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the United States Court of Appeals for the Federal Circuit is now open and in session.

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God save the United States and this honorable court.

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The first case for argument this morning is 20-2251 shockwave medical versus cardiovascular system.

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Mr. McPhee, whenever you're ready.

[00:00:26] Speaker 03:
Good morning, Your Honors, and may it please the court, David McPhee for the appellant shockwave.

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The board aired in its final written decision, finding the oh nine one patent claims unpatentable.

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I'd like to focus in particular on two problems with that decision.

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First, the boards errors on claim construction and second it's failure to make the required showing on motivation to combine and expectation of success on claim construction.

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We can clearly see where the board went wrong by looking at the plain language of the claims themselves and look at an exemplary claim one, which is found on the first page of the blue brief.

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For context, we see the second to last element of claim one describes a power source for supplying voltage pulses to the electrodes.

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explains that each of those pulses generates an electrical arc, which produces a shockwave.

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And the key language for purposes of this appeal is found in the final element, element E. According to this element, you first detect or measure the current flow during each voltage pulse.

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You do that because the arcing is unpredictable.

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Then, if the current reaches a predetermined threshold, you take action by generating a signal

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And finally, this signal, it's described in the last two lines as something that, quote, causes the power source to terminate the voltage supply to the electrodes for that pulse.

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And it's this last phrase that is the main point of contention.

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The question on appeal is whether that phrase is to be interpreted as encompassing the termination of voltage supplied for future pulses.

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And the answer to that question is no.

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The last three words of the claim make clear that the termination of voltage supply must be for that pulse.

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That is, the same pulse in which the current was detected as exceeding the predetermined threshold.

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And that's just standard basic English.

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The modifier applies to the most proximate subject.

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In this case, termination.

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I'm sorry to interrupt, but this is Judge Prove.

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I'm just trying to understand really, because frankly my tentative conclusion was that the board probably agreed with the board and I wasn't buying your reading out argument.

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But can you describe, maybe you'll be clarifying for me if you describe what the board construed it as and what your construction is so we can kind of see the difference between the two.

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Certainly, Your Honor.

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And I think part of the problem here is that the board, if you'll turn to

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Actually, just page 15 of the board's decision.

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Is that in the kind of site?

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Okay, yes.

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Yes.

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And really, I think the confusion comes up in that there are really two timing issues presented by the claim language.

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One of the disputes that came before the board was about the difference between terminating voltage at the power supply

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And then in that split second between what happens when you terminate at the power supply and what happens at the tips of the electrodes.

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And this debate was framed as a debate about whether the termination is voltage supplied to the electrodes or terminating the voltage at the electrodes.

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And we could argue about whether... Sorry to interrupt, but I want you to go on, but I guess the problem I'm having is

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Isn't the for that pulse limitation applied to the antecedent voltage termination?

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Does anybody dispute that?

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Is that what you're disputing?

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That is exactly what we're saying, Your Honor, that for that pulse has to do with the termination of the voltage supplied, which means

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your honor, that if you terminate the voltage supplied for a subsequent pulse, for a future pulse, then it doesn't fall within the scope of the claims.

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And what the board did in this instance was it was so focused on this other question about what happens between the termination of the power supply and the tips of the electrodes that it overlooked

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that additional, that second timing requirement for that pulse, that it cannot be that the termination simply applies to future pulses.

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And you see that, for example, when we have the board look at the Chernenko reference.

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This is just an example.

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We pointed out with respect to Chernenko that Chernenko only applies termination for future pulses.

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It stops the future pulses.

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And the board said, in essence,

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We don't need to address that issue because of our claim construction.

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Well, that was just an error because regardless of this issue of voltage supplied to the electrodes versus at the electrodes, you still have to give meaning to those last three words for that pulse.

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In fact, this specific issue on this specific reference, Chernenko, was addressed during prosecution.

