription for search; preserved printed pages are authoritative

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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

BARDY DIAGNOSTICS, INC.,

Plaintiff and Counter-Defendant,
Case No. 1:24-cv-01355-JDW

IRHYTHM TECHNOLOGIES, INC.,

Defendant and Counter-Plaintiff

MEMORANDUM

Bardy Diagnostics, Inc. alleges that iRhythm Technologies, Inc., infringes four
Bardy patents. iRhythm, in turn, claims that Bardy infringes five iRhythm patents. The
Parties dispute the meaning of eleven claim terms across eight asserted patents: (1) U.S.
Patent No. 12,161,473 (the ‘473 Patent); (2) U.S. Patent No. 12,171,562 (the ‘562 Patent);
(3) U.S. Patent No. 12,285,261 (the ‘261 Patent); and (4) U.S. Patent No. 12,310,735 (the
‘735 Patent). iRhythm’s asserted patents are: (5) U.S. Patent No. 12,133,734 (the ‘734
Patent); (6) U.S. Patent No. 12,274,554 (the ‘554 Patent); (7) U.S. Patent No. 12,303,277 (the
‘277 Patent); and (8) U.S. Patent No. 12,245,859 (the ‘859 Patent). I held a Markman

hearing on January 15, 2026, and now resolve the disputed constructions.

