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Before we begin our proceedings, I'd just like to thank the University of Chicago Law School for all their courtesies.

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This is a very special week for us.

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We travel around the country one court week a year.

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And one of the best parts of our jobs is that we get to sit at quite a large number of law schools and have an exchange with them.

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So I'd just like to thank the law school for all of their courtesies.

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We'll begin with case 17-2463, Berry v. Matronic.

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Mr. Waxman, good morning.

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Good morning, Your Honor.

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May I please the court?

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The judgment in this case should be reversed for at least three independent reasons.

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First, under section 102B, because Dr. Berry's prior sale and public use of the invention claimed in the 358 patent is invalidating.

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Second,

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under 102G because another inventor, Dr. Lawrence Lenke, conceived of and reduced to practice the claimed inventions in both patents long before Dr. Barry.

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And third, because the survey that was used to establish direct infringement, inducement, and the royalty base for damages

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did not establish and was legally incapable of establishing any of those things.

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Can I turn you to the first issue you described, the public use?

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Of course.

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Two just sort of general questions about that.

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One is where the line is drawn between fact and law with respect to experimental use and ready for patenting.

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And two, where the burdens fall with respect to experimental use.

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Because this was a jury trial, so you got a verdict against you.

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Correct.

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So where do we stand on those two issues?

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OK, so taking the second first, the burden of proof is always with

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the party asserting the on sale bar.

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But this court has made clear repeatedly that once there is a prima facie case of a commercial sale or a public use, the burden of production shifts to the inventor to demonstrate that not withstanding those, that fax, what was being issued.

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And number two, the question of the

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Proof of the on sale bar including the experimental use defense to the on sale bar and public use is a question of law informed by subsidiary predicate facts.

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But this court has established that there are some

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factual, there are some legal requisites as a matter of law in order to establish the experimentally used defense and two of them are operative here.

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The court has said repeatedly that an inventor's litigation stage assertion that he or she was engaged in a commercial sale or otherwise invalidating use primarily for experimental purposes is insufficient in and of itself to carry the burden of production.

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in the event there must be... I have to interrupt you.

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I'm sorry, but I thought I recalled that experimental use is a question of fact, and I thought that was well established in our case law.

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The ultimate question of the on-sale bar is a legal one, but the subsidiary question of whether there was experimentation is a question of fact.

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Am I misremembering our case law?

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I believe you're remembering a good deal of the case law, but perhaps not remember, and I'll explain both of them.

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Have we said that experimental use is a question of fact?

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I can't cite you chapter or verse.

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There's no- I don't understand.

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You're here arguing, and one of your primary arguments, in fact your very first one, is whether or not there's a public use or an on sale bar.

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And the primary argument or issue is whether or not the use was explained.

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Simple question of whether the precedent establishes that that question is one of fact versus law.

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Judge Moore, here is my simple answer.

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In two respects,

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It is a question, this court has said it is a question of law.

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It is a quest, as a matter of law, if there is no corroboration of an inventor's litigation stage assertion, the experimental use defense fails as a matter of law.

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The court so stated in electromotive division and a number of other cases.

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So otherwise it's a question of fact, right?

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If there is.

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Wait, stop please.

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application is a question of fact, except in limited circumstances where there's basically no evidence we decided as a matter of law.

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Correct?

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Correct.

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Well, there is one other principle of law that also applies here that the court has made very, very clear, and that is that if the customers or patients or clients are not informed,

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of the fact that the process is being done for primarily an experimental purpose.

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The defense is unavailable as a matter of law.

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Can I ask you about that?

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When I was looking at the cases where that point is made, it seemed to me, and I'd like you to tell me if I missed something, that every single one of those cases, Labonte, C.R.

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Barr, Luff,

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one after the next, are about the situation where the invention is a physical thing, a device, an assembly, et cetera.

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And it is passed, and I think this is the Leboudi language, placed outside the control of the inventor.

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And it makes a kind of sense there to say, if I'm giving you something, so it's no longer in my control, that it gets put into the public domain

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If I don't tell you, by the way, we're not quite sure where this works for its intended purpose.

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I'm not aware of any case, and tell me if there is one, where a method kept completely within the control of the inventor is subject to that same principle.

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I wish I could remember the cases well enough to tell you whether one of the cases requiring that

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the customer or patient be informed, it does involve a method.

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Sinski comes to mind, but I'm not sure there are any cases involving a patient.

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Well, the Sinski, no, no, with respect, the Sinski case involved an ophthalmological procedure in which, very similar to this case, the lens that- Did the Sinski recite that principle?

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It did, I believe.

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As an absolute?

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I don't want to stand up here and represent that it recited it as an absolute principle.

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But Judge Toronto, as to your question generally, it is true that one of the important factors in what absent an issue of law, to Judge Moore's point, is a factual determination, is whether or not the invention was, quote, placed out of control.

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There is no case, that is an independent requirement from the fact that the patient or customer be told.

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And I would cite electromotive division for that proposition.

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And I also don't a ball bearing inside a locomotive engine.

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We're actually given to various other people and they were not told this is an experimental thing.

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So as far as they knew this was a perfectly useful product that they could go and.

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Know that the, I think it was General Electric that was, General Motors was making the locomotive, General Electric was buying it.

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And because they had not informed General Electric that there were, quote, experimental ball bearings in the case, it was not, General Motors did not make out a case of primary experimental use.

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Those are our two propositions of law to Chief Judge Pro's question and Judge Moore's question.

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To the extent that we were wrong on whether those things are dispositive, the evidentiary factors in this case are all on one side.

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There is no witness, no document, and no objective fact corroborating Dr. Berry's trial testimony that he was experimenting.

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His assistant in the surgery, who happens to be Dr. Yvonne Berry, testified under oath at pages 2854 and 2855 of the appendix that the method he was using in these three surgeries was not experimental and was not for the purpose of experimenting.

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And here, I think it's important to understand what the facts show about what was going on in those commercial surgeries.

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Does this point depend on finding that not just the two August surgeries and the October surgery, but earlier ones involved the practicing of the claimed method?

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Because I think what you just said was that

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I think July.

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Well she testified that she assisted in the three surgeries that are in question here.

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But she also generally testified that what

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Dr. Berry, what the surgeon himself was doing, was not engaging in an experimental method.

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And here it's very important, I think, to understand that what is claimed in the 358 patent is a method, it's not a tool, it's not a product.

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What the evidence showed is... Can I interrupt before your time?

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Just to follow on a little, and I'm going to ask your friend about this too.

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On the one hand, you could look at it, are these three surgeries experimental?

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But your easier case, I think, for you to prevail on, but it raises a different question, was just involving the third, because the other two cometh in the time for period, right?

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That's correct.

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So it goes to the point that Dr. Berry was raising that he needed all three surgeries

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the conclusions of that, the post three months of every one of those surgeries in order to establish ready for patenting.

