[00:00:00] Speaker 01:
Electa Limited versus Zap Surgical Systems Inc.

[00:00:05] Speaker 01:
Attorney Nall, did I pronounce your name correctly?

[00:00:09] Speaker 02:
You did, Your Honor.

[00:00:11] Speaker 01:
You have reserved three minutes of your time for rebuttal, is that correct?

[00:00:14] Speaker 02:
Yes, Your Honor.

[00:00:15] Speaker 01:
All right, you may proceed.

[00:00:16] Speaker 02:
Thank you.

[00:00:17] Speaker 02:
May it please the court, Jennifer Lebrock Nall for Appellant Patent Owner Electa.

[00:00:22] Speaker 02:
There are two main issues before the court today.

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First, reasonable expectation of success, and second, motivation to combine.

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I'll begin with reasonable expectation of success.

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It is undisputed that the final written decision does not expressly address reasonable expectation of success.

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That is an error as a matter of law that requires this court at a minimum.

[00:00:44] Speaker 01:
Is this really a reasonable expectation of success case?

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Or is it just simply the combination

[00:00:52] Speaker 02:
Your honor, it is a reasonable expectation of success.

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I say that because normally, not all the time, but normally those type of cases involve an infinite group of results that can emanate from a particular experiment or a combination.

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A combination can result maybe in a whole host of chemical salts.

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But here you're just simply arguing that it's

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It was unreasonable to expect that the weight of components of the prior would operate.

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Your Honor, I respectfully disagree.

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Here, the claims require treatment.

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The patent's title is about treatment.

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The specification is all about treatment.

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The preamble requires that the ionizing radiation be used for treatment.

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It provides antecedent basis for limitations in the claim.

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And what we know is that petitioner's expert testified that he had no opinion.

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He was unqualified to testify about treatment.

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He said in the appendix at his deposition at 3499, quote, I'm not a medical physicist.

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I'm not considering treatment.

[00:02:08] Speaker 01:
Why do you say that?

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Claim one says it's a device.

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Isn't this an apparatus case?

[00:02:15] Speaker 02:
Uh, your honor, there's an apparatus claim and a method claim at issue here.

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Um, however, even with the apparatus, there is no testimony that this treatment using ionizing radiation is predictable.

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In fact, their expert petitioners, experts said that he couldn't consider treatment because he's not a medical physicist.

[00:02:35] Speaker 04:
I thought your reasonable expectation of success argument was that the line act would be too heavy and that it would fall.

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The arm would break.

[00:02:43] Speaker 04:
So isn't that your reasonable expectation of success argument?

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And didn't the board address it?

[00:02:48] Speaker 04:
Well, it didn't use the language reasonable expectation of success.

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It did talk about the argument itself about the weight of the Line Act.

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Your Honor, there's more than evidence on the weight of the Line Act.

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For sure, the weight of the Line Act was... There's more below, before the board.

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What was your reasonable expectation of success?

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What did you argue

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resulted in there not being a reasonable expectation of success.

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Your Honor, below the evidence about reasonable expectation of success is in the appendix at 3371 through 3375.

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The board collected the evidence on appendix page 30 through 32 and appendix page 35.

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Well, your argument seems to be that the board didn't address reasonable expectation of success.

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So I'm just asking you, what specifically was your argument on reasonable expectation of success?

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Because when I looked at the record,

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I didn't see that it was a lengthy argument.

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It was rather short, in fact.

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Your Honor, the evidence that there would be no reasonable expectation of success, that the proposed combination wouldn't work for treatment, included the evidence of Dr. Sedley regarding the orders of magnitude difference in the energies of the radiation.

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The fan-shaped beam of an x-ray tube versus the narrow beams of a treatment using ionizing radiation.

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The difficulty in accommodating heavy Linux, though your honor is right that the board did address the difficulty on heavy Linux.

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What it doesn't say is what the difference between x-ray tubes is versus ionizing radiation treatment.

[00:04:27] Speaker 04:
The only place where I saw there was a reasonable expectation of success argument presented by the patent owner was at page JA3887.

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Do you think that there are some other places, I'm looking at the patent owner's response specifically, to see what was argued to the board?

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Because it's really hard to say that the board erred on something if it wasn't argued to the board in the first place.

