[00:00:09] Speaker ?:
Thank you.

[00:00:54] Speaker 03:
OK.

[00:00:56] Speaker 03:
The next target case is number 181550, Hologic Incorporated against Minerva Surgical Incorporated.

[00:01:05] Speaker 03:
Mr. Wolfe.

[00:01:05] Speaker 00:
Thank you, Your Honor.

[00:01:06] Speaker 00:
May it please the court, Matthew Wolfe for Hologic.

[00:01:09] Speaker 00:
In essentially every instance where petitioner and patent owner disagree, the PTAB resolved that dispute by turning to Dr. Pierce.

[00:01:18] Speaker 00:
For example, on the core issue of motivation to combine, this is at appendix 42, quote,

[00:01:24] Speaker 00:
Petitioner's reason is supported by the testimony of Dr. Pierce.

[00:01:28] Speaker 00:
We've thus determined that Petitioner provides a sufficient rationale to combine the references.

[00:01:33] Speaker 00:
The problem is Dr. Pierce had no experience whatsoever, either actual or academic, in the field of uterine ablation.

[00:01:41] Speaker 00:
He didn't have any experience in uterine medical devices, in uterine perforations, in uterine fluid flow, in the risks of distending the uterus, in the risks caused by entravization

[00:01:53] Speaker 00:
and perhaps most importantly did not know what the preferences of physicians were at the relevant time in 1999 for what would and would not motivate them to look for a new or different procedure.

[00:02:04] Speaker 02:
Didn't the board determine the level of ordinary skill in the art on the basis of the title of the patent and the specification?

[00:02:13] Speaker 02:
In other words, that this dealt with ablation of body cavities as opposed to just a uterine?

[00:02:19] Speaker 00:
It did, Your Honor, and that was plain error for multiple reasons.

[00:02:22] Speaker 00:
First of all, if we start with the statute, Section 103 says that a claim is obvious to one of skill in the art, quote, to which the claimed invention pertains.

[00:02:34] Speaker 00:
So we have some broader references in the specification to additional applications.

[00:02:39] Speaker 00:
But the claims at issue here were all indisputably limited to uterine procedures.

[00:02:46] Speaker 00:
And so Section 103 tells us,

[00:02:47] Speaker 00:
We've got to look to the claims first.

[00:02:49] Speaker 00:
And the claims are about uterine procedure, something that Dr. Pierce had no experience on.

[00:02:54] Speaker 00:
Now, even despite knowing that he had no such experience, Dr. Pierce himself said, and this is at A754, the 183 patent is generally directed to methods of detecting perforations in a uterus.

[00:03:07] Speaker 00:
And then he went on in defining what a person of skill in the art is after giving the

[00:03:12] Speaker 00:
The first part of the definition, the one that PTAB adopted to say, quote, Apoosa would have been familiar with known techniques for uterine surgery.

[00:03:21] Speaker 00:
He wasn't so familiar.

[00:03:22] Speaker 00:
He himself said, Minerva itself said, this is part of the definition of a person of skill, and the PTAB simply disregarded it.

[00:03:30] Speaker 00:
So if you start from the perspective of the claims, obviously in red and light of the spec, but you start from the claims, which are about uterine surgery,

[00:03:38] Speaker 00:
and then go to a person that has no experience in uterine surgery of any kind.

[00:03:42] Speaker 00:
This wasn't a situation where he was lacking experience and then went and read up on it.

[00:03:48] Speaker 00:
He didn't know.

[00:03:49] Speaker 00:
And at his deposition, he said, I didn't do anything to prepare for this quiz.

[00:03:54] Speaker 00:
And so what basis did the PTAB have to rely on him over Dr. Martin and Dr. Eventash, who were replete with experience in the relevant art?

[00:04:05] Speaker 00:
Now, I said essentially every instance

[00:04:07] Speaker 00:
And the reason I said essentially every instance, not everyone, is this gets even more complicated with regard to Claim 7.

[00:04:14] Speaker 00:
Claim 7 says, not only do you do this procedure, but first, before you start the ablation, first you test for a perforation with a pressure sensor.

[00:04:24] Speaker 00:
You do that first.

[00:04:27] Speaker 00:
The only person that spoke to that was Dr. Morobly, their other expert for Minerva.

[00:04:33] Speaker 00:
The problem with Dr. Morobly is he didn't review at all the references at issue in the IPR.

[00:04:39] Speaker 00:
Not at all.

[00:04:42] Speaker 00:
And what did the PTAP do with his testimony?

[00:04:44] Speaker 00:
They said they accepted as to Claim 7 that you would have lengthened the procedure.

[00:04:50] Speaker 00:
And this is important.

