`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________
`
`AXONICS MODULATION TECHNOLOGIES, INC.
`Petitioner
`v.
`
`MEDTRONIC, INC.
`Patent Owner
`
`____________________
`
`Case IPR2020-00712
`Patent 8,738,148
`____________________
`
`REBUTTAL DECLARATION OF DR. RICHARD T. MIHRAN
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`
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`MEDTRONIC EXHIBIT 2010
`Axonics Modulation Technologies, Inc. v. Medtronic, Inc.
`IPR2020-00712
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`Page 1 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
`
`
`I.
`II.
`
`TABLE OF CONTENTS
`Introduction ...................................................................................................... 1
`Response to Dr. Panescu’s Opinions ............................................................... 2
`A.
`Schulman (Ex. 1005) ............................................................................. 2
`B.
`Fischell (Ex. 1006) ................................................................................ 8
`III. Conclusion .....................................................................................................10
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`Page 2 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`I, Dr. Richard T. Mihran, declare as follows:
`
`I.
`
`Introduction
`I have been retained by Medtronic, Inc. (“Patent Owner”) as an
`1.
`
`independent expert consultant in this proceeding before the United States Patent and
`
`Trademark Office (“PTO”). I previously provided testimony in this proceeding in
`
`my December 22, 2020 declaration. (See Ex. 2002.) As with my previous work
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`relating to this proceeding, no part of my compensation is contingent on the nature
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`of my findings, the presentation of my findings in testimony, or the outcome of this
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`or any other proceeding. Relevant aspects of my educational background, career
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`history, and other qualifications were provided in my December 22, 2020
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`declaration. (See id. at ¶¶5-17.)
`
`2.
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`I have been asked to review and consider certain testimony provided by
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`Dr. Dorin Panescu in his declaration submitted March 19, 2021 in support of
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`Axonics’ Reply (Ex. 1012) and provide my opinions regarding his positions. My
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`rebuttal opinions are set forth below, which respond to certain opinions offered by
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`Dr. Panescu. My opinions in this rebuttal declaration are based on the documents I
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`reviewed and my knowledge and professional judgment. In forming my opinions in
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`this rebuttal declaration, I considered the Declaration of Dr. Panescu (Ex. 1012) and
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`any other materials I refer to in this declaration in support of my opinions. In
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`forming these opinions, I have also drawn on my knowledge and experience
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`1
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`Page 3 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`regarding methods and components used for charging of batteries in portable
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`devices, including implantable medical devices, and rely on my opinions and
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`discussions set forth in my December 22, 2020 declaration relating to my rebuttal
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`positions, including my opinions regarding the level of skill of one of ordinary skill
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`in the art.1 In providing my rebuttal to Dr. Panescu’s positions, I provide my
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`opinions below to explain why I believe certain of Dr. Panescu’s positions are
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`incorrect.
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`II. Response to Dr. Panescu’s Opinions
`A.
`Schulman (Ex. 1005)
`3.
`Dr. Panescu contends that Schulman discloses an external power source
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`that varies its power output based on two separate inputs: (1) “a value associated
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`with said current passing through said internal battery” and (2) “a signal proportional
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`to said current passing through said internal battery” or “measured voltage
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`associated with said current passing through said internal battery” as recited in
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`1 As with my prior declaration, the opinions I provide below remain the same under
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`both my definition and Dr. Panescu’s definition of a person of ordinary skill in the
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`art. (Ex. 2002 at ¶¶21-24.)
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`2
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`Page 4 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`claims 3, 6, 9, 12, 15, and 18 of the ’148 patent.2 (Ex. 1012 at ¶¶11-17.) For the
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`second input (the “Signal Limitation” or “Measured Voltage Limitation”), Dr.
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`Panescu opines that “Schulman teaches automatically varying the output power of
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`the external power source based on a measured voltage or a signal, where the signal
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`is the voltage across the output leads 51 and 52.” (Id. at ¶16.)
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`4.
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`I disagree with Dr. Panescu’s position that the voltage between nodes
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`51 and 52 (highlighted in red in annotated Figures 2 and 3 of Schulman below) is
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`used as a separate input to vary the output power of a power source in Schulman.
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`The voltage between nodes 51 and 52 is never provided to the external power source
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`in Schulman. As I explain below, Dr. Panescu relies on the same input as satisfying
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`both the first input (“Value Limitation”) and the second input (“Signal Limitation”
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`or “Measured Voltage Limitation”).
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`2 Dr. Panescu mistakenly states that claim 18 recites a “signal proportional to said
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`current passing through said internal battery” (Ex. 1012 at ¶10), but claim 18 does
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`not include that limitation. Instead, the second input of claim 18 is a “measured
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`voltage associated with said current passing through said internal battery.” (Ex.
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`1001 at 25:9-25.)
