Respironics, Inc.v.ZOLL Medical Corporation

Patent Trial and Appeal Board

Sep 17, 2014

10197159 (P.T.A.B. Sep. 17, 2014)

Trials@uspto.gov Paper 46
Tel: 571-272-7822 Entered: September 17, 2014

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
RESPIRONICS, INC.,
Petitioner,

v.

ZOLL MEDICAL CORPORATION,
Patent Owner.
_______________

Case IPR2013-00322
Patent 6,681,003 B2
_______________

Before BRYAN F. MOORE, BRIAN J. MCNAMARA, and
SCOTT E. KAMHOLZ, Administrative Patent Judges.

KAMHOLZ, Administrative Patent Judge.

FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73(b)

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I. INTRODUCTION
A. Background
Petitioner Respironics, Inc. (“Respironics”) filed a Petition (Paper 1,
“Pet.”) requesting an inter partes review of claims 1, 2, 4, 5, 8, 9, 16, 19, and
20 of U.S. Patent No. 6,681,003 B2 (Ex. 1001, “the ’003 patent”). The
Board instituted trial for the challenged claims on the ground, asserted by
Respironics, of anticipation by WO 98/39061 (Ex. 1003, “Owen”). Decision
to Institute (Paper 9, “Dec.”) 11.
After institution of trial, Patent Owner ZOLL Medical Corporation
(“Zoll”) filed a Patent Owner Response (Paper 14, “Resp.”). Respironics
filed a Reply (Paper 20, “Reply”).
Zoll also filed a contingent Motion to Amend (Paper 15). In its
Motion to Amend, Zoll proposed claim 36 to substitute for patent claim 1, if
claim 1 is determined to be unpatentable. Motion to Amend 1-3.
Respironics filed an Opposition to the Motion to Amend (Paper 21, “Opp.”).
Zoll filed a Reply to the Opposition (Paper 27, “Amend Reply”).
Respironics filed a Motion to Exclude certain of Zoll’s evidence
(Paper 31, “Pet. Motion to Exclude”). Zoll filed an Opposition (Paper 38),
and Respironics filed a Reply (Paper 39).
Respironics relies upon declarations of Dr. Igor Efimov in support of
its Petition (Ex. 1007), its Reply (Ex. 1011), and its Opposition to the
Motion to Amend (Ex. 1021). Zoll relies upon declarations of Mr. Charles
M. Gropper in support of its Response (Ex. 2006), its Motion to Amend
(Ex. 2009), and its Reply to the Opposition to the Motion to Amend
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(Ex. 2011). Zoll also relies on deposition testimony of Dr. Efimov
(Ex. 2010). Zoll filed a Motion for Observations on Cross-Examination of
Dr. Efimov (Paper 34, “Obs.”), and Respironics filed a Response to the
Observations (Paper 37).
Oral argument was conducted on June 26, 2014. A transcript is
entered as Paper 45 (“Tr.”).
The Board has jurisdiction under 35 U.S.C. § 6(c). This final written
decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
Respironics has proved that claim 1 is unpatentable. Respironics has
not proved that claims 2, 4, 5, 8, 9, 16, 19, and 20 are unpatentable.
Zoll’s Motion to Amend is denied.
Respironics’s Motion to Exclude Evidence is denied.
B. The ’003 Patent
The ’003 patent relates to a medical device worn by a patient and used
to provide therapy to the patient, as well as to collect and transmit
information about the patient, the device, and the patient’s interaction with
the device, to a remote location. Ex. 1001, Abstr. Types of data collected
and transmitted include, e.g., patient medical information (id. at 3:1-4),
device performance data (id. at 4:28-32), and patient compliance data (id. at
4:35-43). The device has a connection, such as a modem (id. at 3:45-50), to
a communications network, such as the Internet (id. at 3:50-51), over which
recorded data may be sent to a remote location (id. at 3:51-53) and
instructions or upgrade software may be received (id. at 6:55-58).
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Claims 2 and 4 are illustrative of the claimed subject matter and are
reproduced below:
2. A method of monitoring patient medical
information for the treatment of a patient, the
method comprising the steps of:
providing a wearable medical device for
treating the patient and monitoring patient medical
information;
operatively connecting the medical device to
the patient such that the medical device is worn by
the patient;
recording the patient medical information,
device performance data and patient compliance
data in a storage means of the medical device;
operatively connecting the medical device to a
communications system;
transmitting the patient medical information,
device performance data and patient compliance
data to a health care provider by means of said
communications system and recording the patient
medical information, device performance data and
patient compliance data in an information
database, wherein said transmitting step is
performed while the medical device is operatively
connected to the patient for providing treatment to
the patient; and
providing access to the patient medical
information, device performance data and patient
compliance data to individuals.