[00:04:51] Speaker 00:
The PTAP acknowledged, and this is at A33, that for Claim 7 purposes, you're not substituting a part of one reference into another.

[00:04:59] Speaker 00:
You're actually combining them, basically turning one procedure into two.

[00:05:03] Speaker 00:
They used the word, it's not a substitution, but a supplementation.

[00:05:08] Speaker 00:
The PTAB said, we're OK with that.

[00:05:10] Speaker 00:
We're OK lengthening the procedure, notwithstanding everything Dr. Martin and Dr. Evantash said about the risks that presents to a patient.

[00:05:18] Speaker 00:
Because, quote, Dr. Moraboli gladly would have extended the duration of the procedure if the ultimate result was a safer treatment.

[00:05:26] Speaker 00:
Well, what procedure are they even talking about?

[00:05:29] Speaker 00:
Dr. Moraboli didn't review the procedures, the Masterson or the Isaacson procedure, that were before the p-tab.

[00:05:36] Speaker 00:
He was instead, his declaration only talks about something called thermochoice, which was not a reference before the p-tab.

[00:05:43] Speaker 00:
and was very different than the procedures before the PTAB, because it involved fluid in a balloon.

[00:05:48] Speaker 00:
And if you contain fluid in a balloon, by definition, you're not worried about the fluid in the other procedures that were put directly into the uterus leaking through ruptures or otherwise, or perforations, as the claim talks about.

[00:06:00] Speaker 00:
So he says, I know about this procedure called thermochoice, and I don't worry about lengthening thermochoice.

[00:06:05] Speaker 00:
There's no risk here.

[00:06:07] Speaker 00:
And the PTAB, for some reason, then applies that to Masterson and Isaacson, the two lead references,

[00:06:12] Speaker 00:
and says, well, there's no problem with lengthening the procedure, but those are different procedures.

[00:06:17] Speaker 00:
So at the end of the day, we have Dr. Pierce, who has no experience in uterine arts, opining about the uterine references.

[00:06:25] Speaker 00:
And on the other hand, we have Dr. Morobly, who didn't review the references, does have experience in the art, but doesn't review the references, and the PTAB combines them.

[00:06:34] Speaker 00:
Put simply, there was no expert with knowledge of the problem play that said, I have looked at Mattresson and Isaacson,

[00:06:40] Speaker 00:
And I can tell you a person of skill and art would have been motivated to combine.

[00:06:46] Speaker 00:
Next issue that I'd like to raise is about the substitute claims.

[00:06:50] Speaker 00:
And focusing, for example, on 18 and 22, the substitute claims essentially took what were the original claims and added mechanical features disclosed in the specification, or talked about specific features of the ablation device.

[00:07:06] Speaker 00:
Features that were not present in the lead references, Masterson or Isaacson.

[00:07:11] Speaker 00:
They were present, though, in Truckeye, which was a related application.

[00:07:16] Speaker 00:
And the PTAP said, well, we can just combine those with literally no analysis of motivation to combine, literally none.

[00:07:23] Speaker 00:
There is no discussion of why one would have taken Truckeye, a totally different approach to ablation, and combined it with either Masterson or Isaacson when Masterson and Isaacson worked just fine.

[00:07:36] Speaker 00:
I mean, I think the kinetic concepts case is particularly trenchant here.

[00:07:40] Speaker 00:
When it said, because each device independently operates effectively, a person having ordinary skill in the art who was merely seeking to create a better device to drain fluids from a wound would have no reason to combine the features of both devices into a single device.

[00:07:55] Speaker 00:
Here we have Masterson that works fine on its own.

[00:07:58] Speaker 00:
Doesn't indicate that it has any problems.

[00:08:01] Speaker 00:
Similar, Isaacson, they're very similar devices.

[00:08:03] Speaker 00:
Then we have Truckeye, which is off here.

[00:08:06] Speaker 00:
Also works well on its own.

[00:08:08] Speaker 00:
Why would these three things be combined?

[00:08:11] Speaker 00:
In order to suggest why three perfectly fine-working devices would be combined, you would expect one in skill and the art to say there was something missing, there was some motivation.

[00:08:19] Speaker 00:
But that is entirely absent from the final written decision.

[00:08:22] Speaker 00:
There is zero discussion of it.

[00:08:25] Speaker 00:
With that, unless there are questions, I'd like to turn to the claim construction issue at Bled here.

[00:08:30] Speaker 00:
The claim construction language is monitoring for the presence of a perforation with a pressure sensor.

[00:08:36] Speaker 00:
That's what the procedure must do.

[00:08:39] Speaker 00:
It must monitor for the presence of a perforation with a pressure sensor.

[00:08:43] Speaker 00:
It can, of course, do other things as well.

