[00:00:08] Speaker 00:
All rise.

[00:00:29] Speaker 00:
The United States order fields for the Federal Circuit is not open in any session.

[00:00:34] Speaker 00:
God's day in the United States ends on the whole circuit.

[00:00:37] Speaker 01:
Good morning.

[00:00:38] Speaker 01:
Please be seated.

[00:00:49] Speaker 01:
First case for argument this morning is 162597, gold standard instruments versus endotonics.

[00:00:57] Speaker 01:
Mr. Lieberman, whenever you're ready.

[00:01:13] Speaker 05:
Good morning, Chief Judge Crost, and may it be pleased with the court.

[00:01:16] Speaker 05:
My name is Steve Lieberman.

[00:01:18] Speaker 05:
In its final written decision, the board expressly held that for each of the two obviousness grounds, Matsutani ground and Acune ground, Matsutani and Acune, respectively, did not disclose the required element of heat treating the entire shank of the endonomic file.

[00:01:36] Speaker 05:
And it never, at any point in the decision, identified where that element was disclosed

[00:01:42] Speaker 05:
by any other reference in either of the two combinations.

[00:01:46] Speaker 05:
So you have a missing element.

[00:01:48] Speaker 05:
Reaching the conclusion that it would have been obvious to modify the relied upon references to add that element, the board made at least three procedural errors with respect to each ground.

[00:01:59] Speaker 05:
Errors that this court has found requires at least remand, and we would suggest reversal.

[00:02:06] Speaker 05:
Those three errors are the following.

[00:02:09] Speaker 05:
The board never discussed whether a person of ordinary skill would have had a motivation to change the references by adding heat treating the entire shank with a reasonable expectation of success.

[00:02:21] Speaker 05:
Indeed, the words reasonable expectation of success are entirely absent from the final written decision.

[00:02:27] Speaker 05:
They don't appear anywhere in the decision.

[00:02:30] Speaker 05:
Number two.

[00:02:32] Speaker 03:
What do you mean in that context by reasonable expectation of success?

[00:02:36] Speaker 03:
Reasonable expectation of success in what?

[00:02:39] Speaker 03:
What's the accomplishment that heating the entire shank achieves that isn't achieved by heating, say, three-quarters of the shank?

[00:02:54] Speaker 05:
Probably the closest reference in this case is a pat to a fellow named Matsutani.

[00:02:59] Speaker 03:
Yeah, I understand.

[00:03:01] Speaker 03:
We're with you on that.

[00:03:02] Speaker 05:
Right.

[00:03:03] Speaker 05:
In the Matsutani reference, Matsutani says, well, let me take a step back as to the physics

[00:03:09] Speaker 05:
the file.

[00:03:10] Speaker 03:
Well, yeah, I'm actually asking a much more discreet question.

[00:03:14] Speaker 03:
What I'm asking, and it was a problem that I had all the way through here, was what is it that is the big advantage?

[00:03:22] Speaker 03:
What's the big leap forward by heating the entire file as opposed to just heating three quarters of it?

[00:03:28] Speaker 05:
OK.

[00:03:28] Speaker 05:
So Masutani explains exactly what the problem is.

[00:03:31] Speaker 03:
If you heat the... Masutani says there's a problem, potentially,

[00:03:36] Speaker 03:
That's right.

[00:03:37] Speaker 03:
If you heat the whole file.

[00:03:38] Speaker 03:
Right.

[00:03:39] Speaker 03:
My question is, what is it that your invention does that makes it an advantage to heat the entire file?

[00:03:47] Speaker 05:
OK.

[00:03:48] Speaker 05:
Heating the entire file, according to Lupin, and for 17 years, from 1988, when nickel titanium files were first introduced, nobody heat treated the nickel titanium files.

[00:03:59] Speaker 05:
It was thought that having a super-elastic file, one that would bend as it went through a curved root canal,

[00:04:05] Speaker 05:
And then spring back was a valuable thing.

[00:04:08] Speaker 05:
Lou Geith thought that there was a problem with that.

[00:04:10] Speaker 05:
And he said, what I want to do is I want to eliminate or reduce the super elastic characteristic so that the file is sort of floppy, almost like a piece of clay.

[00:04:20] Speaker 05:
So you can mold it to the shape of the canal.

