[00:00:00] Speaker 03:
Our third case is number 20, 2071, Sanofi and Mentis versus Mylan Pharmaceuticals.

[00:00:11] Speaker 00:
This is Stern.

[00:00:11] Speaker 00:
Your Honors, may it please the Court, Sarah Sternling, the Appellant.

[00:00:15] Speaker 00:
You've heard from my colleagues already on the other related patents the Board invalidated in this series of IPRs.

[00:00:20] Speaker 00:
I'd like to discuss the fundamental errors the Board made in invalidating the O8 patent, which relates to a drive mechanism for use in a drug delivery device.

[00:00:29] Speaker 00:
Mylan proposed that combining molar, which uses a rack and pinion gearing, with Steenfeld-Genson's threaded gearing system, renders the O8 patent invalid as obvious.

[00:00:39] Speaker 00:
But the board's cursory analysis made numerous errors, which can be grouped into two grounds for reversal that I'd like to discuss today.

[00:00:46] Speaker 00:
First, the claim construction error.

[00:00:48] Speaker 00:
The board erred in finding that molar and Steenfeld-Genson disclosed the claim limitation, a housing comprising a helical thread and an insert provided in the housing based on its incorrect holding

[00:00:59] Speaker 00:
that the claim language does not require an insert separate from the housing.

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And second, the board erroneously rejected teaching away, despite recognizing that Mueller expressly criticized Steenfeld-Jensen, criticism being the quintessential hallmark of teaching away.

[00:01:13] Speaker 00:
The board came to this conclusion using impermissible hindsight, which erroneously and inexplicably ignored the language of Mueller.

[00:01:21] Speaker 00:
Turning first briefly to the claim construction issue, Mylan's argument about the specifications language that permits an integrally formed housing as an alternative makes it crystal clear.

[00:01:31] Speaker 00:
Appendix 88, column 7, line 33, discusses the claimed embodiment and stating in the illustrated embodiment an insert provided at the end of the main housing.

[00:01:43] Speaker 00:
But the rest of that paragraph then goes to say that alternatively, the insert may be formed integrally with the main housing.

[00:01:49] Speaker 00:
This alternative embodiment is a clear juxtaposition to the illustrated claimed embodiment that is encompassed, of course, by the plain language of the claim one.

[00:01:58] Speaker 00:
Provided in here necessarily requires that the insert be relative to the housing.

[00:02:03] Speaker 00:
Otherwise, provided in has no meaning, an insert cannot be both the insert and the housing.

[00:02:10] Speaker 01:
Where a patent describes numerous- Can I just ask, what would be incorrect about thinking about this phrase?

[00:02:18] Speaker 01:
as thinking about, well, what is this an insert into?

[00:02:22] Speaker 01:
I kind of, I guess I'd understood your picture to be that this insert has to be inserted into the housing.

[00:02:32] Speaker 01:
Why isn't it natural to read it to say what it's being inserted into is the central, the core of the pen.

[00:02:43] Speaker 01:
So the insert doesn't have to be something done to the housing.

[00:02:47] Speaker 01:
The housing contains something that inserts a projection into the interior of the pen.

[00:02:55] Speaker 01:
And therefore it can be integral, it can be soldered on, whatever.

[00:03:00] Speaker 00:
Well, the claim language requires an insert be provided in the housing and it has to be

[00:03:06] Speaker 00:
within the housing itself.

[00:03:08] Speaker 00:
What Mylan proposes is that the housing is the insert itself.

[00:03:12] Speaker 00:
The pieces of the patent of Muller that Mylan proposes would disclose this teaching is Muller's housing one, wall two, and tubular element five.

[00:03:24] Speaker 00:
that they all have to be put together, that wall two has to connect those two pieces in order to make this a full housing.

[00:03:31] Speaker 00:
And an insert provided in that doesn't make any sense if the insert has to be both an insert itself and the housing.

[00:03:37] Speaker 00:
And Mylan doesn't explain how an insert can be both an insert and a housing here.

[00:03:42] Speaker 00:
And again, if you look at their argument about the alternative language, it's clearly

[00:03:46] Speaker 00:
drawing a distinction between what's in the claim language, which is an insert provided in the housing, which is stated, again, in the specification, and an alternative embodiment that alternatively the insert may be formed integrally of the housing, to your point that if an insert could just be integrally formed, then the patent wouldn't have written alternatively.

[00:04:07] Speaker 00:
That wouldn't make any sense there.

[00:04:10] Speaker 00:
There's only one clear evidence-supported finding here.

[00:04:14] Speaker 00:
And this requires no further fact-finding based on the clear language of the patent.

[00:04:19] Speaker 00:
If I may turn briefly to the teaching away point.

[00:04:21] Speaker 02:
Was this on the in as opposed to in or only?

[00:04:25] Speaker 02:
Is this a claim construction issue on your BRI?

[00:04:28] Speaker 00:
We do believe this is a claim construction issue.

[00:04:31] Speaker 00:
Both parties have treated this as a claim construction issue.

[00:04:35] Speaker 00:
And what the board found was clearly that it was construing what these terms meant.

