[00:00:00] Speaker 02:
Could we do likewise, Your Honor?

[00:00:06] Speaker 02:
Could we do likewise?

[00:00:07] Speaker 04:
Yes.

[00:00:07] Speaker 04:
Minister, Mr. Walker will help.

[00:00:12] Speaker 04:
Be strong.

[00:00:37] Speaker 04:
Okay, the next argued case is number 151498.

[00:00:42] Speaker 04:
How Medica Estionics Corporation against Zimmer is the remaining party?

[00:00:49] Speaker 02:
Yes, your honor, that's correct.

[00:00:50] Speaker 04:
Okay, thank you.

[00:00:51] Speaker 00:
May it please the court.

[00:00:53] Speaker 00:
Today I'll focus on one issue, the proper legal standard for proof of anticipation by inherency, leaving the other two issues to our briefs.

[00:01:05] Speaker 00:
For half a century,

[00:01:07] Speaker 00:
from in Ray Brink in 1970 to the present, this court and its predecessor have applied a rigorous legal standard for anticipation by inherency.

[00:01:19] Speaker 00:
That rigorous legal standard requires proof that the missing claim element, missing from the reference, was necessarily present in the prior reference.

[00:01:30] Speaker 00:
Possibly present and even probably present are legally insufficient.

[00:01:36] Speaker 00:
as a matter of law.

[00:01:39] Speaker 00:
The board's decision in this case misapplied this legal and controlling standard.

[00:01:45] Speaker 00:
Instead the board held, and I quote, it's only necessary to quote, take reasonable steps to find a similar material to that available at the time of the reference.

[00:01:59] Speaker 00:
No reasonably, reasonable not necessarily successful, similar

[00:02:05] Speaker 00:
not substantially identical and available, not necessarily disclosed in the reference.

[00:02:11] Speaker 05:
What do you think is required?

[00:02:14] Speaker 05:
There's no such thing as complete certainty in this world.

[00:02:18] Speaker 05:
So what level of certainty do you think is required in this setting, for example, to determine that

[00:02:27] Speaker 05:
The substance that was used by Lou was, in fact, the same substance or one of the two substances that was used by Dr. Clough, is it, or Clough?

[00:02:37] Speaker 00:
I believe it's Clough, although I've said Clough, so let's go with Clough.

[00:02:41] Speaker 05:
It'll be Clough then, I guess.

[00:02:42] Speaker 00:
In this case, where there are options, Your Honor.

[00:02:46] Speaker 05:
Well, but what's the standard?

[00:02:48] Speaker 05:
What's the test that we should be applying?

[00:02:50] Speaker 05:
You say it's not reasonable steps.

[00:02:53] Speaker 05:
But what is it?

[00:02:54] Speaker 00:
Not possible, and not probable, but necessarily present.

[00:02:58] Speaker 05:
Well, but we know it's not.

[00:03:00] Speaker 05:
I mean, there's going to be some room for doubt, no matter how conclusive the testimony.

[00:03:05] Speaker 05:
Even if Mr. Cattivo had said, I'm absolutely certain.

[00:03:09] Speaker 05:
I remember Mr. Liu came in, and I'm absolutely certain I gave him either $41.30 or $40.30, one could argue, what does he remember that far back?

[00:03:19] Speaker 05:
We're not absolutely certain.

[00:03:20] Speaker 05:
So absolute certainty can't be the requirement.

[00:03:22] Speaker 05:
What do you think is the requirement?

[00:03:24] Speaker 00:
I would say something close to it and where you have options, where there are defined options that were quote available and where the report, the reference fails to identify which of those options are the one that was in fact reported in the reference, then there's no inherency.

[00:03:42] Speaker 00:
And it's a tough standard, but it's a rather rare defense because what we're talking about is a reference that has a missing piece already.

[00:03:50] Speaker 00:
It's got a missing claim element.

[00:03:52] Speaker 00:
So where are you going to build that in?

[00:03:53] Speaker 00:
In this case, we've got two problems.

[00:03:56] Speaker 00:
The first one is that we're not dealing with the conventional details of a chemical compound, as, for example, was the case of Spada, which they rely on, and which was determined because there were disclosed in writing monomers identical to those in the patent.

[00:04:15] Speaker 00:
We're not dealing with that.

[00:04:16] Speaker 00:
We're dealing with ultra-high molecular weight polyethylene, which we know from Lew, the reference itself,

[00:04:22] Speaker 00:
is dramatically different depending on what happened to it.

[00:04:26] Speaker 00:
And here we've got five different options of what that ultra-high might have been.

[00:04:31] Speaker 00:
It might have been ultra-high without modification.

[00:04:33] Speaker 00:
It might have been ultra-high with PTFE fillers.

[00:04:37] Speaker 00:
It might have been ultra-high with carbon fillers.

[00:04:40] Speaker 00:
It might have been ultra-high with, as Katibo said, quote, other things in it.

[00:04:47] Speaker 04:
And it might have been.

[00:04:47] Speaker 04:
But didn't they cross that bridge in terms of narrowing?

[00:04:51] Speaker 04:
the parameters, the description of the product that they obtained?

[00:04:57] Speaker 00:
Forgive me, Your Honor.

[00:04:57] Speaker 00:
I didn't understand the question.

[00:04:59] Speaker 04:
Well, you're saying it might have had fillers.

[00:05:01] Speaker 04:
It might have had this and that.

[00:05:03] Speaker 04:
I don't recall that variability being raised in the product or being appropriately

[00:05:13] Speaker 04:
there in terms of that which they obtained from the producer?

[00:05:17] Speaker 00:
That's the problem, Your Honor.

[00:05:19] Speaker 00:
It was identified by Kativo, who is the only person they brought to testify what was the ultra-high material at the time that Lew obtained the material from a company called Dixon.