AUTHENTICATED
U.S. GOVERNMENT
INFORMATION

GPO

2
I. 	LEGAL STANDARD
A. 	Claim Construction
“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the
invention to which the patentee is entitled the right to exclude.’”
Phillips v. AWH Corp.,
415 F.3d 1303, 1312 (Fed. Cir. 2005) (quotation omitted). Claim construction is a matter of
law.
See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 837 (2015). “[T]here is no
‘magic formula or catechism’” for construing a patent claim, nor is a court “barred from
considering any particular sources or required to analyze 	sources in any specific
sequence[.]”
Phillips, 415 F.3d at 1324. Instead, a court is free to attach the appropriate
weight to appropriate sources “in light of the statutes and policies that inform patent law.”
Id. (citation omitted).
A court generally gives the words of a claim “their ordinary and customary
meaning,” which is the “meaning that the term would have to a person of ordinary skill in
the art at the time of the invention, i.e., as of the effective filing date of the patent
application.”
Id. at 1312-13 (quotations omitted). Usually, a court first considers the claim
language; then the remaining intrinsic evidence; and finally, the extrinsic evidence in
limited circumstances.
See Interactive Gift Exp., Inc. v. Compuserve, Inc., 256 F.3d 1323,
1331-32 (Fed. Cir. 2001). While “the claims themselves provide substantial guidance as to
the meaning of particular claim terms[,]” a court also must consider the context of the
surrounding words.
Phillips, 415 F.3d at 1314. In addition, the patent specification “‘is
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always highly relevant to the claim construction analysis’ and indeed is often ‘the single
best guide to the meaning of a disputed term.’”
AstraZeneca AB v. Mylan Pharms. Inc., 19
F.4th 1325, 1330 (Fed. Cir. 2021) (quotation omitted).
But, while a court must construe claims to be consistent with the specification, the
court must “avoid the danger of reading limitations from the specification into the claim
….”
Phillips, 415 F.3d at 1323. This is a “fine” distinction.
Comark Communications, Inc. v.
Harris Corp., 156 F.3d 1182, 1186–87 (Fed.Cir.1998). In addition, “[e]ven when the
specification describes only a single embodiment, the claims of the patent will not be read
restrictively unless the patentee has demonstrated a clear intention to limit the claim
scope using ‘words or expressions of manifest exclusion or restriction.’”
Hill-Rom Svcs.,
Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quotation omitted) (alterations
in original). “The court’s task is not to limit claim language to exclude particular devices
because they do not serve a perceived ‘purpose’ of the invention. Rather, the court’s
function is to interpret claims according to their plain language unless the patentee has
chosen to be his own lexicographer in the specification or has clearly disclaimed coverage
during prosecution.”
E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1370 (Fed. Cir. 2003)
(citing
Inverness Med. Switzerland GmbH v. Princeton Biomeditech Corp., 309 F.3d 1365,
1371-77 (Fed. Cir. 2002)). An invention may possess several advantages or purposes, and
there is no requirement that every claim directed to that invention be limited to
encompass all of them.
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A court may refer to extrinsic evidence only if the disputed term’s ordinary and
accustomed meaning cannot be discerned from the intrinsic evidence.
See Vitronics Corp.
v. Conceptronic, Inc., 90 F.3d 1576, 1584 (Fed. Cir. 1996). Although a court may not use
extrinsic evidence to vary or contradict the claim language, extrinsic materials “may be
helpful to explain scientific principles, the meaning of technical terms, and terms of art
that appear in the patent and prosecution history.”
Markman v. Westview Instruments,
Inc., 52 F.3d 967, 980 (Fed. Cir. 1995). Extrinsic evidence is used “to ensure that the court’s
understanding of the technical aspects of the patent is consistent with that of a person of
skill in the art[.]”
Phillips, 415 F.3d at 1318. The Federal Circuit has cautioned against
relying upon expert reports and testimony that is generated for the purpose of litigation
because of the likelihood of bias.
Id.;
see also Daubert v. Merrell Dow Pharms., Inc., 509
U.S. 579, 595 (1993) (“Expert evidence can be both powerful and quite misleading because
of the difficulty in evaluating it.”) (quotation omitted).
Ultimately, “[t]he construction that stays true to the claim language and most
naturally aligns with the patent’s description of the invention will be . . . the correct
construction.”
Renishaw PLC v. Marposs Societa’ per Anzioni, 158 F.3d 1243, 1250 (Fed.
Cir. 1998). It follows that “a claim interpretation that would exclude the inventor’s device
is rarely the correct interpretation[.]”
Modifine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d
1545, 1550 (Fed. Circ. 1996, abrogated on other grounds by,
Festo Corp. v. Shoketsu
Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Circ. 2000), vacated, 535 U.S. 722 (2002).
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B. 	Indefiniteness
“Indefiniteness is a matter of claim construction, and the same principles that
generally govern claim construction are applicable to determining whether allegedly
indefinite claim language is subject to construction.”
Kyowa Hakka Bio, Co., Ltd. v.
Ajinomoto Co., No. CV 17-313, 2020 WL 3403207, at *5 (D. Del. June 19, 2020) (internal
quotations omitted). “The internal coherence and context assessment of the patent, and
whether it conveys claim meaning with reasonable certainty, are questions of law.”
Teva
Pharm. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1342 (Fed. Cir. 2015). A party seeking to
prove indefiniteness must do so by clear and convincing evidence.
See BASF Corp. v.
Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017).
“A patent's specification must ‘conclude with one or more claims particularly
pointing out and distinctly claiming the subject matter which the applicant regards as
[the] invention.’”
Teva, 789 F.3d at 1340 (quoting 35 U.S.C. § 112, ¶ 2). A patent claim is
indefinite if, “viewed in light of the specification and prosecution history, [it fails] to inform
those skilled in the art about the scope of the invention with reasonable certainty.”
Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014).
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Il. CONSTRUCTION OF DISPUTED TERMS

A. Bardy’s Patent Terms

1. “wireless transceiver” '
Bardy’s Construction iRhythm’s Construction Court's
Construction
Plain and ordinary meaning, | “component that transmits “a component that
i.e., “a component that can electrocardiographic signals can transmit
transmit wirelessly” wirelessly” wirelessly”

The Parties dispute whether the term “wireless transceiver” applies only to a
component that transmits electrocardiographic signals. It does not. Claim 1 recites “a
wireless transceiver” and imposes only one express requirement, that it “draws power
from the battery.” (‘473 Patent at 17:41-42.) By contrast, the same claim requires
electrodes “configured to sense electrocardiographic signals” and a_ processor
“configured to process” those signals. (/d. at 17:16-17, 17:37-38.) Moreover, several of
the dependent claims specify that the wireless transceiver is “configured to communicate
with an external device via Wi-Fi, mobile phone communication standards, or Bluetooth.”
(Id. at 17:46-48.) Others recite that electrocardiographic signals may be retrieved by an
external device “via the wireless transceiver” after conversion to a different format. (/d.
at 17:53-57.) These limitations address how the wireless transceiver communicates and

what data it might communicate in certain embodiments. They would be unnecessary if,

1This term appears in Claims 8 and 15 of the ‘562 Patent and Claims 1, 8 and 15 of the
‘473 Patent.

