[00:00:00] Speaker 04:
Give me the mic.

[00:00:59] Speaker 01:
The next case is Number 17-1389, a logic incorporated against Smith and Nephew, Incorporated.

[00:01:08] Speaker 01:
Mr. Wheeler.

[00:01:08] Speaker 03:
Thank you, may it please the Court.

[00:01:10] Speaker 03:
This is not a case about substantial evidence.

[00:01:14] Speaker 03:
This is rather about the proper application of the law of written description.

[00:01:18] Speaker 03:
The question is, has possession been shown of the limitation in question within the four corners of the patent?

[00:01:27] Speaker 00:
whether the specification reasonably conveys that the inventor had possession of the invention within the four corners of the document.

[00:01:35] Speaker 03:
That's exactly right, Your Honor.

[00:01:36] Speaker 03:
And so let's look within the four corners of this specification.

[00:01:41] Speaker 03:
There is no allegation anywhere, no suggestion, no hint that the text of the specification tells us how or where the light-guided issue

[00:01:51] Speaker 03:
is placed, and this isn't the game of gotcha, Your Honor.

[00:01:53] Speaker 00:
Can I ask you a question?

[00:01:54] Speaker 03:
Yes, Your Honor.

[00:01:55] Speaker 00:
What is the difference between a light guide and a fiber optic?

[00:02:00] Speaker 03:
A light guide is a genus of the fiber optic species.

[00:02:04] Speaker 00:
What other light guides are there besides fiber optics?

[00:02:08] Speaker 03:
There are solid glass light guides, there are LED light guides, or any number of other kinds of ways that physicians look inside the human body.

[00:02:19] Speaker 00:
Do all of these endoscopes have to have a light source so that you can see inside the body?

[00:02:28] Speaker 03:
In one way or another, yes, Your Honor.

[00:02:31] Speaker 03:
Some are separate devices.

[00:02:32] Speaker 03:
Sometimes you have a physician's assistant holding it.

[00:02:35] Speaker 03:
Sometimes it's fixed within the device.

[00:02:38] Speaker 03:
Sometimes it's removable within the device because you want different kinds.

[00:02:41] Speaker 03:
You want very bright.

[00:02:42] Speaker 03:
You want broad.

[00:02:42] Speaker 03:
I mean, think of a flashlight where some are very broad but not as strong and others

[00:02:47] Speaker 03:
So you have removable, there's all different species of lycoids.

[00:02:50] Speaker 03:
But yes, I don't think you'd want a doctor performing a procedure in the body without some external form of light.

[00:02:57] Speaker 03:
But here, let's see.

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

[00:03:01] Speaker 03:
Here the question is, and remember, the language we're talking about, as I was about to say, this isn't the game of gotcha, Your Honor.

[00:03:08] Speaker 03:
Where, like, posing where we all know that prescription information is on a piece of paper.

[00:03:16] Speaker 03:
This limitation was added specifically to overcome prior art.

[00:03:21] Speaker 03:
This limitation was added to overcome prior art that had removable light guides.

[00:03:25] Speaker 03:
And so not only do they say our light guide is permanent, and that's different from the prior art, they also say it's in the first channel, and that's different than the prior art.

[00:03:33] Speaker 00:
Isn't the first channel, though, the light channel?

[00:03:38] Speaker 03:
It's called the viewing channel in the patent.

[00:03:40] Speaker 03:
And as the examiner noted, every description of the viewing channel and every description and every picture of the viewing channel

[00:03:46] Speaker 03:
only shows a lens.

[00:03:48] Speaker 03:
It doesn't show light coming in, not light going out.

[00:03:51] Speaker 00:
What about the one picture that has the lines drawn that suggests the light source?

[00:03:57] Speaker 03:
Your Honor, the only lines I'm aware of are in figure three.

[00:04:05] Speaker 03:
And if you look at figure three,

[00:04:10] Speaker 03:
The light is coming in.

[00:04:12] Speaker 03:
That's a camera.

[00:04:13] Speaker 03:
So the light is, that's a lens.

[00:04:14] Speaker 03:
And 13 is described as the lens.

[00:04:17] Speaker 03:
So that's saying the light is coming in from the outside.

[00:04:20] Speaker 03:
It's another way of saying that's taking pictures.

[00:04:23] Speaker 03:
So that's not describing light going out.

[00:04:26] Speaker 03:
That's describing light coming in.

[00:04:27] Speaker 03:
And that's well-described in the patent.

[00:04:29] Speaker 00:
There's no... Where would it be the connection for the light source in that figure three?

[00:04:32] Speaker 00:
Is it identified as being element eight?

[00:04:35] Speaker 03:
Correct, Your Honor.

[00:04:35] Speaker 03:
Okay.

[00:04:36] Speaker 00:
So it's your position that the light could be somewhere other than the viewing channel six.

[00:04:41] Speaker 03:
In fact, it's pretty clear that it's not Viewing Channel 6.

