Neurovision Medical Products, Inc. v. Medtronic Public Limited Company et al

Filing 89

CLAIM CONSTRUCTION MEMORANDUM OPINION AND ORDER. Signed by Magistrate Judge Roy S. Payne on 10/26/2016. (ch, )

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
MARSHALL DIVISION
Neurovision Medical Products, Inc.,
Plaintiff,
v.

Case No. 2:16-cv-127-JRG-RSP

Medtronic Public Limited Company, et al.,
Defendants.

CLAIM CONSTRUCTION MEMORANDUM OPINION AND ORDER
Before the Court is the opening claim construction brief of Neurovision Medical
Products, Inc. (“Plaintiff”) (Dkt. No. 70, filed under seal on September 6, 2016), 1 the response of
Medtronic Xomed, Inc., Medtronic, Inc., Medtronic PLC, HCA Holdings, Inc., and Healthtrust
Purchasing Group, L.P. (collectively “Defendants”) (Dkt. No. 76, filed on September 20, 2016),
and the reply of Plaintiff (Dkt. No. 82, filed on September 27, 2016). The Court held a hearing
on the issues of claim construction and claim definiteness on October 17, 2016. Having
considered the arguments and evidence presented by the parties at the hearing and in their
briefing, the Court issues this Order.

1

Citations to the parties’ filings are to the filing’s number in the docket (Dkt. No.) and pin cites
are to the page numbers assigned through ECF.
1

Table of Contents
I.

BACKGROUND ............................................................................................................... 3

II.

LEGAL PRINCIPLES ..................................................................................................... 7
A.
B.

Departing from the Ordinary Meaning of a Claim Term ...................................... 10

C.

Functional Claiming and 35 U.S.C. § 112, ¶ 6 (pre-AIA) / § 112(f) (AIA) ......... 11

D.
III.

Claim Construction ................................................................................................. 7

Definiteness Under 35 U.S.C. § 112, ¶ 2 (pre-AIA) / § 112(b) (AIA) ................. 13

CONSTRUCTION OF DISPUTED TERMS ............................................................... 14
A.
B.

“positioned to contact …”..................................................................................... 19

C.

“[located] further proximal thereof,” “[located] proximal [of said first
electrode plate],” “[located at said same predetermined distance or] further
proximal [thereof]” ............................................................................................... 26

D.

“trace” ................................................................................................................... 30

E.

“applied […] directly to the surface of the tube,” “applied […] directly to
the tube surface” ................................................................................................... 35

F.

“electrical leads” ................................................................................................... 38

G.

“trachea” ............................................................................................................... 41

H.
IV.

“electrode,” “electrode plate” ............................................................................... 14

Preambles of ’844 Patent Claims 1, 4 and ’894 Patent Claims 1, 4, 10, 14. ........ 45

CONCLUSION ............................................................................................................... 49

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I.

BACKGROUND
Plaintiff alleges infringement of two U.S. Patents: No. 8,467,844 (the “’844 Patent) and

No. 8,634,894 (the “’894 Patent) (collectively, the “Asserted Patents”). The Asserted Patents are
each entitled “Electrode for Prolonged Monitoring of Laryngeal Electromyography.” The
application leading to the ’844 Patent was filed on September 21, 2010 and the patent issued on
June 18, 2013. The application leading to the ’894 Patent was filed on June 4, 2013 and the
patent issued on January 21, 2014. The ’894 Patent purports to have issued from a division of the
’844 Patent’s application. Each Asserted Patent claims priority to a provisional application filed
on September 21, 2009.
In general, the Asserted Patents are directed to technology for monitoring electrical
signals during laryngeal electromyography. The technology can be generally understood with
reference to Figures 7 and 8 of the Asserted
Patents, reproduced below and annotated by the
Court. The patent teaches that an endotracheal
tube (12) may be used to support a patient’s
respiration. These tubes may include electrodes
that are used to collect electrical signals from
anatomical tissue (e.g., from the muscles of
larynx).

These

signals

are

called

electromyographic signals. The tube is placed
through the patient’s mouth and down into the
trachea. Electrodes (62, in blue; 64, in purple)
are positioned along the length of the tube to

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pick up electromyographic signals from, for example, the vocal cords and tongue. The signals
collected by the electrodes are conducted up the tube (to the proximal end, 18, at the patient’s
mouth) and from there are sent to monitoring equipment. The prior-art approaches purportedly
have two main failings: (1) adding the electrodes and their electrical connections to the tracheal
tubes results in raised portions on the tube that can cause injury to the patient during the
procedure, and (2) the electrodes and their connections require the addition of material to the
tube that is less flexible than the tube and, therefore, placing the electrode-laden tube in the
patient may be more difficult than placing the tube alone.
The invention of the Asserted Patents addresses the purported failures of the prior-art
devices by creating electrodes (62, in blue; 64, in purple), conductive traces (20, in green; 66, in
green), and conductive pads (22, in red) directly on the surface of the tube by applying a
conductive ink or paint to the surface. In this way, the detrimental effects of the wires, metallic
plates, and adhesives of the prior-art devices are eliminated. That is, the invention reduces the
threat of injury by minimizing raised surfaces and increases the ease of placement in the patient
by minimizing the decrease in the tube’s flexibility due to the electrodes and their connections.

4

FIG. 7

The abstracts of the Asserted Patents are identical and provide:
Laryngeal surface electrodes are devices designed to hold a conductive surface
against the vocal cords in order to pick up small electrical signals from the muscle
known as electromyographic signals. Several embodiments of a laryngeal
electromyography tube include a conductive electrode surface that is painted,
screen printed or otherwise applied directly onto the body of an endotracheal tube,
such that the final device has no raised surfaces which can injure the vocal cords.
These endotracheal tube with integral laryngeal surface electrodes can be safely
used placed for prolonged, continuous monitoring during surgery, after surgery
and during intensive care treatment intubation without a need to remove and
replace the tube at these various stages of treatment. In one embodiment, one
electrode contacts the vocal cords and a second electrode contacts the tongue.
Claim 4 of the ’844 Patent, Claim 10 of the ’894 Patent and Claim 14 of the ’894 Patent,
exemplary formation-method, device, and use-method system claims respectively, recite as
follows:
’844 Patent
4. A method of forming an electrode bearing endotracheal tube for laryngeal
electromyography comprising:
providing an endotracheal tube having a retaining balloon at a distal end
thereof,
5

forming on an exterior surface of the endotracheal tube one or more electrode
plates, at least one trace attached to each of the one or more electrode
plates and a conductive pad attached to a proximal end of the traces, a first
of said electrode plates located at the distal end of the endotracheal tube
proximal of the retaining balloon, the conductive pad or pads located at a
proximal end of the endotracheal tube,
the electrode plates, traces and electrode pads formed by applying a conductive
ink in a liquid carrier to the exterior surface of the endotracheal tube,
evaporating the liquid carrier to provide an electrically conductive path from
the electrode plates to the endotracheal tube proximal end, and
forming an insulating barrier over the traces, the barrier extending from a point
of connection of the traces to the electrode plates to a point of connection
of the traces to the electrode pads
wherein a second electrode plate is located proximal of said first electrode
plate, the first electrode plate positioned to contact the vocal cords and the
second electrode plate positioned to contact the tongue when properly
positioned for performing laryngeal electromyography.
’894 Patent
10. A method of conducting monitoring of electrical signals during laryngeal
electromyography for a period of time in excess of 8 hours without injury to
the trachea comprising:
providing an endotracheal tube having a retention balloon at or adjacent a
distal end thereof,
forming on the outer surface of said tube
a) one or more electrically conductive electrodes applied proximal of the
balloon directly to the surface of the tube, without the inclusion of a carrier
film between the tube surface and the electrodes,
b) electrically conductive traces connected to or integral with the electrodes,
the traces applied directly to the tube surface and running along the length
of the endotracheal tube to a proximal portion thereof,
c) connection points connected to or integral with the conductive traces applied
directly to the tube surface at a proximal end of the traces, and
d) electrical leads attached to the connection points, said leads adapted for
connection to monitoring equipment,
e) the electrically conductive traces covered by an insulating material along
their length from a point adjacent the electrodes to a point adjacent the
proximal ends of the traces,
wherein said electrically conductive electrodes, traces and connection points
comprise a conductive paint or printing ink,
placing the endotracheal tube in the trachea with at least one electrode in
contact with the vocal cords, and
monitoring electrical signals with the at least one electrode, said monitored
electrical signals not showing a detrimental reduction in the quality thereof
during the period of monitoring.
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14. A device for use in monitoring electrical signals during laryngeal
electromyography comprising:
an endotracheal tube having a retention balloon at or adjacent a distal end
thereof, said tube having on its outer surface at least first and second
electrically conductive electrodes applied proximal of the balloon directly
to the surface of the tube, without the inclusion of a carrier film between
the tube surface and the electrodes, said first and second electrodes
electrically isolated from each other, at least one of the first or second
electrodes positioned to contact the vocal cords, a wall of the trachea or the
tongue when the tube is positioned for electromyography in the trachea
with the retention balloon distal of the vocal cords,
said tube having on its surface first and second electrically conductive traces,
said first trace connected to or integral with the first electrode and said
second trace integral with the second electrode, the traces applied directly
to the tube surface, electrically isolated from each other, and running along
the length of the endotracheal tube to a proximal portion thereof, and
electrical leads connected to the electrically conductive traces or to conductive
pads connected to or integral with the conductive traces, said leads
configured to connect to monitoring equipment,
the electrically conductive traces covered by an insulating material along their
length from a point adjacent the electrode to which it is attached to a point
adjacent the electrical leads or the conductive pads.
II.