[00:08:46] Speaker 00:
No one is suggesting, we're not suggesting that if a prior art reference did that, but also monitored for something else with a pressure sensor, that that would make it not invalidated.

[00:08:56] Speaker 00:
But you must at least monitor for the presence of a perforation in the uterus with a pressure sensor for this to be relevant.

[00:09:05] Speaker 00:
For some reason, the PTAB disagreed.

[00:09:07] Speaker 00:
They said, and this is at 27 of the appendix 27, that it may be caused by perforation, but may alternatively be caused by malfunctions.

[00:09:20] Speaker 00:
So what they're saying is, and this is kind of hard to follow because it's a claim construction decision, but it's not actually put in the claim construction section of the final written decision.

[00:09:30] Speaker 00:
They actually move it into the body and then say that our arguments are rejected because

[00:09:35] Speaker 00:
Broadest reasonable interpretation is much broader than what we suggest.

[00:09:39] Speaker 00:
But we have the prior art references that Masterson and Isaacson that monitor for things other than perforations with a pressure detector, with a pressure sensor, particularly mechanical failure.

[00:09:51] Speaker 00:
That's really what we're talking about here.

[00:09:53] Speaker 00:
For example, kink tubes is one of the specific examples given.

[00:09:57] Speaker 00:
The pressure sensors, they are monitored for things other than perforations.

[00:10:02] Speaker 00:
And the panel says, well, the PTAB said that's good enough.

[00:10:06] Speaker 00:
because the claim construction should be broader.

[00:10:08] Speaker 00:
But how can it be the case that language that calls for monitoring for the presence of a perforation is satisfied if you're not monitoring for the presence of a perforation?

[00:10:18] Speaker 00:
And if you look at A2329, for example, Dr. Pierce, despite not being an expert, agreed, for example, that Isaacson cannot measure pressure drops due to perforation.

[00:10:30] Speaker 00:
So the panel found that Isaacson satisfied this claim limitation

[00:10:34] Speaker 00:
because it could monitor for kinks and hoses, when that's not what the claim is talking about.

[00:10:40] Speaker 00:
That's not what the claim language is referencing.

[00:10:44] Speaker 00:
I want to conclude, I have just a minute or so before my rebuttal, by talking about what Dr. Pierce opined on, notwithstanding the fact that he had no expertise.

[00:10:54] Speaker 00:
He opined about what was conventional in the uterine arch, that's at 754 to 6.

[00:11:00] Speaker 00:
What Masterson and Isaacson taught to a person of skill in the art.

[00:11:03] Speaker 00:
That's at 777 and 817.

[00:11:05] Speaker 00:
The motivation for combining these references to one in skill in the uterine arts at 773 or 810, et cetera.

[00:11:13] Speaker 00:
He actually uses phrases like, one who knew what was going on in the uterine field would understand that, when he was not someone that would understand that.

[00:11:24] Speaker 00:
Last point I would make is just about Masterson and Isaacson specifically on the merits.

[00:11:29] Speaker 00:
Both of these devices maintain constant pressure.

[00:11:32] Speaker 00:
That's the whole idea.

[00:11:33] Speaker 00:
In fact, if you look at Masterson, this is at 1071, column 14, lines 34 to 37.

[00:11:39] Speaker 00:
It says pressure will be constant.

[00:11:42] Speaker 00:
That's the whole idea of the device.

[00:11:43] Speaker 00:
You maintain, of both devices, Masterson and Eisen, you maintain a column of fluid that keeps pressure so that the fluid pressure in the uterus is constant.

[00:11:53] Speaker 00:
That's the whole purpose of the device.

[00:11:56] Speaker 00:
Masterson tells you it cannot be used to detect for perforations.

[00:11:59] Speaker 00:
It cannot be used for this purpose.

[00:12:01] Speaker 00:
Isaacson doesn't explicitly say that, but it's the same mechanical principle.

[00:12:05] Speaker 00:
So how could it?

[00:12:06] Speaker 00:
With that, how could it be said that that device would be used, as the PTAB suggested, to monitor for perforations?

[00:12:14] Speaker 00:
With that, I see I'm in my rebuttal time.

[00:12:15] Speaker 03:
And thank you.

[00:12:16] Speaker 03:
Okay.

[00:12:17] Speaker 03:
Thank you.

[00:12:20] Speaker 03:
Mr. Rosato.

[00:12:23] Speaker 01:
Thank you, Judge Newman.

[00:12:24] Speaker 01:
May it please the Court?

[00:12:25] Speaker 01:
I'd like to start by first noting

[00:12:29] Speaker 01:
A correction to an issue that was raised first in the reply brief.

[00:12:34] Speaker 01:
And it's just a comment that along the lines that the district court had made some findings and an argument that confirming the board's decision here would somehow be in contrast or contradict that.