7
as iRhythm suggests, transmission of electrocardiographic signals was inherent in the
term “wireless transceiver” itself. Courts avoid constructions that render some portion of
the claim language superfluous.
SimpleAir Inc. v. Sony Ericsson Mobile Commc’ns AB,
820 F.3d 419, 429 (Fed. Cir. 2016).
The absence of an express definition of “wireless transceiver” in the ’473 Patent
does not alter my construction, as nothing in the specification suggests that the term is
limited beyond its ordinary meaning.2 To the contrary, the specification contemplates
that the wireless transceiver may, but need not, provide certain functions, confirming
that it can perform other functions as well. For example, the specification describes the
wireless transceiver as an optional and interchangeable component that enables
communication of “data or other information” with a range of external devices, including
wearable sensors, mobile communications devices, servers, and personal computers.
(’473 Patent at 4:28-29.) It also discloses embodiments in which wireless communication
is unnecessary, including hardwired data transfer to a download station. (
See ’562 Patent
at 15:52-61.) Although the specification describes some embodiments that will include a
wireless transceiver that communicates electrocardiographic signals, a patent “need not
include a working example of every possible embodiment to enable the full scope of the
claims.”
Bayer HealthCare LLC v. Baxalta Inc., 989 F.3d 964, 982 (Fed. Cir. 2021). Courts
2 The Parties agree that the specification does not describe a wireless transceiver as a well-
known or well-understood component.
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may not confine claim scope to particular embodiments absent a clear intent to do so.
Arlington Indus., Inc. v. Bridgeport Fittings, Inc, 632 F.3d 1246, 1254 (Fed. Cir. 2011).
iRhythm urges a narrower construction based on what it characterizes as the
objective of the invention—electrocardiographic monitoring—and asks me to treat that
objective as limiting the function of the wireless transceiver. That argument fails. In
construing claims, courts may not import limitations based on the perceived purpose of
an invention. £-Pass Techs., 343 F.3d at 1370. Instead, it is “[t]he construction that stays
true to the claim language and most naturally aligns with the patent's description of the
invention [that] will be, in the end, the correct construction.” Phillips, 415 F.3d at 1315.
The purpose of the overall invention might be to provide electrocardiographic

monitoring, but that doesn't mean that every component is limited to that function.

2. “vertically aligned”?

Bardy’s iRhythm’s Court's Construction
Construction Construction

Plain and “aligned along a patient's | “aligned on an axis that connects
ordinary sternal midline when the monitor recorder with the
meaning worn” extended wear electrode patch”

Claim 1 recites “a battery vertically aligned with a sealed housing,” but it does not
define the orientation against which to judge verticality. And the specification does not

use any form of the word “vertical,” let alone the phrase “vertically aligned.” At the same

3 This term appears in Claims 1, 15, 20 and 23 of the ‘473 Patent and Claims 9, 14, 20, 23
and 28 of the ‘562 Patent.

9
time, neither side argues that the term is indefinite (and with good reason). In that
posture, I must “strive to capture the scope of the actual invention, rather than strictly
limit the scope of claims to disclosed embodiments or allow the claim language to
become divorced from what the specification conveys is the invention.”
Retractable
Techs., Inc. v. Becton, Dickinson & Co., 653 F.3d 1296, 1305 (Fed. Cir. 2011).
As a starting point, a POSA would understand “vertically” to have its plain English
meaning of top-to-bottom. The specification informs a POSA that, for these purposes,
the top is the face of the device, which faces away from the user when in use. Figure 4
illustrates the device, including the monitor recorder, which is item 14. The monitor
recorder includes a sealed hosing. (‘437 Patent at 9:42-43.) Then, Figure 5 is a view of the
monitor recorder with a button that has a “top outer surface.” (
Id. at 9:56-58 (emphasis
added).) Figure 6, in turn, illustrates the extended wear electrode patch that attaches to
the skin and into which the monitor gets inserted. The specification explains that there
is a battery compartment on the “bottom surface of the non-conductive receptacle.” (
Id.
at 10:37-40 (emphasis added).) These and other, similar references in the specification
demonstrate to a POSA that the top of the device, for these purposes, is the face of the
device, and the bottom is the part that attaches to the extended wear electrode patch.
A POSA would therefore know to assess vertical alignment on that axis.
This construction focuses on the orientation of the components of the device,
regardless of how the device is used (or whether it is in use). It stands in contrast to
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iRhythm’s proposed construction, which would import a limitation from a particular

embodiment and which would not determine verticality until a user wears the device.