[00:04:23] Speaker 05:
And when you put it into the root canal, it traces exactly the path of the root.

[00:04:30] Speaker 05:
So that was what he was dealing with.

[00:04:32] Speaker 05:
He was dealing with the problem of,

[00:04:34] Speaker 05:
non-heat-treated, super-elastic flats.

[00:04:37] Speaker 02:
Now, the Matsutani reference says... Let me ask you something, just building on to the questions that have been asked by Judge Bryson.

[00:04:45] Speaker 02:
Where in your patent does it say that heat treating the entire shank is important or provides some value?

[00:04:53] Speaker 02:
And in fact, where does it say that you would heat treat the entire shank?

[00:04:57] Speaker 05:
Right.

[00:04:58] Speaker 05:
So the claims say heat treat the entire shank.

[00:05:01] Speaker 05:
what about in uh... bring description of the the specification also also talks about treating the entire shank where is that uh... the words entire shank i believe appear throughout the specification in a number of places there is not an express discussion of heat treating the entire shank versus three quarters because monsoon time was very close why does it say why you want to heat treat the entire shank the reason you want to heat treat in the specification what is the reason given yes because

[00:05:31] Speaker 05:
It provides flexibility where the file is not going to be springing back.

[00:05:37] Speaker 01:
I'm sorry, are you referring to, can you cite to us the specific sections in the specification?

[00:05:42] Speaker 01:
You're talking about what the specification says now, right?

[00:05:44] Speaker 05:
Yeah, the specification does not specifically deal with the question of getting three quarters versus the whole thing.

[00:05:50] Speaker 05:
The patent talks about the importance of heat treating the product so that the file itself is flexible.

[00:05:58] Speaker 05:
a short period of time before the stat application was filed.

[00:06:02] Speaker 05:
Saluki wasn't addressing in the specification three quarters versus the whole.

[00:06:07] Speaker 05:
But what Matsutani says is you may have a problem that the rotational axis will not be fixed if you heat treat the whole thing, meaning it's going to wobble.

[00:06:15] Speaker 05:
And when you have a file in a root canal in a tooth and it's wobbling, you don't have a fixed rotational axis, it's going to be ripping away live tooth.

[00:06:24] Speaker 05:
That's a real problem.

[00:06:25] Speaker 05:
It would be analogous to

[00:06:27] Speaker 05:
Now, a teaching which says, if you're building a skyscraper, don't use an I-beam that is less than a certain width.

[00:06:36] Speaker 05:
Because if you do, the building may fall down.

[00:06:40] Speaker 05:
So that's equivalent to what Masutani is saying.

[00:06:42] Speaker 05:
He's saying you should not heat treat more than 3 quarters.

[00:06:48] Speaker 05:
Because if you do, you'll have a wobbly rotational axis.

[00:06:52] Speaker 05:
And that's a big problem.

[00:06:54] Speaker 05:
Loopy's invention from the very beginning,

[00:06:56] Speaker 05:
Well, Lukey's invention, it's reflected in the claims, say he treated the entire shack.

[00:07:02] Speaker 03:
And how does that, how does Lukey get around the perceived Matsutani problem of the rotational axis issue?

[00:07:10] Speaker 05:
Well, that was actually a point that the PTAB addressed, and I would say in doing so it aired as a matter of law.

[00:07:18] Speaker 05:
It looked to Lukey's own work and said Lukey never found the problem with he treating the entire shack.

[00:07:26] Speaker 05:
Right.

[00:07:26] Speaker 05:
But they're not allowed to look at the inventor's own work in making invention.

[00:07:30] Speaker 05:
This is classic hindsight bias.

[00:07:32] Speaker 05:
Matsutani specifically warned, don't do this.

[00:07:35] Speaker 05:
This is the closest reference.

[00:07:37] Speaker 05:
It says, don't do this.

[00:07:38] Speaker 05:
And if you do this, you may have this big problem.

[00:07:42] Speaker 05:
Luky, when he heat treated the entire shank, didn't have that problem.

[00:07:46] Speaker 05:
Maybe he didn't have it because of the temperature he used, or the time, or a particular technique.

[00:07:52] Speaker 05:
But he didn't have a problem.

[00:07:55] Speaker 05:
But Lukey's own work is not prior art that can be looked to.

