[00:00:47] Speaker 00:
Please proceed.

[00:00:48] Speaker 00:
Thank you.

[00:00:48] Speaker 00:
Thank you, Your Honors.

[00:00:49] Speaker 00:
May it please the court?

[00:00:51] Speaker 00:
Matt Wolf for Conformis.

[00:00:53] Speaker 00:
The claimed embodiments are a device for essentially a drill guide, a saw guide, that sits on top of, in this case, a knee joint and is designed so that it can take into account the fragile, frayed, degraded, diseased cartilage

[00:01:13] Speaker 01:
It's not your fault, but you're really close, and you're speaking very loudly.

[00:01:17] Speaker 00:
I apologize, Your Honor.

[00:01:19] Speaker 00:
I've been accused of that more than once, and I should have learned by now.

[00:01:22] Speaker 00:
It sits on top of the knee and preserves the cartilage while at the same time providing a firm fixation so that when you drill, you're drilling in the right place.

[00:01:31] Speaker 00:
When you saw off a piece of bone, you're sawing in the right place, and the patents teach

[00:01:36] Speaker 00:
how to do this.

[00:01:37] Speaker 00:
It teaches how to assess the defects, how to image, model, select the proper materials, and most importantly, shape and size the temporary device so it sits on top of the cartilage and the bone and provides that stable platform we're talking about.

[00:01:54] Speaker 00:
The primary reference here that the PTAB relied upon, Rademacher, is similar in that it's designed to provide a temporary drill guide, but it rests on bone.

[00:02:07] Speaker 00:
It rests on bone, and there is no mention of cartilage in the patent.

[00:02:11] Speaker 00:
There's no mention of cartilage anywhere in the history.

[00:02:15] Speaker 00:
And perhaps more importantly, all those teachings I mentioned that the patents that issue tell you how you can incorporate and rely upon the cartilage for that negative image to sit there properly.

[00:02:28] Speaker 00:
None of that teaching of assessment of defects, imaging, shaping, sizing, selection, modeling, none of that is in Radomod.

[00:02:36] Speaker 00:
So that's what we're talking about today.

[00:02:38] Speaker 01:
Well, but the story doesn't end there because it was an obvious, obviousness combination of Rademacher with Fell and Alexander.

[00:02:47] Speaker 00:
Yes and no, Your Honor, and I say the no part because if you read the PTAB's opinion, it really reads like a single reference obviousness case.

[00:02:56] Speaker 00:
What Fell and Alexander add, I'm not clear sitting here today.

[00:03:02] Speaker 00:
What the PTAB's final written decision says is, in essence, Rademacher teaches everything.

[00:03:08] Speaker 00:
Well, the problem is, well, one of the problems is that the PTAB expressly refused to institute Rademacher as a single reference obviousness ground.

[00:03:18] Speaker 00:
This is an A6, the appendix.

[00:03:20] Speaker 00:
So having rejected Rademacher as single reference obviousness, as it should have, because Rademacher doesn't teach making a mirror image of cartilage to be able to rest on and preserve the cartilage in a stable and secure way.

[00:03:33] Speaker 00:
Having rejected that ground, it then turned around and looked at Alexander and Fell, and I'm speculating wildly here, Your Honor, and for that I apologize, but said, whoops, Fell and Alexander don't add anything.

[00:03:45] Speaker 00:
Alexander, and of course we've argued waiver in our briefs for the obvious reason that it's not mentioned in the PTAB's responsive brief here, but Alexander just teaches MRI techniques that were known that don't have anything to do with creating a mirror image template and fell

[00:04:01] Speaker 00:
is exactly the opposite of what the claimed embodiments are.

[00:04:06] Speaker 00:
I mean, at A1030, for example, the purpose is to achieve a span-like effort to bridge the defective areas, not to reflect, not to image the defective areas, but to bridge them, to go over them in the way that in a pothole on the street, you can either repair it or you can throw a big metal plate over it,

[00:04:24] Speaker 00:
Our patents are talking about engaging the hole, filling in the hole, using it for solidity, whereas FELL is saying go over it.

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And that's not disputed.

[00:04:33] Speaker 00:
Their expert, Dr. Mabry, and this is at 88144, does it match the patient's joint surface, meaning FELL?

[00:04:41] Speaker 00:
Answer, one word, no.

[00:04:44] Speaker 00:
So we have Rademacher that doesn't teach anything about the core of the invention of the claims at issue.

[00:04:52] Speaker 03:
Well, let me ask a question.