[00:05:31] Speaker 00:
And Dixon had gone out of business.

[00:05:33] Speaker 00:
There was another company by another name that Kativo had worked for or was involved with.

[00:05:40] Speaker 00:
And then Kativo himself admitted

[00:05:42] Speaker 00:
literally no personal knowledge of what was manufactured at the time of Lue.

[00:05:48] Speaker 00:
So Lue's reference is missing a reference type, a reference grade, a reference number, or any other qualifications.

[00:05:57] Speaker 00:
And then the additional extrinsic evidence, which Robertson has said must show necessary presence.

[00:06:04] Speaker 00:
The extrinsic evidence, as Katibo is saying, I really don't recall much, but I know there were at least five alternatives

[00:06:12] Speaker 00:
of ultra-high available at Dixon, which were these five that I've already listed.

[00:06:17] Speaker 00:
And we don't know which of those five were reported by Lou.

[00:06:22] Speaker 00:
And certainly, Dr. Clough, who relied on Cotevo's rather fragile recollection, didn't know either.

[00:06:32] Speaker 00:
So we've got that major problem.

[00:06:34] Speaker 00:
And those five alternatives alone, in view of the case law, doom inherency is a matter of law.

[00:06:41] Speaker 00:
And this court has gone for time and time again reversed this kind of reliance of inherency.

[00:06:50] Speaker 00:
In Brink, there was a material that was available at the time, but because it wasn't shown to be necessarily present in the reference, the CCPA reversed the board determination.

[00:07:01] Speaker 00:
In Finnegan, this court reversed the ITC inherency determination, where the claimed element was only one of two possibilities, let alone five.

[00:07:11] Speaker 00:
resonance or non-reversal of the ITC.

[00:07:14] Speaker 00:
In Inrei Gafrida, not for publication, but cited, this court reversed, again, the PTAB, Inherency Determination, where the claimed element was one of two portable or not, not sufficient as a matter of law.

[00:07:29] Speaker 00:
And then in Robertson, the court did the same thing, reversed inherency of the PTAB, and stated something I think is pertinent.

[00:07:36] Speaker 00:
The board's analysis, this is a quote, but it applies to this case.

[00:07:40] Speaker 00:
The board's analysis rests on the very kind of probability or possibility that this court has pointed out was insufficient to establish inherency.

[00:07:52] Speaker 00:
So on that basis alone, I would suggest that inherency fails as a matter of law, and the decision should be reversed.

[00:08:01] Speaker 00:
But we've got other problems as well with the report.

[00:08:04] Speaker 00:
And I should note that Lew himself recognized it's very difficult, this is in writing in the reference,

[00:08:10] Speaker 00:
very difficult to predict the effects of your radiation on a polymer, because it may vary with material.

[00:08:16] Speaker 00:
That's in appendix 125.

[00:08:18] Speaker 00:
And also, he reported having two different materials.

[00:08:22] Speaker 00:
We don't know what they were.

[00:08:23] Speaker 00:
And it wasn't the numbers.

[00:08:24] Speaker 00:
He reported no numbers.

[00:08:26] Speaker 00:
And he said these two different materials that he had were different in structure and different in behavior.

[00:08:35] Speaker 00:
And he couldn't explain the difference.

[00:08:36] Speaker 00:
He had no explanation.

[00:08:38] Speaker 00:
So Clough's tests.

[00:08:40] Speaker 00:
went on to first start out with a material 30 years later, which the evidence fails to show was, in fact, the one reported by Liu.

[00:08:48] Speaker 00:
But then he used six different deviations from the process reported by Liu.

[00:08:53] Speaker 00:
And the deviations were switched from small to commercial radiation unit, doubling radiation time, varying the radiation temperature by 60 degrees, varying the dosage rate, varying the total dosage,

[00:09:08] Speaker 00:
and adding heat-absorbing glass containers.

[00:09:12] Speaker 00:
Those six deviations also doom the inherency finding of this board.

[00:09:20] Speaker 00:
And as the case of Glaxo versus Apotex 2004 tells us, that variations in the recreation and attempted recreation of the prior art doom inherency.

[00:09:34] Speaker 00:
And I might say there's a good policy reason for why recreations

[00:09:38] Speaker 00:
ought to be subjected to the absolute identical test.

[00:09:42] Speaker 00:
They're not relying on the disclosure of the reference itself.

[00:09:48] Speaker 00:
They're relying on extrinsic evidence about what might that reference have taught if it had been built in the test.

[00:09:55] Speaker 00:
And so we've got two problems.

[00:09:56] Speaker 00:
One is we don't know what the report of the ultra high was in lieu.

[00:10:00] Speaker 00:
And number two, we've got these six deviations.

[00:10:04] Speaker 00:
And I might say,

[00:10:05] Speaker 00:
Lew himself concluded that his product turned yellow, turned yellow, whereas Klaus did not after irradiation.

[00:10:14] Speaker 00:
So we know there's a physical difference.

[00:10:16] Speaker 00:
Lew reported that his product had severe degradation in wear, fatigue, and tensile strength.

[00:10:22] Speaker 00:
Both those reports are consistent with oxidation.

[00:10:26] Speaker 00:
Kluff made no report on those particular properties.

[00:10:29] Speaker 00:
But his conclusion of no oxidation is directly at odds with the Lew report.

[00:10:35] Speaker 00:
yet another hole in the inherency proofs.

[00:10:38] Speaker 00:
And the argument that a single case in Ray Spada changed 50 years of this court's precedent holds no water.

[00:10:48] Speaker 00:
Both before and after Spada, the necessarily present standard, has been applied.

