BIOSIG INSTRUMENTS, INC. v. NAUTILUS, INC.
Oral Argument · Case 2012-1289 · 29:24
0:00
Judge Newman
Okay, the next argued case this morning is number 2012-1289,
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Biosig Instruments against Nautilus.
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Mr. Bonilla.
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Judge Wallach
And you can talk, Mr. Bonilla, about the obvious inaccuracy of these machines
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when they say I weigh 20 pounds more than I really do.
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Appellant Attorney (Mark David Harris)
Your Honor, may it please the Court.
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The District Court's judgment of indefiniteness should be reversed
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because there's a clear, bright-line test that's set forth in the intrinsic record
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that's unrebutted, that distinguishes what electroconfigurations are inside the claim
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and which are outside of the claim.
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And that test is merely hooking up an oscilloscope,
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which is a standard piece of electrical equipment.
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Many of us have used it back in college some years ago.
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They go back generations.
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You hook it up to a differential amplifier, look at the input signals,
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look at the output signals.
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The input signals will show that you have muscle signals.
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You can't find the heart signal.
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You look at the output signal.
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If the electrodes are configured properly,
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you will have removed the muscle signals,
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leaving the traditional heart signal where you have an amplitude with an R wave.
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And you can see that.
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And from that, you can measure the heart rate.
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Judge Wallach
And the core of your argument is that any person skilled in the art can do it.
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Appellant Attorney (Mark David Harris)
That's right.
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And it's unrebutted, Your Honor.
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There's no testing from Nautilus.
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They haven't even tried the test.
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Or if they tried it, they haven't told us about it.
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So that's completely unquestionable.
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That's completely unrebutted.
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And once skilled in the art can do it, there's testing from Dr. Galena.
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There's testing from Dr. Lechman.
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The patent examiner understood the testing.
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And we had another expert, Dr. Yanovos, which is extrinsic evidence,
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that confirmed the testing.
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And that's completely unrebutted.
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There's no expert.
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There's no person skilled in the art.
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There's no testing.
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There's no evidence whatsoever from the other side.
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And it's their statutory burden to come forward with evidence to invalidate the patent.
1:57
Judge Schall
So let me ask you, I look at our Exxon research case,
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Honeywell, Power One, Aeroproducts, Border Regions of Texas, University of Texas,
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I'm sure there are others.
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They all seem to say a claim is not indefinite if it can be construed.
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Correct?
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Appellant Attorney (Mark David Harris)
Yes, Your Honor.
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Judge Schall
Here, the judge construed the claim.
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Correct.
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Albeit with a broad construction, not the narrow construction that Nautilus favored.
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So we have a claim construction.
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The judge construed it.
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Nobody seems to be saying,
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it couldn't be construed, it was construed, isn't that the end of it?
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Simply because we have a claim construction here,
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albeit a broad one, that's the end of the case.
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Appellant Attorney (Mark David Harris)
I think that's generally true, Your Honor.
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In fact, it's interesting.
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Judge Schall
Why doesn't that end the issue right there?
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Appellant Attorney (Mark David Harris)
I think it does end the issue because the claim was construed,
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and now we're off in a claim application.
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And I think that does end the issue.
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And I think it's interesting that you raise that because when we did claim construction,
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indefiniteness wasn't raised.
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And that's typically the form where,
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someone's going to raise indefiniteness.
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Judge Schall
Let me ask you, if we, obviously, if we say the claim's indefinite,
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the case is over, you lose.
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But if we say the judge erred in finding the case indefinite,
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it would go back to the district court.
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What remains pending there in the way of issues?
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Obviously infringement, I guess, but what in terms of validity issues?
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Appellant Attorney (Mark David Harris)
Well, infringement and damages, obviously.
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But there hasn't been a lot of discovery, actually, that's taken place.
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We didn't actually have expert reports before this happened.
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We haven't actually had a lot of factual discovery from Nautilus,
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the way this case was postured because of the previous litigation.
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There was a lot of things that did not happen in previous litigation
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that Nautilus elected to go to read them.
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Judge Schall
Did Nautilus advance some validity arguments?
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Appellant Attorney (Mark David Harris)
In the previous case, they advanced enablement and written description
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and invalidity over the prior art that they took to the Patent Office.
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And now it's all been litigated.