[00:04:40] Speaker 00:
The final written decision was looking at the plain language of the claim and looking at whether an insert requires to be separate from the housing or it can be part of the housing.

[00:04:49] Speaker 00:
So we do believe this is a claim construction issue and that that would merit reversal solely on those grounds.

[00:04:56] Speaker 00:
If I might turn to the teaching away.

[00:04:58] Speaker 00:
This court has repeatedly held that where a reference criticizes, discredits, or otherwise discourages investigation into the invention claim, that it teaches away.

[00:05:08] Speaker 00:
No one here disputes that Mueller criticizes Steenfeld-Jensen.

[00:05:11] Speaker 00:
And again, criticism is the quintessential sign of a teaching away.

[00:05:15] Speaker 03:
It criticizes part of Steenfeld-Jensen.

[00:05:19] Speaker 03:
But if you look at page nine of the red brief and this item 17, as I understand Mueller criticism, it relates to the use of that piece as creating additional friction.

[00:05:39] Speaker 03:
Am I correct about that?

[00:05:41] Speaker 00:
We disagree.

[00:05:42] Speaker 00:
I believe what you're referring to is Mylan's argument that Mueller's criticism extends only to Steenfeld-Jensen's first embodiment and not to the second embodiment.

[00:05:50] Speaker 00:
But we disagree.

[00:05:51] Speaker 00:
There's nothing in Mueller or the board's decision discussing Mueller that limits Steenfeld-Jensen's criticism.

[00:05:59] Speaker 03:
I understand your restatement of the argument, but it's not really answering my question.

[00:06:04] Speaker 03:
What I'm asking about is the figure that appears on page nine of the red brief.

[00:06:09] Speaker 03:
And this item 17 here, is that not the item that Muller criticizes as creating additional friction?

[00:06:21] Speaker 00:
That is the dose setting drum, which is what Muller discusses in paragraph eight.

[00:06:26] Speaker 00:
And again, what Muller says in paragraph eight.

[00:06:28] Speaker 03:
OK, but that's not used in the embodiment that's being combined here, correct?

[00:06:39] Speaker 00:
It's using the embodiment, but what Milan is discussing is about the second embodiment uses the spindle.

[00:06:47] Speaker 03:
But not to translate the injection force, right?

[00:06:50] Speaker 00:
Excuse me?

[00:06:51] Speaker 03:
Not to translate the injection force.

[00:06:53] Speaker 00:
Not to transfer the injection force.

[00:06:57] Speaker 00:
That is the spindle or the piston rod.

[00:06:59] Speaker 00:
But again, neither the board nor molar distinguish between whether it's used with the piston rod or the dose setting drum.

[00:07:08] Speaker 00:
And if you look at paragraph 11 from Mueller, which notably Mylan doesn't even respond to, it's clear that Mueller is criticized in threaded hearings in general.

[00:07:17] Speaker 00:
Mueller looks at both rack and pinion systems and threaded hearings, and it says don't use a threaded hearing.

[00:07:24] Speaker 00:
It says avoid threaded hearings.

[00:07:26] Speaker 03:
If that's not a T2... What page is the appendix we're talking about here?

[00:07:29] Speaker 00:
That's the appendix 2793, and that's in paragraph 11 of Mueller.

[00:07:54] Speaker 00:
that paragraph 11 explicitly uses the words that threaded gearing should be avoided.

[00:07:59] Speaker 00:
And Moeller, himself a skilled artisan at the time, was looking at the different approaches, either threaded gearing or... It should be avoided because it creates friction.

[00:08:10] Speaker 00:
Excuse me?

[00:08:11] Speaker 02:
It should be avoided because of enhanced friction.

[00:08:13] Speaker 02:
Exactly, that's precisely... But the embodiment in SJ that Mylan is relying on

[00:08:19] Speaker 02:
And I don't think you disagree with the fact that they are relying on this other embodiment has very much minimized friction because they shrunk the side of the drum.

[00:08:29] Speaker 00:
We disagree that there is still a significant amount of friction there.

[00:08:33] Speaker 00:
Even though it doesn't use a drum, there's still friction with the piston rod.

[00:08:36] Speaker 00:
And again, this is threaded gearings in general.

[00:08:39] Speaker 00:
And all threaded gearings.

[00:08:40] Speaker 02:
Didn't the board conclude, OK, fine.

[00:08:42] Speaker 02:
Well, there's a little bit of friction, but that's not harmful because there are other things that are OK.

[00:08:48] Speaker 00:
We disagree.

[00:08:49] Speaker 00:
What the board found was that there were benefits of steam-filled Jensen, but the board impermissibly looked to the O8 patent in writing off the concerns of friction.

[00:08:59] Speaker 00:
The board found that while Moller did have a concern with reducing friction, it found that the patent owner here couldn't identify where this was a benefit.

[00:09:08] Speaker 02:
Is your view that Moller teaches that you absolutely avoid all friction?

[00:09:14] Speaker 02:
When you say that this paragraph 11 says, you know, we don't want to do this, do you understand Moller to say that no one would ever do anything that added any friction?

