`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 1 of 44 Page ID #:4050
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`UNITED STATES DISTRICT COURT
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`CENTRAL DISTRICT OF CALIFORNIA
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`Case No. 2:19-cv-06301-AB (KSx)
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`LAMKIN DECL ISO
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`Philips North America, LLC,
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`Plaintiff,
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`v.
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`Garmin International, Inc., Garmin LTD
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`Defendants.
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`DECLARATION OF RACHAEL D. LAMKIN
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`I, Rachael D. Lamkin, declare as follows:
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`1.
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`I am lead counsel of record for Defendants Garmin International, Inc.
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`and Garmin Ltd. (“Garmin”).
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`2.
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`I am an attorney licensed to practice law in all state and federal courts
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`Lamkin Decl. ISO
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`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 2 of 44 Page ID #:4051
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`in California, the Eastern District of Texas, Colorado District Court, the Court of
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`International Trade, the International Trade Commission, the Federal Circuit Court
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`of Appeals, and this Honorable Court.
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`3.
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`4.
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`I have personal knowledge of all facts attested to herein.
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`Attached as Exhibit AA is a true and correct copy of the relevant pages
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`from Dr. Martin’s declaration submitted with Philips’ Response in the ’233 IPR.
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`5.
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`Attached as Exhibit BB is a true and correct copy of some of the relevant
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`pages from Dr. Martin’s expert report in this matter.
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`6.
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`Attached as Exhibit CC is a true and correct copy of some of the relevant
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`pages of Garmin’s rebuttal expert report (Dr. Kiaei) explaining the different between
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`medical devices and fitness devices in the context of the ’233 and ’542 Patents.
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`7.
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`Attached as Exhibit DD is a true and correct copy of the relevant pages
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`of Garmin’s rebuttal expert report (Dr. Bellasario) explaining that Garmin watches
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`are not medical devices as that term is used in the relevant industries.
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`Signed under penalty of perjury on this date, February 8, 2021, in Sausalito,
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`California.
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`________________________
`Rachael D. Lamkin
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`Lamkin Decl. ISO
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`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 3 of 44 Page ID #:4052
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`Exhibit AA
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`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 4 of 44 Page ID #:4053
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`types of content information such as entirely new content titles, additional sections
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`or content elements for existing titles such as scripts and voice files, general
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`information such as weather information and advertisements, and educational
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`material.” Id., 11:13–16.
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` DETAILED RESPONSE TO GROUNDS OF REJECTION
`A. Ground 1: Jacobsen Fails to Disclose all Features of Claims 1, 7–10,
`and 14
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`1. Claim 1
`Jacobsen does not disclose “a security mechanism governing
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`70.
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`information transmitted between the first personal device and the second device.”
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`Ex. 1001, 15:10–12. Security is a key aspect of the invention of the ’233 patent,
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`particularly in view of the fact that the patent contemplates that the system of claim
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`1 would be used in medical settings. To that end, the ’233 patent explains how it
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`provides a system with “multiple levels of prioritization, authentication of a
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`person (task, step, process or order), and confirmation via interrogation of
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`person, device, or related monitor.” Id., Abstract (emphasis added).
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`71. Of particular note is the embodiment of Figure 5 of the ’233 patent,
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`which describes a personal device associated with a victim V. Id., 11:49–53. In
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`the situation described in Figure 5, the personal device of victim V may be in
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`short-range wireless communication with a second device of a bystander B, via, for
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`example BLUETOOTH. Id., 11:54–66. The personal device of victim V can then
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`31
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`IPR2020-00783
`Philips North America LLC EX2026
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`

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`communicate with other aspects of the network (e.g. a dispatcher or responding
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`personnel) via the second device of bystander B in order to facilitate medical
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`assistance in some form to victim V. Id., Fig. 5; 12:1–37. Important in this
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`embodiment is the idea that “the ability of various entities spread around a network
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`to receive and/or transmit to and control the personal device 100 requires some
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`measure of security.” Id., 13:27–30. To that end, the ’233 patent goes on to
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`describe how
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`“Only authorized agents should be allowed access to
`device 100. For example, in the example shown in FIG.
`5, only responding personnel RP (such as trained
`paramedics) who are on the scene of the event may be
`allowed to send a command to the personal device 100
`causing the personal device 100 to dispense medication
`to the victim. Certainly, the bystander B should not be
`allowed this level of access, even though the bystander
`B’s personal wireless device 600 may be acting as an
`intermediary in communication from the personal device
`100 to the dispatcher D.”