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And so what I see on page 387 is an argument directed to the ability of the heavy structure of the Line Act.

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Your Honor, the

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The evidence is also at 3887.

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It says that a posito would not have expected the structure to be a viable solution for focusing the therapeutic radiation source on the target, which was the stated goal of the invention of the 648 patent.

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The test for reasonable expectation of success is whether or not the proposed combination would work for the intended purpose.

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So that sentence was also about reasonable expectation of success.

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at 3886.

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The board did make a finding that this would work, that the combination would work.

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Your Honor, the board made a finding that the combination... Your argument is that the board did not, and I'm looking at your brief on page 17, where you say the board failed to address whether Steele Artisan would have had reasonable expectation of success.

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That's really your argument on appeal, isn't it?

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That is one of the arguments on reasonable expectations.

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Yes, Your Honor.

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So the question is, to what extent does a board have to address or expressly make a lengthy statement concerning an expectation of success?

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We have case law that says that, for example, that it's not required that there be an explicit statement of a reasonable expectation of success in every case.

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We've already ruled on this particular issue that you're arguing.

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Your honor, KSR was not about the review under the APA.

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This court in Alacratec, in Inri Venas, in Renuvasiv, in OSI, all stated that under the APA, what is required is a

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express analysis that allows for this court to do a meaningful review.

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And what was not addressed by the final written decision was whether or not a person of ordinary skill in the art had any expectation that this proposed combination could be used for treatment.

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There's no evidence that treatment is predictable.

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The only evidence... To the extent that's true, it seems like it's because

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the way the parties argued reasonable expectation of success was kind of subsumed and blended into the motivation to combine.

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Wouldn't you agree with that?

[00:07:33] Speaker 02:
No, Your Honor.

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I do not agree with that because Pat Nohner did expressly argue.

[00:07:39] Speaker 00:
Well, other than 3887, where did you expressly argue reasonable expectation of success is not here in a way separate from your motivation to combine argument?

[00:07:52] Speaker 02:
Your Honor, it was at 3886 through 3887 that it was expressly addressed.

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So first of all, is it just those two pages in all of the briefing?

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Those are the two pages that address reasonable expectation of success.

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Yes, Your Honor.

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So help me with this.

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You tell us in the blue brief at 22 that ZAP, your friends on the other side, did discuss reasonable expectation of success.

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You say in only one filing the reply to the patent's owner's response to the petition.

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Is it right?

[00:08:24] Speaker 02:
Yes, Your Honor.

[00:08:26] Speaker 00:
So when I go and look at the pages you cited, you cite all of 281 to 316 of the appendix.

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When I look through there, the only place where they seem to mention reasonable expectation of success is on page 310.

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And 310 is under a section about motivation to combine.

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Is there anywhere that ZAP expressly talks about reasonable expectation of success separate and apart from motivation to combine?

[00:08:57] Speaker 02:
No, Your Honor.

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In fact, ZAP's petition doesn't mention reasonable expectation of success at all.

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Right.

[00:09:01] Speaker 00:
So doesn't that just prove my point that both parties presented this case to the board as reasonable expectation of success was just subsumed within motivation to combine?

[00:09:12] Speaker 02:
No, Your Honor.

[00:09:13] Speaker 02:
I don't believe that patent owner did present it as subsumed.

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Patent owner said that there is no reasonable expectation that this proposed combination would work for treatment.

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That is a major theme of both the Steadley Declaration

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and those two pages in the patent owner response.

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Which part of the Steadley Declaration would we find that?

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It's in 3371 through 3375, Your Honor.

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And you think that discussion was separate and apart and not subsumed or overlapping Steadley's motivation to combine discussion?

[00:09:54] Speaker 02:
Your Honor, the two are very related.

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And I can't say that it did not also address motivation to combine.

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However, there were definite statements in those sections that a person of ordinary skill in the art, a medical physicist, would have had no expectation that the proposed combination would work for treatment.

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And so even though some of those statements probably also address motivation to combine, they do address reasonable expectation of success.

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And it was petitioner's burden to show

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that there was a reasonable expectation of success below.

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And the petitioner put forward no evidence to show a reasonable expectation of success.

[00:10:35] Speaker 01:
It's not your argument that the board failed to make any analysis whatsoever concerning whether the combination would work.