[00:04:44] Speaker 03:
If we look at Figure 1a, we see, if you look at Figure 1a of the patent, we see an empty unmarked circle that is the viewing channel.

[00:04:53] Speaker 03:
So that top of the, you kind of look at it as a Figure 8.

[00:04:57] Speaker 03:
That is empty, Your Honor.

[00:04:58] Speaker 03:
And that is the lens.

[00:05:01] Speaker 03:
That's although it's the working channel.

[00:05:04] Speaker 00:
I'm sorry.

[00:05:04] Speaker 03:
That's where you put the snipper, whatever you're going to put in there.

[00:05:08] Speaker 03:
So in this case, you're talking about

[00:05:09] Speaker 03:
the device for removing tissue.

[00:05:12] Speaker 03:
But with endoscopes, generally, you put anything in there.

[00:05:14] Speaker 03:
You can put a loop resection device.

[00:05:17] Speaker 03:
You can put RF energy device.

[00:05:19] Speaker 03:
You can put scissors, effectively.

[00:05:21] Speaker 03:
That's called the working channel.

[00:05:22] Speaker 00:
Would it make sense to put a light source in the working channel?

[00:05:27] Speaker 03:
Sure.

[00:05:27] Speaker 03:
There's no reason.

[00:05:28] Speaker 00:
Why?

[00:05:28] Speaker 00:
But then you couldn't work, right?

[00:05:30] Speaker 03:
Well, in fact, Your Honor, there are, and for example, our expert, Mr. Walbring, talked about this at A2659.

[00:05:37] Speaker 03:
Let's suppose you want to do two different things, one requiring a wide source of light, another very powerful narrow source of light.

[00:05:44] Speaker 03:
You could actually put the light source and connect it to the working device.

[00:05:49] Speaker 03:
So rather than having the endoscope being the source of light, you could have in the one case the lupus sector have the light source.

[00:05:55] Speaker 03:
And then so you want to scrape it first and then you want to go in more finely and put scissors or whatever.

[00:06:01] Speaker 03:
I'm just picking things out of the prior art.

[00:06:04] Speaker 03:
You can have the light source attached to the working device

[00:06:07] Speaker 03:
And that's, in fact, what the prior art does.

[00:06:10] Speaker 03:
That was the prior art they overcame.

[00:06:11] Speaker 03:
Grossi, for example, had a removable light guide precisely because you might want to change what kind of light you use.

[00:06:18] Speaker 00:
Do you agree with the definition of the person of ordinary stoney art as found by the board here?

[00:06:27] Speaker 03:
Yes, essentially, Your Honor.

[00:06:29] Speaker 00:
Material.

[00:06:29] Speaker 00:
You're not appealing.

[00:06:30] Speaker 03:
No, no.

[00:06:31] Speaker 03:
For all, yes.

[00:06:32] Speaker 00:
And that's somebody with five years of experience.

[00:06:34] Speaker 03:
That's right.

[00:06:35] Speaker 00:
Do you agree that that's highly relevant to the written description in court?

[00:06:39] Speaker 03:
Oh, yes, Your Honor.

[00:06:41] Speaker 03:
And I think that person would be aware that there are multiple like guides.

[00:06:45] Speaker 03:
But remember, one thing that the board, and I really want to focus on figure 1A, because this isn't just a case where we're arguing there's an absence of evidence.

[00:06:53] Speaker 03:
Here we're saying there's evidence of absence of the limitations.

[00:06:56] Speaker 04:
You argue in the blue brief that it was

[00:06:59] Speaker 04:
error for the PTAB not to consider the drawings of Figure 1A?

[00:07:05] Speaker 04:
Absolutely, Your Honor.

[00:07:06] Speaker 04:
If the PTAB was able to find adequate written description without looking at the drawings at all, would this still be error?

[00:07:16] Speaker 03:
Yes, Your Honor, and that would be the PharmaStem case, Your Honor's PharmaStem case, the Boston Scientific case.

[00:07:22] Speaker 03:
Let's suppose that this is a coffee cup, and I said,

[00:07:26] Speaker 03:
that my claim was a cup with coffee in it.

[00:07:29] Speaker 03:
And they had experts that came in and said, I know from looking at the outside that there must be coffee inside.

[00:07:35] Speaker 03:
Now, we would say that's not sufficient.

[00:07:37] Speaker 03:
But clearly, if I now have a figure, the exact same embodiment, and I now can look in the cup and see that it's water, not coffee, clearly, not only is that relevant, but under the court's LA Biomed case, the Allergan case, the Rivera case, when you have evidence that

[00:07:56] Speaker 03:
that contradicts what the experts say, then you've got to take that into account, that that overwhelms the effect of obviousness finding.

[00:08:07] Speaker 03:
So here we have figure 1a and figure 3, for that matter, that actually show us what's inside the endoscope.