The claims do not necessarily require the device to be worn along the sternum, however,

and they do not suggest that the internal alignment of the battery and sealed housing

changes based on where the user places the device on the body.

3. “removably secured”*
Bardy’s Construction iRhythm’s Construction Court’s Construction
Plain and ordinary meaning, | “secured such that it may be | “secured in a manner
Ze, secured such that it may | removed without destruction” | that contemplates or
be removed intends for removal and

potential reuse”

The dispute over “removably secured” is not about whether the wearable housing
can be taken out of the receptacle—it plainly can. (‘261 Patent at 4:57-62.) Where the
Parties part ways is whether the patent requires that removal be non-destructive. The
claims do not say that, and the specification does not impose it. Claim 1 recites “a
receptacle ... into which the wearable housing can be removably secured.” That language
describes a designed relationship between two components. The housing is held in place
during use, but it is not permanently affixed. The claim says nothing about the manner
of removal, the amount of force required, or the condition of the components after
separation. It requires only that removal be contemplated by design. In addition, the

specification makes clear that the purpose of removal is to permit further use, including

“This term appears in Claims 1 and 10 of the ‘261 Patent.
10

11
downloads of data, reprogramming, and “transfer to successive electrode patches to
ensure continuity of monitoring.” (‘473 Patent at 9:65-67.)
Construing “removably secured” as “secured in a manner that contemplates or
intends for removal and potential reuse” captures all aspects of the term and is in line
with the intrinsic record. The housing must be
secured, that is, intentionally retained
within the receptacle, and it must be
removable by design, which allows for its reuse.
This construction aligns with the Federal Circuit’s holding in
Dorel Juv. Grp., Inc. v. Graco
Children's Prods., Inc., which explained that “‘removably secured’ mean[s] only that the
seat and base ‘are designed at some time or another to come apart’” and that the term
carries “an implication that the detachment or unsecuring process not do violence to the
[invention].” 429 F.3d 1043 (Fed. Cir. 2005).
iRhythm’s proposed limitation that removal must occur “without destruction”
finds no footing in the claims nor the specification. The patent never uses the word
“destruction,” nor does it draw a distinction between destructive and non-destructive
removal. Introducing that qualifier would raise questions the patent does not pose, such
as what qualifies as “destruction,” whether damage to one component is sufficient, and
how much damage or change is too much. The patent does not speak in those terms,
and I will not supply them.
Bardy’s construction, by contrast, does too little. Saying only that the housing is
“secured such that it may be removed” risks draining the term of meaning. While the
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Patent does not claim reusability of the housing, the housing is not merely placed in the

receptacle in a way that allows theoretical removal under extreme conditions. The claims

and specification describe an intentional securing mechanism, one that holds the

housing in place during normal use while allowing disengagement when desired.

4. “distal/proximal”>
Bardy’s iRhythm’s Court's Construction
Construction Construction
Plain and Indefinite; “distal” means “positioned farther
ordinary alternatively “relative | relative to the monitor recorder’;
meaning to the housing” “proximal” means “positioned nearer

relative to the monitor recorder”

The claim terms “distal” and “proximal” are not indefinite. “[A] patentee need not
define his invention with mathematical precision in order to comply with the definiteness
requirement.” See Sonix Tech. Co. v. Publ'ns Int’, Ltd, 844 F.3d 1370, 1377 (Fed. Cir. 2017)
(quotations omitted). Although these terms are relative terms, they do not require a
subjective assessment of extent or magnitude. Rather, they describe where a component
is situated relative to an objective reference point. The absence of an express reference
point in the claim language does not render the terms indefinite so long as the intrinsic
record provides sufficient context to inform a POSA of their meaning with reasonable
certainty or where the intrinsic evidence provides an objective reference point. See

Liberty Ammunition, Inc. v. United States, 835 F.3d 1388, 1395 (Fed. Cir. 2016).

>This term appears in Claim 1 and 11 of the ‘735 Patent.

