[00:00:04] Speaker 02:
We have quite a busy, um, docket for today with a number of cases being heard solely on the briefs.

[00:00:12] Speaker 02:
Uh, we have two cases scheduled for argument this morning.

[00:00:16] Speaker 02:
The first case is 21-1981, Sanofi-Ventus, Deutschland, versus Modern Pharmaceuticals.

[00:00:26] Speaker 02:
Um, Mr. Darby, I understand that you've asked for three minutes of rebuttal time.

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

[00:00:35] Speaker 02:
You may proceed.

[00:00:57] Speaker 00:
Good morning, your honors and may it please the court.

[00:00:59] Speaker 00:
This is Kenneth Darby speaking for the appellant, Sanofi Aventis.

[00:01:03] Speaker 00:
And I'm here today because the board invalidated Sanofi's patent directed to pen type drug delivery devices based on a clutch release bearing for a car transmission.

[00:01:13] Speaker 00:
Besides lacking substantial evidence to support its factual findings, the board also committed two critical legal errors, each of which independently and separately supports reversal.

[00:01:25] Speaker 00:
The board's first error is that it ruled in favor of a petitioner that built its case on the wrong legal standards for analogous art.

[00:01:32] Speaker 00:
Instead of holding Mylan to its petitioner's statutory burden, the board instead carried that burden for Mylan and shifted it improperly to Sanofi.

[00:01:42] Speaker 00:
The board's second error is that it misapplied this court's test for analogous art, specifically the reasonable pertinence criterion.

[00:01:51] Speaker 00:
Instead of applying this court's test, which tells us to look to the particular problem solved by the claimed invention, the board created its own test, whereby any problem merely relevant

[00:02:02] Speaker 00:
to the claimed invention can set the benchmark for pertinence.

[00:02:07] Speaker 00:
These errors infected the remainder of the board's analysis regarding Dejean and those portions of the final written decision.

[00:02:13] Speaker 02:
Does it matter if you have a situation where the prior art states the particular problem to base the particular problem on the prior art and not the invention itself, not the patent?

[00:02:28] Speaker 00:
Thank you, Your Honor.

[00:02:28] Speaker 00:
Yes, I think there is a problem when we're not looking to the particular problem solved by the claimed invention.

[00:02:34] Speaker 00:
So certainly, any reasonable pertinence analysis should start with the challenge pattern.

[00:02:39] Speaker 00:
And it should find the challenge pattern's particular problem and then look to the prior art and find the problem solved by the prior art referencing in question.

[00:02:47] Speaker 00:
And we should compare those problems.

[00:02:49] Speaker 00:
And there should be a determination through the lens of a person of skill in the art as to whether or not the prior art's problem

[00:02:56] Speaker 02:
But in order to have art that's analogous, you're dealing with prior art.

[00:03:03] Speaker 02:
So is it totally necessary to base the permanent problem test on the problem expressed in the patent?

[00:03:12] Speaker 02:
Or can it be based on the problem expressed in the prior art that you're looking at because you're trying to determine whether that reference is indeed analogous?

[00:03:22] Speaker 00:
Right, Your Honor.

[00:03:22] Speaker 00:
I think we should certainly be looking to the challenge patents

[00:03:25] Speaker 00:
problem when we're looking to determine what is analogous art.

[00:03:31] Speaker 00:
The court's cases, for example, most recently in the Donner Technologies case decided in 2020, the court made clear that we look to the challenge patents problem, we look to the problem in the art, and we make a comparison amongst them.

[00:03:44] Speaker 00:
I'm feeling I maybe didn't get to the kernel of your question there.

[00:03:47] Speaker 00:
Maybe can you throw it back at me one more time?

[00:03:49] Speaker 02:
No, I think you're hitting around the edges of where

[00:03:54] Speaker 02:
We're looking at whether the reference is reasonably permanent to the particular problem.

[00:04:02] Speaker 02:
So the problem that we're looking at, do we search for the problem in the claim, I mean in the patent, or are we talking about a problem that's disclosed in the prior art?

[00:04:14] Speaker 00:
Right.

[00:04:14] Speaker 00:
Yeah, we're certainly looking to the particular problem of the challenge patent and not simply any problem out there in the prior art.

[00:04:20] Speaker 00:
I think that there is a difference between, for example, motivation to combine, where we can look to any problem solved out there in the art.

[00:04:28] Speaker 00:
But analogous art is a little bit different of an inquiry.

[00:04:30] Speaker 00:
It's related, but different.

[00:04:31] Speaker 00:
We're trying to determine which art are we going to consider prior art that qualifies for the test of obviousness.

[00:04:38] Speaker 00:
So it's a little bit different inquiry.

