[00:00:00] Speaker 02:
That leads us to the second case, 20-2066, Sanofi and Ventis versus Milan Pharmaceuticals, Mr. Banks.

[00:00:13] Speaker 00:
May I proceed, Your Honor?

[00:00:14] Speaker 00:
Good morning, Your Honors.

[00:00:16] Speaker 00:
Adam Banks for the Appellant of Sanofi.

[00:00:18] Speaker 00:
There are three sets of issues in this group of appeals.

[00:00:21] Speaker 00:
I will focus my time today on the written description issue as it relates to the 844

[00:00:27] Speaker 00:
I'll also address the proposed substitute claims to the 486 patent.

[00:00:32] Speaker 00:
And the Steenfilt Jensen issue that we were all just discussing is also present in these appeals.

[00:00:37] Speaker 00:
My colleague, Mr. Ainsley, addressed those already this morning.

[00:00:39] Speaker 00:
Happy to address any additional questions the court has about that.

[00:00:42] Speaker 01:
I've got one.

[00:00:44] Speaker 01:
The relationship between the 844 piece of this IPR and the district court decision, just to understand the relation, if we were to affirm

[00:00:59] Speaker 01:
the district court's determination of lack of written description, does that decide the 844 piece of this IPR?

[00:01:15] Speaker 00:
I think it might.

[00:01:17] Speaker 00:
The issues are different and the records are different.

[00:01:21] Speaker 00:
So it depends on the reason.

[00:01:22] Speaker 01:
I'm sorry.

[00:01:22] Speaker 01:
It would be the same claims with one exception, namely the substitute claim.

[00:01:27] Speaker 01:
But you've argued the substitute claim is identical.

[00:01:30] Speaker 01:
In this one, you make no separate argument for 31 surviving if 21 doesn't.

[00:01:36] Speaker 01:
And the district court decision, if we were to affirm unwritten description, would end up cancellation of 21 through 30.

[00:01:44] Speaker 00:
I think the way I would approach this analysis is that it's particularly as it relates to the amended claim.

[00:01:50] Speaker 00:
Obviously, the district court decision doesn't relate to that at all.

[00:01:52] Speaker 00:
We have argued them together.

[00:01:54] Speaker 00:
But I think the error here with respect to the amended claim is plainer with respect to the 844 decision and the group two appeals that we're talking about here.

[00:02:02] Speaker 00:
I think if you look at the language of the claim and the language of the application, the disclosure, they are identical.

[00:02:09] Speaker 00:
So you've got a disclosure of a threaded piston rod.

[00:02:13] Speaker 00:
and a claim to a threaded piston rod.

[00:02:15] Speaker 00:
And the error that the board made here with respect to finding that it lacked written description support is much clearer to see with the lens of looking at the amended claim, because what the board essentially did was read threaded in the disclosure to mean only externally threaded.

[00:02:30] Speaker 00:
And the reason it did that is because of the way that the figure is depicted in the application.

[00:02:36] Speaker 00:
And there's no unambiguous limitation in the specification or elsewhere that would limit the disclosure just to that embodiment.

[00:02:43] Speaker 00:
And so therefore, the error of doing so is clear on the record here, especially when viewed in the lens of the amended claim.

[00:02:52] Speaker 00:
Now, we have argued that they have the same scope.

[00:02:55] Speaker 02:
Help me here.

[00:02:56] Speaker 02:
As I understand it, if we were to agree with the district court's description decision, that would knock out

[00:03:05] Speaker 02:
all of the existing claims.

[00:03:07] Speaker 02:
There's an overlap between the ones in the IPR and the district court.

[00:03:12] Speaker 02:
Is that correct?

[00:03:13] Speaker 02:
That would necessarily have that result, right?

[00:03:16] Speaker 00:
That's correct, but the amended claim obviously was not asserted.

[00:03:18] Speaker 02:
Why is the amended claim, which is not involved in the district court case, patently distinct?

[00:03:25] Speaker 02:
Why is it different in terms of written description?

[00:03:28] Speaker 00:
It's different for the reason that I was just mentioning.

[00:03:31] Speaker 00:
But the claim language is identical to the description in the patent, right?

[00:03:38] Speaker 00:
So the burden that Miling would have to show to demonstrate a lack of written description support is that much greater with respect to the amended claim given the identity of a language between the description and what is claimed.

[00:03:52] Speaker 00:
So may I start going into the argument about the written description?

[00:03:58] Speaker 00:
But focusing on the board's decision here, again, the application discloses a threaded engagement between a piston rod and a driver.