[00:10:52] Speaker 00:
And Spada involved a unique fact pattern, which involved identical monomers comparing a written disclosure in the prior art to a written patent

[00:11:03] Speaker 00:
and identical monomers disclosed in the prior art as were described later in the patent.

[00:11:09] Speaker 00:
It was that that dictated in Respada.

[00:11:12] Speaker 00:
Here, on the contrary, there are no identical chemical structures to elude description.

[00:11:19] Speaker 00:
And the record's completely silent as to the type of ultra-high that was used.

[00:11:24] Speaker 05:
There was some discussion, I guess, before the board about the

[00:11:32] Speaker 05:
problems that you have alluded to with respect to the radiation, the difference in the devices used and so forth.

[00:11:40] Speaker 05:
But that all seemed to get resolved, and I think Lou says something to this effect, with the

[00:11:47] Speaker 05:
proposition that what really matters when you're talking about the radiation is the total dose.

[00:11:51] Speaker 05:
It doesn't matter how you get there.

[00:11:53] Speaker 05:
What matters is where you end up.

[00:11:55] Speaker 05:
I mean, if that's true, that sort of takes care of a number of your deviations, it seems to me, doesn't it?

[00:12:00] Speaker 00:
It certainly doesn't take care of the glass containers.

[00:12:03] Speaker 00:
It doesn't take care of the radical difference in 60 degree temperature variation.

[00:12:07] Speaker 00:
during the irradiation.

[00:12:09] Speaker 00:
So no, it doesn't solve the problem.

[00:12:11] Speaker 05:
Why would the temperature difference during radiation matter?

[00:12:16] Speaker 00:
Well, as Lou says, minor variations in the process of irradiation have major implications.

[00:12:25] Speaker 00:
Lou says at 8125, very difficult to predict the effects of irradiation on a polymer.

[00:12:37] Speaker 00:
And also, at 93, appendix 93, Lew reports small chemical changes from moderate radiation could cause large changes in physical properties.

[00:12:48] Speaker 05:
But that's a different issue.

[00:12:49] Speaker 05:
That's saying that different total amounts of radiation can produce unpredictable results.

[00:12:54] Speaker 05:
Fine.

[00:12:55] Speaker 05:
But that doesn't say that different ways of getting to that total amount of radiation have different effects, right?

[00:13:01] Speaker 00:
But I think that, for example, the glass container heating and the temperature variations are both

[00:13:07] Speaker 00:
factors that raise unknown results in the changes.

[00:13:14] Speaker 00:
If I could, I'd like to reserve my remaining time for rebuttal.

[00:13:18] Speaker 04:
Yes, indeed.

[00:13:18] Speaker 04:
Thank you, Mr. Malloy.

[00:13:23] Speaker 04:
Mr. Callahan.

[00:13:38] Speaker 02:
Good morning, Your Honors.

[00:13:38] Speaker 02:
May it please the Court.

[00:13:40] Speaker 02:
Let me start by taking on the issue of inherency, which is what my colleague addressed.

[00:13:47] Speaker 02:
First, there was an extensive factual record.

[00:13:51] Speaker 02:
You'd be unlikely to see one as factually developed, because we were running in parallel with the district court litigation, which is why there are expert reports referenced, depositions of both experts and non-experts.

[00:14:04] Speaker 02:
There is an extensive factual record.

[00:14:07] Speaker 02:
Both the examiner and the PTAB considered that factual record and made factual findings that this court looks at for substantial evidence.

[00:14:17] Speaker 02:
So what we're looking for is, is there substantial evidence to support the board's factual determinations that the inherency in lieu was shown?

[00:14:29] Speaker 02:
At the end of the day, we frequently see in the cases

[00:14:35] Speaker 02:
the P tab looks only at the reference itself and says, I see that you're using the same process.

[00:14:43] Speaker 02:
I assume you will reach the same results, and puts the burden back on to the patent owner.

[00:14:49] Speaker 04:
But how do you get around, for instance, the discoloration as a clear and conspicuous example of difference?

[00:14:58] Speaker 02:
So that may be a different matter, but it doesn't have any distinction.

[00:15:02] Speaker 02:
And let me walk you through why.

[00:15:04] Speaker 02:
the type of resin, because all the arguments they're making really go to, did you get the right resin?

[00:15:12] Speaker 02:
And there are multiple reasons why, in the record, the board correctly determined, as a factual matter, that the type of ultra-high resin you use doesn't matter.

[00:15:23] Speaker 02:
First, the board points out that the O2O patent and all of the prior art references talk about its teachings

[00:15:30] Speaker 02:
being widely applicable to ultra-high and other kinds of polyethylenes and other kinds of polymers.

[00:15:37] Speaker 02:
Second.

[00:15:37] Speaker 04:
Well, that may go to the breadth of the claim.

[00:15:41] Speaker 02:
That's right.

[00:15:41] Speaker 02:
And the claims talk about ultra-high molecular weight polyethylene, but with a special and much broader definition.

[00:15:49] Speaker 02:
The board said most ultra-high molecular weight polyethylene, million and a half to 2 million molecular weight.

[00:15:56] Speaker 02:
But Helmetica has a special definition of only 400,000

[00:16:00] Speaker 02:
So its definition of ultra-high molecular weight polyethylene is much broader than what these references are talking about.

[00:16:07] Speaker 02:
They're talking about a narrow subset of that.

[00:16:10] Speaker 02:
So we don't have the situation that we have in all the in-ray cases where you have a narrow claim limitation.

[00:16:19] Speaker 02:
And this court has found in some instances that a broad disclosure that may or may not include that narrower limitation

[00:16:28] Speaker 02:
does not do inherence.

[00:16:29] Speaker 02:
Here we've got the opposite situation.