[00:04:53] Speaker 03:
Yes, Rhonda.

[00:04:54] Speaker 03:
I'm going to encourage you to try to speak more softly also, because your volume hasn't actually changed, and it is really loud.

[00:05:01] Speaker 03:
But the board did find that Rademacher teaches a surgical tool that

[00:05:12] Speaker 03:
mates with the knee joint, which naturally includes cartilage.

[00:05:16] Speaker 03:
and they said that because this includes operational, quote, the natural not pretreated surface of the osseous structure that that is without removing the cartilage so that it is in fact teaching use on cartilage, even though it may never mention the word cartilage in the reference, one of skill in the art would understand that it makes with a knee joint in its natural state, which includes cartilage.

[00:05:40] Speaker 03:
So that was their, as I understand it, their fact finding, which we have to review for substantial evidence.

[00:05:45] Speaker 03:
What's wrong with that?

[00:05:47] Speaker 00:
So, Your Honor, I think the quote from Fell, so let's separate what Fell says and what Radamacher says.

[00:05:52] Speaker 00:
What Fell is talking about is using a prosthetic meniscus.

[00:05:56] Speaker 00:
And it does say, made it, in the sense of, you want it to be the right shape.

[00:05:59] Speaker 03:
But I'm talking to you about what the board explicitly held as a fact-finding with regard to Radomach, or match, or whatever it is.

[00:06:08] Speaker 00:
The quote you were citing was actually pulling part of fell, because that's why I think there was a conflation.

[00:06:13] Speaker 00:
And I apologize if I misunderstood.

[00:06:15] Speaker 03:
No, it's probably my fault.

[00:06:16] Speaker 03:
I probably mixed them up.

[00:06:18] Speaker 00:
Your Honor, in terms of Rademacher, the board acknowledged, and this is at A84, that it doesn't say anything about cartilage.

[00:06:30] Speaker 00:
It repeatedly said... No, I said that.

[00:06:31] Speaker 03:
The board expressly indicates that it doesn't use the word cartilage, but it works on the natural

[00:06:37] Speaker 03:
meaty, which at that joint a skilled arsonist would know includes cartilage.

[00:06:41] Speaker 00:
So, Your Honor, they do talk about a sentence at 839 where it talks about a computer mold of parts of the individual natural, i.e.

[00:06:50] Speaker 00:
not pretreated, surface of the osseous structure.

[00:06:55] Speaker 03:
What I said is true.

[00:06:57] Speaker 03:
On page 84, when discussing rottermatcher,

[00:07:02] Speaker 03:
they said the terms bone and us us structure reflects an affirmative disclosure of matching only this is your contention bone and osseous material not cartilage rather we find the use of this language reflects a broad disclosure of different embodiments of bones some of which include natural cartilage on their outer surface and some of which do not so basically what i said is

[00:07:24] Speaker 03:
Correct.

[00:07:25] Speaker 01:
And then they say it again in 86 where they rely on the witnesses' testimony.

[00:07:29] Speaker 00:
Your Honor, I apologize if I misheard you.

[00:07:33] Speaker 00:
What it is saying about Rademacher is indisputably true that you can have cartilage on the knee of Rademacher.

[00:07:42] Speaker 00:
What Radamacher doesn't teach, doesn't say anything about, is that the device you're creating, the claimed device, reflects that cartilage, incorporates that cartilage.

[00:07:54] Speaker 00:
In some way, it mirrors that cartilage.

[00:07:56] Speaker 00:
That's why the fell language was, that was the confusion there.

[00:08:02] Speaker 00:
But Radamacher doesn't say anything about

[00:08:05] Speaker 00:
cartilage.

[00:08:06] Speaker 00:
To the contrary, every place that Rademacher talks about what it connects to, how it images, and let me just give you some examples.

[00:08:15] Speaker 00:
It is replete with statements like, quote, the template is on the exposed surface of the bone.

[00:08:20] Speaker 00:
That's at A838.

[00:08:21] Speaker 00:
The individual template 4 is set onto the bone 17.

[00:08:25] Speaker 00:
That's at A857.

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The individual template is, quote, set directly onto the exposed bone surface in a clearly defined manner, end quote.

[00:08:34] Speaker 00:
That's at A849.

[00:08:36] Speaker 00:
So Rademacher, not surprisingly, has an MRI procedure that can see the cartilage.

[00:08:41] Speaker 00:
We're not suggesting it's blind to the cartilage.