[00:04:39] Speaker 00:
And for analogous art, we're certainly looking to the inventor's particular problem.

[00:04:43] Speaker 00:
And this court's cases are very clear on that.

[00:04:48] Speaker 00:
And so that's certainly our position on the matter.

[00:04:50] Speaker 00:
Did I get there with an answer for you there?

[00:04:54] Speaker 00:
OK, great.

[00:04:55] Speaker 00:
So returning to the board's first error, its failure to hold Mylan into its petitioner's burden, I think it's telling that the board's final written decision found a gen pertinent based on a theory that doesn't have any basis in Mylan's papers, either the petition or the reply.

[00:05:12] Speaker 00:
And so if we turn together to the petition, this is at page 111 of the appendix.

[00:05:20] Speaker 00:
What we don't see in the petition is a formal analogous art analysis.

[00:05:24] Speaker 00:
We don't see the petition quote this court's standard for reasonable pertinence.

[00:05:28] Speaker 00:
We don't see the petition identify the problem solved by the 614 patent, a particular problem.

[00:05:33] Speaker 00:
We don't see a comparison of that problem to Degen's problem.

[00:05:37] Speaker 00:
We see instead, and what the board cited to you is here on appendix 111.

[00:05:41] Speaker 00:
And my lens says,

[00:05:42] Speaker 00:
Professor Erdman explains how de Gen, while concerned with the clutch bearing, addresses a problem analogous to that addressed in Buran.

[00:05:51] Speaker 00:
But Buran is, of course, not the 614 pat.

[00:05:54] Speaker 00:
It's another art reference that's offered in combination with de Gen.

[00:05:59] Speaker 00:
And so here, we have a petition that's deficient on its face as a matter of law.

[00:06:02] Speaker 00:
It's applying the wrong test for analogous art.

[00:06:05] Speaker 00:
It's out of step with this court's precedent.

[00:06:08] Speaker 00:
And if we turn to the reply,

[00:06:10] Speaker 00:
Now skipping ahead here in the appendix to 3154.

[00:06:12] Speaker 00:
In the reply, things actually get worse for Mylan.

[00:06:18] Speaker 00:
Because there, Mylan reiterates and in fact doubles down on its improper focus on Burin.

[00:06:25] Speaker 00:
Of course, in Mylan's view, the problem Burin defined is what set the benchmark for pertinence.

[00:06:31] Speaker 00:
And Mylan says 3154 bridging to 3155.

[00:06:35] Speaker 00:
Burin's suggestion provides the pertinent problem in this case.

[00:06:39] Speaker 03:
Didn't your expert, though, understand that the appropriate framing was with respect to the 614 patent?

[00:06:45] Speaker 03:
Are you asking us to elevate form over substance here?

[00:06:48] Speaker 00:
Thank you for the question, Your Honor.

[00:06:49] Speaker 00:
Our expert was asked to evaluate the axial fixation problem that Mylan put forward, and to evaluate whether or not that could be the 614 patent's problem.

[00:07:00] Speaker 00:
And so he did that analysis and came to the conclusion that it could not be the 614 patent's problem.

[00:07:04] Speaker 00:
Axial fixation is not referenced in the 614 patent as being its problem.

[00:07:08] Speaker 00:
In fact, it's overly broad as Mr. Rowe set forth in his declaration.

[00:07:12] Speaker 00:
Mr. Rowe is not a legal expert, and so he wasn't evaluating whether Miland was applying the correct test for analogosar.

[00:07:19] Speaker 00:
What he was evaluating is axial fixation, a problem statement that's particular to the 614 patent.

[00:07:25] Speaker 00:
He came to the conclusion that it was not.

[00:07:31] Speaker 00:
So turning back here to the reply, again, I'm at 3154, now I'm reading from footnote four, the bottom of the page here, and it says, this is Mylan responding to Sanofi's patent on a response where we, of course, quoted the court's cases, quoted the court's precedent, and did a full analysis under the reasonable pertinence criterion.

[00:07:50] Speaker 00:
And Mylan in response says, Sanofi's interpretation of analogous art law would force the very hindsight that Sanofi bemoans, because the posa could only consider the inventor's disclosed problem.

[00:08:02] Speaker 00:
But of course, that's the test for analogous art.

[00:08:05] Speaker 00:
And we see here very clearly Mylan telling us in his reply that it's not going to apply that test.

[00:08:10] Speaker 00:
It's going to look to Byrne's problem instead.

[00:08:13] Speaker 03:
Can you address footnote four of the board's decision, just that sort of explanation that was provided there?

[00:08:20] Speaker 00:
Absolutely, Your Honor.

[00:08:22] Speaker 00:
And I was headed there.