4. A system for monitoring patient medical
information and providing treatment to a patient,
the system comprising:
a wearable medical device for monitoring and
storing medical parameters and treating the patient
in response to a monitored medical condition, the
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medical device operatively attachable to the patient
such that the medical device is worn by the patient;
a communications network;
means for connecting the medical device to the
communication network;
a patient database;
means for monitoring and storing operations
information of the medical device and patient
compliance and use data;
means for connecting the patient database to the
communication network; and
means for exchanging information between the
medical device and the patient database, including
means for transmitting the medical device
operations information and the patient compliance
and use data to the patient database via the
communication network.

II. DISCUSSION
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are
interpreted according to their broadest reasonable construction in light of the
specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14,
2012). Claim terms are given their ordinary and customary meaning, as
would be understood by one of ordinary skill in the art in the context of the
entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
Cir. 2007). Any special definition for a claim term must be set forth in the
specification with reasonable clarity, deliberateness, and precision. In re
Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
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A limitation using the term “means for” creates a rebuttable
presumption that the drafter intended to invoke 35 U.S.C. § 112 ¶ 6.1
Personalized Media Commc’ns. LLC v. Int’l Trade Comm’n, 161 F.3d 696,
703-04 (Fed. Cir. 1998). When construing a means-plus-function limitation
under 35 U.S.C. § 112 ¶ 6, we first must identify the claimed function, and
then we look to the specification to identify the corresponding structure that
performs the claimed function. Medical Instrumentation & Diagnostics
Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003); Cardiac
Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1119 (Fed. Cir.
2002). With respect to the second step, “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.” Golight, Inc. v. Wal-Mart Stores Inc., 355 F.3d 1327,
1334 (Fed. Cir. 2004) (citations and quotation marks omitted).
1. “patient compliance data” and “patient compliance and use
data”
Respironics argued, in its Petition, that “patient compliance data” and
“patient compliance and use data” both should be construed as “data related
to patient use.” Pet. 5 (citing Ex. 1007 ¶¶ 17-19).
Respironics’s initial construction did not accord sufficient weight to
the term “compliance.” Although Respironics and its expert, Dr. Efimov,

1 Section 4(c) of the AIA re-designated 35 U.S.C. § 112 ¶ 6, as 35 U.S.C.
§ 112(f). Because the ’003 patent has a filing date before September 16,
2012 (effective date of the statute), we will refer to the pre-AIA version of
35 U.S.C. § 112.
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cite numerous passages in the ’003 patent, none of these passages serves to
define “patient compliance [and use] data” in a manner that justifies
disregarding that term. Although the ’003 patent does describe patient
compliance data as relating to whether the patient is using the device
improperly, or at all (Ex. 1001, 5:49-52), it is used within the context of
assessing whether the patient is following (i.e., complying with) instructions.
To construe the terms as encompassing any data related to patient use is,
therefore, unreasonably broad.
We determined, for purposes of instituting inter partes review, that
the broadest reasonable construction of “patient compliance [and use] data,”
in light of the Specification of the ’003 patent, is “data indicating whether a
patient has followed instructions for use.” Dec. 7 (citing Ex. 1001, 4:39-43).
Respironics has since indicated that it does not contest this construction.
Reply 1-2; Paper 44, 2; Tr. 6:4-5.
Zoll argues that “patient compliance data” should be construed as
“data quantifying an extent to which a patient correctly follows
instructions,” based both on how the term would be understood by one of
ordinary skill in the art, and also on how the term is used in the ’003 patent.
Resp. 3, 5-14.
We have considered Zoll’s arguments and evidence but determine that
neither the use of the term “patient compliance [and use] data” in the ’003
patent, nor its understanding by one of ordinary skill in the art, justifies
Zoll’s argument that the broadest reasonable construction should be
constrained to require that the data quantify the extent to which a patient
correctly follows instructions. In short, although Zoll shows that patient
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compliance data may be quantitative, Zoll does not explain why patient
compliance data must be quantitative.
For these reasons, we maintain our initial determination that the terms
are properly construed to mean “data indicating whether a patient has
followed instructions for use.”
2. Means-plus-function limitations
Respironics argues that several limitations are to be construed as
mean-plus-function limitations, in accordance with 35 U.S.C. § 112 ¶ 6, and
proposes constructions for those terms. Pet. 7-11 (Table). We adopted
Respironics’s proposed constructions for purposes of instituting inter partes
review. Dec. 8. Zoll does not contest the applicability of § 112 ¶ 6 to these
limitations, and does not contest most of the proposed constructions.
We focus our analysis on the “means for monitoring and storing”
limitation in claims 4 and 19. Claim 4 recites: “means for monitoring and
storing operations information of the medical device and patient compliance
and use data.” Claim 19 recites: “means for monitoring and storing patient
medical parameters, device performance data and patient compliance data.”
Respironics argues that the structures disclosed in the ’003 patent as
performing the “monitoring” and “storing” functions are a medical device
and a memory. Pet. 8. Zoll does not contest this structural correspondence.
We maintain our determination that these limitations invoke 35 U.S.C. § 112
¶ 6, and that the structures corresponding to each of these limitations are a
medical device and a memory.
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We have considered the parties’ arguments and evidence concerning
the other means-plus-function limitations, but we determine that express
construction of these limitations is not material to this decision.
3. “Personnel”
Zoll proposes construing “personnel,” in claim 16, as “the body of
persons employed by or active in an organization, business, or service.”
Resp. 4. Respironics opposes this construction. Reply 8-9. We determine
that express construction of this term is not material to this decision.
B. Anticipation of Claims 1, 2, 4, 5, 8, 9, 16, 19, and 20 by Owen
We instituted review based on Respironics’s contention that Owen
anticipates claims 1, 2, 4, 5, 8, 9, 16, 19, and 20 under 35 U.S.C. § 102(b)
(2010).
1. Overview of Owen
Owen discloses wearable defibrillator 10. Ex. 1003, Abstr. The
defibrillator may be provided as a belt that can be worn around the waist or
chest. Id. at 30:30-31.2 The device includes electrodes that are used to
monitor the patient and to deliver energy to the patient. Id. at 5:19-21. The
device also includes a visual indicator that displays, e.g., statements
indicating that the patient has been wearing the device “for greater than a
recommended period of time.” Id. at 31:24-32. The defibrillator also
includes a response button, which the user can push in response to an