12

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The intrinsic evidence supplies that reference point with consistency and clarity.
Although the claims themselves do not state that the reference point is relative to the
monitor recorder, the specification uses the monitor recorder (and not the sealed
housing) as the structural anchor of the device. The specification describes the “proximal
end" of the electrode patch as the end “located under the monitor recorder,” while the
“distal end” is the opposite end extending away from it. (‘735 Patent at 5:63-6:2.) The
figures reinforce this orientation, as they depict the monitor recorder positioned at one
end of the device, with the flexible backing and electrodes extending from that point.
(See ‘735 Patent at Figs. 5, 7.)

Read in light of the specification, the terms “distal” and “proximal” thus convey an
objective spatial relationship that a POSA will understand. The claims do not leave open
which end of the device is being referenced, nor do they require the reader to speculate
about multiple competing baselines. Instead, the intrinsic evidence establishes a frame

of reference that resolves any potential ambiguity.

B. iRhythm’s Patent Terms

1. “electrical connection” ®
iRhythm’s Bardy’s Court's Construction
Construction Construction
Plain and ordinary “wire” “a connection that permits the
meaning transmission of electricity”

6 This term appears in Claim 1 of the ‘734 Patent and Claim 1 of the ‘554 Patent.
13

14
A POSA, a jury, and I can understand that the term electrical connection means “a
connection that permits the transmission of electricity.”
See Summit 6, LLC v. Samsung
Elecs. Co., 802 F.3d 1283, 1291 (Fed. Cir. 2015). The electrical connection extends from
the physiologic data collection circuit to the electrode and is positioned between a
polymer upper layer and a polymer lower layer. (‘734 Patent, 15:34-16:4.) While the
claims define the electrical connection by what it does and where it is located, nothing
in the claim language demonstrates a “clear intention” to limit the electrical connection
to a wire or to any particular conductive structure.
See Liebel-Flarsheim Co. v. Medrad,
Inc., 358 F.3d 898, 906 (Fed. Cir. 2004). And although many embodiments describe wiring,
the patent states that “wiring or other suitable” electrical connections can connect the
electrodes with the electrical components. (‘734 Patent at 8:49-51.) That language is
deliberate. It makes clear that wiring is an example of an electrical connection, not its
exclusive definition.
Bardy’s proposed construction limiting “electrical connection” to a wire has no
basis in the claim language, and the specification’s express reference to other suitable
electrical connections rules out that construction. Adopting it would improperly import
a preferred embodiment into the claims and would exclude alternatives the patent
contemplates.
Eko Brands, LLC v. Adrian Rivera Maynez Enters., Inc., 946 F.3d 1367, 1373
(Fed. Cir. 2020);
Apple Inc. v. Wi-Lan Inc., 25 F.4th 960, 967 (Fed. Cir. 2022). Bardy’s
reliance on prosecution arguments fares no better. Where, as here, the meaning of a
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term is apparent from the claim language and reinforced by the specification, there is no

basis to narrow it.

2.

“Telectrical connection] extending from the physiological data

"7,

collection circuit to the electrode”’;
extending linearly from the physiologic data collection
circuit”®; and “[first substrate layer] extends horizontally away

from the housing”?

Bardy’s

iRhythm’s

[electrical connection]

Court's Construction

“Telectrical
connection]
extending from the
physiologic data
collection circuit to
the electrode”

“Telectrical
connection]
extending linearly
from the

Construction
“originating at the
physiological data
collection circuit
and continuing
directly to the
electrode without
intervening
components”

Construction
Plain and ordinary
meaning

“Telectrical connection]
extending in the direction
away from the physiologic
data collection circuit to the
electrode”

“Telectrical connection]
extending linearly in the
direction away from the
physiologic data collection

physiologic data circuit”

collection circuit”

“[first substrate “originates at the | Plain and ordinary | “[first substrate layer]
layer] extends housing and meaning extends in the direction

horizontally away continues horizontally away from the
from the outward” housing”
housing”

Because these terms employ the same structure and raise the same dispute about

whether “extending” imposes origin, direct, or intervening component requirements, I

7 This term appears in Claim 1 of the ‘734 Patent.
8 This term appears in Claim 1 of the ‘554 Patent.
° This term appears in Claim 1 of the ‘277 Patent.

