[00:00:00] Speaker 02:
Case for argument today is 2018-2220, Nevereau versus Boston Scientific.

[00:00:08] Speaker 02:
Ms.

[00:00:08] Speaker 02:
Maynard, please proceed.

[00:00:11] Speaker 00:
Good morning, and may I please report Deanne Maynard for Nevereau.

[00:00:14] Speaker 00:
I'd like to reserve five minutes.

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The district court misapplied the law to three sets of claim terms in holding Nevereau's system and device claims invalid as indefinite.

[00:00:27] Speaker 00:
I'd like to start with the system claims

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reciting the parasthesia-free limitations.

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The district court held that this limitation has a clear meaning.

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They mean does not produce sensation, usually described as tingling, pins and needles, or numbness.

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And the patents teach

[00:00:50] Speaker 00:
the signal characteristics for providing that paresthesia-free therapy and for providing traditional paresthesia-based therapy.

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So at appendix 99 in column 5, starting at line 6, there's an entire section of the patent called representative therapy parameters.

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And it discusses a study that NETRO did, first providing patients with the traditional paresthesia-based therapy,

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And it describes the signal parameters and characteristics used in that.

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And that starts at line 34 in column 6.

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And it has a paragraph about the signal characteristics.

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And then it goes on to say, after that portion of the study,

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It describes the paresthesia free therapy that was provided.

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An entire study population of patients and the signal characteristics that were used to do that.

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And in column nine it shows that the patients preferred, 100% of the patients preferred the paresthesia free therapy.

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So the intrinsic record teaches a person of skill in the art both how to get the paresthesia free therapy and what's not.

[00:02:00] Speaker 06:
Well, can I just ask you, I mean, on the method claim, for example, your position is that you run through the method, patient doesn't tingle, then you know you've practiced it.

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None of which depends on any advanced knowledge of the

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I guess everybody calls them parameters, but the frequency, pulse width, and current.

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Why, with respect to the system claim, does one need to know anything in advance about what signals will do this as long as you test the system and sometimes it produces non-tingling therapy?

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So it's a system for doing that.

[00:02:46] Speaker 00:
That's our position is that that's right at the system claims a system the system claims a signal generator that produces this parasitia free therapy and as long as it does so then it is an infringing system and that's where the district court went awry because it thought that if at times it

[00:03:05] Speaker 00:
a system perhaps would not provide the parasitia free therapy, then it wouldn't be infringing.

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But that's not the way one measures system claims.

[00:03:15] Speaker 00:
And I would take issue, I mean, I don't want to tread into their cross appeal on my opening, but we do think that although we agree with the district court, there is lots of guidance in these patents that a person will know in advance, both when they're practicing the method and when they're designing the systems, exactly what they need to do and what kind of system it is.

[00:03:34] Speaker 00:
And the extrinsic record confirms that.

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Never did an FDA monitored study in which 100% of the patients in the paresthesia free therapy arm received

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and the study was premised on the notion that one arm of the study received a paresthesia-free therapy and another arm did not.

[00:03:55] Speaker 06:
Can I, since time is short, can I ask you to talk about the configured to generate a therapy signal, which I find the most challenging of the issues.

[00:04:09] Speaker 06:
First of all, at a more doctrinal level, before getting into the specifics,

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What in your view is the relationship between the difficulty of deciding between two possible claim constructions and the indefiniteness standard of Nautilus?

[00:04:28] Speaker 00:
So the Supreme Court rejected the view that as long as there were two reasonable readings the claim was indefinite and said instead the question is whether or not

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a person – as you know, a person of skill in the art.

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construction is better than the other.

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Why is that not a basis for concluding indefiniteness?

[00:05:07] Speaker 00:
Well, here it's not, because I would like to fight the premise.

[00:05:10] Speaker 00:
Right.

[00:05:11] Speaker 00:
But in this court, where this court has found indefiniteness, where that's the situation on very different facts than this, like in Teva, where there's a measured quantity, and the patents and prosecution history, in terms of record, give no guidance.

[00:05:25] Speaker 00:
In fact, in Teva, conflicting guidance on the exact same indefiniteness question.

[00:05:29] Speaker 00:
There's nothing like that here, Judge Toronto.

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Here, in fact, the district court's discussion of the term that's at issue, which is signal generator configured to generate or deliver, when he was discussing that term, he recognized that the record pointed only in one direction, and that was in the direction that it needs designed to.

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And that is the ordinary meaning, as this Court has recognized, of Configure 2.

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So where the judge concluded there was conflict... I thought the District Court found evidence, in his view, going both ways.

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That's why he found it indefinite.

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He didn't only cite the evidence that supported your preferred construction of Configure 2.

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But my point, Judge Chen, is when he was pointing to the other evidence that he thought pointed away from our construction, he was looking at different terms in different kinds of claims, like method claims, and not looking at the term that's at issue, signal generator configured to generate or deliver.

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And especially in a word like configured or configured to, which takes its meaning, it's a connector word, takes its meaning from the words surrounding it, the context is key.