[00:09:27] Speaker 00:
I think it's clear that Moller is saying don't use a threaded earring because it adds friction and that that's a very important consideration in the design of these injector pins.

[00:09:35] Speaker 00:
Both experts agreed that in the design of injector pins that reducing

[00:09:40] Speaker 00:
that reducing the amount of force that you need to inject the medicine is important design consideration.

[00:09:46] Speaker 00:
And you have to think about what the purpose of these are.

[00:09:49] Speaker 00:
The purpose of these are often for individuals to self-administer medication.

[00:09:55] Speaker 00:
Often these are diabetics with weakened hand function.

[00:09:58] Speaker 00:
And the higher the injection force needed because of more friction, the harder it is to insert the medication, to press down on the button and insert the medication.

[00:10:06] Speaker 00:
And that's why friction is a very important concern here.

[00:10:09] Speaker 03:
And again, the board was... But Mueller doesn't say don't use it.

[00:10:14] Speaker 03:
It says that a gearing which produces linear movement as opposed to rotational movement avoids friction, right?

[00:10:25] Speaker 00:
What Mueller states, I believe, you have to look at it in context, where Mueller is walking through the... It doesn't say, I'm correct, it doesn't say don't do this.

[00:10:34] Speaker 03:
It says that doing it in this alternative way results friction.

[00:10:40] Speaker 00:
It says that this sort of gearing and using the rack and pinion gearing, which doesn't have those friction concerns, avoids that transformation of rotational movement to linear movement.

[00:10:51] Speaker 03:
Which is not quite the same thing as saying don't do the rotational approach.

[00:10:59] Speaker 00:
Well, Moller is clearly saying, though, that it's clear that Moller is discouraging this use of using a threaded gearing, including in Steamfield-Johnson's second embodiment.

[00:11:07] Speaker 00:
And this court's case law is clear that when a reference is discouraging investigation into the invention claim, that that would constitute a teaching away.

[00:11:16] Speaker 00:
And again, there are reasons why the board wrote off this teaching away.

[00:11:19] Speaker 03:
I'm not sure that constitutes a teaching away.

[00:11:22] Speaker 03:
It avoids a problem.

[00:11:26] Speaker 03:
It doesn't say don't use it.

[00:11:28] Speaker 03:
Teaching away seems to say don't use the approach.

[00:11:36] Speaker 00:
Teaching away is, again, whether it's discredit, whether it's discrediting, criticizing, or discouraging, is what the Hayslaw says, and that's in Depute Spinal.

[00:11:45] Speaker 00:
But here, we have the board even recognizing that Mueller criticizes this aspect of Steenfeld-Jensen.

[00:11:52] Speaker 00:
So again, we believe this does amount to a teaching away here.

[00:11:55] Speaker 00:
But it's important to recognize why the board found this wasn't a teaching away, because it looked to whether the Frederick hearing was desirable for other purposes, and it found that

[00:12:06] Speaker 00:
The O8 patent wasn't concerned with the disadvantages of concern in molar, i.e.

[00:12:10] Speaker 00:
friction, because the O8 patent was concerned with providing a drug delivery device that allows a user to set the dose, which was the same purpose as Seinfeld Jensen, and therefore the board found that threaded gearing was suitable for another purpose.

[00:12:24] Speaker 00:
But that was wrong.

[00:12:25] Speaker 00:
The very first sentence of molar states that its purpose is also

[00:12:29] Speaker 00:
for a syringe by which a dose can be set.

[00:12:31] Speaker 00:
It makes no sense to distinguish molar and simple gentsin based on this ground.

[00:12:36] Speaker 02:
What does friction have to do with setting the dose?

[00:12:39] Speaker 02:
Excuse me?

[00:12:39] Speaker 02:
What does friction have to do with setting the dose?

[00:12:42] Speaker 00:
Well, that's exactly where the point is that the board was in... Both patents are concerned about setting the dose.

[00:12:48] Speaker 02:
We want to be able to make certain you get the dose set right.

[00:12:51] Speaker 02:
Right.

[00:12:52] Speaker 02:
And then there's an argument that you might enhance the friction.

[00:12:55] Speaker 02:
Well, who's worried about friction?

[00:12:58] Speaker 00:
Well, that's what we're saying, that Opposa would be worried about friction.

[00:13:01] Speaker 00:
We had expert testimony that stated that.

[00:13:03] Speaker 00:
And again, Mueller is clear.

[00:13:04] Speaker 02:
We're worried about friction in the context of a whole lot of patents and a whole lot of field of art and all these patents.

[00:13:10] Speaker 02:
But in particular, of these particular patents that we're talking about, where's the worry about friction?

[00:13:16] Speaker 02:
The worry about friction is... Especially minimize friction as a result of the embodiment of SGA that Island uses for purposes of this analysis.

[00:13:27] Speaker 00:
Nowhere did the board find that the embodiment that Mylin is proposing, the second embodiment, reduced friction here.