[00:12:49] Speaker 01:
That's not true.

[00:12:50] Speaker 01:
Prior invalidity has not been litigated at district court.

[00:12:55] Speaker 01:
The PTAB is the only form in which that issue is litigated, so there is no instance of inconsistency here.

[00:13:01] Speaker 01:
And just wanted to clarify that point of the record.

[00:13:04] Speaker 01:
Beyond that, with the argument we heard from my friend from Hoologic, I would say as a general matter, much of the argument seems to reflect arguments that don't match what happened in this case at all.

[00:13:19] Speaker 01:
And there are a number of instances that are just

[00:13:23] Speaker 01:
flatly incorrect statements or representations of the record.

[00:13:26] Speaker 01:
And I would start with the issue of the board's reliance on Dr. Pierce's testimony.

[00:13:33] Speaker 01:
There's actually not a single instance or single issue here in dispute where the board relied only on Dr. Pierce's testimony.

[00:13:40] Speaker 01:
For each of the disputed issues, the board is relying on numerous pieces of evidence, including the prior references themselves, content of those references,

[00:13:50] Speaker 01:
as well as testimony from Hologic's witnesses as well.

[00:13:54] Speaker 01:
You won't find a single instance of a disputed issue here where the board solely relied on Dr. Pierce's testimony.

[00:14:01] Speaker 01:
It's also incorrect to characterize Dr. Pierce as having no experience in uterine ablation.

[00:14:09] Speaker 01:
And I would direct the court's attention to page 51A51 of the decision where the board made factual findings to this effect.

[00:14:17] Speaker 01:
noting in the context of denying Hologic's motion to exclude Dr. Pierce's testimony that Dr. Pierce has extensive knowledge relating to electrosurgical ablation device and knowledge of endometrial ablation devices as well.

[00:14:32] Speaker 02:
That's not to say that he has experience or knowledge in the uterine area, correct?

[00:14:41] Speaker 01:
No, the finding was that he does have.

[00:14:43] Speaker 01:
That he does?

[00:14:44] Speaker 01:
That he does have knowledge of endometrial.

[00:14:45] Speaker 02:
What's that citation?

[00:14:47] Speaker 01:
And again, this was in the context of denying their motion to exclude an issue that has not been brought up on appeal here.

[00:14:56] Speaker 01:
I'll give you a moment to find that.

[00:15:02] Speaker 01:
But at the end of the day, the other thing to point out is that there's not a single instance in this case where the substance of Dr. Pierce's testimony has been

[00:15:13] Speaker 01:
shown to lack credibility.

[00:15:15] Speaker 02:
What's that citation again?

[00:15:17] Speaker 01:
A-51, Your Honor.

[00:15:18] Speaker 01:
A-51.

[00:15:21] Speaker 01:
It's page 51 of the board's final written decision, where the board's talking about why they're denying WholeLogic's motion to exclude Dr. Pierce's testimony as unfounded.

[00:15:35] Speaker 01:
It's right in the middle of the page.

[00:15:47] Speaker 01:
And this, of course, makes sense, as Dr. Pierce is a professor of bioengineering.

[00:15:52] Speaker 01:
He's a renowned expert in electrosurgical devices.

[00:15:55] Speaker 01:
He literally wrote the textbook on electrosurgical devices, which covers uterine ablation technologies.

[00:16:02] Speaker 01:
And he described during cross-examination some experience actually working and consulting on uterine ablation projects.

[00:16:12] Speaker 01:
So this is an unfounded argument.

[00:16:14] Speaker 01:
But at the end of the day, what we ask is, is the substance of a witness' testimony credible and corroborated by the evidence?

[00:16:21] Speaker 01:
In every single instance, it is.

[00:16:23] Speaker 01:
And there has not been a single instance identified where anything Dr. Pierce had to say lacked credibility, because there is no such instance.

[00:16:32] Speaker 01:
This is a, a sideshow issue.

[00:16:35] Speaker 01:
Now, the other thing I would say is, one of the problems here with this appeal is that whole logic largely avoids

[00:16:44] Speaker 01:
the board's factual findings on the two key core issues that were litigated in front of the Patent Office.

[00:16:51] Speaker 01:
The first is on the content of the primary prior art references of Masterson and Isaacson.

[00:16:59] Speaker 01:
And that is particularly on the issue of whether those references disclose monitoring for a perforation using a pressure sensor, the alleged invention in this case.

[00:17:11] Speaker 01:
For both of those references, the board made detailed findings of fact corroborated with various pieces of evidence that both of those references did in fact disclose that aspect.

[00:17:24] Speaker 01:
Again, the invention that's being claimed.