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So I guess following up on Judge Toronto's doctrinal question, I guess you agree then, or your understanding of the law is, if there are two equally strong understandings of a claim term, two competing understandings that are on balance equal, then therefore the claim term is indefinite.

[00:07:02] Speaker 00:
I don't think this court has held that.

[00:07:05] Speaker 04:
I thought you were suggesting Teva was something like that.

[00:07:09] Speaker 00:
I think Teva is stronger than what you just articulated, Judge Jen.

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In Teva, there were conflicting prosecution history answers.

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There were three possible measurements.

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Everybody agreed.

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The range depended on which measurement was chosen.

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The claim scope would turn on which measurement was chosen.

[00:07:24] Speaker 04:
The prosecution history did something like this.

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There were two indefinite rejections.

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the same indefinite rejection and at one point the patent applicant answered molecular MW and at one point MP.

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So that was conflicting.

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That's a direct conflicting, irreconcilable answer and a person of skill in the art needed to know what that claim term meant.

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to measure the range quantities.

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That's nothing like this case here.

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Every time the patent uses the word signal generator configured to deliver, it's talking about the kinds of parameters, the signal parameters that need to be available to the user to select to program the

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when using the device.

[00:08:08] Speaker 04:
Your brief said something about how configured to in this instance means designed to.

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And I'm still wondering what does that mean exactly?

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What is it that the inventors here have done to a signal generator that configures it to generate a

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in your understanding of configured to meaning designed to.

[00:08:41] Speaker 00:
So just to be clear, this court has said that it has equated, configured to, with, designed to, in at least three cases, aspects, manned mission interface, and GNLE.

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Right.

[00:08:52] Speaker 04:
And that, to me, is actually a different problem for you.

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But let's get to my question first.

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And then we'll get to what you just triggered me will be in the follow-up question.

[00:09:03] Speaker 00:
What the patent teaches and what the patent's claim with the signal generator is one that's configured to generate, so making the certain signals available to the user to select in the product as finished, but not what BSC would like, which is that the actual parameters are already chosen.

[00:09:25] Speaker 04:
Let me, I just want to understand, what is it that the inventors

[00:09:31] Speaker 04:
here from NEVRO did to configure the signal generator.

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Let's, I assume we're just talking about a pretty standard signal generator and now the claim says let's configure that signal generator to generate a paresthesia free therapy signal.

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So what is that action that the inventors have undertaken to accomplish the configuration?

[00:10:00] Speaker 00:
They've created a signal generator that allows the user to select the parameters of signals described in the claims.

[00:10:08] Speaker 04:
And when you say they created, they created, what is it specifically that they created?

[00:10:14] Speaker 00:
Well, they implemented the ability to choose those signals on a signal generator.

[00:10:18] Speaker 00:
And the evidence shows it took BSC months and months to take their signal generator and change it into the signal generator that would produce the claimed

[00:10:27] Speaker 00:
The claimed device and that's that's what configured to means in this context.

[00:10:34] Speaker 04:
I guess the other side is saying that Your understanding of signal generator configured to really at bottom is nothing more than a prior art signal generator and then the prior art

[00:10:51] Speaker 04:
signal generator ultimately is programmed, i.e.

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parameters are selected, amplitude, pulse width, all of that.

[00:11:01] Speaker 04:
But that programming step, of course, is not what you think Configure2 means.

[00:11:05] Speaker 04:
And so I'm just trying to understand to what degree is the other side correct that at bottom your understanding of signal generator is

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a ready-made prior art signal generator that can then be

[00:11:24] Speaker 04:
programmed later on.

[00:11:26] Speaker 00:
Well, so I think there's a spectrum, right?

[00:11:27] Speaker 00:
And at times, they want, for prior purposes, to say that what we're claiming is just a signal generator whose hardware, software, and firmware could potentially be changed completely to make it into the claimed invention.

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And on the other end, they want to say, and the user's already selected the signal parameters for the signal.

[00:11:47] Speaker 00:
But what we're saying is no, it's a device that allows the user to select

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to make the selection at the end in a device as finished where a user can't modify the hardware, software, or firmware, but it's provided to the user in such a way that they can practice the claimed parameters.

[00:12:07] Speaker 06:
Would it be a fair summary to say that a signal generator configured to generate the desired signals if with merely a selection by a user among presented choices it will do so when powered on?

[00:12:22] Speaker 06:
Well, it could – so – So it builds in the idea of presenting the user, the surgeon or the attendant or whoever.

[00:12:32] Speaker 00:
Often the company representative here.

[00:12:33] Speaker 00:
Let's call it – what's that?

[00:12:34] Speaker 00:
It's often the company representative, right.

[00:12:35] Speaker 06:
Right, right.

[00:12:37] Speaker 06:
But let's call it a menu of options.

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I don't mean a specific menu.

[00:12:41] Speaker 06:
It could be three knobs or something, but that the only thing that stands between the generation of the

[00:12:50] Speaker 06:
having the device in there and the generation of the signal is turning the power on and punching in or selecting the three, say, parameters that are discussed in these briefs.

