[00:00:03] Speaker 02:
We now move from the groin to the bone.

[00:00:08] Speaker 02:
Our next case is Four Mile Bay versus Zimmer Biomet Holdings, 2017.

[00:00:14] Speaker 02:
Mr. Lyron.

[00:00:16] Speaker 02:
Yes, sir.

[00:00:25] Speaker 00:
May it please the court, my name is Philip Lyron.

[00:00:26] Speaker 00:
I am counsel for Four Mile Bay Patent Owner.

[00:00:31] Speaker 00:
I'm also the inventor of the 582 patent.

[00:00:35] Speaker 00:
This case presents four important legal issues relating to the claim construction that will significantly impact the PTAB and IPR and PGR proceedings.

[00:00:45] Speaker 00:
These four legal issues include, first, due process under the Fifth Amendment.

[00:00:52] Speaker 00:
Can the PTAB change claim construction midstream in an IPR without giving the patent owner notice?

[00:00:57] Speaker 00:
Number two, relying on disavowed claim construction.

[00:01:02] Speaker 02:
Isn't this simply a question of whether two references were properly combined?

[00:01:10] Speaker 00:
That's a substantial evidence question.

[00:01:13] Speaker 00:
I'm addressing the legal issues, the legal issues on claim construction.

[00:01:19] Speaker 00:
There are two substantial evidence questions true.

[00:01:22] Speaker 00:
Did the reference and teaser suggest the claims?

[00:01:28] Speaker 00:
legal issue is relying on a disavowed claim construction.

[00:01:33] Speaker 00:
Can the PTAB rely on a claim construction that it previously disavowed as being unreasonable to invalidate a patent in an IPR proceeding?

[00:01:41] Speaker 00:
The third regards functional gist.

[00:01:44] Speaker 00:
When can a PTAB reduce the claim language to a functional gist to invalidate a patent instead of looking at the actual words in the claim?

[00:01:54] Speaker 00:
The fourth legal issue is

[00:01:57] Speaker 00:
When can the PTAB read out words expressly recited in the claim?

[00:02:03] Speaker 00:
And the two issues regarding substantial evidence are whether Zulman and Rosteker, the combination, and the combination of Zulman and Boban, cease or suggest the claims.

[00:02:15] Speaker 00:
So let's look at the due process issue.

[00:02:19] Speaker 00:
Let's look at the facts briefly.

[00:02:21] Speaker 00:
In the institution decision, the board gave its first claim construction for the porous metal structure claim terms.

[00:02:28] Speaker 00:
Formile Bay relied on that claim construction in its response and presented all evidence based on that claim construction.

[00:02:35] Speaker 00:
In the final written decision, the board completely changed the claim construction from what was different in the institution decision and invalidated the patent based on the new claim construction.

[00:02:45] Speaker 00:
Formile Bay, we never had an opportunity to address the new claim construction.

[00:02:49] Speaker 00:
We never had an opportunity to present evidence of the new claim construction.

[00:02:53] Speaker 00:
And in fact, all the evidence that we presented was given little or no weight

[00:02:58] Speaker 00:
because the board said it was essentially directed to a wrong claim construction.

[00:03:01] Speaker 00:
So the indispensable right of due process is an opportunity of notice and to be heard, and we weren't given either, by changing claim construction midstream.

[00:03:10] Speaker 04:
As I understood the institution decision, the claim construction for this bone fixation body or whatever the claim term is, they pretty much just

[00:03:25] Speaker 04:
track the claim, the plain language of the claim, except for exchanging the word emulate for the word imitate?

[00:03:33] Speaker 04:
Correct.

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

[00:03:35] Speaker 04:
So how did it change from what is essentially a plain language interpretation of imitation to whatever you think they did at the final decision?

[00:03:48] Speaker 00:
So procedurally, Your Honor, what happened is when Petitioner Zimmer filed its initial petition,

[00:03:54] Speaker 00:
it asked for a claim construction.

[00:03:56] Speaker 00:
The claim recites a size and a shape of bone.

[00:03:58] Speaker 00:
That's what the porous material looks like.