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They seem to be continuing to advance the same arguments that are in the Patent Office.
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I can't speak for them.
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Judge Schall
I was going to ask counsel the same question.
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So, in other words, I'm trying to understand.
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In your view, are there, if this case goes back,
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are there validity issues pending in the district court that would have to be resolved?
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Appellant Attorney (Mark David Harris)
We didn't have interrogatories when we went back to the district court, Your Honor,
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so it's hard for me to answer because we came out of the re-exam,
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went back to the district court.
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We had a, the first thing the court did was schedule a markment.
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No discovery, no interrogatories, no contentions, no experts.
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We went to markment, and then the court said, after the markment decision,
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issued an order, said, file summary judgment briefs if you would like,
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which Nautilus did.
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And so, we haven't had contentions, but in that.
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Judge Schall
In the summary judgment, did it urge more than just indefinite?
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Appellant Attorney (Mark David Harris)
Yes, it did.
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It was like an omnibus motion.
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They argued non-infringement, anticipation, obviousness, and indefiniteness.
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So, those were the issues that were raised.
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So, they could go back and raise anticipation and obviousness
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and the things that were generally litigated in the re-exam.
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Judge Schall
Okay.
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I just wanted to make, to clarify.
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Right.
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Appellant Attorney (Mark David Harris)
So, there is work to be done.
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I don't know exactly what their positions would be on that.
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I do want to clarify to make sure that the court is clear on this catch-22 argument
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that they seem to have tried to make.
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They try to say, they line up all these devices and they say,
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they look similar.
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They all have to be in or out.
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There's no test.
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Well, we did provide a test in the intrinsic record and they never tried to apply it.
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So, for them to say there's no test that distinguishes it isn't really fair
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when they haven't even applied the test.
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And those configurations are all different in many other respects.
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And this is a multi-faceted problem that depends upon electrodes spacing, length, width, thickness.
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And for them to pick out one characteristic between those devices and say the length is greater than the width
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doesn't make them equal.
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They're just not.
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That's like saying all electrodes that are common.
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Hopper are equal.
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They're not because they have different lengths, thicknesses, widths, etc.
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So, that Hobson's choice argument that they've tried to create below and they've tried to create here
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is just not factually correct.
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And I'll reserve the rest of my time for rebuttal.
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Thank you, Your Honor.
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Judge Newman
Okay.
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Thank you, Mr. Vanilla.
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Mr. Garage.
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Appellee Attorney (James E. Geringer)
May I please?
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Court.
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Though a claim can be construed into other words, it does not end the indefinite inquiry
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as the Halliburton case, for example, cited in, for example, Star Scientific.
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With a different result.
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Judge Schall
Well, let me tell you, we have here a case where, we have a situation where the district
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court construed the claims.
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Granted, it adopted a very broad construction, which may leave the claim subject to some
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kind of a validity challenge other than indefiniteness below.
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I don't know.
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You'd know better than me.
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But those cases that I looked at seem to say that if a claim can be construed, it's not
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indefinite.
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So why isn't that the end of the issue, at least on this issue here?
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Now, maybe if it goes back, you win on some other issue below.
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But why doesn't that end the indefiniteness inquiry as far as we're concerned?
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Appellee Attorney (James E. Geringer)
Your Honor, because the words given to the claim still need to be applied.
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So we argued Halliburton insolubility for indefiniteness, because though the judge raised
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indefiniteness at the district court level, he initially agreed with Nautilus that the
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file history.
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Did contain a disclaimer, paragraph 79, joint appendix 241, for example, in which patentee
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said, the prior art features wide electrodes with a narrow gap in between.
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The invention features narrow electrodes with a wide gap in between.
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The judge said, I think that's a clear statement.
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And though you point to some inconsistent statements, allegedly inconsistent statements
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elsewhere, the Hockerson-Halberstadt case, the DuPont case.
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These cases that say, we will hold you to your clear statement.
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Judge Schall
But none of that dealt with the space to part limitation that we're dealing with here, did it?
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Appellee Attorney (James E. Geringer)
It dealt exactly with that, Your Honor.
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That's exactly what it dealt with.
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The judge said, I agree with Nautilus that those statements, such as paragraph 79, JA241,
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they count.
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And I'm going to hold them.