[00:13:33] Speaker 00:
Again, the board wrote off the concerns of friction solely by looking at the 08 patent, which was an impermissible use of hindsight bias.

[00:13:40] Speaker 00:
And again, it was also wrong, A, in the purpose that we just looked at.

[00:13:44] Speaker 03:
We have a somewhat different situation of the patent here.

[00:13:47] Speaker 03:
It said the virtue of this design is it avoids friction.

[00:13:51] Speaker 03:
And it doesn't say that, right?

[00:13:53] Speaker 00:
Excuse me?

[00:13:55] Speaker 03:
We have a different situation here if the Sanofi patent said the design avoids friction, but it doesn't say that.

[00:14:04] Speaker 03:
It doesn't tout an advantage of the invention of avoiding friction.

[00:14:09] Speaker 00:
Well, the OA patent doesn't use the magic word friction, but it's clear in the patent that it's discussing that its objective is to create a pen with lower injection force for the point that we discussed that the higher the injection force, the harder it is

[00:14:24] Speaker 00:
for patients to be able to inject the medicine themselves.

[00:14:28] Speaker 02:
And again, that's... Where is the patent talking about lesser injection force?

[00:14:38] Speaker 00:
You can find that on page... Appendix 85 at column one, line 41.

[00:14:48] Speaker 00:
where it states that a prime objective of the device is to achieve low injection force.

[00:14:52] Speaker 03:
Which is achieved by using the thread and grooves, right?

[00:14:57] Speaker 00:
Well, our patent did use the thread and grooves, but it shows the inventiveness of the patent that it found a way to do this, including by using a clutch, to reduce friction while also making a superior pen.

[00:15:10] Speaker 00:
And again, looking at the patent itself, which the board was improper to do to find obviousness,

[00:15:16] Speaker 03:
is incorrect, it only shows the inventiveness, because Moeller clearly said... But it says that we reduce the force by using a thread and groove approach, right?

[00:15:26] Speaker 03:
It does, but again, it found a better way to use the thread and groove approach, and that's... And the approach of using thread and groove, according to you, necessarily creates friction.

[00:15:36] Speaker 00:
It does necessarily create some friction, but again, looking at the OOA patent is... But the overall force

[00:15:43] Speaker 03:
may be reduced even with the friction as opposed to an actual approach, right?

[00:15:50] Speaker 00:
Sorry, can you say that again?

[00:15:51] Speaker 03:
If you use the thread and groove approach, you may be increasing friction, but the idea is that you reduce the overall force required because of the thread and groove approach.

[00:16:05] Speaker 00:
When you have a threaded UV, you will have some friction, but again, looking to the OA patent here,

[00:16:10] Speaker 00:
is an impermissible use of hindsight.

[00:16:12] Speaker 00:
This shows that the inventor was able to find a way, despite these teaching a way, despite the problems here, and made an inventive pen that was not obvious.

[00:16:20] Speaker 03:
They didn't invent the thread and groove approach, right?

[00:16:23] Speaker 00:
They didn't invent the thread and grooves, but they invented a better way to make it, using superior parts in what we believe.

[00:16:30] Speaker 00:
But again, this is using the OA patent as a consideration here, looks to the impermissible hindsight when we should really be focusing on what the prior art references state, including especially with molar that discusses that threaded earrings should be avoided.

[00:16:46] Speaker 03:
OK.

[00:16:47] Speaker 03:
All right.

[00:16:47] Speaker 03:
Unless there are any questions, I think we're out of time.

[00:16:49] Speaker 03:
We'll give you two minutes for a model.

[00:16:51] Speaker 00:
Thank you, Your Honor.

[00:16:52] Speaker 03:
Mr. Karsten again.

[00:16:56] Speaker 04:
Good morning.

[00:16:56] Speaker 04:
May it please the court?

[00:17:02] Speaker 04:
We have another standard KSR obviousness application here of Mueller in view of St.

[00:17:10] Speaker 04:
Paul Jensen.

[00:17:13] Speaker 04:
The panel considered everything.

[00:17:17] Speaker 04:
And it made a finding.

[00:17:21] Speaker 01:
Sure.

[00:17:22] Speaker 01:
Panels that consider everything sometimes get things wrong.

[00:17:25] Speaker 01:
Why did they not get this wrong?

[00:17:26] Speaker 04:
Oh, they didn't get this wrong because they found that a person of ordinary skill in the art would have a reason to combine the teachings of Muller and Steenfeld Jensen.

[00:17:36] Speaker 04:
That's would, not a could.

[00:17:38] Speaker 04:
And they found that the so-called criticisms, the first one of paragraph eight, talks about the large surface friction bearing surfaces in Steenfilt-Jensen, which there's testimony that Steenfilt-Jensen embodiment two does not share that drum that is in the force chain.

[00:18:01] Speaker 04:
Their expert, Dr. Slocum, confirmed at deposition that that drum was not in the force chain in embodiment two.

[00:18:08] Speaker 04:
Uh, and that the proposed advantages of that combination on balance outweighed the disadvantages.

[00:18:18] Speaker 04:
That's a finding at APPX 28.