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So am I right that if we were to conclude that the October surgery did not involve experimentation with respect to anything recited in the claim, then that would be sufficient.

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Yes.

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And in fact, I mean, I think we have two points here.

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But his argument to that, right, is that he needed to operate on various types of people in order to really firmly establish that this worked all right.

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So the October patient, the October surgery, was necessary to complete the experimental phase.

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This court has been clear, and Allen Engineering is the case that comes to mind, that there is patients in various circumstances

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This court said that efforts to, quote, determine whether the invention would suit a particular customer's purposes doesn't fall within the experimental use exception.

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The innovation of the 358 patent was the ability to mechanically link spinal derotators so that force would be applied across multiple vertebrae together and simultaneously.

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That, to the extent that there was even a claim that the first operation on a scoliosis patient was experimental, we knew at the time that the patient was sewn up that it worked.

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I mean, it's obvious as a matter of physical principles.

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Sorry, how do we know that there weren't, that as soon as the patient is sewn up,

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that the thing worked for its intended purpose.

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Wouldn't you, at least I thought there was evidence, and then it seems to me a fact question, not a lawyer's argument question, that the standard of ready for patenting, shown or known to work for its intended purpose, can reasonably be thought not to be met until there's enough of a follow-up period

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stress fractures or something that didn't appear until several months later.

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Why is that not a factual claim?

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There is no claim.

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There is no element in the claim invention of stable results.

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I know this is something you've talked about.

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Let me ask you about this.

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It seemed to me, tell me if I'm wrong, that the standard of work towards intended purpose has never required that the purpose be claimed.

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With respect, it has always... Indeed, it would be a little bit odd.

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phrase the test that way as intended purpose instead of claimed purpose, particularly for methods and devices that ordinarily are not claimed with respect to their purpose.

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They're claimed for what they do.

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In any event, what case says the intended purpose has to be claimed?

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Well, your decision in Bresler says that the need that follow up

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is irrelevant to any limitation in the claim.

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And you have said that intended purpose is determined by reference to the patent itself.

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The intent here and the claim here.

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Well, the claim, the patent itself recites the innovation as the addition of a mechanical link in order to simultaneously de-rotate vertebrae.

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And it is that element.

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Mr. Waxman, isn't, but claim one, which is

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one of the claims at issue, right?

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Claim one?

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Well, claim four depends from claim one, doesn't it?

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Yes, and adds to it.

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Three, this is a test.

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Grew claim four, correct?

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Correct.

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OK, so claim one has as not only its preamble, but one of its elements implanted to achieve an amelioration of an aberrant spinal column deviation condition.

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Correct.

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OK, so this actually seems like a claim, which to some extent requires as one of its actual claim elements

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the purpose, which is ameliorating an aberrant spinal column deviation condition.

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And what Dr. Barry testified to, and Dr. Yasser, if I'm saying his name right, as well, the expert who corroborated Barry's testimony and went further, was that when you do this to a patient who's lying down, you correct their spine, you straighten their spine,

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You have no idea if it's going to work, for example, when they stand up.

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You have to have them heal.

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And you spend weeks in bed after this surgery.

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But to know whether the curvature is going to be repaired, you don't know until some period of time has passed, at least that's their testimony, because you don't know whether these devices will maintain the straight spine.

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The laying down position is not the actual use of a person's spine for the most part.

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You know, you think of them standing up and walking around, and that's what the testimony is.

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They actually said, you don't even know if it's going to stay straight when they stand up.

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You have to wait and see.

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And that's part of what he was experimenting on, which is what was justifying not just the period of the surgery and knowing it was ready for patenting right after the surgery was done, but why there needed to be a period of time to see if it would hold a straight spine position.

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I don't think that's correct with respect, Judge Moore.

[00:16:15] Speaker 01:
First of all, it's not correct, meaning I don't have a correct assessment of the testimony.

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I don't understand the claim language.

[00:16:21] Speaker 01:
Which part is incorrect?

[00:16:23] Speaker 03:
Well, I wouldn't make it as strongly as that, but I think you may be mistaken as to both, somewhat mistaken as to both.

[00:16:29] Speaker 01:
Oh, excellent.

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Please enlighten me.

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The purpose of the claimed invention was surgical correction of vertebrae in amelioration.

[00:16:40] Speaker 01:
I'm reading from a claim.

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What the heck are you reading from?

[00:16:45] Speaker 03:
I'm reading from the- That's not a claim limitation.

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I'm reading from the claim limitations which directly cover amelioration of the curvature of the spine.

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Okay, and my point is amelioration was a construed claim.

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The judge construed the term amelioration to mean some change or some movement of the vertebrae, some straightening of the vertebrae.

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There is no doubt in this case that at the end of this operation not only have the effective vertebrae been rotated, but rods have been inserted and locked down so that it is physically impossible, whether you are standing, running, crouching, or lying down, for those

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vertebrae that are now held in a straightened position by metal rods and screws will move.

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The testimony in this case about follow-up, and by the way, Dr. Berry tested, it wasn't as if he left the patient on the table and then had the patient come back in three months.

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He saw the patient regularly.

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He testified a week after surgery, three weeks after surgery.

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Yeah, but the testimony is also they spend the first two weeks in bed.

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They're not allowed to stand up and put any weight or pressure on it.

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So for at least those first two weeks, you can't even test if the spine is going to stay curved.

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or be straight in a standing position.

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There is no question, Judge Ward, that a three-month follow-up could tell you whether there was, as a clinical matter, there were complications from the surgery.

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There was testimony.

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Your time is up and I have to move you on because I need to ask you with the indulgence of the Chief Judge a different question on your second point.

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You wanted to hit three points and we didn't let you get beyond point one.

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I really want to ask you a question about the inventorship because I really think that there's a problem with Dr. Lenke's testimony, which is what you're relying on.

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They claim Dr. Barry invented it.

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Your client claims Dr. Lenke invented it.

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And Dr. Lenke also provided testimony on many different issues in this trial.

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And if I remember the record right, the district court judge said Dr. Lenke's testimony and his lack of credibility was a gut punch to your client.

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He said, and if I remember the facts right, Dr. Lenke lied on his resume

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and actually claimed to have been the inventor on patents that not only had he not been the inventor on, but that Dr. Barry was actually the inventor on.

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So he produced a resume as an expert in this case, which lied about his own credentials.

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And that was exposed to the jury.

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I read the trial transcript.

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And the district court described it as a gut punch to your client.

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So why in light of a clear

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instance of a lack of credibility by your expert who's claiming to be the first inventor is the jury not able

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to conclude that he is not credible and therefore not an earlier inventor.

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I will explain why the judge's gut punch observation is completely unsupported by the record.

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But the salient point, Judge Moore, is you can eliminate any consideration of Dr. Lenke's testimony.