[00:07:59] Speaker 05:
It's not something that a person of ordinary skill can look to.

[00:08:02] Speaker 05:
And this court has said again and again, you can't look at the inventor's own work, which conceitedly is not prior art.

[00:08:09] Speaker 05:
Sure.

[00:08:09] Speaker 02:
I want to ask you to go back to the question I had earlier.

[00:08:13] Speaker 02:
I had asked you whether your specification talked about heat treating the entire shank.

[00:08:17] Speaker 02:
You said it says entire several times.

[00:08:20] Speaker 02:
I don't see it in there at all.

[00:08:22] Speaker 02:
And so I'm struggling with your answer.

[00:08:24] Speaker 05:
Right, Your Honor, the specification talks about heat treating the file.

[00:08:28] Speaker 05:
It doesn't, it doesn't, I don't believe it uses the word entire.

[00:08:31] Speaker 05:
It talks about heat treating the file.

[00:08:34] Speaker 05:
During the prosecution of one of the related applications, Matsutani was cited and the words entire shank were put into the claims to get over Matsutani.

[00:08:45] Speaker 02:
Is there anywhere in the specification where it talks about why you want to, I mean, it just says heat treat the file.

[00:08:54] Speaker 02:
But is there any discussion at all of why that's advantageous?

[00:08:59] Speaker 02:
I mean, other than the idea of, you know, as compared to not treating the entire file?

[00:09:06] Speaker 05:
The specification doesn't address heat treating the entire file versus heat treating three quarters.

[00:09:12] Speaker 05:
The specification is focused on heat treating the file, which nobody had done in the 17 years since nickel titanium files have been introduced.

[00:09:20] Speaker 05:
That is, they've been on the market since 1988.

[00:09:23] Speaker 05:
This application was filed in 2005.

[00:09:26] Speaker 05:
There were a lot of nickel titanium files that were sold.

[00:09:28] Speaker 05:
Nobody had ever heat treated them.

[00:09:30] Speaker 05:
Now, you have some academic articles, and that's what the PTAB was relying on.

[00:09:36] Speaker 05:
And you have the Monsutani patent.

[00:09:38] Speaker 05:
But nobody had actually come out with a product which says heat treat the nickel titanium files.

[00:09:44] Speaker 05:
This was the big invention.

[00:09:46] Speaker 05:
Now, the closest piece of prior art was Monsutani.

[00:09:52] Speaker 05:
Masutani specifically warned against, and this is very similar to the Dow Chemical versus me Industries case, where you had the prior art saying that 2% was an operational maximum.

[00:10:09] Speaker 05:
And the PTAB said, well, I find that 2% teaches or suggests 2% to 8%.

[00:10:18] Speaker 05:
And the Federal Circuit reversed and said, no, that's not the case.

[00:10:22] Speaker 05:
This is Dow Chemicals versus me.

[00:10:23] Speaker 05:
You have an operational maximum set out in a piece of prior art, which teaches away from what's in the Luke piece of claims.

[00:10:31] Speaker 02:
What about the Kuhn prior art?

[00:10:33] Speaker 02:
That's prior art where it doesn't say that the entire file is treated, but it does say he's treating the file.

[00:10:40] Speaker 05:
Right.

[00:10:41] Speaker 05:
So the PTEP made a factual finding that Kuhn did not disclose he's treating the entire file.

[00:10:48] Speaker 05:
It said that gold standard has argued for anticipation that all of these elements are here.

[00:10:53] Speaker 05:
And they said, we find that Kuhn does not adequately disclose heat treating the entire file.

[00:10:59] Speaker 02:
Because it didn't expressly say it.

[00:11:00] Speaker 05:
Well, what he did was he was cutting the files up, and he was heat treating only little pieces of the files.

[00:11:05] Speaker 05:
That's what the PTAB found.

[00:11:07] Speaker 05:
He was cutting up the files, and he was doing that because he wanted to see what the effect would be on the metal of the heat treatment.

[00:11:13] Speaker 05:
What the effect of the metal would be on the heat stream.

[00:11:16] Speaker 03:
Can I ask just a Monday question?

[00:11:17] Speaker 03:
I'm sorry.

[00:11:19] Speaker 03:
A Monday question about the figures, which I want to make sure I've got it right.

