[00:00:00] Speaker 03:
We have four related cases this morning.

[00:00:03] Speaker 03:
The first is number 20-1871, Sanofi, Aventis versus Milan Pharmaceuticals, Mr. Ansley.

[00:00:14] Speaker 03:
Good morning, Your Honors.

[00:00:15] Speaker 03:
You can take your mask off.

[00:00:18] Speaker 00:
Thanks.

[00:00:18] Speaker 00:
It's a habit by now.

[00:00:21] Speaker 00:
Good morning, Your Honors.

[00:00:22] Speaker 00:
May it please the Court.

[00:00:23] Speaker 00:
Sutton Ansley, Council for Appellants.

[00:00:24] Speaker 00:
I'd like to reserve three minutes of my time for rebuttal.

[00:00:30] Speaker 00:
To provide opening marks for all the appeals we'll hear about today, the board found that 67 of the 69 challenged claims were patentable.

[00:00:38] Speaker 00:
That's a rejection rate of 97%.

[00:00:41] Speaker 00:
As will be discussed today, these sweeping rejections, which are based on prior art that was previously before the Patent Office, was the result of improper hindsight stemming from the board's misapplication of the law.

[00:00:51] Speaker 00:
Under the court's precedent, these decisions should be reversed or vacated.

[00:00:55] Speaker 00:
Now, for Consolidate Appeal Number 20-1871,

[00:00:59] Speaker 00:
I plan to discuss and focus on the Steenfeld-Jensen ground before turning to the Burroughs ground with the time that I have remaining.

[00:01:07] Speaker 00:
For the Steenfeld-Jensen ground, what the board effectively... These are two alternative grounds, right?

[00:01:11] Speaker 00:
This is correct, Your Honor.

[00:01:13] Speaker 00:
And for the Steenfeld-Jensen ground, the board effectively did... What it effectively did is found that a person of skill in the art would have been motivated to make a pinjecture worse simply because the posits could have done themselves.

[00:01:26] Speaker 00:
Here the question is whether Steenfield-Johnson renders obvious claims reciting an internally threaded driver tube.

[00:01:33] Speaker 00:
Notably, Steenfield-Johnson discloses five separate pin injector embodiments, each having different components and mechanisms for operation.

[00:01:41] Speaker 00:
Mylan relies on the fifth embodiment for teaching the challenge claims, but neither the fifth embodiment nor the other four embodiments disclose an internally threaded drive sleeve.

[00:01:51] Speaker 00:
Nonetheless, the board found that a teaching specific to the first embodiment purportedly suggested putting an internal thread on a driver tube.

[00:02:00] Speaker 03:
So if there's in the prior art reference an expressed suggestion to combine and there's no indication that there's a disadvantage in the prior art reference to the combination, you're suggesting that

[00:02:19] Speaker 03:
the patentee can come in in the IPR and present evidence that there's a disadvantage and that that's sufficient?

[00:02:31] Speaker 00:
That's a different case in here because there is no express teaching to modify the fifth embodiment.

[00:02:35] Speaker 00:
Again, Mylan's relying on the fifth embodiment for teaching the challenge claims and the board found, for example, at Appendix Site 61, that we determine that this express teaching applies directly to the first embodiment.

[00:02:48] Speaker 00:
So there is no direct, expressed teaching to modify the fifth embodiment.

[00:02:53] Speaker 00:
What the court found, excuse me, what the board found is that this teaching could be applied to the fifth embodiment, and a person of ordinary skill and the art would consider doing so because of analogous components.

[00:03:04] Speaker 04:
But analogous... The parts are interchangeable.

[00:03:07] Speaker 00:
For this ground, for the Steenfeld and Jensen ground, Mylan argued and the board found that a POSA would consider applying the teaching from the first embodiment to the fifth, not on interchangeability.

[00:03:19] Speaker 00:
The interchangeability reason or rationale was used for the borough's ground, and then also for claims 30 and 32 with respect to the Steenfeld-Jensen ground.

[00:03:29] Speaker 00:
But here, the NADA's components rationale... Did you challenge the borough's grounds in your brief?

[00:03:36] Speaker 04:
Excuse me, Your Honor?

[00:03:38] Speaker 04:
In the blue brief, you were charging the Senfield-Jensen rounds.

[00:03:42] Speaker 04:
Where specifically in your brief were you challenging the Burroughs rounds?