[00:16:32] Speaker 02:
Also, Your Honor, in the intrinsic record, the only way, Your Honor, that the patent owner got these claims in the first place was to utilize the general rule and do testing of the striker reference.

[00:16:47] Speaker 02:
When Halmedica tested the striker reference to say to the patent office, this is not anticipatory,

[00:16:56] Speaker 02:
They didn't use the resin disclosed in Stryker.

[00:16:59] Speaker 02:
And so for all these reasons, when you got to the examiner and the board having repeatedly factually considered these highly fact-intensive arguments and rejected them, it concluded at the final hearing where the board asked a very specific question of the patent owner.

[00:17:19] Speaker 02:
Is there anything in the record here?

[00:17:21] Speaker 02:
Is there anything in the record that suggests that

[00:17:24] Speaker 02:
the type of resin makes a difference.

[00:17:27] Speaker 02:
And Hametka admitted, this is at A2496, which is the transcript of that hearing, that it doesn't matter, lines 10 through 11.

[00:17:34] Speaker 02:
They don't have anything in the record that demonstrates that the type of resin you start with makes any difference with respect to the claimed properties here.

[00:17:45] Speaker 02:
And that, Your Honors, is the reason, the principal reason, why this court ought to affirm the highly fact-intensive decision

[00:17:54] Speaker 02:
of the PTAB that Lew necessarily and always discloses a material that has all of the characteristics, all of the claimed characteristics of claims 1 through 6.

[00:18:08] Speaker 02:
Now, we're also cross-appealing their determination, the board's determination that claims 7 through 12 were not invalid, as the examiner found.

[00:18:18] Speaker 02:
And this court may wonder, because we're holding

[00:18:21] Speaker 02:
summary judgment of non-infringement of claims seven through twelve does this really matter the answer that question is yes it very much matters because that decision is based on the district courts holding that the claim term is limited the claim term annealed at a temperature greater than 25 degrees C means between 25 and below the melting temperature and in that argument

[00:18:49] Speaker 02:
Hamedika argued exactly the opposite of what they're now saying.

[00:18:53] Speaker 02:
They're now saying that is the right limitation, and they're using that to dismiss lu, which is an hour at 150 degrees.

[00:19:01] Speaker 02:
But below, they said that term was not limited.

[00:19:05] Speaker 02:
And if that term isn't limited, if annealed at a temperature greater than 25C means just greater than 25C with no upper limit, well, then lu anticipates.

[00:19:16] Speaker 02:
for exactly the same reason that it anticipates claims one through six.

[00:19:20] Speaker 05:
Is this patent expired?

[00:19:23] Speaker 02:
It is expired, Your Honor.

[00:19:24] Speaker 02:
It expired in June of 2013.

[00:19:26] Speaker 05:
So what is the?

[00:19:30] Speaker 05:
You said you're holding a summary judgment of non-fringed patents.

[00:19:33] Speaker 02:
Which has not yet been appealed to this court yet.

[00:19:35] Speaker 02:
So our concern is that Halmedica would succeed in telling you that Lew doesn't anticipate because it's too high a temperature.

[00:19:42] Speaker 02:
And then they would come back to this court and say that Zimmer,

[00:19:45] Speaker 02:
whose product is made at 150 degrees the same as Lew does in French.

[00:19:52] Speaker 02:
That's the argument they made below, both as a matter of claim interpretation, that the claim has no upper temperature limit, and if the claim does have an upper temperature limit of 140 degrees or less, that a product made at 150 degrees C just like Lew.

[00:20:09] Speaker 05:
Wouldn't you be likely to wave their blue brief at them if they made such an argument?

[00:20:13] Speaker 02:
Well, but they're making the argument under the doctrine of equivalence as well, Your Honor.

[00:20:18] Speaker 02:
And these claims are invalid.

[00:20:21] Speaker 02:
They add nothing to claims one through six other than this process limitation.

[00:20:28] Speaker 02:
And the board found all the right facts, Your Honor.

[00:20:35] Speaker 02:
And then they stopped.

[00:20:37] Speaker 02:
They ran into this four-hour thing, and they just stopped, and they didn't complete

[00:20:41] Speaker 02:
the KSR analysis.

[00:20:42] Speaker 02:
The board correctly found that the product, the characteristics of the product described in claims seven through 12, exist in the prior art.

[00:20:51] Speaker 02:
That's Lue.

[00:20:52] Speaker 02:
They found that if you heat at one hour for 150 degrees, you'll get a product with all the claimed characteristics.

[00:20:59] Speaker 02:
The board also found that the Lawton reference discloses expressly to a person of ordinary skill in the art that you should heat below the melt for precisely

[00:21:11] Speaker 02:
the same reason that the 020 patent 20 some years later said, which is if you heat below the melt, we're not concerned about structural integrity or the sort of sloppiness of the item that you're irradiating.

[00:21:26] Speaker 02:
So the board got those fact questions correct.

[00:21:29] Speaker 02:
But then they stopped.

[00:21:31] Speaker 02:
They didn't ask the two KSR questions, which is one, is there any motivation when I've got this lube product an hour for 150 degrees

[00:21:39] Speaker 02:
Is there a motivation for me to go below the melting temperature?

[00:21:43] Speaker 02:
Yes.

[00:21:44] Speaker 02:
It's not just a motivation.

[00:21:45] Speaker 02:
It's an express, unequivocal statement from Lawton to do that.

[00:21:49] Speaker 02:
So the board missed that.

[00:21:51] Speaker 02:
The board also missed the expectation of success.

[00:21:54] Speaker 02:
What a person of ordinary skill in the art who knows that they can get all the claimed properties one hour for 150 degrees expect that at 130 degrees you could also get those claimed properties?

[00:22:08] Speaker 02:
Of course they would.

[00:22:09] Speaker 02:
Why?