[00:08:15] Speaker 03:
And there's no light guide at all.

[00:08:17] Speaker 00:
What about the two expert declarations that are provided?

[00:08:22] Speaker 00:
that talk about one, I think, is a former patent examiner in this field, and the other one is a doctor.

[00:08:27] Speaker 00:
And both of them rely on things other than Figure 1 in order to come to the conclusion that one of ordinary, that the specification does convey the claim limitation to one of ordinary skill in the art.

[00:08:40] Speaker 03:
Your Honor, that is an analytical error on the part of the PTAB to accept that.

[00:08:44] Speaker 03:
Because what they say is that the entire of the argument, as we look at Figure 2,

[00:08:48] Speaker 03:
And the outside of figure two looks like the kind of endoscopes we know have permanently affixed light guides.

[00:08:54] Speaker 03:
Now, there are multiple problems with that analysis, analytical problems, not evidence problems.

[00:09:00] Speaker 03:
Number one, as the district court found in the related litigation and as is plain from the patent, there's no claim that this is an improvement on the prior art or relies upon the prior art.

[00:09:10] Speaker 03:
In fact, it explicitly says this is a new endoscope.

[00:09:13] Speaker 03:
So that's a problem.

[00:09:14] Speaker 03:
The second problem and the more fundamental problem is,

[00:09:17] Speaker 03:
that we see inside the scope.

[00:09:19] Speaker 03:
So if it was just figure 2, if that's the only figure in the patent, we'd have a harder hill to climb.

[00:09:26] Speaker 03:
We think we'd still climb it, but it would be harder.

[00:09:28] Speaker 03:
But once you throw figure 1a and figure 3 in the mix, and we no longer have to guess what's inside the cup, but they've now shown us what's inside the cup, we now know it's water, not coffee.

[00:09:39] Speaker 03:
And here, we now know there is no light guide in the working channel.

[00:09:44] Speaker 00:
with your argument is that you started by standing up here and saying, this is not a substantial evidence case.

[00:09:51] Speaker 00:
But I think all we've discussed so far is facts.

[00:09:54] Speaker 00:
And I don't understand why this is not a substantial evidence case.

[00:09:57] Speaker 03:
Your Honor, and this, I think this is analogous to Your Honor Smith and Nephew v. Wray case, that there are facts, but if the facts are proving the wrong thing, what their evidence proves, if you accept it, is that it would have been obvious to add a light guide in

[00:10:13] Speaker 03:
some channel somewhere.

[00:10:14] Speaker 03:
That's what their evidence says.

[00:10:16] Speaker 03:
I look at the outside of this, and based on my knowledge of the art, I believe I can see it in there.

[00:10:22] Speaker 03:
I would expect it to be in there.

[00:10:24] Speaker 03:
But that's not what the law is.

[00:10:26] Speaker 00:
That's what obviousness is, either.

[00:10:28] Speaker 03:
Well, Your Honor, maybe the closer analogy is the TurboCare case, then.

[00:10:33] Speaker 03:
And let me make sure I get the language right.

[00:10:35] Speaker 03:
This court found that even though the, quote, only viable location for a mountain spring was where the claim said it,

[00:10:43] Speaker 03:
You were still obligated to show within the four corners of the specification that there was a mounting spring where they said the mounting string should be in the claims.

[00:10:51] Speaker 03:
Here, there is literally nothing.

[00:10:53] Speaker 03:
At the board's argument, they acknowledged, admitted there is no depiction of the light guide.

[00:11:00] Speaker 03:
So what is it within the four corners?

[00:11:02] Speaker 03:
What language within the four corners?

[00:11:03] Speaker 03:
What picture within the four corners says that this inventor had possession?

[00:11:08] Speaker 03:
He told the world he had invented a novel endoscope.

[00:11:11] Speaker 03:
And now he's saying, but I'm just kidding.

[00:11:12] Speaker 03:
When it comes to other things, I'm going to rely on what you know about prior art endoscopes.

[00:11:17] Speaker 03:
And now when we look, again, all of this.

[00:11:21] Speaker 00:
What about where it says a connection for the light source is also present for connection to a fiber optics bundle, which provides for lighting at the end of lens 13?

[00:11:33] Speaker 00:
Does that in any way suggest the location of where it would have to be, since it has to provide light at the end of lens 13, which is in channel 6?

[00:11:42] Speaker 03:
First of all, I think that sentence profoundly supports our position.

[00:11:46] Speaker 03:
Because if there was a light guide there, as opposed to merely a connection for a light guide, if I buy a new DVD player and it says HDMI connector, that means that there's a plug there, not that the cable, the actual HDMI cable's in the box.

[00:11:59] Speaker 03:
This says a connection for a light source is present.

[00:12:01] Speaker 00:
I hear what you're saying.

[00:12:02] Speaker 00:
I thought about that, too.