[00:04:08] Speaker 02:
What is the language of the substitute claim?

[00:04:11] Speaker 00:
The substitute claim is a piston rod comprising a thread.

[00:04:15] Speaker 02:
Where do we find that?

[00:04:18] Speaker 00:
That is, bear with me, Your Honor.

[00:04:21] Speaker 00:
If you look at...

[00:04:29] Speaker 01:
210, I think it's set out.

[00:04:32] Speaker 00:
I'm sorry?

[00:04:33] Speaker 01:
It's at appendix 210.

[00:04:34] Speaker 00:
210, that's right.

[00:04:41] Speaker 00:
Well, 218 as well.

[00:04:44] Speaker 00:
Which page?

[00:04:45] Speaker 00:
218, I see it.

[00:04:47] Speaker 00:
218.

[00:04:47] Speaker 00:
Yeah.

[00:04:49] Speaker 00:
It's a driving member comprising a third thread and a piston rod comprising a fourth thread.

[00:04:55] Speaker 01:
The full claim is at 210.

[00:04:58] Speaker 01:
It shows old claim 21.

[00:05:00] Speaker 01:
And the only thing 31 does is remove six words, either an internal or an external, and then substitute the word A for a fourth thread.

[00:05:11] Speaker 00:
That's correct, Your Honor.

[00:05:12] Speaker 00:
OK.

[00:05:12] Speaker 00:
And I think one way to think about this is a thought experiment that's a real experiment in terms of what the language of the claim says.

[00:05:20] Speaker 02:
And the language of the claim says...

[00:05:25] Speaker 02:
include both an internal and external thread?

[00:05:29] Speaker 00:
The scope of it does include both an internal and external thread.

[00:05:32] Speaker 00:
That's right, Your Honor.

[00:05:34] Speaker 00:
But I think it illustrates, looking at it this way.

[00:05:37] Speaker 01:
So what you did is you took a claim that referred expressly to both and just generalized it so that it covers both but no longer expressly enumerates the two options.

[00:05:49] Speaker 00:
That's correct, but I think looking at this again helps crystallize the error that the board made here.

[00:05:54] Speaker 00:
There are only two ways to configure a threaded connection between a driver and a piston rod.

[00:06:00] Speaker 00:
Either the driver has external threads that engage internal threads on the piston rod or vice versa.

[00:06:05] Speaker 00:
They are interchangeable.

[00:06:06] Speaker 00:
They are necessarily complements of each other.

[00:06:09] Speaker 00:
One requires the other one.

[00:06:12] Speaker 00:
You have to have internal

[00:06:13] Speaker 00:
Threads on one component engage with external threads on another component.

[00:06:17] Speaker 00:
And both of these ways were known in the art.

[00:06:19] Speaker 00:
There's prior art of medical injection devices comprising internally threaded piston rods.

[00:06:26] Speaker 00:
that was before the board.

[00:06:28] Speaker 00:
And so putting these pieces together, the question really is, was there anything in the specification or the application that would limit the broad disclosure of the threaded engagement to only one of the two ways?

[00:06:40] Speaker 00:
And there's nothing in the specification that does that.

[00:06:43] Speaker 00:
There's nothing that limits unambiguously the broad disclosure to only the illustrated embodiment.

[00:06:50] Speaker 00:
And that's the core error that the board went down.

[00:06:52] Speaker 02:
I don't understand why that's an error.

[00:06:54] Speaker 02:
I mean, if it covers both,

[00:06:56] Speaker 02:
both have to have written description support.

[00:07:00] Speaker 00:
Correct, and I think that's correct, but the description of threaded necessarily includes both.

[00:07:04] Speaker 00:
As I was mentioning, the nature of a threaded connection, you can see this based on the party's own definition of thread, is that one set of components engages with another set of components, and it doesn't matter which has internal threads and which has external threads, they both operate in the same way.

[00:07:22] Speaker 00:
And that was the teaching that was known in the arts at the time

[00:07:25] Speaker 00:
uh, of the invention.

[00:07:27] Speaker 00:
And I think beyond this, uh, okay.

[00:07:29] Speaker 01:
Can I ask you in the, I think it's in the district court case or maybe it's here, the, your expert, um, testified and said, Oh, let me show you how to do this.

[00:07:40] Speaker 01:
And, uh, roughly speaking, I think it got very complicated.

[00:07:45] Speaker 01:
Is that only in the district court case, or does that evidence appear in this IPR also?