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There are dozens of documents in this case and multiple witnesses in the case

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including Mr. Armstrong, Mr. Meyer, and Mr. Johnson, who testified that he not only conceived it, both of these inventions in 2002, but that he reduced the

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the linkage on one side of the spine in three different surgeries in the fall of 2002.

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You don't need Lenky's testimony for this at all.

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You need the testimony of three independent witnesses who observed it.

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And with respect to the 121 patent,

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that Mr. Myers testified that not only did Medtronic make a cross linking for him, but he observed Dr. Lenke successfully perform all of the steps of the 121 patent in a cadaver surgery in February of 2003.

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So you can dismiss Lenke.

[00:21:08] Speaker 03:
That would be inappropriate.

[00:21:09] Speaker 03:
What happened in this case,

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was that a half an hour before his testimony, Dr. Leckie realized that in his 400-page resume, that includes two pages of patents.

[00:21:22] Speaker 01:
Okay, Mr. Wexman, thank you.

[00:21:23] Speaker 01:
I understand your answer.

[00:21:24] Speaker 01:
I need to take you back to something, because I will tell you honestly, when you said the word amelioration in the claim was construed by the district court to mean any correction at all to the curvature of the spine,

[00:21:34] Speaker 01:
As I tend to do I have a computer up here on the bench and when somebody says something like that and it doesn't ring a bell to me and I've read all of the documents you presented I asked my law clerk and she says the district court did not in fact construe the word amelioration.

[00:21:48] Speaker 01:
The district court was asked whether the word was indefinite and concluded it was not and said it should just have its normal and plain meaning.

[00:21:53] Speaker 01:
And he did not construe it.

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And that's on page 831 and 34 of the record.

[00:21:57] Speaker 01:
So I would really like it if you could point me, and you can do it on rebuttal, to the place where the district court judge construed the word amelioration in the manner in which you represented to me in the answer to my question that it did.

[00:22:09] Speaker 03:
I will attempt to do so.

[00:22:10] Speaker 03:
Very good.

[00:22:11] Speaker 03:
May, I realize my time is up.

[00:22:14] Speaker 04:
I haven't spoken at all about the infringement.

[00:22:16] Speaker 04:
Can I ask you about the survey question, which I think was your third point?

[00:22:20] Speaker 04:
It is.

[00:22:22] Speaker 04:
I take it you're, maybe you have two problems with the survey.

[00:22:26] Speaker 04:
One is that it didn't ask about some claim elements.

[00:22:30] Speaker 04:
And the second is that by not asking about the VCM by in name, it may well have captured real world

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products and methods using those products that would be beyond the BCM.

[00:22:45] Speaker 04:
Can you pinpoint what there is, what claim element was not missing that a surgeon might well have not performed, missing from the survey, had not performed, if the surgeon performed everything asked about in the survey, then the survey said, did you do A, B, C, D, E, F, and G or something?

[00:23:07] Speaker 04:
And then on the second piece, the BCM,

[00:23:10] Speaker 04:
Are there products in the market that would have been, in particular within the market as defined by the questions in the survey, that the surgeon might well have been using, still coming within the terms of the survey, but not being the accused product?

[00:23:29] Speaker 03:
Yes, there were three.

[00:23:31] Speaker 03:
Well, and let me also say that you've identified two of the three problems I have with the survey.

[00:23:36] Speaker 03:
The third problem is that it doesn't prove inducement and the question that was asked wasn't designed to elicit that.

[00:23:43] Speaker 03:
But as to direct infringement, those are the two issues.

[00:23:47] Speaker 03:
There are three aspects of the claimed elements that were not included in the survey but that are in the patent.

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the use of handle means as opposed in addition to the derotators themselves.

[00:24:01] Speaker 03:
The requirement that the handle means be mechanically linked to the derotators.

[00:24:08] Speaker 03:
And with respect to the 121 patent, the requirement in the patent but not in the survey that there be three vertebrae on either side when the testimony

[00:24:22] Speaker 03:
both from our expert and their expert was that the operation can be performed with two vertebrae or one vertebra on one side and four or five on the other side.

[00:24:34] Speaker 03:
As to the VCM, there was definitely, there were definitely other products on the market, including Medtronic products.

[00:24:44] Speaker 03:
that is tool kits, like the VCM, surgical tools, that could have been used and that, that could have been used that would meet all of the elements of the survey and that, and it's this, Medtronic makes another system called SmartLinks, which is surgical tools,

[00:25:08] Speaker 03:
In discovery, they saw discovery of medtronics.

[00:25:13] Speaker 04:
Is that the one that in the JMOL order the district court says you was removed from the case by your assertion?

[00:25:21] Speaker 04:
Right, so what happened was they... How does that not solve the problem?

[00:25:25] Speaker 04:
That is, you can't rely on smart links now because...

[00:25:28] Speaker 04:
you weren't going to give discovery on it and therefore said it's not part of this case.

[00:25:33] Speaker 03:
Let me explain what happened and then why it doesn't solve this problem.

[00:25:38] Speaker 03:
They move for discovery on smart links in the context of a case in which the only accused device was the VCM.

[00:25:48] Speaker 03:
We objected on the grounds of relevance because the only accused device was the VCM.

[00:25:55] Speaker 03:
They then moved, if memory serves me, to amend the complaint to add a claim about Smart Links, which the judge denied.

[00:26:05] Speaker 03:
So the judge made clear that Smart Links wasn't in the case and we were not going to use Smart Links in the case.

[00:26:11] Speaker 03:
We objected first in a downward motion and then subsequently during the trial.

[00:26:19] Speaker 03:
to the ability of the survey fairly to estimate the number of instances of direct infringement.

[00:26:29] Speaker 03:
Because as the judge knew and everybody else knew, there were other Medtronic products on the market that alleged that if used in a particular way would have met the survey results.

[00:26:42] Speaker 03:
And the judge

[00:26:43] Speaker 03:
in his denial of our JMAW motion, actually says, well, we claim that there were other devices that could have been used in a way that met the survey conditions, but those are all Medtronic devices, and so there is no harm here.

[00:26:59] Speaker 03:
But the harm here is that the issue is not whether the jury heard about spinelinks or not.

[00:27:05] Speaker 03:
The issue is whether the response to the survey

[00:27:10] Speaker 03:
accurately reflected the number of instances not only in which the VCM kit had been used, but that had been used in a way that actually infringed the patent.

[00:27:21] Speaker 03:
And that's my answer to that question.

[00:27:25] Speaker 02:
And I know I'm way over time, so you can tell me to sit down.

[00:27:45] Speaker 06:
I want to pick up on the, I want to do the Linkey prior invention first because it's the quickest for me to do.

[00:27:53] Speaker 06:
Mr. Waxman said we can forget Dr. Linkey.

