[00:00:00] Speaker 00:
21, 71, and Mary Trudy.

[00:00:03] Speaker 00:
Mr. Wallach.

[00:00:05] Speaker 01:
Your Honor, good morning.

[00:00:06] Speaker 01:
May it please the court.

[00:00:07] Speaker 01:
In finding the claims 1, 7, and 10 anticipated, the board erred for at least two reasons and should be reversed.

[00:00:14] Speaker 01:
First, there's no substantial evidence in the records supporting that the references meet the configured to or configured for elements of claims 1, 7, and 10.

[00:00:24] Speaker 01:
And second, those elements impart a structural limitation to the claims

[00:00:28] Speaker 01:
that the cited references expressly and inherently lack.

[00:00:33] Speaker 01:
With respect to claims 1 and 10, the anchor and suture of the on-spot reference is too short to be disposed in the four portions of the shoulder anatomy required by the claims.

[00:00:45] Speaker 03:
In the case of... What do you understand the disposed language means with respect to whether

[00:00:54] Speaker 03:
it has to be in all four places at the same time, either with the ends poking out or not, but at least in all four places at the same time.

[00:01:02] Speaker 01:
Yes, Your Honor.

[00:01:04] Speaker 01:
It is our position that it has to be in all four of those identified portions of the anatomy at the same time.

[00:01:11] Speaker 01:
The conjunction and in that clause requires that the tip be in those places at the same time.

[00:01:18] Speaker 01:
Otherwise, you would expect to have an or

[00:01:21] Speaker 01:
in the clause there that identifies the four portions.

[00:01:25] Speaker 04:
Or maybe, go ahead.

[00:01:26] Speaker 04:
No, no, go ahead.

[00:01:28] Speaker 04:
Or maybe the and is signals that the tip portion has to be able to be located in each of those places, that it's sized to such a degree that it can fit in each of those four locations, but not necessarily all at the same time.

[00:01:49] Speaker 01:
We don't think that that is the proper reading of the claim in view of the claims language itself and also when read in light of the specification.

[00:01:58] Speaker 01:
If you look at figure 32, clearly the pin there is extending through the anatomy and the and clause imparts this requirement that it be in all four locations at the same time.

[00:02:16] Speaker 03:
Is there something about the desired operation of this device, this kind of harpoon-like thing that requires that it be in all four places at the same time?

[00:02:29] Speaker 03:
You're just trying to get the suture from here to here through a couple of things.

[00:02:35] Speaker 03:
Why does the actual harpoon have to be in all four places?

[00:02:41] Speaker 01:
Well, Your Honor,

[00:02:45] Speaker 01:
We believe that the claim requires that it do that in specification.

[00:02:49] Speaker 03:
No, but I'm trying to connect that to some sense of the purpose of this invention as described.

[00:02:57] Speaker 03:
And I guess if the purpose is just to get the suture through those things, I'm not prejudging whether there's a, what the answer is to this question.

[00:03:11] Speaker 03:
an argument for a particular reading of a claim language is a lot better if you can connect it to the purpose as described in the spec.

[00:03:19] Speaker 01:
Yes.

[00:03:20] Speaker 01:
The long pen enables the guiding as it goes through the inserter or the guide tool that's the subject of claim seven.

[00:03:32] Speaker 01:
And it's my understanding that it assists in making its path through the whole area that it is to be

[00:03:41] Speaker 01:
provided.

[00:03:42] Speaker 01:
The guide comes up to the edge of the humerus bone and then from there the pin is coming through the bone and then travels further through, in some cases being used with the guide.

[00:03:55] Speaker 00:
But you're not saying that it's new to have a guide.

[00:04:01] Speaker 00:
The claim is really quite broad, is it not?

[00:04:06] Speaker 01:
Well, claim one is directed to the pin itself and the guide is separately in claim seven.

[00:04:11] Speaker 01:
Yes.

[00:04:12] Speaker 01:
So the pin here is particularly configured to be disposed in these four areas.

[00:04:20] Speaker 01:
And that is where we distinguish over the cited reference of Ansbach, where the Ansbach anchor is very short.

[00:04:30] Speaker 01:
The Ansbach anchor is described as 0.625 inches long.

