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` UNITED STATES DISTRICT COURT
` CENTRAL DISTRICT OF CALIFORNIA
`
`_________________________________
` )
`MEDTRONIC, INC., et al., )
` )
` Plaintiffs, )
` )
`vs. ) No. 8:19-CV-02115
` )
`AXONICS MODULATION TECHS., INC., )
` )
` Defendants. )
`_________________________________)
`
` REPORTER'S TRANSCRIPT OF PROCEEDINGS
` San Francisco, California
` Wednesday, September 12, 2022
`
`Reported by:
`CATHERINE A. RYAN, RMR, CRR, B.S.
`CSR No. 8239
`Job No. 5345508
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`PAGES 1 - 194
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`Axonics Exhibit 1032
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
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`Page 1 of 25
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` UNITED STATES DISTRICT COURT
` CENTRAL DISTRICT OF CALIFORNIA
`
`_________________________________
` )
`MEDTRONIC, INC., et al., )
` )
` Plaintiffs, )
` )
`vs. ) No. 8:19-CV-02115
` )
`AXONICS MODULATION TECHS., INC., )
` )
` Defendants. )
`_________________________________)
`
` REPORTER'S TRANSCRIPT OF PROCEEDINGS
` San Francisco, California
` Wednesday, September 12, 2022
`
`Reported by:
`CATHERINE A. RYAN, RMR, CRR, B.S.
`CSR No. 8239
`Job No. 5345508
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`PAGES 1 - 194
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`Axonics Exhibit 1032
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
`
`Page 1 of 25
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`Page 117
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` SPECIAL MASTER KEYZER: Okay. So we'll take a
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`30-minute lunch recess. We'll resume at 12:30 p.m.
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` (Lunch Recess.)
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` SPECIAL MASTER KEYZER: Okay. We're back on
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`the record after our lunch recess, and let me check. I
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`think the next term we have for argument is the
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`"associated with" term; is that correct?
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` MR. NATHAN: Yes.
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` SPECIAL MASTER KEYZER: Okay. Which side
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`would like to go first?
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` MR. NATHAN: Axonics will go first.
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` SPECIAL MASTER KEYZER: Is that okay with
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`Medtronic?
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` MS. WICKRAMASEKERA: Yes, it is.
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` SPECIAL MASTER KEYZER: Okay. Please state
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`your name and begin when you're ready.
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` MR. NATHAN: Thank you, Mr. Keyzer. Aaron
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`Nathan for Axonics.
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` With respect to the value "associated with"
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`said current term, the question for the house in light
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`of the tentative ruling is whether the term "associated"
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`should be construed to be proportional or whether it
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`should be unconstrued and presented to the jury as a
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`plain-meaning term.
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` In the context of the claims and the
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`specification, the term "associated" has a specific
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`meaning, but that needs to be clarified for the jury.
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`It can't be left to the jury to decide for itself what
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`constitutes an appropriate degree or form or manner of
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`association.
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` If we read the claims -- I have exemplary
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`claim 1 of the '758 patent on slide 4 -- we see that
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`this claim involves an external power source that's
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`providing energy to an implantable medical device. That
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`energy generates a current. The current has a value.
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`The current passes through the internal power source of
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`the implant. The external power source is then required
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`to automatically vary power output based on a value
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`associated with that current, the electrical current
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`passing through the battery of that implanted device.
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`"Associated" in this context cannot be unhinged.
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` And I'll start my discussion -- my discussion
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`of the intrinsic evidence beyond the claims themselves
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`with the reference to the Special Master's tentative
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`ruling.
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` We have there the quote that I have on the
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`screen from page 59 that says the phrase "associated
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`with" is broad such that there may indeed be many
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`different types of values related to the current. Fair
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`enough. "Associated with," as written, is a potentially
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`broad term. However, its breadth is not one that will
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`be apparent to the jury, and it must be construed, as
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`you know, in the context of the purpose of the invention
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`and the disclosures of the invention that are actually
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`provided in this patent so that the jury is not left at
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`sea, attempting to decide, in the context of an
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`electrical system that is implanted in a human body,
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`what degree of association with a specific electrical
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`current is sufficient, what form or manner of
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`association is within what the inventors claimed and
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`what the specification describes.