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That is not the argument, Your Honor.

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The argument is that there was argument as to, and the board did analyze whether the combination would work.

[00:10:53] Speaker 02:
Yes, Your Honor, the Board did say the proposed combination would work, but the Board didn't analyze whether or not a person of already skilled in the art without hindsight knowing that these, that what is in the 648 patent would have known taking Grady, which is an x-ray imaging stand with an x-ray tube, would work if you modify it to provide an ionizing radiation treatment source.

[00:11:20] Speaker 01:
Did you make those arguments to the Board?

[00:11:23] Speaker 02:
Yes, Your Honor.

[00:11:25] Speaker 01:
Why do you say the board didn't hear the arguments or didn't consider them?

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The board is required to do an express analysis and provide a basis for this court to do a reasoned review.

[00:11:35] Speaker 01:
That kind of takes us back to the point.

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That's really your argument here, that the board failed to make a sufficient statement as to reasonable expectation of success.

[00:11:47] Speaker 02:
Your Honor, yes, but also that the board is unable to make a sufficient statement because there was no evidence other than patent owner's evidence regarding reasonable expectation of success.

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So if we were to find that

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The board did consider reasonable expectation of success when it considered whether the combination would work.

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And it heard the arguments that you say now are based on reasonable expectation of success, but the board entertained and heard those arguments on the basis of combination.

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Then we would have a situation where the reasonable expectation of success is inherent

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in the decision of the board with respect to combination or implicit rather, not inherent.

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Your Honor, substantial evidence does not support a finding that the treatment is inherent in the proposed combination.

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And this court shouldn't do that in ab initio without any direction from the board.

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But if you look at the petitioner's expert,

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He is a mechanical engineer and he said he could not, it is not inherent.

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He didn't, he couldn't testify about treatment.

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At 3499, he says he is, those statements, he is unqualified as a mechanical engineer to testify about treatment.

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He had to look to a medical physicist.

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Treatment is not inherent or implied in the combination.

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And a person of already skilling art looking at Grady,

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and putting a ionizing radiation device on it would not know, the only evidence of record is that they would not have any expectation that that would work.

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That the differences in both the structure, the weight and the fan size and the

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The efficacy and precision and pretreatment planning, all of this is detailed, collected by the board at 35, where they analyze whether or not that evidence would have dissuaded somebody from doing the motivation to combine.

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But that evidence is not the burden to show reasonable expectation of its success.

[00:14:03] Speaker 02:
It's whether, with all of that evidence, the only evidence of record about reasonable expectation of success, whether a person of already skill in the art would have expected it to work.

[00:14:14] Speaker ?:
OK.

[00:14:14] Speaker 01:
You're into your rebuttal time, and I'll restore you back to three minutes, OK?

[00:14:18] Speaker 01:
Thank you so much.

[00:14:18] Speaker 01:
Unless you want to use up your time now.

[00:14:20] Speaker 02:
Thank you so much, Your Honor.

[00:14:27] Speaker 01:
All right.

[00:14:28] Speaker 01:
Any questions?

[00:14:29] Speaker 03:
Good morning, Your Honor.

[00:14:30] Speaker 03:
May it please the court?

[00:14:31] Speaker 03:
April Isaacson on behalf of APA Lee.

[00:14:35] Speaker 03:
This was a clear, well-reasoned decision by the board.

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A 72-page decision with a large record underneath that was a very comprehensive record.

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It contained all arguments considering both petitioner's arguments and patent owner's arguments.

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And within the four corners of that, they considered a person of skill in the art.

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So agree with your honors in terms of the motivation to combine.

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But also, when you look at the definition of a person of skill in the art, it's a mechanical engineer.

[00:15:03] Speaker 03:
The board found that it would be a sturdy structure that's actually the scope of the claims.

[00:15:08] Speaker 03:
The scope of the claims doesn't require a particular type of treatment.

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doesn't require a particular type of linear accelerator.

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It doesn't require a particular type of precision either.

[00:15:19] Speaker 03:
So if you look at the grading reference where we talked about, it has everything that you would need in terms of the prior art except the linear accelerator.

[00:15:27] Speaker 03:
And my friend here, even through the grade brief, is talking about this debunked idea that it was a heavyweight linear accelerator.