2 All references to Owen use the page numbers as published, not the exhibit
page numbers applied by Respironics.
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instruction from the device to respond. Id. at 33:13-15. The defibrillator
also may include another button, which the user can push in order to cause
the defibrillator to record a cardiac event. Id. at 33:15-19. The response
button may serve both purposes, so that a user may push it in response to an
instruction, to trigger a recording, or both. Id. at 33:19-22.
The defibrillator includes data memory logging block 57 that stores all
information provided to, or transmitted from, the defibrillator, including
both operational and patient information. Id. at 35:9-10, 36:18-20. Patient
information includes, e.g., the patient’s electrocardiogram, messages
displayed on the visual indicator, and “information concerning patient
interaction with the defibrillator.” Id. at 35:11–12, 17-18 (quotation). The
interaction information concerns, “e.g., if and when the patient has pressed
the response button.” Id. at 35:18-19. The device also includes a base
station that is connected to the defibrillator. Id. at 31:11-12. The base
station includes an external interface over which information is exchanged
with a remote location, such as a central repository or doctor’s office. Id. at
64:2-5. The external interface may include a modem or a network
connection. Id. at 65:14-15. The operational and patient information stored
in data memory logging block 57 may be transmitted from the defibrillator
to the central repository and stored there. Id. at 14:3-4, 65:10-18.
Information stored in the central repository is available for analysis using,
e.g., a computer in communication with the central repository. Id. at 14:6-9.
Data may be received by the defibrillator from the remote location over the
external interface, including instructions that reprogram the defibrillator. Id.
at 68:17-18. The defibrillator also may transmit information to personal
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computer 6 or 201 while a patient wears the defibrillator. Id. at 13:24-26,
31:18-21, 77:17-20, 79:9-11, Fig. 2.
2. Analysis
a. Claim 1
Respironics presents arguments concerning anticipation of claim 1 by
Owen on pages 11-13 of the Petition, supported by paragraphs 34-40 of
Dr. Efimov’s initial declaration (Ex. 1007). Zoll directs no argument to
claim 1 in its Response, or in subsequent papers. Tr. 56:20–57:1.
Claim 1 recites:
1. A method of monitoring patient medical
information for the treatment of a patient, the
method comprising the steps of:
providing a wearable medical device for
monitoring patient medical information and
treating the patient in response to a monitored
medical condition;
operatively connecting the medical device to
the patient such that the medical device is worn by
the patient;
recording the patient medical information in a
storage means of the medical device;
operatively connecting the medical device to a
communications system;
transmitting the patient medical information to
a health care provider by means of said
communications system and recording the patient
medical information in an information database;
and
providing access to the patient medical
information to individuals.
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Respironics argues that Owen meets claim 1 because it discloses
providing a wearable defibrillator to a patient that also monitors the patient’s
electrocardiogram, records the electrocardiogram in memory, connects to a
communication system to send the recorded information over an external
data link, stores the sent information in a central repository, and makes the
stored data available to health care providers for review. Pet. 12-13 (citing
Ex. 1003, Abstr., 1:9-13, 4:31–5:2, 5:19-23, 5:23–6:14, 6:29–7:6, 7:11-19,
8:2-12, 14:2-12, 30:21-31, 31:8-21, 34:15-16, 35:9–36:20, 64:2-16, Figs.
1-2); Ex. 1007 ¶¶ 34-40.
Upon consideration of Respironics’s arguments and evidence, we are
persuaded that a preponderance of the evidence supports its contention that
claim 1 is unpatentable under 35 U.S.C. § 102(b) as anticipated by Owen.
As summarized above in section II.B.1, Owen discloses a method in which a
patient wears a device that can both monitor the patient and deliver
defibrillation therapy while being worn. Ex. 1003, 5:19-21. The device
stores recorded medical information, such as an electrocardiogram, in
memory, and transmits that information over a communication network to a
database for review by individuals. Id. at 14:3-9, 35:9-10, 36:18-20. This
evidence demonstrates that all limitations of claim 1 were disclosed by
Owen, in the claimed arrangement. We determine, consequently, that Owen
anticipates the subject matter of claim 1.
b. Claim 2
Respironics presents arguments concerning anticipation of claim 2 by
Owen on pages 11-16 of the Petition, supported by paragraphs 34-39 and
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41-49 of Dr. Efimov’s initial declaration (Ex. 1007). Claim 2 is reproduced
above at page 4.
We focus our analysis on the claim limitation “patient compliance
data.” Claim 2 requires that patient compliance data be recorded in a storage
