[00:00:00] Speaker 00:
The first case is Best Medical International 21-2084.

[00:00:05] Speaker 00:
Mr. Coyne, when you're ready.

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

[00:00:23] Speaker 00:
The main flaw, I think, in this particular Interparties Review petition was that the panel of the Patent Trial and Appeal Board determined that the level of ordinary skill and art required two years of programming experience.

[00:00:41] Speaker 00:
That was a reversal from what the board had indicated in its institution decision, which didn't include that requirement with the personnel of ordinary skill and art.

[00:00:50] Speaker 01:
Council.

[00:00:52] Speaker 01:
That's a factual question, right?

[00:00:55] Speaker 01:
The level of person of ordinary scale in the yard and the determination of that is a factual inquiry, right?

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

[00:01:03] Speaker 01:
And I was thinking about this issue a lot.

[00:01:06] Speaker 01:
And I was thinking, what sort of factors do courts take into account when they're trying to determine what the person of ordinary scale in the yard is?

[00:01:15] Speaker 01:
And I found some cases on it that list some factors.

[00:01:18] Speaker 01:
They include things like, what is the skill level of the inventor?

[00:01:21] Speaker 01:
What is the skill level that you see displayed in the prior art?

[00:01:27] Speaker 01:
There's many factors, actually, but I don't see those necessarily discussed in the briefs, nor do I see any evidence submitted by your client on those factors.

[00:01:37] Speaker 01:
So I'm wondering what evidence did you rely on to show what the level of ordinary skill in the art is?

[00:01:43] Speaker 00:
Well, I mean, that testimony came from the number one from what's disclosed in the patents themselves, excuse me, the patent itself.

[00:01:53] Speaker 00:
I said patent just because the next appeal also deals with kind of the same issue.

[00:01:57] Speaker 00:
But in the patent itself, in terms of what it discloses, what it's talking about, in terms of what the technology issue is.

[00:02:06] Speaker 00:
So it's a method of determining optimization.

[00:02:09] Speaker 00:
It's a method of determining kilometer angles.

[00:02:13] Speaker 01:
And we are to look at the claims also when we look at what the invention is directed to, right?

[00:02:19] Speaker 00:
That's correct.

[00:02:20] Speaker 00:
So that provides one part of the analysis in terms of what a person with a skill in the art need to know.

[00:02:28] Speaker 01:
And about things like the other factors are sophistication of the technology, education level of active workers in the field, types of problems encountered in the art,

[00:02:39] Speaker 01:
educational level of the inventor, rapidity with which innovations are made.

[00:02:44] Speaker 01:
Those are some of the factors that our President said should be considered.

[00:02:47] Speaker 01:
Was any evidence introduced on those factors?

[00:02:50] Speaker 00:
Yes, Your Honor, that was going to get to you.

[00:02:52] Speaker 00:
Our expert witness, Mr. Chase, did introduce some of that evidence in terms of

[00:02:59] Speaker 00:
In terms of what in his under his definition of what a personal worse than that would be We talk about the education level of the event or types of problems encountered those kinds of things Where did he talk about it?

[00:03:13] Speaker 00:
I was specific site to his to his declaration his his testimony was based on

[00:03:21] Speaker 00:
from his perspective of a person born is going to argue a clinical experience who actually use these systems.

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And his testimony was that

[00:03:31] Speaker 00:
The vast majority of people who worked in actually implementing these optimization programs, that they would have a master's or a PhD in radiation or nuclear medicine or something along that line, but wouldn't necessarily have the experience of a

[00:03:56] Speaker 01:
With all due respect, it sounds a little conclusory, like this is my view.

[00:04:01] Speaker 01:
But is there any evidence or even input on any of these factors that I mentioned, other factors other than the specification and the claims?

[00:04:13] Speaker 00:
I think generally, no.

[00:04:15] Speaker 00:
Generally, it's the testimony of the experts, that in terms of what someone working in this field would be doing.

[00:04:23] Speaker 00:
There's the patent itself in terms of what the claims say and what the specification says in terms of what the level of skill the inventors was.