[00:04:00] Speaker 00:
In its initial brief, Zimmer said, we want to replace that language, the structural language, with functional language, just to say sufficiently porous for bone to grow.

[00:04:11] Speaker 00:
In the institution decision, the board said, I'm reading here, we're not persuaded by petitioners proposed claim construction, i.e., a structure that is sufficiently porous so as to permit bone and growth.

[00:04:23] Speaker 00:
Petitioners' proposed claim destruction does not give sufficient words or sufficient meaning to the words in the claim.

[00:04:28] Speaker 00:
That was correct.

[00:04:30] Speaker 00:
Then what the board did in the final written decision, they turned around and used that exact same claim construction that they disavowed in the initial decision and used it to invalidate the claims.

[00:04:40] Speaker 00:
Let me read the final written decision.

[00:04:42] Speaker 00:
They expressly, we credit specifically Dr. Harrigan's testimony that the porous metal structure disclosed in the... Where are you in the board's decision?

[00:04:52] Speaker 00:
I don't.

[00:04:55] Speaker 00:
I quoted it.

[00:04:56] Speaker 00:
Well, just speak slowly, and maybe I'll hunt around in front of you while you're talking.

[00:05:00] Speaker 00:
This is the final written decision.

[00:05:02] Speaker 00:
It says, we credit specifically Dr. Harrigan's testimony that the porous metal structure.

[00:05:07] Speaker 02:
Page 34.

[00:05:10] Speaker 00:
The porous metal structure disclosed in Rosteker is sufficiently porous so as to permit bone and growth.

[00:05:17] Speaker 00:
And that satisfies the requirement for a porous metal structure having to size and shape a bone.

[00:05:23] Speaker 00:
a size and shape that emulated size and the shape of bone.

[00:05:25] Speaker 00:
So you can see in the final written decision, they use the exact language that they previously disavowed in the, in the, in the.

[00:05:33] Speaker 04:
Isn't that tracking the claim language?

[00:05:37] Speaker 00:
No, not at all.

[00:05:38] Speaker 04:
You know, would have been motivated to fabricate Zollman's porous pad so as to have a porous fiber, fiber metal structure that emulates or imitates a size and a shape of a porous structure of natural human bone.

[00:05:52] Speaker 04:
I thought that was the claim language.

[00:05:55] Speaker 00:
No, the claim language recites that the porous structure has to have a size and a shape of natural human bone.

[00:06:00] Speaker 00:
The claim doesn't recite anything regarding the function.

[00:06:04] Speaker 00:
What the board did is it substituted the structure of size and shape of bone.

[00:06:08] Speaker 00:
That's the specific shape that it has to have.

[00:06:11] Speaker 00:
We'll forget about this, the shape of bone.

[00:06:14] Speaker 00:
We're just going to assume that it just has to have the function to promote bone and growth.

[00:06:19] Speaker 04:
But I guess what I'm saying is it quotes the claim language right in that sentence in 834, so as to have a porous fiber metal structure that emulates or imitates a size and a shape of a porous structure of natural human bone.

[00:06:34] Speaker 04:
It says it right there.

[00:06:35] Speaker 00:
Right, but they never address the issue.

[00:06:37] Speaker 00:
They never address the issue.

[00:06:39] Speaker 00:
Does the art of record teach a structure that has a size and a shape of bone?

[00:06:43] Speaker 00:
It's a simple question, because that's what the claim recites.

[00:06:46] Speaker 04:
Well, what about 824?

[00:06:49] Speaker 04:
We credit specifically Dr. Harrigan's testimony that the porous metal structure disclosed in Rostocker is sufficiently porous so as to permit bone ingrowth and satisfies the requirement for a porous metal structure having a size and a shape that emulate a size and a shape of a porous structure of natural human bone.

[00:07:12] Speaker 00:
Exactly.

[00:07:12] Speaker 04:
And then it goes on and says moreover we find Rostocker teaches fabricating a fiber metal structure that contains

[00:07:19] Speaker 04:
interconnecting pores and a controlled pore size such that the porosity of the metal structure approximates the porosity of surrounding bone permitting bone ingrown.