15

16
address 	them 	together. 	The 	terms 	“[electrical 	connection] 	extending 	from 	the
physiologic 	data 	collection 	circuit 	to 	the 	electrode” 	and 	“[electrical 	connection]
extending linearly from the physiologic data collection circuit” describe the spatial and
functional relationship among the electrical connection, the circuit, and the electrode.
They require electrical continuity between the circuit and the electrode, but they do not
require that the electrical connection originate at a particular point on the circuit,
proceed directly, or exclude intervening components.
The claim language supports this construction. Claim 1 of the ’554 patent
separately adds a “linearly” limitation, confirming that “extending from” alone does not
impose a requirement of directness. Reading such a limitation into “extending from”
would render the “linearly” requirement superfluous.
SimpleAir Inc., 820 F.3d at 429. The
specification likewise does not limit the electrical connection to a direct, uninterrupted
path or one with intervening components. Although some figures and embodiments
depict relatively straight wiring, the specification discloses alternative routing, including
curved paths, conduits, slack, coils, and undulations, to accommodate flexion and
movement 	of 	the 	device. 	(
See 	‘734 	Patent 	at 	8:66-9:1, 	Figs. 	1, 	2B, 	2C.) 	These
embodiments confirm that the invention permits variation in routing so long as it
maintains electrical continuity.
Bardy’s proposal improperly rewrites “extending from” as “originating at” and
imposes additional limitations that appear nowhere in the claim language. Without clear
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intent, embodiments should not limit an invention’s scope, and generalized descriptions
of advantages over the prior art do not amount to a clear and unmistakable disavowal.
See Ventana Med. Sys., Inc. v. Biogenex Labs., Inc, 473 F.3d 1173, 1180-81 (Fed.Cir.2006);
Liebel-Flarsheim Co., 358 F.3d at 907-08. The same reasoning applies to the phrase “[first
substrate layer] extends horizontally away from the housing,” which likewise describes a
relative spatial relationship without imposing requirements of origination or
directionality beyond what the claim language itself states. Thus, I will not limit these
terms by adding requirements such as “originating at,” “continues directly,” or “continues

outward.”

3. “extending at least partially below the housing” '°

iRhythm’s Bardy’s Construction Court's
Construction Construction
Plain and ordinary “adhesive that extends partially, but Plain and ordinary
meaning not completely, below the housing” meaning

The term “at least partially” sets a minimum requirement, not a maximum. See
Quantum Corp. v. Rodime, PLC, 65 F.3d 1577, 1581 (Fed. Cir. 1995); Lantech, Inc. v. Keip
Machine Co., 32 F.3d 542 (Fed.Cir.1994). An adhesive layer that extends partially below
the housing satisfies the claim, and one that extends further does as well. Nothing in the
claim language imposes an upper limit on how far the adhesive may extend. In fact, the

specification indicates that the adhesive can extend completely below the housing. ('734

2 This term appears in Claim 1 of the ‘734 Patent.
17

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Patent at 7:63-67, 11:66-12:3, 12:8-10, Fig. 7B.) By limiting the adhesive to one that

extends “partially, but not completely below the housing,” Bardy adds a negative

limitation that appears nowhere in the claim. If the patentee intended to prohibit

adhesive from extending further beneath the housing, the claim could have said so. It

did not, so I will not adopt that interpretation.

4. “configured to tilt at an angle relative to the lower adhesive
layer in response to movement of the user”"'

iRhythm’s Bardy’s Construction Court's
Construction Construction
Plain and Indefinite or “specifically designed to “designed to move
ordinary move into or out of a sloping relationship _| at angles relative to
meaning relative to the adhesive layer contacting the skin"

the skin in response to movement of the

user”

The Parties disagree whether the claim language requires the housing itself to tilt
or instead describes a relative angled orientation that occurs when the user moves.
Although not indefinite, the term still requires construction because the dispute concerns
how the claimed tilting occurs. I construe the term as “designed to move at angles
relative to the skin.” That construction captures the relative positional relationship
described in the claim and is consistent with the specification’s disclosure of how the

device behaves during use.