[00:07:55] Speaker 00:
They overlap to a certain extent, Your Honor, because it began with a picture that our expert drew on the spot at his deposition in this IPR.

[00:08:04] Speaker 01:
Oh, in here.

[00:08:05] Speaker 00:
I see.

[00:08:05] Speaker 00:
Relating to how the devices

[00:08:08] Speaker 00:
how the device would be configured with an internally threaded piston rod.

[00:08:11] Speaker 01:
But I think that... But why does that not offer meaningful evidentiary support for what after all is a factual finding about, because we said written description is a factual finding, for the idea that if the question is does the written description support describe the entire device with the internals,

[00:08:38] Speaker 01:
That evidence suggests actually it really doesn't, because if you change the external to the, to the internal, you got to do a bunch of other things, rearrange other components, maybe add this stinger piece.

[00:08:49] Speaker 01:
Um, isn't that substantial evidence support for the idea that the fact that they are kind of mirror images in some way or other, just focusing on the thread groove piece does not mean you've described.

[00:09:04] Speaker 01:
devices with the alternative.

[00:09:07] Speaker 00:
Sure.

[00:09:08] Speaker 00:
I think there's two responses to that.

[00:09:09] Speaker 00:
I think the underlying sort of legal point that we would say is that the ultimate question is, given the broad nature of the affirmative disclosure of a threaded pissing rod, the question really is does the description preclude both types

[00:09:22] Speaker 00:
of questions and I think that was the reason why this whole line of inquiry went down.

[00:09:29] Speaker 01:
Why is that the right question?

[00:09:30] Speaker 00:
Because I think if you look at the word threaded and the definition of threaded that the parties had offered and the fact that there are only two ways to engage such a connection and that you have to imagine both necessarily.

[00:09:41] Speaker 00:
You have to necessarily imagine one threaded connection, one threaded element connecting to another one and without regard to which one has

[00:09:49] Speaker 00:
the threads, the pertinent question, and the reason that this became an issue.

[00:09:53] Speaker 01:
And when you say you just read the word threaded, you mean in the claim, or do you mean in an early sentence in the first page of the Great Britain application, presumably in the spec here, too, that also doesn't put the qualifiers in?

[00:10:08] Speaker 01:
Which one are you saying matters?

[00:10:11] Speaker 00:
I'm referring to the description in the application.

[00:10:13] Speaker 00:
And the reason this became an issue and the reason why

[00:10:16] Speaker 00:
the testimony that you're referring to with respect to the district court record was an issue, was that the reason Mylan argued that it could only work one way is because it would buckle.

[00:10:26] Speaker 00:
It wouldn't work if it was done a different way.

[00:10:28] Speaker 00:
And the whole point of what Dr. Slocum did was to rebut the unsubstantiated view

[00:10:33] Speaker 00:
that it wouldn't work the way that he described.

[00:10:37] Speaker 00:
And so the credibility finding, and the discourse finding in this respect, in the boards as well, was backwards in the sense that

[00:10:47] Speaker 00:
where we had evidence on the one hand without support or whatsoever that the device would not work as configured as Dr. Slocum drew it.

[00:10:55] Speaker 00:
And then Dr. Slocum's affirmative testimony that it would, which a district court specifically credited, demonstrating that it would work, I think the credibility read that they came to is the opposite that one would come to, which is you've got no testimony whatsoever

[00:11:10] Speaker 00:
that no evidence whatsoever that it wouldn't work, and only the evidence that it would, that was credited.

[00:11:16] Speaker 00:
And so that underscores the point, to bring it back to the beginning, which is given the breadth of the disclosure, that is the threaded connection and the fact that we've shown that it works to go with it.

[00:11:27] Speaker 01:
I just want to be absolutely clear.

[00:11:28] Speaker 01:
So tell me if I'm wrong about this.

[00:11:30] Speaker 01:
My understanding or recollection of this fact is there's that one statement early on that refers to the threading without saying internal or external.

[00:11:41] Speaker 01:
Otherwise, there is nothing in the spec that is similarly generic.

[00:11:45] Speaker 01:
So you're hanging your hat on that one kind of introductory statement as being generic and therefore having to be limited by something.

[00:11:55] Speaker 01:
Right.

[00:11:58] Speaker 00:
It is in the introduction.

[00:11:59] Speaker 00:
It's on the first two pages of the application inside appendix 39, 34, and 39, 35.

[00:12:06] Speaker 00:
But it's the core description in the summary of the invention of the drive engagement, which is the part that describes the threaded engagement between the piston rod and the driver.

