[00:00:00] Speaker 04:
I have an ex-argued case this morning.

[00:00:02] Speaker 04:
It's number 21, 1939.

[00:00:05] Speaker 04:
Immunogen incorporated against Hirschfeld as acting director of the PTO.

[00:00:12] Speaker 04:
Mr. Jaffrey.

[00:00:17] Speaker 00:
Good morning, Your Honor.

[00:00:18] Speaker 00:
May it please the Court.

[00:00:20] Speaker 00:
I'd like to discuss both indefiniteness and obviousness.

[00:00:23] Speaker 00:
But let me start with obviousness because the office is currently using the district court's decision to reject other applications.

[00:00:31] Speaker 00:
The district court held that the claim was obvious on summary judgment, despite the fact that no one had even recognized the problem of Merituximab causing ocular toxicity in humans.

[00:00:42] Speaker 00:
No one had ever used AIBW dosing before with any ADC, much less to solve that ocular toxicity problem.

[00:00:49] Speaker 00:
And when trying to deal with ocular toxicities with other drugs, scientists had changed other things.

[00:00:54] Speaker 00:
They had never used AIBW.

[00:00:57] Speaker 00:
And indeed, the office's own expert admitted

[00:00:59] Speaker 00:
that six milligrams per kilogram of a patient's adjusted ideal body weight, AIBW, was not obvious.

[00:01:07] Speaker 00:
And the office really doesn't disagree with that.

[00:01:10] Speaker 00:
Rather, it states on page 2 of its brief, the particular dose of six milligrams per kilogram would have been discovered.

[00:01:19] Speaker 00:
But the standard for obviousness is not would have been discovered.

[00:01:24] Speaker 00:
And at a bare minimum, there were factual determinations that should not have been resolved against the mutagen.

[00:01:30] Speaker 00:
The office's obviousness argument hinges upon the LUTs 282 reference.

[00:01:35] Speaker 00:
But that reference only highlights why a immunogen's application is not obvious.

[00:01:40] Speaker 03:
Mr. Jaffe, can I ask you, are you seeking reversal with your first argument?

[00:01:45] Speaker 03:
Is that your suggestion, as opposed to a vacate remand?

[00:01:48] Speaker 00:
We would only suggest that you vacate and remand for financial triumph.

[00:01:52] Speaker 03:
Because there was no cross-motion for some reason.

[00:01:53] Speaker 00:
There was no cross-motion, and this is just purely incorrect summary determination against my client.

[00:01:59] Speaker 03:
So really all you need to show is that there's genuine issues of material fact?

[00:02:03] Speaker 00:
Exactly right.

[00:02:04] Speaker 00:
And there are more than a lot.

[00:02:08] Speaker 00:
And specifically, if we look at the Lutz 282,

[00:02:12] Speaker 00:
I mean, that reference alone is the one that shows why immunogen's application is not obvious.

[00:02:17] Speaker 00:
The office uses LUTs 282 as its primary reference.

[00:02:22] Speaker 00:
But immunogen tried to use the doses in LUTs 282.

[00:02:26] Speaker 00:
And LUTs 282 said in its own words that it solved the problem of ocular capsicillin rabbits.

[00:02:33] Speaker 00:
But when immunogen tried to use that prior reference, you tried to use those doses, it failed.

[00:02:39] Speaker 00:
So there cannot be any reason to think that a reference that you try to use fail and then come up with a different solution that actually works means that the new solution is obvious in light of those failed attempts.

[00:02:52] Speaker 00:
So it is only due to the precise use of the six milligrams of AIBW dosing that solved the problem of ocular toxicity and none other.

[00:03:03] Speaker 00:
So now, if I could direct the court's attention to indefiniteness.

[00:03:07] Speaker 00:
The district court's fundamental error in this regard is that it explicitly declined to understand or consider how a person of skill in the art would read the patent.

[00:03:18] Speaker 00:
Every single one of the experts in this case agreed that the formula that you use in order to determine a patient's adjusted ideal body weight is drug specific.

[00:03:29] Speaker 00:
There is only one formula for AIBW that would actually work for mirabituximab, and it is experimentally determined.

[00:03:37] Speaker 00:
And that comes straight out of their own expert's mouth.

[00:03:40] Speaker 00:
Dr. Figg stated in discussing what AIBW formula would have been used by a person of skill in the art.

[00:03:49] Speaker 00:
He said in the response to the question, you had said that there's different correction factors for the AIBW calculation, right?

[00:03:57] Speaker 00:
Correct.

[00:03:58] Speaker 00:
And that is drug specific.

[00:04:00] Speaker 00:
Right?

[00:04:01] Speaker 00:
Answer?

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

[00:04:03] Speaker 00:
Would it have been obvious to use the specific value of 0.4 given in the 809 application when dosing merbituximab?

[00:04:12] Speaker 00:
Answer, no.

[00:04:14] Speaker 00:
And the reason you didn't know that is because you needed the data.

[00:04:19] Speaker 00:
Answer, correct.

[00:04:21] Speaker 00:
So at the end of the day, there is no confusion among people of skill only art which formula to use.

[00:04:27] Speaker 00:
It's the very formula that is found throughout the immunogen's application.

[00:04:32] Speaker 05:
Can you help me with just a background dumb question?

[00:04:35] Speaker 05:
Why is it so that there's only one AIBW for any particular pharmaceutical?