[00:12:03] Speaker 00:
But then when I looked at the, there's a couple of prior art references that we relied upon that have a permanent light guide.

[00:12:12] Speaker 00:
And in those, there's also something identified as the connection.

[00:12:16] Speaker 00:
So I don't think the use of the word connection necessarily tells me whether it's permanent or not.

[00:12:21] Speaker 03:
I agree.

[00:12:21] Speaker 03:
I think it supports us.

[00:12:23] Speaker 03:
But the point is it doesn't clearly evidence possession.

[00:12:26] Speaker 03:
So the burden is on them to show within the Four Corners a clearly evidence of possession.

[00:12:29] Speaker 03:
I'm not saying it's a slam dunk.

[00:12:31] Speaker 03:
I'm saying it's ambiguous at best and supports us, I believe, to some degree.

[00:12:35] Speaker 03:
But that's not our burden.

[00:12:37] Speaker 03:
It's on their burden to show within the Four Corners absolute possession.

[00:12:41] Speaker 04:
You direct us to some statements made by district court judge in Massachusetts in a related case.

[00:12:50] Speaker 04:
I understand that's currently stayed?

[00:12:55] Speaker 04:
Correct.

[00:12:56] Speaker 04:
What weight should we give those statements?

[00:12:58] Speaker 04:
It seems like they're inapplicable to our review.

[00:13:01] Speaker 03:
The only place, the only relevance we state is when they're trying to avail themselves of the fact that it looks like the prior art.

[00:13:11] Speaker 03:
And the district court said, and for that matter the examiner agreed, the district court said that you read the specification and they're not suggesting to you that this is an improvement on prior art, but rather that it's a new endoscope.

[00:13:23] Speaker 03:
And particularly in light of

[00:13:25] Speaker 03:
the biomed and allergan cases.

[00:13:28] Speaker 04:
But how does that get to us?

[00:13:32] Speaker 03:
It's not binding in any way, Your Honor.

[00:13:33] Speaker 03:
I just think it's further persuasive evidence that other people agree with us that this isn't saying this is an improvement on the prior art, that this is saying here's a new endoscope and therefore you shouldn't be relying on what the experts say about it.

[00:13:49] Speaker 03:
I'm not saying it.

[00:13:50] Speaker 04:
I didn't think you were saying it was binding, but I don't see a place for it exactly.

[00:13:55] Speaker 03:
Well, if you agree with us that the fact that it's particularly inappropriate to say we're going to gap fill with prior art when the specification is saying this isn't any old prior art device, this is a new scope, then the fact that someone else agreed with us is just a pat on the back.

[00:14:19] Speaker 03:
We're not crazy on this.

[00:14:22] Speaker 03:
I'm obviously into my rebuttal time.

[00:14:24] Speaker 01:
Let's hear from the other side.

[00:14:26] Speaker 01:
Yes.

[00:14:26] Speaker 01:
We'll save you rebuttal time.

[00:14:31] Speaker 01:
Mr. Albert.

[00:14:32] Speaker 02:
Thank you, Your Honor.

[00:14:33] Speaker 02:
May it please the Court.

[00:14:35] Speaker 02:
This appeal turns on a question of fact, whether substantial evidence supports the Board's conclusion that a person of ordinary skill applying their practical knowledge would have understood with reasonable clarity from the priority document, the PCT, that the inventor had possession of the claimed invention.

[00:14:52] Speaker 02:
In other words, of using a known endoscope with a fixed light guide to practice the claimed medical treatment method.

[00:14:59] Speaker 02:
Council suggested the invention was an endoscope.

[00:15:02] Speaker 02:
We respectfully disagree.

[00:15:03] Speaker 02:
The invention makes clear it's a medical treatment method, and it used known endoscopes.

[00:15:08] Speaker 02:
And what does the record show?

[00:15:10] Speaker 02:
And by the way, all the board did here, to be clear, was to find that the patent owner was entitled to his own PCT's priority date.

[00:15:17] Speaker 02:
Now, how did they get there?

[00:15:19] Speaker 02:
The record showed that there were two types of... I would like to ask you a question.

[00:15:23] Speaker 00:
Yes, Your Honor.

[00:15:24] Speaker 00:
One of the things that I was very confused about was there's testimony and a finding by the PTAB saying that the light guide in your patent is like Bonnet and Kuboto and not like Grossi and Savage in looking at these figures.

[00:15:43] Speaker 00:
And I would like you to walk me through why

[00:15:48] Speaker 00:
the figures are more like Bonnet and Kuboto as opposed to Grossi and Savage.

[00:15:53] Speaker 02:
Certainly, Your Honor.

[00:15:54] Speaker 02:
I'd be glad to.

[00:15:55] Speaker 02:
And perhaps the best place to look for that would be appendix 1534 and 35, which are Dr. Isaacson's declaration.

[00:16:02] Speaker 02:
And what he explained is that there were two types of endoscopes known in the prior art.