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The board found that that was not indeed the case.

[00:15:39] Speaker 04:
Can I ask you, one thing that was said was that, I guess, suggesting that our case law in Merck doesn't apply in a situation involving the board where the APA applies.

[00:15:52] Speaker 04:
There needs to be an express statement regarding reasonable expectation of success.

[00:15:59] Speaker 04:
What is your response to that?

[00:16:00] Speaker 03:
Say, Merck is directly on point here, Your Honor, and it actually goes to the point raised earlier about predictable arts versus unpredictable arts.

[00:16:08] Speaker 04:
But why doesn't the APA somehow displace Merck?

[00:16:11] Speaker 04:
Merck says you don't have to have an express statement on reasonable expectation of success.

[00:16:15] Speaker 04:
And the APA, though, says with respect to the board, there needs to be very clear what their reasoning is.

[00:16:20] Speaker 04:
So how would you respond specifically to that question?

[00:16:24] Speaker 03:
With regard to, for example, the Alafatec case, that was one where they talked about whether or not the board did an appropriate analysis.

[00:16:32] Speaker 03:
And in that case, it said the board's obligated to provide administrative records showing the evidence, which was done here.

[00:16:38] Speaker 03:
They don't require perfect explanations, but will uphold a decision of less than ideal clarity that fits the agency path and it can discern.

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So in this case, that's why I mentioned earlier

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It's clear, well-reasoned.

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So it doesn't fall within a lack of tech of not having that information that would be required for this court to uphold the board's decision.

[00:17:02] Speaker 03:
It was well-reasoned.

[00:17:04] Speaker 03:
They also, in that case, misrepresented a particular combination in terms of motivation to combine as well.

[00:17:13] Speaker 00:
We said in Eli Lilly that a finding by the board that a patent challenger has demonstrated a motivation to combine references

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does not necessarily imply that you've also shown the reasonable expectation of success.

[00:17:29] Speaker 00:
That's governing on us as well, correct?

[00:17:32] Speaker 03:
Yes, Your Honor.

[00:17:34] Speaker 00:
So why here would we hold that the finding, which was explicit about motivation to combine, also implied a finding of reasonable expectation of success?

[00:17:44] Speaker 03:
So this case is about the mechanical arts, which is predictable, much more predictable in terms of the Eli Lilly case.

[00:17:51] Speaker 03:
As we all know, within the pharmaceutical and chemical arts, it's unpredictable.

[00:17:57] Speaker 03:
In that case, for example, they didn't know if it would be able to go through the blunt brain barrier, and it was a migraine medication.

[00:18:03] Speaker 03:
So we're talking about an area of art where it's highly unpredictable.

[00:18:06] Speaker 03:
So the reasonable expectation of success concept becomes much more important.

[00:18:12] Speaker 03:
And the same thing even with the Merck case, which said it doesn't need to be implicit.

[00:18:16] Speaker 03:
That was also a pharmaceutical case, but they still found that

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having explicitly said the motivation combined was enough, and implicitly having the reasonable expectation of success was sufficient.

[00:18:29] Speaker 00:
But what about fear?

[00:18:31] Speaker 00:
The burden was on you to show reasonable expectation of success.

[00:18:34] Speaker 00:
What evidence do we have that would satisfy that?

[00:18:38] Speaker 03:
If you look at the record as a whole, for example, in Appendix 35, it talks about Professor McCarthy and his declaration.

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And he's a mechanical engineer talking about a person of skill in the arts.

[00:18:55] Speaker 03:
And it cites to his declaration that's at appendix 1342 to 43, talking about the weight of the linear accelerator, what a person of skill in the art would be, that they would know that these lightweight linear accelerators.

[00:19:08] Speaker 00:
What about the reasonable expectation of success with respect to treatment?

[00:19:14] Speaker 00:
That seems to be the focus today of where you purportedly failed to meet your burden.

[00:19:20] Speaker 03:
But it's really not about treatment.

[00:19:22] Speaker 03:
The claims do have a treatment element to them, but it's not for a specific type of treatment.

[00:19:28] Speaker 03:
This is really about a mechanical device and a sturdy mechanical device, as the board found.

