[00:00:00] Speaker 03:
Our last case for argument is 24-1389 P-Tech vs. Arthrex.

[00:00:04] Speaker 03:
Mr. Evans, you're up.

[00:00:05] Speaker 01:
May it please the court?

[00:00:19] Speaker 01:
This appeal turns on the definition of two claim terms.

[00:00:22] Speaker 01:
One is notless and the other is secure.

[00:00:26] Speaker 01:
Again, we have the issue of whether a secure suture is allowed to slide.

[00:00:32] Speaker 01:
We submit that it is not.

[00:00:33] Speaker 01:
It must be fixed at this point of attachment.

[00:00:36] Speaker 01:
The board found that a suture that is secure, nonetheless, can slide.

[00:00:43] Speaker 01:
As with all of these cases, I think, or both these cases, I think the problem we have is

[00:00:48] Speaker 03:
You first have to define the word, and then having properly defined it, you go through and... Well, I mean, doesn't this claim with regard to secure actually at 1.6 say secure and 1.7 say configured to slide through?

[00:00:59] Speaker 03:
So how do you reconcile that?

[00:01:01] Speaker 01:
Well, that, Your Honor, is because the word a suture could be more than one suture.

[00:01:05] Speaker 01:
And if you look in the spec, the spec has multiple sutures, and the patent drafter drafted in reliance on the idea that when you say a suture,

[00:01:15] Speaker 01:
It means one or more, and in this case the first one or more was secure, and the second one or more, good slide.

[00:01:23] Speaker 01:
In the spec, there's no suture that both slides and is secure at the same time.

[00:01:28] Speaker 01:
And you have to read the claim in light of the spec.

[00:01:31] Speaker 01:
And here, if one construction reads on the spec and the other does not, then I submit that the construction that reads on the disclosure and the specification is the proper construction.

[00:01:53] Speaker 01:
Here in the prior art, they had the Fumex bone anchor, which was pushed into a passage in a bone.

[00:02:02] Speaker 03:
Just out of curiosity, I mean, the claim at 1.6 and 1.7 both say the flexible hollow fastener.

[00:02:11] Speaker 03:
Isn't that antecedent basis so that we know they're talking about the same one in both instances?

[00:02:16] Speaker 03:
So there aren't two different ones here, one that's secure and one that's configured to slide.

[00:02:21] Speaker 01:
Well, the hollow fastener is actually the anchor of the bone, but the... The flexible elongated fastening member is configured to... That is the suture.

[00:02:28] Speaker 01:
That's correct.

[00:02:29] Speaker 03:
The.

[00:02:32] Speaker 01:
And I think the is just going back to the antecedent basis where there can be more than one suture.

[00:02:36] Speaker 03:
No.

[00:02:36] Speaker 03:
No, that's not what the means.

[00:02:38] Speaker 03:
Where does... Antecedent basis for the is the thing that was mentioned before.

[00:02:44] Speaker 03:
Where is it first mentioned in this claim?

[00:02:48] Speaker 01:
It's the flexible elongated fastening member and the second.

[00:02:50] Speaker 03:
Right.

[00:02:51] Speaker 03:
That's not two, right?

[00:02:52] Speaker 03:
That's an A, flexible elongated fastening member extending through the flexible hollow fastener.

[00:02:58] Speaker 03:
So that's a single one.

[00:03:00] Speaker 01:
Well, it could be more than one.

[00:03:02] Speaker 01:
It doesn't have to be a single one.

[00:03:03] Speaker 01:
A can be one or more.

[00:03:07] Speaker 03:
OK.

[00:03:07] Speaker 03:
Why don't you move on to your knotless argument?

[00:03:08] Speaker 03:
I think we've secured all the time we've got for that secure argument today already.

[00:03:13] Speaker 01:
OK.

[00:03:15] Speaker 01:
For nautilus, Dr. Pedowitz testified that nautilus, in this context where you're talking about how you secure a fastener into a body tissue or a bone, is different than how you would nautilusly attach a suture to an anchor or to some other construct to which you're going to attach the suture.

[00:03:36] Speaker 01:
And so you're looking at two different contexts.

[00:03:38] Speaker 01:
And the board understood that.

[00:03:39] Speaker 01:
We used the word coin.

[00:03:40] Speaker 01:
That was an unfortunate use of the word.

[00:03:42] Speaker 01:
But the point we were trying to make, the point the board did understand, is that the conventional use of knotless for use in tying sutures to things was different than a different structure than the structure of a fastener being pushed into a bone.

