[00:00:00] Speaker 02:
The last case for argument is Inray Zincor, number 24-1870.

[00:00:05] Speaker 02:
Ms.

[00:00:06] Speaker 02:
Goldenberg, when you're ready.

[00:00:08] Speaker 04:
May it please the court?

[00:00:09] Speaker 04:
Zincor invented modifications to an anti-C5 antibody's constant region that increase in vivo half-life, meaning antibodies stay in the body longer.

[00:00:20] Speaker 04:
The invention is not a cure for anything.

[00:00:23] Speaker 04:
Instead, the invention allows for less frequent administration,

[00:00:28] Speaker 04:
regardless of the reason for the administration.

[00:00:32] Speaker 04:
Turning first to Claim 9, the board construed the treating a patient language in the preamble as limiting.

[00:00:38] Speaker 02:
I ask you before we get to that, is there a dispute as to whether the claims cover all types of diseases and conditions, or you accept that that is the breadth of your claims?

[00:00:52] Speaker 04:
So we don't think that that is a requirement of the claims, but we accept the fact that the claims could be used in administration for any purpose, including

[00:01:03] Speaker 04:
diseases or for research purposes.

[00:01:06] Speaker 02:
The board clearly understood your claims as that broad, correct?

[00:01:10] Speaker 04:
Correct, that's correct.

[00:01:11] Speaker 02:
And you've not disputed that for purposes of this appeal, is that right?

[00:01:14] Speaker 04:
We dispute that that is a requirement for terms of written description.

[00:01:18] Speaker 04:
It's just a use.

[00:01:20] Speaker 04:
It's the utility that the claims could be applied in, an application or a purpose.

[00:01:24] Speaker 04:
But the claims themselves are directed to the improvements in the constant region of the antibody.

[00:01:31] Speaker 02:
Do we have to think about whether if we ordered that you get these claims that you'll say they read on using these, practicing these methods in connection with absolutely any disease or condition under the sun?

[00:01:45] Speaker 04:
So these claims, you would only be practicing these claims if you made these specific substitutions in the antibodies constant region, which are

[00:01:53] Speaker 04:
This is not naturally occurring.

[00:01:55] Speaker 04:
You have to engineer the antibody.

[00:01:57] Speaker 04:
So under our interpretation of the claim, whatever you're doing with it, whatever the purpose of your administration, whether it be to cure an inflammatory disease or to inject it into a mouse for research purposes, if you go in and make those specific modifications in the amino acid sequences that are disposed in this patent,

[00:02:18] Speaker 04:
you would be infringing the claims, but we're not preventing anybody from using that same antibody without the modifications and curing any disease that they want to.

[00:02:26] Speaker 04:
They'd have to make that choice.

[00:02:28] Speaker 04:
They want the benefit of the invention, which is increased in vivo half-life, which provides a tremendous benefit.

[00:02:33] Speaker 04:
It's less frequent dosing for someone.

[00:02:35] Speaker 04:
who might be receiving treatment or for someone who's in the lab and giving this to a monkey.

[00:02:39] Speaker 04:
You don't have to use as much and you don't have to do it as frequently.

[00:02:43] Speaker 04:
So if they want to take advantage of that invention, which is undisputably what we disclosed in the written description here, they would be practicing the claim, but they don't have to administer an antibody.

[00:02:53] Speaker 02:
So I appreciate all that.

[00:02:55] Speaker 02:
I think one of the reasons the board rejected these claims though is that they then said you need to have written description support

[00:03:03] Speaker 02:
for using this with all types of or at least more types of diseases and conditions than you actually provided written description for.

[00:03:12] Speaker 02:
Is that in fact part of what you understand to be the reasoning that was given for why you didn't get these claims?

[00:03:17] Speaker 04:
Yes, that is correct.

[00:03:18] Speaker 02:
So why is that wrong then?

[00:03:19] Speaker 04:
If you look at Alcon research, I think that's a great example as to why that approach to written description is wrong.

[00:03:25] Speaker 04:
In that case, there was similarly a claim that just improved something.

[00:03:29] Speaker 04:
It was a method of enhancing the chemical stability of an aqueous composition, comprising a therapeutically effective amount of a prostaglandin.

[00:03:39] Speaker 04:
The chemical stability was enhanced by using a certain amount of a castor oil.

[00:03:46] Speaker 04:
That was the invention.

[00:03:47] Speaker 04:
And in that case, the analysis of written description focused on the inventor's possession of the improvement, which was whether the castor oil stabilized the prostaglandin drug.

[00:03:58] Speaker 04:
And the court actually reversed the district court, which had held that there wasn't written description saying that the ALKON research patentee wasn't required to describe every therapeutically effective prostaglandin drug for every patient in every condition.

[00:04:14] Speaker 04:
It was a narrow claim.

[00:04:15] Speaker 04:
It was directed to an improvement.

[00:04:16] Speaker 04:
the prostaglandin drugs become more stable if you use this new castor oil that we invented.

[00:04:21] Speaker 04:
Likewise here, the antibodies, if you make these modifications to the constant region in anti-C5 antibodies, you're going to get longer in vivo half-life.

[00:04:30] Speaker 04:
It's not going to make the drug any more effective in treating whatever you're trying to do, or if you're administering it for research purposes.

[00:04:37] Speaker 04:
You're just going to get something that's undeniably valuable and beneficial to the world.