LEGAL PRINCIPLES
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) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys.,
Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). To determine the meaning of the claims, courts start
by considering the intrinsic evidence. Id. at 1313; C.R. Bard, Inc. v. U.S. Surgical Corp., 388
F.3d 858, 861 (Fed. Cir. 2004); Bell Atl. Network Servs., Inc. v. Covad Commc’ns Group, Inc.,
262 F.3d 1258, 1267 (Fed. Cir. 2001). The intrinsic evidence includes the claims themselves, the
specification, and the prosecution history. Phillips, 415 F.3d at 1314; C.R. Bard, Inc., 388 F.3d at
861. The general rule—subject to certain specific exceptions discussed infra—is that each claim
term is construed according to its ordinary and accustomed meaning as understood by one of
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ordinary skill in the art at the time of the invention in the context of the patent. Phillips, 415 F.3d
at 1312–13; Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1368 (Fed. Cir. 2003); Azure
Networks, LLC v. CSR PLC, 771 F.3d 1336, 1347 (Fed. Cir. 2014) (“There is a heavy
presumption that claim terms carry their accustomed meaning in the relevant community at the
relevant time.”) (vacated on other grounds).
“The claim construction inquiry . . . begins and ends in all cases with the actual words of
the claim.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998).
“[I]n all aspects of claim construction, ‘the name of the game is the claim.’” Apple Inc. v.
Motorola, Inc., 757 F.3d 1286, 1298 (Fed. Cir. 2014) (quoting In re Hiniker Co., 150 F.3d 1362,
1369 (Fed. Cir. 1998)). First, a term’s context in the asserted claim can be instructive. Phillips,
415 F.3d at 1314. Other asserted or unasserted claims can also aid in determining the claim’s
meaning, because claim terms are typically used consistently throughout the patent. Id.
Differences among the claim terms can also assist in understanding a term’s meaning. Id. For
example, when a dependent claim adds a limitation to an independent claim, it is presumed that
the independent claim does not include the limitation. Id. at 1314–15.
“[C]laims ‘must be read in view of the specification, of which they are a part.’” Id.
(quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc)).
“[T]he specification ‘is always highly relevant to the claim construction analysis. Usually, it is
dispositive; it is the single best guide to the meaning of a disputed term.’” Id. (quoting Vitronics
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)); Teleflex, Inc. v. Ficosa N. Am.
Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). But, “‘[a]lthough the specification may aid the
court in interpreting the meaning of disputed claim language, particular embodiments and
examples appearing in the specification will not generally be read into the claims.’” Comark

8

Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (quoting Constant v.
Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571 (Fed. Cir. 1988)); see also Phillips, 415
F.3d at 1323. “[I]t is improper to read limitations from a preferred embodiment described in the
specification—even if it is the only embodiment—into the claims absent a clear indication in the
intrinsic record that the patentee intended the claims to be so limited.” Liebel-Flarsheim Co. v.
Medrad, Inc., 358 F.3d 898, 913 (Fed. Cir. 2004).
The prosecution history is another tool to supply the proper context for claim
construction because, like the specification, the prosecution history provides evidence of how the
U.S. Patent and Trademark Office (“PTO”) and the inventor understood the patent. Phillips, 415
F.3d at 1317. However, “because the prosecution history represents an ongoing negotiation
between the PTO and the applicant, rather than the final product of that negotiation, it often lacks
the clarity of the specification and thus is less useful for claim construction purposes.” Id. at
1318; see also Athletic Alternatives, Inc. v. Prince Mfg., 73 F.3d 1573, 1580 (Fed. Cir. 1996)
(ambiguous prosecution history may be “unhelpful as an interpretive resource”).
Although extrinsic evidence can also be useful, it is “‘less significant than the intrinsic
record in determining the legally operative meaning of claim language.’” Phillips, 415 F.3d at
1317 (quoting C.R. Bard, Inc., 388 F.3d at 862). Technical dictionaries and treatises may help a
court understand the underlying technology and the manner in which one skilled in the art might
use claim terms, but technical dictionaries and treatises may provide definitions that are too
broad or may not be indicative of how the term is used in the patent. Id. at 1318. Similarly,
expert testimony may aid a court in understanding the underlying technology and determining
the particular meaning of a term in the pertinent field, but an expert’s conclusory, unsupported
assertions as to a term’s definition are not helpful to a court. Id. Extrinsic evidence is “less

9

reliable than the patent and its prosecution history in determining how to read claim terms.” Id.
The Supreme Court recently explained the role of extrinsic evidence in claim construction:
In some cases, however, the district court will need to look beyond the patent’s
intrinsic evidence and to consult extrinsic evidence in order to understand, for
example, the background science or the meaning of a term in the relevant art
during the relevant time period. See, e.g., Seymour v. Osborne, 11 Wall. 516, 546
(1871) (a patent may be “so interspersed with technical terms and terms of art that
the testimony of scientific witnesses is indispensable to a correct understanding of
its meaning”). In cases where those subsidiary facts are in dispute, courts will
need to make subsidiary factual findings about that extrinsic evidence. These are
the “evidentiary underpinnings” of claim construction that we discussed in
Markman, and this subsidiary factfinding must be reviewed for clear error on
appeal.
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015).
B.

Departing from the Ordinary Meaning of a Claim Term

There are “only two exceptions to [the] general rule” that claim terms are construed
according to their plain and ordinary meaning: “1) when a patentee sets out a definition and acts
as his own lexicographer, or 2) when the patentee disavows the full scope of the claim term
either in the specification or during prosecution.” 2 Golden Bridge Tech., Inc. v. Apple Inc., 758
F.3d 1362, 1365 (Fed. Cir. 2014) (quoting Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d
1362, 1365 (Fed. Cir. 2012)); see also GE Lighting Solutions, LLC v. AgiLight, Inc., 750 F.3d
1304, 1309 (Fed. Cir. 2014) (“[T]he specification and prosecution history only compel departure
from the plain meaning in two instances: lexicography and disavowal.”). The standards for
finding lexicography or disavowal are “exacting.” GE Lighting Solutions, 750 F.3d at 1309.
To act as his own lexicographer, the patentee must “clearly set forth a definition of the
disputed claim term,” and “clearly express an intent to define the term.” Id. (quoting Thorner,

2

Some cases have characterized other principles of claim construction as “exceptions” to the
general rule, such as the statutory requirement that a means-plus-function term is construed to
cover the corresponding structure disclosed in the specification. See, e.g., CCS Fitness, Inc. v.
Brunswick Corp., 288 F.3d 1359, 1367 (Fed. Cir. 2002).
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669 F.3d at 1365); see also Renishaw, 158 F.3d at 1249. The patentee’s lexicography must
appear “with reasonable clarity, deliberateness, and precision.” Renishaw, 158 F.3d at 1249.
To disavow or disclaim the full scope of a claim term, the patentee’s statements in the
specification or prosecution history must amount to a “clear and unmistakable” surrender. Cordis
Corp. v. Boston Sci. Corp., 561 F.3d 1319, 1329 (Fed. Cir. 2009); see also Thorner, 669 F.3d at
1366 (“The patentee may demonstrate intent to deviate from the ordinary and accustomed
meaning of a claim term by including in the specification expressions of manifest exclusion or
restriction, representing a clear disavowal of claim scope.”). “Where an applicant’s statements
are amenable to multiple reasonable interpretations, they cannot be deemed clear and
unmistakable.” 3M Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315, 1326 (Fed. Cir.
2013).
C.

Functional Claiming and 35 U.S.C. § 112, ¶ 6 (pre-AIA) / § 112(f) (AIA)

A patent claim may be expressed using functional language. See 35 U.S.C. § 112, ¶ 6;
Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1347–49 & n.3 (Fed. Cir. 2015) (en banc in
relevant portion). Section 112, Paragraph 6, provides that a structure may be claimed as a
“means . . . for performing a specified function” and that an act may be claimed as a “step for
performing a specified function.” Masco Corp. v. United States, 303 F.3d 1316, 1326 (Fed. Cir.
2002).
But § 112, ¶ 6 does not apply to all functional claim language. There is a rebuttable
presumption that § 112, ¶ 6 applies when the claim language includes “means” or “step for”
terms, and that it does not apply in the absence of those terms. Masco Corp., 303 F.3d at 1326;
Williamson, 792 F.3d at 1348. The presumption stands or falls according to whether one of
ordinary skill in the art would understand the claim with the functional language, in the context
of the entire specification, to denote sufficiently definite structure or acts for performing the
11

function. See Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1372 (Fed.
Cir. 2015) (§ 112, ¶ 6 does not apply when “the claim language, read in light of the specification,
recites sufficiently definite structure” (quotation marks omitted) (citing Williamson, 792 F.3d at
1349; Robert Bosch, LLC v. Snap-On Inc., 769 F.3d 1094, 1099 (Fed. Cir. 2014))); Williamson,
792 F.3d at 1349 (§ 112, ¶ 6 does not apply when “the words of the claim are understood by
persons of ordinary skill in the art to have sufficiently definite meaning as the name for
structure”); Masco Corp., 303 F.3d at 1326 (§ 112, ¶ 6 does not apply when the claim includes
an “act” corresponding to “how the function is performed”); Personalized Media
Communications, L.L.C. v. International Trade Commission, 161 F.3d 696, 704 (Fed. Cir. 1998)
(§ 112, ¶ 6 does not apply when the claim includes “sufficient structure, material, or acts within
the claim itself to perform entirely the recited function . . . even if the claim uses the term
‘means.’” (quotation marks and citation omitted)).
When it applies, § 112, ¶ 6 limits the scope of the functional term “to only the structure,
materials, or acts described in the specification as corresponding to the claimed function and
equivalents thereof.” Williamson, 792 F.3d at 1347. Construing a means-plus-function limitation
involves multiple steps. “The first step . . . is a determination of the function of the means-plusfunction limitation.” Medtronic, Inc. v. Advanced Cardiovascular Sys., Inc., 248 F.3d 1303, 1311
(Fed. Cir. 2001). “[T]he next step is to determine the corresponding structure disclosed in the
specification and equivalents thereof.” Id. A “structure disclosed in the specification is
‘corresponding’ structure only if the specification or prosecution history clearly links or
associates that structure to the function recited in the claim.” Id. The focus of the “corresponding
structure” inquiry is not merely whether a structure is capable of performing the recited function,
but rather whether the corresponding structure is “clearly linked or associated with the [recited]

12

function.” Id. The corresponding structure “must include all structure that actually performs the
recited function.” Default Proof Credit Card Sys. v. Home Depot U.S.A., Inc., 412 F.3d 1291,
1298 (Fed. Cir. 2005). However, § 112 does not permit “incorporation of structure from the
written description beyond that necessary to perform the claimed function.” Micro Chem., Inc. v.
Great Plains Chem. Co., 194 F.3d 1250, 1258 (Fed. Cir. 1999).
For § 112, ¶ 6 limitations implemented by a programmed general purpose computer or
microprocessor, the corresponding structure described in the patent specification must include an
algorithm for performing the function. WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339,
1349 (Fed. Cir. 1999). The corresponding structure is not a general purpose computer but rather
the special purpose computer programmed to perform the disclosed algorithm. Aristocrat Techs.
Austl. Pty Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir. 2008).
D.

Definiteness Under 35 U.S.C. § 112, ¶ 2 (pre-AIA) / § 112(b) (AIA)

Patent claims must particularly point out and distinctly claim the subject matter regarded
as the invention. 35 U.S.C. § 112, ¶ 2. A claim, when viewed in light of the intrinsic evidence,
must “inform those skilled in the art about the scope of the invention with reasonable certainty.”
Nautilus Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014). If it does not, the claim
fails § 112, ¶ 2 and is therefore invalid as indefinite. Id. at 2124. Whether a claim is indefinite is
determined from the perspective of one of ordinary skill in the art as of the time the application
for the patent was filed. Id. at 2130. As it is a challenge to the validity of a patent, the failure of
any claim in suit to comply with § 112 must be shown by clear and convincing evidence. Id. at
2130 n.10. “[I]ndefiniteness is a question of law and in effect part of claim construction.” ePlus,
Inc. v. Lawson Software, Inc., 700 F.3d 509, 517 (Fed. Cir. 2012).
When a term of degree is used in a claim, “the court must determine whether the patent
provides some standard for measuring that degree.” Biosig Instruments, Inc. v. Nautilus, Inc.,
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783 F.3d 1374, 1378 (Fed. Cir. 2015) (quotation marks omitted). Likewise, when a subjective
term is used in a claim, “the court must determine whether the patent’s specification supplies
some standard for measuring the scope of the [term].” Datamize, LLC v. Plumtree Software, Inc.,
417 F.3d 1342, 1351 (Fed. Cir. 2005); accord Interval Licensing LLC v. AOL, Inc., 766 F.3d
1364, 1371 (Fed. Cir. 2014) (citing Datamize, 417 F.3d at 1351).
In the context of a claim governed by 35 U.S.C. § 112, ¶ 6, the claim is invalid as
indefinite if the claim fails to disclose adequate corresponding structure to perform the claimed
functions. Williamson, 792 F.3d at 1351–52. The disclosure is inadequate when one of ordinary
skill in the art “would be unable to recognize the structure in the specification and associate it
with the corresponding function in the claim.” Id. at 1352.
III.

