[00:00:03] Speaker 03:
Good morning, ladies and gentlemen.

[00:00:06] Speaker 03:
Because of a number of circumstances where conflicts with counsel schedule and cases going submitted, we only have two argued cases before the court today, which is very unusual for us.

[00:00:19] Speaker 03:
But we're happy it'll be a short morning.

[00:00:22] Speaker 03:
So the first case, case number 171851, C.R.

[00:00:27] Speaker 03:
Bard versus Angio Dynamics, Incorporated, Mr. Belusco.

[00:00:32] Speaker 03:
Did I pronounce that correctly?

[00:00:34] Speaker 03:
Velasco, you want five minutes for rebuttal?

[00:00:37] Speaker 01:
Yes, please, Your Honor.

[00:00:38] Speaker 03:
Okay, you may begin.

[00:00:40] Speaker 01:
Thank you, may it please the Court.

[00:00:41] Speaker 01:
I have three points I'd like to address today.

[00:00:45] Speaker 01:
The claim construction issue, specifically with respect to the 302 and 022 patents, but also claims 89 of the 615 patent, and the public accessibility issue with respect to the ISO MED reference, and finally with respect to the

[00:01:04] Speaker 01:
the board's modification of the examiner's rejection on new grounds that did not give an opportunity for fair hearing and should be vacated.

[00:01:16] Speaker 01:
Let me start, though, with the claim construction issue, which is the paramount issue here.

[00:01:22] Speaker 00:
The patent claims here... Can I just ask you on that, assuming you're correct that the implication of the language is that the device actually has to be power injectable, why does

[00:01:34] Speaker 00:
Why is the board even on that assumption wrong about obviousness?

[00:01:40] Speaker 01:
Well, because the isomet reference, which is relied on for anticipation of many of those claims, and obviousness as the primary reference on the others, is not power injectable.

[00:01:54] Speaker 03:
So the question is, is there evidence in the record from which one could conclude, especially in light of

[00:02:01] Speaker 03:
your spec that talks about power injectable and non-power injectable ports, could the board have reached the conclusion that even if the isomed wasn't power injectable that it would have been obvious to shift from one to the other?

[00:02:17] Speaker 01:
No, Your Honor, I don't believe so.

[00:02:19] Speaker 01:
There's nothing to indicate.

[00:02:21] Speaker 01:
As a matter of fact, the isomed reference itself points out that there is an issue with high pressure.

[00:02:30] Speaker 01:
And that's in the record.

[00:02:32] Speaker 01:
And so you would never use a structure like that.

[00:02:34] Speaker 01:
So the idea that you would modify that particular pump, which is used to... I guess maybe I'm confused about a premise.

[00:02:43] Speaker 00:
I thought it was undisputed that there were, in fact, power injectable ports in the prior art.

[00:02:49] Speaker 01:
There may have been ports that were capable of power injection, yes, Your Honor, but it was not isoment.

[00:02:55] Speaker 00:
So it's not isomet, but there were undisputed, prior art, there were power injectable ports.

[00:03:01] Speaker 00:
Assuming isomet is prior art, maybe even without isomet, having an X-ray readable tag saying, here is what I am, was also in the prior art.

[00:03:12] Speaker 00:
Why is it not obvious to put one of those tags on the prior art power injectable ports?

[00:03:18] Speaker 01:
Well, there is no art that indicated putting on such an indicator, a radio opaque indicator, to indicate something was power injectable at all.

[00:03:29] Speaker 00:
Isn't it obvious that, since as you say, it's very important for the user of the device, who can no longer see it with his eyes, to know what the thing is under the skin, to have an x-ray readable identifier?

[00:03:46] Speaker 00:
self-identifier of whatever the device is?

[00:03:49] Speaker 01:
There is no evidence in the record to indicate any ports were indicated for power injection specifically and this power injection procedure as your honor may be aware is a separate function for these ports.

[00:04:05] Speaker 01:
Traditionally the ports such as isomed were for putting in chemotherapy drugs at very slow even paces.

[00:04:13] Speaker 01:
This need for a

[00:04:16] Speaker 01:
report that could take high pressure came about because you want to do a CT scan where you need to put in a lot of contrast in a short period of time.

[00:04:28] Speaker 03:
So if the board made no findings with respect to motivation to combine anything in the prior art, if we concluded that to write on the claim construction, and so therefore under the APA we couldn't

[00:04:46] Speaker 03:
firm based on the grounds that the Board relied upon, wouldn't it be appropriate to remand for the Board to consider obviousness in light of the correct claim construction?

[00:04:58] Speaker 01:
Well, that's certainly a possibility, Your Honor.

[00:05:00] Speaker 01:
But I submit that I don't think there's any showing that it would be obvious.

[00:05:06] Speaker 01:
There's no motivation to combine, nor I believe is there anything in the record that's going to indicate such a motivation to combine with the references there.

[00:05:15] Speaker 02:
Do you agree that ISOMED teaches a radiographic tag that identifies the model number and also the flow rate?

[00:05:25] Speaker 01:
Yes, it does.

[00:05:26] Speaker 01:
It indicates that it has a very low flow rate.

[00:05:31] Speaker 02:
But it indicates something.

[00:05:32] Speaker 02:
There is some self-identification in ISOMED.

[00:05:35] Speaker 01:
Yes, it does.

[00:05:39] Speaker 01:
But there's two aspects to the claim construction issue.

[00:05:42] Speaker 01:
And the first one you've hit upon already, of course, is that is it power-objectable?

[00:05:47] Speaker 01:
And we certainly say it is.

[00:05:48] Speaker 01:
But the other has to do with the boards throwing out as printed matter the radiographic indicator.

[00:05:59] Speaker 01:
The radiographic indicator is something that is not printed matter that can be given no patentable weight.

[00:06:07] Speaker 00:
It has a very specific weight.

[00:06:09] Speaker 00:
So we have, including in isomed, the physical structure of an X-ray readable message vehicle.

[00:06:18] Speaker 00:
Yes.

[00:06:19] Speaker 00:
Right.

[00:06:19] Speaker 00:
And the only thing that's different here is the words on that vehicle.

[00:06:24] Speaker 00:
I am this rather than I am that.

[00:06:27] Speaker 00:
In what way is simply saying this is what I am outside the printed matter.

[00:06:35] Speaker 01:
Well, because first off, as you indicated, even in isomet, it is something that's etched or printed in some way on the metal itself.

[00:06:47] Speaker 01:
It's taught in the patent.

[00:06:48] Speaker 01:
It's etched into that metal.

[00:06:50] Speaker 01:
That indicator is part of the substrate.

[00:06:53] Speaker 01:
It's structure.

[00:06:54] Speaker 01:
It's not merely printed matter.

[00:06:56] Speaker 03:
That's all it is.

[00:06:57] Speaker 03:
So even assuming it doesn't, as I understand the printed matter analysis, it's a two-step.

[00:07:03] Speaker 03:
One, is it printed matter?

[00:07:05] Speaker 03:
Yes.