[00:08:23] Speaker 00:
I was headed there next.

[00:08:25] Speaker 00:
So this is appendix 22, footnote four, the bottom of the page.

[00:08:30] Speaker 00:
So this is the board making its logical leap from the 614 patent's particular problem, which the board agreed that Sanofi had provided the particular problem of the 614 patent, securing a cartridge against movement in a housing.

[00:08:42] Speaker 00:
And this is the board making a leap to get to Mylan's broader Buran-based problem.

[00:08:47] Speaker 00:
And in the board's view, it was justified in making that leap because the Buran problem is, quote, also relevant to the 614 patent's problem.

[00:08:57] Speaker 00:
But, of course, also relevant isn't the standard either.

[00:08:59] Speaker 00:
The standard is to find a particular problem, not a problem that's merely relevant.

[00:09:04] Speaker 00:
We're looking for the particular problem.

[00:09:05] Speaker 00:
So there's certainly a misapplication of the law here by the board, but also, and maybe not more fundamentally, but equally important, we have the board diverging from what's in the petition and what's in the reply.

[00:09:18] Speaker 00:
So Mylan told us it was not looking for any sort of relationship between the 614 patent and

[00:09:23] Speaker 03:
When they refer to the word relevant, though, aren't they using just to send them to pertinent there?

[00:09:28] Speaker 00:
Yeah, I think that's a really good question, Your Honor.

[00:09:29] Speaker 00:
I'm glad you asked it.

[00:09:31] Speaker 00:
So pertinence is you find the particular problem, and then you determine relevance or pertinence to the prior referencing question.

[00:09:39] Speaker 00:
That would be de jen.

[00:09:42] Speaker 00:
So what the board is doing here is they're saying that Byrne's problem, so not de jen, but Byrne's problem is relevant to the 614 patent.

[00:09:48] Speaker 00:
And therefore, they can substitute Byrne's problem

[00:09:52] Speaker 00:
as a 614 patent's problem for the test, right?

[00:09:54] Speaker 00:
But of course, that's not the test.

[00:09:55] Speaker 00:
These are two different documents.

[00:09:56] Speaker 02:
If there's evidence that Burns identifies a problem in the patent, and Burns and de Genis address the same problem, then why is it unreasonable to say de Genis identifies with a problem in the patent as well?

[00:10:16] Speaker 00:
Sure, I think the main issue there is that BURN is not the 614 patent, right?

[00:10:21] Speaker 00:
And so, and even I'll take a step back here.

[00:10:24] Speaker 00:
We're not convinced that BURN's problem is axial fixation either.

[00:10:27] Speaker 00:
Axial fixation is, well, it's almost hardly a problem.

[00:10:30] Speaker 00:
It's more of an abstract idea or a notion.

[00:10:33] Speaker 00:
And it's taken from paragraphs three and paragraph seven of BURN.

[00:10:36] Speaker 00:
Those are out of context statements.

[00:10:38] Speaker 00:
It's not BURN articulating this problem, right?

[00:10:41] Speaker 00:
Paragraph three is BURN talking generally about springs and medical devices.

[00:10:44] Speaker 00:
And paragraph seven is BURN

[00:10:46] Speaker 00:
really sort of articulating claim language in the summary.

[00:10:50] Speaker 00:
Byrne really talked about his problem in paragraph five of that reference.

[00:10:54] Speaker 00:
But I think he had said in that part of the slide, the problem needs to be based in the challenge to patent net issue.

[00:10:59] Speaker 00:
And just because Byrne is the primary reference in a combination that's asserted against the 614 patent doesn't mean that Byrne's problem is the 614 patent's problem.

[00:11:08] Speaker 02:
Just looking at that footnote, it just seems to me that the board

[00:11:12] Speaker 02:
This is the defined problem is also relevant to the 614 patent.

[00:11:17] Speaker 02:
And it's the defined problem here is the problem in, in Burke.

[00:11:23] Speaker 02:
So, um, isn't that a finding that relates back to the 614 patent?

[00:11:32] Speaker 00:
Well, we would certainly disagree that this is a finding relating back to the 614.

[00:11:37] Speaker 00:
What the board has done here is the board has identified the particular problem back on Appendix 20 and Appendix 21.

[00:11:45] Speaker 00:
This is what the board does, a full analysis of the 614 patent.

[00:11:48] Speaker 00:
It reaches a conclusion.

[00:11:50] Speaker 00:
The board says, makes a factual finding here.

[00:11:51] Speaker 00:
It says, we agree with patent owner's assertion.

[00:11:54] Speaker 00:
And they're talking about securing a cartridge against movement within a housing.