means of the medical device, transmitted to a health care provider, recorded
in an information database, and made accessible to individuals.
In its Petition, Respironics cites a lengthy paragraph in Owen as
providing disclosure of patient compliance data, as well as several other
limitations. Pet. 14 (claim chart) (citing Ex. 1003, 35:9–36:20). This
paragraph describes “data logging memory block 57” and lists many types of
information that are stored in it. Ex. 1003, 35:9–36:20. Respironics quotes
from this list several types of information, including “the patient’s
[electrocardiogram,]” “information concerning patient interaction with the
defibrillator,” “operational errors” of the defibrillator, and patient
parameters, such as information indicating “whether the electrodes are not
attached, or are improperly attached” to the patient. Pet. 14. Respironics
does not identify in the Petition which of these types of information
constitute patient compliance data, but Dr. Efimov cites information
concerning electrode placement and “information concerning patient
interaction with the defibrillator” when addressing patient compliance data.
Ex. 1007 ¶ 44, final sentence. Respironics also cites “information relating to
a plurality of patients that use the type of defibrillator” when discussing
information that is recorded in an information database. Pet. 15 (claim chart)
(citing Ex. 1003, 8:5-6).
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Zoll argues that none of the types of information Respironics cites as
being “patient compliance data” are so. Resp. 14-20. We address each type
of information in turn.
(1) “whether the electrodes are not attached, or
are improperly attached”
Zoll argues that information indicating whether the electrodes are not
attached or improperly attached is not “patient compliance data,” because
Owen does not disclose instructing the patient on the correct way to attach
the electrodes, and also because improper attachment may simply reflect
passive loosening, as opposed to the patient’s failure to follow instructions.
Resp. 18-20 (citing Ex. 2006 ¶ 40). We agree with Zoll. Respironics has
not identified where Owen discloses instructing the patient on the correct
placement of the electrodes. Respironics also has not explained how
information indicating electrode detachment or incorrect attachment
necessarily reflects the patient’s failure to follow instructions, regardless of
whether Owen discloses instructing the patient on electrode placement.
(2) “information concerning patient interaction
with the defibrillator”
In its Petition, Respironics does not specify what types of
“information concerning patient interaction with the defibrillator” it
considers to constitute “patient compliance data.” In our decision instituting
inter partes review, we cited disclosure in Owen that information logged in
memory block 57 includes an indication of “if and when the patient has
pressed the response button.” Dec. 8 (citing Ex. 1003, 35:18-19). The
patient may push the response button in response to the verbal message
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“PLEASE RESPOND” given by the defibrillator to the patient. Ex. 1003,
33:13-15. Respironics argues that the button-push information constitutes
“patient compliance data.” Reply 10; Tr. 9:22–10:3. Respironics also
argues that a statement indicating that the patient has been wearing the
electrode harness for “greater than a recommended period of time”
constitutes “patient compliance data.” Reply 10-11 (citing Ex. 1003,
31:24-32). According to Respironics, Owen discloses displaying this
statement on the defibrillator’s visual display, and “displayed messages” are
among the types of information stored in, and transmitted from, memory
block 57. Reply 10 (citing Ex. 1003, 35:9-10).
(a) Button push
Zoll argues that the information indicating whether and when the
patient pushed the response button is not “patient compliance data” as we
construe that term, because nothing in Owen indicates whether the button
push was in response to the verbal instruction “PLEASE RESPOND.”
Resp. 15-17. According to Zoll, Owen does not disclose storing any
information concerning when a prompt to push the button was issued to the
patient. Tr. 52:7-11. Without information about when a prompt was issued,
argues Zoll, information about when the patient pushed the button does not
provide any indication about whether the patient followed an instruction. Id.
In reply, Respironics argues that when a patient pushes the button in
response to the “PLEASE RESPOND” verbal instruction, the patient has
followed an instruction, and the data indicating that the button was pushed is
indicative of the patient’s compliance with the instruction. Reply 10.
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We agree with Zoll that information indicating whether and when the
patient pushed the response button does not constitute “patient compliance
data.” Although Owen discloses that verbal messages may correspond to
messages displayed on the visual indicator (Ex. 1003, 32:19-20), and that
displayed messages are stored in the memory block (id. at 35:17),