[00:04:41] Speaker 04:
And that's exactly what the written description requirement is supposed to require

[00:04:46] Speaker 04:
It's to ensure that the scope of the right to exclude us set forth in the claims doesn't overreach the scope of the inventor's contribution to the field.

[00:04:55] Speaker 04:
And that's exactly what we've done here.

[00:04:57] Speaker 04:
We've provided written description for the invention.

[00:05:00] Speaker 04:
I do want to focus, however, on the differences between claim nine and claim eight, because they do require different analysis.

[00:05:08] Speaker 04:
Claim nine is a method claim.

[00:05:11] Speaker 04:
And the sole issue here is whether the preamble is limiting.

[00:05:14] Speaker 04:
because the board construed treating a patient language in the preamble as limiting.

[00:05:20] Speaker 04:
And then it required written description for the term.

[00:05:23] Speaker 04:
But that portion of the preamble is not limiting.

[00:05:25] Speaker 04:
So this court must reverse.

[00:05:28] Speaker 04:
The general rule is that the preamble is not limiting.

[00:05:32] Speaker 04:
And that general rule is all the more applicable here, no more under the broadest reasonable interpretation standard.

[00:05:39] Speaker 02:
I think we said, though, for methods, that general rule is maybe not

[00:05:43] Speaker 02:
as generally applicable for method claims?

[00:05:45] Speaker 04:
For method claims, yes.

[00:05:46] Speaker 04:
But you haven't said it's not applicable.

[00:05:48] Speaker 04:
Just in method claims, maybe it's not just as applicable as for composition claims.

[00:05:53] Speaker 02:
But you... I'm a little confused by your argument.

[00:05:56] Speaker 02:
Both of these are method claims for treating a patient.

[00:05:59] Speaker 02:
And if we're treating a patient out, then it's just a method claim for administering the anti-C5 antibody.

[00:06:07] Speaker 02:
Is that what you think you claimed?

[00:06:09] Speaker 04:
For claim nine, yes.

[00:06:11] Speaker 04:
I want to separate out, because claim nine is a Jepson claim that comes with its own requirement.

[00:06:15] Speaker 02:
If that's the case, then what's the point of treating a patient in?

[00:06:18] Speaker 02:
Shouldn't it just be a method of administering an anti-C5 antibody?

[00:06:23] Speaker 02:
I mean, I'll put my cards on the table.

[00:06:25] Speaker 02:
I think our case law on preambles is nonsense and all messed up, and it should be limiting in all situations.

[00:06:35] Speaker 02:
I can't do that because we have different precedent.

[00:06:37] Speaker 02:
But when it says a method of treating a patient by administering something, and you say, well, part of that's

[00:06:44] Speaker 02:
limiting but part of it's not.

[00:06:46] Speaker 02:
What's the basis for that?

[00:06:47] Speaker 02:
It's a method claimed to treat a patient.

[00:06:49] Speaker 02:
Don't you have to have written descriptions for treating patients, not for doing it in the lab, for administering it for other purposes, for research purposes and all that kind of stuff.

[00:07:01] Speaker 02:
That would be what you get if you just had a method of administering.

[00:07:05] Speaker 02:
What's wrong with that?

[00:07:07] Speaker 04:
I'm not going to argue about the policy of limiting versus non-limiting, because I think you understand as well that that is the world we're living in right now.

[00:07:14] Speaker 04:
So under the precedent, it's OK to say your intended purpose without that being limiting.

[00:07:19] Speaker 04:
And we use the Catalina marketing factors here.

[00:07:21] Speaker 02:
Well, isn't there a difference between saying the intended purpose of this invention is in a method claim, which I think is what Judge Sharpe was getting at?

[00:07:30] Speaker 02:
A method claim actually is telling you a method of doing X. And the method here is not administering, it's treating a patient.

[00:07:38] Speaker 04:
So, as I said, that is just an intended purpose, and we do look at whether... We have these catalytic marketing factors that are sort of direct and guideposts for us.

[00:07:48] Speaker 04:
None of them are applied here.

[00:07:49] Speaker 04:
In fact, if you look at the specification, it defines the present invention in paragraph 74 as directed to antibodies that exhibit increased binding to FCRN relative to the wild-type antibody.

[00:08:01] Speaker 04:
That supports our interpretation.

[00:08:03] Speaker 04:
And we see embodiments disclosed that include, in paragraph 182,

[00:08:09] Speaker 04:
a therapeutic, a diagnostic, or a research reagent.

[00:08:12] Speaker 04:
But I hear you, Judge Cues, and I understand that maybe you want to give meaning to method of treatment.

[00:08:19] Speaker 04:
And as we've noted in our briefs, even if you do that, the board erred.

[00:08:23] Speaker 04:
Because what they did is they required treating all patients in all diseases.

[00:08:28] Speaker 04:
And they effectively read into the claims the requirement that treatment be successful.

[00:08:32] Speaker 04:
If you eliminate that requirement, treatment doesn't need to be successful.

[00:08:36] Speaker 04:
You just have to

[00:08:37] Speaker 04:
be administering for the purpose of treatment, because we're now in the world where we're going to interpret those claims to have meaning, if you're going to do that, then there's still written description here.

[00:08:47] Speaker 04:
Because there isn't necessarily written description for successful treatment, but the specification is full of examples of administering this for therapeutic purposes, for treatment.