[00:27:55] Speaker 06:
We had three other people who told us Dr. Linkey was the prior inventor and I agree with them we can forget about Dr. Linkey because Mr. Meyer admitted that the surgeries that Medtronic relies on

[00:28:07] Speaker 06:
as showing prior reduction to practice would not work.

[00:28:14] Speaker 06:
There's two parts to that.

[00:28:17] Speaker 06:
So let's start with the August... Exactly right.

[00:28:20] Speaker 06:
Once you've done the linkage of the derotators, you would not be able to do anything with them.

[00:28:25] Speaker 02:
So why don't we move on to another issue, which is one to start with where your friend started, which is the on-sale bar.

[00:28:32] Speaker 02:
And let me ask you something a little different.

[00:28:34] Speaker 02:
We left off with talking about the claim language and the aberrant language.

[00:28:39] Speaker 02:
But let me ask it a different way.

[00:28:41] Speaker 02:
The first two surgeries satisfied the doctor.

[00:28:45] Speaker 02:
He had three-month post-op visits.

[00:28:48] Speaker 02:
So we're only left with the third surgery, which occurred in October.

[00:28:52] Speaker 02:
So the question I have is, what can you point us to in the claim language

[00:28:57] Speaker 02:
that would have us say that experimental use continued because you needed this third person in this third surgery in order to have satisfied, ready for packing.

[00:29:10] Speaker 06:
Certainly, Judge Prost.

[00:29:12] Speaker 06:
The claim language is the same language that Judge Moore pointed to, the amelioration language.

[00:29:17] Speaker 02:
Okay, where does that tell us that there were certain

[00:29:20] Speaker 02:
you needed experimental use, you needed three separate individuals with three separate conditions in order to just be satisfied.

[00:29:28] Speaker 06:
And I have two parts to my response.

[00:29:30] Speaker 06:
The first is back to the conversation Judge Moore was having about what's the factual versus legal nature of this question.

[00:29:40] Speaker 06:
And the factual question is to satisfy an inventor in an art such as a medical surgery,

[00:29:47] Speaker 06:
What is the factual basis for whether those people would believe an invention worked for its intended purpose?

[00:29:54] Speaker 06:
And the facts that we put in on that were Dr. Berry's testimony that we treat patients, not procedures.

[00:30:00] Speaker 06:
We put in evidence from Dr. Yassir that this industry expects you to do follow-up, including the fact that for the... No, no, no.

[00:30:07] Speaker 02:
Maybe you're misunderstanding my question.

[00:30:09] Speaker 02:
That may be my fault.

[00:30:10] Speaker 02:
I'm talking about why the third person was necessary.

[00:30:14] Speaker 02:
What is there in the record, any objective evidence that says in order to be satisfied,

[00:30:20] Speaker 02:
This device is ready for paneling, obviously.

[00:30:22] Speaker 02:
They wouldn't use that terminology.

[00:30:23] Speaker 02:
We need these three specific types of individuals and follow-up with respect to that.

[00:30:29] Speaker 02:
Why was the third person necessary?

[00:30:31] Speaker 06:
Certainly.

[00:30:32] Speaker 06:
I would point, Your Honor, to appendix at 1157, which is the testimony that there are varying curve types and stiffnesses.

[00:30:38] Speaker 06:
So recall, we're dealing with curves of the spine and the side-to-side direction.

[00:30:42] Speaker 06:
The bigger the curves get, the bigger the derotation that occurs.

[00:30:46] Speaker 06:
When that happens, it gets stiffer.

[00:30:48] Speaker 06:
The whole spine gets stiffer.

[00:30:50] Speaker 06:
It becomes harder to move these things back.

[00:30:53] Speaker 06:
That's the testimony at appendix 1157.

[00:30:56] Speaker 06:
Doctors would expect you to be able to reproduce something.

[00:31:00] Speaker 06:
The claims are not limited.

[00:31:01] Speaker 06:
The claims don't say,

[00:31:02] Speaker 06:
we're going to do correction of the spine up to 60 degrees or up to 20 degrees of curvature.

[00:31:08] Speaker 06:
It's supposed to be able to do any kind of derotation.

[00:31:11] Speaker 02:
Well, that assumes that he obviously couldn't have covered the moon in these seven air periods.

[00:31:17] Speaker 02:
So that assumes that maybe there would have been four, five, six, or 10 dozen surgeries beforehand.

[00:31:23] Speaker 02:
And his position is these three

[00:31:26] Speaker 02:
surgeries satisfied him, but two were not good enough.

[00:31:30] Speaker 02:
And I want to know what in the claims would differentiate the conclusions, because we had them from the post op three month survey on the first two surgeries, what in the claim can you tell us says, yeah, he needed this third guy too, and the post op

[00:31:45] Speaker 02:
The two places in the claim are the amelioration of the spinal condition and the second- But that really does, how does that point us to whether or not he could satisfy that?

[00:31:55] Speaker 02:
He'd need 14 different individuals.

[00:31:57] Speaker 02:
I don't know enough about the technology and the science here, but I don't understand how that claim language tells us that he needed this third individual in his particular issue before he could be satisfied.

[00:32:10] Speaker 06:
So in that regard, Judge Prost, it's very similar to when this court deals with pharmaceutical cases.

[00:32:16] Speaker 06:
A claim in a pharmaceutical case, for example, in this court's Helson decision from 2017, it's just to a pharmaceutical composition that's able to treat emesis.

[00:32:26] Speaker 06:
That's the claim, and then it describes the composition of the pharmaceutical.

[00:32:30] Speaker 06:
Well, even in the Helson decision, it wasn't that they dosed one patient,

[00:32:34] Speaker 06:
and knew that there was amnesis before they determined that it was no longer being experimented on.

[00:32:40] Speaker 06:
So again, the context of who is the intended audience for both this patent and the technique in general is the relevant fact.

[00:32:47] Speaker 06:
So when you say amelioration of a spinal condition, yes, there's a range there.

[00:32:51] Speaker 06:
But the question is whether the inventor would have reason to believe that he can take this invention to the public, which is the whole thing that 102B is supposed to prevent, taking it to the public and then taking it back.

[00:33:03] Speaker 01:
Hold on.

[00:33:03] Speaker 01:
When you say there's a range in the word amelioration, on page 833 the district court says in view of the specification that improvement of an aberrant spinal condition like scoliosis to a quote near normal configuration will provide a standard for measuring.

[00:33:18] Speaker 01:
They challenge the word amelioration as indefinite.

[00:33:21] Speaker 01:
The way you just described it, it would be indefinite.

[00:33:23] Speaker 01:
If Mr. Waxman's definition of some improvement were the definition the district court chose, that would arguably be indefinite.

[00:33:32] Speaker 01:
So the district court didn't choose some improvement.

[00:33:34] Speaker 01:
He recognized that the word amelioration can mean to improve, but he then went on to say the spec in multiple places says to a near normal condition, and that that's not indefinite.