[00:04:30] Speaker 00:
I don't think there was evidence necessarily presented on that letter board.

[00:04:35] Speaker 04:
Mr. Klein, excuse me.

[00:04:39] Speaker ?:
I know you're focusing on the computer programming part of this, but the board considered Dr. Chase's testimony and rejected it for

[00:04:51] Speaker ?:
a number of reasons, independent of his lack of computer coding experience, most clearly because the board took judicial notice, as I understand it, of Dr. Chase's statement that he was not an expert in the design of treatment planning systems.

[00:05:14] Speaker ?:
So I'm...

[00:05:17] Speaker 04:
I mean, even if we give your argument about computer programming some credit and some merit, nonetheless, it seems to me that the board didn't completely discount his testimony and simply weighted in light of what was clearly the extent of his expertise.

[00:05:40] Speaker 04:
What's wrong with that?

[00:05:42] Speaker 00:
Well, Your Honor, you're correct.

[00:05:44] Speaker 00:
The PTAB did not completely discount this testimony.

[00:05:48] Speaker 00:
They actually considered him to be an expert who's qualified to talk about these references that were part of the analysis.

[00:05:59] Speaker 00:
I think in many instances they did rely on him, they did cite him in the opinion, but it was in particular instances and mainly in terms of the motivation to mine the references and then also in a reasonable expectation of success where that is where basically

[00:06:18] Speaker 00:
The PTAB disregarded his testimony because of which he indicated that he said he was not an expert in design and basically manufacturing the systems.

[00:06:32] Speaker 00:
His expertise was in using them, putting them together.

[00:06:35] Speaker 00:
But the board also found that he has a master's degree in physics and nuclear medicine.

[00:06:41] Speaker 00:
He did hundreds of these procedures over time.

[00:06:46] Speaker 00:
So he was well aware of what goes into doing these procedures.

[00:06:52] Speaker 00:
In that field, he keeps up on papers and the technology that goes on in that field.

[00:07:00] Speaker 00:
And so his perspective was that,

[00:07:02] Speaker 00:
He can understand what these references, so the four references that make up the obvious argument for each of the claims, the combination.

[00:07:15] Speaker 00:
He understood, and I don't think there's any dispute, that he could understand those references.

[00:07:22] Speaker 00:
He understood what the combination alleged to be for obvious was.

[00:07:28] Speaker 00:
And it was his testimony that, you know,

[00:07:32] Speaker 00:
from a mathematical standpoint, that one, that he understood what the combinations were, but that no one would, one skill in the art, who knew these references, was familiar with the pathology, would not have actually combined these references together.

[00:07:52] Speaker 04:
But the board considered all of the references and they considered the testimony of the other expert,

[00:07:59] Speaker 04:
weighed and balanced all of that and came up with the conclusion that there was, in fact, a reasonable expectation of success.

[00:08:12] Speaker ?:
Substantial evidence is the standard of review.

[00:08:16] Speaker 04:
And that's, I think, a pretty difficult error for you.

[00:08:23] Speaker 00:
I understand, Your Honor.

[00:08:24] Speaker 00:
And I agree that the PCAP did, in fact,

[00:08:28] Speaker 00:
you know, look at the evidence.

[00:08:30] Speaker 00:
But I think if you look at just the face of some of the evidence that was put together, and again, this was four different references, really in effect to deal with one particular clause of the claims.

[00:08:44] Speaker 00:
And that was to enhance delivery efficiency by reducing a number of radiation beam segments and reducing a number of radiation beam monitoring units.

[00:08:54] Speaker 00:
And the problem that the PTAB has in terms of the arguments, in our view, is that the references cited don't actually disclose delivery efficiency or reducing it in terms of radiation beam segments and the number of radiation beam monitored units.