[00:08:57] Speaker 00:
Does the identity of who or what we're administering to change how we administer the antibody?

[00:09:05] Speaker 04:
Yes, it does.

[00:09:06] Speaker 04:
And that's actually a problem with the board's construction, with the director's proposal.

[00:09:10] Speaker 04:
Because they're saying, on one hand, a patient can be an animal or a human.

[00:09:15] Speaker 04:
But on the other hand, if you're administering it for treating, you're not administering this to monkeys and mice for treatment.

[00:09:21] Speaker 04:
You're administering it to them because you're trying to research.

[00:09:24] Speaker 04:
You're trying to figure out whether or not we can put this in humans.

[00:09:27] Speaker 04:
So those two things can't be true at once.

[00:09:30] Speaker 04:
If the method of treating is limiting, then it necessarily has to be a human, as well as the fact that claim nine requires that the means for binding be dehuman C5 protein.

[00:09:42] Speaker 04:
So that's something you have to have human C5 protein there.

[00:09:44] Speaker 02:
So if you're treating and... Do you think there's sufficient written description if we look at it in terms of method for treating human patients?

[00:09:52] Speaker 00:
Yes.

[00:09:53] Speaker 02:
Any possible use of this particular

[00:09:59] Speaker 02:
whatever you've claimed here.

[00:10:01] Speaker 04:
Yes.

[00:10:02] Speaker 04:
And the reason for that is because we don't need to show success.

[00:10:07] Speaker 02:
I don't care about the success.

[00:10:08] Speaker 02:
I'm just thinking, it seems to me that this specific combination or these specific substitutions, your view is they can be useful for a wide variety of treatments and drugs and whatever.

[00:10:23] Speaker 02:
Do you have this description for that entire universe?

[00:10:27] Speaker 02:
Or do you only have written description for certain specific things?

[00:10:30] Speaker 04:
And my answer is we don't have written description for treating all patients and all diseases.

[00:10:36] Speaker 04:
conceded, but we don't need it.

[00:10:38] Speaker 01:
Because all we need to show... If that's what you're claiming, you need it though, right?

[00:10:42] Speaker 04:
Not if... All we have is a method of a... We have plenty of written description support for administering this for therapeutic purposes.

[00:10:50] Speaker 04:
Now, it'll be up to a skilled artisan whether or not they believe that this is going to actually treat something.

[00:10:55] Speaker 04:
antibodies are known to treat certain conditions, autoimmune, transplant, inflammation.

[00:11:00] Speaker 04:
They can administer that with intent to treat, and they'll have some knowledge knowing it's probably going to work.

[00:11:06] Speaker 04:
But we've given them enough to tell them this can be used for therapeutic purposes.

[00:11:11] Speaker 04:
We used a steel analogy in our brief, where if you invented a new type of steel, the steel is broadly applicable.

[00:11:17] Speaker 04:
It can be used for houses.

[00:11:18] Speaker 04:
It can be used for bridges.

[00:11:20] Speaker 04:
It can be used for airplanes.

[00:11:22] Speaker 04:
You don't have to provide written description for all of those things.

[00:11:25] Speaker 04:
You can just say, this is broadly useful.

[00:11:27] Speaker 02:
What if it was phrased as a method for using steel created by this process?

[00:11:32] Speaker 02:
Wouldn't you have to show all the methods written description, assuming it's limiting, again?

[00:11:36] Speaker 02:
Yes.

[00:11:37] Speaker 02:
Wouldn't you have to show written description support for all the different methods of using it?

[00:11:42] Speaker 04:
No.

[00:11:42] Speaker 04:
And that would be very contrary to both the purpose of the written description requirement, because now you're requiring way more than what the inventor is claiming to have contributed and claimed.

[00:11:51] Speaker 04:
And it also doesn't follow the reasoning in ALKON research.

[00:11:54] Speaker 04:
We cited the case Pharmacia and Upjohn.

[00:11:58] Speaker 04:
That was a Jepson claim.

[00:11:59] Speaker 04:
But we didn't require, for example, all micronized antidiabetic pharmaceutical compositions to be disclosed when it was an improvement claim towards that.

[00:12:09] Speaker 04:
And I do want to touch on the Jepson claims.

[00:12:11] Speaker 02:
I hope you will get to do that.

[00:12:13] Speaker 02:
But before you get to that, on written description, it's a finding of fact, I believe, right?

[00:12:17] Speaker 02:
We review for substantial evidence what the board said about

[00:12:20] Speaker 02:
lack of written description, isn't that correct?

[00:12:23] Speaker 04:
So the legal doctrine is a finding of fact, but here the facts are undisputed, right?

[00:12:27] Speaker 02:
That's what I was going to ask you.

[00:12:29] Speaker 02:
Are you saying there's not substantial evidence, or are you saying that the board had the wrong legal framework in mind?

[00:12:35] Speaker 04:
The board had the wrong legal framework in mind, because the facts are undisputed.

[00:12:38] Speaker 04:
We have written description for the improvement.

[00:12:40] Speaker 04:
We don't have written description for all patients and all diseases.

[00:12:44] Speaker 02:
If I might ask, I know we're into your rebuttal, but on the Jepson,

[00:12:48] Speaker 02:
is it your position that you don't need to provide any written description whatsoever for what was supposedly well known in the prior art?

[00:12:57] Speaker 04:
Absolutely.