[00:07:06] Speaker 03:
And that depends on whether it has a functional relationship to the substrate.

[00:07:10] Speaker 03:
But even if it isn't, whatever that is has to still be novel, new, non-obvious.

[00:07:19] Speaker 03:
So why wouldn't this form of descriptiveness fall outside the second prong?

[00:07:29] Speaker 01:
Well, the second part, it's given patentable weight.

[00:07:33] Speaker 01:
Now you're into the obviousness determination.

[00:07:36] Speaker 01:
So if it's given patentable weight, then the issue is, well, is there such an indicator indicating something is power injectable?

[00:07:45] Speaker 01:
And there's nothing in the record of any art, of anything radio opaque indicating a particular vascular axis port is power injectable.

[00:07:56] Speaker 01:
And that's a very important thing because of the harm and even fatalities which were recognized by the board could happen.

[00:08:04] Speaker 01:
if you try to power inject something that is not power injectable.

[00:08:09] Speaker 02:
And the isomed reference, when it identifies the model and the flow rate, is that in essence identifying to Dr. Hay that I'm not power injectable, so don't power inject into this port?

[00:08:20] Speaker 01:
Absolutely.

[00:08:21] Speaker 01:
It's telling you the opposite.

[00:08:23] Speaker 01:
It's not telling you the positive that we have in the claims.

[00:08:28] Speaker 00:
But the more you keep focusing on what seems absolutely at the heart of the printed matter object,

[00:08:34] Speaker 00:
doctrine which is the content of the message if it says one thing you say the specific content on exactly the same structure assuming the same structure because it says what I am is a power injectable port instead of I am not a power injectable port that that changes that

[00:08:56] Speaker 00:
counts for patentability.

[00:08:58] Speaker 00:
Isn't that exactly what the printed matter doctrine has always been about?

[00:09:01] Speaker 00:
No, because this is still functionally related to... How is this functionally related to the structure in any way that's different?

[00:09:09] Speaker 00:
And maybe your position is it's the same.

[00:09:11] Speaker 00:
The label on any bottle of clear medical liquid.

[00:09:17] Speaker 00:
The label?

[00:09:18] Speaker 00:
Right.

[00:09:18] Speaker 00:
You take any, you know, you have a whole row of

[00:09:21] Speaker 00:
of little vials, and they're all clear, and some of them have, you know, 0.5 percent, I don't know, opium or something in them, and the other, you know, 90 percent opium, and it's really, really important that the user know which it is, and you can't tell it visually, so you put a label.

[00:09:38] Speaker 00:
Does that really change the patentability of what's in the bottles?

[00:09:42] Speaker 01:
First, it's not just a label.

[00:09:44] Speaker 01:
It's something that's on the substrate.

[00:09:47] Speaker 01:
It is part of the structure.

[00:09:49] Speaker 00:
I think you're evading the question.

[00:09:52] Speaker 00:
It's old to put a label of some sort inside on a device when it's under the skin so that people can use x-rays to see it.

[00:10:04] Speaker 00:
You keep coming back to, but this label says it's power injectable.

[00:10:10] Speaker 00:
Content of the label is what you keep coming back to.

[00:10:13] Speaker 00:
How is that different from different content on labels on any bottle?

[00:10:21] Speaker 01:
We'll start with the premise that then if it is something that is on the substrate, we're out of printed matter.

[00:10:29] Speaker 01:
Now we're dealing with obviousness.

[00:10:33] Speaker 01:
Because it's part of the structure and it has a function.

[00:10:36] Speaker 03:
I think that's really the heart of the question.

[00:10:38] Speaker 03:
So you would agree, I take it, that the tag in isomene is functionally related to the substrate.

[00:10:49] Speaker 03:
Yes.

[00:10:50] Speaker 03:
Okay, so say you've got two different identifiers that are functionally related to the substrate, and the question is why it wouldn't be obvious to say one is, that what, it wouldn't be obvious to say, you said I'm not X, why wouldn't it be obvious to say I am X?

[00:11:09] Speaker 01:
Well, there's nothing to indicate that you'd ever want to say that I am power injectable.

[00:11:16] Speaker 01:
That was out there before.

[00:11:17] Speaker 02:
But there is something in the prior art that says I'm not power injectable, so don't use me or you might cause... Cause harm.

[00:11:24] Speaker 02:
That is correct.

[00:11:24] Speaker 02:
Cause serious harm.

[00:11:26] Speaker 02:
But how is that any different?

[00:11:28] Speaker 02:
Why isn't that prior art disclosure evidence of obviousness of also saying I am power injectable, so you can use me for this purpose?

[00:11:37] Speaker 01:
Well, because when it does say that I am power injectable, that permits then the medical practitioners to actually use it.

[00:11:47] Speaker 01:
for its purpose.

[00:11:49] Speaker 01:
Otherwise, they don't see it.

[00:11:52] Speaker 03:
Right, and that goes to the second part of the board's construction, which is whether or not this port has to be power injectable and whether or not there's anything in the prior art that showed the use of power injectable ports.

[00:12:03] Speaker 01:
Yes, that's absolutely right, Your Honor.

[00:12:06] Speaker 03:
Before we use up all your time, I do want to talk about printed matter.

[00:12:11] Speaker 03:
Okay.

[00:12:11] Speaker 03:
So, yes, it's not the best declaration I've ever seen in my

[00:12:17] Speaker 03:
in my life.

[00:12:18] Speaker 01:
Are you saying accessibility?

[00:12:20] Speaker 03:
Accessibility, I'm sorry.

[00:12:22] Speaker 03:
So it's not a great declaration, but the board found it to be sufficient, the board found it to be credible despite the admitted bias.

[00:12:33] Speaker 03:
So why don't we have to defer that finding?

[00:12:37] Speaker 01:
Well, first off, it's supposed to make it so that one of skill in the art can find it.

[00:12:47] Speaker 01:
If you really look at what is described in the declaration, it talks about providing this to particular doctors and others.

[00:12:57] Speaker 01:
But the only reference to what is one of skill in the art here in the record is a medical device designer with many years of experience.

[00:13:09] Speaker 02:
Don't our cases say that it's not just one of ordinary skill in the art?

[00:13:13] Speaker 02:
It's persons interested in this technology?

[00:13:16] Speaker 01:
I would say yes, but the person interested in this technology for the point that we're looking at here would be such a medical designer.

[00:13:26] Speaker 03:
Moreover... So would you say that no matter how widespread the distribution was to the users of the technology, like doctors, that it would never qualify under the public accessibility?

[00:13:37] Speaker 01:
Well, I would say if it's not getting to the right people, it doesn't matter to whom you give it.

[00:13:43] Speaker 01:
But the other thing about this is

[00:13:45] Speaker 01:
while it's distributed as it's said here, how would one find it?

[00:13:51] Speaker 01:
The issue is how could one find it?

[00:13:53] Speaker 00:
So a person interested in these products, I assume, would go out into the marketplace.