[00:22:10] Speaker 02:
Well, because all the prior art, many of the prior art references, do get that result.

[00:22:16] Speaker 02:
And the prior art tells you expressly, Lawton says expressly, how long you must heat.

[00:22:22] Speaker 02:
And it's heat until all, substantially all, of the free radicals are gone.

[00:22:27] Speaker 02:
Just like the Dole reference, just like the de Boer reference, which go a little bit further, they say get rid of all the free radicals.

[00:22:34] Speaker 02:
And as a matter of chemistry, that's what this is all about.

[00:22:37] Speaker 02:
Once the free radicals are gone,

[00:22:39] Speaker 02:
Your claimed properties, are there any free radicals?

[00:22:42] Speaker 02:
No, they're gone.

[00:22:43] Speaker 02:
The references tell you that they're gone.

[00:22:46] Speaker 02:
Will this oxidize when we age it?

[00:22:48] Speaker 02:
No, because all the free radicals are gone.

[00:22:51] Speaker 02:
What happened to those free radicals?

[00:22:53] Speaker 02:
Lawton tells you expressly what happened to those free radicals.

[00:22:56] Speaker 02:
They all hooked back up with one another to form cross-links, which improves the resistance of the material to dissolving in a solvent.

[00:23:09] Speaker 02:
The person of ordinary skill in the art could almost, we know they're not an automaton.

[00:23:14] Speaker 02:
We know in KSR that they have ordinary creativity.

[00:23:19] Speaker 02:
They could almost be an automaton and say, one hour, 150 degrees.

[00:23:24] Speaker 02:
Am I incented to go below the melt?

[00:23:27] Speaker 02:
Yes.

[00:23:27] Speaker 02:
Lawton tells me exactly to do that.

[00:23:30] Speaker 02:
Do I expect that I will be successful in doing that?

[00:23:33] Speaker 02:
Yes, of course I do.

[00:23:34] Speaker 02:
And again, for the very same reason

[00:23:36] Speaker 02:
that Halmedica offered to the Patent Office to get these patents in the first place, the general rule, where Halmedica said, every 10 degrees you go down, you can expect to double the heating time, and vice versa.

[00:23:51] Speaker 02:
So a person of ordinary skill in the art.

[00:23:53] Speaker 05:
I take it the board did not really buy into the general rule.

[00:23:56] Speaker 02:
They didn't.

[00:23:57] Speaker 02:
But the reason they didn't, Your Honor, is expressed, and it's clear.

[00:24:01] Speaker 02:
They said, we think the general rule is just a litigation argument.

[00:24:04] Speaker 02:
So we're going to feel free to disregard a litigation argument that Hametica, which lost on the first three patents below, in an opinion this court affirmed, we're going to disregard that argument.

[00:24:14] Speaker 02:
But they were wrong.

[00:24:15] Speaker 02:
It wasn't a litigation argument.

[00:24:17] Speaker 02:
It was an argument that exists in the intrinsic record of this patent.

[00:24:21] Speaker 02:
And it was the reason that Hametica was able to get each of the predecessor patents, because the patent office said, wait a second, it looks to us that Stryker

[00:24:32] Speaker 02:
anticipates.

[00:24:34] Speaker 02:
Stryker has got the same process conditions, or an equivalent process condition, to 50 degrees at 144 C. Hamedika said, no, no.

[00:24:42] Speaker 02:
You've got to apply the general rule.

[00:24:44] Speaker 02:
And when you apply the general rule, you see that Stryker is just the other side of the process conditions, the total time, temperature, heating combination that we've got.

[00:24:54] Speaker 02:
I'm into my rebuttal time, so I'll stop there unless you have other questions, Your Honor.

[00:24:57] Speaker 04:
Now, you have rebuttal time.

[00:24:59] Speaker 04:
Do you have a cross appeal?

[00:25:00] Speaker 02:
We do have a cross appeal, Your Honor.

[00:25:02] Speaker 02:
I believe we set ours at 10 and 5.

[00:25:05] Speaker 05:
Well, let me just, if I could really quickly, could you tell me what your takeaway from Kativo's testimony is?

[00:25:12] Speaker 05:
Mr. Malloy has suggested that Kativo came up with five possibilities.

[00:25:21] Speaker 05:
of what the starting material could be.

[00:25:23] Speaker 05:
What's your read of his deposition?

[00:25:25] Speaker 05:
I don't think the record reflects that, Your Honor.

[00:25:27] Speaker 01:
If I could, I'd just refer, Your Honor, to the record.

[00:25:34] Speaker 05:
Katibo said there's only two options.

[00:25:36] Speaker 05:
N640 through 656, or whatever it is.

[00:25:39] Speaker 05:
But he talks.

[00:25:41] Speaker 05:
He's not the clearest witness in the world.

[00:25:43] Speaker 05:
I think we can all agree on that.

[00:25:44] Speaker 05:
Absolutely.

[00:25:44] Speaker 05:
The question is, when he gets beyond GUR 4130 and GUR 4030,

[00:25:51] Speaker 05:
I want to see what you think he's saying with the other products that he refers to.

[00:25:58] Speaker 05:
He talks about the, go ahead.

[00:26:02] Speaker 02:
Our view, your honor, is that the only two possible products that he talks about in any real sense is 4030 and 4032.

[00:26:11] Speaker 02:
And that we got one of each of those and we tested them, but at the end of the day,

[00:26:17] Speaker 02:
We shouldn't be faulted for having done substantially more than we needed to do, because the record that the examiner and the board considered reflects strongly that it doesn't make a difference what kind of ultra-high molecular weight polyethylene you use.

[00:26:34] Speaker 02:
And that is, in fact, the test for inherency, that it shouldn't make a difference what kind you use.