[00:12:58] Speaker 02:
It's hard to make sense of that.

[00:13:02] Speaker 02:
I think it's a question of first impression.

[00:13:04] Speaker 02:
Do you agree with that?

[00:13:05] Speaker 04:
This court has never considered written description in the Jepson context.

[00:13:10] Speaker 02:
Why wouldn't the correct answer be

[00:13:12] Speaker 02:
Of course you need written description for the full scope of your claim.

[00:13:16] Speaker 02:
It's just very easy most often and maybe always to satisfy the written description to show that you possessed the part of your invention that was already well known in the prior art.

[00:13:28] Speaker 02:
it may be satisfied by one sentence or a reference in the background of your patent.

[00:13:34] Speaker 02:
But for us to say you don't need anything whatsoever to show that this was really actually well known in the prior art, that would seem inconsistent with a whole lot of case law, wouldn't it?

[00:13:45] Speaker 04:
It wouldn't be inconsistent with Alcon Research, which is the most analogous case that either of the parties have cited here, which is, again, it's an improvement claim where they're claiming an

[00:13:55] Speaker 04:
an enhancement in stability.

[00:13:56] Speaker 04:
And this court reversed and said there was written description, because you don't need to show that the treatment was therapeutically effective for every patient in every condition.

[00:14:08] Speaker 04:
And once again, written description is a judicially made doctrine.

[00:14:12] Speaker 04:
It's something that has been developed through your cases.

[00:14:15] Speaker 04:
And the purpose, as this court said in Ariad, is to ensure that the scope of the right to exclude doesn't overreach.

[00:14:22] Speaker 04:
The invention is fairly modest.

[00:14:24] Speaker 04:
It's directed to specific amino acid substitutions in the constant region for anti-C5 antibodies.

[00:14:31] Speaker 04:
We're talking about the Jepson claim specifically now.

[00:14:33] Speaker 04:
And in that case, we've shown possession of arm ferment.

[00:14:36] Speaker 02:
If that's what you invented was the specific substitution, why didn't you just claim that rather than a method for treating patients by administering that?

[00:14:45] Speaker 04:
So this has a long prosecution history record, as I'm sure you noticed.

[00:14:51] Speaker 04:
there were other claims that were not pursued due to the examiner dislike.

[00:14:55] Speaker 04:
This seemed to be what the examiner preferred at the time.

[00:14:57] Speaker 04:
You might recall that he withdrew his written description rejections when we got to the board and then the board reinvigorated them.

[00:15:05] Speaker 04:
So the board's analysis just

[00:15:07] Speaker 04:
doesn't, it can't apply here.

[00:15:09] Speaker 04:
It doesn't make sense when you try to frame it in terms of what is the purpose of written description and are we over claiming?

[00:15:15] Speaker 04:
Are we asking too much?

[00:15:16] Speaker 02:
Okay, you're out of time.

[00:15:17] Speaker 02:
Did you want, you keep saying you, I can't tell if you touched on the Jepson claim you wanted to or not.

[00:15:22] Speaker 02:
I'll give you a minute to talk about the Jepson if you want to and then I'll restore some of your rebuttal otherwise we can move on.

[00:15:29] Speaker 04:
Sure.

[00:15:29] Speaker 04:
Thank you, Your Honor.

[00:15:30] Speaker 04:
So I'll just add on the Jepson claim that those claims are designed specifically to identify the inventor's contribution to the field via the improvement.

[00:15:40] Speaker 04:
We state the prior art and then we state the improvement.

[00:15:43] Speaker 04:
This court has at least approved Jepson claims in other contexts without any concern of written description of what is the prior art.

[00:15:52] Speaker 04:
And it really doesn't make sense.

[00:15:53] Speaker 04:
It would basically eviscerate all Jepson claims.

[00:15:56] Speaker 04:
If you require disclosure of all of the prior art in order to have the improvement, only the most narrow of Jepson claims would survive.

[00:16:03] Speaker 04:
And the board and the director rely on both Juneau and Boston Scientific and just mechanistically apply

[00:16:11] Speaker 04:
the reasoning without thinking, what is the purpose of written description?

[00:16:15] Speaker 04:
With Jetson claims, we have a gist.

[00:16:18] Speaker 04:
We have a heart of the invention.

[00:16:20] Speaker 04:
And the question here should be, did we provide written description for that?

[00:16:26] Speaker 04:
And I think the answer is unquestionably yes.

[00:16:28] Speaker 04:
So I thank you, Your Honor.

[00:16:32] Speaker 02:
We'll restore your three minutes of rebuttal.

[00:16:34] Speaker 04:
Thank you.

[00:16:46] Speaker 03:
Good morning and may it please the court, Peter Saller on behalf of the USPTO Director.

[00:16:53] Speaker 03:
What we have here is an example of a patentee using novel approach to antibody claiming and taking the unusual step to use Jepsen and means plus function forms to push the boundaries of antibody claims.

[00:17:08] Speaker 03:
But the fundamental problem here is that Zincor's reach exceeds its grasp.

[00:17:12] Speaker 03:
The claims are far broader than what has been disclosed.

[00:17:15] Speaker 03:
And this is a violation of the agreement with the public for any patentee that you must first describe and demonstrate possession of your invention before being entitled to claims to it.

[00:17:28] Speaker 03:
We are correctly pursued the issues in this application in two steps.