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Biosig asked, could we submit another paper, Your Honor?
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We would like you to construe this term space relationship broadly.
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We don't think there was a clear disclaimer.
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Because we think...
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We think the final history was unclear.
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We contradicted ourselves.
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The judge said, be careful.
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I think you are asking for a construction that will lead to invalidity by ambiguity.
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It's in the transcript.
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They asked for that broad construction with renewed paper.
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The judge granted their broad construction after making that due warning.
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We then moved for indefiniteness.
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And the judge said, I invited this motion.
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And we said, yes.
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By your remarks that if we don't take that clear statement as a disclaimer, it's still there.
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On page 13 of the Red Brief, we've circled the electrodes of four devices.
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Two of these are in.
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Two of these are out.
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Regardless of the words that the court was able to come up with for a space relationship,
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the second and fourth devices are clearly out.
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And nobody argues differently.
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BioSig argues that their test, which they read into the whereby clause,
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which came in only on re-exam file history.
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It's not in the specification.
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It was not available to the person with a skill in the art at the time of priority.
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It's not in any publication.
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They say that that whereby clause, which merely states the result,
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just provides a test that will put these two devices' space relationship outside that claim element.
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So the question is.
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In Haliburton, the question is, do you have the claimed fragile gel?
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In this case, the question is, do you have the claimed spacing?
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They all have a spacing between their four electrodes.
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My opposing counsel said if the electrodes are configured properly.
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The apparatus claim tells you how to configure those four electrodes properly.
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You need two on each side.
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Two are connected to a differential amplifier.
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the fire, two are connected to each other. The claim recites this. The prior art recites
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this. All we were focused on is that physical structure. And that does tell you what you
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need for the whereby result. So two are in, two are out. That was the problem. And the
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judge said, well, I agree with Nautilus tentatively that those two are out for the reason you
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said they were out. This one, the pads are too fat, the gap is too narrow. The one at
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the bottom, the E factor, Biosig said in the file history, never retracted, those are asymmetric.
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So they can't be the right space relationship. Do we have the claimed space relationship?
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Yes, no, yes, no. And those two in the middle on page 13, to say yes and no for those and
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to offer a test for a whereby clause.
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So the person with the skill in the art is supposed to do it. What they did was they
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took an unscaled patent, the Fujisaki 200, and they built one model. And they tested
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that one model with a new test that's not in the claim construction. It's a test that
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says at the output of the diff amp, the differential amplifier, will the heart to muscle ratio
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signal, desired signal is the heart, muscle is the noise. Will the signal to noise ratio
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exceed some number? They don't tell us what that number is. We know it's greater than
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1.1, they say, and 2 would be good enough. Somewhere in there, there's a lower bound
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for a test that they injected only in re-exam, and which is not in the claim construction.
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And that test is supposed to re-delineate that broad construction. Because that broad
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construction, as the district court confirmed on the record,
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covers all. That's Joint Appendix 2810, page 23, line 16, of the summary judgment transcript.
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I said, Judge, we lost. We argued that there was a disclaimer in the file history for what
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these electrode spacing must be, paragraph 79, for example, saying that in the intent,
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intervention, the rings are narrow, and the gap between is wider. In contrast, in
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Fujisaki, the pads are fat, and the gap is narrow. Another site for that is Joint Appendix
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797. We've provided that intrinsic evidence. The court initially agreed with us, but then
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we lost. On reconsideration, he said, I'm going to give the broad language. Even though
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he had warned them that he felt that would leave it indefinite.
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And we then did move for summary judgment. We said, based on the intrinsic evidence,
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not varying the claim construction, as these tests would do, but just based on taking that
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broad language, you can't distinguish these four, as you must.
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Mr. Bonella said that indefiniteness was not raised at claim construction, as I mentioned.
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It certainly was. The judge raised it. The judge warned them, and the judge then, on summary judgment, said,
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the construction you asked for can't be applied with the precision required by the court.
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Judge Schall
Mr. Gingrich, what other issues are pending, are potentially, I should say, potentially
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pending, what validity issues are potentially pending in the district court?
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Appellee Attorney (James E. Geringer)
In the district court, Your Honor, very quickly, Your Honor, in this court, there's also the
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IPXL issue, which we can address. In the district court, validity issues are pending.
