[00:00:00] Speaker 03:
Yes, thank you, Judge Moore.

[00:00:03] Speaker 03:
Your Honor, may I take the witness on board, dear?

[00:00:06] Speaker 03:
No.

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

[00:00:11] Speaker 05:
This morning, I'd like to move the admission of Jingyan Luo, who is a member of the Bar and is in good standing with the highest courts of California.

[00:00:21] Speaker 05:
I have knowledge of her credentials and am satisfied that she possesses the necessary qualifications.

[00:00:27] Speaker 05:
I've known Ms.

[00:00:28] Speaker 05:
Luo for

[00:00:30] Speaker 05:
two and a half years now when I went out to interview her for a potential clerkship position when she was then still a law student at Berkeley.

[00:00:41] Speaker 05:
And I knew immediately within five minutes of meeting her that she was a total dynamo and legal eagle.

[00:00:47] Speaker 05:
We talked about divided infringement, Section 101, and the Biosimilar Act.

[00:00:53] Speaker 05:
She told me I was wrong in Amgen versus Sandoz.

[00:00:56] Speaker 05:
I have forgiven her about that.

[00:00:59] Speaker 05:
But she gave a very cogent analysis of why I was wrong.

[00:01:03] Speaker 05:
Nine people down the street disagreed, but it doesn't matter.

[00:01:08] Speaker 05:
She has really helped me over the past 14 months as a clerk.

[00:01:13] Speaker 05:
She's really helped me think more deeply about the issues, helped me from making mistakes.

[00:01:20] Speaker 05:
And it's really been a joy working with her.

[00:01:22] Speaker 05:
She has excellent character, excellent

[00:01:25] Speaker 05:
writing ability and analytical ability.

[00:01:28] Speaker 05:
I know she will be an asset to our bar.

[00:01:30] Speaker 05:
I recommend that she be admitted.

[00:01:35] Speaker 05:
Fine law school.

[00:01:36] Speaker 02:
Any objections?

[00:01:37] Speaker 03:
No objections.

[00:01:38] Speaker 02:
Okay, well with such a sterling recommendation from Judge Chen, the motion is granted.

[00:01:44] Speaker 02:
Would the clerk please square in?

[00:01:48] Speaker 00:
Please raise your right hand.

[00:01:50] Speaker 00:
Do you solemnly swear or affirm that you will comport yourself as an attorney and counsel of his court, uprightly and according to law, and that you will support the Constitution of the United States of America?

[00:02:00] Speaker 00:
I do.

[00:02:01] Speaker 00:
Refer to the Bar of the United States Court of Appeals for the Delegations.

[00:02:08] Speaker 02:
Thank you.

[00:02:09] Speaker 02:
OK, our first case for this morning, 2017-1825, Kumar versus Yanku.

[00:02:15] Speaker 02:
Mr. Bretschneider, please proceed.

[00:02:21] Speaker 04:
Good morning, may it please the court.

[00:02:23] Speaker 04:
My colleague Peter Knutson is with me at the council table.

[00:02:27] Speaker 04:
The case before the court is somewhat unusual in that the director, in a sense, admits that the board's claim construction was incorrect and proposes an alternative claim construction upon which the director urges the court to defer the board's decision.

[00:02:50] Speaker 05:
Putting aside... Well, the Greenberry agrees with the Board that your patient population clauses in the preamble are not entitled to patentable weight.

[00:03:02] Speaker 05:
And that's really the crux of the case, isn't it?

[00:03:04] Speaker 04:
Well, it is and it isn't.

[00:03:07] Speaker 04:
The reason I brought this case, this issue up first, Your Honor, is that under the Administrative Procedure Act, this Court reviews the decision of the Board as presented and not as rewritten by the Director.

[00:03:19] Speaker 04:
However, both the board and the director are wrong in this case in that the in need of recitation in claim one of Kumar, for example, is a limitation.

[00:03:32] Speaker 04:
This is just like Janssen case, which is discussed in the briefs extensively.

[00:03:37] Speaker 04:
In Janssen, the method claimed there was a method for treating megaloblastic anemia comprising the administration of, I think it was folic acid or something like that.