[00:04:36] Speaker 01:
It has a very short length.

[00:04:38] Speaker 01:
It's not stated as one embodiment or some embodiments, but it's that specific link that's provided.

[00:04:44] Speaker 01:
And it's specified down to three decimal places.

[00:04:48] Speaker 01:
And it makes sense that they would have a very short anchor in Anspach because it's designed to be embedded in the bone.

[00:04:54] Speaker 01:
And if it were to penetrate all the way through, if it were long enough for that, it wouldn't achieve its purpose of being embedded in the bone, which is the purpose of the anchor.

[00:05:05] Speaker 03:
If you compare the exemplary... So the length of the unspuck anchor you're suggesting is more or less inherently no more than the width of the bone it's supposed to go into.

[00:05:19] Speaker 01:
It's not disclosed.

[00:05:21] Speaker 01:
I think that may accurately state it.

[00:05:24] Speaker 01:
It's disclosed to being about a half an inch, and its purpose is not to be extending through bone to be embedded in it.

[00:05:31] Speaker 01:
And there's no suggestion in there that it's going to penetrate through or do anything else because that would impede its ability to grasp because it's got those channels in the pin and so forth for gripping bone.

[00:05:47] Speaker 01:
And if those penetrated through and out, it would no longer happen.

[00:05:51] Speaker 04:
The question I have about this argument that you're raising is, what is the relevance of the purpose of Ansbach's anchor if the anchor

[00:06:01] Speaker 04:
as all the physical attributes that are required in your claims?

[00:06:06] Speaker 01:
Well, we think that it doesn't have all the physical elements.

[00:06:09] Speaker 04:
Right, but beyond that, OK, or just for purposes of our argument here, let's assume that it does have all the physical attributes.

[00:06:19] Speaker 04:
Then wouldn't that be enough?

[00:06:21] Speaker 04:
This is a structure device claim, after all.

[00:06:25] Speaker 01:
And we think that the configured

[00:06:29] Speaker 01:
limitation imparts the length structure to our claim which the Anzbach reference can't meet.

[00:06:39] Speaker 01:
And we think that reading Anzbach for what its use tells us what its length could be.

[00:06:45] Speaker 01:
And it's clear and very clear that the length is to be a very short anchor for embedding in the bone and having a suture extend from it.

[00:06:55] Speaker 01:
So we think that

[00:06:57] Speaker 01:
Basically, you have the limitation as to the length, and understanding the use of Anspach helps us understand the limits of what's disclosed as far as the length of that anchor.

[00:07:09] Speaker 01:
So if you compare the path that is provided by the four portions of the anatomy of the claim, the short length of the anchor is clearly not long enough to reach there.

[00:07:21] Speaker 01:
Now, the PTO argues that we cannot distinguish on the basis of length, and we think that's incorrect.

[00:07:28] Speaker 01:
For example, the PTO states that to know what is long enough, Chudok must define the length of this device.

[00:07:34] Speaker 01:
But we assert that we have defined it and can define it in length in terms of the portions of the anatomy that the tip has to be disposed in at the same time.

[00:07:44] Speaker 03:
But what do you do with the suggestion that there's nothing in your application or in the claims about the size of the creature into which this is going to be put?

[00:07:54] Speaker 01:
Well, we think that this argument about

[00:07:58] Speaker 01:
that the office is looking for some definite inches or so forth is an indefiniteness argument, which hasn't been raised and is not raised in relation to this claim.

[00:08:10] Speaker 03:
And that one skilled in the art... Didn't the board or the PTO or somebody talk about infants and mice?

[00:08:17] Speaker 01:
It was raised by the PTO.

[00:08:19] Speaker 01:
And we think that one skilled in the art would understand the length requirement imparted by this

[00:08:26] Speaker 01:
reading in light of the specification as to the various applications that it could be placed in.

[00:08:34] Speaker 01:
So we think it's clear that the specification informs, you know, this is going to be used for human and not in animals.

[00:08:43] Speaker 01:
And we think that that argument is just, and that one skilled in the art would understand the length imparted by understanding the patient they're going to be working on.