« This term appears in Claim 1 of the ‘734 Patent.
18

19
Claim 1 requires configuration of the housing so that it tilts at an angle relative to
the lower adhesive layer in response to the user’s movement. Read in context, the claim
describes what occurs at the interface between the device and the wearer during
ordinary movement. When the user moves, the adhesive layer remains attached to the
skin while the housing can come into a non-parallel orientation. I do not adopt iRhythm’s
formulation to the extent it suggests that the housing is the active source of the
movement. That articulation risks implying that the housing itself actively tilts, pivots, or
rotates, an interpretation that the intrinsic record does not support. The housing does
not actively tilt, pivot, or rotate under its own force. The user moves. The adhesive layer
remains adhered. Other portions of the patch flex. As a result, the housing may assume
an angled orientation relative to the skin. The claim is directed to that resulting relative
position. A construction that treats the housing as the thing that “moves into” an angle
risks obscuring what the claim requires.
Bardy’s alternative construction rewrites the claim. Replacing “configured to” with
“specifically designed to” imports an intent requirement that the claim language does
not support. “Configured to” describes capability and arrangement, not subjective
purpose. 	Bardy’s additional 	“sloping 	relationship” 	language 	fares no 	better 	as it
unnecessarily complicates the jury’s task where “at an angle” already conveys a non-
parallel orientation.
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Bardy's indefiniteness argument is also unavailing. The claim provides an
objective frame of reference, which is the orientation of the housing relative to the
adhered layer when the user moves. The law does not require numerical precision as to
angle or degree of tilt, and nothing in the intrinsic record suggests otherwise. The claim
language at issue recites sufficiently definite structure to allow a POSA to determine the

claimed scope of the patent with reasonable certainty.

5. “the second substrate layer is positioned over the first substrate
layer and extends horizontally beyond a boundary of the first
substrate layer” ‘2

iRhythm’s Bardy’s Court's Construction

Construction Construction

Plain and “the second “the second substrate layer is above the
ordinary substrate layer first substrate layer, and extends beyond
meaning entirely covers, the boundary of the first substrate layer”

and extends beyond
the peripheral edge
of,

the first substrate
layer”

Claim 1 recites two distinct spatial relationships: (a) the second substrate layer is
positioned over the first substrate layer, and (b) it extends horizontally beyond a
boundary of the first substrate layer. Nothing in that language requires the second
substrate layer to entirely coverthe first substrate layer. Thus, I will construe the term as

“the second substrate layer is positioned over the first substrate layer and extends

2 This term appears in Claim 1 of the ‘277 Patent.
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horizontally beyond a boundary of the first substrate layer,” as per its plain and ordinary

meaning.

Bardy's proposed construction adds an “entirely covers” requirement that appears
nowhere in the claim. “Positioned over" describes relative placement, not complete
coverage, and “extends horizontally beyond a boundary” requires extension past at least
one edge, not all of them. Reading an “entire coverage” limitation into the claim would
rewrite the language the patentee chose. The specification does not compel that result.

Although some embodiments depict full overlap, the claims are not limited to the
embodiments shown. The absence of an embodiment depicting partial coverage does
not justify importing a restriction the claim itself does not impose. See Gemstar—TV
Guide Int'l Inc. v. Int'l Trade Comm'n, 383 F.3d 1352, 1366 (Fed. Cir. 2004); Phillips, 415
F.3d at 1323.

6. “electrical contact with” ‘3

iRhythm’s Construction Bardy’s Construction Court's Construction

Plain and ordinary meaning Indefinite or “in physical “contact that conducts
contact with or in capacitive | electricity”
connection with"

“Electrical contact” is clear on its face and is not indefinite. See Summit 6, LLC v.
Samsung Elecs. Co., 802 F.3d 1283, 1291 (Fed. Cir. 2015). It is a term with a settled and

well-understood meaning, and both a POSA and a jury would have no difficulty

3 This term appears in Claim 1 of the ‘859 Patent and Claim 1 of the ‘860 Patent.
21

22
understanding the term’s meaning and limits. Bardy’s alternative construction does not
add anything of value. It recasts “electrical contact” as “physical contact or capacitive
connection,” but that reformulation does not narrow the term, clarify its scope, or resolve
any ambiguity. Bardy concedes that “electrical contact” cannot mean mere physical
contact, making its proposed construction internally inconsistent. The added reference
to “capacitive connection” appears nowhere in the intrinsic record and would only inject
uncertainty, not resolve it. Rewriting the claim to enumerate every possible form of
electrical interaction does not make the term more clear to a POSA or to me, so I will not
adopt it.
III. 	CONCLUSION
I will construe the disputed claims as described above, and I will adopt the Parties’
agreed-upon construction. An appropriate Order follows.
BY THE COURT:
/s/ Joshua D. Wolson
JOSHUA D. WOLSON, J.
February 19, 2026
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