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And the applicant specifically added those words for that pulse to get around Chernenko and to distinguish the Chernenko approach, which simply monitors the creation of the spark channel so that the delivery of the train of pulses can be halted, future pulses.

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An applicant said Chernenko cannot terminate a pulse during the delivery

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of the pulse.

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But tell me if I'm wrong.

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I mean, there's a lot going on in this case.

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This is Judge Prost again.

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But didn't the board rely on three references, one of which was Chernenko, but the other two, Heron and Lee.

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And Lee, he'll present the same problems that you're identifying with respect to Chernenko.

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Am I right about that?

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I'm sorry, you're referring to the Lee reference?

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Lee and Heron?

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Yes.

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Well, we think, in fact, in both of those references, again, the board relied upon its construction where it believed, apparently, that it didn't even need to consider whether the reference was directed to a future delivery of pulses as opposed to something for that pulse.

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It just started from the wrong starting point, if you will, in terms of what the claim required.

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And that's why we said at a minimum,

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the case would need to go back for consideration under a proper consideration of what the claim actually required for that pulse.

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If I could move on, I would actually like to address the second issue, which has to do with motivation to combine and expectation of success.

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And this also goes, Judge Prost, to your question.

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Regardless of the claim construction,

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and how that issue is decided.

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The board's decision is also independently reversible because it fails to demonstrate motivation to combine or expectation of success.

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The board's treatment on these issues actually falters just at the very outset because it assumes without evidence

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that the person of ordinary skill would want to make a change to Shockwave's original invention as it's disclosed in the base Hawkins reference.

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And, of course, it was CSI's burden to prove a motivation to change Hawkins in some way based on contemporaneous evidence.

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CSI could have tried to show, for example, that the original Hawkins system had safety problems or had too much heating, inadequate electrode durability,

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But CSI points to no such evidence.

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This is Judge Crouse again.

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I'm sorry to keep interrupting.

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Yes.

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Time is short.

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Really?

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I mean, I guess you can find a motivation, I think as the board did, to say one would be easily motivated to do something that's more desirable or more efficient.

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So you were suggesting kind of like unless there's a problem, but it's

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It's broader than there's a problem and you've got to fix it.

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It's more that this would be more desirable and more efficient.

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And that's clearly under our case law and under KSR a sufficient motivation, is it not?

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Well, in this case, the problem is that the board assumed the problem, assumed that it was insufficient, the original invention,

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insufficient safety, insufficient ability to have electrode wear, and then reach to disparate, non-analogous arc like Lee, incorporating elements there to try to fix a problem that it didn't even realize existed.

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So the question is, even if you were to start with Hawkins and ask, well, how can I make something like Hawkins better?

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Why would the person of ordinary skill think to look at a reference like Lee, which is just a standard power supply reference, nothing to do with arcing, nothing to do with shock waves?

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Well, the board did find, and we give deference to the board on these points, I would think you would agree, that Lee was an elegance art.

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And I'm not sure I know of any cases that would suggest that the board

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aired in its conclusion that Lee was analogous art.

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Well, the board... How does that affect your... Let's assume, will you assume for the sake of argument that Lee is appropriately analogous art, as the board concluded?

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So what does that do to your argument?

[00:10:28] Speaker 03:
Well, taking that as a given that it was analogous art, and I'll say more about that.

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As a matter of fact,

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there's no evidence presented by CSI through its expert otherwise to explain either why you would have incorporated the teachings of Lee on a non-arcing system and what's more and maybe even more importantly whether there was any expectation of success in taking what was really sort of a standard circuit of Lee and incorporating those concepts

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into the unpredictable and very different system of an arching system producing shock waves in a saline system.

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So it's really all of these issues where CSI had the burden to put forward something, something to show with evidence why you would make that combination and why you would have an expectation of success.

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And if you just scratch beneath the surface of what CSI actually points to,

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For example, it's the expert declaration relying on paragraphs 95 to 98, 103 to 105 of the Jensen Declaration.