[00:04:42] Speaker 00:
Because the AIBW formula is based upon how much adipose tissue, how much fat you have in your body.

[00:04:50] Speaker 00:
And so the more fat that you have in the body, the less likely the drug can move around freely to everywhere that needs to go.

[00:04:57] Speaker 03:
Why is it specific for the drug?

[00:05:00] Speaker 03:
For example, in patent law we have the concept that something could infringe or the claim doesn't have to be perfect.

[00:05:10] Speaker 03:
Something could infringe even if it's not as perfect as what's in the specification.

[00:05:14] Speaker 03:
So why couldn't you have various different formulas?

[00:05:18] Speaker 03:
I think that's one of your arguments is that there's various different ways to calculate

[00:05:23] Speaker 03:
the ideal body weight.

[00:05:25] Speaker 03:
So why do you have to just be limited to one misspecification?

[00:05:28] Speaker 00:
There's several reasons for that, Your Honor.

[00:05:30] Speaker 00:
First, their own expert, Dr. Figg, admitted that AIBW formulas are drug-specific.

[00:05:37] Speaker 00:
You have to actually do these things experimentally.

[00:05:39] Speaker 00:
You can't just sort of a priori determine what AIBW formula to use

[00:05:46] Speaker 00:
Um, without knowing which drug you're using and what application you're using it for, which are clearly spelled out in the claim.

[00:05:53] Speaker 03:
So in your specification, you identify the one that goes with this particular drug in the claim.

[00:05:58] Speaker 00:
Exactly.

[00:05:59] Speaker 00:
And it's all found in example four of that, of the application.

[00:06:03] Speaker 05:
Yeah, I understood the point, but I just didn't understand why.

[00:06:05] Speaker 05:
I mean, I understood why you couldn't say I got this drug and I got this drug.

[00:06:09] Speaker 05:
Why wouldn't the same?

[00:06:10] Speaker 05:
It's each one has its own formula.

[00:06:12] Speaker 05:
The formula could be the same.

[00:06:15] Speaker 00:
Well, the evidence is that they're not because different drugs go through your fat and sit in your adipose tissue in different ways.

[00:06:26] Speaker 00:
Moreover, they're not because this is all experimentally determined because ocular toxicity is extremely unpredictable.

[00:06:33] Speaker 00:
People just don't know ahead of time what amounts of drugs are going to cause

[00:06:38] Speaker 00:
you to have blurry vision and ocular toxicity events.

[00:06:41] Speaker 00:
So you have to determine that, what number experimentally, which is what the inventors did.

[00:06:46] Speaker 00:
They're the first ones to ever determine, let's use this AIBW formula and then figure out, oh, if we use the specific milligrams per kilogram of a patient's AIBW using this formula, we have decoupled

[00:07:00] Speaker 00:
the effect of ocular toxicity, the side effects from the effectiveness of the therapy.

[00:07:05] Speaker 05:
Well, do you find the right amount of AIBW by testing and then looking to see if there are adverse effects?

[00:07:13] Speaker 05:
And then simply adjusting up and down?

[00:07:16] Speaker 00:
Not quite, Your Honor, because there's two things that are going on.

[00:07:19] Speaker 00:
First, you have to try to find

[00:07:21] Speaker 00:
the right formula that allows for there not to be a lot of side effects.

[00:07:25] Speaker 00:
But then the second step of it is you have to still ensure that you are actually treating the cancer.

[00:07:31] Speaker 00:
So it's those two things that you have to juggle.

[00:07:34] Speaker 00:
And it could well have been the case that there was no formula and that there was no amount that could have done both things, which is to reduce ocular toxicity but still treat the platinum-resistant ovarian cancer.

[00:07:47] Speaker 05:
Is this a particular problem for immunotherapy for cancers or does it affect blood pressure and all sorts of other diseases?

[00:07:54] Speaker 00:
This is a particular problem in particular for these antibody drug conjugates that take the antibody and link it up with a toxic drug.

[00:08:04] Speaker 00:
using a charge linker.

[00:08:06] Speaker 00:
There's been only something like six ADCs that have ever been approved by the FDA because most of them turn out to be unacceptably toxic.

[00:08:14] Speaker 05:
This is targeted technology.

[00:08:16] Speaker 00:
Exactly.

[00:08:16] Speaker 00:
And so the fact that the vendors came up with this solution at all is shocking because normally you'd expect the more drug you give somebody, the more likely it's going

[00:08:27] Speaker 00:
but also the more likely that it's going to have bad side effects.

[00:08:30] Speaker 00:
And they were able to, using this very specific formula, able to decouple those two things.

[00:08:36] Speaker 00:
And so that's why.

[00:08:37] Speaker 05:
I don't want to use up your argument, but I was just curious about the background.

[00:08:41] Speaker 00:
Yeah, no.

[00:08:41] Speaker 05:
I'm a history major, so I need help once in a while.

[00:08:49] Speaker 05:
When you talk about the Renaissance and the Reformation, all you want.

[00:08:52] Speaker 00:
I probably won't go there in this argument, Your Honor.

[00:08:57] Speaker 00:
The point, though, is that there were specific factual findings that would have made it clear that AIBW in the immunogen application is only that one that is actually printed there in hyperba.

[00:09:20] Speaker 00:
And that's both the fact that their own expert admits that the AIBW formula is drug specific.