`Id., 13:30–41 (emphasis added).
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`72. This disclosure demonstrates that, beyond the communications
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`protocols (such as BLUETOOTH) that might be utilized to implement a short-
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`range wireless communication scheme between the first personal device of victim
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`V and a second device of bystander B (or a second device of responding personnel
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`RP once on site), a layer of security is required for authorizing a person’s access
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`to device 100 over the network—not simply authentication of devices across a
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`32
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`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 6 of 44 Page ID #:4055
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`network.
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`73. By authorizing access to a user over the communications link (for
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`example, authorizing RP to access Personal Device 100 over the bi-directional
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`communications link) the invention provides a security mechanism that governs
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`information transmitted between a first personal device and the second device.
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`74.
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`In my view, Petitioners and their expert, Dr. Paradiso, interpret
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`“governing information transmitted between the first personal device and the
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`second device” such that any form of security for any purpose meets the claims
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`requirement that the security mechanism “govern[] information transmitted”
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`between devices over a bi-directional communications link. This is confirmed by
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`the way Dr. Paradiso reads this claim term on the prior art, as well as his
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`deposition testimony, where he admitted that under his interpretation simply
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`disabling a device or turning it off satisfies this limitation of the claim. Dr.
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`Paradiso went so far as to suggest that, smashing a device with a hammer so as to
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`make it inoperable would meet the requirements of a security mechanism that
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`“govern[s] information transmitted” despite the fact that in neither of those
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`situations is information transmitted. One cannot “govern[] information
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`transmitted” between two devices if there is no information transmitted. Dr.
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`Paradiso deposition testimony on this point is copied below for reference:
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`Q. What’s the difference between securing a device
`and securing the data?
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`33
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`IPR2020-00783
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`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 7 of 44 Page ID #:4056
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`A. Yeah. Can you go back to the claim? I will go
`back to the claim. It’s here.
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`The claim—the claim talks about stream [sic.]
`mechanisms to actually govern the information that’s—
`that’s transmitted between the devices. If you were to
`secure the device, depending on how you secure it—
`Jacobsen will disable the device. That prevents the
`device from—from sending or receiving data. Then,
`obviously, as I say in my declaration, it cannot transmit
`or receive data. So in that case, you secure the device,
`you secure the data. That satisfies the claim.
`Q. So preventing the—so would disabling a device
`govern the transmission of information?
`A.
`If the device is disabled, it’s not going to be
`transmitting information, so yes, that would govern it.
`So if I took a device and smashed it with a
`Q.
`hammer so that it wasn’t operative, that would
`govern the information transmitted?
`A.
`That wouldn’t be a strategy that—that you would
`normally go around doing; but it would prevent
`information from being, certainly, transmitted to the
`device or from it.
`Q. And—in your view, that would govern information
`transmitted of the [sic.] ?
`It does govern information transmitted because
`A.
`if the devices is destroyed, however you destroy it,
`there’s no information going to or from the device.
`Ex. 2030, 62:7–63:17 (objections omitted, emphasis added).
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`75.
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`I disagree with Fitbit and Dr. Paradiso that a POSITA would regard
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`Jacobsen’s self-disabling means as a “security mechanism governing information
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`transmitted.” The claim expressly requires a security mechanism governing
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`34
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`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 8 of 44 Page ID #:4057
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`information transmitted. Yet, under Fitbit and Dr. Paradiso’s understanding of the
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`claim, there would be no information transmitted. As I stressed earlier, Dr.
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`Paradiso effectively ignores the requirement of “governing information
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`transmitted” by alleging that any form of security would meet the claim limitation.
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`That reading, however, is contradicted by the language of the claim itself (which
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`requires that information actually be transmitted) as well the exemplary
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`embodiments of the specification, which describe security implementations that
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`govern information that is actually transmitted. See Ex. 1001, 11:47–67; 12:1–49
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`(describing how RP’s access to Personal Device 100 may be governed—not by
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`disabling devices or preventing the transmission of information, but rather by
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`applying a security mechanism that authorizes access to information transmitted
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`between the devices).