[00:09:15] Speaker 00:
So for example, AUTO, which is one of the references, it talks about

[00:09:24] Speaker 00:
Doubling the number of being segment store optimization So in our view that actually, you know teaches away from delivery efficiency So combining that with the other references to try to come up with a system that that enhances delivery efficiency Just wouldn't be you know doesn't make doesn't make sense in terms of what auto itself discloses the Chang reference It discloses the delivery efficiency in terms of

[00:09:53] Speaker 00:
not being rotated between segments in a step-and-shoot delivery system.

[00:09:59] Speaker 00:
So basically, it's a totally different system than the computer-implemented method of determining kilometer angle that is part of the claim one and the other claims at issue.

[00:10:11] Speaker 00:
Mohan, which is one of the other references in this group of four references that are put together to try to obviate the patent claims, it again, in our view, teaches a way from delivery efficiency enhancing it.

[00:10:32] Speaker 00:
It just includes a quote, and this is an A590, where orientations with minimized fluctuations is possible but not trivial.

[00:10:42] Speaker 00:
In our view, that basically says that it's not a trivial problem to combine these things and minimizing fluctuations was kind of a stand-in for delivery efficiency in terms of Mohand, at least according to the petitioners.

[00:10:59] Speaker 00:
That statement by Mohand.

[00:11:01] Speaker 00:
And then the fact that Mohand itself doesn't actually refer to segments.

[00:11:06] Speaker 00:
And though it makes no mention of delivery efficiency,

[00:11:10] Speaker 00:
But it's focused on reducing leakage of unwanted tissue by minimizing fluctuations.

[00:11:15] Speaker 01:
And that, yes?

[00:11:17] Speaker 01:
I don't recall teaching away being a specific ground that was argued in the brief.

[00:11:21] Speaker 01:
I don't think.

[00:11:22] Speaker 01:
Maybe I've got the two appeals you have confused.

[00:11:25] Speaker 01:
But is it in there?

[00:11:26] Speaker 01:
Where would I find that?

[00:11:28] Speaker 00:
I believe it's in the reply brief.

[00:11:34] Speaker 00:
And that would be.

[00:11:41] Speaker 01:
But is it in your opening brief?

[00:11:44] Speaker 00:
I don't know if the words, teaching away, was in the opening brief.

[00:11:47] Speaker 00:
But the argument was that argument, basically, that these references do not disclose what is in, it does not disclose what is claimed in the claims.

[00:12:01] Speaker 00:
And therefore, it doesn't disclose

[00:12:07] Speaker 00:
And since it discloses something that's not in the claims, it doesn't disclose what's in the claims.

[00:12:11] Speaker 00:
It doesn't provide the teachings necessary to combine these references as they allegedly combined.

[00:12:22] Speaker 00:
Does your coin your intent to rebuttal now?

[00:12:24] Speaker 00:
OK.

[00:12:24] Speaker 00:
Thank you, officer.

[00:12:24] Speaker 00:
I'll reserve the time for rebuttal.

[00:12:57] Speaker 02:
Good morning.

[00:12:59] Speaker 04:
Ms.

[00:13:00] Speaker 04:
Frazier, excuse me.

[00:13:01] Speaker 04:
Before you begin, let me ask the courtroom deputy to please turn off the volume of the judge's microphone, if that's possible, please.

[00:13:12] Speaker ?:
Sorry for that.

[00:13:22] Speaker 00:
When you're ready.

[00:13:23] Speaker 02:
Thank you.

[00:13:25] Speaker 02:
So, Your Honors, let me, I guess, first just remind us all that the patented invention here is about a system and a method for radiation therapy treatment planning, which is a very sophisticated field.

[00:13:44] Speaker 02:
And it's about optimizing the rotation of a collimator angle, optimization with a cost function,

[00:13:52] Speaker 02:
And a cost function that has two parts one optimizing conformality the other optimizing efficiency How does that support review that the board was correct in its definition of the POSA?

[00:14:10] Speaker 02:
Well, that's a very good question the fact that the field is sophisticated is one of the factors that are considered and

[00:14:18] Speaker 02:
for defining the level of the post-heteroposa?

[00:14:22] Speaker 01:
And what exactly does that have to do with computer skill and reduce?

[00:14:28] Speaker 01:
One could argue.