[00:12:18] Speaker 00:
And so that's where one would look for it.

[00:12:19] Speaker 01:
But then you would acknowledge that everything else in the spec is limited to the internal or external.

[00:12:30] Speaker 00:
The picture demonstrates or describes

[00:12:33] Speaker 00:
draws an externally threaded rod.

[00:12:35] Speaker 00:
But nowhere else in the spec does it describe the threading one way or the other.

[00:12:38] Speaker 00:
So the point of why this is important is that you've got a general description here of the way the threaded engagement works that doesn't specify or limit it to only one of the two.

[00:12:49] Speaker 01:
Could we make anything of the fact that what the engagement is with is a sleeve?

[00:12:57] Speaker 00:
I think that it's obviously part of what the claim talks about.

[00:13:01] Speaker 01:
Doesn't that rather suggest that the threads are on the outside of the piston rod that's inside the sleeve?

[00:13:08] Speaker 01:
You don't talk about a sleeve as inserted into the thing that it is a sleeve around.

[00:13:18] Speaker 00:
I think it can work that way, which is why it's illustrated that way.

[00:13:22] Speaker 00:
But it can also work the other way, which is the way that Dr. Slocum described it.

[00:13:26] Speaker 00:
And if you look at his picture, what's that?

[00:13:29] Speaker 01:
That wouldn't be much of a sleeve.

[00:13:31] Speaker 00:
Well, I think it's useful to actually look at the drawing that he drew, because you can see that the sleeve has a component, the stinger part that he called it, that is in the very center of the pen, but is connected to the rest of the sleeve, which surrounds the piston rod.

[00:13:44] Speaker 00:
So it's still a sleeve.

[00:13:45] Speaker 00:
It only has a driver.

[00:13:46] Speaker 00:
It only has the stinger, as he called it, in the middle.

[00:13:50] Speaker 00:
And you can think about a thing like a deodorant dispenser, which has a spindle in the middle, but connected to the broader container, which you might imagine as a sleeve.

[00:14:01] Speaker 00:
And the point that Dr. Svokum made is that you can take the sleeve and just simply add the stinger in the middle, and you've got the device that's described in the specification.

[00:14:14] Speaker 00:
And importantly, he demonstrated that it would work.

[00:14:16] Speaker 00:
And that's important because, again, the main claim that Mylan made was the only way you can envision and construct a device in the spec is with the externally threaded piston rod.

[00:14:29] Speaker 00:
And he just proved that.

[00:14:31] Speaker 00:
And that's important in considering, again, the way the court and the board here came to understand

[00:14:41] Speaker 00:
the uh... uh... understand yet uh... you're almost out of time give you a minute to talk about the uh... forty-six sure so that the forty-six uh... the board here in and denying the contingent motions to the men with respect to the forty-six patent i think that

[00:15:00] Speaker 00:
A common theme across each of these errors is that the board did not attend to the specific claim language or the specific disclosures in the prior art.

[00:15:09] Speaker 00:
Emblematic of this, I think, is claim 58, which relates to an arc-shaped body that's configured to track each dose of medicament delivered.

[00:15:19] Speaker 00:
There are no prior art examples of a device having only one arc-shaped body.

[00:15:24] Speaker 00:
To the extent there are things like half-nuts and so forth in the art,

[00:15:28] Speaker 00:
two halves joined together to function together as a whole.

[00:15:31] Speaker 02:
With respect to these structural limitations, is it not the case that you didn't make this argument before the board?

[00:15:38] Speaker 00:
I do believe we made these arguments before the board, Your Honor.

[00:15:43] Speaker 02:
Can you show me where?

[00:15:44] Speaker 00:
In my rebuttal time I can certainly find

[00:15:48] Speaker 00:
But I don't think that was an argument that was raised in the red brief.

[00:15:53] Speaker 02:
I mean, they said in the petition that these other limitations were satisfied.

[00:15:57] Speaker 02:
The board, according to you, didn't address them, other than to summarize the record evidence, the arguments that they presented.

[00:16:07] Speaker 02:
But if you didn't argue that those limitations were not satisfied, I'm not sure why the board has to address it.

[00:16:16] Speaker 00:
I think the board did address these limitations, Your Honor.

[00:16:19] Speaker 00:
So the board did address them, and we think that got them quite wrong.

[00:16:23] Speaker 00:
I mean, if you would look at the appendix, I want to say 90.

[00:16:48] Speaker 00:
The part I'm talking about, actually 65 to 67 is the piece I'm discussing right now.