[00:26:38] Speaker 02:
And the record reflects that fact, Your Honor.

[00:26:41] Speaker 04:
OK.

[00:26:42] Speaker 04:
Thank you, Mr. Callahan.

[00:26:43] Speaker 04:
Thank you, Your Honor.

[00:26:46] Speaker 04:
Mr. Malloy.

[00:26:48] Speaker 00:
It's Cativo first.

[00:26:50] Speaker 00:
That was the last taken up.

[00:26:52] Speaker 00:
Cativo said at appendix page 641 to 642 that there was ultra-high.

[00:27:00] Speaker 00:
Then he testified about blended with carbon fillers.

[00:27:03] Speaker 05:
Then he testified about... That blended with carbon fillers is... Where is that?

[00:27:08] Speaker 00:
That's at 641 to 642 appendix page.

[00:27:17] Speaker 00:
At the same set of pages, he then testified about blended with other things.

[00:27:21] Speaker 00:
I can get the line.

[00:27:22] Speaker 05:
No, I have it.

[00:27:24] Speaker 00:
All right.

[00:27:24] Speaker 00:
And then he testified that blended with PTFE at 641 and 2.

[00:27:30] Speaker 05:
And finally, those are things that are not purely UMW, UHMWPE, right?

[00:27:42] Speaker 00:
They are.

[00:27:42] Speaker 00:
They're ultra-high molecular weight polyethylene.

[00:27:45] Speaker 05:
options that are blended with other things.

[00:27:47] Speaker 00:
Exactly right.

[00:27:48] Speaker 00:
But nobody knows what Lou reported on.

[00:27:52] Speaker 00:
And they were all available.

[00:27:54] Speaker 05:
The way Lou expresses it, he bought UHMWPE, not some blend, right?

[00:28:03] Speaker 00:
No, he never said not some blend.

[00:28:04] Speaker 00:
He just said, I got whatever I got.

[00:28:06] Speaker 00:
And he also said that he had two different materials.

[00:28:10] Speaker 00:
And he didn't know why.

[00:28:11] Speaker 00:
And he described them as having different structures,

[00:28:14] Speaker 00:
and different results.

[00:28:15] Speaker 00:
And he had no clue why.

[00:28:17] Speaker 00:
And it wasn't the 41-30 versus 40-30, because Katibo started out saying it was 40-30.

[00:28:26] Speaker 00:
And then he said, oh, I heard from my production folks.

[00:28:29] Speaker 00:
I was dead wrong.

[00:28:30] Speaker 00:
We don't know who these people are.

[00:28:32] Speaker 00:
It's 41-31.

[00:28:32] Speaker 00:
Take my word for it.

[00:28:35] Speaker 00:
And we have no documentation to support whether he was right the first time, right the second time, or wrong both times.

[00:28:41] Speaker 00:
But we do know that he went on to testify that all these different alternatives, and there was one more, by the way, Your Honor, the one was resins from other suppliers that they then resold.

[00:28:53] Speaker 00:
And that's at, I believe, appendix page 660.

[00:28:57] Speaker 00:
So that's the fifth alternative.

[00:29:00] Speaker 00:
Plain UH, we've got two different types of blends.

[00:29:03] Speaker 00:
Then we've got blended with other materials.

[00:29:05] Speaker 00:
And then we've got resin from other suppliers, which they then made up and then resold to customers.

[00:29:13] Speaker 00:
And this record is completely silent on which of those were involved.

[00:29:18] Speaker 00:
Completely silent.

[00:29:20] Speaker 00:
So Contivo capped it off by saying he had no personal knowledge of these things in any event.

[00:29:24] Speaker 00:
So it's a pretty slippery record on which to base a necessarily present standard

[00:29:30] Speaker 00:
But a couple of comments by my opponent.

[00:29:33] Speaker 00:
We have a broad claim versus a narrow one, not correct.

[00:29:35] Speaker 00:
We've got very detailed solubility, free radical, and non-increasing oxidation index portions of these claims, which are nowhere found in the prior art.

[00:29:46] Speaker 00:
We've got Lou concluding that, and we heard a lot about Lawton.

[00:29:50] Speaker 00:
I almost thought that we weren't talking about an anticipation case here, that it was an obvious in this case, but the board only found anticipation.

[00:29:57] Speaker 00:
But in any event, we've got his reliance on Lawton.

[00:30:09] Speaker 00:
But Lawton dealt with high density.

[00:30:11] Speaker 00:
And Lew says that high density is a, quote, completely different material than ultra-high when we're talking about the properties.

[00:30:21] Speaker 00:
And if the court

[00:30:25] Speaker 00:
Which is, that's it, A125, appendix page 125.

[00:30:32] Speaker 00:
So in terms of the cross appeal, this was a brand new argument in terms of claim construction.

[00:30:38] Speaker 00:
We ought to now ignore the term annealed.

[00:30:42] Speaker 00:
Zimmer first stopped from making that argument because they made it at the district court.

[00:30:48] Speaker 00:
They said annealed counts, and they won a summary judgment of non-infringement.

[00:30:53] Speaker 00:
They've waived the argument.

[00:30:54] Speaker 00:
It's nowhere made in their re-examination petition.

[00:30:58] Speaker 00:
They say, well, please look at footnote 10 of one of our supplemental papers where we say, if the court, if the board were to find annealed didn't mean anything, then here is the result.

[00:31:09] Speaker 00:
But they never cited a case or told the board in their re-exam petition that the board had to ignore the term annealed.

[00:31:17] Speaker 00:
And the board properly interpreted it consistent with the examiner.

[00:31:21] Speaker 00:
It's requiring heating below the melt.

[00:31:23] Speaker 04:
So that was the reason why the board didn't discuss obviousness?