[00:08:43] Speaker 00:
But Rademacher doesn't suggest doing anything with it.

[00:08:46] Speaker 00:
It doesn't suggest that you take the information you may have about cartilage that may be there, likely is there, and then therefore create the image that is the heart of the claim.

[00:08:56] Speaker 00:
The claim is about taking the image of cartilage and mirroring it.

[00:09:01] Speaker 00:
And Radamacher says, take whatever image you want.

[00:09:04] Speaker 00:
But then what you're mirroring is the bone.

[00:09:07] Speaker 00:
What you're attaching to is the bone.

[00:09:09] Speaker 03:
I'm sorry.

[00:09:09] Speaker 03:
Perhaps I misunderstand the board's opinion at page 86 when they cite Dr. Mabry's testimony.

[00:09:14] Speaker 03:
which they explained that some would include cartilage only.

[00:09:19] Speaker 03:
Some would include cartilage and bone.

[00:09:20] Speaker 03:
Others would include only exposed bone.

[00:09:22] Speaker 03:
And they wanted to say this is consistent with Rottemeyer's broad disclosure.

[00:09:27] Speaker 03:
of applying this to various types of bone, some of which include and some of which exclude cartilage.

[00:09:32] Speaker 00:
Your Honor, we don't disagree with any of those fact findings.

[00:09:35] Speaker 00:
We absolutely agree with all of that.

[00:09:37] Speaker 01:
The question is not, does Rademacher, in step one... Yeah, but then, okay, so then if you're talking about combining it with the other references, the board goes on to conclude, even if Rademacher only teaches matching a surface to the bone,

[00:09:52] Speaker 01:
It would have been obvious to swap out the bone only imaging information of Rademacher with bone plus cartilage imaging information taught by Fell and Alexander to make the claim surgical too.

[00:10:05] Speaker 01:
Why don't, why isn't there substantial evidence to support that conclusion?

[00:10:11] Speaker 00:
Your honor, there's, because, and the word imaging kept appearing in the quote you read, your honor, and that's exactly my point.

[00:10:17] Speaker 00:
That's exactly the error.

[00:10:18] Speaker 00:
The quote you just summarized is where we think the PTAB went awry.

[00:10:22] Speaker 00:
The issue is not whether Radamacher images

[00:10:27] Speaker 00:
catches in its MRI cartilage.

[00:10:29] Speaker 00:
Of course it does.

[00:10:30] Speaker 00:
The question is not whether Alexander images cartilage.

[00:10:34] Speaker 00:
Of course it does.

[00:10:36] Speaker 00:
Anybody imaging the knee for any purpose is going to see the cartilage.

[00:10:41] Speaker 00:
The claim is not about imaging.

[00:10:42] Speaker 00:
The claim is about what you do with the image.

[00:10:45] Speaker 00:
The claim is then having the image of cartilage.

[00:10:47] Speaker 00:
Include cartilage information, right?

[00:10:49] Speaker 00:
But then, does your template reflect the image you capture?

[00:10:55] Speaker 00:
Is your template of the bone, or is your template of the bone plus cartilage?

[00:10:59] Speaker 00:
And there's nothing in Rademacher or Fell or Alexander that says your device does anything with the cartilage information.

[00:11:07] Speaker 00:
To the contrary, as I just read that laundry list of Rademacher, it says you match to the bone.

[00:11:13] Speaker 00:
It says it.

[00:11:13] Speaker 03:
But it does say it uses basically non-pre-treated

[00:11:19] Speaker 03:
surface of the osseous structure, which, unless I'm mistaken, given the rest of this closure, sometimes it includes cartilage.

[00:11:27] Speaker 00:
Your Honor, two responses to that.

[00:11:29] Speaker 00:
One is, that is step one, and that's 8003.

[00:11:32] Speaker 03:
Yeah, but if you don't remove the cartilage, and the cartilage is present, and then you're making this template based on that joint, you're including, I think it's certainly substantial evidence would support the idea that you're including the cartilage.

[00:11:46] Speaker 03:
And that's what the board found.

[00:11:48] Speaker 03:
I don't see how on a substantial evidence standard we could undermine that.

[00:11:51] Speaker 00:
Your Honor, because, respectfully, that's not in Rademacher.

[00:11:57] Speaker 00:
You can see the cartilage.

[00:11:58] Speaker 00:
So if the bone is a regular shape and there's cartilage that's in an irregular shape.

[00:12:03] Speaker 03:
Well, they said natural, not pretreated surface, correct?