[00:11:23] Speaker 03:
If you look at figure 1A of the loopy pattern, you've got it there.

[00:11:33] Speaker 03:
Yes, sir.

[00:11:34] Speaker 03:
Now, there, the specification refers to 1B.

[00:11:42] Speaker 03:
which is circled there on 1A as being the shank.

[00:11:46] Speaker 03:
Is the shank just the fluted part that is shown, part of which is shown in 1B, or does the shank include 42 going all the way up to what I guess you would call the handle?

[00:11:57] Speaker 05:
The shank includes 42.

[00:11:59] Speaker 03:
The fluted portion is what's known as the working part of the shank.

[00:12:04] Speaker 03:
OK.

[00:12:04] Speaker 03:
Well, 1B in the specification says, OK, it's a partial detailed view of the shank.

[00:12:11] Speaker 03:
But you mean then the shank is all the way up to the handle.

[00:12:15] Speaker 03:
That's correct.

[00:12:16] Speaker 03:
OK.

[00:12:16] Speaker 05:
That's correct.

[00:12:17] Speaker 05:
And what Mazzantani says is it talks about a maximum of 3 quarters only of the working portion.

[00:12:24] Speaker 05:
So the claim here is he treating the entire shank, not just the working portion, but the part that goes all the way up to the handle.

[00:12:33] Speaker 03:
So a number of the other areas.

[00:12:36] Speaker 03:
The part that goes all the way up to the handle, presumably,

[00:12:39] Speaker 03:
That part doesn't go into the tooth, I take it.

[00:12:42] Speaker 05:
No.

[00:12:43] Speaker 05:
The part that cuts is the part that flutes.

[00:12:47] Speaker 05:
That's what's called a working portion.

[00:12:48] Speaker 05:
Right.

[00:12:49] Speaker 03:
And that's the portion that you want to have capable of curving with memory, shape memory.

[00:12:57] Speaker 05:
My understanding is that you would also want the non-working portion to be flexible, to give the endodontist more ability

[00:13:08] Speaker 05:
to bend the file so that it can follow the route.

[00:13:14] Speaker 05:
He or she has to go on a particular angle and a mouth and having the additional flexibility all the way up to the handle is not an advantage.

[00:13:23] Speaker 01:
You're well into your rebuttal.

[00:13:24] Speaker 05:
Yes, I'd like to reserve some rebuttal time.

[00:13:26] Speaker 05:
Although, if there are outstanding questions the panel has right now, I'd be happy to answer them now.

[00:13:30] Speaker 05:
Thank you.

[00:13:31] Speaker 05:
Thank you, Ron.

[00:13:44] Speaker 04:
Good morning, Your Honors.

[00:13:46] Speaker 04:
May it please the Court, my name is Jeff Ginsburg for Appellee U.S.

[00:13:49] Speaker 04:
Endodontics.

[00:13:51] Speaker 04:
Just in response to some of Mr. Lieberman's arguments, Mr. Lieberman argued and appellant GSI in its brief cited a personal web for the proposition that the Board has to find that a person of ordinary skill in the art would have been motivated to combine the prior art in the way claimed and would have a reasonable expectation of success.

[00:14:11] Speaker 04:
This is precisely what the Board found.

[00:14:13] Speaker 04:
for both the Masutani ground and the Kuhn ground.

[00:14:16] Speaker 04:
The references in each of these grounds make abundantly clear that if you heat treat the shank of a nickel-titanium file, if you subject it to heat treatment, you will achieve the claimed deformation.

[00:14:26] Speaker 04:
The board, in so finding, properly relied on the testimony of U.S.

[00:14:29] Speaker 04:
Senator's expert, Dr. John Goldberg, regarding the motivation to heat treat the entire shank as opposed to just a portion, citing specifically Dr. Goldberg's testimony that heat treating an entire shank would be easier and less expensive.

[00:14:43] Speaker 04:
You can find that in the final determination, page 27 of the appendix.

[00:14:46] Speaker 01:
Can I ask you about, it's in appendix 28, where your friend, I think, referenced Matsutani as teaching away, and the board clearly did not make that finding.

[00:14:57] Speaker 01:
But they have a paragraph that's a little odd to me on page 28, where they suggest that, they acknowledge that he suggests it may be a potential problem.