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If remanded, we have asked that if the court is not inclined to affirm on indefiniteness,
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that we get a clear construction of what the spaced relationship term should be.
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In other words, a definitive construction of the in-spaced relationship term.
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Was the district court's initial construction correct, and there was clear disclaimer,
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and I've cited the cases in the brief.
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Why we think that was true, or was their second construction, what BioSig proposed, correct,
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and then it's any spaced relationship will do.
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Judge Newman
Did the district judge appear to accept the theory that it was acceptable to leave it open,
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that you figure out through trial and error what the spacing should be?
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Appellee Attorney (James E. Geringer)
Quite the opposite, Your Honor. He had a lot of trouble with trial and error. He thought
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that same, as did the Halliburton Court and the United States.
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The 1938 GE case, talking about the vice of functionality, the judge had a lot of trouble
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with this trial and error. Looking at the trial court transcript, you'll see that he
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thought that to throw this to trial and error was the problem. That was paragraph 69, this
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notion of spacing, materials, size.
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All of these factors which aren't clear, which aren't defined, and which he thought
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were just insoluble. So he did not think trial and error would be good.
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Judge Wallach
Isn't it more like tuning than trial and error?
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Appellee Attorney (James E. Geringer)
I think that is a fair point. They did say that the Fujisaki reference and the E-factor
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reference weren't tuned.
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I mean, they weren't balanced. They didn't show. The Fujisaki, they said, well, we measured
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it with this new test for an interim result. Remember, this whereby result, this whereby
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clause, even if you give it patentable weight, which I don't think it should be given, even
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if you gave it to it, that's not the point of the device. The point of the device isn't
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for some interim signal. The point of the device is to get a heartbeat, to count heartbeats.
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They said that the E-factor was asymmetric to their own prior device that was not originally
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disclosed.
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It came in on reading.
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And on re-exam, they said, well, that spacing is different on the left side than the right
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side. So that can't be balanced. It doesn't show the right tuning.
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Other issues remaining in the district report?
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If it were remaining, certainly non-infringement, if, well, sorry, yes, for invalidity issues
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remaining out of it.
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For other elements, Your Honor, I do submit that indefiniteness can be resolved on the
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single element of claim spacing or not, in or out on claim spacing. As a thought experiment
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in this, we can assume, I think, that all the other elements would be met. The person
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still in the yard is struggling with the question, do I have the claim spacing or not? But if
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with a remand of on claim spacing in space relationship and whether the whereby clause
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has any weight, then certainly it would be open to on invalidity. There are other four
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electrode devices which connect two to the diff amp, two to each other.
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To try to cancel out what's the same and amplify what's different. By the way, the reason
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this helps is the heart's on one side of the body. So through your hands, you actually
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are getting a little bit different heart signal. So there's a difference to amplify. Whereas
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by connecting, according to their expert, Dr. Galeana, by connecting two of the electrodes
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to each other and to ground, you create this crosstalk which kind of equalizes the muscle
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more. The heart's a muscle too, but not to be confusing. By equalizing those a bit more,
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you match the difference.
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You can maximize more of what gets canceled. So you're dampening down the muscle, ramping
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up the heart, and then you can have a gain. So that's the point. And remember, her test
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was different than the re-exam test. Her test was when she built this device, the Galeana
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device, which is very dimensioned, indistinguishably from the Fujisaki device. And she said, the
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test is, can I get a heartbeat?
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And I'll use a filter. I'll put the signals into the differential amplifier. I'll take
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the output of that differential amplifier, put it into a bioamplifier, which has filtering,
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a bandpass filter, and which has an amplifier to amplify the heart signal. That's a very
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different test than the test that Dr. Leckman then introduced in which he said, filters
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are bad. Fujisaki would need filtering because it only has a ratio of, you know, a heart
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signal. You know, 1.1. Well, 1.1, it took a weak heart signal, made it stronger than
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the muscle signal, and still could be further filtered and amplified, according to Dr. Galeana.
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Different test. So we really have two different tests. And the second one is not, the Dr.
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Leckman's test, not in the specification, not in the original file history. It's introduced
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16 years, 17 years after, at least after the priority, even longer after the priority date,
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the person was telling me, I had no access to that test. It's not published anywhere.