[00:08:54] Speaker 01:
And in no case of a human patient could the length of the on-spot anchor reach the portions of the anatomy that are identified in the claims.

[00:09:05] Speaker 03:
So that last sentence, how do we know that's true?

[00:09:09] Speaker 01:
Well, Your Honor, point half an inch, basically, is just not long enough to get through a surface of the shoulder.

[00:09:18] Speaker 03:
You're pointing to a point.

[00:09:19] Speaker 01:
I know.

[00:09:20] Speaker 01:
Yes, Your Honor.

[00:09:22] Speaker 01:
proposed that it is not long enough to make it through those portions.

[00:09:26] Speaker 04:
Did you make that argument to the board?

[00:09:30] Speaker 01:
I believe that all the way through this case, we've been arguing that it's not long enough.

[00:09:34] Speaker 01:
It just on appeal here.

[00:09:35] Speaker 04:
I guess for a smaller human like an infant or maybe even something like a mouse or smaller creature that's non-human.

[00:09:48] Speaker 01:
I think was raised first in the briefing at this court.

[00:09:51] Speaker 01:
And I don't think it was raised previously.

[00:09:54] Speaker 01:
I think the assumption was at all times that this was being applied to a human.

[00:10:00] Speaker 01:
And so I'm not aware of that particular issue arising below.

[00:10:08] Speaker 01:
I may be wrong about that.

[00:10:09] Speaker 01:
It may be that the, now that I'm speaking, it may be that the examiner raised this issue.

[00:10:15] Speaker 01:
And it's my recollection that

[00:10:17] Speaker 01:
The point has been made all along that the length is sufficient for the application here in Heumann.

[00:10:30] Speaker 01:
The second point is that the PTO has asserted that we fail to define the locations of the pin, but that's not true.

[00:10:40] Speaker 01:
Any lengthening would be a violation of topless, which prohibits the modification

[00:10:47] Speaker 01:
of a reference.

[00:10:48] Speaker 01:
I'd like to turn now to claim seven.

[00:10:51] Speaker 01:
And claim seven is directed to a guide for inserting and advancing a pin searcher into a shoulder.

[00:10:57] Speaker 01:
And the claim provides that the guide comprises a tip portion containing a leading end that's configured for penetrating engagement with the bone.

[00:11:05] Speaker 01:
And we don't think May or Hayhurst have that attribute.

[00:11:12] Speaker 00:
You're saying they don't have a tip portion or they don't penetrate?

[00:11:16] Speaker 01:
The tools, they don't penetrate.

[00:11:20] Speaker 01:
The tools identified in May and Hayhurst are configured for manipulating soft tissue and cartilage.

[00:11:28] Speaker 01:
And therefore, there's no express indication that they can be used in a bone.

[00:11:32] Speaker 01:
And soft tissue is, you know, tools for soft tissue could be more flexible, lighter, weaker to manipulate delicate tissues.

[00:11:42] Speaker 01:
And there's no indication that it would have the strength or robustness necessary for it to penetrate bone.

[00:11:48] Speaker 04:
So rather, it's your understanding of the claim limitation that the tip portion, the leading end of the tip portion, when it says penetratingly engaged, that it itself has to be digging through the bone.

[00:12:02] Speaker 04:
And your claim necessarily excludes embodiments where something else perhaps creates the

[00:12:10] Speaker 04:
hole in the bone or a divot in the bone in which the tip portion of the guide is then engaging with the bone in a penetrating way in the sense that it is now at least partially going through the bone, thanks to some drill that operated on the bone before it.

[00:12:29] Speaker 01:
Yes, Your Honor.

[00:12:31] Speaker 01:
We think the claim requires that that tip be able to make the penetration.

[00:12:35] Speaker 01:
And that's what the configured for penetrating engagement requires in the claim.

[00:12:40] Speaker 01:
And with respect to Hayhurst, that citation talks about using a drill if it wants to penetrate the bone.

[00:12:51] Speaker 01:
And there would be no reason to talk about a drill if the needle itself could penetrate.

[00:12:56] Speaker 01:
In fact, in the background of Hayhurst, it talks about prior arch techniques that are disparaged for being complex and time consuming.