[00:13:59] Speaker 00:
Maybe there's even a website.

[00:14:00] Speaker 00:
Maybe there's an FDA website and say, who makes access ports?

[00:14:04] Speaker 00:
And they say Medtronic.

[00:14:05] Speaker 00:
And I think you conceded that anybody who saw it upon asking would

[00:14:10] Speaker 00:
get the Medtronic brochure or whatever you call it.

[00:14:14] Speaker 01:
Yes, what we said is anybody who got the brochure could then see where to get the brochure.

[00:14:20] Speaker 00:
Right, but why?

[00:14:21] Speaker 01:
That's kind of a circular thing.

[00:14:22] Speaker 00:
Well, I'm not sure it is circular.

[00:14:23] Speaker 00:
If somebody is interested in what's out there in the marketplace, don't they look at what's out there in the marketplace?

[00:14:30] Speaker 00:
And then they say, I want to know about details.

[00:14:33] Speaker 00:
Ask them the manufacturer.

[00:14:36] Speaker 01:
Well, there's certainly no evidence in the record that you could go find it on a website or anything.

[00:14:40] Speaker 01:
There's nothing like that here.

[00:14:43] Speaker 00:
The only evidence is that one person... Is that Medtronic was actively marketing a product.

[00:14:50] Speaker 00:
Somebody interested in the product could get the brochure.

[00:14:54] Speaker 00:
Why is it not just a trivial to... Do you contest that somebody who held in his hand the Isomed Medtronic product would

[00:15:06] Speaker 00:
could, I'm not sure what the right verb is, ask Medtronic for 100 page or more documentation about it.

[00:15:16] Speaker 01:
If you have the product, I assume you could ask for a user manual for the product.

[00:15:23] Speaker 03:
Yes.

[00:15:23] Speaker 03:
How do you distinguish enhanced security?

[00:15:26] Speaker 01:
Well, I think enhanced security actually points out perhaps in that

[00:15:34] Speaker 01:
There are certain holes missing here that aren't necessarily missing there, although there may have been holes in what inferences you can take.

[00:15:45] Speaker 03:
I thought there were holes there, but I didn't win.

[00:15:47] Speaker 01:
Yes.

[00:15:48] Speaker 01:
I agree with you on that.

[00:15:50] Speaker 01:
But be that as it may, really the only thing that came out of the declaration, if you really look at what the findings were, that was that the

[00:16:02] Speaker 01:
board found that ISAMED was available to any member of the relevant public who requested a copy from Medtronic.

[00:16:09] Speaker 01:
That's what's there.

[00:16:10] Speaker 01:
And again, it starts with we got to have it to ask for it.

[00:16:14] Speaker 01:
And so we don't have anything here that fills in all the holes of who, when, where, how.

[00:16:21] Speaker 01:
Your recent GoPro case, for example, had a litany of stuff.

[00:16:25] Speaker 01:
in terms of how that was out there.

[00:16:28] Speaker 00:
A lot of evidence.

[00:16:29] Speaker 00:
That is a few... In a re-examination proceeding, how much is needed for what seems on its face like a quite familiar situation?

[00:16:38] Speaker 00:
A product is out there in the marketplace.

[00:16:41] Speaker 00:
Somebody interested in the product would think of asking the manufacturer, do you have literature on the product?

[00:16:48] Speaker 00:
Well, Your Honor, I would suggest that... And you don't dispute that if

[00:16:52] Speaker 00:
Somebody asked, Medtronic is delighted to give it because it makes it more useful.

[00:16:56] Speaker 00:
Maybe they'll sell more.

[00:16:57] Speaker 01:
Absolutely.

[00:16:59] Speaker 01:
Well, assuming they're an interested person, and I think they should be one of a skill in the art, the question about a re-exam procedure, it should be more.

[00:17:09] Speaker 01:
And the reason for that is we're not even in a position in that re-exam procedure to take the deposition.

[00:17:17] Speaker 01:
So how are we going to check these facts that a

[00:17:23] Speaker 01:
least biased person puts in a declaration.

[00:17:26] Speaker 02:
I hear what you're saying, but also isn't it true that the examiner just has to make a prima facie case and then you have to bring forth evidence.

[00:17:35] Speaker 02:
It's not as if there's a burden of proof issue in this kind of examination by the patent examiner, right?

[00:17:41] Speaker 01:
I believe that's correct, but I do believe that it ultimately is for the patent office to do something here

[00:17:51] Speaker 01:
and to just rely upon a declaration provided by the other side's employee does not seem to be sufficient here to meet the requirements that this was truly public accessible to an arrested person.

[00:18:07] Speaker 03:
And this patent issued before the AIA, right?

[00:18:10] Speaker 01:
Yes, it did.

[00:18:13] Speaker 03:
We'll restore five minutes for rebuttal.

[00:18:15] Speaker 01:
Okay, thank you.

[00:18:16] Speaker 03:
You're lucky we don't have many cases.

[00:18:33] Speaker 04:
Good morning, Your Honors.

[00:18:34] Speaker 04:
May it please the court?

[00:18:36] Speaker 04:
My name is Danielle Tully and I'm here today with my colleagues on behalf of Cross Appellant Angiodynamics.

[00:18:41] Speaker 03:
Can we start with the public accessibility question?

[00:18:46] Speaker 03:
Yes.

[00:18:46] Speaker 03:
So my question is to what extent can we rely upon the disclosures in the document itself for purposes of determining public accessibility?

[00:18:58] Speaker 04:
Well, I think that as this court found in GoPro, the test for public accessibility is actually a flexible standard.

[00:19:04] Speaker 04:
So I think that the court would be right to look at the face of the document itself.

[00:19:07] Speaker 04:
And here, we don't have a dispute that IceMed was, in fact, a publicly sold and used device that was on sale and actually used by doctors before the critical date here.

[00:19:17] Speaker 04:
There's also no dispute that the IceMed manual itself was authored and distributed by Medtronic.

[00:19:23] Speaker 04:
My friend just conceded that somebody who actually wanted a copy of the manual could have gotten it from it.

[00:19:28] Speaker 03:
But when you say no, it means that it was distributed.

[00:19:31] Speaker 03:
So we have one declaration from one of your employees who says, I used to work for a third party distributor, and I gave out, what, several of these?

[00:19:44] Speaker 03:
I mean, it was so nonspecific.

[00:19:47] Speaker 03:
He didn't identify any doctors.

[00:19:49] Speaker 03:
He didn't say how many.

[00:19:50] Speaker 03:
He just said, I gave them out.

[00:19:52] Speaker 02:
He said voluminous, whatever that means.

[00:19:55] Speaker 03:
Right.

[00:19:55] Speaker 03:
So why is that enough from an evidentiary standpoint?

[00:20:00] Speaker 03:
In a court of law, it would certainly not be enough to satisfy an evidentiary burden.

[00:20:07] Speaker 04:
Yes, Your Honor.

[00:20:08] Speaker 04:
And I think that maybe in some circumstances, that wouldn't be enough.