[00:19:34] Speaker 03:
So taking one device that was known in the art that contains all of the claim limitations, and then simply adding onto it a linear accelerator that a person who's still in the art that's a mechanical engineer would know could structurally be done.

[00:19:47] Speaker 03:
And the Rukala reference has not only a linear accelerator, it also has use of it for treatment as well as imaging.

[00:19:58] Speaker 03:
So that in terms of the motivation combined, those two references.

[00:20:01] Speaker 03:
The person of skill in the art here doesn't need to understand the treatment or be a physician.

[00:20:06] Speaker 03:
And as a matter of fact, the board in the record below determined that they didn't find credible the arguments of patent owners

[00:20:17] Speaker 03:
experts in terms of their declarations and deposition testimony because they weren't someone who was a mechanical engineer and would understand how these two references, for example, could be combined.

[00:20:29] Speaker 00:
To affirm the board, do we have to find that there was sufficient evidence to support a finding that a person of skill in the art would have had a reasonable expectation that they could combine these references and succeed for the purposes of treatment?

[00:20:44] Speaker 03:
Wouldn't have to be, no, your honor.

[00:20:46] Speaker 00:
We don't have to find such evidence.

[00:20:48] Speaker 03:
No, your honor.

[00:20:49] Speaker 03:
You don't have to find such evidence that they would succeed in treatment.

[00:20:53] Speaker 00:
No, that they would reasonably expect they could succeed.

[00:20:55] Speaker 00:
Do we have to find that evidence?

[00:20:58] Speaker 03:
I would say that you would be the reasonable expectation of being able to combine the two references and be able to use them in terms of the mechanical device that could be used for treatment.

[00:21:12] Speaker 03:
not necessarily that it would be successful for whatever treatment, because it doesn't specifically say what kind of treatment you would have to have.

[00:21:19] Speaker 00:
OK, but in the way you articulated it, you did have that burden, and we would have to find substantial evidence to support that, correct?

[00:21:27] Speaker 03:
I don't necessarily agree with that, Your Honor.

[00:21:29] Speaker 00:
OK, well, which part do you disagree with?

[00:21:33] Speaker 00:
You did not have a burden to show reasonable expectation of success with respect to the ability to perform some treatment here?

[00:21:40] Speaker 03:
Well, some treatment, and I would say if you look to the board's decision, they cite very heavily to Mr. Asmarov's declaration.

[00:21:49] Speaker 03:
And that's where he talks about he actually works with these types of devices and works in combination with not only physicians, but others within the field so that they can actually make a device that would work for treatment.

[00:22:07] Speaker 03:
And he talks about, in the context of a person of skill in the art, that it would be simple, easy, straightforward to actually make this type of device.

[00:22:16] Speaker 03:
And he's worked on those types of devices himself.

[00:22:17] Speaker 04:
It sounds like you're identifying substantial evidence to support reasonable expectation of success, the kind of evidence that Judge Stark was asking about.

[00:22:26] Speaker 03:
Am I misunderstanding something?

[00:22:28] Speaker 03:
Yeah.

[00:22:29] Speaker 03:
misunderstood the question slightly.

[00:22:31] Speaker 04:
I think the question, as I understood it, was whether we should be looking for substantial evidence to support a reasonable expectation of success here.

[00:22:40] Speaker 04:
And as the appellant seems to be arguing reasonable expectation of success, I don't understand why the answer is not yes.

[00:22:47] Speaker 03:
The answer is yes.

[00:22:50] Speaker 03:
Perhaps I got to it in a roundabout way.

[00:22:52] Speaker 03:
The answer is yes.

[00:22:59] Speaker 03:
As I said before, this is a mechanical device.

[00:23:02] Speaker 03:
It doesn't require precision.

[00:23:03] Speaker 03:
It doesn't require a particular type of treatment.

[00:23:06] Speaker 03:
And there's something also that goes throughout the gray brief.

[00:23:10] Speaker 03:
There's this false narrative that there's a heavyweight linear accelerator that would not motivate the combination of the two.

[00:23:18] Speaker 03:
But even their own experts admitted that lightweight linear accelerators existed at the time.

[00:23:24] Speaker 03:
So the board specifically found

[00:23:27] Speaker 03:
that the evidence below that was a very thorough record supported that there was lightweight linear accelerators.