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`76. Accordingly, because Fitbit and Dr. Paradiso exclusively rely on
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`Jacobsen’s disclosure of a device-disabling means as providing a security
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`mechanism (See Ex 1002, ¶¶ 100–111; Ex. 2030, 62:7–63:17), it is my opinion that
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`the element “security mechanism governing information transmitted” is not
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`disclosed by Jacobsen. Jacobsen’s device disabling means is divorced from any
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`transmission of information, which is inconsistent with the claimed invention, and
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`indeed when Jacobsen’s device disabling means are utilized—there is no
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`information transmitted that could be governed by a security mechanism.
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`35
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`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 9 of 44 Page ID #:4058
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`Exhibit BB
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`PNA-GAR0001916.
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`107.
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` Thus, for the reasons stated above, I conclude that each of the ’233 Infringing
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`Products provide a system which infringes this limitation.
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`(i)
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`Limitation 1-C: “(c) a security mechanism governing
`information transmitted between the first personal device
`and the second device.”
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`108.
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`It is my opinion that each of the ’233 Infringing Products provides a system
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`comprising a security mechanism governing information transmitted between the first personal
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`device and the second device.
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`109. As discussed above, Garmin intends for and instructs its users to pair each ’233
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`(1)
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`Security Mechanism While Pairing
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`Device (the first device) with a smartphone (the second device) via the Garmin Connect Mobile
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`App.
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`110. Before this pairing process can occur, however, Garmin requires its customers to
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`log into the Garmin Connect Mobile App on their smartphone with their Garmin Connect
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`account credentials (both an email and a password). If a customer does not have an account,
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`Garmin instructs the user to create one before the paring process can occur. This is shown, for
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`example, in the user manuals of the ’233 Devices. For instance, the user manual of the Fenix 5
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`gives the following instructions:
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`PNA-GAR0000328. The user manuals of the other ’233 Devices also show that a Garmin
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`Connect Account must be logged into before the ’233 Device can be paired with the phone.xiii
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`111. For the Garmin ‘233 devices intended for children, Garmin requires a parent to
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`have a Garmin Connect account. For instance, the user manual of the Vivofit Jr. 2 gives the
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`following instructions:
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`112. This requirement for customers to have a Garmin Connect account is confirmed
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`by Mr. Henderson, one of Garmin’s engineers, who testified that the a user must log into or
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`create a Garmin Connect account before being able to pair a smartphone with a ’233 Device.
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`Henderson Dep. Tr. at 94:1-96:25. Mr. Henderson further testified that you need a Garmin
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`account to use the Garmin Connect Mobile App and that “[y]ou can’t do anything with the app
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`until you have logged in.” Henderson Dep. Tr. at 94:1-95:11. Mr. Henderson also agreed that the
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`use of a Garmin account for authentication and enabling the Garmin Connect Mobile App helps
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`provide security in the context of identifying the user separate from the device. Henderson Dep.
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`Tr. at 96:4-14.
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`113. Additionally, I understand that Garmin’s engineer, Mr. Heikes, has testified that
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`before connecting one of the ’233 Devices to a smartphone, a customer is first required to set up
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`a Garmin Connect account. Heikes Sept. 16 Dep. Tr. at 32:22-36:22.
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`114.
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`I have personally tested several of the ’233 Devices (Forerunner 245 Music, Fenix
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`5, Vivofit 3, and Vivofit Jr. 2) and before pairing them with my smartphone, I was required to be
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`logged in to my Garmin Connect account on the Garmin Connect Mobile App (or in the case of
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`the Vivofit Jr. 2, I was required to be logged in to my Garmin Connect account on the Garmin
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`Vivofit Jr. app). The following screenshots illustrate this process for both Android and iOS.
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`Android17:
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`17 Android did not permit a screenshot to be taken of the login screen, so I have included a photo of the whole phone
`with that screen instead.
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`Vivofit jr login page on Android:
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`115. Thus, I conclude that a security mechanism (in the form of the additional layer of
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`security provided by authenticating a user via the Garmin Connect App and that user’s Garmin
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`Connect Account) governs the information transmitted between the first and second device in the
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`initial process of pairing. This required login is at the application layer, authenticating the
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`identity of the user, rather than at the layer of the Bluetooth wireless communication protocols,
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`which, as noted by the NIST Guide to Bluetooth Security described previously, can only
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`authenticate devices, not users.
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`116.
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`I have reviewed the relevant source code and have concluded that it is consistent
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`with how I have described this required login process. For instance in File code\mobile
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`apps\android\app\src\main\java\com\garmin\android\apps\connectmobiel\GarminConnectMobile
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`App.java at line 600, when the app comes into the foreground the first thing it does is check
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`whether the user is signed in.