[00:20:11] Speaker 04:
But not in these circumstances.

[00:20:13] Speaker 04:
The declaration itself is not the only piece of evidence we have here.

[00:20:17] Speaker 04:
Bard is asking this court to treat it as if it's the only piece of evidence, but it's not.

[00:20:21] Speaker 04:
actually we have a device and a manual for a device.

[00:20:25] Speaker 04:
Devices are sold with product manuals.

[00:20:27] Speaker 04:
A relevant person would know that they could get a copy of the manual from the device manufacturer.

[00:20:33] Speaker 03:
But you didn't have any evidence that any one of these devices was actually sold with a manual?

[00:20:38] Speaker 04:
It's undisputed in the record that the device is sold.

[00:20:41] Speaker 04:
And I think that it's understood that devices are generally sold to the public by a device manufacturer like Medtronic with

[00:20:48] Speaker 04:
with the manual for use.

[00:20:50] Speaker 04:
Where is that in the record?

[00:20:52] Speaker 04:
I believe the board found at... The findings of fact.

[00:21:09] Speaker 04:
The board says that Medtronic itself actually says... What page are you on?

[00:21:14] Speaker 02:
What paragraph?

[00:21:15] Speaker 04:
Oh, I'm sorry.

[00:21:16] Speaker 04:
I apologize.

[00:21:17] Speaker 04:
Findings of fact.

[00:21:19] Speaker 04:
It's like around appendix page 12?

[00:21:21] Speaker 04:
It's around appendix page 12.

[00:21:25] Speaker 02:
Which paragraph are you referring to?

[00:21:27] Speaker 04:
If we start with paragraph 10, it's actually on appendix page 11.

[00:21:31] Speaker 02:
Yeah, but where specifically does it say that Medtronic had a practice of selling products?

[00:21:37] Speaker 02:
Every time it would sell a product, it would give the manual.

[00:21:40] Speaker 02:
Where is this coming from?

[00:21:41] Speaker 04:
So in paragraph 10, it says that ISOMED itself says that ISOMED was prepared by Medtronic for distribution to physicians and allied professionals.

[00:21:49] Speaker 04:
rather than for internal or restricted use within Medtronic.

[00:21:52] Speaker 04:
And the board based that finding on ISOMED's statement, that ISOMED has been developed for physicians and allied professionals who care for patients using the ISOMED system for hepatic arterial infusion.

[00:22:04] Speaker 03:
But wait, that just says that the device was developed for physicians and allied professionals.

[00:22:12] Speaker 03:
It doesn't say anything about sending it with a manual.

[00:22:16] Speaker 04:
Well, that's actually the statement from the manual.

[00:22:18] Speaker 04:
The statement that the board is quoting there is found in the manual.

[00:22:22] Speaker 02:
But the board is just saying that that statement is evidence that it was for use, for public use, as opposed to being for internal or restricted use.

[00:22:35] Speaker 02:
That's the only thing they found.

[00:22:37] Speaker 04:
I believe that the board went on to conclude.

[00:22:42] Speaker 04:
that the inference was sound in paragraph 14.

[00:22:45] Speaker 03:
But this goes back to my question of the board relying on the document itself, rather than actual facts relating to distribution.

[00:22:54] Speaker 03:
To what extent can they say, well, I look at the document, so it was probably distributed?

[00:22:58] Speaker 03:
I mean, how is that good enough?

[00:23:00] Speaker 04:
Well, I think here, where the document is actually a manual for a medical device,

[00:23:09] Speaker 04:
Medical devices are typically sold with product manuals.

[00:23:12] Speaker 04:
Where's that in the record?

[00:23:14] Speaker 04:
The board inferred it from the fact that La Force actually sold the device and handed out the manual with it.

[00:23:23] Speaker 02:
One of the things that's frustrating about the record is that the amount of detail provided in the declaration, or if there weren't supplemental declarations that could have been obtained to say these things, that you're asking the board to infer and asking us to

[00:23:39] Speaker 02:
find supported by substantial evidence.

[00:23:41] Speaker 02:
It's hard to find those exact statements in the record.

[00:23:45] Speaker 02:
And while I agree with you, Your Honor, that the statements... Can I understand?

[00:23:49] Speaker 02:
I understand the only evidence here is just the one declaration and then the document itself.

[00:23:56] Speaker 02:
There's nothing else that was relied on to show that this was publicly accessible.

[00:24:02] Speaker 04:
Well, the board also inferred from the contact information that was in the document.

[00:24:07] Speaker 03:
But that goes back to it's in the document.

[00:24:09] Speaker 03:
And you don't have any.

[00:24:10] Speaker 03:
I mean, just because a document exists doesn't mean it's publicly accessible.

[00:24:15] Speaker 03:
That's the problem.

[00:24:16] Speaker 04:
That's correct, Your Honor.

[00:24:18] Speaker 04:
But the board did find that on the totality of the circumstances here that there was sufficient evidence to conclude that under the flexible standard that this court has articulated that the document would have been accessible to a member of the relevant public

[00:24:30] Speaker 04:
who exercise reasonable diligence to get a copy.

[00:24:33] Speaker 02:
And so just to answer my question and make sure it's understood, the only thing that you put in the record to show this is the one declaration and the document itself.

[00:24:43] Speaker 02:
Is that correct?

[00:24:44] Speaker 02:
That's correct, Your Honor.

[00:24:45] Speaker 02:
That's the totality of the evidence.

[00:24:47] Speaker 00:
We don't have evidence or findings about

[00:24:52] Speaker 00:
how many units of the product Medtronic distributed before the priority date?

[00:24:57] Speaker 00:
Is it a popular product?

[00:24:58] Speaker 00:
Were there only four in the entire world, or what?

[00:25:03] Speaker 04:
There's no specific evidence in the record of the number of Isemed devices that were sold here.

[00:25:10] Speaker 04:
However, BARD does not dispute that Isemed was, in fact, sold and used before its critical date.

[00:25:15] Speaker 00:
Right.

[00:25:19] Speaker 00:
If the basic theory, which as an abstract matter makes a lot of sense, that a widespread product, particularly a medical device for which details matter about how you use it, that there were a lot of them, and that they pretty much were always accompanied by the manual or whatever one calls this thing, why should we not send it back?

[00:25:49] Speaker 00:
assume that those would be relatively easy facts to either prove or disprove?

[00:25:54] Speaker 04:
Well, there is some evidence of that in the La Force Declaration.

[00:25:57] Speaker 04:
La Force does say that he personally sold... Was the word numerous?

[00:26:01] Speaker 00:
Is that the word?

[00:26:02] Speaker 04:
It was the word numerous.

[00:26:03] Speaker 03:
He sold numerous devices themselves, and he also distributed... Given that he works for you, and given that you put the affidavit in, the weakness and the thinness of the affidavit seems to be even more

[00:26:19] Speaker 03:
And so that's what I'm so surprised at.