[00:03:50] Speaker 04:
And the question was, what effect, legally, did the in need of limitation have in the Janssen claims?

[00:03:58] Speaker 04:
And it was exactly the same situation as here.

[00:04:01] Speaker 04:
The person in need of was found to refer back to the preamble.

[00:04:05] Speaker 04:
The person in need of was the person in need of treatment for megaloblastic anemia.

[00:04:11] Speaker 04:
In this case, the person in need of is the person in need of treatment, I'm sorry, for the reduction or alleviation

[00:04:20] Speaker 04:
inter-individual platelet response variability and metabolic loading.

[00:04:25] Speaker 04:
In the context agreed of the treatment of embolisms and thrombosis, but only after these side effects, inter-individual platelet variability response variability and metabolic loading have been observed.

[00:04:41] Speaker 04:
So in this case, the director's reconstruction of the board's decision

[00:04:49] Speaker 04:
is just as incorrect as the board, because the director says part of the preamble is limiting.

[00:04:56] Speaker 05:
Let me see if I can understand your argument.

[00:04:58] Speaker 05:
Are you arguing that we should, in the body of the claim, I see a single step, administering S-Hoxo, an effective amount of S-Hoxo, right?

[00:05:09] Speaker 05:
Are you suggesting that, given the language in the preambles, we should be thinking of the claim as including two additional steps?

[00:05:19] Speaker 05:
administering Copadogro to a bunch of people, observing this inter-individual variability, and then for the people that are not good responders to Copadogro, now go ahead and administer Essoxo?

[00:05:35] Speaker 05:
Is that how we should interpret the claim?

[00:05:38] Speaker 05:
The claim is written.

[00:05:39] Speaker 05:
I just need an answer to that question first before I can think any further.

[00:05:43] Speaker 05:
Is that the way we should understand the construction of your claims?

[00:05:47] Speaker 04:
in the context of the claim as presented in order to carry out.

[00:05:53] Speaker 05:
Is this a yes or a no coming?

[00:05:55] Speaker 04:
It's basically a yes.

[00:05:57] Speaker 04:
It's a yes.

[00:05:57] Speaker 05:
OK.

[00:05:57] Speaker 05:
So we need to understand the single step presiding the body as really having three steps.

[00:06:03] Speaker 05:
Well, as the claim is stated, you have to first administer copodobro.

[00:06:10] Speaker 05:
Right.

[00:06:11] Speaker 05:
And then you have to observe that it doesn't work.

[00:06:14] Speaker 05:
Right.

[00:06:14] Speaker 05:
And then, after you observe it doesn't work, for those people it doesn't work for you, administer S-OXO?

[00:06:22] Speaker 04:
You have to administer an amount that's effective.

[00:06:25] Speaker 05:
For treating, reducing thrombosis.

[00:06:28] Speaker 04:
Yes.

[00:06:29] Speaker 04:
This argument, is it a single method step or multiple method step claim, is, I think, interesting.

[00:06:36] Speaker 04:
And I understand Your Honor's point.

[00:06:39] Speaker 04:
And the director says it's a single method step claim, pay no attention to

[00:06:45] Speaker 04:
the context to the raison d'etre of the invention, to the intentional purpose for which the administration step is carried out.

[00:06:53] Speaker 04:
Those are not limitations at all.

[00:06:55] Speaker 04:
However, the court and the board both have to read the claim language as a whole.

[00:07:01] Speaker 05:
And when they do... We also have to give the broadest reasonable interpretation.

[00:07:04] Speaker 04:
But the broadest reasonable interpretation, Your Honor, still requires consideration of all the language in the claim.

[00:07:11] Speaker 04:
It's not reasonable to say,

[00:07:12] Speaker 04:
that language doesn't count, especially here, where the, if we're going to analyze this in terms of preemblance and body, remember the, in the administration stamp, it says comprising and ministering to a person in need thereof.

[00:07:28] Speaker 04:
That's in the body.

[00:07:29] Speaker 03:
And that refers back to the person who has... So do you agree that the most important purpose of the invention is the treatment of thrombosis and embolisms in any patient in need thereof?

