[00:00:01] Speaker 02:
Next case for argument is 21-2246, Minerva Surgical versus Hologic.

[00:00:08] Speaker 02:
I'll give you some time to get settled here.

[00:00:10] Speaker 02:
Appreciate people being patient and waiting for the exit.

[00:00:24] Speaker 02:
OK, Mr. Abbey.

[00:00:25] Speaker 02:
Thank you, Betty.

[00:00:30] Speaker 05:
Thank you, Your Honors.

[00:00:31] Speaker 05:
Good morning, and may it please the court, Rob Hockman from Inerva.

[00:00:34] Speaker 05:
I'm going to begin by addressing the invalidity issue, and then I'll turn to the doublet and equivalence issue, of course.

[00:00:40] Speaker 05:
Happy to turn to equivalence any time you'd like.

[00:00:42] Speaker 05:
Now, on invalidity, I think it's fair to say after the briefing,

[00:00:46] Speaker 05:
that HLogix and the district court's reasoning don't get off the ground unless the 420-17 steel device was ready for patenting.

[00:00:54] Speaker 05:
And it wasn't.

[00:00:55] Speaker 05:
And on that basis alone, you can vacate the invalidity judgment.

[00:00:58] Speaker 05:
Indeed, as we maintain in our brief, on that basis alone, you should order summary judgment of no invalidity on remand.

[00:01:05] Speaker 05:
I do also want to emphasize we have two other arguments on invalidity.

[00:01:09] Speaker 03:
there's more than enough evidence that the four twenty seventeen steel design was not brought to the conference but there is some evidence that perhaps they weren't ready you're just ignoring that there's another side that's another body of evidence that perhaps it just said that they were ready so what i think was ready was further research that's literally the only evidence they have and let me explain that because i think when you focus on the ready for patenting issue well in particular the requirement the sdmp requirement that was known

[00:01:40] Speaker 03:
And there's evidence that indicates that he knew about that before the conference.

[00:01:48] Speaker 05:
It was conceived at best, but it was not ready for patenting.

[00:01:51] Speaker 05:
It's this court cases make clear, cases like Barry.

[00:01:53] Speaker 03:
Well, we have to get ready for patenting.

[00:01:55] Speaker 03:
It just has to be different materials.

[00:01:56] Speaker 03:
And in this case, we have different alloys.

[00:01:59] Speaker 05:
No, that's quite the contrary.

[00:02:00] Speaker 05:
Ready for patenting is an absolute requirement of 102B.

[00:02:03] Speaker 05:
That's what Faff and Invitrogen say.

[00:02:06] Speaker 05:
If the invention is not ready for patenting,

[00:02:08] Speaker 01:
I think Judge Raina was suggesting that the only thing that was required was that there would be two different materials of two different sizes, and that was already set forth in numerous documents.

[00:02:20] Speaker 01:
So I don't think he was saying that ready for patenting is not a requirement.

[00:02:26] Speaker 05:
Right.

[00:02:28] Speaker 05:
required for ready for patenting is more than just what's claimed.

[00:02:31] Speaker 05:
That's the Honeywell case.

[00:02:32] Speaker 05:
It's very clear on that as well.

[00:02:34] Speaker 01:
So what specifically are you arguing?

[00:02:35] Speaker 01:
Yeah, and so that's what... What did ready for patenting mean?

[00:02:39] Speaker 05:
In this context, from Barry and Manville Sales and Pallara, I think this court's cases are clear.

[00:02:44] Speaker 05:
Inventors need to be confident that their inventions, when used in the intended environment, are safe.

[00:02:51] Speaker 05:
And that's what's missing in this case.

[00:02:53] Speaker 05:
All of the evidence says, okay, we've got this idea, but the frame keeps deforming.

[00:02:59] Speaker 05:
We'll get there, but it's going to take time.

[00:03:01] Speaker 05:
and when you look at the house it was more than an idea at the conference it was an instrument here but it was in it but it was an instrument that was capable of but it was more than an idea correct right but it wasn't it was an idea for a frame it's a two two inventions right there's the plasma key source that um... that that was that was function and there's the frame out and the frame element was to form and that was the problem that can that persistent mind you for more than a year

[00:03:31] Speaker 05:
after the conference, here's the key facts that they cannot address and they never address.

[00:03:36] Speaker 05:
No time, at no time was the 4-2017 steel device design ever used in a live patient.

[00:03:44] Speaker 05:
And that's the intended environment of this invention.

[00:03:47] Speaker 05:
It says so right at the beginning of the summary invention.

[00:03:49] Speaker 05:
This is for use in a human female.

[00:03:51] Speaker 01:
Does the claim say that?

[00:03:53] Speaker 01:
The claim says it's preamble only and it says

[00:03:58] Speaker 01:
believe it says an ablation device.

[00:04:00] Speaker 01:
It's an endometrial ablation device.

[00:04:01] Speaker 01:
A system for endometrial ablation and then nowhere else in the claim is it mentioned.

[00:04:07] Speaker 01:
When I look at ready for patenting am I supposed to

[00:04:10] Speaker 01:
go beyond the claim?

[00:04:11] Speaker 05:
You're supposed to consider the intended use in the intended environment.

[00:04:14] Speaker 05:
That's what Pallara and Manville say.

[00:04:16] Speaker 05:
Pallara, right, you've got this signal.