[00:03:47] Speaker 00:
So we challenged, I believe, the analysis begins.

[00:03:51] Speaker 04:
Just maybe give me a site to the page in the brief.

[00:03:53] Speaker 00:
Certainly, Your Honor.

[00:03:57] Speaker 00:
It's the first section of our opening argument.

[00:04:00] Speaker 02:
Page?

[00:04:02] Speaker 00:
Page.

[00:04:05] Speaker 00:
This is from the blue brief at page, begins at page 28, your honor.

[00:04:10] Speaker 04:
Page 28?

[00:04:11] Speaker 00:
Yes, sir.

[00:04:16] Speaker 00:
And boroughs specifically at page 29.

[00:04:20] Speaker 00:
Beginning of the heading, the board erred in holding that Opposso would have had a reason to modify boroughs.

[00:04:24] Speaker 00:
Doe Stiles need to have agreed.

[00:04:28] Speaker 02:
So back on Steenfeld, Jensen, what do you get to say, again, what you think the board did wrong in borrowing for the Fifth Embodiment some teaching elsewhere in the same prior art, not specifically directed to the Fifth Embodiment?

[00:04:49] Speaker 02:
And the board said, we think a skilled artisan would have, in fact, been motivated to borrow that piece from the same document.

[00:04:56] Speaker 02:
Is that a fair description, at least?

[00:04:58] Speaker 02:
of what you're criticizing and then?

[00:05:01] Speaker 00:
In ways, I think the, so the board did conclude that a person of skill in the art would be motivated to apply the teaching from the first to the fifth, but what they did is they relied on rationales that only addressed the question of a reasonable expectation of success.

[00:05:15] Speaker 00:
They didn't actually identify any incentive, benefit, or anything else that would motivate a person of skill in the art to actually apply this teaching from the first.

[00:05:23] Speaker 03:
Why is that necessary if there's an express teaching?

[00:05:26] Speaker 00:
Because, again, the express teaching here is to a separate embodiment, the first embodiment, as the board found.

[00:05:31] Speaker 00:
It's not an express teaching to modify the fifth embodiment.

[00:05:35] Speaker 00:
And I should note, too, we take issue with the fact that

[00:05:37] Speaker 00:
It is indeed express teaching.

[00:05:39] Speaker 03:
That's a pretty limited view of express teaching.

[00:05:42] Speaker 03:
I don't think our cases have required that kind of specificity.

[00:05:47] Speaker 03:
If you have an express teaching to use a particular claim element in the prior art, don't the cases say that's sufficient?

[00:05:57] Speaker 00:
We disagree that it's express teaching and that that finding is supported by substantial evidence.

[00:06:01] Speaker 00:
But even still, this is not a teaching that's applicable to all five embodiments.

[00:06:06] Speaker 00:
The board acknowledged, for example, Appendix Site 62 of the 069 final written decision, for example, that this teaching that is discussed at the end of the first embodiment and the board found applied directly to the first embodiment, that it's not a general teaching that applies to all the embodiments, at least because, as the board acknowledged, it doesn't work for the second embodiment.

[00:06:28] Speaker 00:
So the board found that a person of skill in the art, what they'd have to do is determine

[00:06:32] Speaker 00:
for each of the embodiments, second, third, fourth, and fifth, which, again, different pens in each of these, whether a teaching in the first could work.

[00:06:41] Speaker 00:
So what we're left with is, again, we're asking the question, could a person of ordinary skill in the art take a teaching from the first embodiment and apply it to the fifth to get it to work?

[00:06:50] Speaker 00:
And importantly here, Your Honor, I haven't gotten to this point yet, but importantly, the record shows that the only evidence, the only evidence that goes to a person of ordinary skill in the arts incentives and motivations

[00:07:01] Speaker 00:
shows that the pin injector modification would be substantially worse.

[00:07:06] Speaker 00:
And the board didn't identify any reason to make a worse pin, other than that a posit could do it because of the analogous parts.

[00:07:14] Speaker 00:
That is because a modification to one set of components in the first embodiment could work in the fifth embodiment.

[00:07:22] Speaker 02:
Now the board... Can I just ask, is it right that it is a

[00:07:29] Speaker 02:
factual determination that the board made on page 63 of that.

[00:07:36] Speaker 02:
It read this piece of prior art as suggesting that the particular component described in the context of the first embodiment, but with slightly broader language actually would

[00:07:58] Speaker 02:
teach a person of skill in the art to use that with sufficiently similar component-wise other embodiments, which would include the fifth.