[00:18:21] Speaker 04:
Now, there's been some suggestion, and all of those findings were supported by substantial evidence and expert credibility determinations.

[00:18:30] Speaker 04:
The credibility determinations are a little bit less in this case in terms of the final written decision that you see in some of the others.

[00:18:36] Speaker 04:
But nevertheless, they credited the expertise of Mr. Leising, Mylan's expert below, in reaching those conclusions.

[00:18:44] Speaker 04:
In fact,

[00:18:45] Speaker 04:
At APPX 17, after considering the record as a whole, they specifically adopt findings in Miland's proposal from pages 19 to 41.

[00:19:00] Speaker 04:
That's APPX 127 to 149.

[00:19:03] Speaker 04:
And at APPX 135, there is a specific finding that a person of ordinary skill in the art would have a reason to combine the teachings of Muller and Steenfeld-Jensen.

[00:19:15] Speaker 04:
Because Steampel Jensen makes use of a simple piston driving mechanism and the simplification and reduction of internal components is advantageous and an objective in the industry.

[00:19:28] Speaker 04:
That's supported by St.

[00:19:30] Speaker 02:
Stephen.

[00:19:31] Speaker 02:
And you relate that statement to the embodiment of S.J.

[00:19:36] Speaker 02:
that Myline proposed to use?

[00:19:38] Speaker 02:
Yes.

[00:19:39] Speaker 02:
Although it doesn't expressly say so.

[00:19:41] Speaker 04:
It does not, in that sentence, specifically identify St.

[00:19:44] Speaker 04:
Stephen Jensen embodiment 2, but as we identified,

[00:19:48] Speaker 04:
There is that suggestion that you're cautious about having large surfaces that slide over each other, and depot gents and embodiment two does not contain that.

[00:19:58] Speaker 02:
Even if the Borden had not expressly adopted the fact findings with regard to the embodiment that you chose from SJ, the facts are in the record.

[00:20:11] Speaker 02:
Exactly.

[00:20:11] Speaker 02:
And they aren't contested.

[00:20:13] Speaker 02:
by your opponent that that other embodiment shows a reduced amount of friction.

[00:20:20] Speaker 02:
Exactly right, Your Honor, and so therefore I think... Your view would be we could rely on that even if it hadn't been a specific fact finding by the board?

[00:20:28] Speaker 04:
Yes, Your Honor.

[00:20:29] Speaker 04:
I mean, I think

[00:20:31] Speaker 04:
the alternative would be for the court to remand and to say all right uh... panel please look at that right despite despite the hundred-odd pages that you've decided here we need to make this specific finding because that's absent but you know uh... we we know what the panel is going to do they make similar factual findings in the other i'd be ours about the disparity or differences

[00:20:54] Speaker 02:
between the particular steamfield jensen and monuments and i think that was i missed and this was the only one of the six and which the boys specifically adopted the fact-finding zone as stated in your petition that's correct i believe that that's absolutely just jumped out at me and so i'm trying to find out exactly how much does that embrace well i think it embraces the pet the pages that uh... that places everything your experts on every topic uh...

[00:21:21] Speaker 04:
not not and then why didn't you feel didn't embrace everything on every topic it certainly embrace the claim charts uh... so that the depictions and descriptions that went along with the claim charts about where each evidence where the evidence that supports the findings for each of the elements being found in the art certainly those are that's clearly in those pages that the board adopted and you know i think

[00:21:46] Speaker 04:
Properly so, it would just have to retype essentially what we offered in terms of those.

[00:21:53] Speaker 04:
But it did do independent separate analysis on the motivation.

[00:21:57] Speaker 04:
It did do separate independent analysis in terms of considering the balancing of the advantages.

[00:22:04] Speaker 02:
Am I correct in thinking that your adversary did not counter the fact that your proposed

[00:22:12] Speaker 02:
combination relied on the embodiment and SJ that showed the smaller drum and the lesser friction.

[00:22:19] Speaker 04:
They fully understood that and appreciated that.

[00:22:22] Speaker 04:
They had their experts say whatever their expert said about increases in friction and so forth.

[00:22:27] Speaker 02:
But their expert also recognized, as I think I said... Of course, because the embodiment you relied on changed the structure of the device and when you changed the structure you had less material over which to

[00:22:39] Speaker 02:
create a friction by rubbing something else against it.

[00:22:42] Speaker 04:
That's exactly right.

[00:22:43] Speaker 04:
And if you're interested in finding where their expert sort of begrudgingly agreed with that, it's on the record, APPX 3962.

[00:22:50] Speaker 04:
That's his deposition.

[00:22:55] Speaker 02:
OK, thank you.

[00:22:55] Speaker 02:
I don't want to use up all your time.

[00:22:58] Speaker 04:
It's fine, Your Honor.

[00:22:59] Speaker 04:
We're here to help you.

[00:23:00] Speaker 04:
And so if it's troubling, Your Honor, we're happy to give you whatever insight and help we can give Judge Toronto.

[00:23:06] Speaker 01:
Can you address this?