CONSTRUCTION OF DISPUTED TERMS
A.

“electrode,” “electrode plate”

Disputed Term 3
“electrode”
•
•

Defendants’ Proposed
Construction
“element designed to hold a
conductive surface against a
body part in order to pick up
EMG signals from that body
part”

Plain and ordinary meaning.

“plate designed to hold a
conductive surface against a
body part in order to pick up
EMG signals from that body
part”

’844 Patent Claims 1, 4
’894 Patent Claims 1, 4,
10, 14

“electrode plate”
•

Plaintiff’s Proposed
Construction
Plain and ordinary meaning.

’844 Patent Claims 1, 4

Because the parties’ arguments and proposed constructions with respect to these terms
are related, the Court addresses the terms together.
3

For all term charts in this order, the claims in which the term is found are listed with the term
but: (1) only the highest level claim in each dependency chain is listed, and (2) only asserted
claims identified in the parties’ Patent Rule 4-5(d) Claim Construction Charts (Dkt. No. 85; Dkt.
No. 86) are listed.
14

The Parties’ Positions
Plaintiff submits that “electrode” and “electrode plate” are each readily understood
without construction—as something that conducts electricity. Dkt. No. 70 at 26. Plaintiff
contends that Defendants’ proposed construction is improper as it distinguishes between the
“electrode” and a “conductive surface.” Id. According to Plaintiff, the “electrodes” of the
Asserted Patents were not redefined as something that “hold[s] a conductive surface against a
body part.” Id. Specifically, Plaintiff argues the statement in the common abstract that
“[l]aryngeal surface electrodes are devices designed to hold a conductive surface against the
vocal cords” is not definitional of “electrode” but rather refers to a “device.” Id. at 26–27. And,
Plaintiff contends, the abstract statement should be read in context of the rest of the patent, such
as the summary statement,
the endotracheal tube laryngeal surface electrode incorporates imprinted
patterns which provide conductive electrode plates on the surface without adding
any additional structure or materials to the standard endotracheal tube other than
the conductive ink or materials applied to the surface to form the electrodes.
Id. at 26–27 (quoting ’844 Patent col.2 ll.33–38 (emphasis added by Plaintiff).
In addition to the claims themselves, Plaintiff cites the following intrinsic and extrinsic
evidence to support its position: Intrinsic evidence: ’844 Patent, at [57] Abstract, col.1 l.46,
col.2 ll.33–38, col.4 l.20. Extrinsic evidence: Otto Decl. 4 ¶¶ 35–38 (Dkt. No. 70-1 at 10–11).
Defendants respond that the “electrode” and “electrode plate” of the Asserted Patents
“refer to electrically conductive elements that pick up EMG signals from the area of the anatomy
of interest.” Dkt. No. 76 at 14. According to Defendants, that the electrodes are “sensing”
electrodes (i.e., that they pick up EMG signals) is evinced by the description of the exemplary
embodiments and by arguments made during prosecution. Id. Specifically, Defendants contend
4

Expert Declaration of Dr. Randal A. Otto, Dkt. No. 70-1.
15

that the patentee distinguished a prior-art reference on the ground that the disclosed “electrode”
was not a “sensing electrode.” Id. And, Defendants contend, the only “electrodes” of the patents
are electrodes that pick up (i.e., receive) EMG signals. Id. at 14–15.
In addition to the claims themselves, Defendants cite the following intrinsic and extrinsic
evidence to support their position: Intrinsic evidence: ’844 Patent, at [57] Abstract, col.1 ll.45–
46, col.4 ll.14–21; ’894 Patent File Wrapper, October 25, 2013 Amendment/Response
(Defendants’ Ex. I at 89–99, Dkt. No. 76-9 at 89–99). Extrinsic evidence: Otto Dep. 5 at 103:9–
25 (Defendants’ Ex. B, Dkt. No. 76-2 at 103).
Plaintiff replies that the statement in the abstract of the Asserted Patents that “[l]aryngeal
surface electrodes are devices designed to hold a conductive surface against the vocal cords in
order to pick up small electrical signals from the muscle known as electromyographic signals”
does not define the invention, but rather refers generically to laryngeal surface electrode devices.
Dkt. No. 82 at 9. Plaintiff further replies that the term at issue is “electrode” not “laryngeal
surface electrode device.” Id. And the electrode is the conductive surface, not a device for
holding the conductive surface. Id. Plaintiff further replies that while the electrodes of one
exemplary embodiment are described as “picking up” or “receiving” signals, it would be
improper to read a feature of an exemplary embodiment into the claims. Id. at 10.
Plaintiff cites further intrinsic evidence to support its position: ’844 Patent col.3 ll.34–
39, col.4 ll.14–18.
Analysis
There are two issues raised by the dispute. First, whether “electrode” and “electrode
plate” refer to something that holds a conductive surface against an anatomical feature. Second,

5

Deposition of Randal A. Otto, M.D., September 12, 2016, Dkt. No. 76-2.
16

whether “electrode” and “electrode” plate are sensing electrodes configured to pick up
electromyographic signals. With respect to the first, issue, the Court determines that the
“electrode”/“electrode plate” of the Asserted Patents does not necessarily hold a conductive
surface against a body part. With respect to the second issue, the Court determines that the
“electrode”/“electrode plate” of the patents is an electrode to sense electromyographic signals—
it is a sensing electrode.
The “electrode”/“electrode plate” of the patents does not necessarily hold a conductive
surface against a body part. The patents distinguish between the “laryngeal surface electrode,”
which is a device, and the “electrode”/“electrode plate,” which is a feature of the device. For
example, the patents provide that
the endotracheal tube laryngeal surface electrode incorporates imprinted patterns
which provide conductive electrode plates on the surface without adding any
additional structure or materials to the standard endotracheal tube other than the
conductive ink or materials applied to the surface to form the electrodes.
’844 Patent col.2 ll.32–38. Similarly, the patents provide that
[a]n additional object is to provide a PVC laryngeal surface electrode with the
electrodes painted, printed or sprayed on the surface thereof, thereby providing
the flexibility of the PVC material throughout the length of the device. The
painted, printed or sprayed on electrodes does not create a zone of stiffness
anywhere along the length of the endotracheal tube, and particularly near the
vocal cords.
Id. at col.2 l.66 – col.3 l.5. That is, the “electrode”/“electrode plate” is a surface deposited on the
endotracheal tube and together the electrode and tube comprise the laryngeal surface electrode
device. See also, id. at col.3 ll.65–67 (“conductive electrode plates 14 are imprinted on the linear
body of the tube 12”). Indeed, other than how the surface is affixed to the tube, this is how
“electrode” is used to describe the prior art:
it is common practice to monitor laryngeal electromyography using laryngeal
electrodes (the electrical signal pickup surfaces used to collect the muscle signals)
17

which are either adhesively secured to the surface of the endotracheal tube or are
embedded into the tube surface during the manufacture of the endotracheal tube
Id. at col.1 ll.44–49. And this is how the patentee explained an “electrode” in prosecution. See,
e.g., ’894 Patent File Wrapper, October 25, 2013 Amendment/Response at 7–8, Dkt. No. 70-8 at
8–9 (referring to “electrodes printed on the surface of the endotracheal tube”).
In this context, the Court understands the statement in the patents’ Abstracts that
“[l]aryngeal surface electrodes are devices designed to hold a conductive surface against the
vocal cords” refers to a device (the laryngeal surface electrode) that holds the electrode (the
conductive surface) against the vocal cords. Indeed, the Abstracts further provide that
[s]everal embodiments of a laryngeal electromyography tube include a
conductive electrode surface that is painted, screen printed or otherwise applied
directly onto the body of an endotracheal tube, such that the final device has no
raised surfaces which can injure the vocal cords.
Id. at [57] Abstract (emphasis added). Simply, the Abstract statement is not a definition of
“electrode” as Defendants contend.
That said, the “electrode”/“electrode plate” of the patents is a sensing electrode. When
read in the context of the patents’ disclosures and prosecution histories, this is apparent from the
claims. For instance, Claim 1 of the ’894 Patent is directed to a device for monitoring electrical
signals. The electrodes are positioned to contact various body parts and are electrically connected
to electrical leads that are adapted for connection to monitoring equipment. The patents explain
that the “electrodes are located for optimal signal collection” and that they are “optimized
for . . . collection of electrical signals from the muscles and nerves comprising the vocal cords.”
’844 Patent col.2 ll.8–12, col.2 ll.22–26. In fact, the patents refer to the prior-art electrodes that
the invention purportedly improves upon as “the electrical signal pickup surfaces used to collect
the muscle signals.” Id. at col.1 ll.44–49. And the electrodes of the patents are also characterized
in the prosecution history as sensing electrodes, as distinguished from electrodes that only
18

deliver current. See ’894 Patent File Wrapper, October 25, 2013 Amendment/Response at 9–10,
Dkt. No. 70-8 at 10–11 (distinguishing a prior-art reference by stating “[t]he current electrode 42
or electrode patch 44 [of the reference] are clearly not sensing electrodes and are in fact
components for delivering current to the tracheal tissue”). That is, the electrodes are the sensing
elements of the system for monitoring electrical signals, regardless of whether the electrodes
may also deliver current.
The patents use “electrode” and “electrode plate” interchangeably. See, e.g., ’844 Patent
col.2 ll.32–38 (referring to that which is deposited on the tube as “electrode plate” and
“electrode”), col.2 l.66 – col.3 l.5 (referring to that which is deposited on the tube as
“electrode”), col.4 ll.12–35 (describing various placements of the “electrode plate” on the tube
and noting “that other electrode placements may be desired”). In the Asserted Patents, the
“electrodes” and “electrode plates” are surfaces that are adapted to collect the electrical signals.
Finally, and as set forth in detail in the discussion of “trace” below, the electrode of the
claims is formed of conductive ink or paint.
Accordingly, the Court construes “electrode” and “electrode plate” as follows:
•

“electrode” / “electrode plate” means “surface that is adapted to collect electrical
signals and that is formed of conductive ink or paint.”

B.

“positioned to contact . . . ”

Disputed Term

“positioned to contact the
vocal cords when placed
within the trachea”
•

Plaintiff’s
Proposed
Construction
Plain and ordinary
meaning.