[00:14:29] Speaker 01:
I think they take the position that computer programming is just reducing invention practice, and that a person with ordinary skill does not have to have that computer programming knowledge.

[00:14:39] Speaker 02:
Well, I think that the patent, first of all, demonstrates otherwise.

[00:14:42] Speaker 02:
And that's nicely reflected in the PTAS decision.

[00:14:46] Speaker 02:
And they cite numerous points where the patent explains that optimization is a computer-implemented method.

[00:14:55] Speaker 02:
fundamentally can't be done in your head.

[00:14:58] Speaker 02:
And that it's also something that involves sophisticated systems, computerized systems.

[00:15:04] Speaker 02:
The claims also specify it's computer implemented, and it includes a computer for implementing them.

[00:15:14] Speaker 02:
On the issue of the POSA, though, I would also point out that there is additional evidence in the record, and that was discussed in the response brief, and that includes

[00:15:25] Speaker 02:
the prior art references, which also indicate some of the points I just made, and also the experts.

[00:15:35] Speaker 02:
Their CVs are included in the record, and you can see just how sophisticated they are from those CVs, at the educational level, quite high.

[00:15:51] Speaker 02:
I will address then, I guess, a couple of other points that were made.

[00:16:07] Speaker 02:
Mr. Coyne indicated that best medicals expert understood the prior art.

[00:16:16] Speaker 02:
But I'd suggest that understanding the prior art is very different than understanding the field and having the level of skill to both implement it and to understand what that level of creativity is of the ordinary person of skill.

[00:16:31] Speaker 02:
And that level of ordinary creativity is very important.

[00:16:34] Speaker 02:
Under KSR, we've been instructed to consider

[00:16:41] Speaker 02:
the prior art through the lens of the POSA, and to understand how the POSA would understand those disclosures.

[00:16:50] Speaker 02:
The fact that one of these references does not use the words delivery efficiency is simply neither here nor there.

[00:16:57] Speaker 02:
Because when you look at that reference through the lens of a POSA, a highly educated person that understands all of these factors in radiation therapy, it's very clear that, in fact, it is directed to efficiency.

[00:17:11] Speaker 02:
It's about reducing the time it takes to deliver a treatment, specific treatment.

[00:17:16] Speaker 02:
That's efficiency.

[00:17:18] Speaker 02:
Again, this is explained, I think, in the brief, nicely.

[00:17:26] Speaker 02:
On the point of the disclosure of the references, again, the references need to be considered together.

[00:17:42] Speaker 02:
And the board here carefully, carefully explained what each reference explains, why it's important, and how it fits together.

[00:17:53] Speaker 02:
And I'm happy to reiterate that, but I think it's on the record.

[00:17:59] Speaker 02:
Each of these references, though, is about optimizing collimator angles.

[00:18:05] Speaker 02:
They're all directed to the very fundamental problem and issue here.

[00:18:10] Speaker 02:
And each of them teaches an aspect that nicely complements another.

[00:18:16] Speaker 02:
They fit together.

[00:18:18] Speaker 02:
And if you look at them together, they do disclose all of the elements, all of the limitations of the claims.

[00:18:27] Speaker 02:
The fact that one reference may have actually implemented an optimization routine in a step and shoot

[00:18:38] Speaker 02:
planning.

[00:18:39] Speaker 02:
Is that the auto reference?

[00:18:43] Speaker 02:
So the auto reference actually describes both.

[00:18:48] Speaker 02:
The Chang reference also describes both, both being step and shoot and dynamic.

[00:18:53] Speaker 02:
And the fundamental difference is whether or not you're leaving the beam on while you're changing the window of your collimator.

[00:19:01] Speaker 02:
And it's much simpler.

[00:19:02] Speaker 02:
Think about it.

[00:19:03] Speaker 02:
If you turn the beam off,

[00:19:06] Speaker 02:
set your new collimator angle, shoot radiation, turn the beam off, get your other collimator angle, shoot the radiation.

[00:19:14] Speaker 02:
But you don't have to.