[00:11:58] Speaker 00:
And it's only then that the board makes its logical leap, not based on what's in the 614 patent, but merely to get to a broader version of the problem statement.

[00:12:06] Speaker 00:
The board has left the realm of the 614 patent, where it was left with the impression that securing a cartridge against movement was a particular problem.

[00:12:14] Speaker 00:
And it's now trying to get to a broader problem so that it can sweep in Degen's prior art.

[00:12:18] Speaker 02:
Okay, so let's say that the board erred with the reasonably pertinent particular problem analysis.

[00:12:27] Speaker 02:
Isn't that cured with the same field of endeavor analysis?

[00:12:31] Speaker 00:
Well, that's a great question, Your Honor.

[00:12:33] Speaker 00:
I'm glad you asked that one.

[00:12:34] Speaker 00:
Certainly not in this case, in this particular case.

[00:12:36] Speaker 00:
There are two criteria as you're hitting on.

[00:12:40] Speaker 00:
And here the parties agree.

[00:12:42] Speaker 00:
Everybody agreed that DeGene was far afield in a totally different field of endeavor than the 6.4 patent.

[00:12:49] Speaker 00:
And I am sure that the board notes that here, and I'm going to find it for you.

[00:12:59] Speaker 00:
This is on Appendix 19.

[00:13:01] Speaker 00:
Bottom of the page, full paragraph there, second sentence.

[00:13:05] Speaker 00:
Petitioner concedes that Degen is not in the same field of endeavor as the 614 patent.

[00:13:09] Speaker 00:
Okay.

[00:13:09] Speaker 00:
Right.

[00:13:10] Speaker 00:
So if the court were to find that something went wrong here with the analogous heart test and the reasonable pertinence criterion, then certainly the inquiry would be concluded in Sanofi's favor.

[00:13:20] Speaker 02:
Okay.

[00:13:21] Speaker 02:
Counselor, you're into your rebuttal time.

[00:13:23] Speaker 02:
Do you want to reserve it?

[00:13:24] Speaker 00:
I will reserve it.

[00:13:24] Speaker 00:
Thank you very much, Your Honor.

[00:13:25] Speaker 02:
Thank you.

[00:13:28] Speaker 02:
Let's hear from Mr. Karsten.

[00:13:55] Speaker 01:
Good morning, and may it please the court.

[00:13:58] Speaker 01:
My name is Doug Karsten.

[00:14:00] Speaker 01:
What we have below here is a straightforward application of a textbook KSR case.

[00:14:08] Speaker 01:
We have familiar elements arranged by known methods yielding predictable results.

[00:14:15] Speaker 01:
And the art itself provided a direct suggestion on how to solve the problem that the 614 patent inventors had, i.e.

[00:14:26] Speaker 01:
using a spring washer in order to bias two components against each other.

[00:14:33] Speaker 02:
Which reference are you talking about?

[00:14:36] Speaker 02:
Which prior art reference?

[00:14:37] Speaker 01:
I'm referring to the Buran reference specifically, which was our fundamental reference below.

[00:14:44] Speaker 01:
Um, Sanofi has, uh, has tried to establish or argue for essentially two errors.

[00:14:50] Speaker 01:
One, they're saying that the board created a new theory, uh, by marrying or, um, by, by saying that, um, the 614 problem, uh, was not contained within Mylan's analysis.

[00:15:04] Speaker 01:
And that's absolutely wrong.

[00:15:06] Speaker 01:
I mean, if you look at page 8, PPX 89, the very first page of the very first submission made by Mylan,

[00:15:14] Speaker 01:
and there is an analysis of the six one four patent and talking about the claimed invention of the six one four patent and how the problem was biasing one component against another which is the same problem that we've alleged all along but for for analogous art purposes was the uh... the burn reference compared to the the problem stated in in the

[00:15:41] Speaker 01:
yes your honor fact is a specific factual finding at eight p p x twenty uh... one three twenty two in which of which uh... the panel which of course just looked at in fact in which the panel below the board below found that the problems were the same uh... there was that direct comparison in fact as you go through the position

[00:16:03] Speaker 01:
The footnote four, which is APPX 22, the defined problem is also relevant to the 614 patent, especially given that the 614 patent acknowledges that burn spring performs the same function.

[00:16:19] Speaker 03:
Where did you and the record tie the problem of the 614 patent to the problem discussed in burn?

[00:16:25] Speaker 01:
So if you look at the first page of our petition, APPX 89, you go through and we're talking about the claimed invention.

[00:16:34] Speaker 01:
I'd be happy to direct you there.

[00:16:37] Speaker 01:
In the second paragraph towards the end, to ensure the cartridge does not move within the cartridge retaining member, the device incorporates a spring element, a spring washer, to apply an axially directed biasing force that presses and holds the cartridge against the cartridge retaining member.