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There's no, there's no claim by anyone that this existed before Dr. Leckman coined it
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during the re-exam.
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Judge Newman
Any more questions for Mr. Galeana? Any more questions? Okay, I think we have the position.
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Thank you, Your Honor.
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Thank you, Mr. Galeana.
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Mr. Vanilla.
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Appellant Attorney (Mark David Harris)
Thank you, Your Honor. I'd like to address a few points. And one, I'd like to talk about
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the claim construction versus what happened, because I think there's some confusion here,
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but what happened during claim construction was we argued for the claim construction space
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relationship, for lack of a better word, the broader construction. And they argued that
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the claim should be limited based on a disavowal of structure during the prosecution. And they
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said biotech disavowed all structures where the electrode length was greater than the
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spacing between the electrodes. That was the argument. That cannot be true.
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Because we expressly showed structures of that type that were covered by the claim.
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Now, all structures that have length, gradient, spacing are not equal. They're not the same,
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because it's a multifaceted problem based on length, spacing, material, width, thickness.
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And they agree with that point. If you look at JA905, when they asked for a second re-exam,
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they cited the DelVal reference. And this is in response to what we did during the re-exam.
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They said DelVal teaches a geometric configuration.
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Size and location spacing of the electrode configuration affects noise, which includes
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EMG. And the muscle noise spectrum is non-uniformly distributed and subject to a large degree of
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variability. So they were agreeing with that point. And so all these configurations are
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not the same, just because they have four electrodes.
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And so the point being that during the claim construction, they argued for this disclaimer.
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We showed that that was not a disclaimer. And the point that the claim was allowed on,
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and the point that was discussed,
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during a re-exam, was whether the prior art devices substantially removed EMG signals
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to the differential amplifier. You go throughout the prosecution history,
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okay, JA142, that's the reason the claim was allowed and the reasons for allowing it.
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That was called the critical language, the essence of the invention, the essential feature.
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It wasn't the space relationship that was really being debated. It was removal of EMG.
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Judge Schall
What is your response to Mr. Gerringer's argument that Halliburton controls it?
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Appellant Attorney (Mark David Harris)
Halliburton does not control it.
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Well, because in Halliburton, what was claimed was a fragile gel, an inherently subjective term
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that raises a problem on space. So you have a subjective term, and the court said, well,
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let me look to the spec to see if I can define that term. And when you go to the spec, it was
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full of all types of other subjective terms. It was like easily thin, transitions relatively
23:40
quickly, fast. There was a whole host of subjective terms. They said, well, that's not very helpful.
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So then they said, well, let's look at this graph. Maybe this graph will be able to tell us what
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fragility is.
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And they said, well, the graph, how fast something transitions from a liquid state to a gel state.
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And they said, well, I'll try to pick a definition out of the graph.
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The problem with that was the patentee admitted that the SF 12.1, I think, prior art, exhibited
24:09
that very same feature. And the patentee admitted that. So in that case, there was no way to
24:15
define fragility and define it in a way that would not encompass the prior art.
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So the claim was indefinite. Here, we don't have that problem because we don't the only
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potentially subjective term is the substantial removal of EMG. And it's a clear guideline
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in the patent file history that shows how to do that with the oscilloscope meter testing.
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Judge Wallach
And if you look at the expansion case, you're saying it's more like star scientific because
24:43
it's manipulable objectively. Exactly, Your Honor. If you look at the expansion, the star scientific
24:48
Appellant Attorney (Mark David Harris)
case, you will get the end of bio biothecurses.
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case, those cases,
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the ones we cited in brief, they all have
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a guideline that one skill in the
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arc can apply. And there's no evidence that one skill
25:00
in the arc can't apply the test. None.
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None. They even try it.
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So for them to say that
25:06
they all have to be in or out, it's just incorrect.
25:08
But I want to get back to the prosecution,
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the district court's claim
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construction, because I think there's confusion.
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And the argument they were making
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was disclaimer. And what we
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said was, there's no
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disclaimer because the file history did not
25:22
disclaim on the point of the length
25:24
ratio to the spacing.
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And for them to prove
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a disclaimer, they had to prove that there was
25:31
an unmistakable assertion.
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And if the file history is ambiguous
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on the disclaimer point,
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they can't prove a disclaimer.