[00:17:28] Speaker 01:
There's no showing that any of that evidence fails to qualify as substantial evidence.

[00:17:34] Speaker 01:
And again, there are multiple sources of evidence there to support those key factual findings.

[00:17:39] Speaker 02:
The second core argument... Most of the prior seems to be directed towards detecting decreases in pressure for purposes or reasons other than perforations.

[00:17:55] Speaker 01:
Is that...?

[00:17:57] Speaker 01:
I would say that's not accurate, Your Honor.

[00:18:00] Speaker 01:
Okay.

[00:18:00] Speaker 02:
So both the... Point me to a prior... to one of the...

[00:18:04] Speaker 02:
the prior art references that deals with decrease in pressure due to a perforation.

[00:18:10] Speaker 01:
Okay, well there's the Isaacson reference, your honor, and that is the primary reference in the, there's two grounds of challenge, one based on the Masterson reference, one based on the Isaacson reference.

[00:18:22] Speaker 01:
And in the final written decision, the board goes through and explains and makes detailed findings of fact

[00:18:29] Speaker 01:
precisely why the Isaacson reference is monitoring for uterine perforation using pressure sensor.

[00:18:38] Speaker 01:
This is explained on pages A39 through A41 of the final written decision.

[00:18:52] Speaker 02:
I'm looking at the blue brief and on page 19 it says, Isaacson does not disclose monitoring

[00:18:58] Speaker 02:
for the presence of perforation using the pressure sensor.

[00:19:01] Speaker 02:
Is that statement correct?

[00:19:02] Speaker 01:
No.

[00:19:04] Speaker 01:
And the board made findings a fact that that's not correct.

[00:19:07] Speaker 01:
And on page 41, in multiple places, page 40, the board states, Isaacson teaches using the pressure transducers to monitor for the presence of a perforation in the uterus.

[00:19:22] Speaker 01:
Again, on page 41, the board concludes,

[00:19:25] Speaker 01:
Isaacson indicates that uterine perforation can be detected from changes in flow rate, which can be measured using pressure.

[00:19:33] Speaker 01:
And the board goes through and makes a very detailed analysis of the content of the Isaacson reference, explains how that reference is expressly stating that they're monitoring for perforations, they're doing it based on a calculation of flow differential, and the board explains that their flow measurements

[00:19:53] Speaker 01:
are made using pressure sensors.

[00:19:55] Speaker 01:
And then the board concludes, therefore, Isaacson teaches monitoring for a uterine perforation using pressure sensors.

[00:20:04] Speaker 03:
Where is the board's suggestion of combining these references?

[00:20:10] Speaker 01:
It comes in two places.

[00:20:11] Speaker 01:
So again, let's look at what's being offered and what's being combined, so to say.

[00:20:18] Speaker 01:
We're looking at the combined teachings of references.

[00:20:21] Speaker 01:
In each instance, the board's making factual findings that the primary references themselves teach this key limitation.

[00:20:29] Speaker 01:
The secondary references are confirming that interpretation.

[00:20:32] Speaker 01:
That's true in the context of the Masterson reference, where Masterson specifically mentions using pressure sensors to detect an under-pressure situation in the uterus, and then alarming the physician of such an instance.

[00:20:46] Speaker 01:
The question is, would an under-pressure situation

[00:20:50] Speaker 01:
including urine perforation and the board interpreted that reference and said yes in fact it would and they had multiple reasons for coming to that conclusion.

[00:20:59] Speaker 01:
One is looking at the secondary reference of Balduque which was the combination here where the Balduque reference is specifically measuring for perforations using a pressure sensor.

[00:21:13] Speaker 01:
So it's looking at the combined teachings there.

[00:21:15] Speaker 01:
They went through Dr. Pierce's testimony that confirmed

[00:21:18] Speaker 01:
Logics expert Dr. Martin's testimony that confirmed that such an under pressure situation would be a uterine perforation.

[00:21:25] Speaker 01:
There are multiple pieces of evidence to support this.

[00:21:27] Speaker 01:
Again, key factual findings where you won't see in the blue brief some analysis as to why those factual findings lack substantial evidence.

[00:21:38] Speaker 01:
They don't lack substantial evidence and there's no showing that they do.

[00:21:42] Speaker 01:
Same type of analysis when we get to Isaacson.

[00:21:45] Speaker 01:
Walk through

[00:21:46] Speaker 01:
And the board makes detailed factual findings why that reference is monitoring for appropriation using a pressure sensor, and then looking at various pieces of evidence that confirm that.

[00:21:58] Speaker 01:
As far as the safety rationale, which Hologic focuses on in terms of a lacking rationale, there's no mystery there as to what argument the board was

[00:22:15] Speaker 01:
crediting and why they were crediting it.