[00:15:09] Speaker 01:
So I'm not talking about a teaching away, but at least he potential problem.

[00:15:13] Speaker 01:
But they sort of don't toss that aside because they say the record before us does not include any evidence that the problem he prophesied ever actually materialized.

[00:15:25] Speaker 01:
Is that the way we would look at it?

[00:15:27] Speaker 01:
I mean, if somebody suggests there's going to be a problem, we're looking at the art and we use that, do you also have to show that indeed it ended up being a problem?

[00:15:37] Speaker 04:
Well, in addition to that, Your Honor, the board did make that statement.

[00:15:40] Speaker 04:
But in addition, they also cited Dr. Goldberg's testimony, specifically paragraphs 201 and 203 to 206 of his declaration, where Dr. Goldberg at length went through the partial heat treatment methods of Matsutani.

[00:15:57] Speaker 04:
These are these needle-like files that are used as drills and root canals where you're heat treating the nickel-titanium portion.

[00:16:03] Speaker 04:
And nickel-titanium, of course, is a metal.

[00:16:05] Speaker 04:
It conducts heat.

[00:16:07] Speaker 04:
So if you were to practice a partial heat treatment method, you had to use some alternative cooling means.

[00:16:12] Speaker 04:
Masatani talks about dipping a portion in a cooling solution, somehow putting an insulating sleeve around these little files that are mass produced.

[00:16:21] Speaker 04:
And Dr. Goldberg spoke in length about how this would be something that would be very difficult and expensive, providing the motivation not to do that, to try heat treating the entire shank.

[00:16:33] Speaker 02:
I think I have the same concern where it says the record before us does not include any evidence that the problem Masutani prophesied ever actually materialized.

[00:16:47] Speaker 02:
The question I think I heard was, is that really required for a teaching away?

[00:16:52] Speaker 02:
I mean, that would seem to swallow the whole rule if it were required.

[00:16:57] Speaker 04:
Your Honor, I don't believe that's something that's actually required, but that's not all the board relied on.

[00:17:01] Speaker 04:
and also important to note.

[00:17:03] Speaker 03:
But you're not defending, I take it, what the board said.

[00:17:07] Speaker 04:
I'm saying it's additive, I believe, to what the board found.

[00:17:11] Speaker 04:
Do you think it's right?

[00:17:13] Speaker 04:
I actually think in looking at all of the evidence, and it's something that informed the board's decision, I think it's something that could be taken into consideration.

[00:17:22] Speaker 04:
Because one thing that's interesting to get back to your questioning of Mr. Lieberman, one thing that's very important to note

[00:17:31] Speaker 04:
that GSI's counsel acknowledged that the disclosure of the 773 patent does not attribute any significance to heat treating the entire shank as opposed to just a portion.

[00:17:40] Speaker 04:
And if you look at the disclosure of Masutani, all it says is that if you heat treat more than three quarters of the working portion of the shank, you may have a problem.

[00:17:50] Speaker 04:
All this talk about wobbling, et cetera, that's Mr. Lieberman's argument.

[00:17:53] Speaker 04:
No expert mentions the word wobble at all.

[00:17:55] Speaker 03:
And all it says is that there may be a problem if you treat... Well, Masutani refers to the vocational access problems, which I actually interpreted as wobble.

[00:18:05] Speaker 03:
But maybe both I and Mr. Lieberman are wrong.

[00:18:13] Speaker 02:
I think you're right that it does say may.

[00:18:16] Speaker 02:
And your expert has lots of reasons for why it might not teach away.

[00:18:19] Speaker 02:
And it is a fact-finding.

[00:18:21] Speaker 02:
But the specific question is, do you think that it's required

[00:18:24] Speaker 02:
that the problem ever actually materialized?

[00:18:27] Speaker 04:
I don't think that's a requirement, Your Honor.

[00:18:29] Speaker 04:
But I do think that the board's decision is supported by, it didn't rely just on that statement.

[00:18:34] Speaker 04:
It specifically cited the paragraphs from Dr. Goldberg's declaration that I specifically mentioned, paragraphs 201, 203 to 206.

[00:18:43] Speaker 04:
In paragraph 203, Dr. Goldberg goes on at length as to why he believed that the problem would not occur, or a person's skill in the art would be motivated, that he treat the entire shank.