[00:03:59] Speaker 03:
The hard thing for me is I'm 100% with you on the Plain and Ordinary meeting of knotless to me.

[00:04:04] Speaker 03:
You know, that this knotless fastener's got to show up with no knots in it and you can't make a knot out of it.

[00:04:08] Speaker 03:
That is what knotless suture

[00:04:11] Speaker 03:
or in this case, what is it, knotless.

[00:04:14] Speaker 03:
The hollow fastener is knotless.

[00:04:15] Speaker 03:
That to me means there shouldn't be any knots in it.

[00:04:17] Speaker 03:
It seems pretty straightforward.

[00:04:18] Speaker 03:
The problem is there's this special word in the art that has a different meaning, knotless suture anchor, where everyone seems to agree that means you don't make a knot when you're putting it in, but it doesn't somehow preclude the fact that it might have a preexisting knot in it.

[00:04:33] Speaker 03:
I don't understand that to be consistent with my plain and ordinary meaning of the word, but I'm also not a skilled artisan.

[00:04:38] Speaker 03:
And both parties seem to have

[00:04:41] Speaker 01:
agreed that there is an art-specific meaning to Nautilus when used as a... When attaching a suture, as distinguished from when attaching an anchor or a fastener into a bone or into a body part.

[00:04:54] Speaker 00:
Wait, so you're saying there's a difference between retaining a suture within a fastener.

[00:04:58] Speaker 00:
You agree, retaining a suture within a fastener is the chief's explanation.

[00:05:03] Speaker 00:
But then you say it's different when retaining fasteners themselves?

[00:05:08] Speaker 01:
When you retain the fastener into the bone.

[00:05:10] Speaker 01:
So you have three parts.

[00:05:11] Speaker 01:
You have the suture that has to connect to the fastener.

[00:05:14] Speaker 01:
The fastener has to connect to the bone.

[00:05:17] Speaker 01:
And when you have the three in combination, the word knotless was used when the doctor is trying to attach the suture to something that's already anchored in the bone.

[00:05:26] Speaker 01:
You can't tie a knot in a bone.

[00:05:27] Speaker 01:
Everyone agrees with that.

[00:05:28] Speaker 01:
There's just no room in there.

[00:05:29] Speaker 01:
You can't do it.

[00:05:30] Speaker 01:
So to say it's a knotless bone anchor is like saying, you know, everyone knows it's a knotless bone anchor because you can't tie a knot in it if you want to.

[00:05:39] Speaker 01:
And in the prosecution history, they showed you figure six of the application, the 440 application, not the patent, but figure six of the application, where they had a mechanical fastener that was mechanically secured to the bone.

[00:05:53] Speaker 01:
And in the patent office, the examiner said, that is a knotless fastener.

[00:05:57] Speaker 01:
And we agree, because there is no knot.

[00:05:59] Speaker 01:
It's just a mechanical fastener into the bone.

[00:06:02] Speaker 01:
And what's going on with this claim language is it's saying, you need that type of mechanical fastening into the bone without a knot.

[00:06:09] Speaker 01:
And here, Dr. Pedowitz said it's a knot.

[00:06:12] Speaker 01:
Their expert, Dr. Jordan, said it's a knot.

[00:06:15] Speaker 01:
He said, as you tension it, it becomes a bigger knot.

[00:06:18] Speaker 01:
So use a bigger knot to hold it in place.

[00:06:20] Speaker 01:
Well, if you're using a bigger knot, how can it be a knotless structure?

[00:06:23] Speaker 03:
Well, for that part, you're assuming that we agree with your construction of knotless.

[00:06:29] Speaker 03:
Like, you've now moved past the construction point and into, I think, the application point.

[00:06:37] Speaker 03:
How do I get past the board's construction?

[00:06:40] Speaker 03:
The board used extrinsic evidence to decide that this notless term had a special meaning in the art.

[00:06:48] Speaker 03:
And they defined the art.

[00:06:49] Speaker 03:
Don't I have to give deference to that?

[00:06:51] Speaker 03:
I mean, whenever I see the board using extrinsic evidence for claim construction, I think that means I have to give substantial evidence deference to what they conclude about that evidence.

[00:07:01] Speaker 01:
I would say unless the intrinsic evidence resolves the issue.

[00:07:04] Speaker 01:
The intrinsic evidence is reviewed de novo.

[00:07:06] Speaker 01:
And if the intrinsic evidence resolves the issue, you don't get to the extrinsic evidence.

[00:07:10] Speaker 03:
Well, that doesn't make sense, because that would mean that whenever there's a special meaning for something in the art, you would never get to it, right?