[00:09:27] Speaker 00:
There's only one.

[00:09:28] Speaker 00:
But also, remember, this was prosecuted before the office.

[00:09:32] Speaker 00:
So the office had never raised any given point that the examiner never said, I don't understand which AIBW formula you're using.

[00:09:42] Speaker 00:
He was perfectly clear about which formula to use.

[00:09:45] Speaker 00:
The applicant was quite clear that

[00:09:47] Speaker 00:
The AAW formula was the one that was in the specification.

[00:09:50] Speaker 00:
The board itself had no problem understanding at no point before the agency when we could have amended our claims and said, all right, if you don't understand what AAW means, which we think you do,

[00:10:03] Speaker 00:
It's actually, let's just put that formula right into the claims.

[00:10:07] Speaker 00:
No point did they do that.

[00:10:08] Speaker 00:
It was only after once they were sued in district court under section 145 that they raised for the first time, we don't understand what you mean by this term.

[00:10:18] Speaker 00:
That background, that prosecution history should have been looked at and considered at a bare minimum by the district court

[00:10:25] Speaker 00:
in coming to the conclusion about whether the term AIBW was actually indefinite or not.

[00:10:30] Speaker 00:
And this court's case law strongly supports that, at a bare minimum, the district court ought to consider what arguments had been made previously before the office.

[00:10:40] Speaker 03:
On this issue, are you looking for a vacay remand on the indefiniteness issue, or is it because indefiniteness is an ultimate legal question?

[00:10:47] Speaker 03:
Do you think reversal is appropriate?

[00:10:50] Speaker 03:
And with that comes, you know, you're telling us we should be looking at expert testimony.

[00:10:54] Speaker 00:
Yes.

[00:10:54] Speaker 03:
And which raises facts.

[00:10:56] Speaker 00:
I agree.

[00:10:56] Speaker 00:
So that's why we only suggest vacator and remand so that the board can properly consider the expert testimony, which was all in line and all of the court and said that AIBW met one specific thing.

[00:11:09] Speaker 00:
And so as to the question of whether or not Judge Stoll, that there are two grounds

[00:11:15] Speaker 00:
But the problem that we're facing is that the obviousness determination is being used preclusively on other immunogen applications.

[00:11:25] Speaker 00:
So there are other immunogen applications out there that are being found to be obvious based upon issue preclusion.

[00:11:31] Speaker 00:
And so we would ask that this court

[00:11:34] Speaker 00:
uh... vacate uh... that the obvious this determination to besides obviously uh... regardless of what what this court determined that's what i would have alleged that you think there's a lot of genuine issues and material fact you want to list what those are that in the tournament in your briefs on the other hand so the district court made many many findings of fact uh... in its opinion at eighty twenty nine

[00:12:00] Speaker 00:
It states, the prior art teaches every individual element of the asserted claims.

[00:12:05] Speaker 00:
That's a finding of fact.

[00:12:07] Speaker 00:
District court stated,

[00:12:08] Speaker 00:
At A30, for many patients, dosing by total body weight and dosing by AIBW would not result in significant differences.

[00:12:16] Speaker 00:
Another finding of fact.

[00:12:17] Speaker 00:
A poster would have been motivated to investigate dosing methodologies such as AIBW.

[00:12:21] Speaker 00:
A31, another finding of fact.

[00:12:23] Speaker 00:
Ocular Toxicity and Mervituximab would have been known as a result of human testing.

[00:12:28] Speaker 00:
A31, another finding of fact.

[00:12:29] Speaker 00:
I could keep going on and on.

[00:12:31] Speaker 03:
And these are facts that you contend?

[00:12:33] Speaker 00:
Every single one of those are contended.

[00:12:35] Speaker 00:
Exactly.

[00:12:36] Speaker 00:
Every one of those is contested.

[00:12:38] Speaker 00:
Many of those are not only contested, but they're wrong based upon the office's own experts saying the contrary.

[00:12:46] Speaker 00:
I have said, into my rebuttal time, I will reserve the rest of the floor.

[00:12:49] Speaker 04:
Anything else at the moment?

[00:12:52] Speaker 04:
I think we'll save you rebuttal time.

[00:12:54] Speaker 00:
Thank you.

[00:13:03] Speaker 01:
May it please the court, Daniel Casbin on behalf of the USPTO.

[00:13:07] Speaker 01:
I guess I'll start with obviousness, because Mr. Joffrey focused on that.

[00:13:12] Speaker 01:
I think it's important to recognize here what LUTs teaches.

[00:13:16] Speaker 01:
LUTs teaches doses of 6 milligrams per kilogram of the claimed immunoconjugate based on total body weight.

[00:13:23] Speaker 01:
It should be undisputed, I think it is undisputed, that for a patient who's at their ideal body weight, there is no difference

[00:13:30] Speaker 01:
between adjusted ideal body weight and total body weight.

[00:13:33] Speaker 01:
The reason, if you look at the formula, is that the weight in kilograms minus IBW is zero.

[00:13:38] Speaker 01:
So adjusted ideal body weight is the same thing as ideal body weight, which is the same thing as total body weight.

[00:13:43] Speaker 01:
Basically, if they get their claim, you cannot dose a patient who's at their ideal body weight, at six milligrams per kilogram, even though that's exactly what LUTs is telling you to do.