[00:04:19] Speaker 01:
So your view is that for any medical device, it's not going to be ready for patenting until there's human experimentation?

[00:04:25] Speaker 05:
Until you know it's going to be safe to use in the intended environment?

[00:04:28] Speaker 01:
Absolutely.

[00:04:29] Speaker 01:
So do you need FDA approval?

[00:04:30] Speaker 05:
Well, not necessarily FDA approval, but the patentee has to be far enough along that the patentee is confident.

[00:04:37] Speaker 05:
And again, take a look at Pallara.

[00:04:38] Speaker 05:
That's not even a medical device.

[00:04:40] Speaker 05:
That's a don't walk, don't walk signal.

[00:04:44] Speaker 05:
And they've got to be sure it's going to work in all conditions.

[00:04:47] Speaker 05:
So they test it in some generally pleasant weather conditions, it works.

[00:04:52] Speaker 05:
And then they have to test it still in weather conditions that are fierce.

[00:04:56] Speaker 05:
Because they know.

[00:04:58] Speaker 02:
What's the case law?

[00:05:00] Speaker 02:
The case law says about undue experimentation.

[00:05:03] Speaker 02:
The case law doesn't preclude further experimentation.

[00:05:06] Speaker 02:
It uses the word undue experimentation.

[00:05:10] Speaker 02:
And why, given the claim language is still pointed out, does what you're saying wasn't shown?

[00:05:17] Speaker 05:
Because the undue experimentation language is for priority.

[00:05:21] Speaker 05:
And that's a fundamental confusion.

[00:05:23] Speaker 05:
In priority cases, that's Maricar.

[00:05:25] Speaker 05:
That's what they say in Maricar.

[00:05:26] Speaker 05:
Maricar is a priority case.

[00:05:27] Speaker 05:
And in priority cases, you can have priority with conception so long as there's diligence in reducing to practice.

[00:05:35] Speaker 05:
Fath and in Beecher Beach say that's not true for 102B.

[00:05:39] Speaker 01:
What about Hamilton Beach that talks about fine tuning?

[00:05:42] Speaker 01:
Something could be ready for patenting.

[00:05:45] Speaker 01:
even if there's fine-tuning.

[00:05:46] Speaker 05:
I agree, but it's well beyond fine-tuning on this record, and certainly on this record, a jury could conclude that it's well beyond fine-tuning.

[00:05:53] Speaker 01:
What about the bill of materials and very specific diagrams depicting the dimensions as well as the materials?

[00:06:02] Speaker 05:
Of course, because when you're experimenting, you've got to build things to experiment with.

[00:06:06] Speaker 05:
So yes, they could build something, it just would deform.

[00:06:09] Speaker 05:
And if it deforms during use, it's not ready for patenting.

[00:06:13] Speaker 05:
Because you can't get it out of the patient under those circumstances where it's not safe to get it out of the patient.

[00:06:18] Speaker 03:
Do we have cases, any of our case laws say that a device is not ready for patenting until all the experimentation has taken place?

[00:06:25] Speaker 05:
No, and that's not my position.

[00:06:27] Speaker 03:
It's absolutely not my position.

[00:06:28] Speaker 03:
It sounds like your position.

[00:06:29] Speaker 05:
No, no, no.

[00:06:29] Speaker 05:
My position is you have to be confident it can be safely used in the intended environment.

[00:06:35] Speaker 05:
You can still fine tune after that.

[00:06:37] Speaker 05:
But there's a point.

[00:06:38] Speaker 05:
There's a point before fine tuning where you know what you have.

[00:06:43] Speaker 05:
Consider this.

[00:06:44] Speaker 05:
The 4-2017 steel design, that's all we have.

[00:06:47] Speaker 03:
What are the extirpated uterine study?

[00:06:51] Speaker 05:
Yeah, that's the brochure.

[00:06:53] Speaker 05:
So extirpated uterine or even removed from a live patient.

[00:06:57] Speaker 05:
And if you look at that, that's 12-175-76 of the record.

[00:07:02] Speaker 05:
If you look at that, what you see is

[00:07:04] Speaker 05:
There's a discussion of an experiment on 13 extirpated uteri, as I said, removed from patients.

[00:07:10] Speaker 05:
So not the intended environment.

[00:07:11] Speaker 03:
That's a human flesh though, right?

[00:07:13] Speaker 05:
Right, but it's not in a live patient.

[00:07:15] Speaker 05:
It's not a live patient.

[00:07:17] Speaker 05:
Right.

[00:07:17] Speaker 05:
So you can test.

[00:07:18] Speaker 05:
So it's a good way to test whether you have successful ablation, but it's not a great way to test whether you have safe removal.

[00:07:24] Speaker 03:
The only testing left.

[00:07:25] Speaker 03:
in your view, was that it had to be tested on live patients.

[00:07:29] Speaker 05:
Yes, I think that's absolutely essential.

[00:07:32] Speaker 01:
Doesn't the investigators for sure indicate that it had been used in clinical studies?

[00:07:36] Speaker 05:
No, no.

[00:07:38] Speaker 05:
It suggests that on the next step, it might be ready for the next step for the research in prehistorectomy studies.

[00:07:48] Speaker 05:
That's what it says.

[00:07:49] Speaker 05:
It says it had been used in 13 extirpated uteri.

[00:07:53] Speaker 05:
11 of those were safely removed.