[00:18:54] Speaker 04:
Again, recognizing that it's less expensive and less difficult to heat the entire shank, but he acknowledged and he's aware that these files come in different diameters, different thicknesses.

[00:19:04] Speaker 04:
And the potential problem, only a potential problem that Masutani referenced, a problem may occur, would be less likely to occur according to Dr. Goldberg on thicker files, thereby providing the motivation for a person's skill in the arc to heat treat the entire shank as the board found.

[00:19:20] Speaker 01:
Can I ask you a process question?

[00:19:22] Speaker 01:
Because these process questions just come up with increasing frequency when we're all learning about these PTAP proceedings.

[00:19:29] Speaker 01:
And one that your friend raises is that I think you relied on Coon for anticipation and not for obviousness.

[00:19:38] Speaker 01:
And the board rejected that when it instituted, but then went on to evaluate the claims in light of Coon as obvious.

[00:19:49] Speaker 01:
Did you see a procedural problem, particularly one with respect to adequate notice?

[00:19:54] Speaker 04:
So in terms of adequate notice, the problem identified of just not heat treating the entire shank was specifically argued and discussed by both the petitioner and the patent owner and addressed by the board.

[00:20:06] Speaker 04:
Regarding Coon and the Coon Round, the board, and it was discussed in everyone's papers, this was not a new issue that was raised as GSI's council has proposed.

[00:20:16] Speaker 04:
Specifically, the board cited paragraphs from Dr. Goldberg that talked about Kuhn in combination with the other references that make up that ground as providing the motivation to heat treat the entire shank.

[00:20:30] Speaker 04:
In addition to noting Kuhn's disclosures, the board recognized that McSpadden and Pelton also describe heat treating medical tools that include a nickel-titanium component.

[00:20:42] Speaker 04:
That's right in the decision.

[00:20:43] Speaker 04:
That's at the appendix in page 17.

[00:20:45] Speaker 04:
McSpadden, in particular, teaches heat treating a fully formed endodontic file, which of course includes the entire nickel-titanium shank, in order to achieve a desired degree of super-elasticity and in order to set a desired file shape, which is pretty curved, meaning when you bend it, it stays bent.

[00:21:02] Speaker 04:
That's the exact problem that Dr. Loopy stated was his invention, that you would heat treat a portion of the nickel-titanium file such that when you bend it, it stays bent.

[00:21:15] Speaker 04:
You heat treat it.

[00:21:15] Speaker 04:
You want to raise its shape recovery temperature to above body temperature.

[00:21:20] Speaker 04:
So when you're actually using this file, it's going to bend.

[00:21:22] Speaker 04:
It's not going to spring back.

[00:21:23] Speaker 04:
It's going to follow the root canal.

[00:21:26] Speaker 04:
To Judge Bryson's question of Mr. Lieberman, when you're using this file, that's a portion of the file.

[00:21:32] Speaker 04:
A portion of the file that he treated, as disclosed by Masatani and suggested by the references in the Coon ground, is a portion of the file that goes into the patient's tooth.

[00:21:40] Speaker 04:
It's achieving the very goals that

[00:21:42] Speaker 04:
Dr. Lupe says he invented it, and Mr. Lieberman says Dr. Lupe invented it.

[00:21:47] Speaker 04:
That's precisely the problem that Mr. Lieberman says, this was a cat's pajamas in the reply brief.

[00:21:54] Speaker 04:
He said everybody thought he wouldn't remove the super elasticity.

[00:21:57] Speaker 04:
Well, the references that make up both the Masutani ground and the Kuhn ground make it clear that it was not Dr. Lupe's invention.

[00:22:05] Speaker 04:
He was not the one who thought of heat treating a nickel titanium file, a portion of that file.

[00:22:10] Speaker 04:
so that you could remove the super-elasticity.

[00:22:13] Speaker 04:
That was well known in the prior art.

[00:22:15] Speaker 04:
That was known in Mazzotani, that was known in Kuhn, and in combination with the references that the board relied on.

[00:22:22] Speaker 04:
And that included Dr. Kolker's testimony.