[00:22:17] Speaker 01:
This can be found at both A25 and A27 of the record, pages 25 through 27 of the board's final written decision, where the board expressly states, as to the safety rationale, they're specifically crediting the argument that was advanced in the petition materials, that this perforations holes in the uterus during this ablative procedure

[00:22:44] Speaker 01:
We recognize safety risk because, you know, as admitted in the blue brief, this is actually on page, page seven of the blue brief.

[00:22:54] Speaker 01:
It's acknowledged that this is a recognized risk in the field.

[00:22:58] Speaker 01:
The board credits the argument and states, at page 27, exactly why they are crediting that argument.

[00:23:05] Speaker 01:
They say Minerva's argument is specifically corroborated by the prior art references.

[00:23:12] Speaker 01:
And they point to multiple prior references, including the Masterson reference, which specifically states that they're using a under pressure alarm detection monitoring for the purposes of, and I'm quoting, increased safety to the patient.

[00:23:29] Speaker 01:
So the board's looking at an argument that's presented, saying it's credited, and then saying exactly why it's credited.

[00:23:35] Speaker 01:
It's an argument that's expressly corroborated with the prior references.

[00:23:39] Speaker 01:
That's as good as a rationale gets.

[00:23:42] Speaker 01:
and that's explained, it's certainly reviewable, which was the issue that was raised.

[00:23:49] Speaker 01:
Unless there are any questions about the rationale, I want to turn briefly to the claim construction issue.

[00:23:58] Speaker 01:
And, you know, as explained in the response brief, this is less about a claim construction issue, and really it has to be taken in context of the argument that was being advanced of what the Board was stating.

[00:24:09] Speaker 01:
The Board, you know,

[00:24:11] Speaker 01:
makes a secondary paragraph about the scope of the claims.

[00:24:16] Speaker 02:
Was there ever any actual dispute over the phrase monitoring for the presence of a perforation in the uterus using a pressure sensor?

[00:24:26] Speaker 01:
No.

[00:24:28] Speaker 01:
No.

[00:24:29] Speaker 01:
Hologic never proposed some construction of that which would have excluded the prior art.

[00:24:35] Speaker 01:
What they were arguing, they were essentially trying to read,

[00:24:39] Speaker 01:
really came back to arguments about the content of the prior references.

[00:24:44] Speaker 01:
The logic was trying to advance an argument that the primary references must be limited only to certain types of causes of under pressure situations.

[00:24:55] Speaker 01:
And the board went through and evaluated the evidence on that issue and said that just doesn't make sense.

[00:25:00] Speaker 01:
The language of the claim is monitoring for perforation using a pressure sensor.

[00:25:05] Speaker 01:
The language is not monitoring only for

[00:25:09] Speaker 01:
a perforation using a pressure sensor.

[00:25:12] Speaker 01:
And that was important in view of how this is described in not only the 183 patent, but in all of the prior references.

[00:25:21] Speaker 01:
Perforation detection based on pressure is described as measuring with a pressure sensor the detection of an under pressure situation.

[00:25:32] Speaker 01:
Once that's detected, an alarm goes off to the user

[00:25:35] Speaker 01:
And they're instructed to investigate the cause of that, whether it's some equipment malfunction or a perforation.

[00:25:43] Speaker 01:
That is exactly how it's described in a 183 patent, where it repeatedly references an under pressure situation as a possible perforation and indicates that the physician should be alerted to investigate the situation.

[00:25:58] Speaker 01:
That's how it's described in the other prior references.

[00:26:02] Speaker 01:
And that is how it's described in the thermo-choice product literature, an admitted prior art system that existed at the time.

[00:26:10] Speaker 01:
That system describes the process as running a pressure check.

[00:26:15] Speaker 01:
If a pressure problem is detected, the manual instructs the user to inspect the equipment, rule out an equipment malfunction.

[00:26:24] Speaker 01:
If they can't rule out an equipment malfunction, inspect the uterine cavity for appropriation.

[00:26:29] Speaker 01:
So what the board was saying is,

[00:26:31] Speaker 01:
what, you know, you're arguing, in trying to argue that limitation into the prior art, you seem to be ignoring what your claim requires and how this process is described in your own specification.

[00:26:45] Speaker 01:
So it's more about an issue of the content of prior references, less about a claim construction per se.

[00:26:51] Speaker 01:
This is briefed.

[00:26:53] Speaker 01:
I do want to address one issue, if I may, before.

[00:26:55] Speaker 01:
And that is this, you know, I mentioned there were two issues that were really, you know, core to the,

[00:27:02] Speaker 01:
to the Board's decisions and key arguments in the case.

[00:27:07] Speaker 01:
The second was this argument about there being no rationale for obviousness on the basis of the alleged conventional wisdom or state of the art at the time.