[00:07:55] Speaker 05:
Still not the intended environment.

[00:07:56] Speaker 05:
And it suggests the next step of research would be appropriate.

[00:08:00] Speaker 05:
And here's the key.

[00:08:01] Speaker 05:
Here's the key.

[00:08:02] Speaker 05:
The next step of research that that document anticipates did not happen for more than a year.

[00:08:08] Speaker 05:
More than a year.

[00:08:10] Speaker 05:
And the inventor, Mr. Toth, they point to his testimony, oh, and by the way,

[00:08:15] Speaker 05:
A 42017 steel device has never once, that design has never once, to this day, been tested in a live patient.

[00:08:24] Speaker 05:
So what you would have to say is that, and we don't know to this day, nobody, including the inventors, can be confident to this day that that design could have been patented.

[00:08:34] Speaker 05:
It needed to do more to be able to be sure it could be used in its intended environment.

[00:08:40] Speaker 05:
And the only way, the only way you get it in validity is if you throw away

[00:08:45] Speaker 05:
cases like Barry and Manville Sales and Pallara, and you allow and you encourage premature patenting before you have confidence that you have a device that's actually useful.

[00:08:57] Speaker 05:
Because after all, utility is required.

[00:08:59] Speaker 05:
It's not useful to have a device that's going to deform.

[00:09:03] Speaker 05:
And consider Mr. Todd's testimony at 6645.

[00:09:05] Speaker 05:
The deformation, that frame design, deformed too much.

[00:09:10] Speaker 05:
The issues were too serious to use in going forward tests, and they didn't use them.

[00:09:14] Speaker 05:
in going forward tests.

[00:09:16] Speaker 05:
And they didn't even do a test on a live patient for more than a year.

[00:09:19] Speaker 05:
I don't think the priority case requirement that the diligence in reducing the practice applies.

[00:09:26] Speaker 05:
But even if it did, another full year of trial and error before you could get there is far too much.

[00:09:33] Speaker 05:
And more importantly, it's not the right standard.

[00:09:36] Speaker 05:
That's what FAF and the future can make clear.

[00:09:40] Speaker 05:
If there are no further questions on this, I'd like to turn to the equivalence issue.

[00:09:45] Speaker 05:
On equivalence, the district court's doubtful ruling comes down to an officiation argument.

[00:09:50] Speaker 05:
Unless Dr. Bryant's equivalence analysis amounts to claim officiation, a jury should hear it.

[00:09:55] Speaker 05:
So let's look at the district court and the logic's reasoning.

[00:09:58] Speaker 05:
The claim language, substantially dissimilar material properties,

[00:10:01] Speaker 05:
has been construed to mean different thicknesses and different compositions between the inner and outer flexors.

[00:10:06] Speaker 05:
We agree, Dr. Bryan agrees.

[00:10:08] Speaker 05:
A logic's device uses different thicknesses and a logic's device uses the same composition between inner and outer flexors.

[00:10:15] Speaker 05:
We agree, Dr. Bryan agrees.

[00:10:17] Speaker 05:
The difference is a logic and the district court say, that's all you need to know because the same composition cannot be equivalent to a different composition.

[00:10:26] Speaker 05:
And emphatically, that is contrary to this court's cases

[00:10:29] Speaker 05:
on uh... on initiation it is exactly the kind of short cut reasoning but this court has said i'll rat edgewell at the concierge company is inappropriate and here's why it destroys the whole doctrine of equivalence entire entirely it is always possible so our laws somewhat confused in this in this area and i'm intrigued by by

[00:10:55] Speaker 03:
your expert's theories on vitiations and what occurred.

[00:11:01] Speaker 03:
But I'm not sure that the correct arguments were made below.

[00:11:06] Speaker 03:
So can you just very concisely tell me what the problem is here?

[00:11:13] Speaker 05:
Yeah.

[00:11:14] Speaker 05:
So fundamentally, the problem is this.

[00:11:16] Speaker 05:
The reasoning of the district court is that a claim that requires A plus B

[00:11:23] Speaker 05:
It always cannot mean that A without B is an equivalent.

[00:11:28] Speaker 05:
And that's the shorthand.

[00:11:30] Speaker 05:
That's the shorthand that doesn't work.

[00:11:32] Speaker 05:
And that's not what Dr. Bryant did.

[00:11:34] Speaker 01:
I've read the district court's opinion slightly differently than you.

[00:11:37] Speaker 01:
One thing the district court said was, because your expert said, I think it was something like, the claim construction doesn't matter.

[00:11:45] Speaker 01:
It's exactly what he said.

[00:11:47] Speaker 01:
He said, then the district court said, this testimony would be confusing.

[00:11:53] Speaker 01:
to a jury.

[00:11:55] Speaker 01:
That to me invokes Rule 403, right?

[00:11:59] Speaker 01:
And so I wasn't looking at it the same way as you.

[00:12:03] Speaker 01:
You seemed to be looking at it per se, almost as if it's a summary judgment analysis.

[00:12:08] Speaker 01:
Oh, this testimony cannot per se prove that there is infringement under the doctrine of equivalence.

[00:12:15] Speaker 01:
But I think there was more to it than that.

[00:12:17] Speaker 01:
I think it was, if you read the district court's opinion, they're just talking about

[00:12:23] Speaker 01:
confusing to the jury because of the way the climate construction was

[00:12:27] Speaker 01:
said that it could be disregarded, that it doesn't matter.