[00:13:02] Speaker 00:
Assuming, right.

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It's like programming a VCR.

[00:13:07] Speaker 00:
It comes and you can select the parameters that are allowed and it is different from the prior edition.

[00:13:13] Speaker 00:
It took them months and months and months to develop it.

[00:13:15] Speaker 06:
Does the patent actually describe doing things to the signal generator to make it ready for user input choice?

[00:13:26] Speaker 00:
It talks about the parameters that, you know, need to be available to perform.

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That's the representative therapy parameters that I was discussing earlier.

[00:13:37] Speaker 06:
Is there material down at the bottom of column three, top of four that talk about setting the thing up before the inputting of the parameter values?

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And then it talks about the user selecting like lower down in column four.

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Judge Toronto likes starting at line 40 where it talks about the practitioner can use the external programmer to vary the modulation parameters provided to the signal delivery element.

[00:14:01] Speaker 00:
So in other words, input the parameters.

[00:14:03] Speaker 00:
It's set up for them to input the parameters.

[00:14:04] Speaker 04:
But just to follow up, I'm just curious, is there any other action that

[00:14:10] Speaker 04:
is a precursor to the programming, whether it's an external programmer, a physician programmer, a patient programmer, is there some other precursor or step that this patent discloses that might be understood as something where the inventors are configuring the signal generator?

[00:14:32] Speaker 00:
Yes, because they're making the, they're configured to, so it's a past tense, and we are taking account of the past tense.

[00:14:39] Speaker 00:
As provided, as made, the signal generator allows a user to select these particular parameters.

[00:14:46] Speaker 00:
And we know it's not, Judge Chen, what BSC wants it to mean, which is we already programmed, because there's an independent and a dependent claim that where the only added limitation is programming.

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the signal generator.

[00:15:00] Speaker 00:
And that makes clear that they're not the same.

[00:15:08] Speaker 06:
Right, but – The H-42 Patton claims, is that what you're talking about?

[00:15:11] Speaker 00:
Yes, Your Honor.

[00:15:11] Speaker 00:
Yeah, I wasn't quite sure – 18 and 21.

[00:15:14] Speaker 06:
Right, I wasn't quite sure about that because 21 has an and in it, right?

[00:15:19] Speaker 06:
It's also configured to do two things.

[00:15:22] Speaker 06:
The second thing is the and delivered the signal, which it seems to me is not necessarily already incorporated in claim 18 so that it

[00:15:32] Speaker 06:
I'm not sure you need this argument, but it seems to me you may have overstated the point that there is no difference between that dependent claim and its independent claim except for the punching in of the values.

[00:15:46] Speaker 00:
Well, I take your point about the end, but I still think the point stands that the signal generator in claim 18 is not already programmed.

[00:15:53] Speaker 06:
Can I ask you just a kind of a practical question?

[00:15:56] Speaker 06:
Yes, please.

[00:15:56] Speaker 06:
I was just trying to think.

[00:15:59] Speaker 06:
Maybe you can answer this or not, but the difference between these two positions on the Configure 2 seems to me to be whether an accused infringer, the device manufacturer, is by selling the device directly infringing, or by making the device, is then and there directly infringing.

[00:16:19] Speaker 06:
Or on the other hand, the company representative in the operating room is the one completing the device.

[00:16:28] Speaker 06:
Why, as a practical real-world matter, should that make a difference to you as patent owner?

[00:16:33] Speaker 06:
Either way.

[00:16:34] Speaker 06:
Assuming instructions, right, to do it so that – why is an inducement case not pretty easy?

[00:16:41] Speaker 00:
Well, and I think actually it's actually direct infringement by the company representative who's finishing the device.

[00:16:47] Speaker 06:
That's your IP, right, if it's the same person.

[00:16:48] Speaker 00:
Yes, I agree with you.

[00:16:50] Speaker 00:
We will have an infringement case either way.

[00:16:52] Speaker 00:
we think the correct construction is ours but we will have an infringement case either way because if in their theory the company representative is completing sort of a tailor-made device at the bedside.

[00:17:07] Speaker 02:
I was just wondering along those same lines is it possibly too late for you to make those inducement related claims?

[00:17:14] Speaker 02:
Well we've made inducement claims for if we were to deviate

[00:17:21] Speaker 00:
on the claim construction and include programmed you haven't made a claim have you did you make an inducement claim we made we included inducement claims in our complaint okay then the court held configured to made these patent claims indefinite so they didn't reach infringement of the device claims at all I've already run out my time I will restore some of your rebuttal time okay Mr. Wolf

[00:17:53] Speaker 07:
May I please the court, Matt Wolf for Boston Scientific.

[00:17:55] Speaker 07:
Judge Toronto, if I may begin with your question about paresthesia-free.

[00:18:00] Speaker 07:
I recognize a lot of the discussion was about Configure II, but I don't want to lose the heart of the paresthesia-free argument.

[00:18:08] Speaker 07:
NEVRO told the Patent Office, and this is at A12574, that the high-frequency stimulation such as claimed by applicant may or may not cause paresthesia.

