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`Nimalka Wickramasekera (SBN: 268518)
`NWickramasekera@winston.com
`Joe S. Netikosol (SBN: 302026)
`JNetikosol@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`George C. Lombardi (pro hac vice)
`GLombard@winston.com
`J.R. McNair (pro hac vice)
`JMcNair@winston.com
`Vivek V. Krishnan (pro hac vice)
`VKrishnan@winston.com
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601-9703
`Telephone: (312) 558-5600
`Facsimile:
`(312) 558-5700
`
`Attorneys for Plaintiffs
`MEDTRONIC, INC.; MEDTRONIC PUERTO RICO OPERATIONS CO.;
`MEDTRONIC LOGISTICS, LLC; MEDTRONIC USA, INC.
`
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`
`MEDTRONIC, INC.; MEDTRONIC
`PUERTO RICO OPERATIONS
`CO.; MEDTRONIC LOGISTICS,
`LLC; MEDTRONIC USA, INC.,
`
`Plaintiffs,
`
`v.
`
`AXONICS, INC.,
`
`Defendant.
`
`
`
`
`
`
`Case No. 8:19-cv-02115-DOC-JDE
`
`
`DECLARATION OF DR. RONALD D.
`BERGER, M.D., IN SUPPORT OF
`PLAINTIFFS’ RESPONSIVE CLAIM
`CONSTRUCTION BRIEF
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`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONSIVE CLAIM
`CONSTRUCTION BRIEF
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`Axonics Exhibit 1028
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
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`Page 1 of 17
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`Case 8:19-cv-02115-DOC-JDE Document 139-8 Filed 07/15/22 Page 2 of 17 Page ID
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`I.
`
`I, Ronald Berger, declare as follows:
`INTRODUCTION
`1.
`I have been retained by Plaintiffs as an independent expert consultant in
`this litigation to provide my opinions regarding United States Patent Nos. 8,457,758,
`8,738,148, and 9,463,324. I understand that Defendant Axonics has submitted a
`declaration from Dr. Pedro Irazouqi in support of its opening claim construction brief.
`This declaration provides my opinions regarding the understanding of certain terms of
`the ’324, ’758, and ’148 patents from the viewpoint of a person of ordinary skill in the
`art at the time of invention of each of the patents, including responding to certain
`opinions of Dr. Irazouqi. In arriving at these opinions, I have considered various
`materials associated with this litigation. My opinions are set forth below.
`2.
`I am being compensated for my work in this proceeding at my standard
`consulting rate of $750/hour. My compensation is in no way contingent on the nature
`of my findings, the presentation of my findings in testimony, or the outcome of this or
`any other proceeding. I have no other interest in this proceeding.
`II. BACKGROUND AND QUALIFICATIONS
`
`3. My qualifications are fully set forth in my curriculum vitae attached as
`Attachment 1.
`4.
`I have been working/involved in the field of biomedical engineering for
`over 25 years. I am currently Professor of Medicine and Professor of Biomedical
`Engineering at Johns Hopkins University. In addition, I am currently Director of
`Inpatient Cardiology, and Co-Director of Cardiac Electrophysiology and Director of
`the Clinical Cardiac Electrophysiology Training Program at Johns Hopkins Hospital.
`I have trained over 60 Cardiac Electrophysiology fellows in techniques for
`implantation of electronic stimulation devices, particularly pacemakers, implantable
`cardioverter defibrillators (ICDs), and phrenic nerve stimulators.
`5.
`I have published over 300 scientific peer-reviewed articles, many related
`to medical devices and biomedical engineering. Some exemplary articles include:
`1
`PLAINTIFFS’ OPENING CLAIM CONSTRUCTION BRIEF
`CASE NO. 8:19-CV-02115-DOC-JDE
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`Case 8:19-cv-02115-DOC-JDE Document 139-8 Filed 07/15/22 Page 3 of 17 Page ID
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`“Safety and Effectiveness of Placement of Pacemaker and Defibrillator Leads in the
`Axillary Vein Guided by Contrast Venography” (1997), “Relation between Impedance
`and Electrode Temperature During Radiofrequency Catheter Ablation of Accessory
`Pathways and Atrioventricular Nodal Reentrant Tachycardia” (1998), “Prospective
`Randomized Comparison of the Safety and Effectiveness of Placement of Endocardial
`Pacemaker and Defibrillator Leads Using the Extrathoracic Subclavian Vein Guided
`by Contrast Venography Versus the Cephalic Approach” (2001), “Modern pacemaker
`and implantable cardioverter/defibrillator systems can be magnetic resonance imaging
`safe: in vitro and in vivo assessment of safety and function at 1.5T” (2004), “Novel
`Electrode Design for Potentially Painless Internal Defibrillation Also Allows for
`Successful External Defibrillation” (2007), “Appropriate and Inappropriate Electrical
`Therapies Delivered by an Implantable Cardioverter-Defibrillator: Effect on
`Intracardiac Electrogram” (2011), and “Premature Failure of a Riata Defibrillator
`Lead Without Impedance Change or Inappropriate Sensing: A Case Report and
`Review of the Literature” (2011).