[00:31:31] Speaker 00:
They dealt with the claims 7 to 12 in detail in obviousness.

[00:31:35] Speaker 00:
But as to claims 1 to 6, there was no position ever made that was argued in terms of the board decisions about obviousness.

[00:31:47] Speaker 00:
There was one and only one issue that we're here for, which is, is

[00:31:52] Speaker 00:
Our claims, 1 to 6, anticipated by inherency by Lou.

[00:31:56] Speaker 00:
So 7 to 12 that they dealt with the obviousness on.

[00:31:59] Speaker 00:
1 to 6 was really an anticipation.

[00:32:07] Speaker 05:
We did hear a little bit of an objection to the process limitation.

[00:32:12] Speaker 05:
Because they didn't raise it before the board.

[00:32:13] Speaker 05:
Correct.

[00:32:14] Speaker 05:
And to the extent that they raised it, they raised it in the context, in a different context from the way they raised it.

[00:32:18] Speaker 00:
I don't even think we could say they raised it.

[00:32:20] Speaker 00:
They just said, if we were to ignore a kneel.

[00:32:23] Speaker 00:
But they never said, yeah, you have to ignore it.

[00:32:26] Speaker 00:
Cited a case to explain why it ought to be ignored.

[00:32:29] Speaker 04:
And I would say also- Just to be clear, you're saying this at 7 to 12, and the obvious is the cross appeal is not a proper procedure?

[00:32:39] Speaker 00:
Well, it's a proper procedure for them

[00:32:42] Speaker 00:
to argue, but it's not proper for them to invent a new argument that wasn't presented in their petition for reexamination.

[00:32:51] Speaker 00:
And regarding the term annealed, which is in claims 7 to 12, they have invented a new argument.

[00:32:57] Speaker 00:
And it's not explained.

[00:33:01] Speaker 00:
Nowhere did they tell the patent office in their reexam filing, you must ignore annealed for the following reasons.

[00:33:08] Speaker 05:
But that's only one of the arguments they make on the cross piece.

[00:33:10] Speaker 00:
Well, it's a critical one.

[00:33:13] Speaker 05:
They could lose on that and still win on the cross.

[00:33:17] Speaker 05:
You wouldn't agree with their winning, but they have arguments which, if accepted, would lead to their winning on the cross.

[00:33:24] Speaker 00:
I would disagree that they should win even without regard to that.

[00:33:30] Speaker 00:
They've got basically a hodgepodge of references that lead nowhere.

[00:33:34] Speaker 00:
If we start with Lou, Lou tells us

[00:33:37] Speaker 00:
that you probably should not either irradiate or heat, because you get severe degradation of properties.

[00:33:42] Speaker 00:
He says that at the abstract at page 58, and at the end of his article at page, I think it's 197.

[00:33:47] Speaker 00:
I'm referring to the appendix pages.

[00:33:50] Speaker 00:
So he leads the way.

[00:33:51] Speaker 00:
He says, don't do these things.

[00:33:53] Speaker 00:
And then in a burst of hindsight reconstruction, in my view, they say, well, Lawton taught us to heat, but Lawton was only six minutes, and it was high density.

[00:34:06] Speaker 00:
not ultra-high, and Lou says those are two completely different materials and they behave completely differently.

[00:34:12] Speaker 00:
Then we have some heating above the melt, some heating below the melt, some with a radiation, some not with a radiation.

[00:34:20] Speaker 00:
And by and large, they really make no basis for reversal of this board's detailed findings.

[00:34:27] Speaker 00:
And the fundamental finding of this board on the obviousness of 7 to 12 was that there was no reasonable expectation of success

[00:34:36] Speaker 00:
that was established, as a matter of fact, when you start out thinking, well, everyone wants to pursue the Holy Grail, but nobody ever got there.

[00:34:44] Speaker 00:
And certainly not Lou, who said that the results led to severely adverse properties in both tensile strength and wear resistance and didn't recommend it.

[00:34:57] Speaker 00:
And by the way, caused a yellowing of the property.

[00:35:00] Speaker 00:
So I thank this court.

[00:35:03] Speaker 00:
Any further questions?

[00:35:04] Speaker 00:
I'll be happy to entertain.

[00:35:05] Speaker 04:
I think we're OK.

[00:35:07] Speaker 04:
All right, you have rebuttal on the cross-appeal.

[00:35:10] Speaker 02:
Your Honor, thank you.

[00:35:12] Speaker 02:
I will go with claims 1 through 6 first, try to hit the points there, particularly on some of these issues that have come up on the resin, Your Honor.

[00:35:20] Speaker 03:
Well, you have the right on the claim 1 through 6.

[00:35:22] Speaker 03:
This is your argument for cross-appeal.

[00:35:23] Speaker 02:
I'm sorry, Your Honor.

[00:35:24] Speaker 03:
You're right.

[00:35:25] Speaker 02:
You're correct.

[00:35:26] Speaker 03:
I'd like you to address the point of waiver.

[00:35:28] Speaker 02:
Sure.

[00:35:30] Speaker 02:
In our initial re-examination petition, Your Honor, we did say claims 1 through 12.

[00:35:35] Speaker 02:
were invalid as anticipated by the Lew testing.

[00:35:39] Speaker 02:
So that was out there.

[00:35:40] Speaker 02:
We did not, I will concede, make the Amgen-Inre-Thorpe version of that argument.

[00:35:47] Speaker 02:
But we did say that claims 1 through 12 were anticipated by the inherent disclosures of Lew.

[00:35:54] Speaker 02:
So we made that argument that was out there in front of the board right away.

[00:36:00] Speaker 02:
Because we had a Markman hearing,

[00:36:02] Speaker 02:
And because we had a Markman ruling that said claims 7 through 12 are limited to 140 degrees or less, that ended up not going anywhere.