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Just look at those actual paragraphs.

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You'll see lots of conclusory statements from the expert, but no actual evidence.

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That, of course, was CSI's burden, and they failed to meet it here.

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I'll reserve the rest of my time unless there's anything else.

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That's hearing no other questions.

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Thank you.

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We'll reserve the balance of your time.

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Let's hear from the other side.

[00:12:11] Speaker 01:
Good morning, Your Honors.

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This is Mark Nelson representing Appellee Cardiovascular Systems Bank.

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The board's decision here should be affirmed in all grounds.

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I'll jump right into the claims instruction aspect here.

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The board construed the term in issue that sensor generates a signal that causes the power source to terminate the voltage supplied to the electrodes for that pulse.

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The board said that the power source, and this is at appendix 15, the power source terminates the voltage supplied to the electrodes and not, as patent owners suggest, a signal that instantaneously terminates the voltage pulse across or at the electrodes at the terminal end

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some six feet away from the power source.

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The board goes on at appendix 17 to say, as written, the signal causes the power source to terminate the voltage supplied to the electrodes without expressed limitations on the timing or effect of the voltage pulse across the electrodes, again, at the terminal end.

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And it's really this last section that I read that patent owner seizes on to try to find error here.

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But the claim language itself is clear.

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The claim is directed to the power source in this element.

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And you have a current sensor that senses the current across the electrodes.

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That current sensor generates a signal.

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That signal causes the power source to terminate the voltage supplied to, not at, supplied to the electrodes for that pulse.

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The claim language is very clear here.

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When it wants to use the term voltage pulse, it used the term voltage pulse, as counsel pointed out.

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When it wants to use the term arc, it uses the term arc.

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And it wants to use the term voltage supply, it uses the term voltage supply.

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This is Judge Chen.

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So then, assuming that you're right that the final limitation in this claim is about just cutting off the voltage,

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being supplied to the electrodes.

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What are we to make of the phrase for that pulse?

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What work is that phrase doing?

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Yeah, so the claim is saying that you cut off the voltage supplied to the electrodes for that pulse.

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So the current is monitored during the pulse.

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The signal is sent during the pulse.

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And the signal causes the power source to turn off.

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for that pulse.

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The focus here is on the power source.

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Pamela tries to frame it as sort of some... Mr. Nelson, you're right.

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Are they not that under the board's construction, the claim would be satisfied if the supply is stopped so late that its only effect is to cut off future pulses?

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So the claim...

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is talking about the power source terminating the voltage supplied for that pulse.

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It doesn't have a timing element per se in it other than the signal is generated, causing the power source to terminate the voltage supplied forth to the electrodes for that pulse.

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So the effect of the termination is based on the signal that is based on the current sent during that pulse and the signal sent during that pulse.

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causing the power supply to terminate the voltage supplied to the electrodes for that pulse.

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So the answer to me is, yes, they are correct.

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They could apply to instances where the only effect was to cut off future pulses.

[00:16:07] Speaker 01:
I don't know if it could apply to that or not, Your Honor.

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The way the patent owner chose to draft this claim

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was to focus on the power source and what the power source is doing in response to sensing a current during a particular pulse and terminating the power source for that pulse.

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Now, the ultimate effect of that is there's some amount of time lag between the time the power source terminates the voltage to the electrodes and the terminal end of the electrodes, which is what

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patent owner is doing here.

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Patent owner is trying to basically conflate the voltage pulse at the terminal end of the electrodes and the arc and saying, well, if you take that argument, then patent owner's inductance and negative resistance arguments that it made to the board

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They're trying to justify those arguments.

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But basically, the intrinsic evidence is clear that this entire control scheme that the patent is talking about is directed to the power source receiving a signal during a pulse and terminating the voltage supplied to the electrode in response to that signal for that pulse.

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So for that pulse aspect of this is included and considered in the board's construction.