`6.
`I have designed and developed medical devices and hold over 30 patents
`in the fields of arrhythmia detection, catheter ablation, defibrillation, and
`cardiopulmonary resuscitation. Examples include a cardiac shock electrode system
`and corresponding implantable defibrillator system (U.S. Patent No. 6,633,780 and
`No. 7,596,409), technology for live assessment of rate and depth of chest
`compressions during CPR (U.S. Patent Nos. 6,390,996; 6,827,695; 7,074,199;
`7,108,665; 7,118,542; 7,122,014; and 8,096,962) and a system and method for
`magnetic-resonance-guided electrophysiologic and ablation procedures (U.S. Patent
`Nos. 6,701,176; 7,155,271; and 8,099,151).
`7.
`I have participated in numerous clinical trials involving medical devices,
`such as a randomized trial of pacemaker and ICD implantation via the axillary and
`cephalic veins, a trial on the efficacy of ventricular defibrillation with low energy
`margins, and several trials examining the benefits of cardiac resynchronization
`2
`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONSIVE CLAIM
`CONSTRUCTION BRIEF
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`Case 8:19-cv-02115-DOC-JDE Document 139-8 Filed 07/15/22 Page 4 of 17 Page ID
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`therapy (CRT).
`8.
`I have a B.S. degree in Electrical Engineering and Computer Science
`from Massachusetts Institute of Technology, conferred in 1981; an M.S. in Electrical
`Engineering and Computer Science from Massachusetts Institute of Technology,
`conferred in 1983; a Ph.D. in Electrical Engineering and Computer Science from
`Massachusetts Institute of Technology, conferred in 1987; and a M.D. from Harvard
`Medical School, conferred in 1987. My Ph.D. dissertation is titled “Analysis of the
`Cardiovascular Control System Using Broad-Band Stimulation.”
`III. MATERIALS CONSIDERED
`9.
`In forming my opinions, I have considered:
`•
`U.S. Patent No. 7,774,069 and its prosecution history;
`•
`U.S. Patent No. 8,457,758 and its prosecution history;
`•
`U.S. Patent No. 8,738,148 and its prosecution history;
`•
`U.S. Patent No. 9,463,324 and its prosecution history;
`•
`U.S. Patent No. 9,821,112 and its prosecution history;
`•
`Axonic’s Opening Claim Construction Brief (Dkt. 111) and all
`documents cited therein, including the unredacted declaration of
`Dr. Pedro Irazoqui (“Irazoqui Decl.”, Dkt. 113-1) and all
`documents cited therein;
`•
`All documents cited in this declaration;
`•
`The Joint Claim Construction Chart.
`IV. RELEVANT LEGAL STANDARDS
`10.
`I am not an attorney. In formulating my opinions, counsel in this case
`has informed me of certain principles of U.S. patent law that govern claim
`construction and indefiniteness of claim terms. The discussion of legal principles set
`forth below is not intended to be exhaustive and is merely intended to provide some
`context for the opinions that I provide.
`11.
`I understand that terms in a patent claim are given the meaning they
`3
`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONSIVE CLAIM
`CONSTRUCTION BRIEF
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`Case 8:19-cv-02115-DOC-JDE Document 139-8 Filed 07/15/22 Page 5 of 17 Page ID
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`#:8413
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`would have to a person of ordinary skill in the art at the time of the invention in view
`of the patent’s claims, the specification, and prosecution history. I understand that the
`words of the claims provide the starting point for claim construction and must be
`given their ordinary and customary meaning in the field of the invention.
`12.
`I further understand that “extrinsic evidence,” such as dictionaries or
`treatises, are not given as much weight as the claim language, specification, and
`prosecution history. I understand that extrinsic evidence sometimes also demonstrates
`the ordinary and customary meaning of a term to a person of ordinary skill in the art.
`13.