[00:23:35] Speaker 03:
So from our perspective, they continued this false narrative that there was this heavy weight that would dissuade the motivation to combine.

[00:23:49] Speaker 00:
Do you ask us to read the board's finding that a person's skill in the art would not have been dissuaded from this combination?

[00:23:58] Speaker 00:
as at least implicitly a finding about reasonable expectation of success?

[00:24:02] Speaker 03:
Yes, Your Honor, because the board very carefully determined petitioners' arguments, plaintiff owners' arguments, and one of their arguments was the heavyweight would dissuade.

[00:24:14] Speaker 03:
And that was debunked, that there was a heavyweight linear accelerator that was all that was available at that time in 2000.

[00:24:21] Speaker 03:
So I look at that as another thing in terms of the grand factors of talking about the indicia of non-obviousness and looking at dissuading as something that they found was not persuasive.

[00:24:32] Speaker 03:
And they did not agree with or find credible.

[00:24:36] Speaker 00:
So why does dissuading not just go to motivation to combine?

[00:24:40] Speaker 00:
How does it also go to reasonable expectation of success?

[00:24:44] Speaker 03:
Well, it goes to the reasonable expectation of success in the sense that I know that Your Honors said earlier that

[00:24:51] Speaker 03:
the motivation to combine reasonable expectations of success are kind of argued together here.

[00:24:57] Speaker 03:
But I would say that in addition to that, in terms of the dissuading, there's also, as I mentioned before, Mr. Asmarov's declaration where he is one of skill in the art that makes these types of devices.

[00:25:09] Speaker 03:
And within the person of skill in the art section, he talked about how it would be easy to do this, simple, very straightforward.

[00:25:17] Speaker 03:
So that very much debunks anything where they say you would be

[00:25:21] Speaker 03:
weighted from doing that.

[00:25:22] Speaker 03:
And although it's in the person of skill in the arts section, it's still talking about things that are really going to reason by expectation of success, of saying it would be simple, easy, straightforward.

[00:25:33] Speaker 03:
Someone within the mechanical arts would know how to do it.

[00:25:37] Speaker 01:
Shouldn't the board have made that statement?

[00:25:39] Speaker 03:
Say that again, Your Honor?

[00:25:41] Speaker 01:
Shouldn't the board have made that statement that you're making now?

[00:25:44] Speaker 03:
Well, ideally, that would have been

[00:25:49] Speaker 03:
Wonderful, however, it was implied as opposed to explicit, but they did cite in their decision, like I said, that was very clear and well reasoned.

[00:25:59] Speaker 03:
They cited to Mr. Asmarov's declaration where he went through all of this and it happened to be in the person of skill in the arts section, but they did cite to it.

[00:26:08] Speaker 03:
So that is in terms of it being implicit, which goes along the lines of the Merck case.

[00:26:15] Speaker 01:
Does the board have an affirmative obligation

[00:26:18] Speaker 01:
to make a distinct, clear, concise statement on reasonable expectation?

[00:26:25] Speaker 03:
No, Your Honor, not according to the Merck case, and even with KSR.

[00:26:28] Speaker 01:
Did you get away with not saying anything?

[00:26:31] Speaker 03:
When you say not saying anything.

[00:26:33] Speaker 01:
Right.

[00:26:34] Speaker 01:
Making no statement at all?

[00:26:36] Speaker 03:
Well, under Merck, there was no statement at all, and they found that it was sufficient.

[00:26:41] Speaker 03:
And as I said before, that was within the pharmaceutical arts as opposed to the more predictable mechanical arts.

[00:26:47] Speaker 03:
So the Merck decision, which is obviously for us in terms of the precedent, says that it's not required to have an explicit statement in terms of reasonable expectation of success.

[00:26:58] Speaker 04:
But the argument of reasonable expectation of success must be addressed, even though the opinion doesn't use the magic words reasonable expectation of success, right?

[00:27:08] Speaker 04:
Correct.

[00:27:09] Speaker 03:
Yes, the words don't have to be there, but at least the analysis was there.

[00:27:13] Speaker 03:
And as I said before, there was robust analysis looking at both sides and also weighing the credibility of the different experts in terms of their declarations as well as their testimony.

