Respironics, Inc. v. Zoll Medical Corporation , 656 F. App'x 531 ( 2016 )

NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
RESPIRONICS, INC.,
Appellant
v.
ZOLL MEDICAL CORPORATION,
Appellee
______________________
2015-1485
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2013-
00322.
______________________
Decided: July 29, 2016
______________________
DENISE WHELTON DEFRANCO, Finnegan, Henderson,
Farabow, Garrett & Dunner, LLP, Boston, MA, argued for
appellant. Also represented by CLARA N. JIMENEZ, JASON
LEE ROMRELL, Washington, DC.
RICHARD BIRNHOLZ, Irell & Manella LLP, Los Angeles,
CA, argued for appellee. Also represented by DAVID
GINDLER; KEVIN JON DEJONG, Fish & Richardson, P.C.,
Boston, MA; JOHN A. DRAGSETH, Minneapolis, MN; JOHN
C. PHILLIPS, San Diego, CA.
2 RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION
______________________
Before REYNA, MAYER, and CHEN, Circuit Judges.
CHEN, Circuit Judge.
This case arises from an inter partes review that
Respironics, Inc. filed against U.S. Patent No. 6,681,003,
owned by Zoll Medical Corporation. Respironics alleges
that International Patent Publication No. WO 98/39061 to
Owen et al. anticipates claims 1, 2, 4, 5, 8, 9, 16, 19, and
20 under pre-AIA 35 U.S.C. § 102(b) (2006). The Patent
Trial and Appeal Board found claim 1 unpatentable as
anticipated and claims 2, 4, 5, 8, 9, 16, 19, and 20 not
anticipated and therefore patentable. Respironics, Inc. v.
Zoll Medical Corp., IPR2013-00322, 2014 WL 4715644, at
*15 (PTAB Sept. 17, 2014) (Board Opinion). Respironics
appeals on all claims that the Board found patentable.
We agree with Respironics that the Board erred, vacate,
and remand for further consideration.
BACKGROUND
The ’003 patent addresses wearable medical devices
that can record and remotely communicate a patient’s
medical information. Such a device might take the form,
for example, of a wearable heart monitor, defibrillator, or
insulin pump and might communicate measurements
about the patient’s medical status and use of the device to
his doctor. Claim 2 is exemplary and addresses a method
including providing a patient with a wearable medical
device that monitors his medical information, transmit-
ting it over a communications system to a database, and
then providing access to it:
2. A method of monitoring patient medical infor-
mation for the treatment of a patient, the method
comprising the steps of:
RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION 3
providing a wearable medical device for
treating the patient and monitoring pa-
tient 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 com-
pliance data in a storage means of the
medical device;
operatively connecting the medical device
to a communications system;
transmitting the patient medical infor-
mation, device performance data and pa-
tient 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 in-
formation, device performance data and
patient compliance data to individuals.
Independent claims 4 and 19 are similar but include
means-plus-function limitations. Notably for our purpos-
es, claims 2, 4, and 19 all contain requirements for the
types of medical information that is transmitted: claim 2
requires this information to include (1) “patient medical
information,” (2) “device performance data,” and (3)
“patient compliance data”; claim 4 requires it to include
(1) “operations information of the medical device” and (2)
“patient compliance and use data”; and claim 19 requires
4 RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION
it to include (1) “patient medical parameters,” (2) “device
performance data,” and (3) “patient compliance data.” In
order to anticipate all claims, a prior-art reference must
disclose, among other things, that the medical infor-
mation it transmits satisfies all of these categories. The
parties’ dispute in this appeal centers on whether the
Owen reference discloses “patient compliance data.”
Because each claim contains the limitation “patient
compliance data” (or “patient compliance and use data,”
which the parties agree we need not consider separately),
any prior-art reference that anticipates all claims must
disclose transmitting medical information that qualifies
as “patient compliance data.” Dependent claims 5, 8, 9,
and 16 depend on claim 4 and thus incorporate its “pa-
tient compliance data” limitation. Claim 20 depends on
claim 19 and incorporates its similar limitation. Claim 1
does not include any particular requirements for the type
of medical information transmitted and therefore requires
no disclosure of “patient compliance data.”
Owen discloses a wearable medical device that com-
bines a heart monitor and a defibrillator. This device
measures a patient’s heart rhythms and determines
whether he is conscious. When the information it moni-
tors indicates the patient requires defibrillation, it admin-
isters a shock. The Board found Owen to disclose that
this device stores medical information and transmits it
over a network to a central computer, where a doctor can
review it. Board Opinion at *7. Owen discloses various
types of medical information that its device stores and
transmits. One type of information relates to a button
that the patient can push to cancel a shock. Owen at
33:2–8. If the device detects an abnormal cardiac rhythm
requiring defibrillation, it plays an audio message re-
questing that the patient press the button. Id. at 48:33–
49:25. If the patient is unconscious, he cannot press the
button, and the defibrillator will administer a shock. Id.