`I have been informed that a patent claim is invalid as indefinite if the
`claims, read in light of the specification and prosecution history, fail to inform with
`reasonable certainty a person skilled in the art at the time the patent application was
`filed about the scope of the invention.
`V. LEVEL OF ORDINARY SKILL IN THE ART
`14. Dr. Irazoqui provides his opinion on the level of ordinary skill for the
`’324 patent in paragraphs 33-34 of his declaration. I have considered the level of
`ordinary skill determined by the PTAB in IPR2020-00713 of U.S. Patent No.
`9,821,112, which is a continuation of the ’324 patent and shares a common
`specification and priority date: “a bachelor’s degree in electrical or mechanical
`engineering and at least three years of experience in the industry working with
`rechargeable medical implantable devices; or a bachelor’s of science with at least six
`years of experience designing, manufacturing, or overseeing rechargeable medical
`implantable systems.” IPR2020-00713, Paper 42 at 11-12. I adopt this level of
`ordinary skill, and I met this definition at the time of invention, the conception date of
`May 23, 2003.
`15. Dr. Irazoqui provides his opinion on the level of ordinary skill for the
`’148 and ’758 patents in paragraphs 35-36 of his declaration. I have considered the
`level of ordinary skill determined by the PTAB, “at least a bachelor’s degree in
`electrical engineering or an equivalent as well as at least five years of experience in
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`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONSIVE CLAIM
`CONSTRUCTION BRIEF
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`Case 8:19-cv-02115-DOC-JDE Document 139-8 Filed 07/15/22 Page 6 of 17 Page ID
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`the industry working with implantable medical devices such as cardiac pacemakers or
`defibrillators,” and I adopt this level of ordinary skill. I met this definition at the time
`of invention, the conception date of May 23, 2003. IPR2020-00712, FWD at 15-16.
`VI. OVERVIEW OF THE PATENTS
`A.
`’324 Patent
`16. The ’324 patent “relates to implantable medical devices and, in
`particular, to energy transfer devices, systems and methods for implantable medical
`devices.” (’324 patent, 1:28-30.) The ’324 patent explains that some medical devices,
`implanted in a patient, included a rechargeable battery that can be charged by a power
`source from outside the body with the external power source transferring energy to the
`implant’s battery “transcutaneously.” (Id., 1:42-2:14.) The ’324 patent provides an
`overview of several techniques for transcutaneous energy transfer. (See id., 2:15-
`4:64.) These techniques involved driving current in a primary coil (which is part of an
`external device) to induce a current in a secondary coil (which is part of the implant).
`(Id., 4:65-5:10). The current induced in the secondary coil “can then be used to power
`the implanted medical device or to charge, or recharge, an internal power source, or a
`combination of the two.” (Id.)
`17. One issue with wireless charging, however, is that it generates heat in the
`surrounding components. (Id., 5:12-16.) It is possible that placing the external device
`housing in contact with a patients’ skin during recharging could cause burns on the
`patient if it is hot enough during the energy transfer process. (Id., 15:55-16:5.)
`18. The ’324 patent discloses an embodiment to prevent harm to the patient
`through excess temperature in which an external charging device 48 incorporates a
`temperature sensor 87 “positioned in close proximity to” the surface of the external
`device that contacts the patient. (Id., 20:4-22, FIG. 3.) For example, “[p]ositioning
`temperature sensor 87 in the proximity or touching thermally conductive material 62
`enables an accurate measurement of the contact temperature.” (Id.) In one exemplary
`embodiment, the temperature sensor is “located in proximity to the AC coil.” ’324
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`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONSIVE CLAIM
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`patent, 6:47-48. As illustrated in Figure 3, because this primary coil of the charger
`may not be positioned at the side of housing of the charger, “[i]n a specific
`embodiment, an antenna may house the AC coil and the sensor may be thermally-
`coupled to a surface of the antenna to provide an indication of a temperature of the
`surface of the antenna.” ’324 patent, 6:52-55. The specification describes that the
`temperature sensor “can be positioned in close proximity to the thermally conductive
`material [] in order to obtain reasonably accurate information on the temperature of
`the external surface of external antenna [] contacting patient.” ’324 patent, 20:11-15.
`In yet another example (illustrated above), the specification describes that
`“[p]referably, [the] temperature sensor [] is affixed to thermally conductive material []
`with a thermally conductive adhesive.” Id., 20:15-17. The external charging device
`48 further includes “control circuitry” that uses “the output from temperature sensor
`87” to “limit the energy transfer process in order to limit the temperature which
`external antenna 52 imparts to patient 18.” (Id., 20:4-9, 20:23-33.)