[00:07:43] Speaker 04:
That is the context in which the invention is carried out.

[00:07:47] Speaker 04:
But the invention as claimed, Your Honor, is the reduction or alleviation of these side effects in that context.

[00:07:55] Speaker 03:
Where in the 442 patent does Kumar express any type of clear intent to limit patient to persons with acute coronary symptoms who had previously been administered clopidogrom?

[00:08:09] Speaker 04:
I don't believe that that really is the issue.

[00:08:12] Speaker 04:
There's no question of written description or enablement here, Your Honor.

[00:08:16] Speaker 04:
The question is, what does the claim mean?

[00:08:19] Speaker 04:
And the board and the director both focus on portions of the patent that don't directly relate to this.

[00:08:28] Speaker 04:
The board refers in footnote seven on page 16 of the appendix to the... But you're taking your argument in directions away from the questioning.

[00:08:39] Speaker 03:
Yes.

[00:08:41] Speaker 03:
And I appreciate you want to make an argument, but we want to ask questions.

[00:08:44] Speaker 03:
Oh, I understand that.

[00:08:46] Speaker 03:
The PTAB's decision finds that reading the, quote, effective amount as that amount required for reducing or alleviating inner individual platelet response variability and metabolic loading in humans ellipses would not make sense chemically.

[00:09:03] Speaker 03:
And Kumar argues

[00:09:05] Speaker 03:
that that statement is not supported by any evidence.

[00:09:07] Speaker 04:
There is no evidence to support that.

[00:09:08] Speaker 03:
I'd like you to respond to the merits of the PTO's assertion.

[00:09:12] Speaker 03:
Where in the patent specification does it say that administering clopidogrel acts in a patient to reduce or alleviate that patient's earlier poor response to clopidogrel, that is, S-oxo?

[00:09:29] Speaker 04:
Unfortunately, as I stand here right now, Your Honor, I cannot answer that question directly, but I would be delighted to.

[00:09:34] Speaker 04:
The thing is, this issue was not presented or briefed below, and the parties did not join issue on this point.

[00:09:42] Speaker 03:
Well, can you answer this for me?

[00:09:43] Speaker 03:
Isn't it, is it true that a patient remains clopidogrel-resistant after administration of SOXO clopidogrel?

[00:09:53] Speaker 03:
I'm sorry?

[00:09:54] Speaker 03:
Is it true that a patient remains clopidogrel-resistant

[00:09:58] Speaker 03:
after administration of S-OXO?

[00:10:01] Speaker 04:
It's possible, Your Honor.

[00:10:02] Speaker 04:
I don't think it matters.

[00:10:04] Speaker 05:
Wait a second.

[00:10:05] Speaker 05:
I mean, there is no evidence or argument by you that the administration of S-OXO turns an otherwise poor clopidogrel responder into a good clopidogrel responder.

[00:10:19] Speaker 05:
Is that fair to say?

[00:10:20] Speaker 05:
Yes, it is.

[00:10:20] Speaker 05:
There is no evidence or argument that it turns a clopidogrel

[00:10:25] Speaker 05:
a poor clopidogrel responder into a good clopidogrel responder.

[00:10:31] Speaker 04:
The purpose of the invention is to overcome side effects from the administration of clopidogrel.

[00:10:38] Speaker 04:
Oh, how do you pronounce it?

[00:10:41] Speaker 04:
I just need to know how to pronounce it.

[00:10:44] Speaker 04:
I'm just curious.

[00:10:45] Speaker 04:
That's okay.

[00:10:45] Speaker 04:
Clopidogrel.

[00:10:47] Speaker 04:
Clopidogrel.

[00:10:48] Speaker 04:
Okay.

[00:10:48] Speaker 04:
That's how I heard how to pronounce it.

[00:10:50] Speaker 04:
All right.

[00:10:50] Speaker 04:
Thank you.

[00:10:50] Speaker 04:
Yeah.

[00:10:52] Speaker 04:
What do we know?

[00:10:53] Speaker 04:
Actually, on that, what do I know?