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And if you look at the specification, in Pat Noonan's own expert, it identifies this IGB transistor as the thing that is terminating the voltage.

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That supplies, that exists within the power source.

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Pat Noonan's expert explained that the termination is accomplished by open circuiting the IGBT.

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That's the pink in the figure of the red brief.

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And then you look at the prosecution history as well, which counsel mentioned.

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So counsel, patent owner here, patent owner added the word voltage pulse or pulse on five separate occasions in amending this claim.

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Patent owner could have amended voltage supplied to the electrodes and said voltage pulse supplied to the electrodes.

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Patent owner didn't do that.

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Instead, patent owner amended supply to re-supplied, added for that pulse at the end to clarify that what is being discussed here again is the power supply, the focus is on the power supply, and then added during each voltage pulse in several other places.

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Claim terms are presumed to have different meanings if different words are used.

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And here, the patent owner did use different words and made those choices.

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And so for all of those reasons, Your Honor, we don't believe here that this claim reads for that, that the morgue's construction here reads before that halt limitation are the claims.

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In fact, before that halt limitation is considered as part of the claim because it's absolutely consistent with the morgue's construction.

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Because the focus here is on what's going on at the power source and how the power source reacts to receiving the signal during the pulse and turning off the voltage supply in response to that signal for that particular pulse.

[00:19:35] Speaker 01:
I'm not sure I answered your question, Your Honor.

[00:19:37] Speaker 00:
OK.

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Well, you want to move on, if my colleagues don't have any other further questions on that, to what your friend was discussing about motivation and expectation of success.

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And in particular, the question of whether or not Lee is or is not analogous art?

[00:19:53] Speaker 01:
Sure, Your Honor.

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So I want to point out for Lee, for example, as well, that the Lee reference teaches to deactivate a pulse early, such that even under patent owner's construction, Lee still teaches this limitation.

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And that's Appendix 18 and 19 and 26, 27.

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and also the Lee reference at appendix 758 and 59, paragraphs 19 through 21.

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But with respect to motivation to combine, the board found numerous motivations to combine and supported those.

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Well, the board first of all found it and supported that with substantial evidence as well as reasonable expectation of success.

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So the board said in Appendix 25, Hawkins provides some protection against shock, but a posita would have identified other options.

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Remember, this is a system that's going in a person's body.

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So the fact that there is some protection there, that isn't necessarily good enough.

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Of course, a posita is going to look.

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Can I make this better?

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Can I control the current better?

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Also, Appendix 20.

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The board found reducing excessive current leads to an improved device life and enhanced reliability and supported that finding with evidence.

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The board credited petitioners' expert testimony that Lucita would have understood that Hawkins' mechanisms to control the magnitude of the shock wave to reduce heat and the reducing heat could have been accomplished by early termination of the pulpit.

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That's despite this also operating in an antiplasmic balloon that has failing solution that helps it dissipate heat.

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Again, we're talking about a system that's going into a person's body.

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So of course the fatigue is going to be motivated to look for further improvements that could be made.

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The board found that Lee is from the same field of control arrangements and reasonably pertinent to EHL devices.

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The board relied on patent owner's own expert's testimony here that the O9-1 patent is concerned with voltage pulse production and control.

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That is that Appendix 29 and 30, citing Pat Noehner's expert deposition testimony.

[00:22:07] Speaker 01:
Pat Noehner's counsel said something interesting in his opening argument as well.

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Lee is a standard power supply reference.

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The board relied on predictable uses of known prior art elements, routine feedback control for expectation of success,

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that Shockwave never contested and frankly now admits in oral argument here.

[00:22:33] Speaker 01:
The argument that Shockwave made with respect to Lee and motivation to combine expectation of success was that, well, you wouldn't look to Lee because these power transistors that Lee uses, they're not high enough.

[00:22:50] Speaker 01:
Well, they can't handle the voltages of the Hawkins reference.