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` I won't tarry on this law. We've seen it
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`already today, but the Cohesive Technologies case makes
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`clear that claim construction is not intended to be
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`conducted in a vacuum. It is intended to be conducted
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`with a view to ensuring that the claims actually fulfill
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`the purpose of the invention as stated in the patent.
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` What is that purpose? On slide 11, I'm
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`presenting two parallel call-outs from the specification
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`of the '148 patent. It's the same in '758 as well.
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`We've got a diagram showing a flow-through software
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`where the external charger must evaluate whether the
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`current actually going through that battery on the
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`implant exceeds a certain value. It uses that
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`determination, not some vague determination about some
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`other value that might be, in some way conceivable,
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`associated with that current -- the current, how much
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`current is going through the battery, the one we're
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`trying to charge. It tests it. It interrogates whether
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`it's above a certain threshold. If it is, it reduces
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`the power. If it's not, it asks further questions about
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`the amount of power and whether the amount of power
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`being sent is too high or too low, and then it makes an
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`adjustment accordingly.
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` And then, finally, if the current, again, the
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`one actually going through the battery that we're
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`attempting to charge, is below a certain minimum floor,
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`the external charger assesses that the charging process
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`is now complete. This is what the invention is about.
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`This is what having a value associated with the current
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`going through the internal power source is for. This is
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`its purpose. The specification describes exactly how
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`it's to be used.
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` And if you think, and reasonably so, that the
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`specific values -- 50 milliamps, for instance, greater
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`than that, 5 milliamps at the end, less than that --
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`that these are exemplary, fair enough. They may well
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`be, but the concept that you have to have a value that
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`actually tells you how much current is going through the
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`battery, the one you're trying to charge, is not
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`exemplary. It's not optional. It's what this invention
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`is about. "Associated" unconstrued does not explain
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`that to the jury.
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` Now, the specification -- and this is a
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`portion of the specification that I -- that I will
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`linger on because it's much discussed, and it's very
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`important. On slide 14, we see it, columns 20, line 65
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`through 21:12 of the '148 patent. This disclosure is
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`going to be the only disclosure anywhere in these
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`patents that tells you anything about what is meant by a
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`value associated with that current, the one that goes
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`through the battery.
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` You have more than one way, concededly, to
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`find out what that current is. One is you measure it
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`directly, the actual current, the one going through the
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`battery. You measure it. That's option one. The
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`specification is very clear about that.
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` The specification is also concededly clear,
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`which we'll see from the highlights on slide 15, that
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`this is not necessary. It is not necessary in order to
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`know how much current is going through that battery to
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`measure the specific current going through that battery
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`directly. Instead, it is permissible to measure a value
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`that the specification refers to as "associated," and
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`then it gives one lone example of what "associated"
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`means, associated with that current going through that
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`battery. It says something that's proportional to it.
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` So if we're not going to measure the current
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`directly, we're going to measure a current or a voltage
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`that is proportional to the current going through the
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`battery. That is, the patent discloses an acceptable
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`and an accepted way to find out the information that we
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`know the software that I was showing to you earlier
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`needs in order to fulfill the purpose of this invention
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`and these claims.
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` Now, fair enough. "e.g." is an abbreviation
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`of a Latin phrase that means "for example." This is
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`true. We don't dispute it. However, in this
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`circumstance where the only possible example provided by
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`the specification is a proportional value, one that is
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`proportional to the current that you actually care about
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`in order to fulfill the purpose of the invention, the
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`use of the potentially broadening phrase "e.g." must
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`cede to what the inventors actually disclosed in their
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`specification as the only plausible meaning of an
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`otherwise completely vague and borderless term.
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` Now, I'll linger here for a moment longer to
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`address a point that you raised in the tentative ruling.
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`In the tentative ruling, you cited to a portion of a
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`reply in the IPRs related to these patents in which
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`Axonics stated -- and I'm paraphrasing -- that "e.g.,"
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`the earlier "e.g." phrase, not the one that relates to
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`specifically the meaning of the word "associated," but
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`that relates to the meaning of the word "value" in this
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`same disclosure -- that this "e.g." indicated or implied
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`that there is a genus of possible values. It could be
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`current. It could be voltage. I'm talking about the
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`phrase "measuring a value, e.g., current or voltage,"
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`that phrase.