[00:33:45] Speaker 01:
Do you agree that that was how the district court construed the word amelioration?

[00:33:49] Speaker 06:
Absolutely.

[00:33:50] Speaker 06:
And the whole point here was to get a cured patient.

[00:33:54] Speaker 06:
And that's why I keep emphasizing.

[00:33:56] Speaker 01:
When you say a cured patient, I mean, you quoted from 1157 to Chief Judge Prost where they talked about varying curve types.

[00:34:04] Speaker 01:
But why aren't you quoting from 1193 and 1195 where Dr. Barry testified, there are three most common curve types.

[00:34:11] Speaker 01:
These three patients represented

[00:34:13] Speaker 01:
those three most common curve types.

[00:34:16] Speaker 01:
And so I needed to be able to represent that this is going to work to treat scoliosis patients.

[00:34:21] Speaker 01:
I needed to hit the three big ones, and that's what this did.

[00:34:24] Speaker 01:
So why aren't you, is that, am I missing something?

[00:34:27] Speaker 01:
Wouldn't that have been really responsive to the Chief Judge?

[00:34:30] Speaker 06:
Yes, I answered 1157 and then got another question.

[00:34:33] Speaker 06:
I have a litany of sites.

[00:34:34] Speaker 06:
So we've got 1157.

[00:34:35] Speaker 06:
The reproducibility is where Your Honor was pointing to, which is 1192 to 1194.

[00:34:39] Speaker 06:
At 1194 to 1195, it's applying these new forces that had not been seen before to a variety of curve types in order to obtain

[00:34:50] Speaker 06:
reproducibility.

[00:34:51] Speaker 01:
Not just a variety of curve types, he testifies that these represent the three, this is his direct quote, 1195 at 195, four to seven, the three most common curve types of scoliosis.

[00:35:04] Speaker 01:
That's correct.

[00:35:06] Speaker 04:
Can you address the topic I was discussing a little bit with Mr. Waxman?

[00:35:12] Speaker 04:
I think he may be pointed to Brassler or some case like that.

[00:35:23] Speaker 04:
much of the range of application of a broadly worded claim does an inventor have to know is covered by a workable process in order for either the ready for patenting standard to be met or for the experimentation

[00:35:53] Speaker 04:
to come to an end legally speaking.

[00:35:55] Speaker 06:
And that's why this court does it as a factual inquiry, not a legal inquiry.

[00:35:59] Speaker 06:
Because the factual circumstances of whether an inventor would know the invention works for its intended, not claimed purpose, your honor is correct, its intended purpose, and its intended purpose that's measured both in claimed and unclaimed features, that comes out of the electromotive General Motors decision we were just talking about.

[00:36:16] Speaker 06:
with Mr. Waxman, but the record evidence before the fact-finder in this case is what it would be required for a physician to feel confident with the invention that he's come up with so that he can move to the patenting phase.

[00:36:31] Speaker 06:
And in this instance, the patenting phase was one of the two ways in which Dr. Berry brought his improved technique to those of skill in the art.

[00:36:38] Speaker 06:
He did it through the patent in exchange for the rights that a patent gives you, but he also went to his colleagues

[00:36:43] Speaker 06:
very soon after the January 2004 follow-ups to explain his technique.

[00:36:50] Speaker 06:
So your honor asked me that question as I was talking about reproducibility because I think that matters.

[00:36:55] Speaker 06:
The General Motives case stands for the proposition that this court recognizes you get to test unclaimed things such as durability.

[00:37:04] Speaker 06:
And I would suggest to you that the durability in the General Motors case, in the testing of the dock in EZDoc, the testing of the lamppost in Manfill,

[00:37:15] Speaker 06:
the testing of the weather mat in Seal Flex, which are all cited in the GM opinion, these are all instances where it doesn't say in the claim that the bearing has to be durable or that the weather mat has to be durable.

[00:37:27] Speaker 06:
But everyone who reads these patents as a person of skill in the art would say it has to work.

[00:37:31] Speaker 06:
You want it to work in the circumstances that are described in the specification.

[00:37:35] Speaker 06:
So back to Judge Moore's point, it's supposed to be trying to get to a normal spine.

[00:37:40] Speaker 06:
And maybe the answer to this question is both.

[00:37:45] Speaker 04:
that is about ready for patenting or about experimental use that is primarily something for which you did get money, but primarily for experimental use.

[00:37:59] Speaker 04:
So Judge Fondreau, it is both, and I think your last part is important.

[00:38:14] Speaker 06:
While these facts and the nature of the facts that I walked through with Judge Moore

[00:38:19] Speaker 06:
and their application to either the ready for patenting prong of say FAF or the public use test versus experimental use, which applies to the first prong.

[00:38:30] Speaker 06:
Experimental use deals with whether or not something was a sale or whether or not its use was public.

[00:38:37] Speaker 06:
these facts fall under both prongs and the nuance I think your honor was getting to is it does matter because if I'm, Dr. Berry, yes, Dr. Berry was paid his typical rate for performing scoliosis surgeries but the reason he did his method in those procedures was not to obtain a profit, it was to test the necessary attributes of whether the invention worked.

[00:39:01] Speaker 04:
So I think Mr. Watson's very first point was

[00:39:08] Speaker 04:
say I think that there is something like there's no record evidence before of an expression of experimental purpose before basically the litigation got going.

[00:39:24] Speaker 04:
You can't go back and find Dr. Barry then saying, Mrs. Barry then saying, somebody else then saying, I'm going to try this out.

[00:39:39] Speaker 04:
And that's a problem under the case law.

[00:39:44] Speaker 06:
Uncorroborated, subjective evidence without an objective counterpart would be a problem, but that's not this case.

[00:39:52] Speaker 06:
So, putting aside Dr. Berry's testimony, you've got the testimony of Dr. Stephanie Davidson, who was his primary anesthesiologist, and this is in Appendix 1733, where she testifies that in the relevant time period, she knew Dr. Berry was working on an inventive technique.

[00:40:08] Speaker 06:
We don't have... It's actually not when you compare it to the timeline that Dr. Berry gave for how he came up with the invention.

[00:40:22] Speaker 06:
He starts experimenting with the idea of unlinked D-rotators in December of 2002.

[00:40:28] Speaker 06:
January 2004.

[00:40:29] Speaker 06:
Okay, so you've got, Dr. Davidson says that.

[00:40:35] Speaker 06:
The second is, while we don't have a notation that says this was an experimental procedure, you do have that by the end of January 2004, Dr. Berry has submitted an abstract for peer review to the IMAST

[00:40:50] Speaker 06:
Association to provide a presentation in July of 2004 about the evolution of his technique, which began in 2002, and proceeds through the three procedures in 2003 that we've been talking about now, leading him to feel as though he was comfortable enough to present his new technique to the population.