[00:07:20] Speaker 03:
That can't be the case.

[00:07:23] Speaker 03:
I mean, if there's like a layman's understanding of a word, that can't be the same.

[00:07:29] Speaker 03:
Here, they gave this word, not list.

[00:07:32] Speaker 03:
Both parties seem to accept that in some instances,

[00:07:35] Speaker 03:
It has a different meaning than what me and not ordinarily skilled artisan but just a random person would think it means.

[00:07:42] Speaker 03:
And they used extrinsic evidence, the board did, to kind of get to that conclusion, didn't they?

[00:07:47] Speaker 01:
Well, what the board did is the board conflated attaching a suture to a fastener with attaching a fastener to a bone.

[00:07:56] Speaker 03:
And those are two distinct- I understand your argument, but the problem for me is the board kind of said, in this art,

[00:08:03] Speaker 03:
You know, this has a specialized meaning, and here's what it means.

[00:08:06] Speaker 03:
It's different than what you might ordinarily think the word means.

[00:08:10] Speaker 03:
So I'm just trying to understand if that's part of the legal part or part of the factual part.

[00:08:17] Speaker 01:
Well, I think claim construction is a question of law.

[00:08:20] Speaker 01:
And you have to figure out for yourselves what it means.

[00:08:25] Speaker 01:
I think the fact that they injected this application

[00:08:32] Speaker 01:
That is not what the claim is directed to.

[00:08:34] Speaker 01:
The claim is directed to securing the fastener end of the bone.

[00:08:39] Speaker 01:
And when you're talking about that, that's the part where the claim requires to be knotless.

[00:08:43] Speaker 01:
And if you do that with a knot, that is not the same thing as attaching a suture to something that's already attached to the bone.

[00:08:51] Speaker 01:
There are just two different parts, and I believe the board erred in conflating them.

[00:08:55] Speaker 01:
Nobody said that those two conflate, and nobody said the two are the same.

[00:08:58] Speaker 01:
There were two distinct things.

[00:09:00] Speaker 01:
The board examined them as two distinct things.

[00:09:01] Speaker 01:
The board said, hey, we have to decide whether one applies to the other.

[00:09:06] Speaker 01:
And when it posed that question, it made its own conclusions about it.

[00:09:15] Speaker 03:
Do you want to save the remaining time for a bottle?

[00:09:18] Speaker 01:
Sure.

[00:09:18] Speaker 01:
Thank you.

[00:09:29] Speaker 02:
Good afternoon, Your Honors.

[00:09:35] Speaker 02:
May it please the Court?

[00:09:37] Speaker 02:
There are two claim construction disputes.

[00:09:39] Speaker 02:
I kind of spend the majority of my time on the second one, which is not less.

[00:09:43] Speaker 02:
I would just point out with regard to secure that the only argument that we heard today as to how to reconcile the fact that the claim requires the suture to be both

[00:09:53] Speaker 02:
secure and able to slide is that a or the might refer to two or more different sutures.

[00:10:01] Speaker 02:
That argument where there has been a used or an indefinite article with then using the later in the claim was rejected multiple times by this court, most notably in the Inrei Varma case.

[00:10:16] Speaker 02:
Where in a playful example, the court said, for a dog owner to have a dog that rolls over and fetches sticks, it does not suffice that he have two dogs, each able to perform just one of those tasks.

[00:10:28] Speaker 02:
That's exactly the case that we have here.

[00:10:30] Speaker 02:
The appellant is suggesting that you can have two different sutures, one that has each of these claim characteristics.

[00:10:39] Speaker 02:
That has been repeatedly rejected by this court.

[00:10:43] Speaker 02:
Moving on, then, to knotless.

[00:10:45] Speaker 02:
There is no dispute that within the orthopedic industry, at least in some contexts, knotless refers not just to the absence of any knot, but to the absence or elimination of knot tying by the surgeon during the surgical procedure.

[00:11:02] Speaker 02:
Appellant or PTEC has tried to avoid the clear import of that known meaning by suggesting... Wait, does it mean both?

[00:11:09] Speaker 02:
I think you just said it meant it means both.

[00:11:11] Speaker 02:
Does it mean both?

[00:11:12] Speaker 02:
No, it does not, it does not mean the absence of a knot.

[00:11:17] Speaker 02:
It means the absence of knot tying, the absence of tying a knot during the procedure.

[00:11:22] Speaker 02:
Can you bring a preformed knot to the game?

[00:11:25] Speaker 02:
Absolutely.

[00:11:25] Speaker 03:
How is something knotless if you're bringing it and it's got a knot in it?