[00:23:09] Speaker 01:
unusual, seemingly unusual use by the board of the 008 patent in its teaching away analysis.

[00:23:19] Speaker 04:
I don't think it did use the 008 patent in the teaching away analysis.

[00:23:23] Speaker 04:
It cited the 008 patent.

[00:23:24] Speaker 04:
It's the last paragraph.

[00:23:26] Speaker 04:
In its teaching away analysis, but it did that.

[00:23:29] Speaker 04:
It made a finding.

[00:23:30] Speaker 01:
It has some idea that the purpose

[00:23:39] Speaker 01:
where the concern of the 008 patent is relevant to the question of whether Mueller teaches away from this particular limitation.

[00:23:56] Speaker 01:
So it cites to... This is at A23 of the appendix.

[00:24:00] Speaker 01:
Right.

[00:24:02] Speaker 01:
And I'm trying to understand

[00:24:05] Speaker 01:
What's the ordinary logic and doctrinal framework in which to understand why that use of the 008, the patented issue, is proper?

[00:24:25] Speaker 04:
I think that if you look at page 22, there's

[00:24:31] Speaker 04:
That's where, to my mind, the panel actually dispatches of the argument about teaching away.

[00:24:38] Speaker 04:
I mean, it says in the first full sentence in the last paragraph on page 22, although we agree with patent donor that Mueller criticizes, and then it quotes Mueller, we do not agree that this criticism rises to the level of a teaching away.

[00:24:55] Speaker 04:
And it cites paragraph eight.

[00:24:57] Speaker 04:
I think that's the finding.

[00:24:59] Speaker 04:
It then turns.

[00:25:01] Speaker 04:
to the only patent and it it does this in connection with the suitability analysis so uh... synovia had suggested that steam felt jensen no way you know how is going to get you to lower friction any embodiments including too and i think this is the the patent office responding to that unsuitability argument i think you're i think you're honest put your finger right on it

[00:25:28] Speaker 04:
You know, Sanofi in the IPR was saying there's no way that the Steenfeld Jensen can reduce friction, and yet the OLA patent supposedly solves this friction problem or lower injection force problem by just wholesale adopting essentially

[00:25:49] Speaker 04:
the doubly-threaded piston rod approach from Steve Pilchinson to reduce friction.

[00:25:55] Speaker 04:
So there's a tension there.

[00:25:57] Speaker 04:
And I see this as the panel was actually responding to Sanofi's suitability argument as having already made a determination that there was no teaching away.

[00:26:08] Speaker 04:
and candidly the teaching away uh... at paragraph eight is very weak i don't think it is teaching way at all in fact that paragraph ends by saying because of these issues we prefer the rack and pinion or the the you know that the year and we'll be real and and and rack mechanism it doesn't say we would never do uh... never do a threaded engagement but it is simply said for her if the objective here is to come up

[00:26:38] Speaker 03:
with an injection pin which reduces force.

[00:26:43] Speaker 03:
As I understand the approach of the patent, it reduces the force by using a thread and gear approach instead of axial injection.

[00:26:54] Speaker 03:
And if that, if someone wants to pursue that objective, that person necessarily would realize that there's some increase in friction.

[00:27:06] Speaker 03:
as a result of using the thread and groove approach, but that the overall benefit would be that there's less force required.

[00:27:16] Speaker 03:
And isn't that essentially what the board found?

[00:27:19] Speaker 04:
I think that's exactly right, as well as other benefits that we talked about, so the reduction of parts and so forth.

[00:27:25] Speaker 04:
And the panel below at APPX 28, I believe, expressly made that balance and that finding, saying that a person of skill in the art

[00:27:36] Speaker 04:
that those the advantages of this approach would outweigh the disadvantages, which is exactly what the panel presumably ought to be doing here, assuming that we even need to get to a weighing of the advantages and disadvantages, given that this really is, again, another example of the ER-KSR case, right?

[00:27:56] Speaker 04:
You've got familiar elements, known methods, predictable results.

[00:28:02] Speaker 04:
And so, you know, I think this

[00:28:04] Speaker 04:
We've got motivation.

[00:28:07] Speaker 04:
uh... there's no teaching way sure there's criticism of certain embodiments of the steeple jensen approach but this is the trend this is this is a direct translation of one known operational mechanism for transferring force down through to uh... in place of the rap companion which is exactly the substitution that's driving the the the the molar patent where he says i just prefer to have this this gear wheel mechanism

[00:28:37] Speaker 04:
In terms of the, I'd like to just address briefly the insert argument.

[00:28:41] Speaker 04:
The specification is very clear.

[00:28:43] Speaker 04:
It contains a must express definition of insert and it talks about how an insert can be part of the housing.

[00:28:52] Speaker 04:
I can have some sites for you.

[00:28:53] Speaker 04:
This is a APPX 85 to 86, column two, line 66 to column three, line two.

[00:29:00] Speaker 04:
And then there was some apparent bafflement by how

[00:29:04] Speaker 04:
an insert could be still part of the housing and of course at APPX 88 column 7 lines 37 to 39 it says an insert may be formed integrally and it talks about using a flange.