[00:16:07] Speaker 02:
There was the kind exemplified by Bonnet and Kuboto, which is a kind with a permanently affixed light guide.

[00:16:14] Speaker 02:
And there was another kind, the kind exemplified by Grossi and Savage, which was the kind of the removable or telescoping light guide inserted from the outside.

[00:16:22] Speaker 02:
And what Dr. Isaacson testified in his declaration, and he's on the faculty of Harvard Medical School, 25 years experience practicing using both the inventive method and the prior art method.

[00:16:34] Speaker 02:
And his declaration explains, a person of skill in the art, looking at figures two and three of the priority document, the PCT, would understand

[00:16:43] Speaker 02:
that what was shown here was the bonnet or Kuboto type of endoscope.

[00:16:48] Speaker 02:
In other words, it was the kind with a permanently affixed light guide.

[00:16:51] Speaker 02:
And he goes on.

[00:16:52] Speaker 02:
Let me explain exactly, Your Honor, why.

[00:16:55] Speaker 02:
So what he explains is, if we look at figure three on 1535, and by the way, there are additional labels added to this in Mr. Apley's declaration.

[00:17:04] Speaker 02:
That's appendix 1539 to 42.

[00:17:08] Speaker 02:
But looking at figure three, what we see are a couple of things that Dr. Isaacson emphasizes.

[00:17:13] Speaker 02:
Element 8, which is the light-guide connection, and Element 7, which is the viewing tube, you can see in Figure 2, and even more clearly in Figure 3, which is the cutout, the cross-section, they are permanently attached to the endoscope.

[00:17:28] Speaker 02:
Now, why does that matter?

[00:17:30] Speaker 02:
That matters because it was undisputed that the optical components of an endoscope, which include the observation and the illumination parts, have to be aligned.

[00:17:39] Speaker 02:
So they're always made in such a way that they're fixed together.

[00:17:42] Speaker 02:
But that can be done in one of two ways.

[00:17:44] Speaker 02:
They can be affixed to the endoscope itself, the bonnet or Kuboto type shown here, or they can be affixed to this thing called the telescope, which is inserted from the outside.

[00:17:54] Speaker 02:
What Dr. Isaacson explained here is because you can see elements seven and eight in figure three are actually attached to the endoscope, that teaches a person of skill, oh, this is the bonnet kind, the Kuboto kind.

[00:18:08] Speaker 02:
This is the kind in which the light guide is permanently affixed.

[00:18:12] Speaker 02:
And that alone, Your Honor, is substantial evidence.

[00:18:15] Speaker 02:
And again, the standard of review here, of course, the board's standard of review of the CRU examiner was de novo.

[00:18:22] Speaker 02:
They made the findings here.

[00:18:24] Speaker 02:
This Court's review is substantial evidence.

[00:18:26] Speaker 00:
Can I just back me up for a second?

[00:18:27] Speaker 00:
So I think you're saying that, for example, in Bonnet and Caboto, which are at page appendix 1534, the things that are permanently affixed for Bonnet, for example, are the elements designated 7 and 5.

[00:18:38] Speaker 02:
Correct, Your Honor.

[00:18:39] Speaker 02:
They match up with elements 8 and 7.

[00:18:42] Speaker 02:
respectively.

[00:18:43] Speaker 00:
And in Kuboto, if I understand it correctly, it's elements 16 and 24.

[00:18:50] Speaker 02:
Yes, I believe that's right, Your Honor.

[00:18:52] Speaker 02:
So what Dr. Isason is explaining is what would a person of skill in the art coming to this PCT figure understand from it?

[00:18:59] Speaker 02:
And he testified at great length and in detail showing these figures that looking at figure two and figure three of the PCT, that's what the person sees.

[00:19:07] Speaker 02:
Now, he was backed up by two additional expert declarations, Mr. Apley,

[00:19:12] Speaker 02:
and also Mr. Chinick, who's an endoscope designer.

[00:19:14] Speaker 02:
So we have a doctor.

[00:19:15] Speaker 02:
We have an endoscope designer.

[00:19:17] Speaker 02:
Really, Hologic's expert didn't actually tackle that question head on.

[00:19:21] Speaker 02:
Although, even if they had, it would have been a conflict of evidence to be resolved by the board.

[00:19:26] Speaker 02:
But they actually didn't really rebut that.

[00:19:28] Speaker 02:
What they did was they basically sidestepped it and argued that, well, it would be theoretically possible to take figure two and somehow design a different type of endoscope

[00:19:40] Speaker 02:
in which the light guide wasn't fixed.

[00:19:43] Speaker 02:
But that theoretical construct about what could happen are not the test.

[00:19:47] Speaker 02:
The test under VASCAP, yes, Your Honor.

[00:19:49] Speaker 00:
I was just going to ask for the appendix site on that.

[00:19:51] Speaker 00:
Do you happen to know the appendix site for what you're referring to?