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

[00:12:05] Speaker 00:
That's in the imaging step.

[00:12:07] Speaker 00:
That's talking about imaging, not the creation of the template.

[00:12:10] Speaker 00:
It's literally step one and step two.

[00:12:12] Speaker 00:
So if you look at that page of Rademacher, that is in the imaging step.

[00:12:16] Speaker 00:
That's where you see whatever's there.

[00:12:18] Speaker 03:
But the board found there's no disclosure of removing the cartilage before you get to the template step, so why wouldn't it not be included?

[00:12:25] Speaker 00:
Because there's a third option, and that's precisely what the invention's about.

[00:12:29] Speaker 03:
When there are options, though, Mr. Wolf, that's when we have to defer on a substantial evidence standard to the PTO's choice among those options.

[00:12:37] Speaker 00:
But you're not allowed to pull, respectfully, you're not allowed to pull a disclosure of a device that's simply not mentioned.

[00:12:44] Speaker 03:
Wait, and on page 839, Raschermacher generates a negative mold of the natural surface.

[00:12:53] Speaker 03:
It's more about the generating the mold part of the natural surface, the same natural surface that they described as the pre-treated surface that is capable of including

[00:13:00] Speaker 00:
That's step one, Your Honor, and that's in the computer.

[00:13:03] Speaker 00:
That's not the template.

[00:13:05] Speaker 00:
That's paragraph one.

[00:13:07] Speaker 00:
And if you go to paragraph two, the above negative mold can reproduce segments of a bone surface.

[00:13:15] Speaker 00:
So it tells you precisely what the mold is of.

[00:13:18] Speaker 00:
The mold is of bone surface, not of cartilage that may or may not be there.

[00:13:23] Speaker 00:
So this is not merely the PTAB inferring something from an absence.

[00:13:27] Speaker 00:
This is a PTAB inferring something that is directly contradicted by the reference itself.

[00:13:33] Speaker 00:
The reference tells us that what you're reproducing is the bone surface, not cartilage.

[00:13:39] Speaker 00:
And that's not surprising because it doesn't teach you all the things that our patents teach you about how you deal with a fundamentally different material.

[00:13:46] Speaker 00:
Disease cartilage, which is inherently less stable, inherently less predictable, inherently less of a foundation than bone is.

[00:13:54] Speaker 00:
So Your Honor, you're right, we have a substantial evidence standard, and that is a hurdle that we have to overcome.

[00:13:59] Speaker 00:
But when the reference itself says bone, bone, bone, bone, bone, you don't get to then say, but we infer that you really meant cartilage when you're talking about what you're building, not what you're seeing, not the imaging, but what you build.

[00:14:13] Speaker 00:
Yes, Your Honor.

[00:14:14] Speaker 01:
No, finish, because you're in general.

[00:14:16] Speaker 00:
Yeah, no, I apologize.

[00:14:17] Speaker 00:
I think I've... The only thing else, the last point I'll make, Your Honor, is on the reasonable expectation of success.

[00:14:23] Speaker 00:
I think this is laid out in our brief, clearly, but it is required that if you're combining references, you have a reasonable expectation of success.

[00:14:29] Speaker 00:
There is literally eight words in the record that goes to this point, the dissent properly found at conclusory.

[00:14:37] Speaker 00:
I don't believe there is any evidence, substantial or otherwise, upon which the PTAP could have found a reasonable expectation of success.

[00:14:44] Speaker 00:
Thank you.

[00:14:56] Speaker 03:
Well, why don't you start with the reasonable expectation of success and tell us how the board found that sometimes there's smooth cartilage and there's no reason to suspect it wouldn't work on smooth cartilage.

[00:15:08] Speaker 02:
Sure, so the reasonable expectation of success

[00:15:11] Speaker 02:
The board talked about how Radermacher images cartilage using MRI, that cartilage and bone are the only two possible surfaces, that matching cartilage would simplify the surgery consistent with Radermacher's goals, that Radermacher doesn't teach that a doctor would avoid matching cartilage.

[00:15:33] Speaker 02:
that Radermacher discloses operating on joints that naturally include cartilage and matching it to them.

[00:15:40] Speaker 03:
But their expert testified that damaged cartilage would be frayed or something, he said, and that's why this wouldn't work.

[00:15:47] Speaker 03:
It wouldn't be a reasonable expectation of success.

[00:15:50] Speaker 02:
So there are a few responses to that, Erin.

[00:15:52] Speaker 02:
There's not all damaged cartilage is frayed.