[00:22:54] Speaker 01:
And that's simply not the case.

[00:22:56] Speaker 01:
The board, again, provided

[00:22:58] Speaker 01:
Numerous examples of supporting evidence.

[00:23:03] Speaker 01:
Appendix at 22 and 23, the Hawkins reference, or the 091 patent operates as low as 500 volts.

[00:23:11] Speaker 01:
And this is especially interesting here, Your Honor.

[00:23:15] Speaker 01:
So at appendix 22 and 23, 500 below made an argument that the Hawkins reference, which contains a sentence that the voltage

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is from 100 to 3,000 volts.

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And that was a typographical error, and should be 1,000 to 30,000 volts.

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And the petitioner pointed out to the board, and the board accepted that that was unlikely, because that error was carried forward numerous times.

[00:23:42] Speaker 01:
And I just want to say yesterday, we checked on the applications that have now issued its patents.

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And that supposed error has still not been corrected, despite it being identified over a year ago.

[00:23:54] Speaker 01:
And I think that speaks volumes of sort of the length that Shockwave went here to try to discredit these references, which really are solid on motivation, which really are solid on their teaching and solid on motivation to combine.

[00:24:11] Speaker 01:
I'll just jump really quickly to the Heron reference as well, which we haven't discussed.

[00:24:17] Speaker 01:
The Heron reference, like the Lee reference, the board found on appendix

[00:24:24] Speaker 01:
45 and 46, that the Lee reference itself also taught terminating a voltage pulse early with respect to receiving a signal from a current sensor that had reached a predetermined level.

[00:24:44] Speaker 01:
And the board, in fact, found that Heron's disclosure expressly contradicted patent owner's assertions in that regard.

[00:24:52] Speaker 01:
and cited numerous evidence that the operational parameters of Heron, which included voltage, duration of voltage, that those things could be adjusted not only on a per-pulse basis, but also the board found in the middle of a pulse.

[00:25:13] Speaker 01:
And patent owner makes an argument with respect to Heron that, well,

[00:25:19] Speaker 01:
The figure 702, 704, and 706 only shows the mid-pulse adjustment of voltage going from 100% to 50%.

[00:25:30] Speaker 01:
And the figure 704 shows the adjustment of duration in subsequent pulse.

[00:25:36] Speaker 01:
And the board considered that argument and rejected it.

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noted that the Heron reference also teaches that you can dynamically adjust the pulse and you can terminate the voltage to zero, which the board credited patent owner's expert's testimony that adjusting or reducing the pulse duration necessarily sets the pulse termination at the end of a given pulse.

[00:26:03] Speaker 01:
With respect to motivation to combine for Heron,

[00:26:07] Speaker 01:
The board noted these arguments at Appendix 46 and Appendix 40 and 41.

[00:26:16] Speaker 01:
Again, Patent Order never really challenged these arguments.

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And so counsel here is finding fault on the board's failure to articulate motivation combined and reasonable expectation of success.

[00:26:29] Speaker 01:
But for the most part, other than inductance and negative resistance arguments, Patent Order never challenged those

[00:26:38] Speaker 01:
motivations to combine.

[00:26:39] Speaker 01:
And so they're basically faulting the board to address arguments that were never made to the board, that were basically accepted by the patent owner.

[00:26:49] Speaker 01:
And that patent owner focused on the teachings of the reference, those references, and on the inductance and negative resistance arguments, which the board declined.

[00:27:02] Speaker 01:
I think I'm almost out of time, Your Honor.

[00:27:06] Speaker 01:
So with that, unless there's any other questions, I want to thank the board for their time.

[00:27:12] Speaker 01:
And I submit that the court should affirm the board's decision here in all respects, because the board's decision is correct, it's supported by substantial evidence, and its reasoning is readily discernible.

[00:27:28] Speaker 01:
Thank you, Your Honors.

[00:27:30] Speaker 00:
Thank you.