[00:07:27] Speaker 04:
So to me, I don't quite follow the line of your argument when you say that the board here in the final written decision abandoned the claim language and the claim interpretation that it chose in the institution which tracked the claim language when there

[00:07:47] Speaker 04:
They're parroting the claim language right here in their analysis for why Rostaker, in fact, teaches this particular claim limitation.

[00:07:54] Speaker 00:
Well, what they should have said, if they wanted to say it correctly, is they should have said that Rostaker teaches the size and the shape of bone, which they didn't.

[00:08:02] Speaker 00:
In other words, they're avoiding the central issue in this case.

[00:08:08] Speaker 00:
Is the porous structure and the prior art have both the size and the shape of bone?

[00:08:13] Speaker 00:
That's the question.

[00:08:14] Speaker 00:
And then the question is, what is the shape of bone?

[00:08:27] Speaker 00:
The other issue, the other legal issue is, when can a board read out limitations that are expressly recited in a claim?

[00:08:34] Speaker 00:
The claim recites that it has to have a size and a shape of bone.

[00:08:39] Speaker 00:
But in the final written decision, the board affirmatively read that out.

[00:08:43] Speaker 00:
They said, we determined that the broadest reasonable interpretation consistent with the specification of the porous middle structure claim terms is they do not require emulating the size and the shape of bone.

[00:08:55] Speaker 04:
Where does it say that?

[00:08:57] Speaker 00:
That's in the final written decision.

[00:08:59] Speaker 00:
I don't have the page number.

[00:09:02] Speaker 04:
I mean, as I recall from the board's decision, they rejected your theory that emulating natural human bone is restricted to cancerless bone, right?

[00:09:16] Speaker 04:
Because they saw in the specification that human bone could be referring to cancerless bone or cortical bone.

[00:09:25] Speaker 04:
And so therefore, it

[00:09:27] Speaker 04:
said that your narrow reading of limiting bone to just cancerless bone is too narrow and it couldn't accept that theory of the claim.

[00:09:38] Speaker 04:
Is that a correct understanding of what the board said?

[00:09:44] Speaker 04:
I understand you disagree with it, but is that a correct understanding of what the board said?

[00:09:49] Speaker 00:
Yes.

[00:09:49] Speaker 00:
That was what the board's position is.

[00:09:51] Speaker 00:
The problem with that argument is it disregards the claim language.

[00:09:56] Speaker 00:
I submitted publication evidence showing that the shape of bone was cortical and cancerless bone is the same.

[00:10:01] Speaker 00:
So was it cancerless or cortical?

[00:10:03] Speaker 00:
Regardless of whether the substantial evidence of both parties submitted evidence saying that it was cancerless bone, that aside, you still have to answer the question, does the porous metal structure of the prior art have the shape of bone?

[00:10:18] Speaker 00:
That's what the claim says, and that's the question that needs to be addressed when you're doing your analysis.

[00:10:23] Speaker 00:
They did not do that.

[00:10:26] Speaker 00:
In fact, they read it out.

[00:10:27] Speaker 00:
They read out.

[00:10:28] Speaker 00:
And there was nothing in the file history to read out anything from the claim that supported reading anything out from the claim.

[00:10:35] Speaker 00:
So my time is up.

[00:10:36] Speaker 00:
So I'll.

[00:10:37] Speaker 02:
You could continue.

[00:10:39] Speaker 02:
It is your rebuttal time.

[00:10:40] Speaker 02:
I'll save it for you.

[00:10:41] Speaker 02:
OK, thank you.

[00:10:41] Speaker 02:
Thank you.

[00:10:43] Speaker 02:
Mr. Park.

[00:10:56] Speaker 01:
You may please the court.

[00:10:58] Speaker 01:
I am Young Park, representing Petitioner and FLE Zimmer Biomed Holdings.

[00:11:06] Speaker 01:
I guess I'll just jump right into some of the arguments that were made by FMB in its opening remarks.

[00:11:13] Speaker 01:
First of all, there was no change in the claim construction between the institution and the final decision.

[00:11:21] Speaker 01:
As Judge Chen recognized,

[00:11:25] Speaker 01:
Basically, in the institution decision, the board had substituted the word imitate for emulate.