[00:29:20] Speaker 04:
It's an insert that's still part of the housing.

[00:29:22] Speaker 04:
It's still an insert.

[00:29:24] Speaker 02:
And I really do believe... Is this a matter of claim construction with BRI?

[00:29:28] Speaker 04:
uh... what's the all right and so you know it's a good i'm asking you'd have to find that that there's a clear disavowal of the of that description by virtue of the preposition in and the preposition in just refers to look like that we were decided as a matter of a claim instruction and then the issue goes away

[00:29:48] Speaker 04:
Yeah, I don't see that the preposition in gives rise to a determination about method of manufacturing.

[00:29:55] Speaker 04:
It simply directs you to location, and the insert is in regardless.

[00:30:00] Speaker 04:
And so I think the claim construction issue is the panel considered that argument and made a finding.

[00:30:11] Speaker 04:
And I think that finding is consistent with the broadest reasonable interpretation of the claim.

[00:30:18] Speaker 04:
I see I have a minute left on the clock.

[00:30:22] Speaker 04:
I'm happy to address any questions that you all have.

[00:30:28] Speaker 02:
Save your breath.

[00:30:29] Speaker 02:
We've got another case to deal with.

[00:30:31] Speaker 04:
I do.

[00:30:31] Speaker 04:
Three or four.

[00:30:32] Speaker 04:
But it's fun to argue in person again.

[00:30:36] Speaker 04:
And I want to thank the court for opening the court and allowing us to show up here in person.

[00:30:40] Speaker 04:
It really is very special.

[00:30:43] Speaker 03:
So thank you.

[00:30:43] Speaker 03:
Thank you, Mr. Karsten.

[00:30:46] Speaker 03:
Ms.

[00:30:46] Speaker 03:
Sternleib, you've got two minutes.

[00:30:49] Speaker 00:
Your Honor, briefly addressing Judge Clevenger's question about whether it needs to disavow a patent, it's clear from the patent language itself that this is an alternative embodiment that Mylan is relying on.

[00:31:02] Speaker 00:
The integral formation is not part of the claim language and it would be incorrect to, when a patent describes multiple embodiments,

[00:31:10] Speaker 00:
It doesn't need to, the claim language doesn't necessarily extend to every embodiment, and that's clear when the plain language itself would not allow that here.

[00:31:18] Speaker 00:
And again, the plain language, it's not just the word in, it's provided in.

[00:31:21] Speaker 00:
It just doesn't make sense for the way that Mylan argues it.

[00:31:25] Speaker 00:
Turning to Judge Sharonto's question, you're right, this is a very unusual use of the O08 patent in its analysis, and they can't identify why the use of the O08 patent was improper here, but it was, this is hindsight analysis.

[00:31:40] Speaker 00:
hindsight bias.

[00:31:42] Speaker 01:
Why isn't that paragraph just superfluous?

[00:31:46] Speaker 00:
Well, that's exactly what I'd like to address, Your Honor, and that's because it's not superfluous, because the very last line of that, after going through the purposes, says, for this reason, in this case, Mueller does not teach away from the proposed combination.

[00:32:00] Speaker 00:
And it's clear that this reason is talking about the purpose.

[00:32:03] Speaker 00:
It comes after four sentences of discussing the purpose of Seinfeld-Johnson in the OOA patent.

[00:32:08] Speaker 00:
And again, the very first sentence of Mueller states that the purpose is exactly the same for the user to set the dose.

[00:32:14] Speaker 00:
So again, it's for this reason.

[00:32:16] Speaker 01:
It's clear that that was a part of the... Are there or are there not essentially independent findings by the board that what Mueller criticizes is a big surface situation where friction would be great and doesn't sufficiently criticize

[00:32:39] Speaker 01:
lesser arrangements that have friction.

[00:32:43] Speaker 01:
Most things will have some, and therefore it doesn't rise to the level of teaching away.

[00:32:52] Speaker 01:
Or have I just made up a different opinion?

[00:32:55] Speaker 00:
We don't believe that the board says that, and also that's not what Mueller says.

[00:32:59] Speaker 00:
Mueller is clearly criticizing threaded gearing in general.

[00:33:02] Speaker 00:
If you look at paragraph seven, it discusses another prior reference where it's talking about where the threaded gearing is on a spindle, aka a piston rod, which is exactly what you have in the second embodiment.

[00:33:14] Speaker 00:
And then if you look again back at paragraph 11, it's saying that you should use a direct gearing, i.e.

[00:33:19] Speaker 00:
a rack and pinion,

[00:33:20] Speaker 00:
because that avoids these transformations of rotational movement to linear movement and linear movement to rotational movement, and that sort of transformation occurs both in the second embodiment and the first embodiment.

[00:33:32] Speaker 00:
There's nowhere in Moeller to suggest that it's only talking about one versus another.

[00:33:35] Speaker 00:
Moeller is clearly looking at threaded gearing and saying, these should be avoided.

[00:33:39] Speaker 00:
We should use a rack and pinion itself.