[00:27:21] Speaker 01:
This is a core argument that Whole Logic advanced before the Board.

[00:27:25] Speaker 01:
And the Board explained in its final written decision exactly why it had rejected this argument.

[00:27:30] Speaker 01:
There's no ambiguity here.

[00:27:32] Speaker 01:
The board made specific findings of fact of multiple evidence and found, quote, patent owner misrepresents the conventional wisdom or state of the art, end quote.

[00:27:44] Speaker 01:
The whole logic tried to advance a false narrative in their non-obviousness arguments before the board, and the board called them out on it.

[00:27:51] Speaker 01:
And there's really no way for me to sugarcoat that.

[00:27:55] Speaker 01:
And you can see that.

[00:27:56] Speaker 01:
The quote I mentioned, by the way, is A31.

[00:28:00] Speaker 01:
of the record, and there are detailed findings and explanations by the board on that point.

[00:28:06] Speaker 03:
Okay.

[00:28:06] Speaker 03:
Any questions for Mr. Resenter?

[00:28:08] Speaker 01:
Thank you, Mr. Resenter.

[00:28:12] Speaker 00:
Thank you.

[00:28:13] Speaker 00:
Mr. Reiner.

[00:28:13] Speaker 00:
Thank you.

[00:28:13] Speaker 00:
I'd like to begin, Judge Reiner, with your question about whether Dr. Pierce had any experience.

[00:28:20] Speaker 00:
This is the quote, this is the underlying site that the board relied on

[00:28:26] Speaker 00:
What personal experience?

[00:28:27] Speaker 00:
This is at Appendix 2246, page 24.

[00:28:30] Speaker 00:
What personal experience do you have that would lead you to know how a uterus was conventionally distended in November 1999?

[00:28:38] Speaker 00:
Well, that's what the VESPA system did.

[00:28:40] Speaker 00:
Is the VESPA system discussed or mentioned at all in your CV?

[00:28:43] Speaker 00:
It is not, sir.

[00:28:44] Speaker 00:
And I think you told me earlier this morning that you didn't rely on your one-day experience with the VESPA system informing any of your opinions in this case, right?

[00:28:52] Speaker 00:
I didn't rely upon it.

[00:28:53] Speaker 00:
Yes, you're correct.

[00:28:55] Speaker 00:
So the PTAB says, Dr. Pierce has experienced in this when Dr. Pierce himself says, I have one day experience and I didn't even rely on it.

[00:29:03] Speaker 00:
This is the kind of substantial evidence question we're facing.

[00:29:07] Speaker 00:
Similarly, counsel, my friend just said he didn't want to sugarcoat our supposed under misrepresentation about the state of the art.

[00:29:14] Speaker 00:
Remember, the state of the art was offered not by Dr. Pierce, but by Dr. Moroboli, Dr. Moroboli who never reviewed the art in question.

[00:29:23] Speaker 00:
So when they said, well, the conventional wisdom was wrong, we misrepresented it, he was talking about this thermo-choice device that has nothing to do with the IPR.

[00:29:32] Speaker 00:
He was not reviewing at all the actual references at issue in this case.

[00:29:38] Speaker 00:
I want to talk secondly about this notion that the evidence was replete.

[00:29:42] Speaker 00:
It wasn't just Dr. Pierce.

[00:29:44] Speaker 00:
But I would ask you to look at appendix 41 and 42, where the PTAB is explaining why they found the motivation to combine.

[00:29:52] Speaker 00:
They say, Third Patent Owner argues that petitioner fails to provide a sufficient rationale to combine Masterson and Bulldog.

[00:29:58] Speaker 00:
The PTAB then cites two sentences referencing petitioner's reasoning, not evidence, no evidence.

[00:30:06] Speaker 00:
The only evidence then they cite is Dr. Pierce.

[00:30:10] Speaker 00:
So we have on the one hand Dr. Evan Tash and Dr. Martin who say, and let's focus just on claim seven for the moment.

[00:30:15] Speaker 00:
If nothing else, Your Honors, I ask you to look at claim seven.

[00:30:19] Speaker 00:
It was unambiguous, the PTAB said, this would lengthen the procedure.

[00:30:23] Speaker 00:
This would be stacking one reference on top of another.

[00:30:25] Speaker 00:
It would unambiguously lengthen the procedure.

[00:30:28] Speaker 00:
Dr. Martin and Dr. Avantash said, you wouldn't want to do that.

[00:30:31] Speaker 00:
That would have been contrary to the state of the art at the time.

[00:30:34] Speaker 00:
Everything would push you against that.

[00:30:36] Speaker 00:
The only response to that was Dr. Pierce, who acknowledged he had no experience.