[00:41:12] Speaker 06:
So taking this out of the medical context, if we were looking for the lab notebook,

[00:41:17] Speaker 06:
that led to the scientific journal paper.

[00:41:20] Speaker 06:
Yeah, we don't have the lab notebook.

[00:41:21] Speaker 06:
We have the journal paper.

[00:41:22] Speaker 06:
And the journal paper talks about the evolution of this technique.

[00:41:25] Speaker 06:
And this is testimony at appendix 1201 to 1205.

[00:41:29] Speaker 06:
And the IMAS presentation is cited in our briefs as well.

[00:41:32] Speaker 06:
So we've got a contemporaneous account of doing research.

[00:41:38] Speaker 06:
So that is a non-subjective piece of evidence.

[00:41:41] Speaker 04:
There's another question that I was discussing with Mr. Waxman.

[00:41:44] Speaker 04:
And that's his question about whether a statement that this court has made repeatedly as essentially an absolute rule, that is, in a variety of contexts, activity cannot be experimental unless the customer is told.

[00:42:04] Speaker 04:
That's an experiment that I was suggesting.

[00:42:08] Speaker 04:
I have not been able to find a case in which that statement was made

[00:42:13] Speaker 04:
outside the context of turning over a device to put it outside the inventor's control.

[00:42:24] Speaker 04:
I think maybe Mr. Waxman pointed to the evidence.

[00:42:27] Speaker 04:
He pointed to Simsky.

[00:42:29] Speaker 04:
Is that such a case?

[00:42:32] Speaker 04:
And are you aware of other cases?

[00:42:35] Speaker 04:
Because we really have stated this as a minimum requirement.

[00:42:38] Speaker 04:
And I'm trying to understand whether there is either an express or an implicit

[00:42:43] Speaker 04:
condition the circumstances in which that minimum requirement applies.

[00:42:48] Speaker 06:
May I answer your question?

[00:42:52] Speaker 06:
I'll start with the second part and then I'll come back to Senski.

[00:42:55] Speaker 06:
There are cases, and your honor has hit the nail on the head, that deal with control.

[00:43:00] Speaker 06:
Again, remember 102B, don't put something in the public that you retract.

[00:43:05] Speaker 06:
Selling of a thing and sometimes a method that's the scale tech case now come to that in a second But when the thing leaves the possession of the inventor the alleged inventor that's not you know He's supposed to be doing experimentation and the customer is then allowed to go off and do whatever he or she wants to do with the product if the inventor hasn't at least said to the customer

[00:43:27] Speaker 06:
I'm experimenting on this.

[00:43:29] Speaker 06:
I'm going to check in.

[00:43:30] Speaker 06:
I'm going to want you to tell me if it works or not works.

[00:43:33] Speaker 06:
It's really hard to then provide factual evidence that the intended purpose of the transaction

[00:43:39] Speaker 06:
wasn't commercial, because then there's just nothing tying those two together.

[00:43:43] Speaker 06:
We don't have a control problem here.

[00:43:45] Speaker 06:
The method doesn't leave.

[00:43:46] Speaker 06:
The method doesn't leave the surgical suite.

[00:43:48] Speaker 04:
I hope it's clear.

[00:43:51] Speaker 04:
That was the premise of my question.

[00:43:52] Speaker 04:
This is not a case involving loss of control.

[00:43:57] Speaker 04:
The question is, do we have a standard that says, even when control is not relinquished, if you don't tell a customer that this is experimental,

[00:44:08] Speaker 04:
This cannot be experimental use.

[00:44:11] Speaker 06:
No, and the three cases that Medtronic relies on this part are easily distinguishable.

[00:44:15] Speaker 06:
The first which Mr. Waxman said during argument was the Senski decision.

[00:44:19] Speaker 06:
Senski, we can almost ignore the facts of Senski given to how that case was resolved.

[00:44:24] Speaker 06:
Senski got to this court on appeal of a grant of summary judgment to the party alleging the patents were invalid.

[00:44:33] Speaker 06:
The party alleging the patent invalid had obtained admissions from Dr. Senski

[00:44:37] Speaker 06:
that I didn't need to test it.

[00:44:39] Speaker 06:
I knew exactly how it would work.

[00:44:40] Speaker 06:
These were a combination of known things that had been done for years.

[00:44:43] Speaker 06:
Stuck them together and planted them in people's eyes.

[00:44:46] Speaker 06:
Then faced with a motion for summary judgment, Dr. Szynski produces a declaration that says I had no idea this thing would work.

[00:44:51] Speaker 06:
I thought it was experimental.

[00:44:53] Speaker 06:
The entirety of the Szynski analysis, post the facts section in its opinion, is you can't create a self-serving declaration to avoid summary judgment.

[00:45:01] Speaker 06:
So that was a procedural case that the facts don't really apply here.

[00:45:04] Speaker 02:
Well, I mean, the language in Szynski is pretty broad, and it was all over blue, red never even cites the case.

[00:45:10] Speaker 02:
It says, irrespective, I take you at your point about it being summary judgment,

[00:45:14] Speaker 02:
The objective evidence in this case cuts heavily against experimental use.

[00:45:20] Speaker 02:
He did not inform patients they were being treated with the new experimental lens.

[00:45:24] Speaker 02:
He did not obtain any kind of secrecy agreement from the patient.

[00:45:27] Speaker 02:
That's pretty strong language in our case.

[00:45:30] Speaker 02:
And they go on with another point when Judge Toronto gets done with you, I was going to ask, which was the district court's reliance

[00:45:37] Speaker 02:
Strong reliance, I think, on the fact, well, he said it was important that Barry was not paid a premium for the surgeries.

[00:45:45] Speaker 02:
And Szynski clearly seems to cut against that, in terms of the notion that you had to pay more.

[00:45:51] Speaker 02:
In fact, one could argue, should have paid less.

[00:45:54] Speaker 02:
I mean, if it was a good procedure and a new procedure, maybe he should have charged less.

[00:45:58] Speaker 02:
So that's something the district court here relied on, and that seems to be blown out of Szynski as well.

[00:46:02] Speaker 06:
So two points.

[00:46:03] Speaker 06:
The first point that you raised on Szynski,

[00:46:05] Speaker 06:
Again, that's a control problem because we're talking about a thing, not a procedure.

[00:46:10] Speaker 06:
The patient walked out with the lenses.

[00:46:13] Speaker 06:
The patient had the, in possession of the inventive thing.

[00:46:17] Speaker 06:
It wasn't a method for fixing cataracts.

[00:46:18] Speaker 06:
It was a cataract lens repair device.

[00:46:20] Speaker 02:
Okay, and how does that affect?

[00:46:22] Speaker 02:
I mean, wouldn't you expect if a doctor were operating on a patient and was using an experimental method

[00:46:29] Speaker 02:
that would apply equally, that the expectation would be that a newer experimental use would be disclosed to the patient.