[00:27:23] Speaker 03:
And that was cited to by the board and that laid out by a person of skill in the art that this would be easy, simple, straightforward to do.

[00:27:35] Speaker 03:
I'll welcome any additional questions.

[00:27:38] Speaker 03:
Thank you very much.

[00:27:40] Speaker 03:
I yield the remainder of my time.

[00:27:47] Speaker 01:
Council, we're going to restore you to three minutes.

[00:27:50] Speaker 02:
Thank you, your honor.

[00:27:53] Speaker 02:
One thing that my colleague said was that these claims are not about treatment.

[00:27:59] Speaker 02:
However, the whole combination is modifying Grady, which is an x-ray imaging device,

[00:28:05] Speaker 02:
to change this relatively safe x-ray tube to an extraordinarily dangerous ionizing radiation tube.

[00:28:13] Speaker 02:
The only reason anybody would ever modify a simple, easy, not dangerous device to add an extraordinarily dangerous device is if it is all about treatment.

[00:28:23] Speaker 01:
The other side says that that was debunked.

[00:28:28] Speaker 01:
The weight, the problem of the weight, that the combination would result in a weight problem.

[00:28:34] Speaker 02:
Your Honor, the board did address whether or not there was a extraordinarily heavy linac, as was mentioned in the specification, and that there were lighter weight linacs in the art at the time.

[00:28:45] Speaker 02:
But there's no evidence about what the difference is between an x-ray tube's weight and a lightweight linac's weight.

[00:28:52] Speaker 01:
There's still very difference.

[00:28:53] Speaker 01:
Is the weight, is your argument that that renders a combination inoperable?

[00:29:01] Speaker 02:
Your Honor, the argument is that a person of ordinary skill in the art looking at Grady and thinking about combining it with a line act would not have an expectation that it would work for treatment.

[00:29:14] Speaker 02:
Even their expert, Dr. Asmall.

[00:29:16] Speaker 04:
What about the argument that under KSR, a person of ordinary skill in the art is not an automaton?

[00:29:21] Speaker 04:
And the board talked about that as well and said, you know, there could be other additional modifications made to the reference in order to accommodate the heavier weight of the line act.

[00:29:31] Speaker 04:
Why isn't that addressing your argument about reasonable expectation here?

[00:29:38] Speaker 02:
Your Honor, there was no evidence below that a person of ordinary skill in the art would have had any other thoughts about that this proposed combination could work for treatment.

[00:29:48] Speaker 02:
All we know is that mechanical engineers are not able to opine about treatment and medical physicists say this would not have worked.

[00:29:57] Speaker 02:
Treatment is not predictable.

[00:29:58] Speaker 02:
There's no evidence of record that it's predictable and that this would have worked.

[00:30:07] Speaker 02:
Council brought up their expert, Dr. Asimov, and said that he said it was simple.

[00:30:12] Speaker 02:
But if you look at his declaration, he didn't say it was simple.

[00:30:15] Speaker 02:
He said he'd have to consult doctors, medical physicists about treatment, and that would be easy, to talk to somebody else.

[00:30:22] Speaker 02:
But what is not in the record is any doctor or medical physicist saying that this, at the time, a person of ordinary skill in the art would have expected this to work.

[00:30:32] Speaker 02:
Because there's no expectation.

[00:30:34] Speaker 02:
The only evidence is that it wouldn't have worked, that the expectation is that it would not have worked.

[00:30:43] Speaker 02:
Your Honor, you asked about Merck, and a lacrosse attack was brought up that the board is not required to provide perfect explanations in there.

[00:30:55] Speaker 02:
Oh, I see.

[00:30:55] Speaker 02:
I'm out of time.

[00:30:56] Speaker 01:
You can finish your thought.

[00:30:58] Speaker 02:
Thank you, Your Honor.

[00:30:59] Speaker 02:
The board is not required to provide perfect explanations as to each element, but here it is a disputed issue that was raised in patent owner response.

[00:31:09] Speaker 02:
The petitioner had the burden.

[00:31:11] Speaker 02:
It's a key issue, and it was required to be addressed in the final written decision.

[00:31:17] Speaker 02:
And respectfully, the appellant requests this court vacate in remand or reverse.

[00:31:24] Speaker 01:
Thank you, Your Honor.