[00:12:31] Speaker 05:
That was the district court's interpretation of Dr. Bryant's testimony.

[00:12:33] Speaker 05:
I don't think it's a fair one.

[00:12:35] Speaker 01:
But it's the district court's analysis, and your job here is to explain to us why the district court abused its testimony.

[00:12:42] Speaker 05:
So as I said, Dr. Bryant accepts the district court's claim instruction.

[00:12:45] Speaker 05:
He does so expressively.

[00:12:46] Speaker 05:
And the whole passage, and it's worth reading the whole section.

[00:12:49] Speaker 01:
But why did the district court abuse its discretion in excluding his testimony?

[00:12:53] Speaker 05:
Because he did not, first of all, he did not ignore

[00:12:56] Speaker 05:
of the district court's claim construction, he said, and the district court's claim construction is this.

[00:13:01] Speaker 05:
It requires different thicknesses and different compositions, right?

[00:13:05] Speaker 05:
Dr. Bryant explains that there are different bulk thicknesses between Hologic's, and everybody agrees on this, Hologic's inner and outer flexures, but that instead of different compositions, it uses a different geometry.

[00:13:18] Speaker 05:
It just substitutes a change in the geometry of the interflexure for a change in the composition.

[00:13:23] Speaker 05:
And he says, that's elementary.

[00:13:26] Speaker 05:
Judge Stoll, that's not ignoring the district court's claim construction.

[00:13:30] Speaker 05:
That's taking it.

[00:13:31] Speaker 05:
It's doing exactly what an ideal doctrine of equivalence case does.

[00:13:35] Speaker 05:
It says, here's your construction.

[00:13:38] Speaker 05:
Here's the difference.

[00:13:39] Speaker 05:
And here's why that difference is insubstantial.

[00:13:42] Speaker 05:
And it achieves the same function

[00:13:44] Speaker 01:
uh... the same for the same way to achieve the same result where he said by having a combination of dissimilar material properties grand as one non-limiting example different thickness and different composition and you say non-limiting he says non-limiting that does and reports construction was has to be different thickness and different composition so why is that non-limiting well it's not limiting when you get to an equivalent

[00:14:13] Speaker 05:
is what he's saying.

[00:14:14] Speaker 05:
I think he's not using it in a technical sense.

[00:14:17] Speaker 05:
I think what he's saying is, when you get into equivalence, the question is, is there a way to achieve the same, to apply the function way result test to this construction that doesn't give you exactly the same way?

[00:14:29] Speaker 05:
You don't use different compositions.

[00:14:30] Speaker 05:
You use different geometries.

[00:14:31] Speaker 05:
I understand what you're saying.

[00:14:32] Speaker 01:
But what about if the district court judge then says, I look at this, and in my experience, I think the jury will be confused by this.

[00:14:39] Speaker 01:
OK.

[00:14:40] Speaker 05:
If this court's opinion is,

[00:14:42] Speaker 05:
that I don't think it's accurate to say.

[00:14:45] Speaker 05:
I think the district court aired to the extent he believed that it was simply contradicting.

[00:14:49] Speaker 05:
his claim construction.

[00:14:50] Speaker 05:
He was applying the doctrine of equivalence, as this court has required it, exactly the way I think it's appropriate.

[00:14:56] Speaker 05:
But putting that aside, if this court on remand wants to say, sure, absolutely, do not permit him to say the district court's claim construction is wrong, and he can say everything else he says, then that's fine.

[00:15:07] Speaker 05:
That's what he's going to do.

[00:15:09] Speaker 01:
Can I ask you another question?

[00:15:10] Speaker 01:
I have an important question I want to ask you that is kind of troubling me about the record before you run out of time, which is

[00:15:16] Speaker 01:
You argued on appeal on the public use issue that the SDMP aspect of the device wasn't visible to a person of ordinary scale in the art.

[00:15:26] Speaker 01:
And you cite a number of cases to support that.

[00:15:29] Speaker 01:
One concern I had is I went back and pulled your briefing before the district court on that issue.

[00:15:35] Speaker 01:
And I don't see where you presented that argument at all or presented those cases to the district court in cases like the great varietal case.

[00:15:45] Speaker 01:
And I see where you made other arguments, but this argument wasn't expressly made.

[00:15:50] Speaker 05:
Well, I think we did make the argument that we made the general argument.

[00:15:53] Speaker 05:
It may not have been made as clearly, but I think it was enough to preserve the general argument that there was a mere display and not ease.

[00:16:01] Speaker 01:
But I hear what you're saying, mere display, not use.

[00:16:03] Speaker 01:
But that's different than nobody could see the differences between the inner and outer Franks.

[00:16:09] Speaker 05:
I mean, I think it's just true, but I don't see much of a difference, actually.

[00:16:15] Speaker 05:
Because I think it's just a component, just another point.

[00:16:17] Speaker 05:
To the extent that they're pressing that this model was up there, there's no reason why a jury would have to conclude that that was done.

[00:16:27] Speaker 02:
OK.

[00:16:27] Speaker 02:
You've exceeded your time.

[00:16:28] Speaker 02:
Yeah, I apologize.

[00:16:29] Speaker 02:
Will you start with a rebuttal, and let's hear from Mr. White?