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` Now, in that context, in those IPRs -- and
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`this is clear in our briefing -- the only values that
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`Axonics actually addressed were proportional ones, but I
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`want to linger for a moment on the implication of the
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`statement that "e.g." proposes the existence of a genus.
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`That is the beginning, not the end of claim
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`construction.
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` In the IPRs, there wasn't a dispute that
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`current and voltage were in the genus. And there wasn't
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`a question as to the -- there wasn't the resolved
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`question as to the breadth of other possible
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`embodiments, other possible implementations of the term
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`"value" in the specification. There was not. Had there
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`been, or should there arise one here, such as, for
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`instance, in addition to current, in addition to voltage
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`as standard measures of current, would magnetism
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`suffice? Would using a magnet as an indication of the
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`strength of current flowing through a part of a circuit
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`-- would that be within the proposed genus? This would
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`be a question of claim construction, not one for the
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`jury.
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` It would not be for the jury to decide should
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`there be a dispute about the scope of the genus
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`associated with value in this disclosure. It would not
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`be for the jury to decide what are the undisclosed,
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`implied members of that genus that would be apparent to
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`a person of skill in the art. That is not a jury
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`question.
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` So, too, here where the word is "associated,"
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`if your reasoning from the -- from the tentative ruling
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`applies to the phrase "e.g., proportional," just as it
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`did to the phrase "e.g., current or voltage," then the
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`implication is the specification proposes the existence
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`of a genus without stating any other members of the
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`genus besides the one, the only proportional. If we
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`believe that "e.g., proportional" indicates or implies
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`the existence of a genus, it is a question of claim
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`construction: What else if anything is a member species
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`of that genus? That is the implication of the
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`reasoning. That is the implication of the reasoning.
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` It is not an implication that the jury is able
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`to resolve for itself based on competing expert
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`arguments about what degree of so-called association
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`constitutes a claimed association in the context of a
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`complex printed circuit board assembly implanted into
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`the human body where the question is: Precisely, which
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`current are we measuring? How are we measuring it? How
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`are we using that measure of current in order to control
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`a charge process that has to not burn people and that
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`has to actually facilitate the replenishment of power on
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`the implant? This passage of specification following
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`that reasoning requires claim construction. It does not
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`avoid it.
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` Now, we have read your comments on
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`indefiniteness, and we are, of course, mindful of them.
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`We raised the indefiniteness issues because, as we've
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`said, in the absence of a construction, asserting that
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`the term "associated" in the context of this patent and
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`this invention is the one disclosed example, the only
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`disclosed example, proportionally -- in the absence of
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`that, there are no boundaries and there's no -- there is
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`no -- there is no indication to the jury what would be
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`in and what would be out. So if that is adopted, we
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`will be bringing, at the appropriate time by appropriate
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`motion under the appropriate burden of proof, a full
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`submission of testimony and opinions from experts the
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`issue of whether these claims are invalid as indefinite.
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` I'd like to address briefly a few of
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`Medtronic's arguments. First, Medtronic argues that the
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`term "associated with" is ubiquitous in patents. They
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`cite a couple of cases for this in particular that I'm
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`going to address.
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` I'm want to start by noting, however, that
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`there was the case that you cited on page 29 of the
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`tentative in connection with a different term, the
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`E-Digital versus -- the E-Digital versus FutureWay
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`(phonetic) case, and the language of the quote that was
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`included in the tentative is claims of unrelated patents
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`must be construed separately.
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` The patents at issue in the cases Gracenote
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`and American Calcar could not be more unrelated from the
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`patents at issue here. Those patents -- we'll do
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`Gracenote first. This involved a music database. It is
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`well within the purview and the competence of a lay jury
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`to be able to understand what is meant when we say that
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`"On the Nature of Daylight" isn't associated necessarily
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`with the same artist or album as the Four Seasons. What
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`we're talking about is a music database that associates
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`related information and unique identifier of a CD, the
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`title, the titles of the tracks, the artist, perhaps the
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`year that it's published. "Associated" in this context
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`is well within the parameters of what a jury is able to
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`assess on its own and says absolutely nothing whatsoever
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`about how a jury is to ascertain what is associated with
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`a particular current going through the battery of a
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`medical implant and what is not.