[00:46:36] Speaker 06:
So that gets into the much bigger conversation that my colleague didn't bring up, which is the idea of how does experimental use in the medical context relate to the facts of this case when we're dealing with experimental use in the patent context.

[00:46:50] Speaker 06:
And I would draw your attention, Your Honor, back to the Helsin decision that I referenced,

[00:46:53] Speaker 06:
This court has said the standards for, for example, surviving phase three clinical trials, which was the question in Helson, do you have to be able to do that for you to say that we knew the invention in Helson, which was a pharmaceutical, would work for its intended purpose?

[00:47:10] Speaker 06:
And this court said, there's no legal bar one way or the other, but every case must be decided on its own facts.

[00:47:19] Speaker 06:
So what Helson was saying is- But that's helpful, isn't it?

[00:47:22] Speaker 06:
Well, for me it is, because we had a fact fight below and it was resolved and there's substantial evidence that supports it.

[00:47:29] Speaker 06:
But in Helson, just to spend a second on Helson, the reason Helson actually supports our position, it's not something I want to distinguish.

[00:47:37] Speaker 06:
In Helson, again, we're dealing with a pharmaceutical that they wanted the test, the argument for the patent owner was we didn't know it would work for its intended purpose because we hadn't finished phase three studies.

[00:47:48] Speaker 06:
And this court held, but what you had done was a lot of testing and a lot of analysis of the data to know that it did work for its intended purpose.

[00:47:57] Speaker 06:
And I would point the court to the fact that in Helsing, all of these doses of the pharmaceutical were done.

[00:48:04] Speaker 06:
They then had months of follow-up to see if the treatment was working.

[00:48:08] Speaker 06:
They then prepared statistical analyses and then reports on the statistical analyses that says this works for its intended purpose, including telling the FDA it worked for its intended purpose.

[00:48:20] Speaker 06:
All of those dates were before our critical date.

[00:48:22] Speaker 06:
We don't have those facts.

[00:48:24] Speaker 06:
All we have here is the performance of the procedure, a follow-up window that bridges the critical date, and then the analysis of whether or not the procedures worked for their intended purpose.

[00:48:36] Speaker 04:
Can I ask you two things?

[00:48:36] Speaker 04:
One, I think we were going to discuss

[00:48:38] Speaker 04:
three cases, one of them since he and then there were two more.

[00:48:41] Speaker 04:
And just while we're talking about Helsin, is there any reason we should wait for the Supreme Court to decide Helsin before deciding this case?

[00:48:48] Speaker 06:
I don't think so to the Helsin question, Your Honor.

[00:48:50] Speaker 06:
I don't think so because the issue to Helsin is not this whether or not it was reduced to practice question.

[00:48:57] Speaker 06:
It's much more of the medicine shop aspect of that case.

[00:49:02] Speaker 06:
The other two cases that are cited in the gray brief by Medtronic on this point, Your Honor, are the ScaleTech and Abbott Labs decision.

[00:49:10] Speaker 06:
ScaleTech is the only one that's a method.

[00:49:12] Speaker 06:
Abbott Labs is another pharmaceutical case where the medicines were put out into the stream of commerce.

[00:49:18] Speaker 06:
Scaletech had to do with, Scaletech was performing at Chevron's facilities for, it's a coke refinery, so they were working on the coke refinery aspect.

[00:49:29] Speaker 06:
But the issue in Scaletech was what was sold.

[00:49:33] Speaker 06:
All the analysis about whether or not they had disclosed it was experimental had to do with the fact that, like I was saying, we didn't even know what was in the method.

[00:49:42] Speaker 06:
They had been performing the method and then the results of the method were very specific particulate sizes.

[00:49:48] Speaker 06:
And this was basically an inherency case where the court came down and said, very consistent with the Federal Circuit's inherency law, that it doesn't matter if it's in there and you sold it, you sold it.

[00:49:58] Speaker 06:
It doesn't matter if you knew it was in there or not.

[00:50:01] Speaker 06:
Just like Abbott Labs.

[00:50:02] Speaker 06:
So that's a much easier one because they sold the thing and you could test it.

[00:50:05] Speaker 06:
But in ScaleTech, only Chevron was in possession of the thing that evidenced infringement.

[00:50:11] Speaker 02:
If your time is way up, but since Mr. Waxman, I think, discussed a third issue related to the inducement and direct infringement, if you want to spend a couple minutes on that.

[00:50:22] Speaker 06:
With the collection, I would like to talk about the survey for a second.

[00:50:26] Speaker 06:
Of the conversation that you had with my colleague, I think the most important is the notion of whether or not there is record evidence that you could infringe the claims by practicing what was asked in the survey using a Medtronic set of instruments other than VCM, and the answer is decidedly no.

[00:50:48] Speaker 06:
The two things we've heard about on this appeal, today for the first time Medtronic is going to use the word smart link.

[00:50:54] Speaker 06:
SmartLink was excluded at the case, not just at the court's insistence, because he denied our motion to amend our infringement contentions.

[00:51:05] Speaker 06:
And he denied that motion because it was too late?

[00:51:08] Speaker 06:
At the point in time when we discovered SmartLink, it was six weeks left of fact discovery.

[00:51:12] Speaker 06:
So he denied the motion there.

[00:51:14] Speaker 06:
And at the hearing, and I would point the court to appendix 15132, where the court says to counsel for Medtronic,

[00:51:23] Speaker 06:
What you're saying here is, it's not in the case for any purpose.

[00:51:27] Speaker 06:
So later on, don't argue to me that something other than VCM is going on.

[00:51:32] Speaker 06:
And the answer is, it's not in this case for any purpose.

[00:51:36] Speaker 06:
So they made their bet on that issue.

[00:51:39] Speaker 06:
The other is whether or not the issue that was tried in front of the jury

[00:51:43] Speaker 06:
is whether or not you could use those same tube derotators that I talked about with Judge Moore and your honor about how you put the pin through with Mr. Meyer and then can't get the screwdrivers in.

[00:51:54] Speaker 06:
That's the other thing that Medtronic argued to the jury.

[00:51:59] Speaker 06:
And Medtronic's witness, Dr. Marco, just like Mr. Meyer did.

[00:52:06] Speaker 04:
I'm sorry, just so I'm clear, this connects to, I guess,

[00:52:12] Speaker 04:
not the VCM, but the missing elements issue as to the survey, like missing handles.

[00:52:18] Speaker 06:
No, Your Honor, so he had three points on the survey with you, the inducement point, the fact that other products could be infringing.

[00:52:24] Speaker 06:
They're willing to involve direct infringement.

[00:52:26] Speaker 06:
That's right, so other products and then the claim term, what I would call the claim term issues, which are mechanically and handling.

[00:52:32] Speaker 06:
This is still in the first part, whether or not there were Medtronic products.

[00:52:35] Speaker 06:
other than VCM that could be infringing and therefore the survey over counted is essentially the point.