[00:16:31] Speaker 02:
Thank you.

[00:16:38] Speaker 04:
May it please the court, Matthew Wolf, for a logic.

[00:16:42] Speaker 04:
I'll start where my esteemed colleague started, which is in validity.

[00:16:47] Speaker 04:
Ready for patenting, the Supreme Court has told us there are multiple ways to prove ready for patenting.

[00:16:53] Speaker 04:
One of them is drawings and descriptions sufficient for you to make the invention.

[00:16:59] Speaker 04:
This argument, the district court expressly found

[00:17:03] Speaker 04:
that this prong was met based on this, as well as the reduction to practice approach to establishing ready for patenting.

[00:17:12] Speaker 04:
And this was waived.

[00:17:14] Speaker 04:
There is not a mention in the opening brief by Minerva that rejecting, challenging, in any way, suggesting the district court got this analysis at 820 wrong.

[00:17:27] Speaker 04:
So ready for patenting, that argument, where counsel started, was waived.

[00:17:33] Speaker 04:
On reply, you heard and saw the citation to Palera and Manville and Honeywell.

[00:17:39] Speaker 04:
I would note for your honors that those are experimental use cases.

[00:17:43] Speaker 04:
There was no experimental use argument made below.

[00:17:47] Speaker 04:
There was no experimental use argument made in the opening briefs or indeed in the reply briefs.

[00:17:53] Speaker 04:
Palera lays out a 13-prong analysis, which I'm sure your honors are familiar with.

[00:17:57] Speaker 04:
Not all are relevant in all circumstances.

[00:18:01] Speaker 04:
But experimental use in any event is a response to the second question, whether there's been a public use, not first whether there was ready for patenting.

[00:18:09] Speaker 04:
So argument number one on ready for patenting is it has been waived because the district court found, and it was not challenged, that there were drawings sufficient, drawings and descriptions sufficient before the public use for there to be found that the invention was ready for patenting.

[00:18:28] Speaker 04:
Now, as to the question of, let's assume they hadn't waived it.

[00:18:32] Speaker 04:
Let's assume that hadn't been even adopted by the district court, that the district court had just talked about reduced to practice.

[00:18:40] Speaker 04:
Your honors, I'd like to turn your attention to the section entitled Conclusion on A-12176.

[00:18:48] Speaker 04:
Your honors asked about this, and counsel cited it.

[00:18:51] Speaker 04:
Conclusion.

[00:18:52] Speaker 04:
This is in an FDA-mandated document that was created the very week of the trade show at issue.

[00:19:00] Speaker 04:
FDA-mandated conclusion, the results of this range-finding study, Your Honor, that's the extirpated uterine you were talking about.

[00:19:08] Speaker 04:
The results of this range-finding study confirm that the Minerva device would be considered acceptable for clinical use in pre-hysterectomy cases.

[00:19:20] Speaker 04:
For clinical use.

[00:19:22] Speaker 04:
So not only did they say it probably worked, they were telling potential investigators for the clinical trial they were anticipating that they believed it was acceptable not for preclinical use, not for further experimentation, not hypothetically, not subject to further work.

[00:19:40] Speaker 04:
It was acceptable now for clinical use.

[00:19:45] Speaker 03:
At the conference, were the attendings able to manipulate the device and use it?

[00:19:52] Speaker 03:
And if I recall correctly, in doing so, I think a hinge was broken on one of them.

[00:19:58] Speaker 04:
On one of them?

[00:19:58] Speaker 04:
That's right, Your Honor.

[00:19:59] Speaker 04:
The frame.

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

[00:20:01] Speaker 04:
In fact, at A12189, there's an email from one of the sales reps.

[00:20:07] Speaker 04:
summarizing the interaction between the physicians and the 15 devices that were there.

[00:20:14] Speaker 04:
And the headline, quote, devices have been working well, end quote.

[00:20:20] Speaker 04:
Pretty good evidence of what was going on.

[00:20:23] Speaker 04:
But Your Honor noted that they weren't perfect yet.

[00:20:25] Speaker 04:
There was one device that the hinge broke.

[00:20:27] Speaker 04:
So the devices were working well, but they're not perfect yet.

[00:20:32] Speaker 04:
I would note on this second public use prong, we again have a waiver issue.

[00:20:38] Speaker 04:
There are two ways, at least two ways, you can use public use.

[00:20:41] Speaker 04:
You can prove public use.

[00:20:43] Speaker 04:
One is commercial exploitation.

[00:20:45] Speaker 04:
The second is accessibility to the public.

[00:20:48] Speaker 04:
The district court expressly found both prongs were met, commercial exploitation and availability to the public.

[00:20:56] Speaker 04:
And the commercial exploitation prong was not challenged in the opening brief here.

[00:21:03] Speaker 04:
The district court expressly found Minerva commercially exploited its invention before the critical date, primarily in its efforts to sell the device to competitors like Johnson & Johnson, Covidian, and my client, Hologic.

[00:21:16] Speaker 04:
And this is at A12091.

[00:21:18] Speaker 04:
You see the internal reporting of these very commercial efforts.

[00:21:23] Speaker 04:
And what was said in the opening brief and response?

[00:21:26] Speaker 04:
Nothing.

[00:21:27] Speaker 04:
So this, too, was waived.

[00:21:28] Speaker 04:
In other words, one way of proving wrong, one was waived.