If he is conscious, he will press the button and cancel the
RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION 5
shock. Id. The device logs and transmits information
about the patient’s presses of this response button. Board
Opinion at *6. Another type of information involves the
length of time the doctor recommends the patient wear
the device. When a patient wears the device for longer
than recommended, the device shows a message noting
that the patient has exceeded the recommended wear
time, logs this condition, and transmits this log infor-
mation. Owen at 31:42–32, 35:10–17.
The Board first found that Owen anticipates claim 1,
rendering it unpatentable. Next, it turned to the remain-
ing claims, each of which contains the requirement that
the data stored and transmitted include “patient compli-
ance data.” It construed this term to mean “data indicat-
ing whether a patient has followed instructions for use.”
Board Opinion at *4. It found Owen not to disclose this
type of data. It reasoned that Owen’s disclosure of data
related to the patient’s presses of the response button did
not qualify because Respironics had not pointed to any
evidence that the Owen device also stored information
showing that the patient had been prompted to press the
button. Id. at *9. If the data did not indicate the patient
had been prompted, the Board reasoned, it could not
indicate that he was following instructions when he
pressed the button. Id. And, similarly, it found that
because Owen did not disclose informing the patient what
the recommended wear time is, the log the device creates
when the patient exceeds this recommendation cannot
qualify. Id. Again, the Board reasoned that without
indicating that the patient had been told to take the
device off after a specific amount of time, the data could
not show that the patient had failed to comply with wear-
time instructions. Id. The Board found Owen not to
disclose “patient compliance data” and therefore not to
anticipate independent claims 4 and 19. Because it found
claims 4 and 19 not anticipated, it also found the various
6 RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION
claims depending on them—claims 5, 8, 9, 16, and 20—
not anticipated.
Zoll does not appeal from the Board’s finding that its
claim 1 is unpatentable. Respironics appeals from the
Board’s findings that claims 2, 4, 5, 8, 9, 16, 19, and 20
are patentable over the Owen reference. We agree with
Respironics that the Board erred in finding Owen not to
disclose “patient compliance data.” We vacate the Board’s
finding of no anticipation, and we remand so that the
Board may consider in the first instance whether Owen
discloses all remaining elements of the claims.
ANALYSIS
We have jurisdiction over this appeal under 35 U.S.C.
§ 141(c) and 28 U.S.C. § 1295(a)(4)(A).
The issue at the heart of this appeal is one of claim
construction: whether the Board impermissibly modified
its construction of “patient compliance data” when it
applied that construction to Owen’s disclosures. We
review the Board’s ultimate claim constructions and
findings about the intrinsic record de novo, and its find-
ings based on the extrinsic record for substantial evi-
dence. Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292,
1297 (Fed. Cir. 2015) (citing Teva Pharms. USA, Inc. v.
Sandoz, Inc., 135 S. Ct. 831, 833 (2015)). The parties
agree that we need not consider any extrinsic evidence to
decide the appealed claim-construction issues. The Board
applies a broadest-reasonable-interpretation standard
when construing claims in an inter partes review. Cuozzo
Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2146 (2016).
In its institution decision, the Board found the broad-
est reasonable interpretation of the term “patient compli-
ance data” to be “data indicating whether a patient has
followed instructions for use.” Respironics, Inc. v. Zoll
Medical Corp., IPR2013-00322, 2013 WL 8563952, at *4
(Dec. 2, 2013). The Board noted in its final decision that
RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION 7
it would maintain this construction. Board Opinion at *4.
Respironics had initially proposed a different construction
but, after the Board first construed the term in its institu-
tion decision, Respironics has not challenged that con-
struction, either before the Board or before us. What
Respironics challenges is the Board’s application of its
own construction. In Respironics’ view, although the
Board’s construction was proper, the Board added im-
proper limitations when it applied that construction. We
have recognized such a challenge to an application of a
construction. See In re Abbot Diabetes Care Inc., 696 F.3d
1142, 1150–51 (Fed. Cir. 2012); Intervet Inc. v. Merial
Ltd., 617 F.3d 1282, 1289–90 (Fed. Cir. 2010). Our analy-
sis of this issue includes two components: first, we deter-
mine whether the Board added a limitation when it
applied the construction; second, we determine whether
that limitation is appropriate under claim-construction
law. Id.
First, we find that the Board added a limitation when
it applied its construction. Its initial construction—that
“patient compliance data” is “data indicating whether a
patient has followed instructions for use”—incorporates
no specific requirement relating to the instructions for
use. The Board did not take issue with Respironics’
showings that Owen disclosed playing an audio message
requesting that the patient press a button and storing
information about button presses. Instead, it required
more: evidence that the reference disclosed a system for
“assur[ing] that every, or indeed any, recorded button
push was performed in response to an instruction.” Board
Opinion at *9 (emphasis removed). Specifically, it exam-
ined whether the reference disclosed “record[ing] the time
at which the [instruction] is given to the patient.” Id. In
doing so, it added a limitation not present in its construc-
tion: that the device store information not just about
patient compliance but also about instructions it gave the
patient. This additional limitation represents a modifica-
8 RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION
tion to its construction. The Board repeated this error
when it considered Respironics’ alternative argument that
Owen’s disclosure of storing an indication that the patient
had worn the device for longer than recommended addi-
tionally satisfied the “patient compliance data” limitation.
