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`Document: 45-1
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`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
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`NOTICE OF ENTRY OF
`
`JUDGMENT ACCOMPANIED BY OPINION
`
`OPINION FILED AND JUDGMENT ENTERED: 07/29/2016
`
`The attached opinion announcing the judgment of the court in your case was filed and judgment was entered on
`the date indicated above. The mandate will be issued in due course.
`
`Information is also provided about petitions for rehearing and suggestions for rehearing en banc. The questions
`and answers are those frequently asked and answered by the Clerk's Office.
`
`No costs were taxed in this appeal.
`
`Regarding exhibits and visual aids: Your attention is directed Fed. R. App. P. 34(9) which states that the clerk
`may destroy or dispose of the exhibits if counsel does not reclaim them within a reasonable time after the clerk gives
`notice to remove them. (The clerk deems a reasonable time to be 15 days from the date the final mandate is issued.)
`
`FOR THE COURT
`
`/s/ Peter R. Marksteiner
`
`Peter R. Marksteiner
`Clerk of Court
`
`15-1485 — Respironics, Inc. v. Zoll Medical Corporation
`United States Patent and Trademark Office, Case No. |PR2013-00322
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`
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`Case: 15-1485
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`Document: 45-2
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`Pagezl
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`Fi|ed:O7/29/2016
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`NOTE: This disposition is nonprecedential.
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`Zfintteh évtatesz Qtuurt of Qppealg
`
`for the jfeheral @:iI‘£I1it
`
`RESPIRONICS, INC.,
`Appellant
`
`V.
`
`ZOLL MEDICAL CORPORATION,
`
`Appellee
`
`2015-1485
`
`Appeal from the United States Patent and T1'aLleu1ai'k
`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.
`
`
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`Case: 15-1485
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`Document: 45-2
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`Page:2
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`Fi|ed:O7/29/2016
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`2
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`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 85 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. U.
`Zoll Medical Corp., IPR2013~0O322, 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 ‘O03 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:
`
`
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`RESPIRONICS, INC. V. ZOLL MEDICAL CORPORATION
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`3
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`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;
`
`infor-
`transmitting the patient medical
`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.
`
`include
`Independent claims 4 and 19 are similar but
`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
`
`
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`RESPIRONICS, INC. V. ZOLL MEDICAL CORPORATION
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`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.
`'l‘his 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
`3322-8. 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
`
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`Id. The device logs and ‘transmits information
`shock.
`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
`
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`RESPIRONICS, INC. V. ZOLL MEDICAL CORPORATION
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`claims depending on them—claims 5, 8, 9, 16, and 20—
`not anticipated.
`
`Z011 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(0) 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. U. Proxyconn, Inc., 789 F.3d 1292,
`1297 (Fed. Cir. 2015) (citing Teua Pharms. USA, Inc. U.
`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. U. Zoll
`Medical Corp., IPR2013-00322, 2013 WL 8563952, at *4
`(Dec. 2, 2013). The Board noted in its final decision that
`
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`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, Rcspironics 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
`"priticnt 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-
`
`
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`RESPIRONICS, INC. V. ZOLL MEDICAL CORPORATION
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`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. U. Int’l
`Trade Com’n., 601 F.3d 1319, 1330 (2010).
`In SiRF, we
`addressed a method claiml 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.
`
`
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`9
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`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
`
`
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`RESPIRONICS, INC. V. ZOLL MEDICAL CORPORATION
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`that Owen
`reach Respironics’ alternative arguments
`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.
`
`
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`RESPIRONICS, INC. V. ZOLL MEDICAL CORPORATION
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`1 1
`
`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.
`
`