[00:11:34] Speaker 01:
And in the final decision, the board, again, maintained that plain meaning construction and rejected FMB's attempt to read into a limitation that the forest metal structure is required to have rods and plates that are seen in a particular type

[00:11:55] Speaker 01:
of a bone, namely cancerless or trabecular bone.

[00:12:02] Speaker 01:
In addition, with regard to whether there's substantial evidence, this was a classic battle of experts where, for example, with the Bobbin and Zollman combination, FMB argued that

[00:12:23] Speaker 01:
a person with skill in the yard would not have been able to make the bobbin material to wrap around the Zollman implant.

[00:12:29] Speaker 01:
Zimmer's expert provided testimony that a person with skill in the yard could have made that modification and the board accepted Zimmer's expert's testimony on that and there's no substantial evidence, there's no evidence

[00:12:48] Speaker 01:
demonstrating that the board lacks substantial evidence to support its finding.

[00:12:51] Speaker 04:
There was another argument that if you were to use Zollman's manufacturing method on Bobbin's material, by pressing Bobbin's material, it would end up crushing the material in Bobbin.

[00:13:06] Speaker 01:
Yes.

[00:13:06] Speaker 01:
So to that, again, there's testimony in the record that, well, implicit in FMB's expert's testimony is that

[00:13:18] Speaker 01:
You can, this material is strong and docile, and so it would be able to withstand a certain amount of pressing.

[00:13:25] Speaker 01:
But that said, pressing wasn't even required.

[00:13:27] Speaker 01:
As the board recognized, this is, bobbin is a material that can be made into complex shapes.

[00:13:34] Speaker 01:
And so, as KSR teaches, you don't necessarily have to kind of follow the prior art teaching on a one-to-one scale and do exactly what the prior art

[00:13:47] Speaker 01:
one of the prior art references taught, you know, a person with skill in the art would have skill and creativity to modify the prior art methods to make one reference's teaching work with the other reference's teaching.

[00:14:00] Speaker 04:
Did the board say that?

[00:14:01] Speaker 04:
Did the board say when using Bobbin's material on Zollman's device, you would just use whatever manufacturing method to make Bobbin's material and not use Zollman's manufacturing method for the pad?

[00:14:13] Speaker 01:
No, actually, again,

[00:14:16] Speaker 01:
I was just specifically addressing your honor's question.

[00:14:19] Speaker 03:
Yeah, I thought you said that the board said that.

[00:14:21] Speaker 03:
So that's what I'm trying to figure out if the board actually said that.

[00:14:25] Speaker 01:
No, the board applied the teaching from Zollman in combination with Bobbin's teachings where basically you could make the porous pad and you could wrap that porous pad around the implant and the board relied on evidence presented by

[00:14:45] Speaker 01:
Zimmer's expert, Dr. Harrigan.

[00:14:47] Speaker 04:
Right.

[00:14:47] Speaker 04:
The board relied on your expert's argument that Bobbin's material could handle Zollman's pressing.

[00:14:58] Speaker 04:
Is that right?

[00:14:58] Speaker 01:
To be fair, I don't think the issue of pressing was necessarily presented through Dr. Harrigan's testimony.

[00:15:08] Speaker 01:
And the reason why is because it wasn't necessary to have a pressing step.

[00:15:12] Speaker 01:
So in Zollman,

[00:15:15] Speaker 01:
The pressing step is one of the initial steps that are taken where you form the porous pad.

[00:15:21] Speaker 04:
So what did the board say about Zollman's pressing?

[00:15:24] Speaker 04:
The board said nothing?

[00:15:26] Speaker 01:
I don't recall the board.

[00:15:28] Speaker 01:
I'll recheck the record, but I don't recall the board saying anything about pressing.

[00:15:33] Speaker 01:
If they did say something about pressing, it would have been to the effect of Bobbin's material is stated to be strong, and so it would be able to withstand a certain amount of pressing.

[00:15:43] Speaker 01:
But I think the point here is that,

[00:15:45] Speaker 01:
the board did recognize that Bobbin's material could be made into very complex shapes.

[00:15:53] Speaker 01:
And so you would just avoid the pressing step altogether.