[00:13:53] Speaker 01:
So they're going to preempt you from practicing the prior

[00:13:57] Speaker 03:
is this an obvious misarguing?

[00:13:58] Speaker 01:
It is, because LUS doesn't say just six milligrams.

[00:14:01] Speaker 01:
It teaches ranges right around.

[00:14:02] Speaker 01:
If you look at LUS, it's got doses about five to six, about six to eight.

[00:14:08] Speaker 01:
But they're all centered around the six milligrams.

[00:14:11] Speaker 01:
So it's not an anticipation, because we only have ranges in LUS.

[00:14:13] Speaker 03:
Don't the claims say that you've got to provide the dose based on idealized body weight?

[00:14:23] Speaker 01:
They have never argued that you only infringe if you mentally calculate the dose using a certain formula.

[00:14:31] Speaker 01:
They've always said it's based on the ultimate formula.

[00:14:34] Speaker 01:
There might be issues with it.

[00:14:36] Speaker 03:
Your argument sounds like an infringement argument.

[00:14:38] Speaker 03:
It doesn't sound like an obvious argument.

[00:14:41] Speaker 03:
It sounds like you're concerned that they're going to preempt the field, right?

[00:14:45] Speaker 03:
It doesn't really sound like obviousness to me.

[00:14:47] Speaker 02:
But isn't that which infringes later is anticipated or obvious?

[00:14:51] Speaker 03:
So why don't we talk about what the prior teaches and stick to the subject at hand here, which is whether there's genuine issues of material fact.

[00:14:59] Speaker 03:
For example, on motivation to combine.

[00:15:02] Speaker 03:
Whether there's a motivation to combine, which is a very important factor in an obviousness analysis, that's a fact question.

[00:15:09] Speaker 01:
That is a fact question, but you only need to combine things.

[00:15:13] Speaker 01:
If we start with the LUTs on its own, just if you look at, if there's no difference for patients at their ideal body weight between the types of dosing, then actually the six milligrams per kilogram, there's nothing to combine.

[00:15:24] Speaker 01:
It's all in LUTs.

[00:15:25] Speaker 01:
It's just the specific point within the ranges that LUTs is focusing on six, saying that six milligrams per kilogram is LUTs.

[00:15:33] Speaker 01:
There's no dispute that there is, you don't need AIBW dosing.

[00:15:37] Speaker 01:
If there's no difference between AIBW dosing or total body weight dosing or ideal body weight dosing, they're all the same for a patient at their ideal body weight.

[00:15:44] Speaker 01:
That's the first problem.

[00:15:45] Speaker 03:
What about a scenario where it's not an ideal body weight?

[00:15:48] Speaker 03:
So your obviousness argument only applies in a situation for where the patient's already at their ideal body weight.

[00:15:53] Speaker 01:
We have two arguments.

[00:15:54] Speaker 01:
The first argument is that their claim is broad enough to cover patients at their ideal body weight.

[00:16:00] Speaker 01:
And so those patients, you are preventing them from getting their

[00:16:04] Speaker 01:
their actual, the prior arc dose, or the dose stress in the prior arc.

[00:16:10] Speaker 01:
That's the first argument.

[00:16:11] Speaker 01:
And even if you're right near it, then you're right at the dose optimization, because you're right around the central point that Latta's teaching.

[00:16:17] Speaker 01:
That's the first argument.

[00:16:18] Speaker 01:
The second argument is

[00:16:20] Speaker 01:
will require motivation to combine, which is that the prior art, their own prior art actually says dosing methadone.

[00:16:27] Speaker 03:
I was just looking at the claim.

[00:16:29] Speaker 03:
I'm just having such a hard time with your argument that the claim isn't limited to adjusted ideal body weight.

[00:16:35] Speaker 01:
Well, the claim is a dose.

[00:16:37] Speaker 01:
It's not how you calculate.

[00:16:38] Speaker 01:
It's the dose that you would get if you used adjusted ideal body weight.

[00:16:42] Speaker 01:
But it can't be that the infringement of the claim depends on how the doctor thinks about what dose to give.

[00:16:48] Speaker 01:
Is the ultimate dose, six milligrams per kilogram of adjusted ideal body weight?

[00:16:52] Speaker 01:
If it is, then that should be infringement.

[00:16:54] Speaker 01:
And if it isn't, that shouldn't be.

[00:16:56] Speaker 01:
It should be the ultimate dose that you're giving.

[00:16:59] Speaker 01:
And that already, for a patient at ideal body weight, you'll get there through a different formula.

[00:17:03] Speaker 01:
But the prior art's telling you to use that very dose.

[00:17:06] Speaker 01:
So unless the claims are construed to require this mental step of how you calculate the dose, then you're going to have to say that it's a claim to a dose, not a claim to calculating a dose that would work out based on adjusted ideal body weight.

[00:17:19] Speaker 01:
But it's not how you calculate.

[00:17:21] Speaker 01:
the second one is their own product tells you easy to determine the optimum dosing methodology and then they follow up with a follow-up patent saying but we found the optimum dosing methodology and that actually was not easy and is patentable

[00:17:37] Speaker 01:
that having said that the prior auto-right teaches you, an administering physician can easily determine, that's their own words and their own prior art path.