[00:16:56] Speaker 01:
To ensure the necessary biasing force, the spring washer includes at least two fixing elements to hold the washer in place.

[00:17:02] Speaker 01:
And it goes on to say, as this petition demonstrates, the notion that a spring element, like a spring washer, may be used to secure components against movement within a device was nothing new.

[00:17:14] Speaker 01:
And that's the Buran reference that we start to talk about there.

[00:17:17] Speaker 01:
We identify the problem based upon the claimed element, which is what the law requires.

[00:17:22] Speaker 01:
And then we compare, in the context of the art,

[00:17:27] Speaker 01:
the particular against the claimed invention problem.

[00:17:30] Speaker 01:
That's exactly what the Scourge case law directs us to do and is exactly what the board considered below.

[00:17:39] Speaker 01:
So there was no issue here in terms of the board creating a new theory.

[00:17:47] Speaker 01:
The theory was there from the very first page of the very first submission.

[00:17:53] Speaker 01:
And as we walk through in the petition,

[00:17:55] Speaker 01:
each of the particular claim limitations, we then do the assessment of the particular claim limitation from the 614 patent against the particular prior art.

[00:18:08] Speaker 01:
And so that's the comparison.

[00:18:10] Speaker 01:
That's done here, Your Honor.

[00:18:12] Speaker 03:
Did you just discuss the problem in both patents?

[00:18:15] Speaker 03:
Did you specifically tie the 614 patent to the problem in Bury?

[00:18:20] Speaker 01:
Well, if you look at, for example, the section, well,

[00:18:26] Speaker 01:
First, at APPX99, the level of ordinary skill in the art, which the board below adopts, specifically ties into this very issue.

[00:18:42] Speaker 01:
So, for example, if you look at APPX99,

[00:18:46] Speaker 01:
uh... down below we're talking about the level of ordinary skill in the art we talked about how the person would have considered devices in other fields that exploited the biasing force of springs we work with even the level of ordinary skill in the art and it's undisputed here that the reason that the reasonable pertinence test is done through that filter requires the person of skill here to understand and acknowledge

[00:19:14] Speaker 01:
the exploitation, the types of things that use this biasing force.

[00:19:21] Speaker 01:
And then as we go further through the analysis, Your Honor, with respect to the particular claim limitations, that for example, I'm flipping speedily through, Your Honor.

[00:19:34] Speaker 02:
Are you going to the petition now?

[00:19:36] Speaker 01:
We are in the petition, Your Honor, yes.

[00:19:38] Speaker 01:
At APPX, apologies.

[00:19:43] Speaker 01:
Thank you.

[00:19:45] Speaker 01:
The paragraph below is shown in the annotated views of Figures 1 and below.

[00:20:00] Speaker 01:
Byrne teaches injection pens also having four similar components that perform the same function as those claimed in harms.

[00:20:09] Speaker 01:
We're talking directly about the function, about the problem that's being solved here.

[00:20:15] Speaker 02:
We're in the petition to identify the problem in Degenz as being reasonably pertinent to the problem in the 614 pen.

[00:20:25] Speaker 01:
Well, remember, your honor, Byrne

[00:20:30] Speaker 01:
this case presents a very interesting fact that I don't know that any of the other cases do.

[00:20:35] Speaker 02:
I see the references you're making to Byrne.

[00:20:38] Speaker 02:
I'm asking about De Gens.

[00:20:40] Speaker 02:
Did you make that argument with respect to that reference?

[00:20:44] Speaker 01:
Well, the panel below made specific factual findings based upon the petition and Professor Erdmann's declaration at APPX 3132 that De Gens teaches

[00:20:59] Speaker 01:
It has the cover, it's what it's called in Degeneres.

[00:21:03] Speaker 01:
It has a cover that meets the spring washer limitation, that the cover has legs.

[00:21:09] Speaker 01:
This is APPX 3233.

[00:21:10] Speaker 01:
That it has the claimed fixing elements.

[00:21:14] Speaker 01:
This is APPX 37 to 38.

[00:21:18] Speaker 01:
And all of those specific factual findings that were supported by substantial evidence are undisputed.

[00:21:29] Speaker 01:
The Sanofi didn't challenge any one of those.

[00:21:33] Speaker 02:
Give me that side again, Warren.

[00:21:34] Speaker 02:
Sure.

[00:21:34] Speaker 02:
I see.

[00:21:35] Speaker 02:
Is it Dejene?

[00:21:36] Speaker 02:
Is that how you pronounce that?

[00:21:38] Speaker 01:
I'm not exactly sure how to pronounce it, Your Honor.