`19. This novel system facilitates wireless recharging without compromising
`patient safety. (Id., 20:4-9, 20:23-33.)
`B.
`’148 and ’758 patents
`20.
`In the 2003 time frame, implantable medical devices, such as drug
`infusion pumps and neurostimulators, sometimes included rechargeable batteries as a
`power source. (’148 patent at 1:25-28, 60-61.) These batteries were typically
`recharged transcutaneously (through the skin) through induction. The ’148 Patent
`teaches that there was a need for a system and method to more efficiently transfer
`energy transcutaneously for charging these batteries in order to limit potentially
`harmful heating of the surrounding body tissue and to reduce the charging time
`required to achieve a desired charge. (Id. at 3:3-36.)
`21. The ’148 patent addresses these issues, for example, through a system
`including an external power source that automatically varies the power output of the
`external charging device as a function of parameters associated with the current
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`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONSIVE CLAIM
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`Case 8:19-cv-02115-DOC-JDE Document 139-8 Filed 07/15/22 Page 8 of 17 Page ID
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`passing through the internal power source. (Id. at 3:56- 4:15; 20:65-22:18, FIG. 19.)
`In particular, the ’148 patent discloses, among other things, that the automatic
`variation of the power output of the external charging device can be more efficiently
`and precisely controlled by utilizing multiple inputs relating to the current passing
`through the internal power source. The ’148 Patent describes, for example, the use of
`multiple inputs to the external charging device, rather than a single input, to provide
`more precise control over the charging process to enhance safety and efficiency. (Id.,
`14:18- 43; 21:27-57, FIG. 19.)
`VII. CLAIM CONSTRUCTION
`A.
`“Indicative of”
`
`Medtronic’s
`Proposed
`Construction
`Plain and ordinary
`meaning, which
`is
`synonymous
`with
`“serving as a sign of”
`
`Axonics’
`Proposed
`Construction
`“accurately
`measuring” the
`relevant
`temperature
`
`Claim Terms
`
`“indicative of” in the context of the
`following claim terms:
`
`“a temperature sensor adapted to provide an
`output indicative of a temperature of the
`side of the housing” (’324 patent claims 1
`and 20)
`
`
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`“providing, via a temperature sensor of the
`external device, output indicative of a
`temperature of the side of the housing.”
`(’324 patent claim 12)
`22. Dr. Irazoqui states that “a POSITA would have understood that the
`output of the temperature sensor was required to provide an accurate measurement of
`the relevant claimed temperature—as this is the surface that would have needed to
`meet the safety standards for surfaces that contact patients during operations…”
`Iraqozui Decl ¶ 71. In doing so, Dr. Irazoqui appears to opine that a POSITA would
`understand that the term “a temperature sensor adapted to provide an output indicative
`of a temperature of the side of the housing” means that the temperature sensor must be
`physically located on the side of the housing, and measure the temperature on the side
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`of the housing to a specific degree of numerical precision. I disagree.
`23. First, a POSITA reading the specification would understand that, for a
`temperature sensor to be “indicative of” the temperature at a specific location or part,
`it does not have to be physically placed on, or directly measure that specific location
`or part. Based on the teachings in the specification, there are many reasons why a
`particular application would make it impractical to require direct placement of a
`sensor on a location whose temperature is sought to be measured; for example, the
`location/part may be inaccessible, inconvenient to reach, or damage the sensor
`hardware. For example, in mechanical engineering, an engineer may desire to
`measure the temperature of a part that is so high that it would damage or melt the
`sensor. In such cases temperature can be measured further downstream, and be used
`as a proxy indicative of the temperature at the part. Because the temperature drop
`from the relevant location/part of interest and the downstream measured temperature
`is calculable or verifiable, the downstream location serves as an acceptable proxy for
`the relevant location/part of interest. In the medical field, we frequently place sensors
`at “proxy” locations, such as measuring the patient’s temperature at the forehead,
`underarm, mouth, ear, and rectum as a proxy for core body temperature, which is
`impractical to measure. The temperature measured at these locations serve as a proxy
`for the temperature of the actual region of interest.