Respironics does not identify disclosure that Owen records the time at which
the verbal prompt is given to the patient. Respironics thus has not explained
how Owen provides sufficient context for one to be able to determine
whether a prompt preceded a particular button push. Without this context,
the information recorded upon the pushing of the button is insufficient to
distinguish a prompted button push from an unprompted button push or an
accidental one. There is no assurance that every, or indeed any, recorded
button push was performed in response to an instruction. Button-push
information recorded in the memory block is not usable as patient
compliance data, because there is no way to know that it indicates whether
the patient followed instructions. Because it cannot be known whether the
button-push data reflects patient compliance, we determine that it does not
constitute “patient compliance data.”
(b) “wear time” message
In its Motion for Observations, Zoll cites testimony in which
Dr. Efimov acknowledges that Owen does not disclose that the patient is told
how long to wear the harness. Obs. 12 (citing Ex. 2010, 116:6-21). The
testimony is as follows:
Q. . . . In rendering your opinions in this
matter, you have not identified anything in Owen
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that would identify to the user, or to anyone, the
actual wear time of the device, right?
MS. DEFRANCO: Objection. Scope and
relevance.
A. I can look again. (Witness reviews
document.) Yeah. I didn’t find this particular
clarification, but I did find other examples where
it’s more clarified, but not what exactly the amount
of time patient will be instructed to wear the
harness.
Ex. 2010, 116:8-21. Respironics acknowledges that Owen does not disclose
communicating the recommended wear time to the patient, other than by
displaying the statement that the wear time has been exceeded.
Tr. 22:18-23.
We are not persuaded that the “wear time” statement constitutes
“patient compliance data,” because Respironics has not shown that Owen
discloses telling the patient what the recommended wear time is. Without
evidence that that patient had been told not to wear the harness longer than a
recommended period of time, information that the patient exceeded this time
cannot be said to indicate whether the patient followed instructions for use.
(3) “information relating to a plurality of patients
that use the type of defibrillator”
Respironics cites this type of information when addressing what
information is recorded in the information database. Pet. 15. It is not clear
whether Respironics is citing it as an example of “patient compliance data”
or one of the other data types recited in the claim—patient medical
information or device performance data. Respironics does not make any
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plausible arguments, or cite any credible evidence, to explain how
“information relating to a plurality of patients that use the type of
defibrillator” constitutes “patient compliance data.” We are not persuaded,
consequently, that this type of information is “patient compliance data.”
(4) Analysis
Anticipation is a question of fact and requires a showing of strict
identity between the claimed subject matter and the disclosure of a single
reference. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296
(Fed. Cir. 2002) (noting “strict identity required of the test for novelty”). To
anticipate the subject matter of a claim, a single reference must disclose all
limitations in the claimed arrangement. Wm. Wrigley Jr. Co. v. Cadbury
Adams USA LLC, 683 F.3d 1356, 1361 (Fed. Cir. 2012). It is not enough to
show that a reference is “substantially the same” as the claimed subject
matter. Jamesbury Corp. v. Litton Indus. Prods., 756 F.2d 1556, 1560
(Fed. Cir. 1985), overruled on other grounds, A.C. Aukerman Co. v. R.L.
Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Rather, it
must be shown that the claim at issue encompasses subject matter fully
disclosed by a single reference. In re Skvorecz, 580 F.3d 1262, 1266
(Fed. Cir. 2009).
Respironics has not shown that Owen discloses “patient compliance
data,” as we have construed that term—a construction that Respironics
expressly does not contest. See Tr. 6:4-5; Paper 44, 2. We reach this
conclusion because the evidence Respironics has put forward, as discussed
above, does not persuade us that any of the data that Owen records or
transmits is indicative of whether the patient has followed instructions for
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use. A preponderance of evidence does not emerge, consequently, to show
that Owen discloses every limitation of claim 2 in the claimed arrangement.
For these reasons, we determine that Respironics has not proved that Owen
anticipates the subject matter of claim 2.
c. Claims 4, 5, 8, 9, 16, 19, and 20
Independent claims 4 and 19 are directed to systems for monitoring
patient medical information and providing treatment to a patient. Claim 4
recites the limitation “patient compliance and use data” within the “means
for monitoring and storing” and “means for exchanging” limitations.
Ex. 1001, 10:66-67, 11:6. Claim 19 similarly recites “patient compliance