[00:16:54] Speaker 00:
The board has an extensive discussion about the one arch shaped body limitation.

[00:17:01] Speaker 00:
And the board's conclusion is that there was sufficient art in the record to show that they were things like half nuts and split nuts and so forth in the art.

[00:17:12] Speaker 00:
But the error the board made was that

[00:17:15] Speaker 00:
All of these are examples of half-nuts joined together to function as a full nut, and the claim is to just one.

[00:17:22] Speaker 00:
And that appears nowhere in the art.

[00:17:25] Speaker 00:
And what the board did was fill that gap in the art with no analysis whatsoever, just saying that because these were known, it would work.

[00:17:37] Speaker 00:
It would ease assembly.

[00:17:40] Speaker 00:
That's not a teaching that was in the prior anywhere.

[00:17:42] Speaker 00:
In fact, the teaching that using a half nut to aid assembly is something that's found in the 486 patent itself.

[00:17:48] Speaker 00:
So that's certainly in proper hindsight to have relied on that.

[00:17:52] Speaker 01:
What do you do with the board's finding that using the half nut would in fact have the advantage, a recognized advantage of aiding in the assembling of the thing?

[00:18:03] Speaker 00:
So my answer there is that teaching, that suggestion that it would aid assembly is something that's found in the 486 patent itself.

[00:18:11] Speaker 00:
It's not something that was in the prior art.

[00:18:13] Speaker 00:
I think the board relies solely on the molar reference to provide that gap.

[00:18:20] Speaker 00:
But molar doesn't talk about half-nuts whatsoever.

[00:18:22] Speaker 00:
It talks about other types of components joined together again to function as a full component.

[00:18:28] Speaker 00:
And here, the point is that this is one arc-shaped body to function.

[00:18:32] Speaker 00:
as a half-serval itself.

[00:18:35] Speaker 00:
And that's new, and that wasn't in the prior art.

[00:18:38] Speaker 00:
I see I'm well into my rebuttal time.

[00:18:41] Speaker 00:
Unless the court has further questions, I'm happy to rest in the brief.

[00:18:45] Speaker 02:
What I'm looking for in your rebuttal is whether you argued that the prior art was missing the flexible clicker arms

[00:18:57] Speaker 02:
and the positioning of the second clicker near the distal end.

[00:19:01] Speaker 02:
Okay, I will adjust that.

[00:19:03] Speaker 02:
Thank you.

[00:19:06] Speaker 02:
Alright, Mr. Croson.

[00:19:08] Speaker 04:
You can breathe again.

[00:19:10] Speaker 04:
Good morning and may it please the court.

[00:19:14] Speaker 04:
This is a plain application of Ariad.

[00:19:20] Speaker 04:
Ariad presents written description as a question of fact and the board

[00:19:25] Speaker 04:
properly considered the Great Britain application and they considered it for what it actually discloses to a person of ordinary skill in the art.

[00:19:38] Speaker 04:
And there are significant factual findings that Sanofi can't really overcome by pointing to the single word threaded.

[00:19:47] Speaker 04:
The question that Ariad poses is does the disclosure taken as a whole

[00:19:55] Speaker 04:
teach the person or show the person of ordinary skill in the art, as of the filing date, that the inventors possessed the invention, i.e.

[00:20:01] Speaker 04:
possessed the claim invention, had invented the claim invention.

[00:20:07] Speaker 04:
The claim invention, as we just heard from Mr. Banks, is internal and externally threaded piston rods.

[00:20:13] Speaker 04:
But that's not the claimed invention.

[00:20:14] Speaker 04:
The claimed invention contains that.

[00:20:16] Speaker 04:
But there's factual findings about the complexity of what the claimed invention is.

[00:20:22] Speaker 04:
For example, at APPX 138 through 9,

[00:20:25] Speaker 04:
the panel below credits Carl Leinsing's testimony about how this is a concentrically designed pen, injection pen, where the piston rod is the innermost member.

[00:20:38] Speaker 04:
This is exactly the point that Judge Doronto was asking about earlier.

[00:20:41] Speaker 04:
If it's a sleeve around a rod, then it's obviously externally threaded.

[00:20:48] Speaker 04:
So it's not as straightforward or as simple as Sanofi would have you believe that there are simply two choices here.

[00:20:54] Speaker 01:
To pick up a question that the panel had for... Did the board make anything of this sleeve idea that I injected?

[00:21:03] Speaker 04:
I believe they did, and I just pointed you to, Your Honor, to APPX 138 and 9.