[00:08:11] Speaker 02:
That's the material right in the middle of page 63.

[00:08:13] Speaker 02:
And if that's a factual finding, is that really lacking in substantial evidence support?

[00:08:20] Speaker 00:
I think it is, Your Honor.

[00:08:21] Speaker 00:
Again, the board did conclude that this is a teaching specific to the first embodiment and that it wouldn't

[00:08:27] Speaker 00:
It's not a teaching of general applicability.

[00:08:29] Speaker 00:
It doesn't work for the second body.

[00:08:30] Speaker 02:
But there's some distance between those two things, specific to the first embodiment, general applicability.

[00:08:35] Speaker 02:
I take this page to be a finding that it does suggest applicable for sufficiently similar other structures, of which the fifth embodiment is one.

[00:08:50] Speaker 00:
And see, that gets back to

[00:08:53] Speaker 00:
not a reason to modify, but it gets back to an analysis that the POSA has to conduct.

[00:08:58] Speaker 00:
Could I do it?

[00:08:59] Speaker 00:
Could I apply this teaching from the first to the second to get it to work?

[00:09:03] Speaker 00:
The answer is no.

[00:09:04] Speaker 00:
Could I apply it to the fifth to get it to work?

[00:09:06] Speaker 00:
And the answer is yes.

[00:09:07] Speaker 00:
But that is a reasonable expectation of success in query.

[00:09:10] Speaker 00:
It's actually not a sufficient rationale for a POSA to say, I would modify the fifth embodiment this way.

[00:09:17] Speaker 00:
Particularly, again, when there's only detriments of the proposed modification against no benefits or reason to actually modify the fifth embodiment in such a manner.

[00:09:27] Speaker 02:
Can I just clarify this?

[00:09:29] Speaker 02:
On the assumption, which I'm not going to look at right now, that the board did not recite benefits, did Mylan's evidence purport to recite benefits from borrowing this suggestion from the first embodiment for the fifth?

[00:09:44] Speaker 00:
No, Your Honor.

[00:09:45] Speaker 00:
I believe the red brief did say that the modified PIN in and of itself is a benefit.

[00:09:52] Speaker 00:
That's the first time we've seen that argument.

[00:09:55] Speaker 00:
We think that that type of argument sort of undercuts the actual requirement to have a reason to modify PIN.

[00:10:01] Speaker 00:
If every new embodiment were a benefit in and of itself, then we would need to ask the question, what's the reason or benefit for a proposed modification?

[00:10:09] Speaker 00:
But the answer to your question, no, the petition

[00:10:11] Speaker 00:
didn't allege any benefits for the proposed modification.

[00:10:14] Speaker 00:
The board found there were only detriments.

[00:10:18] Speaker 00:
I see that I'm coming a little close to my rebuttal time, so I'm going to switch to the burl's ground briefly.

[00:10:24] Speaker 00:
For the burl's ground, one of the disputed claim limitations requires a groove on a dose-style sleeve.

[00:10:30] Speaker 00:
Burl's does not disclose this.

[00:10:32] Speaker 00:
It discloses rather threads, a pair of threads on a dial mechanism, which is the purported dose-style sleeve.

[00:10:38] Speaker 00:
And Mylan proposed adding a pair of threads to the dial mechanism to satisfy this claim limitation on the rationale that threads and grooves are interchangeable.

[00:10:49] Speaker 00:
But the fact that features are interchangeable only gets to the question, could Opposa have made the change?

[00:10:55] Speaker 02:
Why is that?

[00:10:56] Speaker 02:
I guess I've been looking at some of the case law and I'd like some help from you in thinking about it.

[00:11:03] Speaker 02:
So KSR treats, I'm not sure it uses the term interchangeable, but an interchangeability situation, a well-recognized, tiny number of alternatives that people would know you could put the buttons on the left side and the buttonholes on the right, or you could flip them.

[00:11:21] Speaker 02:
And that's kind of what's going on here, right?

[00:11:25] Speaker 02:
have we really held that in that situation, where a skilled artisan would immediately recognize there are two alternatives, that in order for there to be obviousness to choose the worst one, that you needed a reason to go and choose it.

[00:11:46] Speaker 02:
Aren't both obvious, even if no one would choose the worst one?