[00:18:22] Speaker 07:
I accept your question, Your Honor, as a possible construction of paresthesia, but Neverote specifically rejected that construction, the capability, the possibility of a paresthesia-free treatment.

[00:18:36] Speaker 07:
They specifically pushed back against that understanding at the Patent Office to get the patent in the first place.

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So, for example, we have Mr. Thacker, who was an employee of Boston Scientific and then left for Neverote.

[00:18:48] Speaker 02:
I'm sorry, what page in the appendix did you say that was in?

[00:18:51] Speaker 07:
A12574.

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Do you know what volume that is?

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It's a one-paragraph summary.

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It's an invention summary.

[00:19:00] Speaker 07:
I can pull it up right here on the side.

[00:19:02] Speaker 07:
Volume five.

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So if you look, maybe six lines down, Your Honor.

[00:19:18] Speaker 06:
In the underlined material?

[00:19:20] Speaker 07:
Yes, Your Honor.

[00:19:23] Speaker 07:
One, two, three, four, five, six.

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Applicant further argued that high frequency stimulation such as claimed by applicant may or may not cause paresthesia and thus it would not be inherent that high frequency stimulation would necessarily achieve pain relief.

[00:19:40] Speaker 02:
I don't see how that contradicts the capable of argument.

[00:19:46] Speaker 04:
And my understanding was that the whole point of this is that high frequency alone doesn't necessarily get you parasthesia free.

[00:19:55] Speaker 04:
It's also the amplitude.

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That's absolute.

[00:19:57] Speaker 04:
And pulse width modulation.

[00:19:59] Speaker 07:
So I don't see what you get out of this sentence.

[00:20:03] Speaker 07:
The point, Your Honor, and I apologize, I wasn't being clear is, and this, at A7, 8, 11, this is admitted.

[00:20:10] Speaker 07:
Nevereau acknowledged that the front.

[00:20:12] Speaker 07:
You're taking us somewhere else.

[00:20:14] Speaker 07:
Well, it's the same concept.

[00:20:15] Speaker 07:
It's the same notion, Your Honor.

[00:20:16] Speaker 02:
Where do you want me to go now?

[00:20:18] Speaker 07:
I'll just stick with what we have, just so we don't jump around.

[00:20:21] Speaker 07:
The prior ART, including ART devices, Boston Scientific Devices, was capable of providing paresthesia-free treatment.

[00:20:32] Speaker 07:
That sometimes it did, and sometimes it didn't.

[00:20:35] Speaker 07:
And this was presented as a ground for rejecting the claims.

[00:20:39] Speaker 07:
And Nevera said, no, because it sometimes does and sometimes doesn't, it doesn't anticipate.

[00:20:46] Speaker 07:
But they then didn't complete the sentence.

[00:20:47] Speaker 07:
They then didn't say, and here's the secret sauce.

[00:20:50] Speaker 07:
Here's the magic formula.

[00:20:52] Speaker 07:
Here's the combination of parameters that will always, almost always, typically, pick whatever adjective you want, create paresthesia.

[00:21:02] Speaker 07:
So that's why I don't want to give up on this paresthesia-free argument, Your Honor.

[00:21:05] Speaker 07:
It's that this was critical to patentability, the notion that the prior art devices that had precisely the same technical capabilities

[00:21:13] Speaker 04:
that because they didn't always create, they didn't inherently create, sometimes they did, sometimes they didn't, create paresthesia, therefore... Doesn't the specification here talk about we want the frequency to be within this range, we think the amplitude should be in this other range, you can have different kinds of duty cycles?

[00:21:31] Speaker 04:
There's some guidance and details in the specification that get you to where they want to get to.

[00:21:37] Speaker 04:
Isn't that true?

[00:21:38] Speaker 07:
respectfully know, Your Honor, because the passages that counsel was pointing to primarily, and there are charts and tables and diagrams, those are all about whether the device alleviates pain.

[00:21:53] Speaker 07:
The statistics, the numbers, are all about whether or not it alleviates the pain.

[00:21:59] Speaker 07:
The paresthesia point here is one paragraph at the end of that chain that says, and lots of people felt paresthesia free.

[00:22:07] Speaker 07:
They didn't tell us at what number, what kilohertz, at what amplitude, at what number you're likely to trigger the threshold.

[00:22:14] Speaker 07:
We have, again, this is Mr. Thacker.

[00:22:18] Speaker 07:
This is at A12017.

[00:22:20] Speaker 07:
Specific details of the sensations vary patient to patient.

[00:22:25] Speaker 07:
Patients can feel paresthesia at frequencies above 2500 hertz.

[00:22:30] Speaker 07:
And of course the typical range of the patent is one and a half and above.

[00:22:34] Speaker 07:
So they're telling the patent office, doing a bit of a soft shoe,

[00:22:38] Speaker 07:
Just because the prior art devices could provide these parameters, unless you show that they actually did it, they actually provided paresthesia free treatment routinely, they're not invalidating.