[00:21:10] Speaker 04:
And I think that that really sort of underscores the panel's skepticism about Dr. Slocum and Dr. Slocum's so-called stinger idea, which was thoroughly discredited.

[00:21:23] Speaker 04:
at pages 8 ppx 143 through 145, it was simply not grounded in time of filing person of ordinary skill in the arts, evidence of what an MIT professor faced with an interesting engineering task unbounded would be able to come up with.

[00:21:43] Speaker 04:
And so it seems to me that

[00:21:46] Speaker 04:
given the factual findings, the extensive factual findings below, the fact that the panel considered the credibility of the experts and made a determination that as a factual matter that Mr. Leinsingh was correct that this disclosure on all four corners, including the claim, including the word threaded, including the figures taken as a whole,

[00:22:11] Speaker 04:
only showed possession of externally threaded piston rods, it seems to me that that's the end of the inquiry.

[00:22:19] Speaker 04:
An interesting question, and obviously if the court were to affirm this decision on the 844, it essentially means that you don't need to decide the district court, because all of the claims in the district court are at issue here in the 844.

[00:22:37] Speaker 04:
So there would be an unpatentability finding here.

[00:22:40] Speaker 04:
And so you need not address the district court.

[00:22:42] Speaker 04:
You would ask your honor.

[00:22:43] Speaker 01:
And that's because of cancellation.

[00:22:47] Speaker 04:
Exactly right.

[00:22:47] Speaker 01:
Not because the finding would actually have issued reclusive effectiveness, because the burden of proof is different.

[00:22:53] Speaker 04:
Exactly right.

[00:22:54] Speaker 04:
But because of the cancellation.

[00:22:55] Speaker 04:
Certainly at least because of the cancellation.

[00:22:58] Speaker 04:
And so that's one way in which you could dispatch of the fourth appeal as well.

[00:23:02] Speaker 04:
The interesting question that Your Honor posed about the effects of the district court firmance on this appeal is less clear in my mind at least.

[00:23:14] Speaker 04:
Certainly the claims that the district court considered, which is a subset of the claims at issue here,

[00:23:21] Speaker 04:
or would be invalidated and null and void.

[00:23:24] Speaker 04:
The reasoning ought to apply and invalidate the remainder of the claims here, as well because of the we're going to take three words out, but we're going to leave the scope the same notion.

[00:23:34] Speaker 01:
There were just four claims in the district court.

[00:23:37] Speaker 04:
That's exactly right, Your Honor.

[00:23:39] Speaker 04:
Well, it was four claims, but one was multiply dependent.

[00:23:42] Speaker 04:
So you'll find that Judge Chessler in the district court appeal talked about some intervening claims which weren't actually considered.

[00:23:50] Speaker 04:
or asserted, but because of the chain of dependency, there were, I think, two other claims that were implicated.

[00:23:59] Speaker 04:
But yes, there were only four asserted claims in the district court case.

[00:24:02] Speaker 04:
So here, I believe that the rationale that the district court applied ought also to support the finding of no written description for the amended claim, but obviously that amended claim had no

[00:24:18] Speaker 04:
really no place in the district court decision, and so we'd be relying upon the Patent Office to jealously protect against attempts by Sanofi, for example, to secure claims of similar or the same coverage.

[00:24:35] Speaker 02:
The argument would be that the substitute claim is not patently distinct from the ones that have been held in balance.

[00:24:42] Speaker 04:
You would assume so, Your Honor, but I'll note that Sanofi is out there on a daily basis seeking more claims, and so we do have some concerns about that, but that's not for the appellate court to worry about today.

[00:24:57] Speaker 04:
We already handled the summary judgment as the Stiefel-Jensen obviousness arguments.

[00:25:02] Speaker 04:
I think they are largely the same as what we had before.

[00:25:05] Speaker 04:
Obviously, the record is different.

[00:25:07] Speaker 04:
But I'm happy to field any questions that the court might have on those.

[00:25:12] Speaker 04:
In terms of the 486, I'm happy to field any questions you have.

[00:25:17] Speaker 01:
What does the record say?

[00:25:22] Speaker 01:
And relatedly, though not identically, what did the board cite to in the record that says there's some reason a skilled artisan would use a half nut without the other half?

[00:25:35] Speaker 04:
Oh, I see.

[00:25:35] Speaker 04:
Yes.

[00:25:36] Speaker 04:
Well, the panel below cited to Mr. Leinsing's

[00:25:47] Speaker 04:
uh... opinions based upon his expertise uh... pages eight p p x sixty five and sixty six

[00:25:55] Speaker 04:
APPX 65 talks about how the board found that partial nuts, split nuts, half nuts were known.