[00:19:15] Speaker 02:
You can leave the beam on, and you just have to be a little more cognizant of the transitions between those windows.

[00:19:22] Speaker 02:
And so the dynamic process is really just a more challenging, I think, process.

[00:19:30] Speaker 02:
But the expert testimony here explains

[00:19:35] Speaker 02:
that one of skill would understand the differences, and the same principles apply.

[00:19:42] Speaker 02:
They're both about multi-leaf collimators, rotating them to form a beam that treats radiation.

[00:19:48] Speaker 02:
And so that's really a distinction that's not relevant for the problems here.

[00:19:59] Speaker 02:
The teaching away point.

[00:20:01] Speaker 02:
possible but not trivial?

[00:20:03] Speaker 02:
Well, you can read it.

[00:20:04] Speaker 02:
I think that the interpretation of a reference, though, again, needs to be viewed through the lens of a posa.

[00:20:12] Speaker 02:
And importantly, Mohan actually did it.

[00:20:16] Speaker 02:
Mohan didn't just say it's possible but not trivial.

[00:20:19] Speaker 02:
Mohan actually did it.

[00:20:20] Speaker 02:
That's not a disclosure.

[00:20:22] Speaker 02:
I'm not sure what is.

[00:20:23] Speaker 02:
The fact that it may be difficult, especially in a sophisticated field like this, is not a teaching away.

[00:20:30] Speaker 02:
There's nothing in the other references to suggest that you could not do it.

[00:20:36] Speaker 02:
There's no discrediting of that.

[00:20:38] Speaker 02:
So there is no teaching away here.

[00:20:47] Speaker 02:
And if there are no questions, one other point I wanted to raise, which relates to enablement here.

[00:20:55] Speaker 02:
In the reply brief, it was suggested that the level of skill for enablement is different than the level of skill for obviousness.

[00:21:05] Speaker 02:
I do not believe that is true.

[00:21:06] Speaker 02:
There is no citation to suggest that is true, not aware of any case law to that effect.

[00:21:13] Speaker 02:
The test is certainly different.

[00:21:16] Speaker 02:
The statute is certainly different.

[00:21:18] Speaker 02:
And the language that's used in those two statutes is different.

[00:21:21] Speaker 02:
So in 103, there's a reference to ordinary skill in the art.

[00:21:27] Speaker 02:
And in section 112, there's a reference to a person of skill.

[00:21:33] Speaker 02:
And we can talk about whether or not 103 refers to the hypothetical person, and 112 is a real person.

[00:21:40] Speaker 02:
But the case law actually demonstrates that the level of skill, in fact,

[00:21:45] Speaker 02:
Just the skill.

[00:21:47] Speaker 02:
What is the skill?

[00:21:49] Speaker 02:
Is the skill computer programming or is the skill not computer programming?

[00:21:54] Speaker 02:
That's the same question for enablement and obviousness.

[00:21:59] Speaker 02:
And you can actually see that in... Yes, you can actually see that demonstrated in the...

[00:22:14] Speaker 02:
Oops, let me find it.

[00:22:30] Speaker 01:
Well, it wasn't the reference here.

[00:22:40] Speaker 02:
In any event, one of the cases that is cited relating to enablement discusses the level of skill and refers to ordinary skill with respect to an enablement assessment.

[00:22:54] Speaker 02:
So there is really no difference.

[00:22:57] Speaker 02:
The reason that's important is because there's a little bit of a squeeze argument here, as the Europeans would say, if the patent

[00:23:10] Speaker 02:
is to be enabled, and it does not describe anything about computer programming or optimization methods and how you do that.

[00:23:20] Speaker 02:
If it's to be enabled, then that has to be within the skill of the ordinary, of the person of ordinary skill.

[00:23:33] Speaker 02:
And if it's not, then it's not enabled.

[00:23:38] Speaker 01:
And as you said before, you don't think, you're not aware of any cases in which our court has given a different definition for a person who has a skill in the art for different statutory provisions.

[00:23:49] Speaker 01:
Correct.