[00:17:35] Speaker 03:
First, looking at claim construction.

[00:17:37] Speaker 03:
and finding that the preambles of both claims 8 and 9 are limiting.

[00:17:43] Speaker 03:
And then finding that they are limiting,

[00:17:47] Speaker 03:
just as with any other limiting claim term, they must have adequate written description support, looking to the specification of the 690 application and finding that there's essentially no written description to support the method of treating a patient limitation that is present in both terms.

[00:18:09] Speaker 02:
Do you agree that we're to apply the broadest reasonable interpretation to claim construction in this context?

[00:18:15] Speaker 02:
That's correct, Your Honor, but... And so doesn't that put another sort of thumb on the scale that the preamble here is not limiting, that the broadest reasonable interpretation of treating a patient will presumably include that it's not limiting, probably also includes that it's limiting, but we're just supposed to take the broadest interpretation.

[00:18:35] Speaker 03:
That's correct, Your Honor, but the key word there is reasonable.

[00:18:38] Speaker 03:
And the claim here can't be construed reasonably without the treating a patient

[00:18:45] Speaker 03:
words in the preamble being limiting.

[00:18:49] Speaker 03:
We're already past the presumption of the preamble being non-limiting, as NCOR agrees that administering an anti-C5 antibody, which is part of the preamble, is limiting.

[00:19:00] Speaker 02:
And so now we're at the step of saying should we... Have we ever said that if we're in a case where you can splice the preamble, that there is no presumption any longer against the part that the patentee presumably says is not limiting?

[00:19:15] Speaker 02:
is still presumed to be not limiting?

[00:19:19] Speaker 02:
I don't think there's a case that would say that, Your Honor.

[00:19:22] Speaker 02:
Why shouldn't we say the starting point here is?

[00:19:25] Speaker 02:
that we presume, generally, that the things they say are not limiting, that treating a patient is not limiting.

[00:19:32] Speaker 02:
Isn't that the starting point?

[00:19:33] Speaker 03:
It is.

[00:19:34] Speaker 03:
I think it's more logical to take that step with the preamble as a whole and say, is some of it limiting or not?

[00:19:42] Speaker 03:
And start from the presumption that none of it is.

[00:19:45] Speaker 03:
But once you've kind of moved past that state, once you find part of it limiting.

[00:19:49] Speaker 03:
But I think the result is the same either way.

[00:19:52] Speaker 02:
The fundamental problem here... This would be that even if we can split it, once you accept that administering this antibody is limiting, then it has to be read in the context of administering to whom or for what purpose.

[00:20:08] Speaker 02:
So that is why treating a patient is included.

[00:20:14] Speaker 03:
I wouldn't rest it on that alone, Your Honor, because there are so many reasons here.

[00:20:18] Speaker 03:
It's because I think more persuasively as to treating a patient, we have the language in the claims that says, increasing in vivo half-life.

[00:20:28] Speaker 03:
And there's no direct antecedent basis there, but one of ordinary skill in the art is going to read

[00:20:34] Speaker 03:
in vivo half-life in view of the reference to treating a patient in the preamble.

[00:20:38] Speaker 03:
They're not going to read that in isolation.

[00:20:41] Speaker 03:
And so that reinforces that treating a patient is informing the context of this claim.

[00:20:47] Speaker 03:
We're also talking about increasing in vivo half-life, and that takes context from treating the patient.

[00:20:55] Speaker 03:
That's the purpose in which we have to judge this result of increasing in vivo half-life.

[00:21:00] Speaker 02:
That isn't administering enough to

[00:21:03] Speaker 02:
to satisfy what you're arguing now.

[00:21:06] Speaker 03:
Well, administering is so incredibly broad that standing alone, it doesn't really do anything.

[00:21:13] Speaker 03:
It falls back into that category of numerous cases that we cited from the court of amounting to an academic exercise.

[00:21:20] Speaker 03:
Sure, you're administering this compound, but to what end?

[00:21:24] Speaker 03:
To accomplish what?

[00:21:25] Speaker 03:
Different question.

[00:21:27] Speaker 02:
The board said that the raison d'etre

[00:21:30] Speaker 02:
of the claimed method is treatment.

[00:21:33] Speaker 02:
You don't seem to be arguing that.

[00:21:35] Speaker 02:
You seem to be accepting the raison d'etre is to increase the half-life.

[00:21:38] Speaker 02:
But are you defending the board on that point, or are you not?

[00:21:41] Speaker 03:
I am defending the board on that point, Your Honor, because the only reason to increase half-life is in conjunction with treatment.

[00:21:48] Speaker 03:
That's how increasing half-life

[00:21:51] Speaker 03:
comes to have value.

[00:21:52] Speaker 03:
Because unless you're treating a patient and therefore able to lower the dosage to that patient or reduce the frequency with which the antibody has to be administered, increasing the half-life on its own has no benefit.

[00:22:08] Speaker 03:
It's just something that happens.

[00:22:10] Speaker 03:
It's not achieving any positive utility or result.

[00:22:14] Speaker 03:
And that's why, again, going back to the phrase that this court repeatedly uses, you need the method of treatment to get life, meaning, and vitality into this claim.

[00:22:27] Speaker 03:
Go ahead.

[00:22:30] Speaker 03:
And once we accept that it's limiting, we can see that in the specification, there's description about how to make these modifications to the FC region.