[00:13:04] Speaker 00:
And therefore, are you telling us that the invention here really is

[00:13:08] Speaker 00:
Just that the tip is somehow solid or has a certain structural strength.

[00:13:16] Speaker 01:
We think that the point of overcoming here is that the tip has the attributes for penetrating the bone and that these soft tissue tools will not have.

[00:13:30] Speaker 00:
But the claim doesn't say what those attributes are.

[00:13:33] Speaker 00:
It just says that it penetrates the bone.

[00:13:35] Speaker 01:
Yeah, and we don't think that

[00:13:37] Speaker 01:
these references can do that.

[00:13:41] Speaker 04:
And how does your tool do that?

[00:13:44] Speaker 01:
I mean, it's very, very sharp, I guess.

[00:13:48] Speaker 01:
I think it's beyond sharp, too, because Heyer talks about being sharp, but it has to have the robustness to be able to get through the chordal layer of the bone, which is very strong.

[00:13:58] Speaker 01:
And there's no indication.

[00:14:00] Speaker 04:
Do I have to have really strong forearms to make it happen?

[00:14:03] Speaker 04:
I'm not trying to be funny.

[00:14:05] Speaker 04:
I'm just trying to find out.

[00:14:06] Speaker 01:
It's a very good question.

[00:14:08] Speaker 01:
And our position on that would be that if a tool is designed for working with the bone, working with tissue, it's not going to have the strength.

[00:14:18] Speaker 01:
And it's going to deform or break rather than going through the bone.

[00:14:22] Speaker 01:
And I'm getting into my federal plan.

[00:14:24] Speaker 00:
So thank you.

[00:14:26] Speaker 00:
You're not saying that it's novel to have a tip.

[00:14:29] Speaker 00:
that actually penetrates the bone?

[00:14:32] Speaker 01:
Well, we think that's where we overcome these references, is by the tip being able to penetrate the bone and extend through that hard outer layer.

[00:14:48] Speaker 00:
OK.

[00:14:48] Speaker 00:
Let's hear from the office.

[00:14:52] Speaker 00:
Mr. Kelly?

[00:14:54] Speaker 02:
May it please the court.

[00:14:54] Speaker 02:
Good afternoon, Your Honors.

[00:14:56] Speaker 02:
I'll start where he left off, which is this limitation in claim seven that the tip be able to penetrate the bone.

[00:15:03] Speaker 02:
What the claim actually says is the tip has to have a penetrating engagement with the bone.

[00:15:08] Speaker 02:
And the specification teaches that as simply a metal sharp point.

[00:15:13] Speaker 02:
The projection itself is disclosed as being between 1 and 5 millimeters.

[00:15:18] Speaker 02:
So what they disclose is something that is potentially 1 millimeter across with a sharp metal tip.

[00:15:24] Speaker 02:
And we would maintain that the prior, both May and Hayhurst, does not deviate structurally from that at all.

[00:15:30] Speaker 03:
The one millimeter is what kind of measurement?

[00:15:34] Speaker 03:
Is it length, width?

[00:15:35] Speaker 03:
What did you say?

[00:15:36] Speaker 02:
The one millimeter is the diameter of the rigid tube trocar tip 150.

[00:15:42] Speaker 02:
And I'm reading right now, Your Honor, from appendix page 66.

[00:15:45] Speaker 02:
So it's the diameter of the tip is what the specification says.

[00:15:51] Speaker 02:
And what I'd like to explain, just

[00:15:52] Speaker 02:
a second is how it actually works because I think it's easy to kind of get the impression that what's happening here is the guy has some sort of means of going through the bone to permit the suture to go through and that's not what happens at all under the specification.

[00:16:08] Speaker 02:
The tip, it says penetratingly engages with the bone and I read that as just kind of holds onto the bone because the way the suture is pushed through the bone is with a drill.

[00:16:20] Speaker 02:
So even in

[00:16:21] Speaker 02:
Chudik's own disclosure, it's a drill that's used to get the suture through the bone and not anything on this guide at all.

[00:16:31] Speaker 02:
And that's in the specification at page 67.

[00:16:35] Speaker 02:
It says, directed by an insertion guide 134, and I'm reading about a third of the way down, a suture pin 140 is advanced by a drill.