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` Similarly, in American Calcar, what was this
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`about? It was about infotainment systems in cars where
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`you press a touchscreen, and the touchscreen describes a
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`function of the automobile, such as windshield wipers,
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`such as radio, such as fuel levels or mileage. We tap
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`on that, and it provides information associated with the
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`function of the car that corresponds to the word on the
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`virtual button on the screen.
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` This is well within the competence of a lay
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`jury to assess for itself. "Associated" in this context
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`is knowledge that a jury can have by driving its -- by
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`driving a car to the courthouse to sit on the jury.
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`This is within lay experience, in other words. And
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`knowing that "associated" did not require clarification
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`in this context beyond a very, very broad, broad meaning
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`does not tell us anything, not anything at all, about
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`how a jury is going to find which way to go on what
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`values are associated with a particular current going
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`through the battery on a medical implant. Not so.
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` Now, Medtronic also argues that because the
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`word "proportional" appears in certain claims,
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`"associated" must not mean "proportional." What we have
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`here is a very soft, very weak form of intraclaim term
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`differentiation.
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` First of all, the terms are different beyond
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`merely the question of whether the term is "associated"
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`or "proportional." We've got a value associated with
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`said current. We've got a signal proportional to said
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`current. There's no disagreement that these are
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`different terms. There is, therefore, little to no
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`weight given to the notion that "associated" cannot mean
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`"proportional," little to none.
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` I'll also state: Medtronic argues that
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`Axonics is improperly attempting to incorporate an
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`infringement analysis in claim construction, and they
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`rely on the SRI case and the NeoMagic case for this.
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`First, we're not. We're saying that the term
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`"associated" requires clarification for the jury.
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`There's only one instance of it being given any meaning
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`at all in the specification. Without that, the jury
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`will be completely at sea. That's what we're saying.
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` Secondly, though, the cases that they've
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`relied on are old cases, and the federal circuit has
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`made it plain since then in the Wilson Sporting Goods
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`case that the rule doesn't go as far as Medtronic says
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`it goes.
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` Claim construction is not meant to be
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`conducted in a vacuum. We've shown examples -- we've
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`shown examples where it is simply impossible to tell
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`what meaning "associated" could indeed have or how a
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`jury is to assess its meaning, and to look at that
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`question in the context of the accused products and how
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`they function is entirely proper.
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` But we don't have to get there. We don't have
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`to get there because we have a specification in a highly
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`technical field of electrical engineering in the context
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`of medical devices where there is an overlay of
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`regulatory compliance and safety and treatment, and if
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`all we had were electrical engineering and the question
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`was what current is associated with what, that would not
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`be a jury question. And in this context where that's
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`being used for a very specific -- specific control
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`purpose by the device, the charging device, that is
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`doubly not a jury question.
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` Now, I'll end with O2Micro. This is, of
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`course, famous language: When the parties present a
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`fundamental dispute regarding the scope of a claim term,
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`it's the Court's duty to resolve it. There's a
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`fundamental dispute here. It's not one for the jury to
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`resolve.
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`Page 130
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` The word "associated" is vague. It is broad,
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`and no one has explained what meaning it could possibly
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`have in this context except for one line in the midst of
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`a specification that everyone agrees is included. To
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`the extent that it declares a genus, we don't know what
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`the other members are. Medtronic hasn't said what they
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`are. Their expert hasn't said what they are. The
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`specification doesn't say what they are, and the jury
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`isn't going to have a clue. So that's why this needs to
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`be construed, and the only intrinsic evidence that's
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`available to construe it with is the term
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`"proportional."
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` If you have any questions, I'd be happy to
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`answer them.
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` SPECIAL MASTER KEYZER: I think it would help
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`first to hear from Medtronic about what the plain
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`meaning is, and then maybe Axonics can reply to that.
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` MR. NATHAN: Thank you.
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` MS. WICKRAMASEKERA: Thank you, Mr. Keyzer.
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` First, Axonics is completely wrong on the law.