`24. Furthermore, mechanical longevity of the sensor itself may necessitate or
`make the use of a proxy location more desirable. POSITAs would have understood
`reading the specification that directly exposing sensors to the environment outside of a
`housing increases the probability of breakage or excessive wear and tear, which can
`lead to premature failure of the sensor or inaccurate measurements. In mechanical
`engineering, putting a sensor on a moving part may not be feasible or may increase the
`complexity of the system, and thus taking a measurement downstream in the system
`can also serve as an acceptable proxy. Based on the teachings in the specification, a
`POSITA would be aware of the design choices and techniques for using a proxy
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`measurement location for the desired region or location of interest.
`25. The specification of the ’324 patent confirms this understanding. It states
`that a temperature “sensor may be used to measure a parameter that correlates to a
`temperature of the system during recharge. For example, the measured parameter may
`be the temperature of a surface of an antenna of the external power source during
`recharge.” ’324 patent, 5:51-54. (emphasis added). Various other of the sensor in the
`specification make clear that it is not limited to a specific location, but is “configured
`for measuring a temperature generated by the external device during coupling of the
`energy into the implantable medical device.” ’324 patent, 6:5-7.
`26. The specification describes locations on or in the charging device at
`which the sensor may be located. The specification states: “[t]he sensor may be
`carried by the antenna. In a more particular embodiment, the sensor may be
`thermally coupled to a surface of the external antenna to measure a temperature to
`which a patient is being exposed.” ’324 patent, 6:17-20 (emphasis added). A
`POSITA would understand from the specification that the implementation described
`in a “particular embodiment” would not be required of all embodiments contemplated,
`and would understand that there may be embodiments that do not require a sensor
`thermally coupled to a surface.
`In one embodiment, the temperature sensor is “located in proximity to
`27.
`the AC coil.” ’324 patent, 6:47-48. The “AC coil” of this paragraph refers to
`“primary coil 54. See id., 5:3-7 (“The external coil, or primary coil, is associated with
`the external power source or external charger, or recharger. The primary coil is drive
`with an alternating current.”) 9:55-58 (“Charging unit 50 contains the electronics
`necessary to drive primary coil 54 with an oscillating current in order to induce
`current in the secondary coil 34 when primary coil 54 is placed in proximity of the
`secondary coil 34.”)
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`28. As illustrated in Figure 3 (annotated below), because this primary coil of
`the charger may not be positioned in relative proximity to the side of housing of the
`charger, “[i]n a specific embodiment, an antenna may house the AC coil and the
`sensor may be thermally-coupled to a surface of the antenna to provide an indication
`of a temperature of the surface of the antenna.” ’324 patent, 6:52-55 (emphasis
`added).
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`29.
` I have annotated the figure above to provide potential locations of the
`sensor disclosed in the specification: (1) “in proximity to the AC coil”; (2) “proximal
`to the thermally conductive material”; and (3) “affixed to the thermally conductive
`material.” A POSITA reading the specification would understand that each of these
`locations, even if it is not directly connected to the side of the external charger, is able
`to provide an output indicative of the temperature of the side of the housing. The
`specification describes facilitating the transfer of heat using a “thermally conductive
`material … located in proximity to the temperature sensor to spread any generated heat
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`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONSIVE CLAIM
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`over a larger area and to make temperature (e.g., on a surface of a patient’s skin) more
`uniform.” ’324 patent, 6:48-50. A POSITA would understand that each of these
`locations, would provide an output that is correlated to or indicative of the temperature
`of the side of the housing, and could, if required for the particular application, correct
`or scale the output accordingly (based on empirical data, testing, simulation, or
`calculation) to obtain the temperature of the side of the housing within the accuracy
`tolerances demanded by the particular application.
`30. The embodiment of the specification states that the temperature sensor
`“can be positioned in close proximity to the thermally conductive material [] in order
`to obtain reasonably accurate information on the temperature of the external surface of
`external antenna [] contacting patient.” ’324 patent, 20:11-15 (emphasis added). In yet
`another example (illustrated above), the specification describes that “[p]referably, [the]
`temperature sensor [] is affixed to thermally conductive material [] with a thermally
`conductive adhesive.” ’324 patent, 20:15-17 (emphasis added). In all of these different
`possible locations in the charging device housing, the temperature sensor is able to
`provide an “output indicative of a temperature of the side of the housing” of the external
`charging device, even though the sensor is not physically located on, or measuring, the
`side of the housing. A POSITA would have no difficulty understanding this,
`particularly in the context of the claims and specification.