[00:21:40] Speaker 01:
I'm doing my best.

[00:21:43] Speaker 01:
I'm looking at APPX 32 and 33, Your Honor.

[00:21:46] Speaker 01:
And this is where the board below is assessing Dejene, or Dejenes, or however Your Honor wishes to pronounce it.

[00:21:54] Speaker 01:
I'm happy to give you any pronunciation you'd like.

[00:21:58] Speaker 01:
And there, there are specific factual findings that Degeneres has a cover that meets the claim spring washer limitation.

[00:22:11] Speaker 01:
There is specific finding that the cover also includes legs, 34, by which the cover is attached to the bearing.

[00:22:19] Speaker 01:
This is bridging on the bottom of 32 onto the top of 33.

[00:22:26] Speaker 01:
This is Degenay.

[00:22:28] Speaker 01:
This is assessing it against the claims and the claim limitations, the problem of the 614 patent, through the filter of Bern.

[00:22:39] Speaker 02:
But there was a suggestion by my friend earlier that the- Looking at page 32 in the paragraph, it says, finally, the patent owner argues that the only basis for petitioners' reliance on Degenay's is hindsight.

[00:22:53] Speaker 02:
And it goes on and addresses the clutch bearing cover indigenase.

[00:22:59] Speaker 02:
This says, petitioner counters a burin plainly teaches at the spring.

[00:23:03] Speaker 02:
But I don't see there where it says that indigenase plainly teaches the spring biases.

[00:23:09] Speaker 01:
Well, it says in a similar manner.

[00:23:12] Speaker 01:
So in that bottom paragraph, indigenase cover 28 includes support zones that are formed by the median portion of the axillary resilient deformable undulation.

[00:23:22] Speaker 01:
Due to the undulations with which it is formed, the transverse wall of the cover elastically presses the outer race.

[00:23:30] Speaker 01:
This is the biasing force.

[00:23:32] Speaker 01:
This is what is giving the biasing force with respect to the Degeneres cover.

[00:23:41] Speaker 03:
Is it proper for the board to make the comparison if your petition did not actually tie Degeneres, Degeneres, however you say it, to the 614 patent?

[00:23:52] Speaker 01:
No, we do tie DeGeneres specifically to the 614 patent in assessing each one of the claim limitations in the petition.

[00:24:01] Speaker 01:
That's what Professor Erdman did as well in his declaration.

[00:24:04] Speaker 03:
Give me your best record site for that, for what you just described.

[00:24:09] Speaker 01:
Sure, Your Honor.

[00:24:14] Speaker 01:
So if you look at APPX 112,

[00:24:27] Speaker 01:
This is talking specifically in this one, where I just was, about burn performing the same function.

[00:24:34] Speaker 01:
If you look at 127 to 128.

[00:24:36] Speaker 01:
On 112, that was talking about the same function.

[00:24:46] Speaker 01:
So if you look, as shown in the annotated views, it's the one that I just read to you.

[00:24:54] Speaker 01:
Burn teaches injection pens having four similar components that perform the same function.

[00:24:59] Speaker 01:
And then it goes on to identify the particular limitations.

[00:25:04] Speaker 01:
If you turn then to APPX 127 to 128,

[00:25:25] Speaker 01:
And on, actually I'm sorry, APPX 130.

[00:25:29] Speaker 01:
In addition, DeGeneres illustrates the common predictable use of a spring washer to solve a similar problem, biasing components for axial fixation.

[00:25:38] Speaker 01:
I apologize, it took me a while to get there, but I'm glad I did.

[00:25:41] Speaker 01:
Here, we are specifically talking about Desjardins in connection with the use of the spring washer, addressing exactly the problem that we're talking about.

[00:25:54] Speaker 01:
And there was a suggestion earlier that there was an error in terms of defining the problem.

[00:25:59] Speaker 01:
That definition of the problem was based upon substantial evidence.

[00:26:03] Speaker 01:
It's a factual finding.

[00:26:04] Speaker 02:
Here, the decision speaks to a similar problem.

[00:26:09] Speaker 02:
We take that to be

[00:26:11] Speaker 02:
Irrelevant problem?

[00:26:12] Speaker 01:
Yes, Your Honor.

[00:26:13] Speaker 01:
Yes, Your Honor.

[00:26:14] Speaker 01:
Well, the similar problem is that this is our petition.

[00:26:17] Speaker 01:
This is not the decision below.

[00:26:19] Speaker 01:
But we're talking about the problem of harms, which is the biasing.

[00:26:25] Speaker 01:
And remember, we're in the context of reasonable pertinence.

[00:26:31] Speaker 01:
So we've got the person of skill in the art.

[00:26:34] Speaker 01:
And the person of skill in the art is not a rigid automaton.

