[00:00:25] Speaker 04:
Next case is Inrei Chudik, 2016, 2673, Mr. Waltmeyer.

[00:00:33] Speaker 02:
Your Honor, may I please the Court.

[00:00:36] Speaker 02:
In finding Claim 5 anticipated by the Leonard reference, the Board erred and it should be reversed for at least two reasons.

[00:00:43] Speaker 02:
First, Claim 24 of Leonard cannot be long-lastingly fixed to the humoral head, as Claim 5 requires.

[00:00:50] Speaker 02:
because the surface is too smooth.

[00:00:52] Speaker 02:
It's a smooth bearing surface that necessarily comprises properties contrary to long-lasting fixation.

[00:00:58] Speaker 02:
And the PTO's attempts to fix that platen to the humeral head result in a modification of Leonard not permitted by TOPLIF versus TOPLIF.

[00:01:08] Speaker 02:
And second, platen of Leonard has a stem, references numeral 40, and claim five requires no stem.

[00:01:17] Speaker 04:
Glen 5 requires that... Is clotting really a stem?

[00:01:21] Speaker 02:
Your Honor, we believe it is.

[00:01:24] Speaker 02:
Its purpose is to connect to the other portion of the glenoid, the base glenoid implant, and it extends from the main body of the platen, and therefore we think it qualifies as a stem.

[00:01:44] Speaker 02:
Turning to the long-lasting fixation,

[00:01:47] Speaker 02:
The PTO asserts that this bearing surface is configured for long-lasting fixation, but it is not.

[00:01:54] Speaker 02:
Leonard discloses a glenoid implant, not a humeral implant, and it's the opposite bone which the humeral implant moves against in the shoulder socket.

[00:02:08] Speaker 04:
That would seem to be a much stronger argument than the stem argument.

[00:02:17] Speaker 02:
We think both have merit, but I think that you're correct that this is an important point.

[00:02:26] Speaker 02:
And this surface that is supposed to necessarily comprise smooth and low friction attributes in order for your arm to be moving in a constant fashion, you wouldn't want it to have, for example, a rough surface.

[00:02:43] Speaker 02:
But a rough surface is the type of thing

[00:02:45] Speaker 02:
that you would want if you were looking for long-term fixation, especially for implantation in a person over long periods of time.

[00:02:55] Speaker 04:
In any event, you've got to shoulder a big burden in overcoming patent office, difference patent office and facts, don't you?

[00:03:05] Speaker 02:
Well, Your Honor, we think that the disclosure in Leonard sets forth a polyethylene

[00:03:15] Speaker 02:
material for that platen and we think it's clear based on the disclosure in Leonard that because that's a bearing surface that's continually bearing the movement of the humeral head that it necessarily has to be smooth and that trying to modify it to rough it up or do something in that fashion would be a modification prohibited and further

[00:03:42] Speaker 02:
We just wouldn't have one skilled in the art that's going to take a surface that's designed for ongoing movement and smooth articulation and try to convert it to one that's used for fixation, especially in the case where no stem is provided.

[00:04:00] Speaker 02:
You'd want a rough surface.

[00:04:05] Speaker 02:
And we think that it's well set forth, both in Leonard and as we've argued in the briefing, that it's clear Leonard

[00:04:13] Speaker 02:
that that platen doesn't have the properties necessary for long-term fixation, particularly on the articulating side.

[00:04:22] Speaker 04:
Well, about the cumeral versus glenoid point, the patent office talks about being capable of connecting to the other.

[00:04:35] Speaker 04:
What's your response on that?

[00:04:37] Speaker 02:
Well, Your Honor, we respectfully believe that it's not capable.

[00:04:42] Speaker 02:
And the limitation is that it's long-lasting fixation of the implant.

[00:04:46] Speaker 02:
And it can't achieve that long-lasting fixation.

[00:04:50] Speaker 02:
So it's just not capable of doing that, given the nature of the smooth bearing surface that you would need on the side of the glenoid, which it's disclosed in Leonard.

[00:05:04] Speaker 02:
So we believe that it's not capable of it because

[00:05:08] Speaker 02:
It must necessarily have smooth and non-friction surface in order for a long-term movement of your arm at every, you know, it's going to be having friction there.

[00:05:20] Speaker 02:
So, and particularly, you know, a surgeon or such isn't going to be taking parts from one type of implant and moving them over and using them on the other side.