[00:23:50] Speaker 01:
So different tests.

[00:23:51] Speaker 02:
So the test is whether or not one of skill can actually practice the invention without undoing experimentation.

[00:23:58] Speaker 02:
That's the question of whether or not a person of skill can read the patent and understand how to do it.

[00:24:03] Speaker 02:
That's different than the question of whether or not the person of ordinary skill looking at the prior art, given that person's creativity and knowledge, would come to see the invention.

[00:24:16] Speaker 02:
And it's important to cap that level because, of course, that level affects, I think, the determination of obviousness.

[00:24:29] Speaker 02:
If you have nothing further, I think we have your argument.

[00:24:33] Speaker ?:
Thank you.

[00:24:37] Speaker 02:
I guess I forgot to say the most important thing, if I may, that we do believe there's substantial evidence to support the evidentiary findings here and that the board provided a very reasoned explanation as it was bound to do.

[00:25:27] Speaker 00:
Just a bottle.

[00:25:30] Speaker 00:
So it's not just delivery efficiency.

[00:25:32] Speaker 00:
It's a specific claim with delivery efficiency.

[00:25:35] Speaker 00:
So even if the references may somehow be taken to deal with delivery efficiency, what the claim language requires is enhanced delivery efficiency by reducing a number of radiation beam segments, reducing a number of radiation beam monitor units.

[00:25:51] Speaker 00:
And that's what the references, Otto Chang, Mohan, that's what they lack.

[00:25:55] Speaker 00:
They don't reduce efficiency or, excuse me, enhance delivery efficiency by reducing radiation beam signals and reducing the radiation beam monitoring.

[00:26:07] Speaker 00:
That is the issue in terms of why those references don't really interfere or obviate the claims.

[00:26:16] Speaker 00:
And then in terms of the enablement argument, obviously that was one that was not before the board.

[00:26:25] Speaker 00:
It wasn't part of the briefing before the board.

[00:26:28] Speaker 00:
It's not an issue that really should be taken up or is allowed to be taken up in an enterprise group proceeding.

[00:26:35] Speaker 00:
And I understand it's in response to the argument

[00:26:38] Speaker 00:
that the appellant has made, the best medical has made, that you don't need to have programming experience to understand these references.

[00:26:50] Speaker 00:
In regard to that, I mean there's nothing in the claims, there's nothing in the patent that talks about programming, coding, or the like.

[00:26:58] Speaker 00:
That's because the issue here is not programmed.

[00:27:03] Speaker 00:
The intervention is not programmed.

[00:27:04] Speaker 00:
We're not doing special purpose computer with kind of special programming.

[00:27:08] Speaker 00:
What we have here is we have

[00:27:11] Speaker 00:
mathematical equations, and that's what's disclosed in the prior art.

[00:27:14] Speaker 01:
What about the fact that the claims refer to computer implemented in several limitations?

[00:27:20] Speaker 01:
Your view, I guess, is that that doesn't require coding.

[00:27:24] Speaker 00:
Yes, our view is it doesn't require coding because with the essence of the claim is even though it's computer implemented, it's the mathematics behind it.

[00:27:32] Speaker 00:
It's the equations being used, how a cost functions are being

[00:27:38] Speaker 00:
are being put together in the combination of those cost functions and how the mathematics works.

[00:27:43] Speaker 00:
So the focus on the claim isn't on programming, it's on the mathematics and the physics of the cost functions and how you enhance the efficiency by reducing beam segments, reducing number of radiation beam monitoring.

[00:27:56] Speaker 00:
That doesn't take programming experience.

[00:27:59] Speaker 00:
And that's why we believe that

[00:28:01] Speaker 00:
that discounting Mr. Chase's testimony because he either because he did not program experience or because he didn't have commercial experience, which in the commercial experience wasn't part of the personal or skill AR definition, the board shouldn't have taken that position.

[00:28:18] Speaker 00:
So thank you, Your Honor.

[00:28:20] Speaker 00:
Thank you.

[00:28:21] Speaker 00:
The case is submitted.