[00:16:46] Speaker 02:
The guide is simply kind of engaged in place by this tip, which is held at the bone so that the surgeon can then use a drill to push the suture through.

[00:16:54] Speaker 02:
And that's how the prior works as well, Your Honors.

[00:16:58] Speaker 02:
So we would say that neither May nor Hayhurst deviates at all from the claimed structure and, in fact, could easily perform the recited function.

[00:17:07] Speaker 02:
Stepping back to the rejection of claims 1 and 10 in view of Onsbach,

[00:17:14] Speaker 02:
The argument that opposing counsels made here this morning is that the on-spot reference is too short.

[00:17:22] Speaker 02:
And the device itself is too short.

[00:17:27] Speaker 02:
And what the examiner said, and the examiner said this from the very beginning of examination in this case, is that the relative dimension is simply not claimed here.

[00:17:36] Speaker 02:
The size of the mammal, adult, child, infant, it's simply not claimed.

[00:17:41] Speaker 02:
So to claim something relative to a size

[00:17:44] Speaker 02:
that's not claimed simply makes the invention very, very broad.

[00:17:49] Speaker 02:
And that's not an unreasonable conclusion to draw by the examiner.

[00:17:54] Speaker 02:
If you look at the specification itself, the specification explains that there's a significant variability in the size of shoulders that these devices are going to be used on.

[00:18:05] Speaker 03:
But does it ever talk about shoulders of the size of mice?

[00:18:10] Speaker 02:
It doesn't, Your Honor, but every dimensional range that the specification gives is quite large.

[00:18:16] Speaker 02:
It talks about a diameter of a shaft between 0.1 and 5 centimeters.

[00:18:21] Speaker 02:
It talks about a guard thickness of between 0.1 and 2 millimeters.

[00:18:25] Speaker 02:
It talks about a glenoid sizer of between 0.1 and 10 millimeters.

[00:18:30] Speaker 02:
It talks about an in-growth layer on a shell from between 0.1 to 10 millimeters, and preferably from 0.1 to 2 millimeters.

[00:18:39] Speaker 02:
And the point I'm trying to make, Your Honor, is that every time, should it did try to put some numbers onto a dimension, the ranges were extraordinarily large.

[00:18:48] Speaker 02:
They were sometimes 150 times greater from the smaller to the larger size.

[00:18:54] Speaker 02:
So for the examiner to step back and say, if you're trying to claim the length of something, you've got to do more than simply give us four components with win.

[00:19:07] Speaker 02:
I'm sorry.

[00:19:08] Speaker 02:
within which this device is disposed.

[00:19:10] Speaker 02:
You've got to tell us at least are you working on an adult human or actually give us a dimension.

[00:19:19] Speaker 02:
He has done nothing.

[00:19:20] Speaker 03:
And is this particular argument you're making now independent of whether the device has to be in all four places at once or

[00:19:32] Speaker 02:
Your Honor, I'd say the argument I'm making right now actually gives that to them.

[00:19:36] Speaker 02:
In other words, I'm saying even if the claim requires that it's in all four of these places, which a couple of them are unspecified because they simply say a surface of the shoulder.

[00:19:44] Speaker 02:
And dependent claims further define what those surfaces are.

[00:19:48] Speaker 02:
But even assuming it has to be in four places at once, there's nothing in the claims, and really there's not much in the specification, that tells us how long a device would have to be to accomplish that.

[00:20:00] Speaker 03:
Do any of the numerical ranges that you were reciting a few minutes ago from the specification of the application overlap with the few numbers in ANSPAC?

[00:20:14] Speaker 03:
There was a 0.625 total length and a 0.25 shaft and so on.

[00:20:22] Speaker 02:
So the best I can say there, Your Honor, is 0.625 centimeters is about

[00:20:30] Speaker 02:
I'm sorry, .625 inches is about 15 and a half centimeters.

[00:20:34] Speaker 02:
I'm sorry, millimeters.

[00:20:36] Speaker 02:
There is a chart, and I'm sort of going beyond the record at this point.

[00:20:39] Speaker 02:
This is something reading through, I've sort of come across.