[00:11:52] Speaker 02:
And have we ever so held to the contrary?

[00:11:55] Speaker 02:
I don't mean language and opinions, I mean a holding.

[00:12:01] Speaker 00:
That interchangeability alone is enough.

[00:12:03] Speaker 00:
Yes.

[00:12:03] Speaker 00:
No, no, you're not.

[00:12:04] Speaker 00:
Not that we're aware.

[00:12:05] Speaker 02:
No, the other way is I'm sorry.

[00:12:06] Speaker 02:
And that have we ever said in this situation of tiny number of limited alternatives, every skilled artisan would recognize them that that we have said, sorry, board, you can't help.

[00:12:20] Speaker 02:
We reverse your obviousness ruling because you didn't show you didn't have a finding that there was an affirmative benefit from going in that direction.

[00:12:30] Speaker 00:
I seem that I'm eating into my rebuttal time.

[00:12:32] Speaker 02:
I'd love an answer anyway.

[00:12:34] Speaker 00:
OK.

[00:12:34] Speaker 00:
Yeah, every case requires, KSR did not remove the requirement to, you have to show a reason for the proposed modification.

[00:12:45] Speaker 02:
KSR did not assert that there always is such a requirement, did it?

[00:12:50] Speaker 02:
Doesn't this say something like it's often useful to have a reason?

[00:12:54] Speaker 00:
Well, I think this court's interpretation of the KSR decision is instructive.

[00:12:59] Speaker 00:
In Procter & Gamble, this court held that under KSR, it remains necessary to identify some reason that would let oppose it to modify the prior art.

[00:13:08] Speaker 02:
And I think that's because... I'm sorry, again, doesn't KSR in the discussion of Secreta say in this extremely limited situation of well-known

[00:13:19] Speaker 02:
interchangeable alternatives that POSA has a reason.

[00:13:24] Speaker 02:
Doesn't KSR say that in terms?

[00:13:28] Speaker 02:
They write automatically satisfying that requirement in that small subset of situations.

[00:13:34] Speaker 00:
Let's see.

[00:13:35] Speaker 00:
KSR says more than that, Your Honor.

[00:13:36] Speaker 00:
I mean, I think that portion of the opinion is at 417.

[00:13:41] Speaker 00:
At 418, the court explains that you do need to find a reason for the proposed modification.

[00:13:46] Speaker 00:
As this court has held, a reason is critical here.

[00:13:49] Speaker 00:
particularly in the predictable arts such as mechanical arts to avoid the temptation of hindsight.

[00:13:54] Speaker 03:
The board has this line of authority.

[00:13:56] Speaker 03:
In many cases, perhaps not in this one, they refer to it as a simple substitution.

[00:14:02] Speaker 03:
And have we disapproved that line of authority at the board?

[00:14:06] Speaker 00:
We're not aware of any case law that says a simple substitution by itself without any reason or benefit or incentive to modify is sufficient for... But have we disapproved that approach?

[00:14:20] Speaker 00:
Not to my... With a simple substitution without a reason to combine, not to our knowledge.

[00:14:27] Speaker 00:
I think I'm eating to my rebuttal time.

[00:14:30] Speaker 00:
We'll give you two minutes.

[00:14:31] Speaker 00:
Okay.

[00:14:31] Speaker 00:
Any further questions, Your Honor?

[00:14:35] Speaker 00:
Thank you so much.

[00:14:38] Speaker 03:
Okay, Mr. Karsten.

[00:14:41] Speaker 01:
Good morning.

[00:14:42] Speaker 01:
May it please the court.

[00:14:44] Speaker 01:
My name is Doug Karsten and I am arguing on behalf of the appellees today.

[00:14:49] Speaker 01:
You'll have your fill of me.

[00:14:50] Speaker 01:
I'm working on all four of them.

[00:14:52] Speaker 01:
This is a simple obviousness application of KSR on two separate and independent bases.

[00:15:01] Speaker 01:
One, Steenfield Jensen and second, Burroughs.

[00:15:04] Speaker 01:
Those are two separate grounds for affirmance.

[00:15:07] Speaker 01:
under KSR, as Judge Toronto noted, there is a teaching suggestion or motivation requirement, and KSR dispatched of a rigid motivation requirement.

[00:15:22] Speaker 01:
Here, there's, for Steenfield-Jensen, an unqualified factual finding supported by substantial evidence that Steenfield-Jensen teaches the modification at APPX 61 to 62.