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`O2Micro does not resolve the -- does not require you to
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`resolve the dispute in terms of defining every species
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`within a genus that is claimed. There is no case that
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`stands for that -- for that proposition. There's no
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`case that Axonics has cited that stands for that
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`proposition.
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` And we've cited numerous cases in multiple
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`contexts where courts have confirmed that "associated
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`with" is not indefinite, that it is a broad term and
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`that it is a term that includes a genus. And I just
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`want to -- I want to give -- this is an example.
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` If we could pull up slide 105, please, Robert.
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` This is just an example of an Axonics patent
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`that claims data associated with the implantable
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`neurostimulator. This is language that is frequently
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`used in -- in patent claims. There's nothing wrong with
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`it. It's not indefinite.
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` And as to the suggestion that the Special
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`Master's requirement to construe a claim is according to
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`whether it results in competence -- competence for a lay
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`jury to assess, that's not the standard for claim
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`construction, and these jurors are not going to be
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`without assistance. That is precisely what experts are
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`for.
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` The issue here is going to be whether specific
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`values that are accused of infringement or that Axonics
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`wants to rely on for invalidity are associated -- have
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`-- have the claimed association, are associated with.
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` So if we could go to -- we could start there
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`at the top, Robert.
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` And the plain meaning, Mr. Keyzer -- I didn't
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`mean to skip over your question. The plain meaning is
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`"related to," and that -- and that's consistent with the
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`case law, and a person of ordinary skill in the art
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`reading the specification understands that there are
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`examples of specific values that are given that are
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`related to -- that are related to the -- the current
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`passing through the battery, and a person of ordinary
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`skill in the art would know what other values are
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`related to the current passing through the battery. And
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`that's the question.
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` It is not an issue of claim construction for
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`you to define the full scope of every value that might
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`fall within a particular genus. It is very clear to
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`people of ordinary skill in the art what that is. It's
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`clear to Axonics too, and they had no issue with that in
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`the IPRs.
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` SPECIAL MASTER KEYZER: So,
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`Ms. Wickramasekera, are you suggesting that there is an
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`understanding a person of skill would have of particular
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`types of association other than "proportional to"?
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` MS. WICKRAMASEKERA: Yes.
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` SPECIAL MASTER KEYZER: So, in other words, we
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`have disclosure about "proportional to." What else can
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`we look at or what would a person of skill bring to the
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`reading of this patent to have an understanding of
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`"associated with"?
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` MS. WICKRAMASEKERA: Well, they would be able
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`to explain -- they would be able to identify particular
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`values -- current, voltage, temperature, for example --
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`and help to explain to the jury how these are associated
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`with the current passing through the battery. In other
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`words, how do they provide you information about it?
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`How -- what is their relationship to the current passing
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`through the battery?
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` So it's not -- it's not narrowly defined to
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`"proportional." And that's precisely why the patent
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`says that that's one example, and this is -- this is
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`purely within the scope of what the experts can provide
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`testimony on. And the experts don't need -- and the
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`jury does not need to decide the full scope of the claim
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`term. What the jury is going to decide is whether
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`particular values are, in fact, associated with a
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`current passing through a battery.
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` And, Mr. Keyzer, "proportional" can't be the
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`right limit- -- it cannot be the right construction for
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`this because it is in the claim language with a
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`different limitation. If the patentees intended
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`"associated with said current passing through the
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`internal battery" to mean "proportional to said current
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`Page 134
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`passing through the internal battery," they knew how to
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`say that.
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` What they are attempting to do is to provide a
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`disclosure that is sufficient for a person of ordinary
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`skill in the art to understand, not for a lay juror to
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`understand. That's not the standard for claim
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`construction. It's whether a person of ordinary skill
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`in the art would understand what the claim term means.
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` And that's precisely what Axonics interpreted
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`this claim term to mean in the IPRs. According to
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`Axonics, it's a -- the value that's claimed represents a
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`collection or a genus. The specification specifically
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`teaches that the value could be a current or a voltage,
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`though it is not limited to these two species. They
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`understood that. A person of ordinary skill in the art
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`can evaluate other values and determine whether they are
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`-- they are associated with the current passing through
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`the battery, and that's precisely what they told the
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`patent office. Their expert agreed with that.