[00:21:32] Speaker 04:
One way of proving prong two was waived, we're done.

[00:21:35] Speaker 04:
The patent is invalid.

[00:21:37] Speaker 04:
The only response in the reply brief, which of course is too late anyway, but the only response to this is a throwaway sentence citing alloyed colloids which said, quote, testing does not convert an otherwise experimental purpose into a public use.

[00:21:55] Speaker 04:
But of course, Minerva's meetings with Johnson & Johnson and Kavitian, Hologic, and Conceptus the week before, those weren't experimental uses.

[00:22:03] Speaker 04:
They were trying to sell the product.

[00:22:05] Speaker 04:
They were trying to cash out.

[00:22:07] Speaker 04:
That's the very definition of a commercial use.

[00:22:10] Speaker 04:
They commercially exploited their invention or attempted to sell it.

[00:22:15] Speaker 04:
They were unsuccessful at the time.

[00:22:19] Speaker 04:
or rather, pronged to, the first way to prove pronged to, has been satisfied, in fact, has been waived.

[00:22:25] Speaker 02:
Can we go back to the ready for patenting?

[00:22:27] Speaker 02:
Yes, Your Honor.

[00:22:28] Speaker 02:
Is your understanding that their argument is it's not an actual reduction to practice unless you've entered human clinical trial phase of development?

[00:22:39] Speaker 04:
That seems to be the case, Your Honor, because I just quoted.

[00:22:43] Speaker 02:
And why is that wrong under the cases they cite, even if they're in gray and not

[00:22:48] Speaker 02:
blue, although they do cite barium blue.

[00:22:51] Speaker 04:
They do, Your Honor.

[00:22:52] Speaker 04:
Now, in fairness, remember there are two different ways to prove this, right?

[00:22:56] Speaker 04:
Description, waived.

[00:22:57] Speaker 04:
So we're just kind of putting that aside for the moment.

[00:23:00] Speaker 04:
That has to be wrong.

[00:23:01] Speaker 04:
I mean, you can imagine claim language.

[00:23:03] Speaker 04:
In fact, barium implicates some claim language where there is a standard or something that you have to

[00:23:09] Speaker 04:
get to before you've shown the invention has actually been reduced to practice.

[00:23:14] Speaker 04:
I have a microwave that needs to get to 200 degrees.

[00:23:17] Speaker 04:
That's a limitation.

[00:23:19] Speaker 04:
Until you prove it gets to 200 degrees, it's not reduced to practice, at least potentially.

[00:23:24] Speaker 01:
Here, as your honor pointed out, this is a straightforward apparatus claim with a straightforward set of limitations that were... Is this like the motionless keyboard case where it included a requirement that the keyboard actually transmit a signal and so there was no

[00:23:38] Speaker 01:
showing of the transmitting of the signal, so therefore it wasn't a public use.

[00:23:43] Speaker 01:
Would you say that's analogous to what you're talking about?

[00:23:45] Speaker 04:
Where, hypothetically, it would not be a reduction of practice, but this case is very much like the art.com case, or art plus com.

[00:23:53] Speaker 04:
I assume that's how you say it.

[00:23:54] Speaker 04:
I recognize it's non-precedential, but it's very close to the facts of the circumstance.

[00:23:58] Speaker 04:
Where a prior art device was ready for patenting when a prototype of the device demonstrated the workability of the invention.

[00:24:05] Speaker 04:
That language is pretty close to what, and I won't repeat it too much, but the review from the trade show, where he said these are working fine except there's the one that had the hinge break, that's almost verbatim what ArtPlusCom says you need to have.

[00:24:18] Speaker 01:
Would you say that there could be some circumstances in which you would have to have clinical testing before it would be ready for patenting?

[00:24:28] Speaker 04:
So clinical testing, of course, Your Honor,

[00:24:31] Speaker 04:
Very specific meaning, right?

[00:24:33] Speaker 04:
It means a live human being as opposed to a dog or a cat or a mouse.

[00:24:37] Speaker 04:
It means in certain controls.

[00:24:39] Speaker 04:
The FDA is defining what clinical means.

[00:24:41] Speaker 04:
If you mean it broadly, I can imagine circumstances where a claim is written where you have to prove something works beyond just on the bench top.

[00:24:50] Speaker 04:
I can imagine claim language.

[00:24:52] Speaker 04:
That's not here.

[00:24:52] Speaker 04:
I could imagine it.

[00:24:53] Speaker 04:
Whether there would ever be a circumstance where actual clinical testing was required, as the FDA defines it and its counsel is using that term,

[00:25:00] Speaker 04:
I don't think so.

[00:25:01] Speaker 02:
I can't imagine what it would be.

[00:25:02] Speaker 02:
They couldn't be claim language that was explicit enough to require that.

[00:25:06] Speaker 04:
I guess if you said, you know, suitable for FDA approval or something like that.

[00:25:10] Speaker 01:
Or what about suitable for human use or we'll accomplish this x in a human, something like that.

[00:25:19] Speaker 04:
Yeah, I guess.

[00:25:20] Speaker 04:
But again, the FDA allows you to prove something suitable for human use, at least for study purposes, by performing it in analogous animals.

[00:25:28] Speaker 04:
So I can imagine at one extreme you could get there, but there are a lot of interim steps.

[00:25:34] Speaker 04:
And of course, here we have in their own words, in the very week of the study, you have them saying it's acceptable for clinical use.