Defendants’ Proposed Construction

Indefinite.
alternative:
• “positioned against the vocal cords in
order to pick up EMG signals from the
vocal cords when placed in a human
patient’s trachea”

’844 Patent Claim 1

19

Disputed Term

“positioned to contact the
tongue”
•

•

Plain and ordinary
meaning.

Plain and ordinary
meaning.

•

Indefinite.

Indefinite.
alternative:
• “positioned against the tongue or
nerves and muscle in the rear of the
trachea in order to pick up EMG
signals from these structures”

’894 Patent Claim 5

’894 Patent Claim 12

“positioned to contact the
vocal cords, a wall of the
trachea or the tongue”

Indefinite.

alternative:
• “positioned against the tissue, nerves
and muscle in the trachea or the
tongue in order to pick up EMG
signals from these structures”

“positioned so as to contact Plain and ordinary
tissue, nerves and muscle
meaning.
in the rear of the trachea or
the tongue”
•

Indefinite.

alternative:
• “positioned against the vocal cords in
order to pick up EMG signals from the
vocal cords”

’894 Patent Claim 1

“positioned to contact the
tongue or nerves and
muscle in the rear of the
trachea”
•

Plain and ordinary
meaning.

’894 Patent Claims 1,
5, 12

“positioned to contact
tissue, nerves and muscle
in the trachea or the
tongue”

Defendants’ Proposed Construction

alternative:
• “positioned against the tongue in order
to pick up EMG signals from the
tongue”

’844 Patent Claim 1

“positioned to contact the
vocal cords”
•

Plaintiff’s
Proposed
Construction
Plain and ordinary
meaning.

Plain and ordinary
meaning.

Indefinite.
alternative:
• “positioned against the tissue, nerves,
muscle in the rear of the trachea or the
tongue in order to pick up EMG
signals from these structures”
Indefinite.
alternative:
• “positioned against the vocal cords, a
wall of the trachea or the tongue in
order to pick up EMG signals from
these structures”

’894 Patent Claim 14

20

Because the parties’ arguments and proposed constructions with respect to these terms
are related, the Court addresses the terms together.
The Parties’ Positions
Plaintiff submits that positioning electrodes to monitor signals during laryngeal
electromyography was well known in in the art. Dkt. No. 70 at 15–16. This knowledge,
according to Plaintiff, is recognized in the Asserted Patents as well as in the prosecution history.
Id. at 16. Further, Plaintiff argues, the patents provide guidance as to the positioning. Id. at 16–
17. For instance, the positon of a first electrode is described with reference to a retention balloon
(“proximal of the balloon”), the position of a second electrode with reference to the balloon
(“further proximal thereof”), and the position of the retention balloon is described with reference
to the patient’s anatomy (“distal of the vocal cords”). Id. (quoting ’844 Patent Claim 1; ’894
Patent Claim 14). Also, the position of the electrode is described with reference to the curve of
the endotracheal tube to which the electrode is attached: “on the outer curved surface for
receiving electrical signals generated from nerves and muscles in the rear of the trachea” and “on
the concave (inner surface of the curve) for picking up signals generated from the vocal cord
located on the front surface of the trachea.” Id. at 17 (quoting ’844 Patent col.4 ll.12–21).
Plaintiff further submits that prior-art references of record in the prosecution history describe
how to determine if the electrodes are in contact with the desired anatomy. Id. at 17–18.
In addition to the claims themselves, Plaintiff cites the following intrinsic and extrinsic
evidence to support its position: Intrinsic evidence: ’844 Patent figs.1–5, col.1 ll.17–21, col.1
ll.44–49, col.4 ll.12–21; ’894 Patent File Wrapper October 25, 2013 Amendment/Response

21

(Plaintiff’s Ex. 6, Dkt. No. 70-8); International Publication No. WO 2006/105121 6 (Plaintiff’s
Ex. 9, Dkt. No. 70-11); U.S. Patent No. 5,125,406 7 (Plaintiff’s Ex. 10, Dkt. No. 70-12).
Extrinsic evidence: Otto Decl. ¶¶ 18–22 (Dkt. No. 70-1 at 5–6); Medtronic, NIM EMG
Endotracheal Tube (Plaintiff’s Ex. 11, Dkt. No. 70-13).
Defendants respond that each of the “positioned to contact” terms are defined with
reference to anatomy that is inherently variable and the terms therefore render the claims
indefinite. Dkt. No. 76 at 16, 28–31. These anatomical references, according to Defendants, are
so divergent in practice that there is no way to determine whether a particular configuration of
electrodes are positioned according to the claims. Id. at 29–31.
Defendants further respond that “positioned to contact” a particular anatomical feature
means that the “electrodes must be positioned against the recited structures in order to pick up
EMG signals from them.” Id. at 16. This, according to Defendants, is because the abstract states
that the electrodes “hold a conductive surface against the vocal cords in order to pick up small
electrical signals from the muscle known as electromyographic signals.” Id. And, Defendants
contend, the electrodes are depicted in the patents’ figures as “against” the anatomical features
that they are positioned to contact. Id. at 16–17. Defendants further contend that nothing in the
patents’ description or claims suggests that one electrode may “contact multiple anatomical
structures.” Id. at 17. Rather, Defendants argue, the claims recite separate electrodes as a
condition of patentability. Id. at 17.
In addition to the claims themselves, Defendants cite the following intrinsic and extrinsic
evidence to support their position: Intrinsic evidence: ’844 Patent File Wrapper, October 15,
6

International Publication No. WO 2006/105121 is cited on the face of the ’844 and ’894
Patents. ’844 Patent, at [56] References Cited; ’894 Patent, at [56] References Cited.
7
U.S. Patent No. 5,125,406 is cited on the face of the ’844 Patent. ’844 Patent, at [56]
References Cited.
22

2013 Office Action (Defendants’ Ex. H at 61–66, Dkt. No. 76-8 at 61–66), January 14, 2013
Amendment (Defendants’ Ex. H at 49–57, Dkt. No. 76-8 at 49–57), April 30, 2013 Notice of
Allowance (Defendants’ Ex. H at 9–12, Dkt. No. 76-8 at 9–12). Extrinsic evidence: Otto Decl.
¶ 22 (Defendants’ Ex. D, Dkt. No. 76-4 at 6); Otto Dep. 67:18 – 68:10, 165:11–24, 191:22 –
193:6, 208:1–14 (Defendants’ Ex. B, Dkt. No. 76-2 at 67–68, 165, 191–93, 208); Medtronic,
NIM EMG Endotracheal Tube (Defendants’ Ex. K, Dkt. No. 76-11).
Plaintiff replies that the statement in the abstract of the Asserted Patents that “[l]aryngeal
surface electrodes are devices designed to hold a conductive surface against the vocal cords in
order to pick up small electrical signals from the muscle known as electromyographic signals” is
not definitional of the invention, but rather refers generically to laryngeal surface electrode
devices. Dkt. No. 82 at 3–4. Plaintiff also argues that a claim is not indefinite simply because it
defines structure according to anatomical references. Id. at 4 (citing Biosig Instruments, Inc. v.
Nautilus, Inc., 783 F.3d 1374, 1382–84 (Fed. Cir. 2015); Young v. Lumenis, Inc., 492 F.3d 1336,
1346 (Fed. Cir. 2007)). And, according to Plaintiff, one of ordinary skill in the art would be able
to position the electrodes to contact the recited anatomical references. Id. at 5–6.
Analysis
There are two issues raised by the dispute. First, whether “positioned to contact [the
anatomical feature]” should be rewritten as “positioned against [the anatomical feature] in order
to pick up EMG signals from [the feature].” Second, whether defining electrode positioning with
respect to anatomical features renders claims indefinite. With respect to the first issue, the Court
declines to rewrite “positioned to contact” as “positioned against.” With respect to the second
issue, the Court determines that Defendants have failed to prove any claim is indefinite because
of the “positioned to contact” term.

23

While the Court agrees with Defendants that the electrodes are positioned to collect
electrical signals from a body part, the Court declines to rewrite the plain term “positioned to
contact” as “positioned against” and rejects any limitation imposed by “positioned against” that
is not also found in “positioned to contact.” As set forth in the section on “electrode” above, the
Court understands that the “electrodes” of the claims are to collect electrical signals from
anatomical tissue, which is consistent with the patents’ description. See, e.g., ’844 Patent col.1
l.45–46, col.2 ll.11–12 (“electrode[s] are located for optimal signal collection”). Indeed, Plaintiff
argues that the positioning of the electrodes can be determined by measuring the electrical
characteristics of the contact between electrode and tissue. Dkt. No. 70 at 17–18; see also, Otto
Decl. ¶¶ 20–21, Dkt. No 70-1 at 5–6. But the patents do not redefine “positioned to contact” as
“positioned against,” as Defendants suggest. As stated above, the Court rejects Defendants’
contention that the Abstract of the patents defines the electrode or its positioning. And while
“positioned to contact” expresses a capability, Defendants proposed “positioned against”
threatens to require that the electrode be in contact with the tissue (the tissue is not required by
all the claims). That is, an electrode is positioned to collect electrical signals from the tissue in
that it is “positioned to contact” the tissue when used. This is plainly expressed in the claims.
The Court also rejects Defendants’ argument that would essentially read a negative
limitation into the “positioned to contact” terms, one that prevents the electrode from contacting
more than one anatomical feature. See Dkt. No. 76 at 17. While the Court agrees with
Defendants that claims do not require that the electrodes be “positioned to contact” more than
one anatomical feature, neither do the claims recite that the electrodes are “positioned to contact”
one and only one anatomical feature. Defendants invoke the prosecution history to exclude
electrodes that contact more than one anatomical feature, but fail to provide any reason why the

24

prosecution history mandates such a result. As such, neither a plain reading of the claims nor any
statement in the prosecution history supports Defendants’ argued negative limitation.
The “positioned to contact” terms do not render claims indefinite simply because they
reference anatomical features. Defendants appear to argue that a claim to a medical device
having a structure defined in part by reference to anatomy is per se indefinite. To the contrary,
the Federal Circuit has found claims definite because the claims provide an anatomical reference
point. Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374, 1382–83 (Fed. Cir. 2015). Biosig
considered claims to a heart-rate monitor that included electrodes “in spaced relationship” with
each other. Id. at 1376. The Federal Circuit twice considered whether that limitation rendered the
claims indefinite. Id. On first consideration and then again on remand from the Supreme Court,
the Federal Circuit held that while the “spaced relationship” was not specifically set forth in the
patents (“e.g., that the space between the . . . electrodes is one inch”), the limitation did not
render any claim indefinite. Id. at 1382–83. Specifically, the Federal Circuit noted that because
the electrodes were to collect electrical signals on a user’s hand, the spaced relationship was not
indefinite because it was implicitly defined, in part, by “the width of a user’s hands.” Id.
Defining electrode spacing by “the width of a user’s hands” is not meaningfully different than
defining electrode positioning by the locations of a patient’s vocal cords, tongue, and trachea.
Like in Biosig, the claims here are not indefinite because they define electrode positioning by
reference to anatomical features.
Accordingly, the Court holds that Defendants have failed to prove any claim is indefinite
because of a “positioned to contact” term and determines that each of these terms has its plain
and ordinary meaning, that meaning is readily understood from the claim language, and the terms
need no further construction.