[00:20:42] Speaker 02:
There is a chart in the specification that talks about various dimensions of shoulder diameters, and I assume it's in adults.

[00:20:50] Speaker 03:
No, let me just make sure we're on the same page.

[00:20:53] Speaker 03:
Okay.

[00:20:53] Speaker 03:
I think earlier you were describing how the specification in the application in front of us

[00:21:00] Speaker 03:
recites a number of numerical ranges, quite large ranges.

[00:21:06] Speaker 03:
Do any of those provide ranges as to length that one can compare to the numerical length numbers in ANSVAC?

[00:21:20] Speaker 02:
No, because what I was trying to

[00:21:22] Speaker 02:
explained to the court was that when ranges are provided for different parts of the invention, for things not even related to this feature.

[00:21:29] Speaker 02:
For example, the implant that goes over the top of the humerus, or another device that goes through the humerus.

[00:21:36] Speaker 02:
When dimensions are given, they're given with extraordinarily broad ranges, suggesting a large degree of variability in the size of the bones that the surgeon is working on.

[00:21:46] Speaker 02:
And so from that, what I was trying to make the point that

[00:21:50] Speaker 02:
The examiner was on solid ground to say, look, there's a huge variation here, because even when the specification gives dimensions, and they don't give dimensions for this part of their disclosure, but when they do give dimensions, they're extraordinarily large in variability.

[00:22:03] Speaker 02:
I wasn't meaning to suggest that this particular dimension is given, because it never is.

[00:22:09] Speaker 02:
The only other thing I'll raise, unless the court has questions, is that there is this argument that ANSFAC teaches an anchor.

[00:22:16] Speaker 02:
It teaches something that cannot be pulled out

[00:22:19] Speaker 02:
And so because of that, it does not teach something that doesn't go through.

[00:22:23] Speaker 02:
And of course, that makes little sense at all.

[00:22:25] Speaker 02:
What ANSPEC does is it goes into the bone.

[00:22:27] Speaker 02:
It's bored into the bone.

[00:22:29] Speaker 02:
And it has a feature, sort of the barbs on the tip, that prevent it from coming back out.

[00:22:33] Speaker 02:
But of course, the claimed invention also has the very same barb on its tip.

[00:22:37] Speaker 02:
The claimed invention presumably couldn't get pulled out either.

[00:22:39] Speaker 03:
Right, but on the assumption that, at least for purposes of what you were saying before, you were

[00:22:47] Speaker 03:
giving to him, namely that the device has to be in all four places at once.

[00:22:56] Speaker 03:
It seems to me that, depending on how the numbers would work out, that if ANSPAC is about a device that is supposed to be lodged in and remain in the bone, that may not preclude it from going through the bone, but it does tell you something about the size.

[00:23:15] Speaker 02:
Well, Your Honor, it only tells us something about the size about the bone in which Onspock uses the anchor.

[00:23:21] Speaker 02:
Right.

[00:23:21] Speaker 02:
So, admittedly, there's a bone somewhere that it's not going to penetrate through to the other side, because, of course, then it wouldn't be an anchor.

[00:23:28] Speaker 02:
But that functionality in Onspock's world does not tell us whether or not that device otherwise.

[00:23:34] Speaker 03:
Thigh bone or otherwise.

[00:23:35] Speaker 02:
Right.

[00:23:36] Speaker 02:
It doesn't tell us otherwise why it doesn't meet the claimed invention here.

[00:23:45] Speaker 02:
So unless the court has any further questions, I'll yield the remainder of my time.

[00:23:48] Speaker 02:
Sit down.

[00:23:50] Speaker 00:
Well, as long as we have time.

[00:23:53] Speaker 00:
There does seem to be some sort of a contribution here.

[00:23:58] Speaker 00:
Is the idea, the theory, that the claims are so broad as the board found, that they essentially read on the prior art?

[00:24:11] Speaker 02:
Yes, the claims are very, very broad.

[00:24:14] Speaker 02:
As this court has said in cases like Shriver and the CCPA said in cases like Swinehart, there's nothing intrinsically wrong with an applicant trying to claim their device structurally by the function it performs.