[00:25:42] Speaker 04:
So we're not within, wherever we are on the continuum,

[00:25:46] Speaker 04:
you know, and these hypotheticals were on the entire other side of the page in the facts of this case.

[00:25:51] Speaker 01:
Can I ask you one more thing, real quickly, about your waiver argument with respect to ready for patenting?

[00:25:55] Speaker 01:
I'm just having a hard time seeing it.

[00:25:57] Speaker 01:
And I look at their brief on page 55, for example, and they do talk about the documents.

[00:26:03] Speaker 01:
And, you know, I'm having a hard time seeing why you think that they didn't say enough.

[00:26:08] Speaker 01:
They've got multiple pages devoted to the ready for patenting argument.

[00:26:15] Speaker 04:
multiple pages on the reduced to practice prong.

[00:26:21] Speaker 04:
So remember, two ways, just documents, descriptions, reduced to practice.

[00:26:25] Speaker 04:
They have multiple pages about reduced practice.

[00:26:27] Speaker 04:
We're not arguing they waived.

[00:26:29] Speaker 04:
We say they're wrong.

[00:26:30] Speaker 04:
We're not arguing they waived the reduced practice.

[00:26:32] Speaker 02:
No, but as Judge Stoll was pointing out, starting at page 53, we're talking about ready for patenting.

[00:26:37] Speaker 04:
Right, but all of that, Your Honor, is going to, if I'm recalling correctly, all of that is about use on humans, right?

[00:26:44] Speaker 04:
It's all about the use idea, that it hasn't been proven.

[00:26:47] Speaker 04:
It's useful.

[00:26:50] Speaker 04:
That's not a component.

[00:26:51] Speaker 04:
That's not a requirement.

[00:26:52] Speaker 04:
That's not a response.

[00:26:54] Speaker 04:
to the drawings sufficient to practice way of showing ready for patenting.

[00:26:59] Speaker 04:
So even if we say that it was a failure of subtitling or of captioning or of labeling, they don't respond to the argument.

[00:27:08] Speaker 04:
If I write down the invention, if I write it down sufficient that one can practice.

[00:27:14] Speaker 04:
And remember, the district court specifically found here there was more detail in these August documents than there were in the patent itself.

[00:27:22] Speaker 04:
that if I write that down such that one of skill and the art can make the invention, we don't even get to the reduction of practice prong, and then it doesn't matter whether it's ready for humans or not.

[00:27:33] Speaker 04:
Then the only argument they would have left is the experimental use argument when it comes to the public use prong.

[00:27:41] Speaker 04:
if i think i use the word prong in particular incorrectly there you are but i think you get my point they really did wave this i think they really were responding to the second way you can prove ready for patting substantively and in name and and i think we could talk unless your answer any more questions about that validity your honor's absolutely right i i had in highlighting uh... before your honor brought it up uh... brian said as one non-limiting example but it's not just

[00:28:09] Speaker 04:
Dr. Bryant, even in the reply briefs themselves, reply 29, nothing in the claim construction ruling suggests that these two requirements follow from the claim language itself.

[00:28:20] Speaker 04:
Well, of course they do.

[00:28:21] Speaker 04:
That was the claim construction.

[00:28:22] Speaker 04:
That's the unchallenged claim construction here.

[00:28:25] Speaker 04:
And that was the kind of rhetoric, both in the briefing and in Dr. Bryant's report, that troubled the district court.

[00:28:31] Speaker 04:
You are disregarding my claim construction at every step of the way.

[00:28:36] Speaker 04:
That's what the district court is saying.

[00:28:38] Speaker 04:
Now, to Your Honor's vitiation point, so we agree that in terms of the actual posture, this being the exclusion of an expert report, the district court was plainly within its rights.

[00:28:48] Speaker 04:
But to turn to the vitiation point, Your Honor, we have kind of an insult and an injury here.

[00:28:53] Speaker 04:
We have a claim that says for element A, you can use any composition under the sun for the first frame element.

[00:29:03] Speaker 04:
For frame two, let's call them frame one and frame two.

[00:29:07] Speaker 04:
For frame two, you can use any composition under the sun with one exception.

[00:29:12] Speaker 04:
You can't use the same thing you used for it.

[00:29:15] Speaker 04:
And what they've now done is said, well, you can also use the same one you used for frame one.

[00:29:22] Speaker 04:
That is the very definition of vitiation.

[00:29:25] Speaker 04:
They have now said that

[00:29:27] Speaker 04:
that composition language is gone.

[00:29:29] Speaker 04:
Because it originally said everything but one, and now we're saying everything including one.

[00:29:34] Speaker 04:
That's the insult.

[00:29:35] Speaker 04:
The injury here.

[00:29:36] Speaker 03:
So assuming that there was vitiation, are you arguing that in such cases there can never be a DOE finding?

[00:29:44] Speaker 04:
Your Honor, I am relying heavily on the language of Moore and Augme.

[00:29:47] Speaker 04:
When Moore said, for this reason, referring to the obviousness of the alternatives,

[00:29:57] Speaker 04:
quote, many limitations warrant little if any range of equivalents.

[00:30:04] Speaker 04:
The injury here is that remember the first part of the claim construction is different thickness.

[00:30:10] Speaker 04:
So you have to have different thickness and different composition.