[00:26:21] Speaker 03:
I mean, if there really was all this evidence and that he could identify who he sold it to or how many times he sold it, then why isn't it in the affidavit?

[00:26:31] Speaker 04:
Your Honor, I believe that the board actually considered the potential bias and they still credited the affidavit.

[00:26:36] Speaker 04:
I think the potential risk here is creating a rule that when there's a product manual that there's somehow a heightened burden of proving how many of the products were sold.

[00:26:46] Speaker 03:
Well, the risk is,

[00:26:48] Speaker 03:
assuming that just because a product manual exists that it was ever publicly accessible.

[00:26:54] Speaker 03:
And that's a really different question because we don't have any evidence other than this affidavit that the product manual was ever given to anyone.

[00:27:03] Speaker 03:
Regardless of whether the product was sold, a lot of times products are sold without product manuals.

[00:27:08] Speaker 04:
Yes, Your Honor, and I do understand that, but I believe that the standard that the court articulated recently in GoPro is that we don't need actual evidence that it was

[00:27:16] Speaker 04:
ever accessed by any particular member of the relevant public, just that it could have been accessed by the relevant public based on the totality of the evidence.

[00:27:25] Speaker 04:
And I believe that the board properly credited the evidence that's provided not only by the declaration, but also by the manual itself that shows that somebody who was interested in ISOMED could have obtained a copy from Medtronic.

[00:27:39] Speaker 03:
This doesn't change the result here, but do you think there's a difference between

[00:27:46] Speaker 03:
pre-AIA cases on public accessibility and post-AIA cases?

[00:27:50] Speaker 04:
I do not, Your Honor.

[00:27:51] Speaker 04:
I believe that the standard would be the same.

[00:27:59] Speaker 03:
So let's turn to the claim construction.

[00:28:02] Speaker 03:
Part of my problem with the board's finding is that it's a straight up grammatical one.

[00:28:09] Speaker 03:
The claim itself says the alphanumeric message indicating

[00:28:13] Speaker 03:
that the power assembly is power injectable.

[00:28:17] Speaker 03:
That is seems to be a pretty strong phrase.

[00:28:20] Speaker 03:
And you're saying the board says, well, it didn't have to really indicate.

[00:28:25] Speaker 03:
It says it's power injectable, but it could have not been power injectable.

[00:28:30] Speaker 03:
That doesn't even make any sense.

[00:28:32] Speaker 04:
Well, that's actually not quite our argument.

[00:28:35] Speaker 04:
Our argument is that all Bard is pointing to is the content of the information conveyed to distinguish the art.

[00:28:41] Speaker 04:
But all of the structure, all of the port structure that Bard has claimed is rudimentary port structure that was long known in the art.

[00:28:48] Speaker 04:
The septum, the outlet stem, the reservoir, the housing, all of that structure existed and we've shown that in the art.

[00:28:54] Speaker 03:
The other part of the art- You're saying it could be not power injectable.

[00:28:57] Speaker 04:
We're saying that based on Bard's disclosure, we don't know what power injectable even, how to distinguish a power injectable port from the art.

[00:29:04] Speaker 04:
Even if you take Bard and its word that its port is somehow different,

[00:29:08] Speaker 04:
There's nothing in its claims or its disclosure that distinguishes over the ARRA.

[00:29:12] Speaker 04:
They've only claimed the same rudimentary structure with known identification techniques.

[00:29:16] Speaker 03:
So what you're saying, so that the board's finding that it could be a non-power injectable port, even though the language says that is power injectable, you're saying that's not really what the board found?

[00:29:29] Speaker 04:
I'm saying that the board found that BARD couldn't simply distinguish by pointing to the content of its label.

[00:29:34] Speaker 04:
That doesn't change its claim structure.

[00:29:36] Speaker 03:
Why doesn't it claim that?

[00:29:38] Speaker 03:
Well, we've got to start with the words of the claim.

[00:29:41] Speaker 03:
And then we also have the prosecution history that makes it clear that they were distinguishing non-power injectable from power injectable, and that there is a very big difference between the two.

[00:29:52] Speaker 03:
So why is it that we should ignore the words, that is power injectable, and say, well, it could have been not power injectable, and we could have accidentally told a doctor that it is power injectable?

[00:30:03] Speaker 03:
That doesn't even make any sense to me.

[00:30:05] Speaker 04:
I think that going back to the prosecution history, as Your Honor pointed out, all that Bard points to in the prosecution history is that they amended the actual content of the information that was to be delivered by the radiographic marker.

[00:30:18] Speaker 04:
Originally the claims is filed, said the radiographic marker indicating information about the court.

[00:30:22] Speaker 04:
All Bard did is fill in the blank about the information.

[00:30:25] Speaker 04:
It could have been any information.

[00:30:26] Speaker 00:
I guess I have a little question.

[00:30:30] Speaker 00:
think that this claim requires that the device be a power injectable port?

[00:30:37] Speaker 04:
I think that Bard can't simply point to the... No, can you answer?

[00:30:41] Speaker 00:
I think the question I asked, do you think that this claim requires that the device be a power injectable port?

[00:30:49] Speaker 00:
The answer to the case doesn't stop at the answer to that question.

[00:30:53] Speaker 00:
What's your answer to that question?

[00:30:54] Speaker 04:
I don't believe that the claims define what a power injectable port is.

[00:31:00] Speaker 00:
That doesn't answer the question.

[00:31:03] Speaker 04:
Then I'm sorry.

[00:31:04] Speaker 00:
Does the device claimed have to be a power injectable port, whatever that may mean?

[00:31:11] Speaker 04:
Even if it has to be a power injectable, I guess I'm sorry, I don't understand your question.

[00:31:18] Speaker 00:
I think you have a whole separate argument that

[00:31:23] Speaker 00:
even if it's a power injectable point.

[00:31:25] Speaker 00:
I'd like to get past the first point.

[00:31:30] Speaker 00:
Do you think that this has to be a power injectable point so that the label is truthful?

[00:31:38] Speaker 04:
I answer dynamics personally.

[00:31:42] Speaker 04:
We do not think that it has to be a power injectable point, but if it does, even assuming that it does, as Your Honor said, all of the structure that is claimed

[00:31:52] Speaker 04:
would have been found in the art.

[00:31:54] Speaker 04:
All of the port structure exists in the art.

[00:31:57] Speaker 03:
All right, so let's assume we disagree with you on whether it has to be power injectable, and disagree with the board on whether it has to be power injectable.

[00:32:05] Speaker 03:
Yes.

[00:32:07] Speaker 03:
What then does that mean with respect to the board's finding of anticipation?

[00:32:16] Speaker 04:
I don't believe that it changes the board's finding with respect to anticipation.

[00:32:20] Speaker 04:
The board actually said it doesn't need to determine whether or not any of the prior art ports were power injectable because all of the structure is there.

[00:32:25] Speaker 02:
So once all... But wait, what if we say, no, the claim requires that it be power injectable?

[00:32:33] Speaker 04:
Then I believe that it would still be found in the art because a port with a... It's still anticipated by the prior art?