[00:24:28] Speaker 02:
But doing so puts them at a little bit of a risk.

[00:24:30] Speaker 02:
Because what it means is when the examiner finds a piece of prior art, that the examiner has a basis to believe will function in the same way as that claim, it pushes the burden back on the applicant

[00:24:43] Speaker 02:
to tell us why, in fact, that can't happen.

[00:24:46] Speaker 02:
Here, the claims, as Your Honor just observed, are extraordinarily broad.

[00:24:51] Speaker 02:
And there is this one functional limitation.

[00:24:53] Speaker 02:
And that's the only limitation that even arguably could separate these claims from the prior applied.

[00:25:01] Speaker 02:
And the examiner had a reasonable basis for concluding that, yeah, the prior art could do everything that you're claiming, because it structurally looks identical to the device as you've claimed it.

[00:25:12] Speaker 02:
What Chuddick has done in his briefing is he's come through and he said there is a litany of physical features that he has identified from his specification that he says can distinguish his inventive device, what he describes from the prior art.

[00:25:30] Speaker 02:
And Your Honor, we would submit that those litany of differences might be fertile ground for him to come up with claim amendments to propose in order to come over the prior art.

[00:25:38] Speaker 02:
But it doesn't get him around the prior art when none of them are claimed.

[00:25:42] Speaker 04:
So you've thought about this case for a while.

[00:25:44] Speaker 04:
What are some versions of amendments that would make the claim all of a sudden patentable in a way that it's not now and you're here?

[00:25:55] Speaker 02:
Well, I'm not going to suggest amendments for it.

[00:25:59] Speaker 02:
But what I'd say is one issue that we have in this case, and the court raised this earlier with Judge Toronto's question, is whether or not this device, this harpoon, really does stick out from the front and the back of the shoulder.

[00:26:12] Speaker 02:
The claim actually said that once.

[00:26:14] Speaker 02:
So the claim actually began, not in its first iteration, but its second iteration.

[00:26:19] Speaker 02:
It actually said, it's long enough, it penetrates out the front, and it comes back out the backside.

[00:26:24] Speaker 02:
And it's this long, and it can stick out each side.

[00:26:26] Speaker 02:
And the examiner said, you didn't tell me the size of your patient.

[00:26:30] Speaker 02:
And instead of coming back at that in some meaningful way, he said, let me change the claim.

[00:26:36] Speaker 02:
And so then the claim talked about something that can enter and exit.

[00:26:40] Speaker 02:
And that's when we got into the debate about ANSPAC and whether or not it's an anchor or not.

[00:26:44] Speaker 02:
But theoretically, he could have come at that amendment a different way.

[00:26:48] Speaker 02:
And he could have come in with a declaration.

[00:26:49] Speaker 02:
He could have come in with an amendment and said, no, no, mine actually does stick out the front and back.

[00:26:53] Speaker 02:
And it's an adult shoulder, a human adult shoulder.

[00:26:56] Speaker 02:
And here's a declaration to tell you how big that would be.

[00:26:59] Speaker 02:
Now, he's got a little bit of a problem, because his specification is quite lean when it comes to the actual details of the structure.

[00:27:06] Speaker 02:
But that's something he could pursue.

[00:27:09] Speaker 02:
That's a direction he could go.

[00:27:12] Speaker 02:
I'm not saying it would be successful, but it's something he could try.

[00:27:18] Speaker 02:
So if the court has no further questions, I'll yield it over to you.

[00:27:21] Speaker 00:
Thank you.

[00:27:21] Speaker 00:
Thank you very much.

[00:27:27] Speaker 00:
Mr. Weld, go ahead.

[00:27:30] Speaker 01:
Your Honor, I want to address back to the first argument of counsel about the drill

[00:27:37] Speaker 01:
In the specification, council made the argument that the claim seven guide doesn't really penetrate that much, instead a drill is used.

[00:27:48] Speaker 01:
But that's not the case.

[00:27:51] Speaker 01:
The drill is used after, and this is what's stated immediately prior to the discussion of the drill at appendix 67, the bore tip is extended into the lateral

[00:28:04] Speaker 01:
humeral 20 cortex under direct or arthroscopic visualization.