[00:26:38] Speaker 01:
This person of skill in the art is one of ordinary creativity.

[00:26:42] Speaker 01:
That's what we know from KSR.

[00:26:44] Speaker 01:
And we know from KSR that this person of skill in the art can be motivated based upon any problem known in the art.

[00:26:52] Speaker 01:
And I take issue with the notion that the reasonable pertinence is different somehow from the motivation.

[00:27:01] Speaker 01:
We really are talking about flip sides of the same coin.

[00:27:05] Speaker 03:
under the concept that we've got at the board here in connecting degenesis to the six one four pan is there anything that yours that there is there anything you would point us to you to kind of cure that yes your honor but it's not so

[00:27:20] Speaker 01:
We know that this is analogous art because Byrne tells us it's analogous art.

[00:27:27] Speaker 01:
So Byrne at paragraph 17 talks specifically about exactly how one can go, the things in the toolkit that a person of skill in the art can go about using and looking for.

[00:27:41] Speaker 01:
in order to solve the problem of biasing one component against the other.

[00:27:47] Speaker 01:
Plate springs, springs with legs.

[00:27:50] Speaker 01:
This is taught directly by the art, directing the person of skill in the art in terms of what things to look for.

[00:27:57] Speaker 01:
This isn't just an automotive clutch.

[00:28:00] Speaker 01:
Frankly, this court's case law allows us to look at automotive fields in order to solve other problems.

[00:28:06] Speaker 02:
The concern I have with your argument is that

[00:28:10] Speaker 02:
You seem to be lifting parts from the final written decision and then labeling them as the argument and relying them on support the argument that you're making right now.

[00:28:27] Speaker 02:
But your burden is to show analogous art by preponderance of evidence, correct?

[00:28:33] Speaker 01:
And we did, below, Your Honor.

[00:28:35] Speaker 02:
Are you saying that the citations you gave us

[00:28:40] Speaker 02:
up to this point, either apart or together, that that rises to a level of preponderance of evidence?

[00:28:49] Speaker 01:
Absolutely, Your Honor.

[00:28:51] Speaker 01:
Absolutely.

[00:28:52] Speaker 01:
The petition was directed at exactly the right test.

[00:28:56] Speaker 01:
It identified the problem from the harm's claims.

[00:29:01] Speaker 01:
Even as early as page one of the first filing below the petition,

[00:29:06] Speaker 01:
And it went through, methodically, those claim limitations against the three references that we identified.

[00:29:14] Speaker 01:
Byrne, Venecia, and Desjardins.

[00:29:17] Speaker 01:
And it identified in Byrne what the problem was.

[00:29:21] Speaker 01:
It identified in 614 what the problem was.

[00:29:23] Speaker 01:
And it compared those two throughout that analysis.

[00:29:26] Speaker 01:
And the board relied upon that analysis.

[00:29:30] Speaker 01:
And upon that substantial evidence crediting Dr. Erdmann or Professor Erdmann, our expert below, and even down to the granular level, the level of ordinary skill in the art, the filter through which we are required to conduct this analysis, your honor, even the person of skill in the art,

[00:29:49] Speaker 01:
has particular sensitivity and knowledge with respect to biasing components together.

[00:29:55] Speaker 01:
All of those are factual findings, which Sanofi has not disputed, Your Honor.

[00:29:58] Speaker 01:
I see I'm past my time, but unless you have questions, Your Honor, I'm happy to.

[00:30:02] Speaker 01:
I could talk about this stuff all day.

[00:30:03] Speaker 02:
If no colleagues have any questions, I think we've got your argument.

[00:30:08] Speaker 01:
Wonderful.

[00:30:08] Speaker 01:
Thank you so much.

[00:30:09] Speaker 01:
And I would like to thank the court for resuming the in-person arguments.

[00:30:12] Speaker 01:
So it is a great pleasure to be here in person.

[00:30:15] Speaker 02:
It is.

[00:30:16] Speaker 02:
From my point of view, it is a pleasure

[00:30:19] Speaker 02:
Thank you.

[00:30:19] Speaker 02:
To put the faces to the argument, let's say.

[00:30:21] Speaker 01:
Exactly.

[00:30:22] Speaker 01:
Thank you, Your Honor.

[00:30:23] Speaker 01:
I appreciate it.

[00:30:24] Speaker 02:
Okay.

[00:30:25] Speaker 02:
Mr. Dodd, we will restore you back to the full three minutes of your rebuttal.

[00:30:30] Speaker 00:
Thank you, Your Honor.

[00:30:42] Speaker 00:
So, Your Honor, I want to clarify that this is not a KSR issue.