[00:32:40] Speaker 04:
Yes, Your Honor.

[00:32:41] Speaker 03:
So it's anticipated by a non-power injectable port?

[00:32:44] Speaker 04:
it would be anticipated by a court with the structure as claimed.

[00:32:48] Speaker 04:
So the structure as claimed.

[00:32:50] Speaker 03:
Well, that's separate.

[00:32:51] Speaker 03:
You're making an enablement argument, and the board didn't go off on saying, well, you didn't tell us what power injectable really means.

[00:32:57] Speaker 03:
So what the board said is, this could be non-power injectable, and the designation calling it power injectable could just be wrong.

[00:33:07] Speaker 03:
And assuming we don't agree with that, where does that leave you?

[00:33:13] Speaker 03:
What is your best argument that even if it has to be power injectable, that any of the board's findings could stand?

[00:33:20] Speaker 03:
Anticipation, obviousness, any of them?

[00:33:24] Speaker 04:
I believe my friend stood up here earlier and said that there was evidence in the art, and they don't dispute that some of the ports were actually being used for power injection.

[00:33:31] Speaker 00:
But the only actual anticipation point was Iceland, right?

[00:33:36] Speaker 00:
And I don't think the board ever made a finding which would be required for

[00:33:43] Speaker 00:
anticipation by ISOMED that ISOMED showed a power injectable port, right?

[00:33:48] Speaker 04:
No, they actually said they didn't need to decide whether or not ISOMED was power injectable.

[00:33:54] Speaker 00:
So that particular finding on the assumption we're now operating on could not stand if only for lack of findings on that point.

[00:34:05] Speaker 03:
And under the APA, we can only affirm based on the grounds that the board relied upon, right?

[00:34:13] Speaker 04:
The board also affirmed for certain 103 combinations.

[00:34:17] Speaker 04:
It wasn't just 102 with ICEMED, but the board actually pointed to additional ports that were part of the record here.

[00:34:24] Speaker 03:
Okay, so let's talk about those.

[00:34:27] Speaker 03:
Were there findings of a motivation to combine a non-injectable port with a power injectable port?

[00:34:37] Speaker 04:
The motivation to combine there is actually based on the disclosure of radiographic markers in both the, in the Jones port as well as... I think that's only one piece of it.

[00:34:48] Speaker 03:
So that addresses the first phrasing, the alphanumeric messaging.

[00:34:54] Speaker 03:
What about use of a power injectable port in this radiographic circumstance?

[00:35:02] Speaker 04:
Your Honor is correct, none of the prior art

[00:35:05] Speaker 04:
actually says that the ports were power injectable.

[00:35:08] Speaker 04:
That's not in the record here.

[00:35:10] Speaker 04:
So a remand would be required?

[00:35:12] Speaker 04:
We still don't believe it would need to be required.

[00:35:14] Speaker 02:
Assuming that we disagree with the board's claim construction, is a remand required?

[00:35:23] Speaker 04:
We don't believe it would be because the factual findings support that the claimed structure was present in the ARC.

[00:35:31] Speaker 04:
We do not think that remand is necessary in these circumstances.

[00:35:37] Speaker 04:
Okay.

[00:35:38] Speaker 04:
Okay.

[00:35:39] Speaker 03:
And then if I, I know that I'm out of time, but if I... Well, I'm giving you a little bit back because I'm giving him back.

[00:35:44] Speaker 03:
So we'll give you a couple of minutes.

[00:35:45] Speaker 04:
Okay.

[00:35:45] Speaker 04:
Would we be able to address our appeal on rebuttal?

[00:35:48] Speaker 03:
Yes.

[00:35:48] Speaker 04:
We have... Okay.

[00:35:50] Speaker 04:
Thank you.

[00:35:54] Speaker 03:
No, you can do it right now.

[00:35:55] Speaker 03:
Oh, I can do it.

[00:35:56] Speaker 04:
Oh, I'm sorry.

[00:35:56] Speaker 04:
I'm sorry.

[00:35:57] Speaker 04:
No, I'm sorry.

[00:35:58] Speaker 03:
No, you could do it right now.

[00:36:00] Speaker 04:
Okay.

[00:36:00] Speaker 04:
Thank you.

[00:36:02] Speaker 03:
It's actually okay with you guys.

[00:36:05] Speaker 04:
It's fine.

[00:36:06] Speaker 04:
Thank you.

[00:36:07] Speaker 04:
We believe that the board erred in reversing the examiner's rejections of claims one through four of the 302 patent.

[00:36:14] Speaker 04:
Like all the other claims of the 302 and the 022 patent, claims one through four are directed to the same subject matter, including the rudimentary port structure that is claimed.

[00:36:23] Speaker 04:
The relevant structure with respect to these claims is the housing that includes a housing base and how that defines the reservoir.

[00:36:31] Speaker 03:
Does ISOMED have a housing base?

[00:36:33] Speaker 04:
It does, Your Honor.

[00:36:34] Speaker 04:
Actually, the easiest way to think about it is if we look at ISOMED, and it's in the record at Appendix 606.

[00:36:43] Speaker 03:
Okay, now the Board found it didn't have a housing base, right?

[00:36:46] Speaker 04:
Board found it didn't have a housing base in Claim 1.

[00:36:50] Speaker 04:
However, with respect to Claim 5, where the Board upheld the examiner's rejections, the Board concluded that ISOMED has a housing.

[00:37:01] Speaker 04:
They specifically concluded that the BART specification, including figure 1B of the specification, teaches that the housing is comprised of a cap and a base.

[00:37:14] Speaker 04:
And then they said that the entirety of ISOMED's titanium shell defines the reservoir.

[00:37:20] Speaker 04:
But then, for some reason, when it got to claim one, it said that ISOMED, which it had already found, has a housing, and already said the housing has to include a housing base.

[00:37:30] Speaker 04:
For some reason, they said that ISOMED doesn't have a housing with a housing base.

[00:37:36] Speaker 04:
But if we look at Appendix 606, we can see what the board pointed to as ISOMED's housing.

[00:37:43] Speaker 04:
It's simply the titanium shell.

[00:37:46] Speaker 04:
It has a top portion and the bottom portion.

[00:37:48] Speaker 04:
The bottom portion is its base.

[00:37:51] Speaker 04:
The bottom portion has an outwardly facing bottom surface, just as in the claim.

[00:37:55] Speaker 04:
And it has an inwardly facing surface that

[00:37:59] Speaker 04:
defines the reservoir.

[00:38:01] Speaker 00:
So we're looking at this little submarine-like figure?

[00:38:03] Speaker 04:
Yes, that is isometric.

[00:38:04] Speaker 00:
But isn't the basic problem here, if you look below the, I don't even know how to describe these things, there's two long rectangular spaces with a line between them, and the thing at the bottom, right in the middle, that line at the bottom goes up and down, and up and down according to how the pump is working, right?

[00:38:24] Speaker 00:
Yes, Your Honor.