data” as part of “means for monitoring and storing” and “means for
exchanging” limitations. As discussed above in section II.A.2, we construe
the “means for monitoring and storing” limitations as invoking
35 U.S.C. § 112 ¶ 6 and as corresponding to a medical device and a
memory.
As discussed above in section II.A.1, we construe “patient compliance
and use data” identically to “patient compliance data,” i.e., as “data
indicating whether a patient has followed instructions for use.” Claim 19
and its dependent claim 20 recite “patient compliance data.”
For reasons discussed above in connection to claim 2, we have
determined that Respironics has failed to show that Owen discloses “patient
compliance [and use] data.” It follows that Respironics has failed also to
show that Owen discloses structure that performs the recited functions
involving “patient compliance [and use] data.” Although it is undisputed
that Owen discloses a medical device (defibrillator 10) and a memory (data
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logging memory block 57), Respironics has not shown that Owen discloses
these structures in the context of performing any operations on “patient
compliance [and use] data.” Respironics has not shown, therefore, that
Owen meets the means-plus-function limitations that recite functions
involving “patient compliance [and use] data.” See Fresenius USA, Inc. v.
Baxter Int’l, Inc., 582 F.3d 1288, 1300 (Fed. Cir. 2009) (disclosure in the
prior art of a particular structure, without discussion of that structure in the
context of the claimed function, does not meet a means-plus-function
limitation).
A preponderance of evidence does not emerge, consequently, to show
that Owen discloses every limitation of claims 4 and 19 in the claimed
arrangements. For these reasons, we determine that Respironics has not
proved that Owen anticipates the subject matter of claims 4 and 19, as well
as dependent claims 5, 8, 9, 16, and 20.
III. MOTION TO AMEND
A. Zoll’s Burden
An inter partes review is neither a patent examination proceeding nor
a patent reexamination proceeding. The proposed substitute claims, in a
motion to amend, are not entered automatically and then subjected to
examination. Rather, the substitute claims will be added directly to the
patent, without examination, if the patent owner’s motion to amend claims is
granted. The patent owner is not rebutting a rejection in an Office Action, as
though this proceeding were a patent examination or a patent reexamination.
Instead, the patent owner bears the burden of proof in demonstrating
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adequate written description support and patentability of the proposed
substitute claims over the prior art, and thus entitlement to add these
proposed substitute claims to its patent. 37 C.F.R. §§ 42.20(c); 42.121(b).
B. Proposed Claim
Zoll proposes claim 36 as a substitute for claim 1. Proposed claim 36
is reproduced below, with additions relative to claim 1 underlined and
deletions in brackets:
36. A method of monitoring patient medical
information for the treatment of a patient, the
method comprising the steps of:
providing, at a remote location, a wearable
medical device for monitoring and collecting
information including patient medical information
and data indicative of patient compliance, and
treating the patient in response to a monitored
medical condition;
providing, at a central host location, a
searchable information database that (i) stores
patient medical information and data indicative of
patient compliance for a plurality of different
patients, and (ii) is internet-accessible
simultaneously by a plurality of authorized
individuals at different locations;
at the remote location, operatively connecting
the medical device to the patient such that the
medical device is worn by the patient;
at the remote location, recording the collected
information that includes the patient medical
information and the data indicative of patient
compliance in a storage means of the medical
device, wherein the data indicative of patient
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compliance includes a quantitative measure of time
that the medical device was worn by the patient;
at the remote location, operatively connecting
the medical device to a communications system;
transmitting the collected information that
includes the patient medical information and the
data indicative of patient compliance from the
remote location to the central host location
accessible to a health care provider by means of
said communications system and recording the
patient medical information and the data indicative
of patient compliance in [[an]] the searchable
information database; [[and]]
at the central host location, providing
simultaneous internet access to the patient medical
information and the data indicative of patient
compliance stored in the searchable information
database to the plurality of authorized individuals
at different locations remote from the central host
location;
at the central host location, receiving medical
device update data corresponding to a treatment
adjustment specified by an authorized individual