[00:15:57] Speaker 02:
That was the smooth thing.

[00:15:58] Speaker 02:
That's why I was trying to get you to go.

[00:15:59] Speaker 02:
I lost, but.

[00:16:00] Speaker 02:
Oh, OK.

[00:16:02] Speaker 02:
I apologize.

[00:16:04] Speaker 02:
Right, not all damaged cartilage is frayed.

[00:16:06] Speaker 02:
And Dr. Mabry pointed out that the reference that Dr. Clark was pointing to was patellar cartilage, which, as Dr. Mabry said, is subject to more shearing forces and more likely to be frayed than the cartilage on the femur or the

[00:16:28] Speaker 01:
And the board, this is we're looking at Appendix 100, 101, the board goes on in some way to discussing that, right?

[00:16:36] Speaker 02:
Right, that's right, 101 in particular.

[00:16:40] Speaker 02:
And on top of that, Conformist's patents themselves don't address frayed cartilage and how, they don't mention frayed cartilage.

[00:16:49] Speaker 02:
So they apparently didn't think that was such a big problem.

[00:16:54] Speaker 01:
This case reading the briefs is a little odd because I think Mr. Wolf is not completely wrong that part of this reads like it's an anticipation of Rademacher, which the board did not institute on anticipation.

[00:17:10] Speaker 01:
So you agree with that, right?

[00:17:12] Speaker 01:
I mean it's a little

[00:17:13] Speaker 02:
I think that's right.

[00:17:15] Speaker 02:
I think that Radermacher doesn't mention cartilage, as Conformist points out explicitly, and so it sort of discloses this because the joint naturally includes cartilage, but even if you didn't have that, we have a second reference that shows matching cartilage.

[00:17:40] Speaker 02:
If the court doesn't have any other questions, I'm happy to

[00:17:42] Speaker 01:
Thank you.

[00:17:44] Speaker 02:
Thanks.

[00:17:54] Speaker 00:
Your Honor, so I'll focus with my brief time remaining on the reasonable expectation of success.

[00:18:00] Speaker 00:
Everything counsel just cited as the evidence, and there's no doubt that on the motivation to combine, the PTAB talks at length about the motivation to combine, and we haven't appealed the motivation to combine.

[00:18:12] Speaker 00:
What we've appealed was the reasonable expectation of success, and if you look at A29, the sum total

[00:18:19] Speaker 00:
of the reasoning of the PTAB on reasonable expectation of successes with a reasonable expectation of success.

[00:18:26] Speaker 01:
So I mean this is difficult for us and we did go back to the briefs and I mean obviously what matters is what arguments you made on reasonable expectation of success and whether the board adequately addressed those arguments.

[00:18:39] Speaker 01:
So what's the argument that you made in your briefing to the board that it did fail to address with regard to regional success?

[00:18:46] Speaker 00:
I will answer your question directly, Your Honor.

[00:18:48] Speaker 00:
I would suggest that the burden might have been flipped in the question because, of course, they have the burden below of showing reasonable expectation.

[00:18:54] Speaker 01:
Yeah, but we think we're reading it.

[00:18:56] Speaker 01:
So I'm looking for what is missing.

[00:18:59] Speaker 01:
So I'm asking you, what is it you raised that they didn't deal with?

[00:19:03] Speaker 00:
Understood, Your Honor.

[00:19:05] Speaker 00:
We talked about, I think we used many metaphors, crab-like structures, febrile, erratic decayed disease that

[00:19:16] Speaker 00:
with that, that is not a stable platform for Radamacher to be built upon.

[00:19:22] Speaker 00:
If you try to take a bone-imaged

[00:19:25] Speaker 00:
device, the mirror image of the bone, and stick it on uncertain, unstable, crab-like, sits on top of the cartilage, that is an unstable platform.

[00:19:43] Speaker 00:
So that was Dr. Clark's explanation for why you would not have a reasonable expectation of success.

[00:19:49] Speaker 00:
That's, I mean, it's kind of common sense, but that's what he laid out.

[00:19:53] Speaker 00:
And that's what neither the PTAB nor the board in its appellate briefing addressed.

[00:20:03] Speaker 01:
Your time has expired.

[00:20:04] Speaker 00:
Thank you, Your Honor.

[00:20:05] Speaker 01:
Okay.

[00:20:05] Speaker 01:
Thank you.

[00:20:06] Speaker 01:
Thank you.

[00:20:07] Speaker 01:
And I apologize for the volume.