[00:15:34] Speaker 01:
There's simply a specific factual finding, also supported by substantial evidence, that Steenfeld-Jensen suggests the modification at APPX 63.

[00:15:47] Speaker 02:
And so... I'm sorry, what's the finding about a motivation on Steenfeld-Jensen?

[00:15:57] Speaker 01:
Yeah, unless I misheard what you just said.

[00:16:01] Speaker 01:
Certainly there's an explicit finding at APPX 63 of a suggestion and also at APPX 70.

[00:16:08] Speaker 01:
But I'm reading, we find that one of ordinary skill in the art at APPX 63 would have understood that Seinfeld Jensen employed this method of description and would have applied

[00:16:19] Speaker 01:
to embodiments with the same or analogous components.

[00:16:23] Speaker 01:
First, third, fourth, and fifth embodiments.

[00:16:26] Speaker 02:
So what would have, that's helpful to you.

[00:16:30] Speaker 02:
For what reason?

[00:16:31] Speaker 01:
Well, I think Sanofi recognizes that they're in a bit of a bind here in the sense of the factual findings.

[00:16:39] Speaker 01:
And so they're seeking to find some legal arguments, some wiggle room.

[00:16:43] Speaker 01:
And they understand, I'm sorry.

[00:16:45] Speaker 02:
No, no, my question is, and I take it,

[00:16:48] Speaker 02:
Well, my question is, does the board say, did you have evidence saying, here is the benefit a skilled artisan would recognize as desirable to achieve by doing this?

[00:17:02] Speaker 02:
The board didn't say that, Your Honor.

[00:17:03] Speaker 02:
Did your evidence say that?

[00:17:05] Speaker 01:
We did present evidence.

[00:17:07] Speaker 01:
I'm not sure it was ever cited in the papers and perhaps not as part of the joint appendix.

[00:17:12] Speaker 01:
But for example, in the oral argument at page 92 of the oral hearing transcript,

[00:17:18] Speaker 01:
There is reference to some advantages.

[00:17:21] Speaker 01:
But I don't think that those advantages are necessary here.

[00:17:24] Speaker 02:
Well, I guess part of what I'm trying to figure out is there are two separate questions.

[00:17:30] Speaker 02:
Are there advantages?

[00:17:31] Speaker 02:
Evidence-supported advantages?

[00:17:33] Speaker 02:
If not, is that a problem?

[00:17:35] Speaker 02:
So that's the unnecessary.

[00:17:37] Speaker 02:
I think I understand the legal argument for why not necessary.

[00:17:41] Speaker 02:
I'm trying to focus on whether I need to get to that legal argument, which is not the most self-evident doctrinal proposition in the world by saying there was actually evidence of this and or the board found it.

[00:17:55] Speaker 02:
And on hearing, no, there isn't.

[00:17:57] Speaker 01:
Well, there isn't a board-specific finding on a benefit.

[00:18:00] Speaker 01:
There is a specific board finding.

[00:18:02] Speaker 03:
I believe that... One other question is, what evidence did you present about advantage?

[00:18:07] Speaker 01:
We presented in paper 76 of the 1670 IPR Neural Hearing Transcript, as well as in the licensing deposition of pages 220 to 221,

[00:18:21] Speaker 01:
advantages such as the ability to lengthen the thread, the ability to pick a different material, which would result in easier molding.

[00:18:30] Speaker 01:
So we did present evidence of an advantage on the Steenfeld-Jensen flip.

[00:18:36] Speaker 01:
The board didn't get to that and didn't need to credit it because, as Your Honor points out,

[00:18:43] Speaker 01:
That's the second step, assuming that there's a requirement to show a benefit at all.

[00:18:48] Speaker 02:
Does the joint appendix happen to contain either of the two things you decided?

[00:18:52] Speaker 01:
Let me check on that, Your Honor, and I will revert.

[00:18:54] Speaker 01:
But I don't believe so, because they didn't.

[00:18:56] Speaker 02:
The first one is just the lawyers talking at the oral argument.

[00:18:59] Speaker 01:
I'm sorry?

[00:19:00] Speaker 02:
The first one is just the lawyers talking at the oral argument, or was it all the oral hearing?

[00:19:04] Speaker 01:
Yes, that's the oral hearing.

[00:19:05] Speaker 01:
Martialing the evidence, Your Honor, yes.