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` In fact, he said that a value associated with
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`a current passing through an internal power source --
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`source was well known before 2005. He went on to say
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`that values associated with intra- -- with the internal
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`battery are consistent with what had been in existence
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`many years before the earliest claim priority date of
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`the patent.
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` They are not presenting any testimony here or
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`evidence that a person of ordinary skill in the art has
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`no understanding of what the scope of that term means.
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`Their argument is that a lay juror does not, but that's
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`not the standard for claim construction, and that's also
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`not the standard you're held under, under O2Micro.
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` And the patent office agreed. The patent
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`office found that the patent -- that the specification
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`-- the patent office construed the term and found that
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`the specification expressly identifies current or
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`voltage as examples of a value and not that they were
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`limited to specifics that were disclosed in the
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`specification. This is part of the intrinsic record,
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`the PTAB's findings, and these terms have to be
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`construed the same way for infringement and invalidity.
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` Now, I'm happy to go through certain case law,
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`but I think that counsel showed you the Wilson case,
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`which, from the excerpt that was put on the slide,
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`appeared to be a decision on the final judgment, not a
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`decision on the claim construction.
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` And the question is whether the scope of the
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`term, as you've construed it to have plain meaning,
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`would be understandable to a person of ordinary skill in
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`the art reading the specification. This is not an
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`exercise where you have to define every single possible
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`permutation that might fall within the purview of the
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`claim. The question is: Would a person of ordinary
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`skill in the art understand whether a value is
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`associated with, and that is precisely the standard for
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`definiteness as well.
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` For definiteness, you do not have to
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`completely define every permutation. You have to have
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`an objective measurement. For the person of ordinary
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`skill in the art, the objective measure is the context
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`of the claim. What is the value that is associated with
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`the current through the battery? If a person of
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`ordinary skill in the art can determine that based on
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`mere experience in reading the specification, that is
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`all that is required. The fact that there may be -- it
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`may be a large genus does not mean that it has no
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`meaning or that the meaning is unclear.
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` So I think that the remaining disputes they
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`raise are really ones of infringement, which is whether
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`specific values are associated with the battery. That
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`cannot be determined in a vacuum. That is an expert
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`issue. We will point to certain values, and then the
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`experts will debate whether those values are associated
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`with the battery through the current, and that's going
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`to be a fact-specific inquiry.
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` Also -- Mr. Keyzer, unless you have any other
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`specific questions for me.
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` SPECIAL MASTER KEYZER: Nope. Thank you.
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` Let's hear a reply.
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` MR. NATHAN: Mr. Keyzer, I'll simply state
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`that Medtronic has not provided one single example --
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`not one -- of a value, an actual value, that is
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`associated with the right current and explained why that
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`is. They haven't answered the question. It's the only
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`question. They haven't given a single response.
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` They want this claim term to be a nose of wax,
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`and what counsel is proposing -- make no mistake -- is
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`for experts to debate matters that are both factual and,
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`for sure, claim construction because nobody is going to
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`know what the boundaries of "associated" are. You heard
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`counsel repeatedly say that a person of skill in the art
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`will know. The jury needs to be told what that person
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`of skill in the art knows. That is the purpose of claim
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`construction. The person of skill in the art is a legal
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`construct. The jury is actually present in the court
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`and needs to be told what the correct legal bounds of
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`the claim are so they can apply it as a matter of fact.
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`Nothing that counsel has said addresses that question.
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` Counsel has indeed confirmed that, under a
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`plain-meaning construction, we will go to trial with an
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`unbounded claim, with unknown parameters, and the
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`experts will debate claim construction in the guise of
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`ipse dixit and technical analysis that the jury is no
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`way equipped to parse. That is not proper. That is
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`what O2Micro requires to be resolved.
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` I'd also like to note, with regard to
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`counsel's reference to the IPRs, every value we pointed
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`to was a proportion. The question of the outer
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`boundaries -- the question of the outer boundaries of
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`"associated" was not addressed. We did not concede that
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`the claim term has definite boundaries, and we certainly
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`did not get a ruling on what its limits were.
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` We now know for sure that, going into trial,
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`there will be disputes as to whether a specific factual
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`matter falls within the scope of a claim term that has
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`not been construed and
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