[00:52:42] Speaker 06:
The tool that was argued by Medtronic to be the other capable tool is shown in the appendix at 10306.

[00:52:50] Speaker 06:
And Dr. Marco gave the same testimony that Mr. Meyer did.

[00:52:55] Speaker 06:
And he was asked, Dr. Marco was asked, at appendix 2822 to 2836, and the line of questioning concluded, when he screws down with the rod in the tube, answer, you couldn't.

[00:53:07] Speaker 06:
So he'd said, this is an example of a non-accused infringing alternative, and then across that it wouldn't work.

[00:53:15] Speaker 06:
So you had handle means, mechanically linked, and the three or more pedicle screw members.

[00:53:20] Speaker 06:
Which one are you specifically asking about?

[00:53:23] Speaker 06:
Okay, well.

[00:53:24] Speaker 04:
I'm not.

[00:53:25] Speaker 04:
I'm not.

[00:53:25] Speaker 04:
I don't think Judge Frost is.

[00:53:27] Speaker 04:
No.

[00:53:28] Speaker 06:
I don't think Judge Frost is.

[00:53:29] Speaker 06:
But the last one is the one I think I would address, Your Honor, and that's the idea that you could do this on, the claim requires, the 121 requires that you do this with a first tool of three or more pedicle and screw engagement members and another tool of three or more pedicle screw engagement members.

[00:53:46] Speaker 06:
The argument at trial by Medtronic is you could develop a construct

[00:53:53] Speaker 06:
which is what the fancy word we use for building these erector sets.

[00:53:56] Speaker 06:
But you can develop a construct that had four rotators on one side and two rotators on the other side.

[00:54:03] Speaker 06:
And it would have used, as the survey said, six or more derotators.

[00:54:07] Speaker 06:
But in their view, that wouldn't fall within the claims.

[00:54:11] Speaker 06:
There was never a claim construction.

[00:54:13] Speaker 06:
In fact, the opposite occurred, that a tool had to be on one side of the spine or the other.

[00:54:17] Speaker 06:
In fact, district court expressly rejected that a tool could cross the spine.

[00:54:21] Speaker 06:
But more to the important point, when Dr. Marco was trying to explain how this would work, I asked him, I shouldn't use the first person anyway, he was asked, explain how that would meet the survey but not the claim.

[00:54:38] Speaker 06:
And his answer was, given the fact that the judge doesn't want me to talk about that claim construction anymore, I can't answer that.

[00:54:43] Speaker 06:
So it was clearly based upon a claim construction that was unsupported.

[00:54:46] Speaker 06:
Thank you.

[00:54:47] Speaker 06:
Thank you, Your Honor.

[00:54:53] Speaker 03:
Several points.

[00:54:54] Speaker 03:
Judge Moore, I'm relying on pages 33 and 34 of the appendix where the judge says during a claim construction argument, a person of ordinary skill in the art would understand that the ordinary use of the word amelioration is, quote, to improve.

[00:55:10] Speaker 01:
But then it goes on to say improvement of an aberrant spinal condition like scoliosis to a, quote, near normal configuration.

[00:55:17] Speaker 01:
provides some standard for measuring the improvement and provides a reasonable certainty regarding the scope of the invention.

[00:55:25] Speaker 01:
So while I grant you that earlier she said the ordinary use of amelioration could be to improve in the context of your indefiniteness argument, which I understood to be to improve is too vague, improved by how much?

[00:55:39] Speaker 01:
And she concluded the specification required it to improve to a near normal configuration.

[00:55:44] Speaker 01:
Am I misreading that?

[00:55:45] Speaker 03:
As to an indefinite claim, you have it, Ms.

[00:55:48] Speaker 03:
Redditch, he then went on to say, no person of ordinary skill in the art would expect a medical device to claim an exact degree of improvement.

[00:55:57] Speaker 03:
I have nothing else on this point.

[00:55:59] Speaker 03:
I just wanted to respond to your honors.

[00:56:01] Speaker 03:
On this issue of whether or not Dr. Lenke had reduced to practice the elements of the 358 patent, my friend is relying on testimony, Lenke, with his prior invention and reduction of practice.

[00:56:18] Speaker 03:
My friend is relying on his testimony that with the device that Dr. Lenke was using, which is displayed in the figures and discussed in the testimony,

[00:56:29] Speaker 03:
In order to lock down the screws, you had to remove the rod that had been used to simultaneously derotate.

[00:56:39] Speaker 03:
That is all that the claim requires.

[00:56:40] Speaker 03:
The claim does not require that the mechanical link be kept in place throughout the surgery, only that it be used simultaneously to rotate.

[00:56:51] Speaker 03:
On the question, Judge Toronto, your questions about

[00:56:59] Speaker 03:
First of all, isn't there a, has the requisite that this court has repeatedly said about the patient or the customer being informed, is that inevitably linked to the absence of control?

[00:57:16] Speaker 03:
So let me just, I don't know that, I can't cite you a case in which

[00:57:22] Speaker 03:
The court has said as a matter of law, this is not available absent telling the customer or the patient that was used in a method case.

[00:57:32] Speaker 03:
But I submit to the court that it just can't be the case.

[00:57:35] Speaker 03:
We're talking about method claims here.

[00:57:38] Speaker 03:
It can't be the case that because a method is never quote carried away.

[00:57:44] Speaker 03:
that there is no need, in fact, to tell patients and customers that what was being done was not just some aspect of experimentation, but primarily for the purpose of experimentation.

[00:58:00] Speaker 03:
I just don't think that the law would recognize that distinction.

[00:58:05] Speaker 03:
And here, again, focusing on the method claims, because those are the claims of the 358 patent.

[00:58:12] Speaker 03:
The evidence in this case was without dispute that Dr. Berry had been doing this method, that is the method of mechanically linking spinal derotators in order to simultaneously rotate for months and months

[00:58:31] Speaker 03:
before the three surgeries that were in question here.

[00:58:36] Speaker 03:
The evidence was he had been, up until July, after which there were no further refinements in the tool, he had been working with the deput representative, Mr. Fefferkorn, in shaving down the width of the derotators and the handles, in drilling a hole through the handles, then three holes, and then slots.

[00:59:01] Speaker 03:
And that's why Dr. Yvonne Berry testified that he was not experimenting with the method, which is what's claimed in the patents.

[00:59:11] Speaker 03:
He was trying out different iterations of the tool in order to find the configuration that best and most easily allowed him simultaneously to rotate.

[00:59:25] Speaker 03:
Oh, I'm over.

[00:59:26] Speaker 03:
Okay.

[00:59:27] Speaker 03:
Well, thank you.

[00:59:29] Speaker 02:
Thank you.

[00:59:29] Speaker 02:
Thank both sides in the cases.

[00:59:39] Speaker 05:
The next case