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`3
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`Page 5 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`(Id. at FIGs. 2, 3 (annotated).)
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`5.
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`As I opined in my previous declaration, Schulman discloses that the
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`sole input provided to the external power source that the external power source
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`uses to automatically regulate its power output is the input that derives from the
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`amount of current flowing through the current sampling resistor R9 (highlighted in
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`blue in annotated figure 2 above). (Ex. 1005 at 4:45-53, 6:35-38, Ex. 2002 at ¶46.)
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`My understanding of Dr. Panescu’s opinion is that he does not contend that the
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`voltage between nodes 51 and 52 is ever sent to the external power source as an
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`input, and instead simply asserts that if “the voltage across leads 51 and 52 exceeds
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`a predetermined amount,” then the current through R9 increases, which in turn
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`“causes the power supplied by the external power source to decrease.” (Ex. 1012 at
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`¶16.) This does not represent a separate input, however, because the input derived
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`from the current flowing through the current sampling resistor R9 (i.e. the load
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`modulation frequency of telemetry circuit 12, the components of which “form a free-
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`running multivibrator") is what Dr. Panescu also identifies as satisfying the first
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`4
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`Page 6 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`input, “a value associated with said current passing through said internal battery.”
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`(Ex. 1012 at ¶14 (“when the current through the internal battery… increases above
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`a predetermined target value, the current regulator turns on, increasing the current
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`through current sampling resistor R9.”) Thus, as I summarize in the chart below,
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`Dr. Panescu points to the same single input, the input derived from the amount of
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`current flowing through the current sampling resistor R9, as satisfying both inputs
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`required by the Challenged Claims.
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`Claim Limitation
`“value associated with current passing
`through said internal battery” (the
`“Value Limitation”; all claims)
`
`“signal proportional to said current
`passing through said internal battery”
`(the “Signal Limitation”; claims 3, 9,
`15)
`“measured voltage associated with said
`current passing through said internal
`battery” (the “Measured Voltage
`Limitation”; claims 6 ,12, 18)
`
`
`
`Panescu Supplemental Declaration
`“current through current sampling
`resistor R9… increases when the
`magnitude of the charging current
`passing through the internal battery
`exceeds a predetermined current” (Ex.
`1012 at ¶12)
`“current through current sampling
`resistor R9 increases… when the
`voltage across the output leads 51 and
`52 exceeds the predetermined
`maximum amount.” (Ex. 1012 at ¶12)
`
`6.
`
`The input to the external power source derived from the amount of
`
`current flowing through the current sampling resistor R9 represents a single,
`
`monitored parameter used to control the output power from the external power
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`5
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`Page 7 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`source.3 While various operating conditions may influence the value of this
`
`parameter, it is nevertheless the only parameter and only value that is communicated
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`to the external power source. Thus, the external power source of Schulman only
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`uses a single input, the input derived from the amount of current through R9, to
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`regulate its power output. That singular input cannot satisfy both of the two inputs
`
`required by claims 3, 6, 9, 12, 15, and 18 of the ’148 patent. As such, I disagree with
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`Dr. Panescu’s assertion that “Schulman teaches separate respective inputs used by
`
`the external power source as a basis for automatically varying its power output.”
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`(Ex. 1012 at ¶17 (emphasis added).)
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`7.
`
`I understand Dr. Panescu’s opinion to be that, because Schulman
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`discloses that the current through R9 is used by the external charger to automatically
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`vary its output, any “value” that influences the amount of current through resistor
`
`R9 is a “separate respective input[] used by the external power source as a basis for
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`3 I disagree with Dr. Panescu’s assertion that the current through R9 is increased as
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`a result of the current regulator R8/Q7 turning on. (Ex. 1012 at ¶14). Instead, it is
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`the increase in current through R9 in excess of the desired 40 mA operating current
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`that causes the current regulator R8/Q7 to turn on, which acts to shunt this excess
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`current through Q7, thereby diverting it away from the battery to maintain the
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`desired operating condition during charging. (Ex. 1005 at 5:2-7, 5:15-38, 9:57-68.)
`
`6
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`Page 8 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`automatically varying its power output.” (Id.) In other words, Dr. Panescu simply
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`identifies a voltage across two points in the circuit that he claims affects the current
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`through R9 and contends that that voltage satisfies one of the two required separate
`
`inputs based on its alleged indirect impact on the output of the external charger.
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`This strained interpretation of the claims renders superfluous the two separate inputs
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`to the external power source required by claims 3, 6, 9, 12, 15, and 18 of the ’148
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`patent: (1) “a value associated with said current passing through said internal
`
`battery” and (2) “a signal proportional to said current passing through said internal
`
`battery” (claims 3, 9, and 15) and “measured voltage associated with said current
`
`passing through said internal battery” (claims 6, 12, and 18). In any circuit, there
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`may be multiple components (e.g., transistors, switches, diodes, etc.) that can
`
`influence the current through a particular resistor. For example, in Schulman the
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`current drawn by the stimulation portion of the implant circuit will influence the
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`amount of current through R9. Dr. Panescu’s interpretation that a voltage or current
`
`at these components represents a “separate input” in Schulman is incorrect, because
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`the sole input that is telemetered back to the external charger is the input derived
`
`from the amount of current flowing through R9.