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`117. Additionally, once paired, information is transmitted between the ’233 Device
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`(2)
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`Security Mechanism During Syncs
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`(the first device) and the smartphone (the second device) via syncs. Each of the ’233 Devices
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`have the capability to “sync” with the Garmin Connect Mobile App18 on the second device (the
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`smartphone), during which information is transmitted between the two devices. See Heikes, Sept.
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`16 Dep. Tr. at 36:23-38:9. Mr. Heikes, Garmin’s engineer, also testified that users can manually
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`initiate a sync between a ’233 Device and the Garmin Connect Mobile App on the user’s
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`smartphone and that the sync will occur automatically when the Garmin Connect Mobile App is
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`brought to the foreground or after a length of time in which there has been no sync. Heikes, Sept.
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`16 Dep. Tr. at 38:10-39:10.
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`118. However, before any syncs occur the user must be logged into the Garmin
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`Connect Mobile App on their phone using their Garmin Connect credentials (email and
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`password). This was confirmed by Mr. Henderson in his deposition that the Garmin Connect
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`App could not be used without a user being logged in. Henderson Dep. Tr. at 95:1-9.
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`119.
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`I have personally tested several of the ’233 Devices (Forerunner 245 Music, Fenix
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`5, Vivofit 3, and Vivofit Jr. 2 ) and syncing would not occur unless I was logged into my Garmin
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`Connect account on the Garmin Connect Mobile App (Garmin Vivofit Jr. app in the case of the
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`Vivofit Jr. 2). In fact, even if I tried to manually initiate a sync from the ’233 Device, the sync
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`would fail unless I was logged into my Garmin Connect account on the Garmin Connect Mobile
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`App. The images below show pictures of my attempts to manually sync the Fenix 5 both while
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`logged in and not logged in to the Garmin Connect app.
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`18 Or the Garmin Vivofit Jr. app in the case of the Vivofit Jr. and Vivofit Jr. 2 devices.
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`Exhibit CC
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`with one specific application being to model excess post-exercise oxygen
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`consumption (EPOC). Id. at 138 - 148.
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`32. Neural networks were well-established in the world of electronics, with
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`the first artificial “neurons” developed in 1943. An Introduction to Neural Networks
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`by Ben Kröse and Patrick van der Smagt at 11. These artificial neurons were
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`modeled after biological neurons and used as circuit components that could perform
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`complex computations. Id. It was well-known that neural networks, and more
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`particularly, artificial neural networks, were composed of a group of nodes that
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`interconnected and processed information based on learning the correct results for
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`certain inputs through provided training examples. An Introduction to Neural
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`Networks by Kevin Gurvey at 13. This differed from traditional computational
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`models which used a predefined set of instructions to determine outputs. Instead,
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`neural networks adaptively learned through experience and example scenarios. Id.
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`at 15.
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`VIII. NONE OF THE ACCUSED PRODUCTS INFRINGE THE ’233
`PATENT
`A. Dr. Martin Either Misunderstands or Misrepresents the ’233
`Patent and the Accused System
`33. The claims of the ’233 Patent are directed towards a system of wireless
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`communication between a personal medical device and a second device with a
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`security mechanism governing information transmitted between the two devices. See
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`generally, ’233 Patent at Abstract, claim 1.
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`34. At claim construction, Philips argued that the specification “broadly
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`characterizes the ‘present invention’ as ‘relating generally to bi-directional personal
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`and health-wellness provider communication system[s]’…before discussing specific
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`embodiments that utilize a ‘medical’ device.” Dkt. 80 at 11. The Court rejected the
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`argument that the first personal device has broader meaning and construed it as a
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`“first personal medical device.” (referred to as a “PMD” throughout my opinions).
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`Claim Construction Order (8/31/20) at 16-18.
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`35. The specification identifies PMDs as able to “monitor individual or
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`combinations of body functions such as heart function, respiration, body chemistry,
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`brain function, or muscular/skeleton actions,” (’233 Patent at 2:2-6) and states that
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`the patent “describe[s] a device and method to couple with PMDs to provide wireless
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`communication and locating functions,” the purpose of which is to “provide health
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`care professionals with access to information for remote diagnostic capabilities, to
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`provide notification of acute conditions possibly requiring immediate assistance,
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`transportation to a medical center, or remote treatment action; to provide a location
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`information of mobile persons for caregivers; to notify responsible parties of the
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`occurrence of a medical condition; and to provide remote intervention assistance by
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`caregivers through verbal or visual interaction.” ’233 Patent at 2:11-24.