[00:19:07] Speaker 01:
And the citation there is the thing that we were talking about was a licensing deposition.

[00:19:12] Speaker 01:
That's Mylan's experts.

[00:19:14] Speaker 01:
Oh, I see.

[00:19:14] Speaker 02:
So that just depends on the second thing.

[00:19:16] Speaker 01:
Right, exactly.

[00:19:17] Speaker 01:
So it's the oral hearing transcript in which we're discussing evidence presented by Carl Leinzing, Mylan's expert below.

[00:19:24] Speaker 02:
And you said what page of the transcript was that?

[00:19:25] Speaker 01:
220, line 12.

[00:19:27] Speaker 02:
No, that's the deposition transcript.

[00:19:29] Speaker 02:
I meant of the oral hearing transcript.

[00:19:30] Speaker 01:
Oh, it's paper 76, page 92 of that.

[00:19:34] Speaker 01:
OK, thank you.

[00:19:40] Speaker 01:
But the board considered the so-called disadvantage that Sanofi was able to muster, saying that there was an increased amount of friction.

[00:19:51] Speaker 01:
And the board made a specific finding that the person of skill in the art would understand how to offset.

[00:19:59] Speaker 03:
I mean, this is about Burroughs now you're talking about?

[00:20:01] Speaker 03:
No, this is Steinfeld-Jensen.

[00:20:03] Speaker 01:
Steinfeld-Jensen, yes.

[00:20:06] Speaker 01:
uh... and we would understand how to offset that that additional friction and so you felt jensen in uh... in suggesting this alternative didn't say increased friction right no they didn't your honor there was no evidence of record in the prior art that it would be a disadvantage whatsoever it's a suggestion and cancer in the alternative says teaching suggestion or motivation what's up is trying to do here is to

[00:20:33] Speaker 01:
put some teeth into motivation or into some would-could analysis such that it actually undermines a finding of suggestion as a grounds for obviousness.

[00:20:46] Speaker 01:
And that goes directly against and essentially declares war on KSR.

[00:20:51] Speaker 01:
It certainly would require this court to somehow disavow significant portions of KSR, which it has never done before.

[00:21:01] Speaker 04:
This evidence that you pointed to referencing benefits in the discussion we're having about Steenville-Genson, is that equally applicable in the borough situation?

[00:21:11] Speaker 01:
Well, Your Honor, there was evidence presented in response to what Sanofi considered would be a disadvantage, widening the pen, and the panel below made a factual... And gave a like-a-like.

[00:21:25] Speaker 01:
...made a factual finding based upon crediting evidence that some users may actually find desirable.

[00:21:31] Speaker 01:
and consider an advantage, a wider pen.

[00:21:33] Speaker 01:
So the friction issue did not come up, is my recollection, in connection with the Burroughs reference.

[00:21:39] Speaker 01:
But that was a plain swap.

[00:21:41] Speaker 04:
I mean, that's... Right, but my point is, unless I've mistaken what's going on here, Sanofi has to prove to us that the board was wrong, both as to Sinfield Jensen and as to Burroughs.

[00:21:56] Speaker 04:
Right.

[00:21:57] Speaker 04:
And if we find that Sanofi Jensen maybe is a little itchy,

[00:22:01] Speaker 04:
But we find Burroughs is not, and the results the same, correct?

[00:22:05] Speaker 01:
Exactly right, Your Honor.

[00:22:06] Speaker 01:
Now, in all candor, in my heart of hearts, I believe that both are not iffy, that both are absolutely single-reference obvious.

[00:22:14] Speaker 01:
Right.

[00:22:14] Speaker 04:
I mean, in terms of the evidence, I mean, from Judge Toronto had been pointing out, then I think we've come to agree that on Stenfield-Jensen,

[00:22:24] Speaker 04:
decision written by the board.

[00:22:25] Speaker 04:
There's no evidence in the board opinion that it was looking at benefits.

[00:22:30] Speaker 04:
Whereas if that is of concern to us, I would think you have a potentially stronger case on boroughs.