[00:27:31] Speaker 00:
Mr. McPhee, you've got some time left to rebuttal.

[00:27:35] Speaker 03:
Yes, so going in reverse order starting with motivation to combine.

[00:27:38] Speaker 03:
Even if Hawkins presents some or just based on background understanding of wanting to improve things, make it safer, make it more efficient, that sort of thing, you still have to explain why the person of ordinary skill would look to a detection and early termination system to achieve those ends.

[00:28:04] Speaker 03:
neither the board nor CSI ever explains that, never points to any prior explaining why you make that leap.

[00:28:10] Speaker 03:
They just jump straight to Lee and other references without explaining how you get there, why a person of ordinary school in the art would think of that particular solution.

[00:28:22] Speaker 03:
And in fact, it's striking the board's decision.

[00:28:26] Speaker 03:
In fact, when you read it,

[00:28:27] Speaker 03:
It never presents the prima facie case on motivation to combine expectation of success.

[00:28:33] Speaker 03:
Instead, it just goes through patent owner's evidence, which is voluminous, and picks at it and objects to certain aspects of it.

[00:28:43] Speaker 03:
That's exactly the approach that was criticized by this court in Magnum Oil and similar cases.

[00:28:49] Speaker 03:
And there was a mention of Huron.

[00:28:52] Speaker 03:
Huron is another example of this.

[00:28:54] Speaker 03:
Huron actually states,

[00:28:57] Speaker 03:
that it is trying to avoid shockwaves, trying to avoid arcing.

[00:29:02] Speaker 03:
This is in the passages that are cited by CSI.

[00:29:06] Speaker 03:
So again, the question is raised, why is the person of ordinary skill looking at a reference like Heron to improve a reference, a system like Hawkins, and CSI never presents any evidence that gets you there.

[00:29:23] Speaker 03:
On the claim construction issue,

[00:29:25] Speaker 03:
I think a council's response was telling on the words for that pulse.

[00:29:30] Speaker 03:
What work does that, do those words do?

[00:29:34] Speaker 03:
CSI has no answer to that.

[00:29:36] Speaker 03:
They essentially try to move those words to an earlier point in the claim to the detecting the current flow or generating a signal.

[00:29:46] Speaker 03:
Well, that's not how the claim was drafted.

[00:29:48] Speaker 03:
That's not where the applicant chose to put those words.

[00:29:53] Speaker 03:
it was intended to attach to termination.

[00:29:57] Speaker 03:
And that's just right at the end of the claim and it's the proximate modifier to that concept.

[00:30:04] Speaker 03:
So it can't be rewritten by CSI at this point.

[00:30:08] Speaker 03:
The fact that CSI leaves open the possibility that the claim could apply to termination of future pulses

[00:30:17] Speaker 03:
In fact, proves our very point.

[00:30:20] Speaker 03:
That is what the board assumed and it is directly contrary both to the plain language of the claims, which we reviewed as well as the prosecution history to the extent there was any ambiguity about what those words meant, what that amendment was intended to do.

[00:30:38] Speaker 03:
In fact, it's clear that before that pulse amendment was intended to eliminate or disclaim from the scope of the claim a system that merely terminated future pulses.

[00:30:51] Speaker 03:
That's in the public record.

[00:30:53] Speaker 03:
It's what the examiner understood, and it needs to be given a fact.

[00:30:58] Speaker 03:
It cannot be ignored or set aside in evaluating the prior art.

[00:31:03] Speaker 03:
which is why we would say at a minimum the case would need to be remanded for consideration under a proper claim construction or we would say reversed in its entirety based on a claim construction error as well as the failure to provide motivation to combine expectation of success.

[00:31:26] Speaker 03:
Unless there's anything further, Your Honors?

[00:31:28] Speaker 03:
I'll close.

[00:31:29] Speaker 00:
Hearing nothing, thank you very much.

[00:31:32] Speaker 00:
Thanks both council and the cases submitted.