[00:22:38] Speaker 04:
Regarding the motivation to combine in both the Masutani and Kuhn grounds, the board specifically considered the evidence of record, including the testimony of Dr. Goldberg, in finding that it would have been obvious to modify and or combine the cited references to heat treat the entire shank as opposed to just a portion.

[00:22:55] Speaker 04:
As mentioned, it's going to avoid, indisputably, it's going to avoid the difficulties and added expense of having these additional steps just to partially heat treat the file.

[00:23:10] Speaker 04:
And Your Honors, with that, unless there's any additional questions for the reasons discussed today and in U.S.

[00:23:14] Speaker 04:
Endo's brief, it is U.S.

[00:23:16] Speaker 04:
Endo's position that the board's decision should be affirmed.

[00:23:19] Speaker 04:
Unless there's any further questions, I'll ask.

[00:23:21] Speaker 01:
Thank you.

[00:23:21] Speaker 04:
Thank you.

[00:23:25] Speaker 05:
I'd like to make four brief points.

[00:23:35] Speaker 05:
The first addresses the question that you would ask Chief Judge Crost

[00:23:38] Speaker 05:
about procedure.

[00:23:41] Speaker 05:
With respect with least vacuum ground, USNDO never raised in its briefs to the board, either of its briefs, an obvious to try or finite number of alternatives argued.

[00:23:53] Speaker 05:
They did not make that argument.

[00:23:55] Speaker 05:
If you search their briefs, you won't find obvious to try.

[00:23:58] Speaker 05:
You won't find the words finite number of alternatives or anything like that.

[00:24:03] Speaker 05:
It is not in their briefs.

[00:24:05] Speaker 05:
This was an argument that the board

[00:24:07] Speaker 05:
raised on its own in a decision to which we did not have the opportunity to respond.

[00:24:13] Speaker 05:
Did you ask for reconsideration?

[00:24:15] Speaker 05:
We did not, Your Honor.

[00:24:17] Speaker 05:
Asking for reconsideration, as you know, what the board is... We didn't think, given all the errors in the board's decision, that that was the appropriate forum to address this.

[00:24:29] Speaker 05:
Because we saw at least four procedural errors, and we thought it would be better to bring those issues to this court.

[00:24:34] Speaker 02:
Did it come up in oral argument?

[00:24:36] Speaker 05:
Oh, it did come up in oral argument.

[00:24:38] Speaker 05:
But it did not come up in the briefs.

[00:24:40] Speaker 05:
It was not an argument made in the briefs at all.

[00:24:42] Speaker 05:
And it wasn't an argument made in the briefs at all, because their only argument with respect to Kuhn was that Kuhn was an anticipatory reference.

[00:24:50] Speaker 05:
And when the board found that it wasn't anticipatory, the board had to cobble together.

[00:24:54] Speaker 05:
And I don't mean that in a derogatory fashion.

[00:24:57] Speaker 05:
They had to cobble together an obviousness argument.

[00:24:59] Speaker 05:
And they chose a logical path that had not been argued by U.S.

[00:25:05] Speaker 05:
Endo, and thus it wasn't

[00:25:06] Speaker 05:
one to which we had the opportunity to respond.

[00:25:10] Speaker 01:
Well, I don't understand then your answer to Judge Still's question about whether it came up at oral argument.

[00:25:15] Speaker 01:
Did it come up in a way that you got to respond?

[00:25:18] Speaker 01:
I mean, if it came up, it came up, right?

[00:25:20] Speaker 01:
So how did it come up?

[00:25:23] Speaker 05:
There were questions at oral argument about different ways of doing things.

[00:25:28] Speaker 05:
Sure, questions aimed at you that you responded to?

[00:25:30] Speaker 05:
I don't remember to whom the questions were asked, but it doesn't matter.

[00:25:33] Speaker 05:
When something is raised only for the first time at oral argument,

[00:25:36] Speaker 05:
This court in the Henry Nuvaceff case has made very clear it's too late.

[00:25:40] Speaker 05:
It's waived.

[00:25:43] Speaker 05:
This court has dealt many times, not just with that issue coming up in appeals for PTAP proceedings, but when parties raise arguments for the first time in an oral argument in this court.

[00:25:51] Speaker 03:
Now, this would affect, I take it, only the Cuban ground and not the Mazzutani ground for obviousness.