[00:22:51] Speaker 07:
But then they don't tell us in the patent what, as I said, the secret sauce is, what the algorithm is.

[00:22:57] Speaker 07:
So that's why, Your Honor, I wanted to push back a little bit, because I think this is an important point.

[00:23:03] Speaker 07:
Most of the claims are structured.

[00:23:05] Speaker 07:
Here are frequencies or amplitudes, depending on the complexity of the claim.

[00:23:11] Speaker 07:
None of that's new.

[00:23:13] Speaker 07:
We have their own expert admitting at A8666 that Nevo didn't invent neurostimulation, SCS, a new lead, or even an IPG.

[00:23:26] Speaker 07:
The asserted claims rely on known hardware components.

[00:23:29] Speaker 07:
So all the numbers in the claims are from known hardware components.

[00:23:33] Speaker 07:
What's supposedly new is paresthesia-free.

[00:23:37] Speaker 07:
Well, then tell us, with at least rough numbers, what gets us to paresthesia-free.

[00:23:43] Speaker 07:
And what His Honor found below and what's subject to clear error review is that you can't do that.

[00:23:49] Speaker 07:
It's patient by patient, just like Caliburton, just like Geneva.

[00:23:54] Speaker 07:
So with that, unless you have other questions, I'll turn to the configured leadership.

[00:23:58] Speaker 04:
In Geneva, this court said effective amount of a composition is, although sometimes you're not going to know until after you do the treatment, that's a classic way of

[00:24:13] Speaker 07:
writing claims and we don't worry about that on the definiteness equation that's a hundred percent correct your honor what we have here is an anti-effective amount claim what geneva said unambiguously is we're going to allow a certain level of experimentation almost kind of bleeds into an enablement analysis it uses the phrase undue experimentation if we can figure out what the parameters are what the claim scope is without undue experimentation we'll let you keep the claim

[00:24:41] Speaker 07:
But here we have NEVRO telling the Patent Office, for a very important reason, time and time again, we can't tell you what that is, before the fact or after the fact.

[00:24:51] Speaker 07:
This isn't a situation where we're coming in here and we say, well, you have to perform this procedure on five patients to figure out what the proper dosing is, what the proper signal parameters are.

[00:25:02] Speaker 07:
What they said over and over again to the Patent Office and what Judge Chabria found, and again, is subject to a clearer review,

[00:25:08] Speaker 07:
You can get as much information as you want, patient to patient to patient.

[00:25:12] Speaker 07:
It doesn't tell you as to the next in line, are you going to get paresthesia free or are you not going to get paresthesia free.

[00:25:19] Speaker 06:
Can I just ask why does that matter?

[00:25:22] Speaker 06:
Because that's exactly what... I guess I'm thinking particularly of the method.

[00:25:29] Speaker 06:
I would have thought that there have been a fair number of patents over time that say here are some sort of objective conditions and then they say where in and they state an effect.

[00:25:41] Speaker 06:
Why, in your view, would those wherein clauses about effects have any meaning at all?

[00:25:47] Speaker 06:
Because either it always has that effect, or it would be invalid.

[00:25:54] Speaker 07:
Your Honor, you're absolutely right.

[00:25:55] Speaker 07:
I could imagine method claims written to these concepts that would not fail the indefiniteness required.

[00:26:00] Speaker 07:
At the end of the day, we think they're all invalid under 102.

[00:26:02] Speaker 07:
But putting that aside, the method claims here are not really

[00:26:07] Speaker 07:
traditional method claims.

[00:26:09] Speaker 07:
I mean, if we look at claim one of the 102, it has three things.

[00:26:12] Speaker 07:
It has a signal via lead, it provides a treatment at 1.5 to 50k, and quote, does not create paresthesia, end quote.

[00:26:20] Speaker 07:
That's the entirety of the method claim.

[00:26:22] Speaker 07:
So I want to use those parameters, because my PriorArt device can provide 1.5k to 50k, but I don't want to do paresthesia.

[00:26:32] Speaker 07:
I don't want to infringe.

[00:26:34] Speaker 07:
from patient to patient to patient.

[00:26:36] Speaker 06:
Right, so you can't know in advance, for sure.

[00:26:43] Speaker 06:
Maybe I'll ask it this way.

[00:26:44] Speaker 06:
I gather that pre-Nautilus, we had a number of cases that said, you don't have to know in advance.

[00:26:50] Speaker 06:
Do you think Nautilus changed that?

[00:26:52] Speaker 07:
It did.

[00:26:53] Speaker 07:
At least at the broadest level, and we argue this in a brief center, it did.

[00:26:56] Speaker 07:
There's still the Nautilus notion of avoiding the trap of uncertainty.

[00:27:03] Speaker 07:
Effectively, what they've done by writing these method claims is monopolize not just paresthesia-free treatment, but paresthesia treatment.

[00:27:11] Speaker 07:
So if I want to have a treat with paresthesia, because I have a patient that prefers a numbing to that weird kind of nothing feeling, I can't perform the method at the risk of being paresthesia free.