[00:19:54] Speaker 02:
Yes, Your Honor.

[00:19:55] Speaker 02:
So there are two.

[00:19:57] Speaker 02:
One is Dr. Domenisis.

[00:20:00] Speaker 02:
At appendix 2289 in paragraph 8, that's the logic's first expert,

[00:20:06] Speaker 02:
He generically states, sort of as an ipsy dixit, that he doesn't believe there's a basis for a person of skill in the art to understand what Dr. Isaacson says they would understand.

[00:20:15] Speaker 04:
I'm sorry, what paragraph is that?

[00:20:17] Speaker 02:
Paragraph 8.

[00:20:18] Speaker 02:
But then on the next page, 2290 of the appendix, in paragraph 11, we actually get his explanation.

[00:20:25] Speaker 02:
And this is all it is.

[00:20:27] Speaker 02:
He says, even if one of skill in the art suspected that the lens or light guide was permanently affixed or not from the drawings, it would not necessarily have to be so.

[00:20:36] Speaker 02:
And it's this necessarily test that's erroneous.

[00:20:40] Speaker 02:
And that's what the board found.

[00:20:42] Speaker 02:
And they were right.

[00:20:42] Speaker 02:
Under Vaskath and under Posen, that's simply not the test that this court has taught.

[00:20:48] Speaker 02:
In fact, this case is really very much on all fours with Vaskath, where precisely the kind of error that Pelagic asked the board to make and is now asking this court to make was corrected by this court in Vaskath when the district court had made it in that case.

[00:21:04] Speaker 02:
The district court in Vascath had suggested that there was this necessarily test.

[00:21:10] Speaker 02:
And this court said, no.

[00:21:11] Speaker 02:
What you look to is what a person of skill in the art would understand, not some theoretical construct about how the device could be designed differently.

[00:21:20] Speaker 02:
So to answer Your Honor's question, I've pointed to where it is in Dr. Domenis' testimony.

[00:21:24] Speaker 02:
They do have one other expert.

[00:21:26] Speaker 02:
And that is Mr. Walbrink, appendix 2649 in paragraph 11 of his declaration,

[00:21:34] Speaker 02:
We have the exact same problem.

[00:21:36] Speaker 02:
He says, in purportedly disputing our expert, all he really says is, I do not agree that this is necessarily.

[00:21:44] Speaker 04:
Paragraph number, I'm sorry?

[00:21:45] Speaker 02:
Paragraph 11, your honor, on 2649.

[00:21:48] Speaker 02:
He says, I do not agree that this is necessarily so.

[00:21:53] Speaker 02:
And then he goes on to suggest that it would have been obvious, but not necessarily the case.

[00:21:57] Speaker 02:
But this is not an obviousness situation.

[00:22:00] Speaker 02:
What Dr. Isaacson testified to very clearly, and there's certainly at least substantial evidence of this, is that a person of skill in the art would know that this is the Bonnet or Kuboto type of light guide, particularly here, whereas the board found this is not an unpredictable art.

[00:22:16] Speaker 02:
They found expressly that the optical guide at issue here is a predictable art.

[00:22:24] Speaker 02:
This is not something that would have required the kind of speculation that some of the cases cited by counsel would have called for.

[00:22:33] Speaker 02:
So we have, and by the way, I should also note that the board's decision was actually fully consistent with many things that had come before.

[00:22:42] Speaker 02:
The original examiner, in fact, had originally found that the PCT, in particular figure two, supported the, there was written description support for the fixed light guide.

[00:22:54] Speaker 02:
the judge and jury in the Massachusetts case came to a similar conclusion.

[00:22:58] Speaker 02:
Now, at the CRU, when Hologic, so Hologic filed two inter-parties re-exam requests.

[00:23:06] Speaker 02:
The first one was rejected.

[00:23:07] Speaker 02:
The second one, which they filed on the eve of trial in July of 2012, the CRU granted that request, but then after considering the expert declarations, including Dr. Isaacson and Mr. Apley,

[00:23:18] Speaker 02:
The CRU examiner withdrew all the rejections and specifically found that the PCT supported claims to methods involving a permanently affixed light guide because artisans would have understood that that was the case from figure two of the PCT.

[00:23:32] Speaker 02:
Now the CRU examiner later changed her mind, but that was in response to Hologic's legally erroneous contention that the PCT had to disclose a light guide that was necessarily permanently affixed.

[00:23:44] Speaker 02:
Again, it was this incorrect legal test.

[00:23:46] Speaker 02:
And so when the case went to the board,

[00:23:48] Speaker 02:
They conducted their de novo review.

[00:23:50] Speaker 02:
And they found from Dr. Isaacson's, as well as the other declarations, that there was substantial support.

[00:23:57] Speaker 02:
And again, appendix 1534 and 35 is perhaps the clearest place to see that.

[00:24:03] Speaker 02:
So that's the issue here.