[00:17:46] Speaker 03:
Why isn't there a genuine issue of material fact because nobody had ever thought to use this adjusted ideal body weight for an antibody drug conjugate before?

[00:17:57] Speaker 01:
Oh, it's, I mean, the reason is because the prior art already tells you, experiment with dosing methodologies and articles like- About for an antibody drug conjugate.

[00:18:06] Speaker 03:
Why doesn't that create a genuine issue of material effect?

[00:18:09] Speaker 01:
But they said, I'm sorry, the prior art about this very antibody drug conjugate says, an administering physician can easily determine the optimum dosing methodology.

[00:18:17] Speaker 03:
It's about this antibody- And does it say that generically or does it say that, you know,

[00:18:24] Speaker 03:
Using this particular technique of using the adjusted-ideal body weight.

[00:18:29] Speaker 01:
No, it says it's just dosing methodology.

[00:18:31] Speaker 01:
I'm sorry.

[00:18:32] Speaker 03:
So just because, so your view is that because there's a prior reference that says for antibody-drug conjugate.

[00:18:39] Speaker 01:
For this antibody-drug conjugate.

[00:18:40] Speaker 03:
And person with ordinary skill in the art could figure out the dosing.

[00:18:43] Speaker 01:
And the dosing methodology.

[00:18:44] Speaker 03:
And the dosing methodology, that that renders obvious this particular dosing methodology.

[00:18:50] Speaker 01:
yes because it's one of nine according to green or one of the few standard dosing methodologies so there are only a few you can use and you've picked one of them so then that would render it obvious so that's the second argument again the first argument is just the dose is the same so unless you're going to read in a mental step into the claims then what about in summary judgment aren't you supposed to make all inferences in favor of the non-movement again

[00:19:18] Speaker 03:
Again, their argument is that it's undisputed that nobody has used this methodology before for this class of drug, the antibody drug conjugate.

[00:19:30] Speaker 03:
And so their argument is that at a minimum, that raises a genuine issue of material fact on motivation to use this particular technique.

[00:19:40] Speaker 03:
And why wouldn't that inference be in their favor, as opposed to in the PTO's favor, when the PTO is the movement for summary judgment?

[00:19:48] Speaker 01:
i'd be interested in the fact that i just want to just again just reiterate that's only if you don't go with the first argument which is that is the dose in the prior act the fact that you calculate the does using a i b w doesn't matter if you end up at the same notes but assuming putting that aside which to me seems very compelling that ultimately it's the dose you give the patient that anybody cares about and they've and it doesn't matter for many for patients at the ideal body weight how you calculate

[00:20:15] Speaker 01:
So that's the first argument, which doesn't even involve a motivation to combine.

[00:20:20] Speaker 01:
It's just the same thing.

[00:20:21] Speaker 01:
But even putting that to the side, once you have a group of nine, like this court said, for example, with finding the bestalate salt in the Pfizer case, for example, it actually reversed the jury finding, I believe, or maybe a trial court finding.

[00:20:36] Speaker 01:
And it said, look, there are 50 salts that people use.

[00:20:40] Speaker 01:
and and uh... and so the fact that you found that the best way to the one that works and look at that it's just like it's it's so obvious to try when there's such as fine a number of that's what case articles is if there's a finite number of uh... possibilities in the there's a you know easy enough to pass which this is then there then that can be obvious even on summary judge that's i think where we are

[00:21:02] Speaker 01:
I can say I'm not persuading you.

[00:21:04] Speaker 03:
Again, it's genuine issue, material fact, and your argument seems, and the court's opinion, to be honest, reads as if it's a bench trial.

[00:21:14] Speaker 01:
The argument kind of sounds like a bench trial argument.

[00:21:22] Speaker 01:
Again, I just want to reiterate, this only gets into the fact that it only matters if you don't care about the fact that the doses are the same as the prior art for some patients.

[00:21:31] Speaker 03:
Your view would be that if there's instructions to provide this drug, and it says nothing about ideal adjusted body weight, that those instructions would be induced infringement in a case like that.

[00:21:46] Speaker 03:
Because it turns out that for some patients, it's

[00:21:51] Speaker 01:
it there is no difference yeah and this is a patient is not like some concocted patient like uh... you know in eight foot twenty pound patients actually the person at the ideal body weight it's actually that's true not me unfortunately but the standard of pay is that's what you're aiming for in a patient's ideal body

[00:22:08] Speaker 01:
uh... and then i'll i want to get indefiniteness uh... briefly so on indefiniteness i think the ultimate point here is we have a definition in the specification that tells you that adjusted ideal body weight can be defined in one of the few ways for example some formula and then it says it optionally accounts for frame size and they're saying all those options you know that's how they defined it in the definition section isn't how persons from the archery decline

[00:22:37] Speaker 01:
And that's obviously, we believe that if you have a definition section, then a person with an ordinary skill in the art would look to the definition section when reading the claim.

[00:22:46] Speaker 01:
And the definition section tells you there are options for how you calculate this.

[00:22:50] Speaker 01:
And they're saying there are no options.

[00:22:52] Speaker 03:
So that to us... Let's assume for a minute there are options.

[00:22:55] Speaker 03:
How many options do you think there are?