[00:05:34] Speaker 02:
And, and so, and they certainly wouldn't be taking surfaces that are designed for ongoing articulation and, and use those for fixation.

[00:05:42] Speaker 02:
They just, they just necessarily have properties that are, are contrary to that long-term fixation.

[00:05:48] Speaker 02:
Again, especially in the case, and as is claimed, in the no-stem configuration, you know, you need something more than a very smooth surface to, to achieve that long-term fixation, and that's why

[00:06:03] Speaker 02:
that platen is not capable.

[00:06:06] Speaker 02:
And we don't believe either side of that platen is capable of long-term fixation because the opposite side is a movable surface that moves in relation to the base of that glenoid implant.

[00:06:26] Speaker 02:
Next, I'd like to discuss that the PTO is incorrect in its attempts to distinguish toplif.

[00:06:32] Speaker 02:
Toplif is not

[00:06:34] Speaker 02:
directed to a situation where there was a significant modification.

[00:06:38] Speaker 02:
Instead, there was only, as the court characterized, a slight modification was proposed to the prior art.

[00:06:44] Speaker 02:
And the court said that it evidently approached very near the invention there.

[00:06:49] Speaker 02:
But still, the court in Topliff refused to find an anticipation.

[00:06:54] Speaker 02:
And so we think here, again, we have more than a slight modification.

[00:07:00] Speaker 02:
The PTO proposed screws at one point.

[00:07:03] Speaker 02:
And glue is not going to hold on a surface such as that or cement without some modification, at least.

[00:07:10] Speaker 02:
And even then, it's highly questionable.

[00:07:12] Speaker 02:
And we don't think one skilled in the art would take, again, that bearing surface and try to fix it to the other side, try to use it as a long-term fixation surface.

[00:07:25] Speaker 02:
And also, Schreiber is distinguishable because in that case,

[00:07:32] Speaker 02:
Court found that no change of the prior art device was necessary to meet the functional limitations.

[00:07:39] Speaker 02:
But here the PTO proposes to change the structure by using screws or by attempting again to use some adhesive, which again wouldn't work.

[00:07:49] Speaker 02:
But again, those are attempted modifications that are different from Schreiber.

[00:07:53] Speaker 02:
Schreiber also notes that the spout there, the prior art, it was mentioned that there was no

[00:08:01] Speaker 02:
There was no way limited to an oil spout, whereas the claims there were for a popcorn dispenser.

[00:08:09] Speaker 02:
But here, everything suggests in Leonard that you would only use the platen as a glenoid implant.

[00:08:15] Speaker 02:
You wouldn't use it on the opposite surface.

[00:08:19] Speaker 02:
And so, and third, Schreiber, again, as we talked earlier, had an inherent disclosure.

[00:08:26] Speaker 02:
But here, we don't think there's any inherent disclosure

[00:08:29] Speaker 02:
because of the properties that are necessary in that surface that has articulation against it ongoing for long periods of time.

[00:08:42] Speaker 02:
I'll return back to the stem.

[00:08:44] Speaker 02:
The stem we think the stem sets forth is a stem because it has a connecting function to the other portion of the glenoid and because the, it extends from the main body.

[00:08:58] Speaker 02:
Therefore, we think that the board's findings are not supported by substantial evidence, and the Platon of Lenard cannot be long-lastingly fixed to the humeral head for the reasons that we discussed.

[00:09:09] Speaker 02:
Further, we think there's a stem, and we think the decision should be reversed.

[00:09:15] Speaker 02:
I'll reserve the balance of my time.

[00:09:17] Speaker 04:
We will save it for you, Mr. Waltmeyer and Mr. Schoenfeld.

[00:09:24] Speaker 00:
May I please report, as my opposing counsel has mentioned,

[00:09:28] Speaker 00:
There's only two structures in this claim.

[00:09:31] Speaker 00:
There's the configured for long lasting fixation on the humeral head, and there's the no stem limitation.

[00:09:37] Speaker 00:
Leonard is configured to be long lasting, for long lasting fixation on the humeral head, because it is shaped in a way that it can be mated onto the humeral head.

[00:09:48] Speaker 00:
And the things that he has mentioned about why it cannot be, or first of all not in the claims,

[00:09:55] Speaker 00:
And there's no showing, just because something is smooth, that it would be prevented from being fixed onto the humeral head.