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`36.
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`Importantly, the specification never uses the word “fitness” or
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`“exercise,” and does not describe monitoring exercise.
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`37. For the reasons discussed in detail below, Garmin’s watches are fitness
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`and exercise devices, not medical devices. In fact, Garmin makes clear that its
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`products are not medical devices.2 As further detailed below, I understand that in
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`previous discussions with Garmin, Philips acknowledged that Garmin watches were
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`not medical devices, such as in the below presentation that Philips prepared:
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`GARM-CDCA-002553 (Pastink Dep. Ex. 6 December 2016 Commercial Offer);
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`and Pastink 9/14/2020 Dep at 143-148.
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`2 https://www.garmin.com/en-US/legal/atdisclaimer/ (“Garmin wearables are not medical
`devices, and the data provided by them is not intended to be utilized for medical purposes and is
`not intended to diagnose, treat, cure, or prevent any disease. Garmin recommends you consult
`your doctor before engaging in any exercise routine.”).
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`38.
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`I further understand from a 2014 License Agreement among other
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`evidence discussed, that Philips draws a distinction between fitness devices and
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`devices designed to treat disease/conditions (medical devices):
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`
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`Korte Dep. Ex. 18 GARM-CDCA-0000062; see also id. at 0000061 (Philips 2014
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`license agreement defining “Licensed Products” as “Watch Products and/or Strap
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`products” that “shall not include any Medical Device” (Section 1.13), and defining
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`“Medical Device” as “defined by or subject to governmental regulations in any
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`country such as, in a non-limiting example, a United States Food and Drug
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`Administration (US FDA) approved device” in Section 1.16.) (emphasis added).
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`39.
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`I understand that Dr. Martin has identified Garmin’s fitness watches as
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`the claimed “first personal medical device” in his Opening Report. Martin Rpt. at ¶¶
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`73-79. Dr. Martin’s identification of Garmin watches as medical devices is contrary
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`to the teachings of the ’233 Patent, the Court’s claim construction order, and Philips
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`own statements.
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`40. Additionally, Dr. Martin opines that a customer’s Garmin Connect user
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`name and password satisfies the claimed “security mechanism governing
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`information between the personal medical device and the second device.” Martin
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`Rpt. at ¶¶ 108-122. However, it is my opinion that Dr. Martin misunderstands or
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`215. The examples provided in the ’542 Patent are all in the medical context,
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`and as explained in my Opening Report on Invalidity, do not apply in the fitness
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`context. Opening Invalidity Report at ¶¶ 66-67 (describing medical applications in
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`the ’542 Patent’s specification). In my Invalidity Report, I explained that the ’542
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`Patent lacks written description support for using a statistical analyzer to detect and
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`warn against “undesirable” non-medical fitness or exercise-related conditions.
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`Opening Invalidity Report at ¶¶ 180-187. Specifically, I explained that the Court
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`noted the claims are directed to the field of “health monitoring,” citing undesirable
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`medical conditions such as “a dangerous falling condition,” SIDS onset in an infant,”
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`or “cardiovascular problems[s].” Id. at ¶ 182. I explained that the specification only
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`uses the word “undesirable” in the context of analyzing “data from the patient”
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`including the “patient’s vital signs such as ECG/EKG” to generate a warning. Id. at
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`¶ 183. I additionally noted that the inventor, Mr. Tran, noted in his deposition that a
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`physical condition is “undesirable” based on whether “in the medical literature” if
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`left untreated, would result in a “medical condition.” Id.
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`216. Using blood sugar as an example, the claim would cover having a
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`statistical analyzer that has been previously trained with the user’s response to sugar
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`intake such that the statistical analyzer would determine whether the user’s blood
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`glucose is at an undesirable level for that user (i.e., too high or too low). The
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`statistical analyzer understands that this level represents a physical condition that is
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`undesirable for the specific user (i.e., hyperglycermia or hypoglycemia).
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`217. When the blood glucose levels reach undesirable levels, a warning is
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`generated letting the user know his physical condition is currently undesirable (i.e.,
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`hyperglycemia or hypoglycemia). These kinds of warnings require emergency and
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`immediate attention, just as if they were occurring in a hospital and the alarms were
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`being triggered from the vital-monitoring station besides each patient.