[00:22:39] Speaker 03:
But there isn't description of using any of this huge laundry list of antibodies that are identified as possible candidates essentially for investigation of this half-life improvement.

[00:22:52] Speaker 03:
There's no description of administration or treatment.

[00:22:56] Speaker 03:
The sole reference to any anti-C5 antibody, which is what is claimed here, is in one paragraph that's at APPX 160, paragraph 133 of the application.

[00:23:12] Speaker 03:
And it's just made in passing that there's a category of antibodies that may be useful for treatment of broad categories like anti-inflammatory or organ transplant, and then

[00:23:25] Speaker 03:
Anti-C5 is identified there and part of a long list.

[00:23:28] Speaker 03:
There's no description of what's known about administering or much less treating patients, much less all patients and all diseases.

[00:23:37] Speaker 03:
So we're nowhere near

[00:23:40] Speaker 03:
any of the cases where adequate written description was found.

[00:23:43] Speaker 02:
This is an easy case, unwritten description, because they're... It responds to their contention that implicitly you're taking the view that treating a limitation has a safety and an efficacy component to it, and they would insist it doesn't.

[00:23:58] Speaker 03:
I think it does have some minimal level of that component that the ARP did not put any numerical or specific requirement on it.

[00:24:07] Speaker 03:
But essentially what the ARP found is that treating is something more than administering, right?

[00:24:16] Speaker 03:
There's some beneficial observable result.

[00:24:20] Speaker 02:
Does that case law allow the director to read into treating a patient, safety and efficacy?

[00:24:28] Speaker 03:
So I want to be very clear about drawing the line there.

[00:24:32] Speaker 03:
It does not allow the director to draw in safety and efficacy limitations that aren't part of the claim.

[00:24:42] Speaker 03:
But this court has said that using the word treating does require some observable positive effect.

[00:24:50] Speaker 03:
And I'll even backstep that.

[00:24:54] Speaker 03:
You know, it doesn't have to be in every single patient.

[00:24:57] Speaker 03:
It's we're reading this specification from the viewpoint of one of ordinary skill in the art.

[00:25:02] Speaker 03:
So there has to be something that's known in the treatment by definition has some intended result.

[00:25:10] Speaker 02:
We don't have to specify what that intended result is, just what the claim itself would express as the intended result.

[00:25:18] Speaker 03:
Yes.

[00:25:20] Speaker 03:
but knowing that there is some understanding in the art of what treatment is, and that there has to be something to satisfy a person of ordinary skill in the art that the inventors here possess the invention, which is not just the change to the FC portion of the antibody, but that has applied to the antibody and used for treatment.

[00:25:45] Speaker 02:
I'll take it to Jepson questions.

[00:25:50] Speaker 02:
Zemcor argues that the Patent Office has never contested that they possess and provide an adequate written description of the improvement in their claims.

[00:25:59] Speaker 02:
Is that correct?

[00:26:01] Speaker 02:
That's correct, Your Honor.

[00:26:03] Speaker 02:
And you agree it's a question of first impression as to whether or not

[00:26:07] Speaker 02:
In a Jepson claim, you have to provide written description for what was supposedly well known in the prior art.

[00:26:12] Speaker 02:
We've never taken a view on that.

[00:26:14] Speaker 02:
Is that right?

[00:26:15] Speaker 02:
Not explicitly, Your Honor.

[00:26:16] Speaker 02:
All right.

[00:26:18] Speaker 02:
So what is your best argument as to why, in a Jepson context?

[00:26:22] Speaker 02:
I'm generally talking about claim aid here.

[00:26:25] Speaker 02:
When that's, we have adjusted the invention.

[00:26:29] Speaker 02:
We know what they're claiming.

[00:26:31] Speaker 02:
is inventive, why do they have to also give written description for whatever is well known in the prior art?

[00:26:40] Speaker 02:
Yes, Your Honor.

[00:26:41] Speaker 03:
I think this Court has taken, made every ruling right up to the point of the one that you said, you know, about explicitly stating that Jepson Preamble has to have written description just like any other claim element in any claim, because the Court has said

[00:26:58] Speaker 03:
a Jepson preamble is part of the claim, and it's limiting.

[00:27:02] Speaker 03:
The court has also separately said, everything in the claim that is limiting has to have written description.

[00:27:07] Speaker 03:
It doesn't matter if it's not the novel part.

[00:27:10] Speaker 03:
It doesn't matter if it's the known part.

[00:27:12] Speaker 03:
It has to have adequate written description.

[00:27:14] Speaker 03:
And we can see that there's no huge burden from your question to counsel earlier that

[00:27:21] Speaker 03:
depending on how well-known something is in the prior art, that the description that's required may be minimal.

[00:27:29] Speaker 03:
But you still have to have, under this court's case law, it can't just be something that's obvious or apparent to one another.

[00:27:36] Speaker 02:
Is part of the reason why you would have us say there is a written description requirement for what's well-known in the prior art, that there could be a dispute as to what's well-known in the prior art?

[00:27:46] Speaker 02:
And maybe the patentee might

[00:27:49] Speaker 02:
you know, think something's well known to prior art, but in the light of day, during fact-finding, you'll determine it wasn't actually well known.

[00:27:56] Speaker 02:
Is that one of the reasons?

[00:28:01] Speaker 03:
I'm not sure that that has an impact at the infringement stage.