[00:24:05] Speaker 02:
And it's one that this court has referred to repeatedly as a fact question.

[00:24:08] Speaker 02:
In fact, in Union Oil, this court called it an intensely factual question.

[00:24:13] Speaker 02:
The board here really did exactly what this court taught in Posen and in Vazcath, which is to take the priority document and to look at it in light of the corresponding expert testimony about how it would be understood by a person of skill in the art.

[00:24:29] Speaker 02:
In fact, in Vazcath, there was no writing at all.

[00:24:31] Speaker 02:
The priority document was a design patent.

[00:24:34] Speaker 02:
And the district court had erroneously required the patentee to show that all possible alternatives to the claim structure were necessarily excluded.

[00:24:42] Speaker 02:
very much like what Hologic's experts are trying to do here.

[00:24:46] Speaker 02:
And this court reversed and said, no, that's not the test.

[00:24:49] Speaker 02:
Likewise, in Posen, there was no express written disclosure in Posen of the therapeutic package.

[00:24:56] Speaker 02:
But this court affirmed a holding that the practicality of the situation made it clear that a person of skill in the art would understand such packaging to be present.

[00:25:04] Speaker 00:
I had asked Mr. Wolf about what is a light guide

[00:25:09] Speaker 02:
Yes, Your Honor.

[00:25:10] Speaker 00:
And what is your answer to that?

[00:25:12] Speaker 02:
My answer is pretty much the same as Mr. Wolf's, Your Honor.

[00:25:14] Speaker 02:
A light guide is a genus and a fiber optic bundle is the species.

[00:25:20] Speaker 02:
And they did make an argument at one point in their brief suggesting that somehow that the fiber optics bundle species wouldn't be sufficient to support a claim to a genus of light guide.

[00:25:30] Speaker 02:
Again, this is a classic fact issue which the board addressed, had more than substantial evidence to do so from

[00:25:36] Speaker 02:
Dr. Isaacson and Mr. Chinnick's declarations in particular.

[00:25:40] Speaker 02:
And in fact, this court held in Bilstad that it's a general rule that the disclosure of a species provides sufficient written description support for a later filed claim to a genus.

[00:25:51] Speaker 02:
And the point was affirmed by this court more recently in Hynex Semiconductor versus Rambus, which is on point here.

[00:25:58] Speaker 02:
In Hynex, the court held that Hynex had failed to argue that the disclosure of the species, which in that case was a multiplex bus,

[00:26:06] Speaker 02:
was not representative of the genus.

[00:26:08] Speaker 02:
And here, likewise, Hologic fails to offer any evidence to suggest that a fiber optic bundle isn't representative of the light guide genus.

[00:26:17] Speaker 02:
So they fail to rebut the board's factual finding that the species supports the genus.

[00:26:23] Speaker 02:
That's particularly true here, where it's a predictable field.

[00:26:26] Speaker 02:
At appendix 25, the board found the field of optical guides is not an unpredictable field.

[00:26:32] Speaker 02:
Now, Ariad teaches that.

[00:26:33] Speaker 02:
What's the evidence that it is predictable?

[00:26:36] Speaker 02:
So, Your Honor, the evidence was in a number of things.

[00:26:39] Speaker 02:
In the declaration of Dr. Isaacson in particular, he explained that the optical components and the illumination components must be fixed together, that it's always done that way.

[00:26:49] Speaker 02:
And particularly the fact that the invention here isn't about an optical guide.

[00:26:54] Speaker 02:
This isn't a light invention or a flashlight type of invention or a laser invention.

[00:26:59] Speaker 02:
It's an invention about a medical procedure.

[00:27:02] Speaker 02:
Using a known endoscope with a known light guide,

[00:27:04] Speaker 02:
for a novel treatment method.

[00:27:07] Speaker 02:
So the particular type of light guide used is not material to the invention.

[00:27:11] Speaker 02:
I would point your honor to Appendix 2556 for that.

[00:27:15] Speaker 02:
That's Mr. Chinnick's declaration at paragraph 17.

[00:27:17] Speaker 04:
I want you to address a question which doesn't hurt you, and that is that the PTAB said that it was irrelevant, your expert's testimony was irrelevant, whether a PASIDA had experience

[00:27:34] Speaker 04:
This is specifically directed to the uterus.

[00:27:38] Speaker 04:
And they said experience with endoscopes specifically related to that wasn't relevant.

[00:27:47] Speaker 04:
How can it not be wrong?

[00:27:48] Speaker 02:
So what I believe Hologic was arguing, I think your honor is referring to the argument that they made in which they point to the fact that one of our experts said a person of skill would not have experience with hysteroscopes.

[00:28:00] Speaker 02:
They used the word hysteroscope.

[00:28:01] Speaker 02:
But what that means is an endoscope

[00:28:03] Speaker 02:
that's used for these intrauterine procedures.

[00:28:06] Speaker 02:
What our expert had said is people were very familiar with endoscopes.