[00:36:11] Speaker 02:
Although, we did an oral argument, raised the in Ray Thorpe argument.

[00:36:17] Speaker 02:
We said at A2526 that there is an in Ray Thorpe argument here.

[00:36:22] Speaker 02:
And in our briefs, we were

[00:36:24] Speaker 02:
It was indicated that we didn't say anything in our briefs about this, about the waiver issue.

[00:36:29] Speaker 02:
We did.

[00:36:29] Speaker 03:
It sounds like we didn't raise the obviousness argument with respect to 7-12.

[00:36:34] Speaker 02:
That's right, Your Honor, we did.

[00:36:37] Speaker 02:
We raised both anticipation based on lieu and a myriad of obviousness arguments with respect to claim 7-12.

[00:36:44] Speaker 02:
We raised the in-ray MGen or the in-ray Thorpe issue, which is the same as MGen, product by process.

[00:36:52] Speaker 02:
You can't take this

[00:36:53] Speaker 02:
product that the PTAB has found existed in the prior loop.

[00:36:59] Speaker 02:
It's got all the claimed characteristics of claims 7 through 12.

[00:37:05] Speaker 02:
But, says the patent owner, but we figured out a way to make it using a different process, using a lower temperature.

[00:37:12] Speaker 02:
That is a matter of law.

[00:37:13] Speaker 05:
That's the issue on which the waiver.

[00:37:15] Speaker 05:
That's right, Your Honor.

[00:37:16] Speaker 05:
And where in your brief did you make that argument?

[00:37:20] Speaker 02:
We didn't make it in our brief to the board.

[00:37:22] Speaker 02:
We made it at oral argument.

[00:37:23] Speaker 05:
That's too late.

[00:37:25] Speaker 02:
Well, Your Honor, we cited the QI press controls case, where in a similar situation, this court said, I've got two sets of claims, one of which is invalid.

[00:37:38] Speaker 02:
We found it invalid.

[00:37:39] Speaker 02:
The other of which wasn't found invalid, but all it adds is a process limitation.

[00:37:44] Speaker 02:
We can't do that.

[00:37:45] Speaker 02:
We don't want to have that inconsistency of result.

[00:37:49] Speaker 04:
You requested reconsideration of the board, but I don't see

[00:37:53] Speaker 04:
that this was raised even there in the request for reconsideration?

[00:37:57] Speaker 02:
We did not make a request for a consideration, Judge Newman.

[00:38:00] Speaker 02:
Well, one of your colleagues?

[00:38:01] Speaker 02:
Hamedika made a request for reconsideration.

[00:38:04] Speaker 05:
On 1 through 6?

[00:38:05] Speaker 02:
That's correct, Your Honor.

[00:38:07] Speaker 02:
But in all events, the most important thing here, Your Honors, is that the prior art unequivocally tells you each of the key prior art references that were before the board on claims 7 through 12.

[00:38:22] Speaker 02:
whether it's Dole, 83 or 79, DeBoer, Lawton.

[00:38:28] Speaker 04:
But you're looking for a combination and obviousness, the law of obviousness, right?

[00:38:33] Speaker 02:
We are, Your Honor.

[00:38:34] Speaker 02:
But we know that the product, we know from Lew, Claims 7 through 12, we know that all the characteristics of the claim products exist in the prior argument.

[00:38:47] Speaker 04:
OK, but then I didn't know who had requested reconsideration.

[00:38:51] Speaker 04:
But then you didn't ask the board to issue a decision on obviousness.

[00:38:59] Speaker 02:
We did not ask the board to reconsider its determination that there was no obviousness of claim 7 through 12.

[00:39:08] Speaker 02:
The board's decision on claim 7 through 12, I don't think there's any question about waiver.

[00:39:13] Speaker 02:
We haven't waived our ability to come into this court and argue obviousness of claim 7 through 12.

[00:39:20] Speaker 02:
That was fully briefed to the board.

[00:39:22] Speaker 02:
That was argued before the board.

[00:39:24] Speaker 02:
And the board went the other way.

[00:39:26] Speaker 02:
The fact that we didn't seek reconsideration of that determination doesn't prevent us from coming into this court and asking that this court reverse the board's determination of no obviousness of claims 7 through 12.

[00:39:40] Speaker 05:
So the waiver just goes to the issue of the process?

[00:39:43] Speaker 02:
Only to the Amgen In re Thorpe issue, Your Honor.

[00:39:46] Speaker 02:
Only.

[00:39:47] Speaker 02:
And if I can conclude, as to that, all of the prior art references, we know we can make this at a higher temperature.

[00:39:57] Speaker 02:
The only question is, can we make it at a lower temperature?

[00:40:00] Speaker 02:
And we see the prior art again and again and again saying, you can.

[00:40:06] Speaker 02:
And telling you, in terms of the length of time you need to heat it, we know you have to heat it for a longer time.

[00:40:13] Speaker 02:
Lower temperature, longer time.

[00:40:15] Speaker 02:
Every person of ordinary skill in the art, if they know one thing, they know that.

[00:40:19] Speaker 02:
Each of the references that was cited to the board provides an endpoint.

[00:40:25] Speaker 02:
Heat it until all of the free radicals are gone.

[00:40:29] Speaker 02:
And once all those free radicals are gone, you will have all the claimed properties, because they relate to getting rid of free radicals.

[00:40:38] Speaker 02:
I thank the court for your time and attention this morning.

[00:40:40] Speaker 02:
Thank you.

[00:40:41] Speaker 04:
OK.

[00:40:41] Speaker 04:
Thank you.

[00:40:42] Speaker 04:
Thank you both.

[00:40:43] Speaker 04:
The case is taken under submission.

[00:40:47] Speaker 03:
All right.