[00:30:40] Speaker 00:
He didn't know what folks wanted to do at the time.

[00:30:43] Speaker 00:
There is no substantial evidence.

[00:30:45] Speaker 00:
Even the site we were led to.

[00:30:48] Speaker 00:
page 40, where, Your Honor, you asked about what Isaacson taught.

[00:30:52] Speaker 00:
And I would note that it's unambiguous that Masterson and Isaacson don't talk about pressure.

[00:30:57] Speaker 00:
They talk about flow rate for Isaacson.

[00:30:59] Speaker 00:
That's at A1091, page 14, 4 to 10.

[00:31:02] Speaker 00:
Look at the site the PTAB uses.

[00:31:05] Speaker 00:
Isaacson teaches using the pressure transducers to monitor for the presence of a perforation in the uterus.

[00:31:11] Speaker 00:
See testimony of Dr. Pierce, someone who admitted he had no experience at the time.

[00:31:17] Speaker 00:
He had no experience at any time.

[00:31:20] Speaker 00:
He didn't try to develop that experience for purpose of the IPR.

[00:31:25] Speaker 00:
Once you pull Dr. Pierce's testimony out or give it the proper weight, the whole house of cards collapses.

[00:31:32] Speaker 00:
Not only is there not substantial evidence, there is quite literally no evidence in support of the PTAB's conclusion.

[00:31:38] Speaker 00:
And particularly as to Claim 7, where there is not a single individual in this case who said,

[00:31:43] Speaker 00:
I've looked at the prior art, and I find that there's a motivation to combine is to claim seven.

[00:31:48] Speaker 00:
Because Dr. Morobly didn't look at the prior art of record, and Dr. Pierce didn't look at the issue of the stacking.

[00:31:56] Speaker 00:
So with that, I'd like to turn just to the final point on the claim construction issue.

[00:32:02] Speaker 00:
If you accept the fact that you must at least, not exclusively, but at least have a pressure sensor monitoring for uterine perforation,

[00:32:11] Speaker 00:
then there is no evidence that Masterson or Isaacson does that.

[00:32:16] Speaker 00:
If you accept, at a minimum, we should be remanded for a proper claim construction where they say that, yes, you can do other things, but you must at least do what the claim says.

[00:32:26] Speaker 00:
That's why there was no claim construction dispute below, because the plain meaning is the plain meaning.

[00:32:30] Speaker 00:
The board, Suez-Fonte said, will add these alternatives instead of monitoring for perforation you can monitor for kinks in the hoses or catastrophic

[00:32:39] Speaker 00:
mechanical failure.

[00:32:41] Speaker 02:
Well, the board cites Isaacson and it says, and I'm not going to read the whole quote, I'm looking at page 40 towards the end of that paragraph.

[00:32:50] Speaker 02:
It says that Isaacson states that by monitoring the volume and flow rate of the fluid discharged from the uterus, then it goes on and says the possibility of uterine perforation can be detected by these means.

[00:33:03] Speaker 00:
So what Isaacson does is it basically, it measures, it says it

[00:33:07] Speaker 00:
Isaacson does test for perforations because it has that column of fluid.

[00:33:11] Speaker 02:
It does or does not?

[00:33:12] Speaker 00:
It tests for perforations, but not with pressure.

[00:33:15] Speaker 00:
It uses an entirely different, perfectly adequate means.

[00:33:18] Speaker 00:
It does it with flow rate.

[00:33:20] Speaker 00:
That's the whole point.

[00:33:22] Speaker 00:
And the only connection between flow rate and pressure sensing, which is our invention, we say we don't want to use flow rate.

[00:33:29] Speaker 00:
We know Isaacson uses flow rate.

[00:33:31] Speaker 02:
The board made a facture finding that the possibility of uterine perforation can be detected by these means.

[00:33:37] Speaker 02:
And it's speaking about Isaacson.

[00:33:40] Speaker 00:
But as I said, Isaacson itself says flow rate.

[00:33:43] Speaker 00:
The connection the board makes is based on Dr. Pierce saying that flow rate and pressure are one and the same thing.

[00:33:50] Speaker 00:
If you look at, again, 1091, page 14, 4 to 10, you will see that Isaacson is talking about flow rate, not pressure.

[00:33:58] Speaker 00:
And the board made that contrary distinction because, and it's right there on the fourth line from the bottom, see exhibit 1002, paragraph 162,

[00:34:07] Speaker 00:
testimony of Dr. Pierce.

[00:34:09] Speaker 00:
It was Dr. Pierce, not Isaacson, that said flow rate is tantamount to pressure.

[00:34:15] Speaker 00:
With that, Your Honor, I'm not sure if there's any other questions, but as I said, thank you very much.