[00:15:58] Speaker 01:
It's just not necessary.

[00:15:59] Speaker 01:
That's the testimony from Harrigan.

[00:16:03] Speaker 04:
And the board said that?

[00:16:07] Speaker 01:
I don't think the board said it because that evidence wasn't presented in that manner through Dr. Harrigan's testimony.

[00:16:14] Speaker 01:
So Dr. Harrigan

[00:16:16] Speaker 01:
and the board recognized you have this material that can be made into a complex shape.

[00:16:21] Speaker 01:
And so you wouldn't need to do the pressing step that you would need with the Zollman-centered wire embodiment.

[00:16:27] Speaker 01:
And so you just basically make the pad with the bobbin material.

[00:16:32] Speaker 01:
And then you would avoid the pressing step.

[00:16:34] Speaker 01:
All you need to do is just wrap it around the staff.

[00:16:37] Speaker 03:
But you don't know if the board said that?

[00:16:39] Speaker 01:
Honestly, I do not recall right now.

[00:16:41] Speaker 01:
I was saying here, I know that specific information.

[00:16:46] Speaker 04:
What about Rostocker?

[00:16:49] Speaker 04:
How is the porous structure, the size and shape of Rostocker's material the same or imitate the size and shape of natural human bone?

[00:17:01] Speaker 01:
Sure.

[00:17:02] Speaker 01:
So first of all, I would like to point out that FMB does not challenge whether Rostocker discloses the porous metal structured claim terms under the board's claim construction.

[00:17:17] Speaker 01:
They argue that Rostocker doesn't disclose the plates and rods that one may find in a particular type of natural bone, which is cancerous bone.

[00:17:29] Speaker 01:
But to answer your honor's question, there's testimony from Dr. Harrigan, Zimmer's expert, saying that the pore size and shape in Rostocker could be modified so that it matches the pore diameter and the porosity

[00:17:47] Speaker 01:
and the characteristics for the porous metal structure that was disclosed in the specification of the 5-82 patent.

[00:18:00] Speaker 01:
One thing I'd like to clarify is that on a few occasions, FMB's counsel characterized the asserted claim limitation, the disputed claim limitation as

[00:18:16] Speaker 01:
a size and shape of bone.

[00:18:18] Speaker 01:
It's actually a porous metal structure having a size and shape that emulates a size and shape of the porous structure of natural bone.

[00:18:31] Speaker 01:
So again, it's not specifically directed to the microstructures that are forming the pores in the porous structure.

[00:18:44] Speaker 01:
I know I still have a large amount of time left to me, but if your honors do not have any additional questions.

[00:18:54] Speaker 02:
No one ever loses points for not using up all of their time, Mr. Stock.

[00:19:01] Speaker 02:
Mr. Lauren, do you have some rebuttal time?

[00:19:11] Speaker 00:
Thank you.

[00:19:11] Speaker 00:
Zimmer mentioned that there was no change in claim construction.

[00:19:14] Speaker 00:
I respectfully ask you to compare the claim construction in the institution decision with the claim construction in the final word decision.

[00:19:23] Speaker 00:
They're very different.

[00:19:25] Speaker 00:
With regard to substantial evidence, and let's look at Zulman and Bowman.

[00:19:35] Speaker 00:
Zulman method requires three steps, press, cut, and bend.

[00:19:43] Speaker 00:
Council is now saying that it doesn't require those steps.

[00:19:45] Speaker 00:
I don't know.

[00:19:46] Speaker 00:
That's the first I've heard of this.

[00:19:47] Speaker 00:
This is a new argument to me, and it wasn't presented to the board.

[00:19:52] Speaker 00:
Four Mile Bay presented a publication evidence called the Maine Publication.

[00:19:57] Speaker 00:
The Maine Publication was published by Dr. Matthew Frank, who's professor emeritus at Iowa State University.

[00:20:06] Speaker 00:
In that publication, they took Bowman's material, exact same material, and they said, let's try to cut it.

[00:20:12] Speaker 00:
They failed.

[00:20:13] Speaker 00:
could not do it.

[00:20:15] Speaker 00:
This was five years after filing the patent application.