[00:38:25] Speaker 00:
So that's the bottom of the reservoir, but

[00:38:29] Speaker 00:
not necessarily the housing base.

[00:38:33] Speaker 00:
Well, actually, Your Honor, if you look... Or do I have that backwards?

[00:38:36] Speaker 00:
I think I'm remembering that was the key point the board said, you want to equate those, and the board said, we don't really see that you've proven that those should be equated.

[00:38:46] Speaker 04:
The board did get hung up on that partition.

[00:38:48] Speaker 00:
But hung up suggests it was something... That it didn't agree with you?

[00:38:53] Speaker 04:
It didn't.

[00:38:54] Speaker 04:
You're correct.

[00:38:55] Speaker 04:
But we believe that the board's error was in trying to find that partition in the claims, rather than looking at the claims and trying to find the elements in ISOMED.

[00:39:05] Speaker 04:
So if we look, actually, there's two reservoirs in ISOMED.

[00:39:09] Speaker 04:
There's what's labeled as the Reservoir Propellant Chamber and the Drug Reservoir.

[00:39:13] Speaker 04:
The claims actually say that the housing base has to define at least one reservoir.

[00:39:18] Speaker 04:
There's no reason for the board to have limited that reservoir to only the top reservoir and not the bottom reservoir.

[00:39:24] Speaker 04:
That isomet is a more complicated structure with multiple reservoirs that, as your honor pointed out, move up and down doesn't mean that it doesn't also teach the same structure that's actually disclosed in Bard's patents.

[00:39:39] Speaker 04:
OK.

[00:39:39] Speaker 04:
Thank you.

[00:39:40] Speaker 03:
All right, thank you.

[00:39:46] Speaker 03:
You have five minutes for your rebuttal and your response to the cross appeal.

[00:39:55] Speaker 01:
May I address something on the other argument as well?

[00:39:59] Speaker 01:
Yes, yes.

[00:40:00] Speaker 01:
I mean, it's both.

[00:40:01] Speaker 01:
You've got a total of five minutes for both.

[00:40:03] Speaker 01:
Yes, understood.

[00:40:04] Speaker 01:
Thank you very much.

[00:40:07] Speaker 01:
With respect to the one issue that was raised, we still say that this distribution of the manual did not go to

[00:40:19] Speaker 01:
one of ordinary skill in the art.

[00:40:21] Speaker 01:
I believe the blue calypso case does require that artisan to be one of ordinary skill.

[00:40:26] Speaker 00:
Am I remembering that this particular point about who the skilled artisan is is made only in your reply brief, not in your opening brief?

[00:40:36] Speaker 00:
I believe that... I don't remember that your opening brief said

[00:40:40] Speaker 00:
And another problem with the board's decision is they were looking at it from the wrong perspective.

[00:40:45] Speaker 01:
That's OK.

[00:40:46] Speaker 01:
Your Honor, you may be right.

[00:40:48] Speaker 01:
I don't remember as I stand.

[00:40:54] Speaker 00:
Can I ask you, if the case were to go back and the board were to inquire into whether the Medtronic product

[00:41:06] Speaker 00:
was, I'm going to use a loose term, widely distributed and whether it was a general practice either in the industry as a whole or for Medtronic to include with these very sensitive medical devices serious instruction manuals.

[00:41:26] Speaker 00:
Are you prepared to contest those propositions?

[00:41:33] Speaker 00:
Or are we talking about a kind of

[00:41:36] Speaker 00:
There isn't something in the record, but it's obvious what the real world would be.

[00:41:40] Speaker 01:
Your Honor, as I stand here, I have no idea what Medtronic's policy was at that time with this particular problem.

[00:41:48] Speaker 00:
What about your client's general policy?

[00:41:51] Speaker 00:
Obviously, you don't know about Isomed's particular, I mean, your client probably does know how many

[00:41:59] Speaker 00:
isomed products were out there, but in terms of general practices of distributing or not distributing manuals with medical device.

[00:42:11] Speaker 01:
It really depends on the products alone, especially very large manuals such as the isomed.

[00:42:20] Speaker 01:
It comes in packaging and many of the products that I'm familiar with are much

[00:42:24] Speaker 01:
more abbreviated.

[00:42:25] Speaker 00:
So you think there might actually be a real factual issue to consider?

[00:42:29] Speaker 00:
There may be a real factual issue.

[00:42:31] Speaker 03:
And what is your answer to the fact that what we said in GoPro was that it doesn't actually have to be publicly accessible.

[00:42:43] Speaker 03:
It just has to be, I mean, it doesn't have to actually be publicly accessed.

[00:42:48] Speaker 03:
It just has to be accessible.

[00:42:50] Speaker 01:
Right.

[00:42:51] Speaker 01:
Again, I think to be accessible, you have to be able to find it if you're looking for it for that purpose.

[00:42:59] Speaker 01:
And I haven't seen no evidence that that is the case, particularly with one of ordinary skill in the art.

[00:43:07] Speaker 01:
If I may, there was also a reference made here to the Jones reference.

[00:43:14] Speaker 01:
That wasn't power injectable either, and I just want to make that clear, and I think Your Honor raised the very fact of what happened in the prosecution history year.

[00:43:23] Speaker 01:
The amendment of the claims to add this is power injectable was to specifically overcome the Jones Prior Art, which was not shown as power injectable.

[00:43:33] Speaker 01:
There's nothing to show anything in the history year was power injectable.

[00:43:39] Speaker 03:
your friend on the other side said, it doesn't really matter if it's power injectable.

[00:43:43] Speaker 03:
It matters if you've disclosed sort of the structure of a port generally.

[00:43:49] Speaker 01:
Well, that would be an awful dangerous thing in the real world, Your Honor, because there are ports that are conventional.

[00:43:54] Speaker 01:
There are ports that are power injectable today in today's world.

[00:43:58] Speaker 01:
And you do not power inject the ones that are the conventional ones, which may have a septum in a body.

[00:44:04] Speaker 01:
all those things.

[00:44:05] Speaker 02:
Are there structural differences between power injectable ports and ports that aren't power injectable?

[00:44:13] Speaker 02:
I assume there must be.

[00:44:14] Speaker 01:
There are, in terms of, just like anything else, you know, there are many containers for pressurized things.

[00:44:26] Speaker 01:
Some have a different strength than others, have different reinforcement, whatever, different welds.

[00:44:34] Speaker 01:
So that is a factor that has to be looked at here in determining whether these ports are okay to put in high volume contrast in a short period.

[00:44:47] Speaker 02:
An alternative way that this could have been claimed would be by putting the power injection limitation in the preamble, for example.

[00:44:54] Speaker 01:
Yeah, it could have been.

[00:44:55] Speaker 02:
Then there would be also a question there, I guess, as to whether that had weight, whether it sufficiently

[00:45:03] Speaker 02:
put life and body into the claim, right?

[00:45:06] Speaker 01:
Well, it could, but I would suggest here, Your Honor, that where it says it is power-injectable and refers to the assembly, which is that preamble, that I think the plain meaning of is is is.