`31. Second, I disagree with Dr. Irazoqui’s contention that “indicative of”
`means “accurately measuring (to within a 0.1º C margin).” Dr. Irazoqui’s construction
`is defined in two parts—he proposes that “indicative of” means “accurately measuring,”
`then defines “accurate” as within 0.1 degrees Centigrade, or confusingly, in some
`scenarios 0.3 degrees Centigrade. I disagree that a POSITA reading the specification
`of the ’324 patent “would have also understood that ‘accurately’ would typically be
`defined by the minimum required resolution (i.e., 0.1º C).” Irazoqui Decl. ¶ 68.
`32. As discussed above, there is nothing in the claim term “output indicative
`of a temperature of the side of the housing” that requires that the output be identical to
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`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONSIVE CLAIM
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`the temperature of the side of the housing, rather than a proxy location or value that is
`correlated with the temperature of the side of the housing. Furthermore, there is nothing
`in the claim language that would suggest to a POSITA that any particular degree of
`precision is required.
`33.
` I disagree that the exemplary embodiments of the specification require a
`precision of 0.1º C. A POSITA would understand that particular regulations or
`operating requirements may be benefitted by higher precision measurement, but this
`does not mean it is required. For example, if the output of the temperature sensor has
`resolution or margin of error of 5º C, the claimed invention could still control the
`transfer of energy to the implantable medical device based on this output to limit a
`temperature to which a patient is exposed. If, in this example, the temperature limit (of
`the side of the housing) targeted by the system was 38º C, the control circuitry could
`limit the transfer of energy to the implantable medical device if the output of the
`temperature sensor reads 33º C. Therefore, even if the difference between the output of
`the temperature sensor and the temperature to which the patient is exposed is 5º C, the
`claimed invention can still ensure that the temperature to which the patient is exposed
`does not exceed 38º C. An error margin of 1º C or .1º C is not necessary to achieve this
`result. Thus, as a practical matter, the claimed control circuit is perfectly capable of
`performing its function without limiting the claims in the manner Dr. Irazoqui proposes.
`34. Furthermore, Dr. Irazoqui’s conclusion that 0.1º resolution is necessary
`because the specification identifies “a general 0.1º C increase (i.e., 38º C reading) in
`temperature over normal patient temperature (for example, 37º C) as ‘deleterious’” does
`not follow. The specification merely states: “[i]n a preferred embodiment, external
`charging device 48 incorporates temperature sensor 87 in external antenna 52 and
`control circuitry in charging unit 50 which can ensure that external antenna 52 does not
`exceed acceptable temperatures, generally a maximum of thirty-eight degrees
`Centigrade (38° C.).” ’324 patent, 20:4-9. As I explained above, ensuring that the
`temperature to which the patient is exposed does not exceed a certain limit does not
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`require the output of the temperature sensor to accurately measure (to within a 0.1º C
`margin) the temperature of the side of the housing. And as discussed above, the
`specification includes an example embodiment in which the temperature sensor is
`“located in proximity to the AC coil.” ’324 patent, 6:47-48. A POSITA would
`understand from these disclosures that the specification and claims allow for the output
`of the temperature sensor to have varying degrees of accuracy with respect to the
`temperature of the side of the housing, while still providing an output “indicative of”
`the temperature of the side of the housing.
`35. A POSITA reading the specification would understand that the resolution
`required by the temperature sensor is a design choice based on the requirements of the
`application and other components in the device. The engineer designing the component
`must balance these factors, along with cost of the components, ease of manufacture,
`durability, among a slew of other factors, to properly select the resolution of the
`temperature sensor. A POSITA would understand all of these considerations in
`designing the claimed device, and would not understand that the claim is limited to one
`of the exact embodiments in the specification.
`36.
`In fact the specification expressly allows for this, stating that, for example,
`“[w]hen the temperature sensed by the temperature sensor is well below preset
`temperature limits, it may be acceptable to report the temperature with relatively
`less precision. As an example, if the temperature sensed by temperature sensor 87 is
`more than two degrees Centigrade (2° C.) away from a preset limit of thirty-eight
`degrees Centigrade (38° C.), it may be acceptable to know the temperature with an
`accuracy of three degrees Centigrade (3° C.).” ’324 patent, 20:34-41 (emphasis
`added).
`37. Dr. Irazoqui attempts to reduce Medtronic’s proposed construction to
`absurdity, arguing that a “sign of a temperature, such as for example ‘hot’ or ‘cold,’
`would not prevent the claimed system from exceeding a temperature limit.” Irazoqui
`Decl. ¶ 68-69. This is not a reasonable interpretation of how a POSITA would
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`DECLARATION OF DR. RONALD D. BERGER, M.D., IN SUPPORT OF PLAINTIFFS’ RESPONS