[00:28:10] Speaker 01:
So basically the tool is going through the cortex which is the hardest part of the bone and then after that a drill may be used because of course the pin has to come out the other side on the top and go through the rotator cuff and another surface of the bone.

[00:28:32] Speaker 01:
So the discussion of a drill here does not really make this guy just simply configured for penetrating engagement there.

[00:28:43] Speaker 01:
That limitation doesn't make it just for touching the edge, but it needs to have penetrating engagement.

[00:28:51] Speaker 01:
It's penetrating, not scratching or coming up to the surface.

[00:28:54] Speaker 01:
And it's going through that portal layer, which is the hardest layer of the bone.

[00:28:59] Speaker 01:
So on that point, again, we're distinguishing over the prior art where the Hayhurst reference and the May reference are for soft tissue and will not have the robustness that's necessary.

[00:29:13] Speaker 01:
I mean, the tools used for penetrating bone are not the same tools that a surgeon is going to use to manipulate soft tissue.

[00:29:21] Speaker 01:
They're just not the same tools.

[00:29:22] Speaker 01:
There are different factors at play as to the construction of those tools.

[00:29:27] Speaker 04:
Do you have any disclosure in the spec on the construction of this tip portion or the materials it's made out of?

[00:29:37] Speaker 01:
I think it's enough that the spec talks about the chordal layer, which it has to penetrate through.

[00:29:45] Speaker 01:
And one skilled in the art would know what requirements are necessary from penetrating that hard layer of bone.

[00:29:52] Speaker 00:
But you're not saying that previously no tip ever existed that could penetrate.

[00:29:59] Speaker 01:
Well, we are, I don't know if we'd go so far as to say that, but we're dealing with the references that were cited.

[00:30:06] Speaker 01:
And the office hasn't cited any references there for penetrating bone.

[00:30:10] Speaker 01:
And we're not dealing with a 103 rejection where the office is saying, well, you could take this and put a hard tip on it from this bone reference, bone penetrating reference, and then we could get there.

[00:30:20] Speaker 04:
Is the sentence, I'm sorry, A67 you're relying on, the sentence the boar tip 150 is extended into the lateral humeral 20 cortex?

[00:30:31] Speaker 01:
Yes, that is the sentence.

[00:30:33] Speaker 04:
Okay.

[00:30:36] Speaker 01:
So we're dealing with the references that need to disclose these features either explicitly or inherently

[00:30:44] Speaker 01:
And it's our position they can't get to inherently disclosing because they're not tools designed for penetrating hard surfaces.

[00:30:52] Speaker 01:
To go back to the Schreiber reference and the reason to believe, we just don't think that the references impart a reason to believe either with respect to the May or Hayhurst references because these are for soft tissue tools or with respect to the Anspach reference

[00:31:11] Speaker 01:
as that is clearly designed to be embedded in a bone, not to extend through the bone, and can't reach the four portions of the anatomy that are in the claims.

[00:31:27] Speaker 01:
And there was a lot of discussion about how the claims are broad and that we could have amended them in some other way.

[00:31:37] Speaker 01:
But the point we're dealing with, especially with Ansbach, is that

[00:31:41] Speaker 01:
We clearly defined the areas of the shoulder that it's necessary to extend in.

[00:31:46] Speaker 01:
And that would be sufficient to one skilled in the art to understand what is necessary, particularly in a human application, as read in line with the specification.

[00:31:59] Speaker 01:
The lengthening, again, is not allowed under topless.

[00:32:09] Speaker 01:
And again, I want to mention that the Hayhurst shark tip is, again, it's not designed for penetrating engagement with bone.

[00:32:17] Speaker 01:
It's a tip for use with cartilage.

[00:32:19] Speaker 01:
And I think there's appreciable differences between tools for soft tissue and tools for bone.

[00:32:25] Speaker 01:
And turning back to the OnStock reference, there's just no express and certainly no express and no inherent disclosure that it can reach the four portions of the anatomy specified.

[00:32:36] Speaker 01:
Thank you.

[00:32:37] Speaker 00:
Thank you, thank you both.

[00:32:39] Speaker 00:
The case is taken under submission.