[00:45:18] Speaker 01:
It has to be that way.

[00:45:20] Speaker 00:
Yeah, but the crucial word is not is.

[00:45:22] Speaker 00:
The crucial word is how you interpret indicate.

[00:45:24] Speaker 00:
Yes.

[00:45:26] Speaker 00:
Miller, the figures indicated that this was one cup and it was false.

[00:45:34] Speaker 00:
It was actually half a cup, right?

[00:45:36] Speaker 00:
There was a whole point of... Right.

[00:45:37] Speaker 01:
Well, they indicated one cup, but it was false.

[00:45:40] Speaker 01:
But they indicated something, which the person reading it can see.

[00:45:44] Speaker 01:
Here, what's indicated is, with that radio-opaque alphanumeric indicator, that it's power injectable.

[00:45:52] Speaker 01:
So it's the same as Miller in that sense, except it's one step different.

[00:45:57] Speaker 01:
because here you have to have an X-ray read it first before the person can see it.

[00:46:03] Speaker 03:
Except this panel won't take traditional notice of the fact that women can't handle fractions.

[00:46:09] Speaker 03:
It would be good for me.

[00:46:13] Speaker 03:
But before you sit down, on the cross appeal, I hit your friend on the other side with basic grammar.

[00:46:20] Speaker 03:
There's a comma in the claim.

[00:46:22] Speaker 03:
And so why isn't it correct that defining only

[00:46:26] Speaker 03:
talks that only modifies one reservoir as opposed to the bottom one.

[00:46:32] Speaker 01:
Well, Your Honor, I think if you look at claim three, for example, you can't read it that way.

[00:46:38] Speaker 01:
That dependent claim, I think, makes it clear.

[00:46:41] Speaker 01:
Okay.

[00:46:42] Speaker 01:
So I don't think you can read that.

[00:46:43] Speaker 03:
I think you're out of time.

[00:46:44] Speaker 02:
Thank you, Your Honor.

[00:46:44] Speaker 02:
Can I ask one question?

[00:46:45] Speaker 02:
Sure.

[00:46:45] Speaker 02:
I just wanted to ask you to quickly.

[00:46:47] Speaker 02:
She's not out of time.

[00:46:49] Speaker 02:
King and AstraZeneca, which are printed matter cases dealing with

[00:46:54] Speaker 02:
a drug or a method of using a drug with instructions on how to use the drug that presumably the person taking the medication should know they're important, much like it's important that the physician know that a port is power injectable.

[00:47:12] Speaker 02:
How do you distinguish those cases which held that

[00:47:15] Speaker 02:
there wasn't a functional relationship between the printed matter and the substrate.

[00:47:19] Speaker 01:
In those cases, effectively, will they have the printed matter out here in a box or in a kit or not?

[00:47:27] Speaker 01:
It doesn't really matter.

[00:47:28] Speaker 01:
It's just telling you, but what is the function that the claim teaches here?

[00:47:33] Speaker 01:
It's a function of a claim to make something that can be seen implanted in the body.

[00:47:45] Speaker 01:
Those instructions here, or in that case, tell you don't use the drug or something.

[00:47:51] Speaker 01:
Here, the function is different.

[00:47:53] Speaker 02:
This is taken with food, I think, and it will have a better use in the body.

[00:47:56] Speaker 01:
Right, which has really nothing to do with what would be the claim there.

[00:48:01] Speaker 02:
But it's a claim method, a method of taking the drug, administering the drug.

[00:48:05] Speaker 02:
Here, you've got a claimed structure, and you've got a label that tells the doctor how to use it.

[00:48:14] Speaker 02:
How does that change the structure?

[00:48:16] Speaker 01:
Because it's part of the structure to begin with.

[00:48:20] Speaker 01:
And the function of it is to tell you it's safe to power inject.

[00:48:25] Speaker 01:
So I think that it's more than just written instruction.

[00:48:29] Speaker 01:
There could be a written instruction saying that comes with a vascular access port that says, don't power inject this, or you can power inject this.

[00:48:39] Speaker 01:
But here, it's something that's part of the substrate that shows up on an X-ray, so you're not having to go look at medical records or anything like that.

[00:48:50] Speaker 00:
If you had a pill and you printed 10 milligrams on it, exactly the same look, color, weight, feel as the 5-milligram one, does putting 10 milligrams on it count?

[00:49:06] Speaker 00:
10 milligrams on it count.

[00:49:08] Speaker 00:
It's not separate, so it's not like the other ones on a piece of paper.

[00:49:11] Speaker 00:
It's actually on the device.

[00:49:12] Speaker 00:
Isn't that remarkable?

[00:49:13] Speaker 00:
I mean, you actually put the identifier on the thing itself, because that's the last thing the user sees.

[00:49:24] Speaker 00:
It's a really good place to put it.

[00:49:27] Speaker 00:
And so the previous pill, in the prior art, now you would count for patentability

[00:49:36] Speaker 00:
the on-the-device label, I have 10 milligrams of the medication in the active ingredient.

[00:49:45] Speaker 01:
So if the prior artist is on the formula and this is an indicator of the proper dose or something like that, it could have a functional relationship in that case that doesn't exist with the prior artist.

[00:50:06] Speaker 03:
Okay.

[00:50:07] Speaker 03:
All right.

[00:50:07] Speaker 03:
Thank you.

[00:50:08] Speaker 03:
The case will be submitted.

[00:50:14] Speaker 03:
Oh, yeah.

[00:50:15] Speaker 03:
I'm sorry.

[00:50:15] Speaker 03:
She gets a rebuttal on the cross tail briefly.

[00:50:19] Speaker 03:
Sorry about that.

[00:50:20] Speaker 04:
I'll be brief, Your Honors.

[00:50:24] Speaker 03:
That's okay.

[00:50:26] Speaker 04:
With respect to the printed publication issue,

[00:50:30] Speaker 04:
I believe that we have... No, you can't.

[00:50:31] Speaker 03:
You're only on the cross-appeal.

[00:50:32] Speaker 04:
Oh, I apologize.

[00:50:33] Speaker 04:
That's okay.

[00:50:34] Speaker 04:
Okay.

[00:50:35] Speaker 04:
With respect to the cross-appeal, Claim 3 just requires that the marker be placed on an outwardly facing bottom surface, and IceMed's titanium shell has an outwardly facing bottom surface.

[00:50:49] Speaker 03:
Does it say outwardly facing bottom surface of the base?

[00:50:52] Speaker 04:
Yeah, of the housing base.

[00:50:53] Speaker 04:
Yes, Your Honor.

[00:50:54] Speaker 03:
Okay.

[00:50:54] Speaker 04:
And we believe that the lower portion of ISOMED is the housing base.

[00:50:58] Speaker 04:
And in any event, this exact structure was already disclosed in the art in the Jones patent.

[00:51:04] Speaker 04:
OK, thank you.

[00:51:04] Speaker 04:
Thank you, Your Honor.