[00:28:11] Speaker 02:
What they were not familiar with, of course, since this was a novel invention, was the use of an endoscope of that type for procedures in the uterus.

[00:28:19] Speaker 02:
And that's the distinguishing factor.

[00:28:21] Speaker 02:
The distinguishing factor was not what type of light guide was used or anything like that, or the endoscope design.

[00:28:26] Speaker 02:
Those were known in the art.

[00:28:28] Speaker 02:
What was novel here was the use of this type of endoscope with various components for a particular novel intrauterine procedure.

[00:28:37] Speaker 02:
So that's the distinction here.

[00:28:38] Speaker 02:
And the board really, I think, correctly called the logic on that suggestion because they were really confounding the notion of a hysteroscope with that of an endoscope.

[00:28:49] Speaker 02:
The patent and the PCT made clear that the endoscope itself was not novel.

[00:28:54] Speaker 02:
And by the way, there was a suggestion made in the briefing, in the reply brief, that that was somehow a new argument not raised before the board.

[00:29:01] Speaker 02:
I would just note for the record that's not correct.

[00:29:03] Speaker 02:
Appendix 3057 and 3082 are places where that was discussed by the board.

[00:29:11] Speaker 02:
So the substantial evidence test here is met.

[00:29:14] Speaker 02:
The board made careful factual findings based on a detailed record and the declarations of highly qualified experts.

[00:29:20] Speaker 02:
They followed Vazcath and Posen and Strack in doing so.

[00:29:24] Speaker 02:
Those are the key cases here.

[00:29:26] Speaker 02:
And in the 25 page unanimous opinion of the board, they really walked through the dispositive issues and the evidence very clearly and with care.

[00:29:35] Speaker 02:
And for that reason, the decision should be affirmed.

[00:29:38] Speaker 01:
Any more questions?

[00:29:40] Speaker 01:
Any questions?

[00:29:44] Speaker 01:
Thank you, Your Honor.

[00:29:45] Speaker 03:
May it please the court.

[00:29:46] Speaker 03:
The board committed clear legal error here.

[00:29:50] Speaker 03:
I'm quoting now from the Los Angeles Biomedical Research case at 1058.

[00:29:55] Speaker 03:
LAB cannot rely on standalone references that it failed to incorporate in the provisional application in order to make out its priority claim.

[00:30:04] Speaker 03:
That is exactly what happened here.

[00:30:06] Speaker 03:
The board and Smith and Nephew relied on standalone references, Bonnet and Caboto, not cited

[00:30:13] Speaker 03:
anywhere in the specification of the prosecution history to find the disclosure, the purported disclosure within the four corners.

[00:30:21] Speaker 03:
It gets worse.

[00:30:22] Speaker 03:
At column two of the patent line 17 to 23, in discussing the prior art, the prior art that they purportedly rely on generically, such a device is consequently not very suitable for use in the treatment of such a cavity.

[00:30:36] Speaker 03:
The object of the present invention is to provide a device which can perform such a treatment.

[00:30:43] Speaker 03:
So they criticize the prior art, say they're providing a device, notwithstanding counsel's claim that it's about a method, they're providing a device.

[00:30:51] Speaker 03:
And now they're saying, but we're going to borrow from the prior art features of a device, despite the fact that A, they're not disclosed, and B, they're criticized.

[00:31:01] Speaker 03:
But the coup de grace here, the thing that the board never, never discussed, is 1A and 3, that don't show the light guide.

[00:31:11] Speaker 03:
If nothing else, Your Honors,

[00:31:13] Speaker 03:
At least send this back to the board to say wrestle with that fact.

[00:31:17] Speaker 03:
We have, the case law that I cited, we have Pharma Stem and BSC that says you can't do that.

[00:31:25] Speaker 03:
You can't ignore contrary evidence.

[00:31:28] Speaker 03:
And here we have actual depictions of the part of the catheter where you would have to find a light guide if there's a light guide, if it was possessed by the inventor.

[00:31:38] Speaker 03:
And they acknowledge it's not there.

[00:31:41] Speaker 03:
So when you're saying, is there substantial evidence?

[00:31:44] Speaker 03:
Your honor says, isn't this a substantial evidence case?

[00:31:47] Speaker 03:
Well, if you skip past the legal error that we assign to the board, which I think is plain, but if you say, we're going to forgive them for that, we're going to give them a pass on that, at least make them wrestle with the only depiction of where we would expect a light guy to be, and there isn't a light guy.

[00:32:04] Speaker 03:
They can't just ignore it.

[00:32:06] Speaker 03:
You can't say, I respectfully submit,

[00:32:09] Speaker 03:
that something does not pass substantial evidence muster if the signal most important piece of evidence is not even a disgust, let alone distinguished.

[00:32:21] Speaker 03:
Thank you for your time.

[00:32:22] Speaker 01:
I'll show further questions.