`
`8.
`
`Thus, Dr. Panescu has failed to show where Schulman discloses the
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`requirement of claims 3, 6, 9, 12, 15, and 18 that two separate inputs to the external
`
`power source are used to vary the power output of the external power source.
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`7
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`Page 9 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`
`B.
`9.
`
`Fischell (Ex. 1006)
`Dr. Panescu contends that Fischell discloses an external power source
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`that varies its power output based on both “a value associated with said current
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`passing through said internal battery” and “a signal proportional to said current
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`passing through said internal battery” as recited in claims 3, 9, and 15 of the ’148
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`patent. (Ex. 1012 at ¶¶22-29.) While Dr. Panescu’s opinion is not clear in this
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`regard, he seems to imply that the battery voltage in Fischell constitutes “a signal
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`proportional to said current passing through said internal battery.” (Id.) However,
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`Dr. Panescu simply ignores the critical remaining portion of the limitation at issue,
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`which requires that the “external power source automatically varies its output
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`based on” that signal.
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`10. Fischell does not disclose that the battery voltage is an input to the
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`external charger used to automatically vary its output. Fischell discloses two types
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`of telemetry data: “a. telemetry by means of pulse rate to measure battery voltage”
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`and “b. telemetry by means of a frequency modulated signal from the pulse generator
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`into the external charger to measure and control charge current into the battery.”
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`(Ex. 1006 at 372.) Dr. Panescu states “[e]ither or both of these values can regulate
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`the charging of the implanted device battery” (Ex. 1012 at ¶26) and relies on
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`telemetry “b” as satisfying the first input (the “Value Limitation”) (id. at ¶24).
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`Though it is by no means clear in Dr. Panescu’s declaration, to the extent Dr.
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`8
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`Page 10 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`Panescu’s opinion is that telemetry “a” satisfies the second input (the “Signal
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`Limitation”), I disagree for the reasons below. (Ex. 1012 at ¶¶24-25.)
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`11. The telemetry based on the battery voltage (telemetry “a”) is derived
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`from the inherent behavior of the stimulation circuitry, which simply exhibits a small
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`change in the pulse rate of the pacing stimuli as the battery discharges, but is not
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`used by and does not affect the operation of the external charger. (Ex. 2002 at ¶42.)
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`Rather, Fischell merely discloses that the doctor and patient can observe the pulse
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`rate of the pacing stimuli to estimate the battery voltage. (See Ex. 1006 at 272 (“Fig.
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`10 shows the pacer rate as a function of cell voltage… the highest battery voltage
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`during discharge is observed immediately after the charge period… The minimum
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`voltage is observed at the end of the discharge period… These pulse rates are
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`nominal and will vary slightly from one unit to another. However all pulse
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`generators have a characteristic which is a change of about 2 ppm after one week of
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`discharge. Four more weeks of discharge will reduce the pulse rate by an additional
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`2 to 4 ppm.”).) Thus, Fischell discloses that the doctor can, by monitoring pulse rate
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`of the pacing stimuli, estimate the charge state of the battery.
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`12. Critically, Fischell does not disclose automatically varying the power
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`output of the external source based on either the pacing pulse rate or battery voltage,
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`nor does Dr. Panescu allege that it does. (Ex. 2002 at ¶55, n. 4; Ex. 1006, 370-373.)
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`Dr. Panescu appears to recognize that Fischell does not actually disclose the second
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`9
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`Page 11 of 12
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`Rebuttal Declaration of Dr. Richard Mihran
`U.S. Patent No. 8,738,148
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`input limitation (the “Signal Limitation”), instead simply asserting that “Fischell’s
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`telemetry circuit can be indirectly understood to be capable of controlling
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`charging energy of the external charger based on the charging voltage
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`determined for the implanted device battery.” (Ex. 1012 at ¶27 (emphasis added).)
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`Therefore, in my opinion, Dr. Panescu has failed to show where Fischell discloses
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`the requirement of claims 3, 9, and 15 that two separate inputs to the external power
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`source are used to vary the power output of the external power source.
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`III. Conclusion
`I declare that all statements made herein of my knowledge are true, and that
`13.
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`all statements made on information and belief are believed to be true, and that these
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`statements were made with the knowledge that willful false statements and the like so
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`made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of
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`the United States Code.
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`Dated: October 31, 2023
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`By: _____________________
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`
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`
` Dr. Richard Mihran
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`10
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`Page 12 of 12
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