[00:11:29] Speaker 02:
It's just the way that the word is used.

[00:11:31] Speaker 02:
I mean, it's football.

[00:11:32] Speaker 02:
We all know that we are not using our feet to play football.

[00:11:36] Speaker 02:
We know what that word means, even as ordinary people.

[00:11:39] Speaker 02:
But within this industry,

[00:11:42] Speaker 02:
The meaning of knotless refers to the absence of knot tying.

[00:11:46] Speaker 02:
That was agreed to by both of the experts, but it's also within several examples that we put into the record.

[00:11:54] Speaker 02:
And we chose these prior art examples for a very particular reason to get over the question that might be raised by your honor.

[00:12:01] Speaker 02:
I'm just curious what you think about field goals.

[00:12:03] Speaker 02:
Do you do those with your hands?

[00:12:05] Speaker 02:
Field goals.

[00:12:06] Speaker 02:
Oh, you kick those.

[00:12:07] Speaker 02:
That's true.

[00:12:08] Speaker 02:
So there is some foot involved, but certainly the touchdowns are going to be with the hands and not the feet.

[00:12:14] Speaker 02:
So I want to turn your honors to the extrinsic evidence.

[00:12:16] Speaker 02:
I think here both the extrinsic as well as the intrinsic evidence are supportive of Nautilus, and that is what the board found.

[00:12:25] Speaker 02:
But the extrinsic evidence, and this is described at page 37 of our brief, each of these references is provided in the appendix starting at 12.934.

[00:12:36] Speaker 02:
And these examples were chosen for this reason in particular.

[00:12:40] Speaker 02:
They all refer to the invention being a knotless suture anchor.

[00:12:44] Speaker 02:
And there's no question that suture anchor and fastener in this context are interchangeable.

[00:12:49] Speaker 02:
So each of these talks about all of the problems of tying knots during these types of procedures.

[00:12:56] Speaker 02:
They want to overcome that.

[00:12:57] Speaker 02:
Knotts are hard to put in.

[00:12:59] Speaker 02:
They are time consuming.

[00:13:00] Speaker 02:
They can come back out.

[00:13:02] Speaker 02:
So all of these problems were there, and they wanted to overcome these by creating a knotless suture anchor.

[00:13:09] Speaker 02:
But each one of these references, and each one of them then describes what they've invented as a knotless suture anchor, each one of these references, again, is described in our brief, contains a knot within the plain and ordinary meaning, or within, excuse me,

[00:13:24] Speaker 02:
the plain English understanding that either have preformed knots or there is going to be a tightening of the suture while the insertion is taking place that under PTAC's definition would constitute the recreation of a knot.

[00:13:40] Speaker 02:
But they are referred to as knotless because none of these require the surgeon to actually tie a knot during the procedure.

[00:13:48] Speaker 02:
P-TECH again has tried to and the board agreed with that in both of the relevant proceedings here and found that these references confirm how Nautilus is used in the industry.

[00:14:02] Speaker 03:
And so was that in the terms of Nautilus suture anchor or what is the industry in which that definition of Nautilus should apply?

[00:14:13] Speaker 02:
It is Nautilus suture anchors which P-TECH has confirmed

[00:14:18] Speaker 02:
And this is, oh, I've got the exhibit number, but it is interchangeable with the term fastener in this claim.

[00:14:27] Speaker 02:
And the board found that this context is relevant to the patented invention.

[00:14:31] Speaker 02:
The one example that I want to highlight is at Appendix 1298.

[00:14:37] Speaker 02:
This is actually an Arthrex patent or patent publication that's entitled, Interference Fit, Not Le Suture Anchor Fixation.

[00:14:47] Speaker 02:
And PTAC has tried to get around all of these prior art references by suggesting that they either relate to suture retention or to tissue retention, but not to anchor retention.

[00:14:58] Speaker 02:
But this patent and the knots that are created, for example, in figures seven and figures eight, are described in paragraph 11 and paragraph 22 of this publication as being specifically, quote,

[00:15:14] Speaker 02:
to enhance the pull-out strength of the suture from the anchor body, or to create a lump or suture nest that likewise improves the pull-out strength of the anchor.

[00:15:27] Speaker 02:
So these, if we all want to turn there, it's again 12-9-8-6.

[00:15:38] Speaker 03:
Now, one of the arguments opposing counsel made was that this is not really involving tissue.

[00:15:46] Speaker 03:
It's involving bone, and you can't have knots when you're tying, basically, in the bone space.