25

C.

“[located] further proximal thereof,” “[located] proximal [of said first
electrode plate],” “[located at said same predetermined distance or] further
proximal [thereof]”

Disputed Term

Plaintiff’s Proposed
Construction

Defendants’ Proposed
Construction

“[located] further proximal
thereof”
•

’844 Patent Claim 1

“[located] proximal [of said
first electrode plate]”
•

Plain and ordinary meaning.

’844 Patent Claim 4

“[located at said same
predetermined distance or]
further proximal [thereof]”
•

“separated from the first
electrode plate along the
length of the tube such that it
is nearer to the proximal end
of the tube”

’894 Patent Claim 18
Because the parties’ arguments and proposed constructions with respect to these terms

are related, the Court addresses the terms together.
The Parties’ Positions
Plaintiff submits that these terms do not need to be construed because they are readily
understandable by one of ordinary skill in the art. Dkt. No. 70 at 21. Plaintiff further submits that
Defendants’ proposed construction is improper because it obfuscates clear claim language
instead of clarifying claim scope. 8 Id. at 21. And Plaintiff submits that Defendants’ proposed
construction is improperly narrow as it requires that the electrodes be longitudinally separated
(i.e., excludes overlapping electrodes) when the Asserted Patents provide that the electrodes may
be placed circumferentially. Id. at 22.

8

Defendants originally proposed a construction “separated from the first electrode plate along
the longitude of the tube such that it is nearer to the proximal end of the tube.” Joint Claim
Construction and Prehearing Statement at 24, Dkt. No. 68.
26

In addition to the claims themselves, Plaintiff cites the following intrinsic and extrinsic
evidence to support its position: Intrinsic evidence: ’844 Patent fig.2, col.4 ll.31–35; ’894 Patent
File Wrapper October 25, 2013 Amendment/Response (Plaintiff’s Ex. 6, Dkt. No. 70-8).
Extrinsic evidence: Otto Decl. ¶¶ 26–28 (Dkt. No. 70-1 at 7–8).
Defendants respond that the “proximal” end of the endotracheal tube in the Asserted
Patents is the end sticking out of the patient’s mouth and thus a feature of the tube that is
“proximal of” another feature is farther along the length of the tube toward the end of the tube
that sticks out of the patient’s mouth. Dkt. No. 76 at 18–19. Defendants argue that “proximal” in
this context does not allow overlap of electrodes, as one electrode cannot be positioned proximal
to another electrode if there is overlap—the patents do not allow for “partially proximal”
electrodes. Id. at 19. Specifically, Defendants argue that because “proximal” is used as a relative
term, the claims are appropriately limited to the separate-and-distinct-electrode embodiments of
the patents as they are the only embodiments. Id. at 19–20 (citing Howmedica Osteonics Corp. v.
Zimmer, Inc., 822 F.3d 1312, 1321 (Fed. Cir. 2016)). Defendants further contend that the
prosecution history and the technological need to separate electrodes to reduce noise and prevent
mixing of signals mandate that each electrode is separately focused on a distinct anatomical
feature. Id. at 21–22.
In addition to the claims themselves, Defendants cite the following intrinsic and extrinsic
evidence to support their position: Intrinsic evidence: ’844 Patent figs.7–8, col.4 ll.4–6; ’844
Patent File Wrapper, October 15, 2013 Office Action (Defendants’ Ex. H at 61–66, Dkt. No.
76-8 at 61–66), January 14, 2013 Amendment (Defendants’ Ex. H at 49–57, Dkt. No. 76-8 at 49–
57), April 30, 2013 Notice of Allowance (Defendants’ Ex. H at 9–12, Dkt. No. 76-8 at 9–12);

27

U.S. Patent No. 5,125,406 (Defendants’ Ex. E, Dkt. No. 76-5). Extrinsic evidence: Otto Dep. at
91:16–19, 227:24 – 228:4 (Defendants’ Ex. B, Dkt. No. 76-2 at 91, 227–228).
Plaintiff replies that it would be improper to require that the electrodes do not partially
overlap because the Asserted Patents provide that “[o]ne skilled in the art will recognize that
other electrode placements may be desired.” Dkt. No. 82 at 6. Plaintiff further replies that
Claim 1 of the ’844 Patent allows for this in that the positions of the two electrodes are recited
with reference to the balloon—one is proximal of the balloon and the other is further proximal of
the balloon. Id. Finally, Plaintiff contends that there is no discussion in the patents regarding the
noise or mixed signals that Defendants argue mandates entirely longitudinally separated
electrodes. Id. at 6–7.
Analysis
The issue in dispute is whether these “proximal” terms mandate that the electrodes are
positioned on the tube such that electrodes are at entirely different distances along the length of
the tube. There is no discernable reason in the evidence of record that would exclude from the
scope of the claims electrodes that overlap (i.e., electrodes each having some portion that is
found at the same distance along the length of the tube).
Nothing in the evidence of record excludes overlapping electrodes as a matter of
technology or prosecution history. In fact, the Court understands Claim 18 of the ’894 Patent to
expressly allow what Defendants contend is excluded; namely, two electrodes at the same
distance along the length of the tube. Claim 18 and Claim 14, from which Claim 18 depends, are
quoted below with emphasis added by the Court. Claim 14 recites first and second electrodes on
the surface of the tube “proximal of the balloon.” Claim 18 further specifies that the “first
electrode is located a predetermined distance proximal of the balloon” and that the “second

28

electrode . . . [is] located at said same predetermined distance or further proximal thereof.” That
is, Claim 18 explicitly states that the first and second electrodes may be at the same distance
along the length of the tube. It is difficult
for the Court to imagine that prosecution
history

statements

or

technological

considerations described in the intrinsic
record exclude an electrode configuration
that is expressly recited in the claims.
The only evidence Defendants have
presented

in

support

of

excluding

overlapping electrodes is unpersuasive.
That mere fact that the claims of the ’844
Patent issued only after the second
electrode plate was defined as “further
proximal” of the balloon (Claim 1) or
“proximal” of the first electrode (Claim 4)
implies

nothing

about

overlapping

electrodes that is not already stated in the
claim

language.

And

Defendants’

contention that there is no electrode

’894 Patent
14. A device for use in monitoring electrical signals
during laryngeal electromyography comprising:
an endotracheal tube having a retention balloon at or
adjacent a distal end thereof, said tube having on
its outer surface at least first and second
electrically
conductive
electrodes
applied
proximal of the balloon directly to the surface of
the tube, without the inclusion of a carrier film
between the tube surface and the electrodes, said
first and second electrodes electrically isolated
from each other, at least one of the first or second
electrodes positioned to contact the vocal cords, a
wall of the trachea or the tongue when the tube is
positioned for electromyography in the trachea
with the retention balloon distal of the vocal cords,
said tube having on its surface first and second
electrically conductive traces, said first trace
connected to or integral with the first electrode and
said second trace integral with the second
electrode, the traces applied directly to the tube
surface, electrically isolated from each other, and
running along the length of the endotracheal tube
to a proximal portion thereof, and
electrical leads connected to the electrically conductive
traces or to conductive pads connected to or
integral with the conductive traces, said leads
configured to connect to monitoring equipment,
the electrically conductive traces covered by an
insulating material along their length from a point
adjacent the electrode to which it is attached to a
point adjacent the electrical leads or the conductive
pads.
18. The device of claim 14 wherein said first
electrode is located a predetermined distance
proximal of the balloon and positioned to contact the
vocal cords, said second electrode electrically isolated
from the first electrode and located at said same
predetermined distance or further proximal thereof.

overlap because “the Neurovision patents
use electrical insulation to focus the electrode on a single area of interest” to prevent noise or
mixed signals is belied by Claim 18 of the ’894 Patent.

29

Finally, while the Court understands that “proximal” in these terms as they appear in the
claims means that the second electrode is nearer to the proximal end of the tube than is the first
electrode, the Court does not understand that all portions of the second electrode must be nearer
to the proximal end than all portions of the first electrode.
Accordingly, the Court rejects Defendants’ proposed “separated” limitation (which the
Court understands is meant to exclude overlapping electrodes) and construes the “proximal”
terms as follows:
•

“located further proximal thereof” means “located nearer to the proximal end of
the tube than is the first electrode plate”;

•

“located proximal of said first electrode plate” means “located nearer to the
proximal end of the tube than said first electrode plate”; and

•

“located at said same predetermined distance or further proximal thereof” means
“located at said same predetermined distance or nearer to the proximal end of the
tube than the first electrode.”

D.

“trace”

Disputed Term
“trace”
•
•

Plaintiff’s Proposed
Construction
Plain and ordinary meaning,
but not a wire.

’844 Patent Claims 1, 4
’894 Patent Claims 1, 4,
10, 14

Defendants’ Proposed
Construction
“element running along the
surface of the tube from the
electrode to a conductive pad
or connection point at the
proximal end of the tube”

The Parties’ Positions
Plaintiff submits that “wires” are excluded from the scope of “trace” in the Asserted
Patents. Dkt. No. 70 at 9. According to Plaintiff, this is clear from the claims, which expressly
require the trace to be “applied directly to the tube surface” by means of “conductive ink or
30

paint.” Id. Plaintiff also argues that this is clear from the description of the invention, which
distinguishes the invention from the prior art based in part on the invention’s lack of wires and
lack of “raised surfaces which can injure the vocal cords.” Id. at 9–10 (citing, inter alia, ’844
Patent, at [57] Abstract, col.6 ll.32–36, col.6 ll.48–49). Plaintiff further contends that “traces”
were distinguished from “wires” during prosecution of the patents. Id. at 10–11. And, Plaintiff
contends that “trace” does not include “wire” under the customary meaning of those terms. Id. at
11. This, according to Plaintiff, is evinced by the Court’s finding in a case involving unrelated
patents that “trace” does not include “insulated wire” based on a dictionary definition of “trace”
as “a conductive path on a printed circuit board.” Id. at 11 (citing Anascape, Ltd. v. Microsoft
Corp., Civil Action No. 9:06-cv-158, 2008 U.S. Dist. LEXIS 98821, at *17 (E.D. Tex. Feb. 2,
2008) (emphasis in original)). Plaintiff further submits that Defendants’ proposed construction is:
(1) improperly broad because it includes “wires,” (2) improperly narrow because it suggests that
the trace is necessarily separate from pad and electrode, and the claims allow that a trace may be
“connected to or integral with” an electrode or pad, and (3) improperly excluding exemplary
embodiments if Defendants’ proposed “at the proximal end of the tube” means at the very end of
the tube, because the exemplary embodiments have traces “extending . . . toward the proximal
end.” Id. at 11–12 (emphases by Plaintiff).
In addition to the claims themselves, Plaintiff cites the following intrinsic and extrinsic
evidence to support its position: Intrinsic evidence: ’844 Patent, at [57] Abstract, fig.2, col.1
ll.44–54, col.3 ll.7–10, col.4 l.4–7, col.4 ll.47–48, col.4 ll.60–66, col.5 ll.43–60, col.6 ll.4–6,
col.6 ll.32–36, col.6 ll.48–49; ’894 Patent File Wrapper October 25, 2013 Amendment/Response