[00:22:58] Speaker 01:
uh... so we adopted the tap show that they're been and there is the incident in parts what is how you define ideal body weight i think he catalogued up a dozen different formulas for how you do ideal body weight

[00:23:11] Speaker 01:
that some with friends i some of our basically for every height uh... how can you take a look at it yeah and then also just specifically before that uh... so it doesn't it doesn't there are some of the best and then when you have a just a little by the way you have to add a correction

[00:23:28] Speaker 01:
And that correction factor can range.

[00:23:30] Speaker 01:
So basically, you take the person's ideal body weight and how far they are from that, and you multiply that by some factor.

[00:23:37] Speaker 01:
And that factor ranges from 0.3 to 0.7, which is actually quite the range.

[00:23:41] Speaker 01:
So between those two facts, you have actually, I mean, you know, with ranges, obviously, you sometimes have an infinite number.

[00:23:47] Speaker 01:
But anyhow, a lot, a lot of options.

[00:23:50] Speaker 01:
And so they've never argued that if all those options are available, their claim isn't

[00:23:55] Speaker 01:
indefinite.

[00:23:56] Speaker 04:
So thank you.

[00:23:58] Speaker 04:
There's something very strange to me about this case.

[00:24:03] Speaker 04:
This isn't an infringement action.

[00:24:06] Speaker 04:
This is an action in which the office exists for the purpose of guiding inventors towards how to determine the meets and bounds, how to claim the invention.

[00:24:20] Speaker 04:
And yet you're telling us, well, it's indefinite, go away, you lose.

[00:24:24] Speaker 04:
Is there an obligation on the office to guide and lead inventors towards if the need, if there's a need to draw boundaries, to tell them so.

[00:24:39] Speaker 01:
That's what they did.

[00:24:42] Speaker 01:
We are actually on the indefinite.

[00:24:43] Speaker 01:
That's not what you're doing here.

[00:24:45] Speaker 01:
You lose.

[00:24:47] Speaker 01:
I don't think go away is exactly right.

[00:24:50] Speaker 01:
They file the continuation, which is what we wanted them to do in terms of indefiniteness.

[00:24:54] Speaker 01:
They file the continuation, and there the claims say, we are in, ideal body weight means this, and adjusted ideal body weight means that.

[00:25:02] Speaker 01:
And those claims don't have an indefiniteness problem.

[00:25:04] Speaker 01:
So it all works out that the public will have a clearer claim.

[00:25:07] Speaker 01:
They're not losing.

[00:25:08] Speaker 01:
They can still file those claims.

[00:25:10] Speaker 01:
In a 145, you can still file a continuation after the action, because the patent hasn't issued yet.

[00:25:15] Speaker 01:
So we're actually just trying to clarify the claims.

[00:25:18] Speaker 01:
Normally, you would do this in prosecution.

[00:25:20] Speaker 01:
That obviously would have been ideal here.

[00:25:22] Speaker 01:
But we didn't do it in prosecution.

[00:25:24] Speaker 01:
We caught it in district court.

[00:25:25] Speaker 01:
We said, just fix these claims, file a continuation, fix the claims.

[00:25:28] Speaker 01:
And they did.

[00:25:30] Speaker 01:
I believe after oral argument of the district court, they went back.

[00:25:33] Speaker 01:
They filed a continuation.

[00:25:35] Speaker 01:
And then in the claim itself, said very clearly, what do they mean by AIBW?

[00:25:40] Speaker 01:
And now we have, not in this case, it's in the continuation, but it'll have the same priority date.

[00:25:45] Speaker 01:
And there isn't this indefiniteness problem.

[00:25:48] Speaker 05:
And you invalidated those claims.

[00:25:50] Speaker 01:
Well, those claims are invalidated for obviousness based on the issue here.

[00:25:54] Speaker 01:
So obviously, if you find this obvious, then the indefiniteness problem is one problem.

[00:25:58] Speaker 01:
They've resolved that.

[00:26:00] Speaker 01:
The obviousness problem is another one.

[00:26:01] Speaker 01:
That's that issue here and that issue there.

[00:26:04] Speaker 01:
But if you reverse this here, then they won't have an obviousness.

[00:26:08] Speaker 01:
then we won't reject them for the same obviousness grounds that we used here.

[00:26:12] Speaker 01:
So the indefiniteness part, I just want to be clear about what we're doing here is we are trying to help them out.

[00:26:19] Speaker 01:
And they've taken that, and they've gone to amend their contracts.

[00:26:23] Speaker 04:
I don't see where what you're telling us here was really pursued in just the ordinary back and forth jury examination to try and guide these inventors towards

[00:26:37] Speaker 04:
complying with the law.

[00:26:38] Speaker 01:
So as your honor knows, the PTO's position used to be that these 145 actions were just, the record was closed, there were no new arguments, and we preferred that.

[00:26:48] Speaker 01:
We went to the Supreme Court on that issue and we lost.

[00:26:51] Speaker 01:
So in some sense, 145 is a continuation of prosecution now.

[00:26:56] Speaker 01:
It's not our preferred system, but that's the system the Supreme Court has told us to use.

[00:26:59] Speaker 01:
This court blessed that in Hyatt v. Capos.

[00:27:03] Speaker 01:
In Hyatt v., I'm sorry.