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Judge Newman
But it wasn't ambiguous in distinguishing
25:41
Appellant Attorney (Mark David Harris)
the references. Because it distinguished
25:43
based on the ability
25:45
to substantially remove EMG.
25:47
If you go to J142,
25:48
reasons for allowance, that was the reasons for allowance.
25:51
Not the length or spacing.
25:53
If you look at JA201,
25:54
239, we talk about it's a multifaceted
25:57
problem. The length,
25:59
the width, the material.
26:00
It's not just the length or spacing. We talk about
26:03
the total surface area.
26:05
So the file history was
26:07
there was no disclaimer, so it's
26:09
ambiguous under the disclaimer law.
26:11
But that doesn't mean that the claim is ambiguous.
26:13
So they're taking ambiguity
26:15
under to say that there's no
26:17
ambiguity. The file history
26:19
doesn't clearly disclaim something.
26:21
That's right.
26:22
And try to create...
26:22
Judge Newman
It wouldn't be ambiguous
26:24
if it's interpreted to
26:27
exclude the references
26:29
which were excluded during
26:31
prosecution. That's right.
26:33
Appellant Attorney (Mark David Harris)
The prosecution history reference,
26:35
Fujisaki, did not disclose
26:37
the substantial removal of EMG.
26:40
If you look at the Fujisaki reference...
26:41
Judge Newman
Then why did you object to
26:43
the district court's concern
26:45
about a claim construction
26:47
sufficiently limited
26:49
to preserve validity?
26:53
Appellant Attorney (Mark David Harris)
The claim construction
26:55
that we argued for
26:58
does preserve validity
26:59
because the prior art doesn't substantially remove
27:01
EMG. It does not have a structure for doing
27:03
that. There's no
27:05
express disclosure in Fujisaki
27:07
of removing EMG. Fujisaki
27:09
doesn't even mention EMG.
27:11
It doesn't say anything about hand muscle signals.
27:13
It doesn't even apply the word.
27:15
So there's no express disclosure on its face.
27:17
So then the question is, is it inherent
27:19
within the Fujisaki reference?
27:21
So we tried to show,
27:22
during the prosecution history, and we were successful
27:24
in doing so, that it's not
27:26
inherent. And the reason is, just like they say
27:28
in J0905, reference to
27:30
the DelVal paper,
27:32
that they're saying it's a function of the spacing,
27:35
the length, the width, the
27:36
ratio, all these factors.
27:38
So it's not inherent in Fujisaki.
27:40
Fujisaki did not disclose substantial
27:42
removal of EMG. We argued that.
27:45
The examiner accepted it, J142
27:47
reasons for allowance.
27:48
So the claim, as construed,
27:51
still distinguishes over the prior
27:52
art, and it's not indefinite.
27:54
It's similar to the prior art, because Fujisaki
27:56
doesn't substantially remove EMG.
27:58
And it's not indefinite, because
28:01
you can apply the test
28:03
to determine what's in and what's out.
28:05
And so there is no problem with
28:07
it reading on the
28:09
prior art. And there was no
28:13
evidence from Nautilus
28:15
that the claim, in fact, does
28:17
read on prior art. They didn't bring in
28:18
an expert or a declaration that said,
28:21
hey, this
28:23
EMG removal is expressed
28:25
and expressly stated in Fujisaki.
28:27
And in fact, on JA904,
28:31
they basically admit that
28:32
it's not, because they ask for a second re-exam,
28:34
and they say, it is true that Fujisaki
28:36
does not expressly state
28:38
that EMG is included in the human
28:40
body noise. So there's
28:43
no express disclosure, and they didn't bring in any
28:45
evidence to show that it was inherent in Fujisaki.
28:47
There's no expert saying it's
28:49
inherently disclosed. They didn't do any testing to
28:51
show that it was inherently disclosed. There's no
28:53
proof. It's their burden of proof.
28:55
And they didn't come forward with any. So the claim was,
28:57
faith distinguishes over the prior
28:59
art, and it's not indefinite
29:01
because you can apply the test to determine
29:03
what's in and what's out.
29:04
Judge Newman
Any more questions for Mr. Bedella?
29:10
Thank you, Your Honor.
29:11
Thank you, Mr. Bedella and Mr. Garringer.
29:13
The case is taken under submission.