[00:27:24] Speaker 02:
Just to be clear, you just called it a weird kind of nothing feeling.

[00:27:27] Speaker 02:
Let me understand the technology.

[00:27:29] Speaker 02:
You can have tingling and pins and needles, or you can have nothing.

[00:27:33] Speaker 02:
And you think the weird one is the nothing?

[00:27:34] Speaker 07:
There are patients that, if you've lived your whole life with back pain,

[00:27:39] Speaker 07:
And then there are patients that prefer paresthesia to non-paresthesia.

[00:27:44] Speaker 07:
The studies have shown, and there are certainly patients that presented with the option of lower frequency and paresthesia, and thus far less frequent battery recharging.

[00:27:55] Speaker 07:
The studies have shown, but this is in our brief, that many patients prefer that.

[00:28:01] Speaker 01:
Could I ask you to move on to the figure to complete limitations?

[00:28:05] Speaker 07:
Yes, Your Honor.

[00:28:08] Speaker ?:
Yes.

[00:28:09] Speaker 07:
This very discussion we're having was had in the prosecution of this family of patents.

[00:28:16] Speaker 07:
On configured to.

[00:28:17] Speaker 07:
Yes, Your Honor.

[00:28:18] Speaker 04:
This dove tails back, I'm sorry, to peristesia free.

[00:28:21] Speaker 07:
Yes.

[00:28:22] Speaker 04:
If we were to construe configured to mean programmed to.

[00:28:28] Speaker 04:
Yes.

[00:28:29] Speaker 04:
Then wouldn't that take care of your indefiniteness concerns about peristesia because what will

[00:28:38] Speaker 04:
the claims will all mean then that you've essentially customized the signal generator in such a way for a given patient to produce a paresthesia free therapy signal outcome and then if that's the case then

[00:28:54] Speaker 04:
You know you're infringing, or not infringing, because you've now designed and customized and altered the parameters in such a way that you are yielding a paresthesia-free signal.

[00:29:06] Speaker 07:
Your Honor, there are, one can envision claims where that would be the result, but with these claims as written, if I am doing an iterative process with the patient, that first signal that I give them, if it is paresthesia-free by blind luck, I've now infringed their patent.

[00:29:24] Speaker 07:
Even though they haven't told me that that signal is or is not likely to cause paresthesia, I know as a factual matter from their own witnesses that it may or may not cause paresthesia.

[00:29:34] Speaker 07:
I'm rolling the dice.

[00:29:35] Speaker 07:
I could set out to be in the 1.5 to 2 kilohertz, therefore battery saving range, and say I don't want to even risk no paresthesia free.

[00:29:46] Speaker 07:
I'm willing to accept the tingling exchange for the battery.

[00:29:50] Speaker 07:
If that first time I plug that in, that's paresthesia free.

[00:29:52] Speaker 07:
They've got me for infringement.

[00:29:54] Speaker 07:
So the way they've written their claims, it's just a crap shoot.

[00:29:58] Speaker 07:
It's a roll of the dice.

[00:30:01] Speaker 04:
Well, go ahead and explain why Configure 2 means program 2.

[00:30:07] Speaker 07:
Well, in fact, we have, and this is an A12929 in the 405 application, which is the exact same spec as the 533 patent.

[00:30:18] Speaker 07:
The patent office said, Configure 2 means at least one instance of actually programming.

[00:30:24] Speaker 07:
actually programming, then they go on a sentence later and use the phrase actually configure.

[00:30:30] Speaker 07:
We see claim language like claim one of the 125 pattern at 148 where it says a step for configuring the signal generator including programming.

[00:30:39] Speaker 07:
So the notion that programming is part of configuring is replete.

[00:30:45] Speaker 07:
And the position that they're taking today, and can I take one step back?

[00:30:51] Speaker 07:
I know this isn't directly your question.

[00:30:52] Speaker 07:
We're very concerned about this design to construction, because it's meant two entirely different things.

[00:30:57] Speaker 07:
The gloss they've put on design to, and at pages 35 to 37 of our opening brief, we have a long colloquy about this.

[00:31:06] Speaker 07:
Design to below meant some kind of subjective intent.

[00:31:09] Speaker 06:
Right, but let's assume that that's been abandoned and abandoned without difficulty, and that it really does mean presenting – setting the thing up so that you present choices to the administrator

[00:31:25] Speaker 06:
And once those choices are made about the parameters to put this, what values to set the parameters at, and the power is on, it does what you say it's supposed to do.

[00:31:36] Speaker 07:
In the prosecution history and the claim language, we believe the much better reading is that programming has to be part of configuring.

[00:31:43] Speaker 07:
In order to be configured ED, you have to be programmed ED.

[00:31:48] Speaker 07:
And we obviously didn't do that.

[00:31:52] Speaker 07:
We didn't program.

[00:31:54] Speaker 07:
in advance.

[00:31:55] Speaker 07:
Now, if you're right, if we're playing games with our salespeople in the field, they have inducement claims and all that, but they said to the patent... Or even direct infringement if they actually are your salespeople.