[00:26:03] Speaker 04:
We credited Mr. Leinsing's testimony about how it would be an ease of manufacture and a reduction in cost in order to simply omit one of the half nuts.

[00:26:13] Speaker 04:
But that may be sort of losing the forest for the trees in the sense that the panel also made a determination at APPX 69 to 70 that ClickGuard itself

[00:26:25] Speaker 04:
taught a single arc-shaped body in and of itself.

[00:26:34] Speaker 04:
So there's a specific factual finding at APPX 69 to 70 that even without talking about partial nuts, half nuts,

[00:26:43] Speaker 04:
whatever nuts, that Clitgard shows an arc-shaped body per the subject claim.

[00:26:50] Speaker 04:
And so you don't even necessarily need to get there.

[00:26:54] Speaker 04:
And that's citing Mr. Leinsing's testimony of paragraph 156 of APPX 7320, I believe.

[00:27:03] Speaker 01:
So I'm sorry, where did you say the board found that Clitgard showed a true half nut?

[00:27:11] Speaker 04:
ClickGuard showed an arc-shaped body.

[00:27:13] Speaker 04:
An arc-shaped body.

[00:27:15] Speaker 04:
It doesn't call it a half nut.

[00:27:17] Speaker 04:
But reasoning through the broadest reasonable interpretation of arc-shaped body, the panel goes through and does the analysis and concludes that ClickGuard itself teaches.

[00:27:26] Speaker 01:
I'm sorry.

[00:27:27] Speaker 01:
When I say where, I mean show me on what appendix page and where on the page.

[00:27:32] Speaker 04:
69 to 70.

[00:27:37] Speaker 04:
And it's under item D.

[00:27:41] Speaker 04:
We find that Figure 3 of ClickGuard shows Nutmember 32 having proximal and distal surfaces, et cetera.

[00:27:47] Speaker 04:
And it goes through and credits Mr. Leinsing's testimony at paragraph 156, which I just referenced.

[00:27:55] Speaker 04:
And then on the top of page 70, Petitioner persuades us the proposed combination of Steamfield Jensen and ClickGuard would result in an arc-shaped body comprising, and it goes through the remainder of the claim language.

[00:28:06] Speaker 04:
That's a specific factual finding that ClickGuard in and of itself

[00:28:10] Speaker 04:
by virtue of the nut depicted there, is an arc-shaped body.

[00:28:15] Speaker 01:
So, yeah, I mean, I'm having trouble finding the words that say that directly.

[00:28:21] Speaker 01:
Would you say it's implicit in the We Credit Lansing's Testimony 1561113?

[00:28:25] Speaker 04:
No, at the top of page 70,

[00:28:29] Speaker 04:
Petitioner persuades us that the proposed combination of Steenfeld, Jensen, and Klitgard would result in that's the actual conclusion and the finding and it's premised upon the finding that figure 3, nut number 32 has all of those particular requirements of an arc-shaped body.

[00:28:48] Speaker 04:
And that's citing and deferring or crediting the testimony in the declaration of Mr. Leinzig.

[00:28:54] Speaker 04:
So I don't believe that on the basis of these factual findings that there's a necessity of saying, yes, you have to find a single half nut in order to meet these limitations.

[00:29:07] Speaker 04:
If you wanted to do that or found that you needed to do that,

[00:29:10] Speaker 04:
I believe the factual findings supported by substantial evidence are here, as I've just walked through.

[00:29:15] Speaker 04:
That is, Mr. Lyonsing's testimony based upon his experience and based upon the understandings and approach that would be typical to one in the art.

[00:29:25] Speaker 04:
But I don't believe you need to get there in order to support it.

[00:29:28] Speaker 03:
Did you make this alternative argument based on the shape and click value in your briefs?

[00:29:35] Speaker 04:
I believe we did, Your Honor.

[00:29:36] Speaker 04:
I apologize, Your Honor, one moment.

[00:29:42] Speaker 04:
I believe it's at page 25, Your Honor.

[00:29:48] Speaker 04:
I believe it's page, excuse me, page 52.

[00:29:50] Speaker 04:
I don't want to sound like a quarterback just calling up numbers, Your Honor, so let me... That's where you talk about clickbait.

[00:30:01] Speaker 04:
Yes, it's page 52, 52 to 54.

[00:30:09] Speaker 04:
What starts at page 52, your honor, and it continues on to page 59.