[00:20:19] Speaker 00:
They came up with a new patented method to actually cut it.

[00:20:22] Speaker 00:
It's called an infiltration.

[00:20:23] Speaker 00:
And then they filed a patent on it.

[00:20:25] Speaker 00:
They figured out a way.

[00:20:26] Speaker 00:
In that publication, and I submitted the diagrams, they go into great detail.

[00:20:29] Speaker 00:
They show diagrams why you can't cut this material, because it's ductile, because it deforms, it destroys the material.

[00:20:38] Speaker 00:
In the final written decision, here's what the PTAB said about that.

[00:20:43] Speaker 00:
The PTAB basically said, we're not going to give any weight to that evidence, because it's, quote, directed to a more fragile version of the material.

[00:20:54] Speaker 00:
How can it be directed to a more fragile version of the material when the main publication showed pictures of Bowman's material, actually cited Bowman's article, saying, this is the material we're going to try to cut.

[00:21:06] Speaker 00:
Oh, we can't cut it.

[00:21:07] Speaker 00:
It failed.

[00:21:08] Speaker 00:
It destroyed it.

[00:21:11] Speaker 04:
There was also another publication that was... Well, the board at A43 was talking about how your expert, Dr. Hemis, was saying, well, he was commenting about Bobbin's biomaterial and how he would have problems if it, Bobbin's material, were made to emulate human bone.

[00:21:35] Speaker 04:
And so the board was confused by

[00:21:37] Speaker 04:
these statements by Dr. Hemis and Dr. Vincelli about if you were to make Bobbin's material to emulate the structure of human bone.

[00:21:49] Speaker 04:
And so the board concluded that the experts were not actually addressing the specific material taught in Bobbin.

[00:21:58] Speaker 00:
Well, Bobbin's material does emulate the structure of human bone.

[00:22:01] Speaker 04:
And most experts said that.

[00:22:02] Speaker 04:
But there was some kind of equivocation

[00:22:06] Speaker 04:
the expert's testimony about making an adjustment to Bobbin's biomaterial.

[00:22:11] Speaker 04:
And then if you were to make that adjustment, then here are the kinds of problems you would have to that version, not the actual version of Bobbin's material itself.

[00:22:22] Speaker 04:
As I understand it, that was the board's criticism of these two doctors' testimony.

[00:22:30] Speaker 00:
I'll give a short closing.

[00:22:32] Speaker 00:
Don't have much time.

[00:22:34] Speaker 00:
I travel all around Asia, Hong Kong, China, Singapore.

[00:22:38] Speaker 00:
And I give talks on US patent law.

[00:22:41] Speaker 00:
And I give talks to large universities, technology centers, and technology companies, some of the largest in the world.

[00:22:48] Speaker 00:
These entities file patents all around the world, including the United States.

[00:22:52] Speaker 00:
At the end of almost every single presentation, I get the same question from an audience member.

[00:22:57] Speaker 00:
Why should we spend our money to file a patent in the United States?

[00:23:02] Speaker 00:
when most of the patents are invalidated by the PTAB anyhow.

[00:23:06] Speaker 00:
You know what?

[00:23:07] Speaker 00:
They're right.

[00:23:09] Speaker 00:
The patent owner has no chance to win at the PTAB if the PTAB can change claim construction midstream and not give notice and an opportunity to be heard based on that claim construction, can reduce it to a functional gist, can read out in the final written decision structure in the claim, can disregard publication evidence

[00:23:30] Speaker 00:
Based on a nebulous concept of what material was being cut when they said it was Bowman's material, by a team of disinterested scientists, disinterested scientists couldn't cut the material.

[00:23:41] Speaker 00:
When the board can do that, the patent owner doesn't have a chance to win.

[00:23:45] Speaker 00:
This court has an opportunity to change how the PTAB invalidates patents using claim construction.

[00:23:52] Speaker 00:
Thank you for your time.

[00:23:54] Speaker 02:
Thank you, Mr. Lyron.

[00:23:56] Speaker 02:
I appreciate your presentation.

[00:23:58] Speaker 02:
Take the case from the submission.

[00:24:01] Speaker 02:
That concludes today's arguments.