It rejected this argument not because Owen failed to
disclose recording when a patient has exceeded the rec-
ommended wear time, but because it did not disclose
instructing the patient what the recommended wear time
is. Id. Without a disclosure of giving the patient a wear-
time instruction, the Board reasoned, a record that the
patient had exceeded a particular wear time could not
qualify as data indicating that the patient had or had not
complied with any particular instruction. Id. Here,
again, the Board modified its construction to impose a
requirement that the device store data about the instruc-
tions it gave to the patient
Second, we find that claim-construction law does not
support the additional limitation that the Board added to
its construction to require particular disclosures about the
instructions given to the patient. As we have previously
made clear, the fact that an unclaimed element may be
necessary for a device to function as claimed does not,
standing alone, allow courts to treat the unclaimed ele-
ment as a claim limitation. See SiRF Tech., Inc. v. Int’l
Trade Com’n., 601 F.3d 1319, 1330 (2010). In SiRF, we
addressed a method claim 1 including steps of “transmit-
ting” data to a remote receiver and processing it in a
particular way at the remote receiver. Id. In this system,
in order to transmit data to a remote receiver and then
process it there, one must send the data to an intermedi-
1 We addressed an additional, similar claim in SiRF
and reached the same conclusion on that claim. SiRF
Tech., 601 F.3d at 1330. We leave it out of our analysis to
streamline our discussion.
RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION 9
ary server, which then forwards the data to the remote
receiver for it to be downloaded there. The defendant
asked us to construe the claim to require these additional
steps of “forwarding” and “downloading” the data. Id. We
rejected this argument, holding that although these steps
were necessary to carry out the claimed “transmitting”
step, they were not claimed and thus did not act as limita-
tions. Id. This precedent applies here as well. The
claimed concept of storing patient compliance data may be
possible only if the patient is provided instructions with
which he can comply. But this fact alone does not elevate
the instructions or any information about them to the
level of a claim limitation. The Board’s additional re-
quirement that the device give the patient particular
instructions or store particular information about the
instructions given to the patient therefore finds no place
in the “patient compliance data” claim term. Neither the
Board nor Zoll cites anything else in the claims or the
record to support this additional limitation. We therefore
reject the modification that the Board made in applying
its construction to require the device to store information
related to instructions given to the patient.
The Board’s opinion makes clear that Owen antici-
pates the “patient compliance data” limitation under its
original construction. The Board found Owen to disclose
that the device plays an audio message instructing the
patient to press a button. Board Opinion at *5. It further
found Owen to disclose storing records of patient interac-
tion with the defibrillator, including information about
button presses. Id. at *5–6. These two factual findings
show that the Owen device stores “patient compliance
data” under the Board’s original, correct construction. We
therefore reverse the Board’s determination that Owen
does not meet the “patient compliance data” claim limita-
tion.
Because we find that the Board erred when it applied
its construction of “patient compliance data,” we need not
10 RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION
reach Respironics’ alternative arguments that Owen
discloses “patient compliance data” even under the
Board’s construction.
The Board based its rejection of Respironics’ anticipa-
tion arguments for independent claims 2, 4, and 19 and
dependent claims 5, 8, 9, 16, and 20 solely on its determi-
nation that Owen did not disclose anything qualifying as
“patient compliance data.” For claim 2, it found Owen not
to disclose “patient compliance data” and therefore not to
satisfy the claim limitations requiring “recording . . .
patient compliance data in a storage means of the medical
device,” “transmitting the . . . patient compliance data,”
“recording the . . . patient compliance data in an infor-
mation database,” and “providing access to the . . . patient
compliance data.” For independent claims 4 and 19, it
found Owen not to satisfy the means-plus function ele-
ments “means for monitoring and storing . . . patient
compliance data” or “means for transmitting the . . .
patient compliance data.” The Board found that, whether
or not Owen disclosed structures satisfying these ele-
ments’ structural limitations, any structure it disclosed
would not monitor, store, or transmit “patient compliance
data” and would therefore not satisfy their functional
limitations. The Board then found that, because Owen
failed to anticipate independent claims 2, 4, and 19, it
could not anticipate dependent claims 5, 8, 9, 16, and 20.
The Board noted various factual findings about what
Owen disclosed. But, because the Board found the “pa-
tient compliance data” limitations to dispose of the in-
quiry before it on all claims but claim 1, it did not need to
apply those factual findings to determine whether Owen
satisfies the remaining claim limitations of those claims.
Based on our holding that Owen satisfies the “patient
compliance data” limitations, we remand to the Board so
that it may determine whether Owen satisfies those
remaining limitations.
RESPIRONICS, INC. v. ZOLL MEDICAL CORPORATION 11
CONCLUSION
We hold that the Board erred in finding that the Ow-
en reference does not disclose “patient compliance data.”
Based on this error, we vacate the Board’s decision reject-
ing Respironics’ anticipation arguments as to claims 2, 4,
5, 8, 9, 16, 19, and 20. We remand this case to the Board
so that it may consider whether Owen satisfies these
claims’ remaining limitations.
VACATED AND REMANDED
COSTS
No costs.