[00:32:09] Speaker 07:
Yes, John.

[00:32:10] Speaker 07:
But they unambiguously said to the patent office that

[00:32:15] Speaker 07:
Actually configured is what this means that at least one instance of actually programming that's the patent office's own words It wasn't rejected.

[00:32:24] Speaker 07:
They got the claim actually program this patent, right?

[00:32:29] Speaker 07:
That's but it's this specification honor.

[00:32:31] Speaker 07:
It's the same space It's the five three three specification the same spec, but you're right.

[00:32:35] Speaker 07:
It's not the same pack

[00:32:37] Speaker 07:
But clearly, when you're talking about language in the same spec, I think this court has felt, I mean, it's not without exception.

[00:32:43] Speaker 07:
But certainly, it's fair for us to read that same discussion.

[00:32:49] Speaker 06:
And this is the passage in which the examiner said, I don't like what you have.

[00:32:54] Speaker 06:
Here's my suggestion.

[00:32:55] Speaker 06:
They said, no, we don't like that suggestion.

[00:32:58] Speaker 06:
We have an alternative.

[00:32:59] Speaker 06:
How do we make?

[00:33:00] Speaker 07:
And then it was rejected again by the examiner, and then they didn't push back on that.

[00:33:04] Speaker 07:
So you're right, there were two steps, Your Honor.

[00:33:06] Speaker 07:
But the second time, the examiner said, no, no, I need actual programming to allow this claim.

[00:33:11] Speaker 07:
They accepted that, and it took the claim.

[00:33:15] Speaker 07:
But we don't even have to go there.

[00:33:16] Speaker 07:
I mean, claim one of the 125, when it says, a step for configuring the signal generator, including programming.

[00:33:24] Speaker 07:
That, to me, Your Honor, respectfully, is unambiguous, that programming is a subset of configuring, and therefore, if you are configured, you are programmed.

[00:33:34] Speaker 07:
That's also the language of the precedent we cited Intel, we cited Edwards and Fortinet and others, that that just makes sense.

[00:33:42] Speaker 07:
That either we're sending it to the customer

[00:33:44] Speaker 07:
as programmed, or we're not.

[00:33:47] Speaker 07:
And if we're not, you know, they have other avenues.

[00:33:48] Speaker 06:
So in, this is perhaps a little bit indirect, and I'm not sure the parties cited the core wireless case.

[00:33:56] Speaker 06:
You know that case?

[00:33:57] Speaker 06:
I'm familiar, but I don't recall it.

[00:33:58] Speaker 06:
It's a case in which, I think, in the course of the opinion, maybe this has, I forget what the language was, maybe adapted to or something, in which the term was

[00:34:09] Speaker 06:
It was explained that the term meant, among other things, configured to.

[00:34:13] Speaker 06:
And the analogy made was to like a three gear gear shift in a car.

[00:34:22] Speaker 06:
And the car is configured to operate in gear one.

[00:34:26] Speaker 06:
It's also configured to operate in gear two.

[00:34:28] Speaker 06:
And it's configured to operate in gear three.

[00:34:31] Speaker 06:
And I think the opinion says expressly

[00:34:34] Speaker 06:
If the claim is configured to operate in gear one, it doesn't matter that it can also be operated in the other way.

[00:34:41] Speaker 06:
And it's configured that way even before the driver pushes it into the correct place.

[00:34:48] Speaker 06:
Why is this not working?

[00:34:50] Speaker 07:
I recognize that, Your Honor.

[00:34:51] Speaker 07:
And this is somewhat an exercise in line drawing, right?

[00:34:53] Speaker 07:
Because how, and Finging kind of hovers over all of this.

[00:34:59] Speaker 07:
But when we sell a device that

[00:35:04] Speaker 07:
that a commercial user can't take and put at in the claimed range.

[00:35:10] Speaker 07:
And they say, and they infringed, they argued that kind of device until a month before the summary judgment hearing, when they realized they were on the, between Silla and Peribdis of 102 and infringement.

[00:35:21] Speaker 07:
They were arguing that was infringing under their definition of design two.

[00:35:25] Speaker 07:
Where literally, we had put a screen that blocked out a commercial user from going into second gear or third gear or fourth gear.

[00:35:33] Speaker 07:
So that's why we're kind of angels on the head of a pin, Your Honor, and I apologize.

[00:35:38] Speaker 07:
But there's a back story to what was accused for the best.

[00:35:40] Speaker 06:
Sometimes, you know, you actually get through Scylla and Corruptus.

[00:35:46] Speaker 07:
Yeah, I guess that's true, Your Honor.

[00:35:48] Speaker 07:
I am well into my red light time, Your Honor.

[00:35:51] Speaker 02:
All right.

[00:35:51] Speaker 02:
Thank you, Mr. Wolfe.

[00:35:53] Speaker 02:
Thank you.

[00:35:53] Speaker 02:
Ms.

[00:35:53] Speaker 02:
Maynard will restore your rebuttal time.