[00:30:46] Speaker 00:
This is an analogous art case.

[00:30:47] Speaker 00:
This is not a motivation to combine.

[00:30:49] Speaker 00:
KSR was obviously about motivation to combine, but it didn't change the test for analogous art.

[00:30:54] Speaker 00:
Both before KSR and after KSR, this court has applied the same test for analogous art under reasonable pertinence.

[00:31:01] Speaker 00:
We've looked to the particular problem solved by the claimed invention.

[00:31:04] Speaker 00:
We've compared that problem to the prior art, to Jen here.

[00:31:09] Speaker 00:
a third pronunciation.

[00:31:10] Speaker 02:
You heard these citations that your friend on the other side gave us, right, as supporting preponderance of evidence.

[00:31:19] Speaker 02:
What's your response to that?

[00:31:22] Speaker 02:
To those citations?

[00:31:25] Speaker 00:
Thank you, Your Honor.

[00:31:25] Speaker 00:
Yes, I was going to get there, and I'm glad you fast-forwarded me to it.

[00:31:28] Speaker 00:
So these citations are addressing principally either other grant factors, like the PACIDAS level of skill, or a claim-by-claim element analysis or motivation to combine.

[00:31:39] Speaker 00:
That's not an analogous art analysis.

[00:31:43] Speaker 00:
If you could just map the art to the claims, or just do a motivation test and analysis, then there would be no need for the test for analogous art.

[00:31:52] Speaker 00:
If all we needed to do was map to the claims and provide motivation, the analogous art test would not exist, but of course it does.

[00:31:59] Speaker 00:
We need to have a very particular and specific analysis in the petition.

[00:32:03] Speaker 02:
Is Mylan actually required to say something to the effect

[00:32:07] Speaker 02:
Now we move to the second part of the permanent art analysis and then get into that argument.

[00:32:17] Speaker 02:
It seems like we've been given some citations, but we cobbled them together.

[00:32:23] Speaker 02:
Is it your argument that this had to have been made in a single unified argument with respect to the two-part test for analogous art?

[00:32:32] Speaker 00:
Well, it certainly would have been easier if they did put it under a heading for us.

[00:32:35] Speaker 00:
But I don't want to elevate form over function here or anything like that.

[00:32:41] Speaker 00:
But I will say that the board is not tasked with playing archaeologist with the record, right?

[00:32:45] Speaker 00:
The board didn't go into all of these different places in the petition and pick and choose from them.

[00:32:50] Speaker 00:
The board found the one place in the petition where Milan addressed Degen

[00:32:55] Speaker 00:
and addressed its analogousness.

[00:32:57] Speaker 00:
They used the term in its colloquial sense, not its really legal sense.

[00:33:00] Speaker 00:
But they found the one place, that's appendix 111, and that's what the board relied on.

[00:33:03] Speaker 00:
So I think we ought to look to what the board relied on, right, and look to the petition that the board signed.

[00:33:09] Speaker 03:
How do you respond to opposing counsel's argument that the petition does discuss the problem of the 614?

[00:33:16] Speaker 00:
we would absolutely disagree with that.

[00:33:18] Speaker 00:
We certainly see that there's discussion of the 614 patent in the petition, as you would expect.

[00:33:23] Speaker 00:
And there's discussion of comparing Burren to the 614 patent, as you would expect, the primary reference.

[00:33:28] Speaker 00:
But again, if all you needed to do was compare Burren to the claims and compare Degen to the claims, the analogous heart test would not exist.

[00:33:37] Speaker 00:
I see that I'm just about out of time here.

[00:33:40] Speaker 00:
I just had one more point.

[00:33:41] Speaker 00:
I wanted to get to substantial evidence just very quickly, Your Honors.

[00:33:44] Speaker 00:
On the question of substantial evidence, there is none for the board to have rejected Sanofi's problem statement after making a factual finding agreeing with it.

[00:33:52] Speaker 00:
And there's also no substantial evidence to find

[00:33:54] Speaker 00:
axial fixation as the particular problem solved by the 614 patent.

[00:33:59] Speaker 00:
There's a leap from language in Buran that's not in the 614 patent.

[00:34:03] Speaker 00:
The board made that leap.

[00:34:05] Speaker 00:
MyLand didn't provide any evidence or argument to that effect.

[00:34:08] Speaker 00:
And in fact, there's unrebutted testimony on the record from Mr. Rowe, patent owner's expert, about the 614 patent's problem.

[00:34:15] Speaker 00:
And certainly those portions of the record, again, that analysis is undisputed, and we certainly think that it refutes the board's findings.

[00:34:23] Speaker 02:
Thank you very much.

[00:34:28] Speaker 02:
We thank counsel for the arguments in this case.