[00:22:36] Speaker 01:
if that's a concern that obviously is a concern or we would not be talking about fair point your honor i appreciate that having said that though there's nothing in case are that says that there has to be a benefit where there is an express suggestion and i'm unaware of any case that has made such a finding by this court or the supreme court and so i i believe it would be an extension of the law

[00:23:00] Speaker 01:
uh... and a change in the law materially to say that there has to be some benefit particularly here where there's no there's nothing in the prior art specifically that would caution against you know there is case law that talks about teaching away and there's even nothing here in this matter that talks at all about discouraging or discrediting somebody from doing this modification in steinfeld jensen

[00:23:29] Speaker 01:
In fact, Dr. Slocum, Sanofi's own expert, talked about or admitted to the similarities, and there's a factual finding on this at APPX 63 between the first and fifth embodiments, and there's a specific finding that those passages of Steenfield-Genson directly apply to the fifth embodiment.

[00:23:50] Speaker 01:
This really does come down in both instances, both Steenfield-Genson and Burroughs,

[00:23:56] Speaker 01:
to familiar evidence, familiar elements, known methods, predictable results.

[00:24:02] Speaker 01:
There's nothing in that KSR framework.

[00:24:04] Speaker 01:
And sometimes that's referred to as known interchangeability.

[00:24:07] Speaker 01:
Sometimes it's called a simple swap, but that's really the heart of the sort of er, obvious, classic example.

[00:24:16] Speaker 01:
And that's exactly what we have here in two separate bases, both of which are independent grounds for affirmance.

[00:24:23] Speaker 01:
I recognize, unless the panel has any questions, I recognize I have five minutes on the clock here, but unless the panel has any questions, I think I've addressed everything that certainly Mr. Ensley raised.

[00:24:35] Speaker 01:
But if anything's bothering the court, I'm happy to field questions.

[00:24:40] Speaker 03:
Any further questions?

[00:24:41] Speaker 03:
Okay.

[00:24:42] Speaker 03:
Thank you, Mr. Prol.

[00:24:43] Speaker 03:
Thank you very much, Your Honor.

[00:24:49] Speaker 03:
Ensley, you've got two minutes.

[00:24:52] Speaker 00:
Hello again your honors to address some of the points that my colleague Mr. Karsten made is that the board did actually and both for the Steenfeld Jensen ground and the boroughs ground examine any Detriments against any alleged benefits and for the Steenfeld Jensen ground it only found made a finding that it would result in a worse pen a pen injector that had higher injection force as for the boroughs ground the board did acknowledge that

[00:25:18] Speaker 00:
there were potential drawbacks with no benefits that would support the reason for the modification.

[00:25:24] Speaker 00:
Again, the board only focused on interchangeability as being the sole reason for the modification.

[00:25:30] Speaker 00:
In all the cases cited by Appellee in the blue brief for the support that interchangeability can support a motivation

[00:25:41] Speaker 00:
modify.

[00:25:41] Speaker 00:
In all those cases, there was a reason in addition to the interchangeability that was put forth as supporting the combination.

[00:25:51] Speaker 00:
And again, I just want to reiterate that this court is held that under KSART remains necessary to identify some reason that would let a posa to modify the prior art.

[00:26:00] Speaker 00:
So you have to have a reason.

[00:26:02] Speaker 02:
Can I just ask, you don't read the board's discussion.

[00:26:07] Speaker 02:
Now I don't remember whether it's Burroughs or Steenfeld-Jensen, where the board says, yeah, there'd be some greater friction, but a person of skill in the art would know what to do about that.

[00:26:20] Speaker 02:
Yeah, as a result of that, you'd have a fatter pen, but some people like fatter pens.

[00:26:26] Speaker 02:
Is that not an advantage, namely, for those people who like fat pens, this result actually offers an advantage?

[00:26:37] Speaker 00:
Well, no one has ever contended, not in the petition nor in the board's decision, that a wider pen was a benefit that would motivate someone to add a pair of threads to the dial mechanism.

[00:26:47] Speaker 00:
The board and Mylan both relied on interchangeability.

[00:26:51] Speaker 00:
And the last thing I would say is that, Your Honors, with respect to steam-filled gents, it wouldn't be obvious to make a pit injector worse for no reason other than the fact that you could.

[00:27:00] Speaker 00:
And that's what we feel the board's decision came down to.

[00:27:03] Speaker 00:
I see my time is up.

[00:27:05] Speaker 03:
Thank you.

[00:27:06] Speaker 00:
All right.

[00:27:06] Speaker 00:
Thank you, Your Honors.

[00:27:07] Speaker 03:
Thank you both, Counsel.

[00:27:08] Speaker 03:
The case is submitted.