31

(Plaintiff’s Ex. 6, Dkt. No. 70-8); U.S. Patent Application No. 61/244,402 9 (Plaintiff’s Ex .5,
Dkt. No. 70-7). Extrinsic evidence: Otto Decl. ¶¶ 11–15 (Dkt. No. 70-1 at 2–4); Dictionary.com
(“integral”) (Plaintiff’s Ex. 7, Dkt. No. 70-2) 10.
Defendants respond that the “trace” of the Asserted Patents is described “as the
conductive element between the electrode plates and the conductive pad” in every exemplary
embodiment and, therefore, “trace” should be so construed. Dkt. No. 76 at 25. Defendants further
argue that “trace” of the patents does not exclude wires because there is no clear and
unambiguous disclaimer of wires from the scope of “trace.” Id. According to Defendants, the
patents equate “trace” with “lead” and there is no dispute that “lead” includes wires. Id. (citing
’844 Patent col.3 ll.8–10). Finally, Defendants argue that excluding wires from the scope of
“trace” obfuscates claim scope as it is unclear what qualifies as a “wire.” Id. at 26.
In addition to the claims themselves, Defendants cite the following intrinsic evidence to
support their position: ’844 Patent col.3 ll.8–10; ’894 Patent figs.1–4, 6, 7, 8, col.4 ll.6–9; U.S.
Patent No. 5,125,406 (Defendants’ Ex. E, Dkt. No. 76-5).
Plaintiff replies to reiterate that the patents and prosecution history distinguish the
claimed “trace” from the prior-art wires. Dkt. No. 82 at 2–3.
Plaintiff cites further intrinsic evidence to support its position: ’844 Patent col.4 ll.6–9.
Analysis
The primary issue in dispute here is whether “trace” of the Asserted Patents encompasses
wires. It does not.

9

The ’844 and ’894 Patents each claim priority to U.S. Patent Application No. 61/244,402. ’844
Patent, at [60] Related U.S. Application Data; ’894 Patent, at [60] Related U.S. Application Data
10
http://www.dictionary.com/browse/integral.
32

The “traces” of the Asserted Patents are formed using conductive ink or paint, not wires.
The patents note that the prior-art laryngeal electromyography devices included features “such as
metallic plates, adhesives, lead wires, and structural elements resulting in raised portions on the
smooth physical profile of the endotracheal tube.” ’844 Patent col.1 ll.44–54. And because of
this, the prior-art devices were not suitable “for monitoring purposes in excess of eight hours.”
Id. at col.1 ll.55–67. Another purported failing of the prior-art devices was that they incorporated
structure or material that diminished the flexibility of the endotracheal tube. Id. at col.2 ll.1–8.
The invention of the Asserted Patents purports to solve these failings in the prior art. Id. at col.2
ll.33–38, col.2 l.47 – col.3 l.14. And the solution is to use conductive ink or paint to form the
electrodes and traces of the device. Id. at col.4 ll.47–50 (“A suitable conductive composition,
referred to as an ink or paint, for forming the plates 14 and the traces 20 comprises a mixture of
conductive materials.”), col.6 ll.30–32 (“The endotracheal tube with imprinted electrode surfaces
allows safe, long term intubation and clinical monitoring of human laryngeal electromyographic
signals.”), col.6 ll.57–60 (“Further, printing the electrode on the surface provides for
optimization of the configuration of the electrode plates on the body of the endotracheal tube
without introducing stiff attachments or physical additions.”). That is, the traces are not made of
wire. See Inpro II Licensing, S.A.R.L. v. T-Mobile USA Inc., 450 F.3d 1350, 1353–57 (Fed. Cir.
2006) (limiting a claim to exclude certain technology when that technology was disparaged in
the patent and prosecution history and when overcoming the failing of that technology was
described as a purpose of the invention); see also, Chicago Bd. Options Exch., Inc. v. Int'l Sec.
Exch., LLC, 677 F.3d 1361, 1371–72 (Fed. Cir. 2012) (disparaged technology excluded from
claims); UltimatePointer, L.L.C. v. Nintendo Co., 816 F.3d 816, 822–24 (Fed. Cir. 2016) (same).

33

The Court’s understanding based on the disclosure of the Asserted Patents is further
supported by the prosecution history. For example, the patentee distinguished the claimed
invention from a prior-art reference that uses “wires embedded in the wall of the tube” instead of
“insulated conductors (traces) on the surface of the . . . tube.” ’894 Patent File Wrapper, October
25, 2013 Amendment/Response at 7–8, Dkt. No. 70-8 at 8–9. The patentee distinguished another
prior-art reference that did not “show or suggest using a conductive ink or paint but instead refers
to a solid metal laid down on the substrate.” Id. at 10–11, Dkt. No. 70-8 at 11–12. According to
the patentee, the claims of the ’894 Patent “all require one or more printed electrodes, leads and
connection points formed directly on the surface of an endotracheal tube using a conductive
ink or paint.” Id. (emphasis added); ’844 Patent col.3 ll.8–9 (“the traces, also referred to as leads
are likewise applied to the surface of the tube”).
Defendants’ proposed construction does not clarify claim scope. The claims of the
Asserted Patents define how the claimed “traces” relate to the claimed electrodes and conductive
pads/connection points, where the “traces” are located relative to the endotracheal tube, and
where the conductive pads/connection points are located on the tube. For example, Claim 1 of
the ’844 Patent recites: (1) the traces are “applied directly to the tube surface,” (2) the traces are
“connected to or integral with the electrode plates,” and (3) the conductive pads are “connected
to or integral with the . . . traces.” Claim 4 of the ’844 Patent recites: (1) the traces are “formed
by applying a conductive ink . . . to the exterior surface of the endotracheal tube,” (2) the traces
are “attached to . . . electrode plates,” and (3) the conductive pads are “attached to a proximal
end of the traces.” Claim 1 of the ’894 Patent recites: (1) the “tube having on its
surface . . . traces,” (2) the traces are “connected to or integral with an electrode,” and (3) the
connection points are “connected to or integral with each of the conductive traces.” Claim 4 of

34

the ’894 Patent recites: (1) the traces are “formed by applying a conductive ink or paint to the
exterior surface of the endotracheal tube,” (2) the traces are “attached to . . . the electrodes,” and
(3) the connection points are “at a proximal end of the . . . traces.” Claim 10 of the ’894 Patent
recites: (1) the traces are “applied directly to the tube surface,” (2) the traces are “connected to or
integral with the electrodes,” and (3) the connection points are “connected to or integral with the
conductive traces.” Finally, Claim 14 of the ’894 Patent recites that: (1) the “tube having on its
surface . . . traces,” (2) the traces are “connected to or integral with the . . . electrode[s],” and (3)
the conductive pads are “connected to or integral with the conductive traces.” Accordingly, the
claims provide adequate scope for the term “trace.”
Defendants’ proposed construction is also inconsistent with the intrinsic record. For
example, Claim 14 of the ’894 Patent recites “electrical leads connected to the electrically
conductive traces or to conductive pads connected to or integral with the conductive traces.” The
Court understands this to mean that the device of claim 14 optionally has “conductive pads”
through which the traces connect to the electrical leads, or has traces that connect directly to the
electrical leads. Defendants’ proposed construction of “trace” would require a “conductive pad
or a connection point” when Claim 14 does not include such a requirement.
Accordingly, the Court holds that “trace” and “electrode” are specially defined in the
Asserted Patents and construes “trace” as follows:
•
E.

“trace” means “element formed of conductive ink or paint.”
“applied […] directly to the surface of the tube,” “applied […] directly to the
tube surface”

Disputed Term

Plaintiff’s Proposed
Construction

35

Defendants’ Proposed
Construction

Disputed Term

Plaintiff’s Proposed
Construction

Defendants’ Proposed
Construction

“applied […] directly to the
surface of the tube”
•
•

’844 Patent Claim 1
’894 Patent Claims 1, 10,
14

“applied […] directly to the
tube surface”
•
•

“applied […] directly [to the
surface of the tube / to the
tube surface] by, for example, “applied […] directly [to the
painting, printing, spraying or surface of the tube / to the
metallizing, as opposed to
tube surface]”
being adhesively secured or
embedded”

’844 Patent Claim 1
’894 Patent Claims 1, 10,
14
Because the parties’ arguments and proposed constructions with respect to these terms

are related, the Court addresses the terms together.
The Parties’ Positions
Plaintiff submits that “applied . . . directly to the surface of the tube” and
“applied . . . directly to the tube surface” each exclude “adhesively securing or embedding
electrodes, traces or pads to a tube.” Dkt. No. 70 at 12. According to Plaintiff, the Asserted
Patents distinguish the invention’s approach to applying electrodes and traces directly to the
surface from the prior art’s approach of adhering electrodes/wires to, or embedding
electrodes/wires in, the surface. Id. at 12–13 (citing, inter alia, ’844 Patent col.1 ll.44–54, col.6
ll.32–36). And, Plaintiff contends, the prosecution history further makes this distinction clear. Id.
at 14.
In addition to the claims themselves, Plaintiff cites the following intrinsic and extrinsic
evidence to support its position: Intrinsic evidence: ’844 Patent, at [57] Abstract, col.1 ll.44–54,
col.2 ll.22–23, col.2 ll.33–46, col.2 l.67 – col.3 l.8, col.3 ll.65–68, col.4 l.15, col.4 ll.47–48, col.5
ll.34–35, col.5 ll.43–60, col.5 l.62, col.6 ll.4–6, col.6 ll.32–36, col.6 ll.57–60; ’894 Patent File
Wrapper October 25, 2013 Amendment/Response (Plaintiff’s Ex. 6, Dkt. No. 70-8); U.S. Patent
36

Application No. 61/244,402 (Plaintiff’s Ex. 5, Dkt. No. 70-7). Extrinsic evidence: Otto Decl.
¶¶ 16–17 (Dkt. No. 70-1 at 4–5).
Defendants respond that the meaning of these terms is apparent without construction.
Dkt. No. 76 at 26. Defendants argue that Plaintiff’s proposed construction is not a construction
but rather a request for “ad hoc findings about what embodiments may or may not meet a claim
term.” Id. at 27.
Plaintiff replies that claimed inventions are described in the prosecution history as
overcoming failings in the prior-art’s “integrated wire ET tube” and the “stick-on electrode,”
which utilized adhesives and wires. Dkt. No. 82 at 3.
Analysis
The issue in dispute appears to be whether “applied . . . directly to” the surface includes
embedding in the surface or bonding to the surface with an adhesive. It does not. The electrode
or trace of the claims is applied to the surface of the tube without an intervening layer—which
the Court understands is the plain and ordinary meaning of “applied . . . directly to” the surface.
The electrodes and traces are formed of conductive ink or paint that is applied to the
surface of the endotracheal tube without any intervening material. As set forth in detail in the
discussion of “trace” above, prior-art laryngeal electromyography devices purportedly failed
because they included features “such as metallic plates, adhesives, lead wires, and structural
elements resulting in raised portions on the smooth physical profile of the endotracheal tube”
which made the devices unsuitable for prolonged monitoring. ’844 Patent col.1 ll.44–67. The
solution to this failing is to use conductive ink or paint to form the electrodes and traces of the
device. Id. at col.4 ll.47–50 (“A suitable conductive composition, referred to as an ink or paint,
for forming the plates 14 and the traces 20 comprises a mixture of conductive materials.”), col.6

37

ll.30–32 (“The endotracheal tube with imprinted electrode surfaces allows safe, long term
intubation and clinical monitoring of human laryngeal electromyographic signals.”). This
conductive ink or paint is deposited directly on the surface of the endotracheal tube, i.e., without
any intervening material. Id. at col.5 l.37 – col.6 l.14 (describing various exemplary ways in
which the ink or paint may be applied directly to the surface), col.6 ll.57–60 (“Further, printing
the electrode on the surface provides for optimization of the configuration of the electrode plates
on the body of the endotracheal tube without introducing stiff attachments or physical
additions.”).
Accordingly, the Court rejects Defendants’ construction to the extent that construction is
meant to encompass an intervening layer of adhesive (or any material) or embedding material in
the surface. The Court determines that these terms have their plain and ordinary meaning without
the need for further construction.
F.