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`218. Another example might be for heart rate and a heart condition. For a
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`certain individual, a heart rate below 45 and above 145 might indicate that his heart
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`condition is in an undesirable state. Thus, the statistical analyzer would be trained
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`with a user’s physiological response to certain heart rates such that when the user’s
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`heart rate drops below 45 or goes above 145, the system generates a warning that the
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`physical condition of the user’s heart condition is in an undesirable state (i.e.,
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`tachycardic or bradycardic).
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`219. Again, these kinds of warnings require emergency, immediate
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`attention, just as if they were occurring in a hospital and the alarms were being
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`triggered from the vital-monitoring station besides each patient.
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`220. Further, the preamble of claims 13 and 14 states that the claims cover
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`“a method for maintaining wellness”. ’542 Patent at 76:9. The specification
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`describes monitoring wellness as follows:
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`Regular monitoring of the basic wellness parameters provides
`significant benefits in helping to capture adverse events sooner,
`reduce hospital admissions, and improve the effectiveness of
`medications, hence, lowering patient care costs and improving the
`overall quality of care. Suitable users for such systems are disease
`management companies, health insurance companies, self-insured
`employers, medical device manufacturers and pharmaceutical firms.
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`Id., at 5:19-28.
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`221. Moreover, the “undesirable” term in the claims appears once in the
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`specification and is equated with a “dangerous condition” for a “patient”:
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`In this embodiment, the statistical analyzer is trained with training
`data where certain signals are determined to be undesirable for the
`patient, given his age, weight, and physical limitations, among
`others. For example, the patient’s glucose level should be within a
`well-established range, and any value outside of this range is flagged
`by the statistical analyzer as a dangerous condition. As used herein,
`the dangerous condition can be specified as an event or a pattern that
`can cause physiological or psychological damage to the patient.
`Moreover, interactions between different vital signals can be
`accounted for so that the statistical analyzer can take into
`consideration instances where individually the vital signs are
`acceptable, but in certain combinations, the vital signs can indicate
`potentially dangerous conditions.
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`Id., at 9:25-39.
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`222. And, as the Court explained in its claim constriction Order at page 40:
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`223. As discussed below, the Garmin devices are not related to “health
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`monitoring.” The accused Garmin products bear no resemblance to the claims of
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`the ’542 Patent as read in light of the ’542 Patent’s specification. As discussed above
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`and below, the Garmin products are for exercise and fitness, and do not fall within
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`the scope of the asserted claims of the ’542 Patent.
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`Limitation 1-B “analyzing the one or more vital parameters using a statistical
`analyzer, trained with training data representing physiological conditions
`determined to be undesirable for the user to analyze the vital parameters to
`determine if the physiological conditions are undesirable”
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`224. I understand that claim 13 is a method claim, and have been informed
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`that to allegedly infringe a method claim, every step of the claimed method must be
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`performed in the United States. Here, it is my opinion that not all steps that are
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`alleged by Dr. Martin to be infringing are performed in the United States. Namely,
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`the evidence establishes that Dr. Martin’s alleged statistical analyzer (e.g., accused
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`neural network) is created (e.g., “trained with training data”) by Firstbeat in Finland.
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`Exhibit DD
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`Case 2:19-cv-06301-AB-KS Document 124-1 Filed 02/08/21 Page 30 of 44 Page ID
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`these minimum qualifications to be a person having ordinary skill in the art as of
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`March 26, 1998.
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`14. Unless otherwise specified, when I refer to a PHOSITA, I am
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`referring to someone with the level of knowledge and understanding described
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`above. I note that the analysis and opinions in my report would not change if a
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`slightly different description of the person of ordinary skill in the art was used.
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`IV. MEDICAL DEVICE
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`15.
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`I am told and I understand that the Court construed the term “personal
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`device” in claim 1 of the ’233 Patent to be a “personal medical device.” Claim
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`Construction Order (8/31/20) at 16-18.
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`16.
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`In general, the term medical device has a common meaning in the
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`industry, referring to a device used for monitoring, diagnosis, or treatment of a
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`disease or other medical condition. Below, I identify a wide range of information
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`supporting this well-understood meaning. I note that all of the information cited
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`below are commonly relied upon, and used by, a PHOSITA in the industry.
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`17. For example, in the 1988 Encyclopedia of Medical Devices, the editor
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`defines the field the encyclopedia covers (Medical Devices) as “The discipline is
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`