[00:28:11] Speaker 03:
What we're talking about here, the fundamental bargain or the fundamental requirement of written description is that the patentee, the putative inventor, has to establish that they, to one of ordinary skill in the art, that they possessed the invention.

[00:28:25] Speaker 03:
A Jepson claim is something in the prior art with an improvement.

[00:28:30] Speaker 03:
The something in the prior art is part of the invention.

[00:28:35] Speaker 03:
the improvement standing alone, it's the improvement as applied to something specific.

[00:28:39] Speaker 03:
You have to show you knew about that part too.

[00:28:42] Speaker 02:
That's where I get confused because normally to be a person born of skill in the art, at least implicitly, we assume you're familiar with the prior art.

[00:28:51] Speaker 02:
It would be hard to imagine being qualified as a person of skill in the art if you don't already bring to the patent process knowledge of what's well known in the art.

[00:29:02] Speaker 02:
Would you agree with that?

[00:29:04] Speaker 03:
That's true, but you can't simply assert that something is well known in the art and make it true.

[00:29:12] Speaker 03:
You have to show that.

[00:29:13] Speaker 03:
Can I ask you a hypothetical?

[00:29:16] Speaker 02:
Absolutely.

[00:29:16] Speaker 02:
So let's assume we have a Jepson claim where it's an improvement to a car.

[00:29:24] Speaker 02:
And let's take it back 20 years before

[00:29:27] Speaker 02:
any kind of electric vehicle is ever known.

[00:29:30] Speaker 02:
So when you're riding the Jepson claim and it's an improvement for the braking system or a passenger vehicle, how much written description and support do you have to have for a car?

[00:29:44] Speaker 01:
Not much, right?

[00:29:45] Speaker 01:
Everybody knows what a car is.

[00:29:49] Speaker 02:
Do they have to have written description support for both an electric?

[00:29:52] Speaker 02:
Like, say we get, you know, a little bit later, did they have written description support for an electric car versus a gas car?

[00:30:01] Speaker 02:
Or the braking system?

[00:30:04] Speaker 02:
Does that matter?

[00:30:05] Speaker 03:
I... If you...

[00:30:18] Speaker 03:
I'm not sure, Your Honor.

[00:30:19] Speaker 03:
An after-rising topic.

[00:30:20] Speaker 02:
I'm not either.

[00:30:21] Speaker 02:
That's why I asked.

[00:30:22] Speaker 02:
I'm just worried about the extent of... Because it does seem to me like it has to be some type of sliding scale.

[00:30:29] Speaker 02:
And this one, do we know that people of skill in the art knew of administering this antibody for all of these different purposes?

[00:30:40] Speaker 02:
I don't know.

[00:30:40] Speaker 02:
I don't see a lot of...

[00:30:42] Speaker 02:
of explanation in the record that somebody of skill and art would have known that you could use this for a whole bunch of things.

[00:30:50] Speaker 02:
But assume they did, then why wouldn't the specific improvement be, you know,

[00:30:58] Speaker 02:
the one you really had to show written description support for, and all you had to do was make a nod to the fact that somebody skilled in the art would know all this.

[00:31:06] Speaker 02:
I mean, maybe that's the problem here is there's no evidence to show that a skilled artisan would know how to use this specific substitution in antibody for all the different kinds of patients.

[00:31:21] Speaker 03:
Right, Your Honor.

[00:31:22] Speaker 03:
So let me answer that in two parts.

[00:31:24] Speaker 03:
One is sort of

[00:31:25] Speaker 03:
I think there is a sliding scale because not all technologies are the same.

[00:31:32] Speaker 03:
I apologize, I can't remember the name of the case off the top of my head, but there was a case from this court about

[00:31:40] Speaker 03:
a decoder, an electronic circuit.

[00:31:43] Speaker 03:
And all it said was a decoder and then it had the name of an article with the magazine title.

[00:31:50] Speaker 03:
And there was evidence from an expert that just seeing that name and the article title was enough written description for him to recognize what that was as a person of ordinary skill in the art.

[00:32:00] Speaker 03:
That's kind of one extreme, right?

[00:32:02] Speaker 03:
That's a lot like your car example.

[00:32:05] Speaker 03:
maybe just saying the car is enough, depending on the particular invention involved.

[00:32:10] Speaker 03:
If it's about some specific improvement to the fuel injection system, maybe you've got to say something about what the engine looks like and not just say car.

[00:32:19] Speaker 03:
But here, we're in the antibody field, and the

[00:32:23] Speaker 03:
we have an admission in this context that they didn't possess all the known area or all the known genus, all the genus of anti-C5 antibodies.

[00:32:37] Speaker 03:
And making, we also know that antibodies and biochemistry are highly unpredictable.

[00:32:45] Speaker 03:
Making a change in a single sequence can radically effect structure.

[00:32:51] Speaker 03:
So here,

[00:32:53] Speaker 03:
we have an extreme where there's no discussion of administering or treating or of the genus of anti-C5 antibodies and yet a claim, multiple claims, both the Jets and endamine plus function, claiming all of that.

[00:33:13] Speaker 03:
I see that I'm over time.

[00:33:14] Speaker 03:
If I could just briefly address one point.

[00:33:16] Speaker 02:
He's going to end up with extra time, so you can go to the four-minute mark.

[00:33:22] Speaker 03:
Thank you, Your Honor.