“electrical leads”

Disputed Term
“electrical leads”
•
•

Plaintiff’s Proposed
Construction
Plain and ordinary meaning.

’844 Patent Claim 1
’894 Patent Claims 1, 10,
14

Defendants’ Proposed
Construction
“electrical wiring connecting
the endotracheal tube to an
external monitoring system”

The Parties’ Positions
Plaintiff submits that the meaning of this term is clear without construction. Dkt. No. 70
at 27. Plaintiff contends that Defendants’ proposed construction improperly limits “leads” to
“wiring,” yet a prior-art reference of record in the prosecution history evinces that “leads” may
or may not be wires. Id. at 28.

38

In addition to the claims themselves, Plaintiff cites the following intrinsic and extrinsic
evidence to support its position: Intrinsic evidence: ’844 Patent figs.2, 6, 8, col.3 ll.10; U.S.
Patent No. 4,461,304 11 (Plaintiff’s Ex. 14, Dkt. No. 70-16). Extrinsic evidence: Otto Decl.
¶¶ 39–40 (Dkt. No. 70-1 at 11).
Defendants respond that they “are not aware of any material issue impacted by this claim
term” and that because Plaintiff “has declined to give the Court a proposed construction, there is
no need for the Court to even address the issue of whether ‘electrical leads’ includes something
more than wires.” Dkt. No. 76 at 27.
Plaintiff replies that the claims separately recite that the electrical leads “connect to
monitoring equipment” so there is no need to read such a limitation into “electrical lead.” Dkt.
No. 82 at 10. And Plaintiff reiterates that there is no disclaimer of claim scope to justify limiting
“electrical leads” to “electrical wiring.” Id.
Analysis
The issue in dispute here is whether “electrical leads” is synonymous with “electrical
wiring.” While an “electrical lead” may be a wire, it is not limited to wires. The Court therefore
declines to rewrite the claim language as Defendants propose.
“Electrical leads” are not necessarily wires. Defendants’ argument to rewrite “leads” as
“wiring” is unpersuasive. Defendants argue that “the asserted patents disclose only external
wiring,” and therefore “electrical leads” are “electrical wiring.” It would be improper, however,
to limit the claims to this single embodiment. See Phillips v. AWH Corp., 415 F.3d 1303, 1323
(Fed. Cir. 2005) (en banc) (“we have expressly rejected the contention that if a patent describes
only a single embodiment, the claims of the patent must be construed as being limited to that
11

U.S. Patent No. 4,461,304 is cited on the face of the ’844 and ’894 Patents. ’844 Patent, at [56]
References Cited; ’894 Patent, at [56] References Cited.
39

embodiment”); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012)
(“It is likewise not enough that the only embodiments, or all of the embodiments, contain a
particular limitation. We do not read limitations from the specification into claims; we do not
redefine words. Only the patentee can do that.”); SRI Int’l v. Matsushita Elec. Corp., 775 F.2d
1107, 1121 (Fed. Cir. 1985) (en banc) (“The law does not require the impossible. Hence, it does
not require that an applicant describe in his specification every conceivable and possible future
embodiment of his invention.”). Defendants have not provided evidence that the “leads” of the
claims are limited to wires. Indeed, the traces of the Asserted Patents are described as a type of
“lead.” ’844 Patent col.3 ll.8–9 (“the traces, also referred to as leads are likewise applied to the
surface of the tube”). As set forth in detail in the discussion of “trace” above, the traces are not
wires. It follows that not all “leads” are wires.
The Court also rejects Defendants’ proposed phrase, “connecting the endotracheal tube to
an external monitoring system.” First, the claims recite that the electrical leads are capable of
connecting to monitoring equipment because the leads are “adapted” or “configured” to make
such a connection. The claims do not require that the leads are actually connected to a
monitoring system, as Defendants’ proposed construction requires. Second, it is unclear what
Defendants mean by connecting the endotracheal tube to the monitoring system. As set forth in
the claims, the leads are connected to the traces which are connected to the electrodes which are
formed on the tube. Thus, the leads are meant to connect the electrodes, not the tube, to the
monitoring system.
Accordingly, the Court determines that “electrical leads” has its plain and ordinary
meaning without the need for further construction.

40

G.

“trachea”

Disputed Term
“trachea”
•
•

Plaintiff’s Proposed
Construction
Plain and ordinary meaning.

’844 Patent Claim 1
’894 Patent Claims 1, 5,
10, 14

Defendants’ Proposed
Construction
Indefinite due to the patent’s
usage of the term contrary to
its customary meaning to a
person of ordinary skill in the
art.
alternative:
• the term should be given
its customary meaning to
a person of ordinary skill
in the art.

The Parties’ Positions
Plaintiff submits that “trachea” is used in the Asserted Patents according to its customary
meaning—not redefined contrary to that meaning, as Defendants contend. Dkt. No. 70 at 23.
Plaintiff contends that the patents’ description of “the vocal cord located on the front surface of
the trachea” is not a redefinition of “trachea” to include the “vocal cord.” Id. (quoting ’844
Patent col.4 ll.20–21). Rather, according to Plaintiff, when taken in context, this statement refers
to the orientation of the curves/electrode of the endotracheal tube. Id. Plaintiff likewise contends
that the prosecution-history statement “tracheal wall proximal of the vocal cords, such as closer
to the tongue” does not redefine “trachea” to include the “vocal cord” or to be placed above the
“vocal cord.” Id. at 23–24. According to Plaintiff, when this statement is taken in context, it
refers to a portion of the tracheal wall that is closer to the vocal cord as opposed to further from
the vocal cord. Id.
Plaintiff further submits that other portions of the patents and prosecution history use the
term “trachea” in a manner suggesting that the vocal cords are distinct from the trachea. Id. at
24–25. For instance, Claim 1 of the ’894 Patent recites a first electrode “positioned to contact the

41

vocal cords” and a second electrode “positioned to contact tissues, nerves and muscle in the
trachea.” Id. at 24. Plaintiff contends that if “trachea” was redefined to include the vocal cords,
then there is no distinction between the first and second electrodes. Id. Plaintiff also notes that a
prior-art reference submitted during prosecution clearly delineates the “trachea” from the vocal
cord. Id. at 25. Finally, Plaintiff submits that the Patent Trial and Appeal Board considered
whether “trachea” was redefined in the Asserted Patents “contrary to human anatomy,” and
determined that it was not. Id. at 25 n.6 (quoting Nuvasive Inc. v. Neurovision Medical Products,
Inc., IPR2015-00502, Paper No. 15 at 10 (P.T.A.B. July 16, 2015), Dkt. No. 70-15 at 11).
In addition to the claims themselves, Plaintiff cites the following intrinsic and extrinsic
evidence to support its position: Intrinsic evidence: ’844 Patent figs.6, 8, col.3 ll.44–46, col.4
ll.20–21; ’894 Patent File Wrapper October 25, 2013 Amendment/Response (Plaintiff’s Ex. 6,
Dkt. No. 70-8); Nuvasive Inc. v. Neurovision Medical Products, Inc., IPR2015-00502, Paper No.
15 (P.T.A.B. July 16, 2015) (excerpts) (Plaintiff’s Ex. 13, Dkt. No. 70-15). Extrinsic evidence:
Otto Decl. ¶¶ 29–34 (Dkt. No. 70-1 at 8–10).
Defendants respond that “every single time the intrinsic evidence talks about the tracheal
electrode, the patent refers to an anatomical structure different from the trachea or an impossible
structure” and therefore “trachea” renders claims of the Asserted Patents indefinite. Dkt. No. 76
at 31–33. Defendants contend that, in customary usage in the art, the trachea is different from the
larynx, and the vocal cords and epiglottis are in the larynx. Id. at 31 (citing Otto Dep. at 36:17 –
37:16, 39:11–40:5, 51:5 – 53:12, 54:9 – 55:17, 228:1–12. But, according to Defendants, the
“trachea” of the Asserted Patents appears to include the vocal cords. Id. at 31–33. For example,
Defendants contend that the “only description of an electrode contacting ‘nerves and muscle in

42

the rear of the trachea’ is an electrode contacting a vocal cord in the larynx, not the trachea.” Id.
at 33
In addition to the claims themselves, Defendants cite the following intrinsic and extrinsic
evidence to support their position: Intrinsic evidence: ’844 Patent figs.1–3, 6, col.4 ll.16–19.
Extrinsic evidence: Otto Dep. 36:17 – 37:16, 39:11 – 40:5, 40:22 – 41:9, 51:5 – 53:12, 54:9–
55:17, 56:10–19, 141:7–20, 147:21 – 148:13, 148:24 – 149:8, 228:1–12 (Defendants’ Ex. B, Dkt.
No. 76-2 at 36–37, 39–41, 51–56, 141, 147–49, 228); Hermes C. Grillo, Surgery of the Trachea
and Bronchi (2004) (excerpts) (Defendants’ Ex. N, Dkt. No. 76-14); M.L. Ajmani, A Metrical
Study of the Laryngeal Skeleton in Adult Nigerians, Journal of Anatomy 171, 187–91 (1990)
(Defendants’ Ex. O, Dkt. No. 76-15).
Plaintiff replies that the “trachea” is not used “every single time” in the way suggested by
Defendants. Dkt. No. 82 at 7. Specifically, Plaintiff contends that references in the ’844 Patent
show that “trachea” is used consistent with its customary meaning. Id. (citing ’844 Patent col.3
ll.44–46, col.3 ll.50–52, col.6 ll.57–63, Claim 1). Plaintiff also contends that Figure 6 of the
patents is described as depicting an electrode adjacent to the vocal cords, and not configured to
contact the trachea. Id. at 7–8 (citing ’844 Patent col.4 ll.19–23).
Plaintiff cites further intrinsic evidence to support its position: ’844 Patent fig.6, col.3
ll.50–52, col.4 ll.16–23, col.6 ll.57–63.
Analysis
The issue with respect to “trachea” is whether it is used in the Asserted Patents contrary
to its well-understood meaning in the art and therefore renders claims indefinite. The Court holds
that “trachea” is used in the patents according to its customary meaning and that Defendants
have failed to prove that any claim is rendered indefinite by the term “trachea.”