[00:10:03] Speaker 00:
It could still be cemented onto the head.

[00:10:07] Speaker 00:
Their Chudik's invention is cemented onto the humeral head.

[00:10:11] Speaker 03:
Chudik also discloses that the... I find this case a little bit confusing.

[00:10:18] Speaker 03:
Frankly, the briefs didn't really clarify this very well for me.

[00:10:21] Speaker 03:
But is the argument that

[00:10:26] Speaker 03:
or your friend's argument that Leonard shows the glenoid implant, which is going to go into that portion.

[00:10:33] Speaker 03:
And so that means that there's some other piece that has to be used attached to the humerus to work with Leonard, where there seems like the exact opposite, that theirs attaches to the humerus and doesn't actually tell you how it's going to be attached to the glenoid.

[00:10:53] Speaker 03:
So it seems like what they're saying is,

[00:10:55] Speaker 03:
The smooth surface, I'm looking at figures 3a and 3b of Leonard, you know, whether or not, setting aside whether you can have screws or not, that's not important to me, but that that surface on there would just never be attached to the humerus.

[00:11:14] Speaker 03:
It's going to be attached to some other unspecified piece that attaches to the humerus.

[00:11:21] Speaker 03:
Does that make any sense?

[00:11:22] Speaker 03:
Probably not, but I find this very unclear.

[00:11:25] Speaker 00:
Our position is that, you know, it's basically building blocks.

[00:11:30] Speaker 00:
I mean, both pieces are between the glenoid and the humerus.

[00:11:34] Speaker 00:
And the piece of Leonard, Platon 24, can be attached to either side.

[00:11:41] Speaker 00:
There's nothing that prevents it.

[00:11:42] Speaker 00:
The claim doesn't require any structure.

[00:11:44] Speaker 03:
Wait, what do you mean it can be attached to either side?

[00:11:47] Speaker 03:
Well, the claim language... The 24 edge doesn't go into the glenoid, does it?

[00:11:53] Speaker 03:
The, like, little...

[00:11:55] Speaker 00:
Right, it's attached to the base 20, which goes into the glenoid.

[00:11:59] Speaker 00:
And then it is in connection, it's mated to, configured to mate with the humeral head.

[00:12:06] Speaker 00:
And so there's nothing about the piece of Leonard that wouldn't meet the language of configured for long lasting fixation.

[00:12:13] Speaker 00:
There's nothing about this piece in Leonard, which is shown as being mated to the humeral head, that would prevent it from being

[00:12:21] Speaker 00:
a fix to the humeral head.

[00:12:23] Speaker 03:
And where in Leonard does it show 24 made it to the humeral head?

[00:12:28] Speaker 00:
I mean, figure 4D in 311 shows that you have the convex piece of platen, and then you have the concave humeral head.

[00:12:39] Speaker 03:
What page were you on?

[00:12:40] Speaker 00:
Oh, I'm sorry.

[00:12:41] Speaker 00:
Appendix 311, the figure 4D, which was, I think, mentioned by the board as well.

[00:12:52] Speaker 03:
And so, oh, I get it.

[00:12:56] Speaker 03:
So 24 is that little middle piece, and it attaches directly to the humeral head.

[00:13:04] Speaker 03:
Correct.

[00:13:05] Speaker 00:
OK.

[00:13:11] Speaker 00:
If there are no further questions, I'll yield the remainder of my time.

[00:13:15] Speaker 04:
Thank you, Ms.

[00:13:15] Speaker 04:
Strongfeld.

[00:13:16] Speaker 04:
Mr. Waltmeyer has six minutes if you need it.

[00:13:21] Speaker 02:
Thank you.

[00:13:22] Speaker 02:
Getting back to your honor's question about fixation, the figure 4D of Leonard, the item 24 there is the same item 24 of figure 3A and 3B.

[00:13:37] Speaker 02:
It's still a figure, it's still an item that attaches to the glenoid base.

[00:13:43] Speaker 02:
And the resected head 12 in figure 4D, again I'm on appendix 311.

[00:13:52] Speaker 02:
is resected, but it's not fixed to the glenoid.

[00:13:56] Speaker 02:
I'm sorry, it's not fixed to platin 24, because that would result in an operable joint, because both sides of the bone, both the base is fixed to the glenoid, and the humeral head would be fixed to the platin, and you'd have a locked joint.