[00:27:04] Speaker 01:
the uncle i think and so that that's how we're doing it now so we have we've now given them a rejection center one forty five but it's still the same thing it basically a rejection during prosecution they take that back to file a continuation and they can fix their claims and that's you know they've said in their breed candidly about that's what they've done uh... so in terms of indefinite as we have tried to just do the regular prosecution because came a little bit later than ideal that's that's the supreme court says something if it's continued prosecution of the statements that they're making

[00:27:35] Speaker 03:
to the PTO and to us and to everybody in these briefs about what the formula is for understanding the scope of their claim.

[00:27:44] Speaker 03:
Are they limited to that?

[00:27:47] Speaker 01:
If they got this claim.

[00:27:49] Speaker 03:
Their view, it's contrary to yours, that it's not just any formula.

[00:27:53] Speaker 03:
It's the specific formula that's in their application.

[00:27:57] Speaker 03:
So why isn't that something that you can rely on to understand the scope of the claim and not have it be indefinite?

[00:28:04] Speaker 01:
So to us, what this is is a prosecution history disclaimer, which is, I think, the legal term that captures, if you say during prosecution exactly what you mean, that that will limit the case, the claims.

[00:28:15] Speaker 01:
But this court has said in Enrique Clark that prosecution history disclaimer doesn't apply while we're still in prosecution.

[00:28:22] Speaker 01:
And the reason is, normally, you can't fix the claims at that point.

[00:28:26] Speaker 01:
So you either have to absolutely invalidate them,

[00:28:28] Speaker 01:
Or you have to say it's okay and you put the limitation.

[00:28:31] Speaker 01:
But while you're still in prosecution under BRI, it's the same motivation for BRI, there's actually another option.

[00:28:37] Speaker 01:
You just go clarify your claims better.

[00:28:39] Speaker 01:
And in an ideal world, the way to understand a claim is not to go to what Pat applicants said in a Federal Circuit case.

[00:28:48] Speaker 01:
It's to see it ideally from the claims or the specification.

[00:28:52] Speaker 01:
yeah and so here we have a specification that has definition if you're viewing the district court's view that the specification doesn't provide a particular formula i think it's even worse than that it's almost explicit like it is explicitly saying optionally like it is telling you it's not just they've said in the specification we want multiple formulas to be allowed

[00:29:10] Speaker 01:
So all we ask, and they've done, is go back, put it in the claims, which formula you mean, and then the problem is solved.

[00:29:17] Speaker 01:
And this is otherwise what you would always have, for example, in auto-listed software.

[00:29:21] Speaker 01:
In any case where somebody comes to you with an indefinite claim, they could say, OK, this is what we mean, and then that disclaimer would apply.

[00:29:27] Speaker 01:
But that's not how we do indefinite.

[00:29:29] Speaker 01:
Especially during prosecution, we don't let you then just fix it by announcing in the court case.

[00:29:35] Speaker 01:
We want it in the claim or in the spec.

[00:29:37] Speaker 01:
And that's under BRI the way we would construe claims.

[00:29:41] Speaker 04:
The purpose of BRI is to guide the applicant towards writing adequately narrow claims.

[00:29:49] Speaker 04:
That's the only purpose of BRI.

[00:29:53] Speaker 01:
Yes.

[00:29:53] Speaker 04:
Not to invalidate in this elaborate, expensive appeal procedure what is not prosecuted by the office.

[00:30:07] Speaker 01:
But this is the problem.

[00:30:09] Speaker 01:
In my view, this is a problem with HIAT.

[00:30:11] Speaker 01:
But anyway, this is the reality of HIAT, the Supreme Court's decision, is that 145 actions are still part of prosecution.

[00:30:17] Speaker 01:
People are raising new arguments.

[00:30:19] Speaker 01:
New evidence is coming in.

[00:30:20] Speaker 01:
And so all we're trying to do is guide them towards clearer claims.

[00:30:23] Speaker 01:
And they took that guidance, and they filed a continuation to get clearer claims.

[00:30:27] Speaker 01:
So that is the system.

[00:30:28] Speaker 03:
Can you say correctly that you're the ones that raised indefiniteness for the first time during this 145 action?

[00:30:33] Speaker 01:
That is correct, Your Honor.

[00:30:36] Speaker 01:
I'm way past my time.

[00:30:37] Speaker 01:
I don't know if anybody has any questions.

[00:30:38] Speaker 04:
Any more questions?

[00:30:40] Speaker 04:
Any more questions for counsel?

[00:30:42] Speaker 01:
Thank you for your time.

[00:30:43] Speaker 04:
Thank you.

[00:30:44] Speaker 04:
Okay.

[00:30:48] Speaker 04:
We have rebuttal.

[00:30:49] Speaker 04:
Mr. Jaffe.

[00:30:51] Speaker 00:
Thank you.

[00:30:52] Speaker 00:
I'd like to just address two quick points.

[00:30:56] Speaker 00:
One is their argument they're making here on obviousness, which is, look, Lutz includes this AIBW formula.

[00:31:04] Speaker 00:
That's what he said.

[00:31:05] Speaker 00:
They're preempting the field, et cetera, et cetera, et cetera.

[00:31:07] Speaker 00:
That fights their own expert.

[00:31:09] Speaker 00:
Quote, and this is on 10043 of the appendix.

[00:31:15] Speaker 00:
Quote, question, we all agree no one had actually dosed any ABC at 6 milligrams per kilogram AIBW as of the priority date.

[00:31:24] Speaker 00:
Right, answer, correct.

[00:31:26] Speaker 00:
So they're fighting their own expert on this point.