[00:30:14] Speaker 04:
What they suggested, what Dr. Bryant suggested below was the different composition was the different thickness.

[00:30:21] Speaker 04:
That's the equivalent.

[00:30:22] Speaker 04:
So not only have you said we can use any composition at all,

[00:30:27] Speaker 04:
vitiating that, we're saying the way you do it is with a limitation that's already in the claim.

[00:30:35] Speaker 04:
And so when Moore and Ogbe, I mean Ogbe says equivalency cannot embrace structure that is specifically excluded from the scope of the claims.

[00:30:44] Speaker 04:
And here we see element one, frame element one, use anything.

[00:30:47] Speaker 04:
Frame element two, use anything but what you used for frame element one.

[00:30:52] Speaker 03:
Do you have an answer to my question?

[00:30:53] Speaker 03:
I'm sorry, your honor.

[00:30:55] Speaker 03:
OK.

[00:30:55] Speaker 03:
In situations where you have vitiations such as here, are you saying there can never be an equivalency finding?

[00:31:03] Speaker 04:
If you've completely vitiated the claim, then I would say more and all of we stand for the proposition that you're done.

[00:31:09] Speaker 04:
There can't be equivalence.

[00:31:09] Speaker 01:
Just to be clear, though, your vitiation theory is not based on the claim language itself so much as the interpretation of that claim language.

[00:31:18] Speaker 01:
Just to be clear.

[00:31:20] Speaker 04:
The unobjected to claim.

[00:31:22] Speaker 04:
In fact, this would be.

[00:31:23] Speaker 01:
Do you need that in order to be successful?

[00:31:25] Speaker 01:
No, not at all.

[00:31:25] Speaker 04:
That's why I started with Your Honor's point.

[00:31:28] Speaker 04:
And frankly, we think in light of the invalidity ruling, we don't even need to get to the Bryant doctrine of equivalence.

[00:31:33] Speaker 02:
I was going to ask that clearly.

[00:31:35] Speaker 02:
I mean, right?

[00:31:35] Speaker 02:
If we were to affirm, hypothetically, if they wanted to be.

[00:31:39] Speaker 04:
Then we're done, Your Honor.

[00:31:41] Speaker 02:
Thank you.

[00:31:41] Speaker 04:
Thank you.

[00:31:50] Speaker 05:
I appreciate the opportunity to be brief here.

[00:31:54] Speaker 05:
On invalidity, here's the key thing.

[00:31:56] Speaker 05:
Ready for patenting, according to FAF, there are two ways to show ready for patenting.

[00:32:01] Speaker 05:
You can either do a device or drawings.

[00:32:07] Speaker 05:
But it has to be of the invention.

[00:32:09] Speaker 05:
And you do not have an invention, according to this court's case law, until you have something that's safe for use in its intended environment.

[00:32:17] Speaker 05:
The intended environment here is right at the top, the very first sentence of the summary of the invention.

[00:32:23] Speaker 05:
It is for the treatment of uterine diseases in human females.

[00:32:29] Speaker 05:
So if you can't confidently get the device out of a live patient, you do not have this invention.

[00:32:36] Speaker 05:
And unless you're going to throw away Honeywell.

[00:32:39] Speaker 01:
My question is, so in other words, what you're saying is that you're prepared drawings.

[00:32:45] Speaker 01:
There are, in fact, drawings.

[00:32:47] Speaker 01:
Your argument is that those drawings can't be relied on because there was no human user.

[00:32:54] Speaker 05:
They are not the invention.

[00:32:55] Speaker 05:
And we know they are not the invention, partly because on the one hand, the inventor said they were still deforming too much.

[00:33:02] Speaker 05:
But on the other hand, because we know they were never even tried in those further experiments that

[00:33:09] Speaker 05:
12176 refers to.

[00:33:12] Speaker 05:
We didn't do it with this device.

[00:33:14] Speaker 05:
We didn't do it with that drawing.

[00:33:15] Speaker 05:
And we took another year, more than a year.

[00:33:20] Speaker 05:
This didn't happen right away.

[00:33:21] Speaker 05:
So when you put all the evidence together, I don't see how.

[00:33:25] Speaker 05:
You could say a jury would be at least precluded from saying, this device just wasn't ready yet.

[00:33:33] Speaker 05:
They didn't have whatever drawings they had.

[00:33:35] Speaker 05:
They weren't for something that could be used in a human being.

[00:33:38] Speaker 02:
And until they believed... Can you just speak briefly to the waiver argument?

[00:33:41] Speaker 05:
Yes, so as for the waiver argument, as you said, it's a heading that the Ready for Patenting is a full-on heading of our brief at page 53, so that whole section addresses the Ready for Patenting issue in general.

[00:33:54] Speaker 05:
And as for the specific drawings, we talk about that on page 46, that the drawings show only conception, not reduction to practice.

[00:34:03] Speaker 05:
That's also clear.

[00:34:05] Speaker 05:
And again, the solution to all of the waiver arguments is the same.

[00:34:09] Speaker 05:
Ready for patenting is a prerequisite.

[00:34:12] Speaker 05:
Until you have either a drawing or a device that reflects the invention, something safe for use for its intended purposes, you don't have, you haven't satisfied the FAF requirement of ready for patenting.

[00:34:30] Speaker 02:
Thank you.

[00:34:30] Speaker 02:
Thank both sides in the case system.