[00:14:11] Speaker 02:
So all that, figure 4D, is kind of an abstracted view of one type of deployment of the platin 24

[00:14:22] Speaker 02:
attached again to the glenoid via the feet and however it's shown in Figure 3A and 3B.

[00:14:30] Speaker 03:
So there's, respectfully... Are you saying that there's something between 24 and 12?

[00:14:36] Speaker 02:
No, I'm saying that 24 is fixed to 20 and 12 moves relevant to it.

[00:14:44] Speaker 02:
It's resected, it's a little unclear

[00:14:47] Speaker 02:
Technically, why you would do that is to resect the head and then leave it resected while it moves.

[00:14:54] Speaker 02:
But it's a proposed method of doing it, I suppose.

[00:14:59] Speaker 02:
The bottom line is that Platin 24 is always fixed to the glenoid.

[00:15:05] Speaker 02:
It's never fixed in Leonard under any movement between them, though.

[00:15:09] Speaker 01:
Can there be movement?

[00:15:10] Speaker 01:
You're using fixed as though it means basically glued down and immobile, but the examiner didn't conclude that.

[00:15:16] Speaker 01:
The examiner held or factually found that fixed would tell when a skill in the art remains in place, stays in place, but not necessarily glued down.

[00:15:28] Speaker 01:
And so I'm asking you, isn't there movement between 24 and 20?

[00:15:31] Speaker 01:
So I'm trying to understand what you mean by fixed.

[00:15:35] Speaker 02:
Yes, there is movement between 24 and 20.

[00:15:39] Speaker 01:
So it's not smooth, stable, immovable.

[00:15:42] Speaker 01:
I mean, if you look at figure two... So then why couldn't the same be true about 24 and 12?

[00:15:47] Speaker 02:
Because 12 is the humeral head.

[00:15:49] Speaker 02:
There's no discussion or description of... Basically, 12 moves relative to 24.

[00:15:59] Speaker 02:
The humeral head, 12, is a bone, and it's resected there, and it moves relative to 24.

[00:16:05] Speaker 02:
24 has a little bit of movement

[00:16:09] Speaker 02:
as shown in Figure 1 at Appendix 309.

[00:16:14] Speaker 02:
You can see the arrow 27 shows there's a little movement of 24 up and down.

[00:16:23] Speaker 02:
But it's, it's fixed in there by the side attachments.

[00:16:27] Speaker 02:
And then the humeral head is then moving relative to that plate.

[00:16:33] Speaker 02:
So these figures 4A through 4E are just

[00:16:37] Speaker 02:
abstracted variations of what is shown in detail in Figure 1.

[00:16:42] Speaker 02:
So the Platon 24 is never in Leonard disclosed to be attached, cemented, or in any way connected to the email head except however the anatomy would move that against in the rotation of the arm.

[00:17:01] Speaker 02:
Therefore, again, that's to our point that

[00:17:07] Speaker 02:
because that's a smooth bearing surface.

[00:17:10] Speaker 02:
And Leonard describes it that way.

[00:17:12] Speaker 02:
He says, the head of the humerus generates at the surface 26, and I'm reading at appendix 495 to 496, generates at the surface a shear stress as it tends to move the plate relative to the base.

[00:17:28] Speaker 02:
That's because the humeral head is moving against that surface of the platen, which again,

[00:17:36] Speaker 02:
connected to the glenoid via the base.

[00:17:38] Speaker 02:
Therefore, again, the key feature here is that surface that faces the humeral head is always configured for ongoing movement of the head against it.

[00:17:56] Speaker 02:
It has a little bit of movement relative to the base, but it's basically attached to the glenoid side, and it's never

[00:18:05] Speaker 02:
fixed long-lastingly.

[00:18:08] Speaker 02:
And so the co-counsel here, our opposing council mentioned that there's no limitation, but that's not true.

[00:18:17] Speaker 02:
We've said it has to achieve long-lasting fixation of the implant.

[00:18:21] Speaker 02:
And that necessarily imparts a structure that the Platon 24 of Leonard can't achieve.

[00:18:32] Speaker 02:
Therefore, we think the board should be reversed.

[00:18:36] Speaker 04:
Thank you, counsel.

[00:18:37] Speaker 04:
We'll take the case under review.