[00:30:14] Speaker 04:
But I believe the first section of that passage, 52 to 56, is all about the fact that the panel found that click art itself teaches an arch-shaped body in and of itself without any further necessity of crediting any testimony from Mr. Lyonsing about reducing two half-nuts to a single knot.

[00:30:44] Speaker 04:
And I'm happy to field some questions about clicker A or clicker B or any of the other modifications that came up in connection with the proposed amended claims.

[00:30:53] Speaker 04:
I see I've got three minutes on the clock.

[00:30:55] Speaker 01:
And just to be clear, the flexible arm is just the spike that's going around like a ratchet and then springing back to cause the sound.

[00:31:08] Speaker 04:
Exactly right.

[00:31:09] Speaker 04:
And you depicted it, Your Honor.

[00:31:12] Speaker 04:
sort of in a in a in an up-and-down motion that they can also you know sort of g uh... you know sort of go side-to-side turn it's sort of in a radial fashion as well you know and and obviously i'm happy to talk through any of those modifications uh... and and the support that we have but i i do believe that here we've got four hundred almost four hundred pages of decisions that address each and every one of

[00:31:39] Speaker 04:
synovies mutating arguments over the course of the i p r you know uh... i'm happy to stand on those four hundred pages uh... it it was a lot of work for the panel they did an amazing job in terms of trying to sift through all this to still things down and get it to a place where you know the panel would uh... the court of appeals will be able to review it and i think they did a remarkable job and given all the changing and shifting that happened here in connection with these amended claims and so forth

[00:32:10] Speaker 04:
So unless the panel has further questions, I'm happy to see a whopping minute of my time.

[00:32:17] Speaker 02:
OK.

[00:32:18] Speaker 02:
Thank you, Mr. Frostman.

[00:32:19] Speaker 02:
Thank you very much.

[00:32:21] Speaker 02:
Mr. Banks, we'll give you two minutes.

[00:32:23] Speaker 00:
Thank you, Your Honors.

[00:32:25] Speaker 00:
Just a few points I'd like to raise.

[00:32:27] Speaker 00:
And to answer your question just about the record, if you look at appendix 89 to 90, that's where the board discusses the party's arguments with respect to

[00:32:38] Speaker 00:
the clicker limitations, and it references the patent owner reply at pages 10 to 14.

[00:32:46] Speaker 00:
Not all of those pages are in the JA because this issue hadn't been raised in the briefs, but if you look in particular at appendix 1078,

[00:32:55] Speaker 00:
That's one place in the record where you show our arguments as it relates to the clicker limitations.

[00:33:03] Speaker 02:
On the written description issue... Does it relate to these two points about the axial movement and the distal?

[00:33:09] Speaker 00:
That's correct, Your Honor.

[00:33:14] Speaker 00:
On the written description issue, counsel pointed to pages 138 and 139

[00:33:23] Speaker 00:
where the board recites Mr. Linesing's testimony.

[00:33:26] Speaker 00:
I think the key there again is that Mr. Linesing is anchoring his opinion in the fact that the application describes this arrangement in the embodiment shown in the figures.

[00:33:40] Speaker 00:
And so again, he's describing that and saying that there's an arrangement where they are concentrically arranged such that there's an externally threaded piston rod.

[00:33:50] Speaker 00:
But that's because it's the way it's shown in this picture.

[00:33:52] Speaker 00:
And again, there's nothing in the specification that would limit it to that disclosure.

[00:33:55] Speaker 00:
I mean, this is, again, a genus of two.

[00:33:58] Speaker 00:
They're well-known in the arts.

[00:34:00] Speaker 00:
There's only two ways to arrange it.

[00:34:01] Speaker 00:
You can easily visualize both arrangements.

[00:34:04] Speaker 00:
And in fact, artisans had envisioned them in the past with medical injection devices comprising internally threaded pustin rods.

[00:34:13] Speaker 00:
Finally, on the ClickGuard reference and the idea that ClickGuard itself demonstrates

[00:34:20] Speaker 00:
a use of an arch shaped body, I would direct the panel's attention to appendix 68.

[00:34:27] Speaker 00:
That is where the board finds that petitioner proposes modifying what the guard describes as nut number 32 into a half nut.

[00:34:37] Speaker 00:
So the idea that it found that it already was a half nut is just not supported by the record.

[00:34:42] Speaker 00:
And I don't think the finding the council pointed you to or the reported finding the council pointed to you says as much.

[00:34:50] Speaker 02:
I think we're out of time.

[00:34:52] Speaker 02:
Thank you, Mr. Crags.