[00:33:42] Speaker 00:
Again, this is

[00:33:45] Speaker 00:
the reduced amount of friction, there is still some friction, like in paragraph seven as it states about the spindle.

[00:33:50] Speaker 00:
And this is important because Mueller is saying, don't use this way, use of rack and pinion, and that is a reason not to modify.

[00:33:58] Speaker 00:
This is why that there would be no reason for a POSA to combine these references, and why we believe that the board's decision should be reversed on this matter.

[00:34:05] Speaker 02:
I didn't recall your reference to Mueller paragraph seven in your brief.

[00:34:12] Speaker 02:
Could you help me out with that?

[00:34:15] Speaker 02:
mine may be a little hazed by all the pages.

[00:34:18] Speaker 00:
I'm not sure if we describe paragraph 7 itself.

[00:34:21] Speaker 02:
In this argument that you're making that paragraph 7 undermines everything your adversary's been saying about embodiment of choice, I just didn't see that either in the description of the debate and by the board level, or I didn't see it in your book.

[00:34:36] Speaker 00:
We were right, it's not in our papers, but it is in Mueller.

[00:34:39] Speaker 00:
And again, we argued it.

[00:34:40] Speaker 02:
I know, but where was the argument made?

[00:34:42] Speaker 00:
We didn't respond.

[00:34:43] Speaker 02:
They need an opportunity to respond if you're going to make an argument that totally slices them off at the knees.

[00:34:49] Speaker 00:
Well, I appreciate you think it slices them off their knees.

[00:34:51] Speaker 02:
Well, I mean, if it slices them off at their knees.

[00:34:54] Speaker 00:
Well, they had Mueller in front of them.

[00:34:56] Speaker 00:
They knew we were arguing Mueller in general.

[00:34:58] Speaker 00:
It's not to say they had no ability to respond to it.

[00:35:01] Speaker 02:
They, I mean, it isn't their obligation to bring up Mueller 7.

[00:35:05] Speaker 02:
Excuse me?

[00:35:05] Speaker 02:
You said they.

[00:35:06] Speaker 02:
When you said they had it in front of them, did you mean the board or did you mean your adversary?

[00:35:11] Speaker 00:
I mean, both of them.

[00:35:12] Speaker 00:
They both had Mueller in front of them.

[00:35:13] Speaker 00:
Mueller was the prime prior art that we were looking at.

[00:35:15] Speaker 02:
Right, but there's nothing in the board decision picking out Mueller 7 to say, to my land, you don't know what you're talking about.

[00:35:24] Speaker 00:
We agree, but that's why we believe the board was wrong that it didn't consider all of Mueller in context and realized that Mueller was criticizing threaded hearings in general.

[00:35:32] Speaker 02:
Well, is the game that we should

[00:35:34] Speaker 02:
start this from fresh like we were the board?

[00:35:38] Speaker 02:
We don't believe that you need to start it from fresh because we believe that the plane... Well, if I can't get, if the only way I can get, because I hear you be saying that you didn't make any reference to, specifically to molar seven, in this connection you're telling me that we should, and I'm reading you to say we should start from scratch.

[00:35:56] Speaker 00:
We believe that based on the plain language of Mueller itself, which the board of the parties considered, that you don't need to remand because, again, this is about Mueller in context and that it's in threaded hearings in general.

[00:36:09] Speaker 00:
Paragraph 7 is helpful, as you note, but it's helpful to show that it's not just Seinfeld Jensen's first embodiment that it's referring to.

[00:36:16] Speaker 00:
And again, paragraph 11, which Mylan doesn't even respond to in their briefs, is saying threaded hearings in general.

[00:36:24] Speaker 02:
That's because you didn't raise it.

[00:36:25] Speaker 00:
We did raise Paragraph 11, Your Honor.

[00:36:27] Speaker 00:
That's in our brief.

[00:36:29] Speaker 02:
I thought I asked you for a citation and you didn't give it to me.

[00:36:32] Speaker 00:
Oh, I'm sorry.

[00:36:32] Speaker 00:
It's in, I can pull up the page.

[00:36:37] Speaker 00:
I know it's in our reply brief on page 14.

[00:36:41] Speaker 00:
Reply what?

[00:36:42] Speaker 00:
The gray brief for 14.

[00:36:45] Speaker 00:
And I believe it's also in our blue brief at, I can pull up the page.

[00:36:53] Speaker 00:
On page 32, on the blue brief.

[00:37:00] Speaker 02:
Page 32.

[00:37:07] Speaker 02:
There's a quotation from Moller there to 7.

[00:37:09] Speaker 02:
Is that where you're... Where it's... That's discussing... What does that matter on page 32?

[00:37:17] Speaker 00:
It's discussing Moller paragraph 11.

[00:37:22] Speaker 03:
From the middle to the bottom of the page.

[00:37:25] Speaker 00:
After the afforded language there.

[00:37:28] Speaker 03:
Okay, thank you.

[00:37:29] Speaker 00:
Thank you, Your Honors.

[00:37:31] Speaker 03:
Thank both counsel.

[00:37:32] Speaker 03:
The case is submitted.