[00:31:29] Speaker 00:
More of they're fighting their own interrogatory response.

[00:31:33] Speaker 00:
Interrogatory found at A9919.

[00:31:36] Speaker 00:
Question.

[00:31:37] Speaker 00:
You have not asserted as prior art any document that discloses an administering an immunoconjugate at a dose of 6 milligrams per kilogram AIBW.

[00:31:47] Speaker 00:
Admitted.

[00:31:48] Speaker 00:
So they're turning around on their own admissions for the first time on appeal saying, look, this is actually included in LUTs.

[00:31:54] Speaker 03:
It is not.

[00:31:55] Speaker 03:
How do you respond to the argument that there's anticipation here as a matter of law?

[00:32:01] Speaker 03:
Because for some particular patients, the actual idealized body weight is the same as their actual body weight.

[00:32:09] Speaker 03:
And therefore, your claims preempt what's in the prior.

[00:32:13] Speaker 00:
Two answers, Your Honor.

[00:32:15] Speaker 00:
The PTAB was presented with the examiner with that exact argument.

[00:32:19] Speaker 00:
The examiner said, this is inherent anticipation.

[00:32:22] Speaker 00:
And the PTAB said no.

[00:32:23] Speaker 00:
And this is found at A6760.

[00:32:26] Speaker 00:
It said no.

[00:32:28] Speaker 00:
There's no inherent anticipation just because LUTs may teach a TBW dosage that might fall within some dosage.

[00:32:35] Speaker 03:
Because I'm not bound by the PTAB, why don't you tell me what your legal argument for why that's incorrect or tell me how I should interpret your claim so I don't have that argument in my head?

[00:32:44] Speaker 00:
essentially make inherent anticipation a dead letter.

[00:32:48] Speaker 00:
Inherent anticipation requires something necessarily to be present in the prior art in order to anticipate.

[00:32:54] Speaker 00:
It has to necessarily be there.

[00:32:56] Speaker 00:
What the office is arguing is saying, well, it may not necessarily be there, but it could be there.

[00:33:01] Speaker 00:
There could be such a hypothetical person.

[00:33:03] Speaker 00:
And so that renders the claim obvious under their view.

[00:33:07] Speaker 00:
So the claim is invalid because something might happen.

[00:33:10] Speaker 00:
But if claims are invalid because they might happen,

[00:33:14] Speaker 03:
for obviousness reason then there's no need to go down that to do with it it isn't inherent yes because it's not necessarily so that there's a single person out there that that would apply to right exactly and on top of it their own the district court didn't find that the court district court specifically said claims your claims cover that scenario assuming it existed

[00:33:36] Speaker 00:
In order to come up with that scenario, you have to use the formulas that are in immunogen's own application to get there.

[00:33:42] Speaker 00:
So you'd have to reverse engineer the formulas that are in immunogen's own patent application in order to figure out if such a person exists.

[00:33:52] Speaker 00:
And on top of it, I mean, the point at the end of the day is LUTs or no other reference teaches dosing based upon a person's height.

[00:34:00] Speaker 03:
Are claims limited dosing based on

[00:34:03] Speaker 03:
actual idealized body weight or if it just turns out that the dose is the same but nobody even considered the actual idealized body weight.

[00:34:12] Speaker 03:
Are your claims still satisfied?

[00:34:13] Speaker 00:
Our claims are specified to the specific amount of drug that is calculated that specific way.

[00:34:19] Speaker 03:
It has to be calculated that specific way?

[00:34:21] Speaker 00:
Well, the number has to be the same.

[00:34:23] Speaker 00:
So the question then is, okay, how do you find that?

[00:34:27] Speaker 00:
Could someone by happen chance randomly come to the same amount of drug?

[00:34:32] Speaker 00:
Perhaps

[00:34:33] Speaker 00:
But then that would be infringement because there's no requirement that you know that you're infringing.

[00:34:40] Speaker 00:
But the point being is simply because if by happenstance somebody might possibly infringe by accident, it doesn't somehow render your claim obvious.

[00:34:51] Speaker 00:
It certainly can't be.

[00:34:51] Speaker 00:
There's been no discussion anywhere that the formula of AIBW that's found in the patent application was used by anyone with regard to an ADC.

[00:35:03] Speaker 00:
And then, so finally, if I have one more minute,

[00:35:07] Speaker 00:
Turning to the question of indefiniteness, the office keeps saying, look, the definitional section somehow says you can use other things.

[00:35:20] Speaker 00:
That's not at all what the definitional section says.

[00:35:23] Speaker 00:
All it does is say that adjusted ideal body weight might refer to a size descriptor that accounts for sex, total body weight, and height.

[00:35:31] Speaker 00:
When later on actually using AIBW in order to dose for a toxin app,

[00:35:36] Speaker 00:
It uses one formula, one formula only.

[00:35:39] Speaker 00:
We have, throughout, represented there is but one formula.

[00:35:42] Speaker 00:
The public is on notice of it.

[00:35:44] Speaker 00:
And we cannot amend now.

[00:35:46] Speaker 00:
So therefore, we should all know exactly what is required by this court's case law.

[00:35:56] Speaker 04:
Thank you.

[00:35:57] Speaker 04:
Thanks to both counsels.

[00:35:59] Speaker 04:
The case is taken under submission.