[00:35:56] Speaker 02:
Go ahead and give her five minutes.

[00:35:58] Speaker 00:
Thank you very much, Your Honor.

[00:36:00] Speaker 00:
First, this is not blind chance.

[00:36:02] Speaker 00:
The patents describe and teach how to provide this therapy.

[00:36:07] Speaker 00:
And the extrinsic record shows that BSC did it in its own study with hundreds of patients where it said one arm was paresthesia-free and one arm was paresthesia-based.

[00:36:20] Speaker 04:
So what are your storm disk specification passages for giving a skilled artisan a clear window into how to achieve a paresthesia-free signal, paresthesia-free therapy signal?

[00:36:35] Speaker 00:
So starting at column six in A99,

[00:36:39] Speaker 00:
At line 51, the patent describes the study that NEVRO did, and it gives the 3 to 10 kilohertz.

[00:36:51] Speaker 00:
And in particular cases, it tells you where to place the leads.

[00:36:55] Speaker 00:
It gives you the kilohertz.

[00:36:57] Speaker 00:
It tells you the amplitudes, the duty cycles, as your honor mentioned, and the amplitudes at the top of column seven, line one and two.

[00:37:09] Speaker 03:
Does this study connect to a paresthesia-free outcome?

[00:37:15] Speaker 00:
Yes, your honor.

[00:37:16] Speaker 00:
So if you go to column nine, the patent makes clear that the patients all preferred

[00:37:24] Speaker 00:
every one of the tested patients preferred the presently disclosed therapy to standards that implicitly suggest they received para-seizure free therapy and we know they did from the extrinsic evidence because this is the study that was

[00:37:39] Speaker 00:
that the FTC monitored.

[00:37:42] Speaker 00:
And in that study, the report was that 100% of the patients in the paresthesia-free arm received paresthesia-free therapy.

[00:37:51] Speaker 02:
So isn't the case... Could I get you to turn to the Configure 2 construction?

[00:37:54] Speaker 00:
Yes, I'd be happy to, Your Honor.

[00:37:58] Speaker 00:
So on Configure 2, the part of the... Maybe as part of that, can you address the reference?

[00:38:05] Speaker 06:
I think Mr. Wolf said your ex-group testified that

[00:38:09] Speaker 06:
Oh, I forget what the phrase was.

[00:38:12] Speaker 06:
Known hardware components.

[00:38:14] Speaker 06:
where it means.

[00:38:16] Speaker 06:
Am I remembering that right?

[00:38:19] Speaker 00:
So that the signal generators are known in the art.

[00:38:22] Speaker 00:
But this is a combination.

[00:38:25] Speaker 00:
The patent is the signal generator that allows a user to select the novel therapy that's described and claimed in the patent.

[00:38:33] Speaker 00:
And that's obviously not unusual.

[00:38:35] Speaker 00:
The part that you were discussing with him in the prosecution history, Your Honor, at A12929,

[00:38:42] Speaker 00:
That, so as Your Honor noted, we expressly declined to agree to amend the signal, the term that's closest to what's at issue here.

[00:38:53] Speaker 00:
And the last sentence of this description makes clear that, so it's about the programmer.

[00:39:01] Speaker 00:
Wherein the programmer is configured to transmit and effectively two signals, the examiner agreed that

[00:39:10] Speaker 00:
a programmer was so configured even if the user didn't select both signals.

[00:39:14] Speaker 00:
So to your car hypothetical, it's like it allows first and second gear, and it would still be configured to do that even though only second gear is chosen.

[00:39:24] Speaker 00:
That's completely consistent.

[00:39:26] Speaker 00:
It's a different claim language and different claim, but it is consistent with our argument.

[00:39:31] Speaker 00:
his claim one on the patent 125 claim one the that that method claim there that configuring comma including program that actually shows that programming and configuring are not equated that the one he was pointing out one two five

[00:39:54] Speaker 00:
Yeah, so it's a method that talks about configuring the signal generator, comma, including programming, and that actually shows that

[00:40:08] Speaker 00:
that programming and configuring, I mean we don't think that claim is what you should look at because it's not the same claim term, it's a method claim, not the signal generator configured to generate, but even if you look at it, it debunks the notion that configuring is equated to programming, otherwise that including step would kind of be superfluous.

[00:40:26] Speaker 06:
Well, but the word equated, I don't think, quite captures the point.

[00:40:30] Speaker 06:
I think his point is that configured, configuring is not complete until the last step, which is programming.

[00:40:40] Speaker 06:
And that's what

[00:40:41] Speaker 06:
language their argument tends to support.

[00:40:46] Speaker 00:
But if configuring, the district court thought that it showed that programming in that context was equated with configuring and obviously if the signal generator were already, if a configured to signal generator were already programmed, the including programming would be superfluous.

[00:41:08] Speaker 02:
Okay, thank you, Ms.

[00:41:09] Speaker 02:
Mayer.

[00:41:09] Speaker 02:
We thank both counsel.

[00:41:10] Speaker 02:
This case is taken under submission.