43

“Trachea” was not redefined in the patents contrary to is plain and ordinary meaning in
the art. There is no dispute that “trachea” has a plain and accepted meaning in the art. Departing
from this plain meaning requires a showing of lexicography or disavowal. GE Lighting Sols.,
LLC v. AgiLight, Inc., 750 F.3d 1304, 1309 (Fed. Cir. 2014). And the standard for such is
“exacting.” Id. For lexicography, the “patentee must clearly set forth a definition of the disputed
claim term and clearly express an intent to define the term.” Id. (quotation marks omitted). Here,
there is no clear expression of an intent to redefine “trachea.” True, it appears that the patentee in
some instances suggests that the vocal cords are part of the trachea. See, e.g., ’844 Patent col.4
ll.17–21 (referring to the “vocal cord located on the front surface of the trachea”). In other
instances, the patentee suggests that the vocal cords are part of the larynx. ’844 Patent col.1
ll.10–67 (referring to laryngeal monitoring by monitoring the “signals from the muscles of the
vocal cords, or larynx” and noting the danger of the prior-art devices “that can also introduce
structures in the vicinity of the larynx and can cause injury to the vocal cords”). In yet other
instances, the patentee distinguishes between the vocal cords and trachea. See, e.g.,’894 Patent
Claim 1 (referring to one electrode “to contact the vocal cords” and another “to contact the
tissue, nerves, and muscle in the trachea”). And during prosecution, the patentee referred to
technical anatomical descriptions of “trachea” that comport with the plain meaning of the term.
See, e.g., ’894 Patent File Wrapper October 25, 2013 Amendment/Response at 9 (“The vocal
cords are located below the epiglottis but above and adjacent the larynx.”), Dkt. No. 70-8 at 10.
In the context of the entirety of the intrinsic record, and given the plain meaning of “trachea,” the
Court holds that “trachea” is not clearly redefined in the patents to encompass anatomical
features that are not part of the “trachea” as that term is customarily used in the art. 12

12

The Court notes that while it is not bound by the construction of “trachea” by the Patent Trial
44

The Court is not persuaded by Defendants’ argument that the claims directed to an
electrode positioned to contact parts of the trachea are indefinite. Defendants contend that there
is no description in the patent of such electrode positioning. But whether there is an adequate
description is a different question than whether the scope of the claims is reasonably certain.
Given the plain meaning of “trachea,” what it means for an electrode to contact a part of the
trachea is reasonably certain. Similarly, given the plain meaning of “trachea,” whether a given
electrode “placed within the trachea” can contact the vocal cords is a question of infringement,
not of definiteness.
Accordingly, the Court determines that “trachea” has its plain and ordinary meaning,
does not render any claim indefinite, and requires no further construction.
H.

Preambles of ’844 Patent Claims 1, 4 and ’894 Patent Claims 1, 4, 10, 14.

Disputed Term
“A device for use in monitoring
electrical signals during laryngeal
electromyography comprising”
•

Plaintiff’s Proposed
Construction
Preamble is limiting.

’844 Patent Claim 1

“A method of forming an electrode Preamble is limiting.
bearing endotracheal tube for
laryngeal electromyography
comprising”
•

Preamble is not limiting.

’844 Patent Claim 4

“A device for use in monitoring
electrical signals during laryngeal
electromyography comprising”
•

Defendants’ Proposed
Construction
Preamble is not limiting.

Preamble is limiting.

Preamble is not limiting.

’894 Patent Claim 1

and Appeal Board (“PTAB”) in IPR2015-00502, it finds the PTAB’s construction persuasive.
See Nuvasive Inc. v. Neurovision Medical Products, Inc., IPR2015-00502, Paper No. 15 at 8–10
(P.T.A.B. July 16, 2015) Dkt. No. 70-15 at 9–11.
45

Disputed Term

Plaintiff’s Proposed
Construction
“A method of forming an electrode Preamble is limiting.
bearing endotracheal tube for
laryngeal electromyography
comprising”
•

’894 Patent Claim 4

“A method of conducting
monitoring of electrical signals
during laryngeal
electromyography for a period of
time in excess of 8 hours without
injury to the trachea”
•

Preamble is not limiting.
Plain and ordinary
meaning.

This preamble requires active
monitoring of electrical
signals during laryngeal
electromyography for over 8
hours without injuring the
trachea of a human patient.

Preamble is limiting.

Preamble is not limiting.

’894 Patent Claim 10

“A device for use in monitoring
electrical signals during laryngeal
electromyography comprising”
•

Defendants’ Proposed
Construction
Preamble is not limiting.

’894 Patent Claim 14
Because the parties’ arguments and proposed constructions with respect to these terms

are related, the Court addresses the terms together.
The Parties’ Positions
With respect to Claim 10 of the ’894 Patent, Plaintiff submits that the preamble is not
limiting because the claimed invention is set forth entirely in the body of the claim. Dkt. No. 70
at 28–29. Plaintiff contends that Defendants’ proposed limiting construction is also improper as
it injects “active monitoring” into the claim, the meaning of which is unclear, and because it
requires monitoring for over eight hours, when such monitoring is “simply a benefit of the novel
invention.” Id. at 29. According to Plaintiff, a preamble that states a benefit of the claimed
invention does not limit the claim. Id. at 29–30 (citing Catalina Mktg. Int’l v. Coolsavings.com,
Inc., 289 F.3d 801, 809 (Fed. Cir. 2002)).

46

With respect to the other independent claims of the Asserted Patents, Plaintiff submits
that the preambles are limiting because they are necessary to understand that the combined
limitations are to “monitor[] electrical signals during laryngeal electromyography.” Id. at 30
(quoting ’844 Patent Claim 1 (quotation modification by Plaintiff)).
In addition to the claims themselves, Plaintiff cites the following intrinsic evidence to
support its position: ’844 Patent col.2 ll.51–55.
With respect to Claim 10 of the ’894 Patent, Defendants respond that the preamble recites
that the monitoring is “for a period of time in excess of 8 hours without injury to the trachea,”
this is not duplicative of any limitation in the claim body, and therefore the preamble is limiting.
Dkt. No. 76 at 23. Defendants also contend that the preamble must be limiting because it
provides antecedent basis for “during the period of monitoring” limitation recited in the body of
the claim. Id. And, Defendants contend, Claim 11, which depends from Claim 10, recites
“wherein the period of monitoring exceeds 24 hours” evincing a distinction between the claims
based on the period of monitoring, namely, Claim 10 requires that the period exceed 8 hours and
Claim 11 requires that the period exceed 24 hours. Id. at 23–24.
With respect to the other independent claims of the Asserted Patents, Defendants respond
that the preambles simply recite intended uses and are therefore not limiting.
With respect to Claim 10 of the ’894 Patent, Plaintiff replies that the claim’s recited
“monitoring electrical signals”—and not the preamble—forms the antecedent basis for “the
period of monitoring.” Dkt. No. 82 at 10–11. According to Plaintiff, the “monitoring electrical
signals” language was added during prosecution for that purpose. Id. at 11.
With respect to the other independent claims of the Asserted Patents, Plaintiff replies that
certain prior-art endotracheal tubes were distinguished from the claimed invention based on the

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use of the tube—the prior-art tubes were used to measure cardiac output rather than for laryngeal
electromyography. Id. at 11.
Plaintiff cites further intrinsic evidence to support its position: ’894 Patent File Wrapper,
October 31, 2013 Office Action (Plaintiff’s Ex. 15, Dkt. No. 82-1), October 25, 2013
Amendment/Response

(Plaintiff’s

Ex. 6,

Dkt.

No.

70-8),

November

4,

2013

Amendment/Response (Plaintiff’s Ex. 16, Dkt. No. 82-2).
Analysis
The primary issue in dispute is whether the preambles are limiting. The Court determines
that the preambles of the independent claims are limiting because the preambles are necessary to
understand the claims.
The preambles are necessary to understand the claims because the use stated in the
preambles, “laryngeal electromyography,” is required to give meaning to the claims. For
example, Claim 1 of the ’844 Patent defines the positioning of the electrodes with reference to
“the vocal cords” and “the trachea” and “the tongue.” The role that these terms play in defining
claimed structure or steps is only apparent when read in the context of laryngeal
electromyography. Indeed, there is no antecedent basis for these terms other than what is implicit
in the use of the device. Further, the positioning of various structures is recited with reference to
“proximal” and “distal.” Again, these terms are understood with respect to the device as it is used
for laryngeal electromyography. The proximal end of the device is the end sticking out of the
patient’s mouth during the procedure. The Court holds that the preambles implicitly introduce
terms that form the antecedent basis for recitation of those terms in the body of the claims and
provide meaningful context necessary to understand the limitations recited in the body of the

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claims. Therefore, the preambles are limiting. See Pacing Techs., LLC v. Garmin Int’l, Inc., 778
F.3d 1021, 1024 (Fed. Cir. 2015).
With respect to Claim 10 of the ’894 Patent, while the Court agrees with Defendants that
the preamble is limiting, the Court rejects Defendants’ proposed “active” monitoring limitation.
Defendants have not provided an explanation of what “active monitoring” is, how it differs from
“monitoring,” or why the Court should rewrite “monitoring” as “active monitoring.” Defendants
argument seems to be that “monitoring” requires “actually monitoring” and therefore
“monitoring” means “active monitoring.” The Court is not persuaded. If the distinction is
between actually monitoring and not monitoring, “monitoring” alone is sufficient and the term
“active” does not help convey the concept. Injecting “active” into the claims also presents an
issue of whether “passive monitoring” is possible and, if so, whether it should be excluded from
the scope of the claim.
Accordingly, the Court determines that each of the preambles is necessary to understand
the claims and therefore each preamble is limiting. The Court further determines that each of the
preambles has its plain and ordinary meaning without the need for further construction.
IV.

CONCLUSION
The Court adopts the constructions above for the disputed and agreed terms of the

Asserted Patents. Furthermore, the parties should ensure that all testimony that relates to the
terms addressed in this Order is constrained by the Court’s reasoning. However, in the presence
of the jury the parties should not expressly or implicitly refer to each other’s claim construction
positions and should not expressly refer to any portion of this Order that is not an actual
construction adopted by the Court. The references to the claim construction process should be
limited to informing the jury of the constructions adopted by the Court.

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SIGNED this 3rd day of January, 2012.
SIGNED this 27th day of October, 2016.

____________________________________
ROY S. PAYNE
UNITED STATES MAGISTRATE JUDGE

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