[00:33:23] Speaker 03:
I just wanted to briefly address counsel's reference to the Alcon research case.

[00:33:30] Speaker 03:
I think that counsel is completely misreading it.

[00:33:34] Speaker 03:
If Your Honors would look at the Alcon research case, which is 745 F3D at 1191, this court did not just focus on the improvement.

[00:33:47] Speaker 03:
uh... of stability to the prostaglandin compound.

[00:33:50] Speaker 03:
It's that the court's opinion states it provides, speaking of the patented issue there, it provides exemplary formulations that embody the claimed invention, reciting concentrations of every ingredient.

[00:34:02] Speaker 03:
It also discloses data generated by the inventor from accelerated stability testing

[00:34:10] Speaker 03:
showing the effect of pico and prostaglandin concentration on stability and comparing the effect of pico to that of a more commonly used surfactant polysorbate 80.

[00:34:19] Speaker 03:
The patent also describes various classes of prostaglandins.

[00:34:22] Speaker 03:
to which the invention was understood to relate, which are covered by the term prostaglandin under the district court's construction of that term.

[00:34:29] Speaker 03:
This court found lots of description about the prior art that was being improved on in that case.

[00:34:36] Speaker 03:
And I do think that this court's decision in E.I.

[00:34:40] Speaker 03:
Lilly is by far the best guidance for this situation, is by far the closest set of claims and analysis.

[00:34:45] Speaker 03:
Thank you.

[00:34:53] Speaker 04:
Thank you, Your Honor.

[00:34:55] Speaker 04:
I'd like to start where he just left off, which was with ALKON research.

[00:34:59] Speaker 04:
So we also have an immense amount of specification support.

[00:35:04] Speaker 04:
The specification says things like this data was proved to be reproducible via repeat experiments with a variety of antigens.

[00:35:12] Speaker 04:
And earlier in the priority chain, there was a declaration that was provided of transferability.

[00:35:18] Speaker 04:
When the examiner had questioned, well, we know this is going to work.

[00:35:21] Speaker 04:
across a wider variety.

[00:35:23] Speaker 04:
The inventors provided a declaration of transferability.

[00:35:27] Speaker 04:
The examiner accepted that declaration, and the issue never came up again.

[00:35:31] Speaker 04:
So we have record evidence and support for the fact that this will work broadly.

[00:35:37] Speaker 04:
And the reason why he mentioned unpredictability of antibodies, that's true, but it's true of the variable region.

[00:35:44] Speaker 04:
That's what binds to things, and that's where all these different changes occur can affect binding

[00:35:50] Speaker 04:
That's where all this court's case law is about.

[00:35:52] Speaker 04:
We're in the constant region.

[00:35:53] Speaker 04:
We're in the stock of the Y. And here, you can consistently make these amino acid substitutions and get longer in vivo half-life.

[00:36:02] Speaker 04:
You're not going to make the antibody work better.

[00:36:04] Speaker 04:
It's not going to kill the antigen better.

[00:36:07] Speaker 04:
It's not going to kill it.

[00:36:08] Speaker 04:
But what it's going to do is it's going to stay in the body longer, which is undisputably an advantage.

[00:36:13] Speaker 04:
I also want to just clarify, to the extent I implied that there was no support and specification for treatment,

[00:36:19] Speaker 04:
I think I said the specification is full of examples of using this for treatment purposes.

[00:36:24] Speaker 04:
It's probably the primary embodiment.

[00:36:26] Speaker 04:
It's not the only embodiment.

[00:36:27] Speaker 04:
It also mentions research and diagnostic testing.

[00:36:31] Speaker 04:
But it's full of examples, and specifically in paragraph 133, it mentions the fact that anti-C5 antibodies can be used to treat autoimmune transplant disorders and inflammation.

[00:36:43] Speaker 04:
And that's what was known about anti-C5 antibodies.

[00:36:46] Speaker 04:
That's why you would administer

[00:36:49] Speaker 04:
this to treat if you have an intent to treat would be to affect diseases of the complement system.

[00:36:56] Speaker 04:
So all of that was known and is described in the specification.

[00:37:00] Speaker 04:
I think, however, going back to what Judge Stark said about the preamble, the easiest way to address claim nine is just to find that it's not limiting.

[00:37:07] Speaker 04:
There's nothing wrong with splicing it.

[00:37:09] Speaker 04:
There's no court precedent that says because you find a portion of the preamble to be limiting, the rest of the preamble must therefore be limiting.

[00:37:16] Speaker 04:
In fact, the opposite was held in TomTom, and this case is very similar to those claims.

[00:37:25] Speaker 04:
I think we just heard for the first time that these claims don't require any safety and efficacy and that the case law doesn't require that.

[00:37:32] Speaker 04:
I think previously from the director and the board, they've read that into the claims.

[00:37:36] Speaker 04:
So if we wipe that out

[00:37:38] Speaker 04:
even if the preamble is limiting in claim nine, all you need to show is you're doing it for the purpose of treating.

[00:37:44] Speaker 04:
We've got that in the specification.

[00:37:47] Speaker 04:
We don't need to show that it's going to be effective or for all diseases and all purposes.

[00:37:52] Speaker 04:
So unless the court has any other questions.

[00:37:56] Speaker 02:
Thank you.

[00:37:56] Speaker 04:
Thank you.

[00:37:58] Speaker 02:
The case is submitted.