that, remotely and via the internet access, has
reviewed information stored in the searchable
information database that relates to the patient
wearing the medical device; and
at the central host location, making the received
medical device update data available for upload to
the medical device at the remote location when the
medical device next communicates with the central
host location.
Motion to Amend 1-2.
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C. Written Description
Zoll’s entire discussion of the written description support for proposed
claim 36 in its Motion to Amend is reproduced below:
Support for the amendment may be found in the
‘003 patent, whose disclosure matches the filed
application (e.g., at 2:17-18, 2:24-30, 2:37-45,
2:58-62, 3:1-8, 3:50-53, 3:55-4:28, 4:32-63, 5:28-
59, 6:33-45, 6:62-7:4, 7:17-22, 8:10-15, 8:66-9:20,
9:33-35, 9:38-53, and Fig. 6. EX 1001) and in U.S.
Provisional 60/157,881 (EX 1010) to which the
‘003 patent claims priority (e.g., 3:7-10, 3:13-16,
3:21-4:3, 4:11-14, 4:17-22, 6:4-6, 6:7-7:9, 7:12-19,
8:9-9:6, 10:9-16, 11:5-11, 11:19-22, 13:14-18,
15:4-17, and Fig. 6).
Motion to Amend 4. Zoll’s expert, Mr. Gropper, does not address
written description support in his declaration that accompanies the Motion to
Amend. See Ex. 2009. Respironics argues, in opposition, that Zoll failed to
identify the written description support for proposed claim 36, both to the
level of detail required, and with regard to support for every limitation in the
provisional application of which Zoll claims the benefit. Opp. 1-2. Zoll
asserts, in reply, that the discussion of written description support in its
Motion to Amend was sufficient such that a person of ordinary skill would
have understood that the inventors had possession of the subject matter of
proposed claim 36. Amend Reply 2 (citing Ex. 2011 ¶ 23). Zoll also
submitted a more detailed listing of support for the limitations of proposed
claim 36 in the provisional application with Mr. Gropper’s declaration that
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accompanies Zoll’s Reply in support of its Motion to Amend. Ex. 2011
¶ 23.
We agree with Respironics that Zoll has not made a sufficient
showing of written description support for proposed claim 36 to demonstrate
its entitlement to the proposed claim. Zoll’s string citations amount to little
more than an invitation to us (and to Respironics, and to the public) to
peruse the cited evidence and piece together a coherent argument for them.
This we will not do; it is the province of advocacy. See Stampa v. Jackson,
78 USPQ2d 1567, 1571 (BPAI 2005) (quoting Ernst Haas Studio, Inc. v.
Palm Press, Inc., 164 F.3d 110, 111-12 (2d Cir. 1999) (“Appellant’s Brief is
at best an invitation to the court to scour the record, research any legal
theory that comes to mind, and serve generally as an advocate for appellant.
We decline the invitation.”)).
This shortcoming in Zoll’s motion is particularly acute because Zoll
proposes extensive modifications relative to claim 1. Zoll seeks to add
hundreds of words to claim 1, more than tripling its length. Yet Zoll offers
only a string of citations to the ’003 patent and to the underlying provisional
application as evidence showing written description support. So extensive a
modification of the claim requires a more detailed showing of how each
limitation of the proposed claim not only is disclosed in the original and
benefit applications, but also is disclosed in combination with all of the other
claim limitations. See Novozymes A/S v. DuPont Nutrition Biosciences APS,
723 F.3d 1336, 1349 (Fed. Cir. 2013) (claim is considered as an “integrated
whole” when assessing written description).
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Zoll’s Reply in support of its Motion to Amend seeks to remedy the
problem, but it is too little, too late. A Reply affords the moving party an
opportunity to refute arguments and evidence advanced by the opposing
party, not an opportunity to improve its position. 37 C.F.R. § 42.23(b);
Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,767 (“[A] reply that
raises a new issue or belatedly presents evidence will not be considered and
may be returned. . . . Examples . . . include new evidence necessary to make
out a prima facie case for the patentability . . . of [a] . . . proposed substitute
claim, and new evidence that could have been presented in a prior filing.”).
The new evidence by Mr. Gropper is offered to bolster Zoll’s motion,
not to refute argument or evidence by Respironics that the claim lacks
adequate written description support. Zoll does not explain why it could not
have presented Mr. Gropper’s Reply evidence with its motion.3 Zoll has not
shown why this late evidence should be considered.
But even if we set aside the procedural infirmities with Zoll’s
evidence, we do not find that the reply evidence is sufficient to meet Zoll’s
burden of proof. Mr. Gropper opines that a person of ordinary skill in the art
would have appreciated that the inventors had possession of the subject
matter of claim 36, but he does not explain adequately the factual basis on
which he reaches that conclusion. At best, he provides a claim chart