[00:25:57] Speaker 05:
Yes, there was a reference in page four to five of the reply brief with respect to the Mazzutani ground.

[00:26:03] Speaker 05:
So the issue was,

[00:26:04] Speaker 05:
Although only obliquely raised, it was raised with respect to Matsutani.

[00:26:09] Speaker 05:
I'm sorry.

[00:26:10] Speaker 03:
Are you saying that the argument you're just now making about the problem with Kuhn, that doesn't apply to Matsutani?

[00:26:18] Speaker 03:
That's correct.

[00:26:20] Speaker 05:
That's correct.

[00:26:21] Speaker 05:
The second point is with respect to Goldberg.

[00:26:24] Speaker 05:
Goldberg's conclusory declaration, let's put aside conclusory for a second, only deals with the issue of

[00:26:31] Speaker 05:
expense and ease of use.

[00:26:33] Speaker 05:
Again, going back to the I-beam example, if a piece of prior art says, you shouldn't have an I-beam that's less than a certain width, because if you do, the building may fall down.

[00:26:42] Speaker 05:
And somebody says, but I can use a lighter I-beam.

[00:26:45] Speaker 05:
It's easier to get in, and it's cheaper to buy.

[00:26:48] Speaker 05:
That doesn't deal with the issue.

[00:26:49] Speaker 05:
And that's what Masutani was saying.

[00:26:51] Speaker 05:
You may have this lack of fixed rotational axis, which is going to cause this terrible problem with the tooth.

[00:26:57] Speaker 05:
And the response is, well, but it would be cheaper to heat the whole thing.

[00:27:00] Speaker 05:
Now, how did the board deal with that?

[00:27:02] Speaker 05:
The board never addressed that.

[00:27:04] Speaker 05:
And that's why this court's rulings would say, you have to deal with reasonable expectation of success.

[00:27:10] Speaker 05:
They're so important.

[00:27:11] Speaker 05:
This court, in an opinion by Judge Lurie last week, a Honeywell case, dealt with an almost identical situation at the Slope opinion in pages 11 and 12.

[00:27:21] Speaker 05:
They said that you have to deal with reasonable expectation of success, and you cannot shift the burden to the patentee to show that.

[00:27:31] Speaker 05:
the prior that uh... uh... that a person who already still would have thought that the invention was unworkable.

[00:27:37] Speaker 05:
That's exactly what the panel did at pages eighteen and twenty-seven of the appendix.

[00:27:43] Speaker 05:
They shifted the burden.

[00:27:44] Speaker 05:
They said GSI has not proven that it would be unworkable to do X. They shifted the burden and they never discussed the question of what do you do with the Masutani problem and how do you weigh that against its less expensive

[00:27:59] Speaker 05:
Would a person of worthy skill have said, OK, maybe it's not such a big risk.

[00:28:04] Speaker 05:
He used the word may.

[00:28:06] Speaker 05:
He didn't say it will.

[00:28:07] Speaker 05:
But if I can say it 20%, the board didn't even talk about that issue.

[00:28:12] Speaker 05:
And that's absolutely critical.

[00:28:14] Speaker 05:
Also, Your Honor, he asked me questions about the specification.

[00:28:17] Speaker 05:
We'll give you two specification sites, column 6, lines 49 to 55, and column 9, lines 19 to 23, talk about the rationale for heat treating the file.

[00:28:29] Speaker 05:
I see my time is up.

[00:28:31] Speaker 05:
I have a concluding point, if the court would permit.

[00:28:37] Speaker 05:
A brief one.

[00:28:38] Speaker 05:
A brief one.

[00:28:41] Speaker 05:
On the issue of McSpadden, which Mr. Ginsburg mentioned, the McSpadden reference is very clear.

[00:28:47] Speaker 05:
And this is appendix 2354 and 2365 to 66.

[00:28:53] Speaker 05:
All three of the embodiments of McSpadden are described as being stiff

[00:28:59] Speaker 05:
stiffer, not more flexible, not less firm, and the abstract also says the file is stiffer than comparable files fabricated from conventional nighttime.

[00:29:10] Speaker 05:
McSpatten is teaching way just as Natsutani is.

[00:29:13] Speaker 05:
Thank you, Your Honors.

[00:29:13] Speaker 05:
We thank both sides of the cases submitted.