[00:15:52] Speaker 03:
Are these tied to bone or to tissue?

[00:15:55] Speaker 02:
They are not.

[00:15:55] Speaker 02:
They are to tissue generally.

[00:15:57] Speaker 02:
That's exactly what the board found in its decision at page 30.

[00:16:02] Speaker 02:
The board also found, by the way, that that argument was waived, that it was untimely.

[00:16:06] Speaker 02:
It was presented for the first time in the sir reply.

[00:16:09] Speaker 02:
That finding is at 29 and was not challenged on appeal.

[00:16:13] Speaker 03:
So you wanted us to go to some page.

[00:16:15] Speaker 03:
What page was it you wanted us to go to?

[00:16:17] Speaker 02:
The reference that starts at 12-9-8-6, and in particular, what you see in figures six, excuse me, seven, and eight.

[00:16:28] Speaker 02:
As the anchor is being placed into the bone, and the description that follows is in paragraphs 11 and 22, the suture is being either twisted, or it says it can come pre-knotted to improve the pull-out strength.

[00:16:44] Speaker 02:
So the purpose of these knots is exactly so that this to better retain the suture anchor within the bone.

[00:16:51] Speaker 02:
It's exactly the context that PTAC says is missing.

[00:16:55] Speaker 02:
The other point that I would make there is that the board disagreed and found that the context of these claims and this patent is broader than just anchor retention.

[00:17:05] Speaker 02:
The claims very clearly also require the anchoring of suture.

[00:17:09] Speaker 02:
The board that found that, for example, at appendix page 18, where it referred to claim one of the 453 patent as requiring the hollow fastener to deform from the first configuration to the second configuration

[00:17:25] Speaker 02:
to provide an anchor for the suture as the suture is tensioned relative to body tissue.

[00:17:32] Speaker 02:
So this is, again, a finding by the board that the context of these claims applies exactly to the context in which both parties agree that Nautilus is a term of art.

[00:17:43] Speaker 02:
The opening line of P-TECH's appeal brief further proves this point.

[00:17:47] Speaker 02:
Although my opposing counsel is now trying to suggest that the context is not tissue retention,

[00:17:54] Speaker 02:
The opening line of their appeal brief says that these patents, quote, are generally directed to fastener systems for positioning deformable fasteners to connect body tissues together.

[00:18:09] Speaker 02:
That's exactly the context in which the board found, and all the parties agreed, that knotless has a known meaning, which is the elimination of tying of knots.

[00:18:19] Speaker 02:
For that reason and the others, unless the panel, excuse me, unless your honors have any further questions, we will rest on our briefs.

[00:18:29] Speaker 02:
Thank you, counsel.

[00:18:31] Speaker 03:
Mr. Evans, you have some rebuttal time.

[00:18:43] Speaker 01:
Thank you, your honor.

[00:18:50] Speaker 01:
The multiple prior references that they put into their reply brief, I'm sorry, their sub-reply, in front of the board, they all involved mechanical anchors that secure into bone.

[00:19:02] Speaker 01:
And then there was a suture that was connected somehow to the mechanical anchor.

[00:19:07] Speaker 01:
That supports our theory that it was a knotless anchor that was secured into the bone.

[00:19:13] Speaker 01:
The board, when it looked at all that, it said, you put it in too late, we can't figure it out, and we're not going to try.

[00:19:18] Speaker 01:
And they didn't look at it.

[00:19:20] Speaker 01:
That's in the board decision.

[00:19:22] Speaker 01:
With respect to body tissue, well, I agree that most of the claims say body tissue.

[00:19:29] Speaker 01:
Claim 14 of the 453 patent talks about implanting the fastener into bone.

[00:19:38] Speaker 01:
And if it's the same fastener and claims are supposed to give the same meaning to the same fastener in Claim 14 as it is in Claim 1, and you can't tie a knot in a bone,

[00:19:47] Speaker 03:
Or is it possible you just didn't separately argue that dependent claim, which is narrower than the independent claim that covers tissue and everything else?

[00:19:55] Speaker 01:
It's a separate independent claim 14.

[00:19:58] Speaker 03:
Okay, but you didn't separately argue it and the board said you waived it.

[00:20:02] Speaker 01:
The board found that it was not possible to tie a knot in a bone and they went on to discuss it.

[00:20:06] Speaker 01:
They said you waived it, but we're going to discuss it anyway.

[00:20:08] Speaker 01:
And I just wanted to respond to that part where the board did discuss it to say we were on point with that.

[00:20:20] Speaker 03:
further questions thank you okay thank both counsel cases taken under the mission