3 Nor is that evidence even properly presented in the Reply; instead, it is
relegated to the declaration. For example, the claim chart with citations to
the provisional application is not reproduced in the Reply. Zoll effectively
seeks to circumvent the Reply page limit by doing this.
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purporting to show disclosure of each limitation of proposed claim 36 in
Zoll’s provisional application. But he does not explain how each cited
passage from the provisional application supports adequately the
corresponding claim limitation, nor does Mr. Gropper explain how the cited
passages from the provisional application, dispersed throughout the
specification and figures, demonstrate possession of the claimed subject
matter as an “integrated whole.” See Novozymes, 723 F.3d at 1349.
We do not conclude that Zoll’s proposed claim 36 lacks the support of
adequate written description. Instead, we conclude that Zoll has not come
forward with sufficient evidence to demonstrate that claim 36 has the
required support. We do not reach the issue of whether Zoll has shown
patentability over the prior art of proposed claim 36.
For these reasons, we deny Zoll’s Motion to Amend.
IV. MOTION TO EXCLUDE EVIDENCE
Respironics seeks to exclude portions of the testimony Zoll elicited
from Dr. Efimov during cross-examination on the basis of scope and
relevance. Pet. Motion to Exclude 1. Respironics cites numerous passages
from the transcript of Dr. Efimov’s deposition in its motion. Id. at 1, 3 n.1,
4, 5, 6 nn.4-5. Some of these citations are marked “[b]y way of example,”
implying that they are not exhaustive lists of passages sought to be excluded.
See id. at 6 nn.4-5.
We will not engage in guesswork, or scour the record, to determine
what other evidence Respironics seeks to exclude in addition to the
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“examples.” Accordingly, we regard Respironics’s motion as being directed
against only those passages identified with pinpoint citations in the motion.
The only portion of Dr. Efimov’s deposition testimony that we rely
upon in reaching our final decision in the proceeding is page 116, lines 6-21.
See section II.B.2.b(2)(b), supra. Respironics does not cite this portion,
however, in its Motion to Exclude Evidence. Consequently, we do not
construe Respironics’s Motion to Exclude Evidence as being directed
against this passage.
Respironics also makes blanket requests to exclude all evidence it
objected to as irrelevant or exceeding scope. Pet. Motion to Exclude 6-7.
As noted above, however, we are not going to scour the deposition transcript
to locate every scope and relevance objection. Respironics did object timely
to Dr. Efimov’s testimony in the passage noted above. Ex. 2010, 116:13-14.
But Respironics provides no discussion of this passage in its motion, or any
credible explanation as to how or why it is irrelevant or exceeds scope. We
are not going to evaluate the propriety of Respironics’s objections in the
absence of a particularized and detailed showing by Respironics to establish
that the evidence is inadmissible. Such blanket requests rarely amount to a
satisfactory showing that the moving party is entitled to the harsh remedy of
exclusion. See 37 C.F.R. § 42.20(c).
For these reasons, we deny Respironics’s Motion to Exclude
Evidence.
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V. CONCLUSION
Respironics has proved, by a preponderance of the evidence, that
claim 1 of the ’003 patent is unpatentable as anticipated by Owen.
Respironics has not proved that claims 2, 4, 5, 8, 9, 16, 19, and 20 are
unpatentable as anticipated by Owen. Zoll has not proved that proposed
claim 36 is patentable.
VI. ORDER
For the reasons given, it is
ORDERED that claim 1 of U.S. Patent No. 6,681,003 B2 is
determined to be UNPATENTABLE;
FURTHER ORDERED that claims 2, 4, 5, 8, 9, 16, 19, and 20 of U.S.
Patent No. 6,681,003 B2 are not determined to be unpatentable;
FURTHER ORDERED that Zoll’s Motion to Amend is denied; and
FURTHER ORDERED that Respironics’s Motion to Exclude
Evidence is denied.

This is a final decision. Parties to the proceeding seeking judicial
review of the decision must comply with the notice and service requirements
of 37 C.F.R. § 90.2.

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FOR PETITIONER:

Denise W. DeFranco
J. Michael Jakes
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P.
denise.defranco@finnegan.com
mike.jakes@finnegan.com

FOR PATENT OWNER:

John C. Phillips
Dorothy P. Whelan
John A. Dragseth
Kurt Glitzenstein
Jennifer Huang
FISH & RICHARDSON P.C.
phillips@fr.com
whelan@fr.com
dragseth@fr.com
IPR14137-0008IP1@fr.com
jhuang@fr.com