[00:10:56] Speaker 04:
But that's how we've been pronouncing it.

[00:10:58] Speaker 04:
OK.

[00:10:58] Speaker 04:
Thank you.

[00:11:00] Speaker 04:
The problem here is that you've obviously raised good points.

[00:11:06] Speaker 04:
The bench raises them there.

[00:11:07] Speaker 04:
They have to be good points.

[00:11:09] Speaker 04:
But the question is, what do the claims actually say?

[00:11:12] Speaker 04:
And what does the evidence of record in this case actually show?

[00:11:17] Speaker 04:
On the administrative record, we have a decision where the board says,

[00:11:21] Speaker 04:
let's forget about everything in these claims that the administration stepped.

[00:11:27] Speaker 04:
And the Parilla reference discloses administering S-oxo-clopidogrel.

[00:11:33] Speaker 04:
And that's the end of it.

[00:11:35] Speaker 05:
Did the board ever construe or make an observation of what does it mean to be an effective amount?

[00:11:40] Speaker 04:
They do.

[00:11:41] Speaker 04:
And this is, by the way, this is the, on page, in Appendix 16, in Appendix 16, the sentence to which the

[00:11:51] Speaker 04:
auspicious footnote 7 is attached reads, we interpret the term effective amount of the amount of S-oxo-clopidogrel effective in the treatment or prophylaxis of thrombosis or embolisms.

[00:12:05] Speaker 04:
Then there's footnote 7.

[00:12:07] Speaker 04:
And this is the discussion of whether the claim preamble is vague.

[00:12:12] Speaker 04:
The board never explains why it's vague.

[00:12:14] Speaker 04:
It seems pretty clear to us.

[00:12:16] Speaker 04:
But there's no argument that the words are unclear or anything like that.

[00:12:20] Speaker 04:
And we go into this in detail.

[00:12:22] Speaker 05:
Well, why isn't it what the Green Brief said, which is that the administration of S-OXO doesn't do anything on a chemical level to cure people that are not good responders to clopidogrel?

[00:12:39] Speaker 04:
My response to that, Your Honor, is that there is.

[00:12:42] Speaker 04:
If you look at the director's brief, they don't cite any evidence to support that.

[00:12:47] Speaker 05:
That is a... Well, I'm just trying to use a little logic and common sense here.

[00:12:51] Speaker 04:
Your Honor, it's not a question of common sense.

[00:12:53] Speaker 04:
Remember, you can't rely on common sense to hold inventions to be unpatentable.

[00:12:58] Speaker 04:
And in this case... We can't?

[00:12:59] Speaker 02:
Actually, KSR says... You can't.

[00:13:01] Speaker 02:
I'm sorry.

[00:13:01] Speaker 04:
Common sense, Your Honor, that doesn't arise out of something in the record.

[00:13:05] Speaker 04:
And remember, this is not... Common sense and the law are not necessarily mutually exclusive.

[00:13:12] Speaker 04:
Now, this is not like KSR in which common sense was pretty obvious.

[00:13:18] Speaker 04:
This is not common sense technology at all.

[00:13:20] Speaker 04:
Not to me, certainly.

[00:13:22] Speaker 04:
I'm not much of a chemist.

[00:13:24] Speaker 04:
But the thing is, we have to go on the administrative record and to see what are these arguments based on.

[00:13:32] Speaker 04:
They're not based on any actual evidence

[00:13:37] Speaker 04:
For example, on page 29 of the director's brief, the director talks about the sole inventive contribution of Kumar.

[00:13:44] Speaker 04:
This is, again, that's not, you don't parse claims to determine the sole inventive concept.

[00:13:51] Speaker 02:
You have to... You're well into your rebuttal time.

[00:13:52] Speaker 02:
Would you like to reserve any?

[00:13:54] Speaker 04:
I would, Your Honor.

[00:13:55] Speaker 04:
Thank you.

[00:13:55] Speaker 04:
I notice I have three minutes left.

[00:13:57] Speaker 02:
Thank you very much.

[00:14:08] Speaker 01:
Good morning, Your Honors.

[00:14:09] Speaker 01:
May it please the Court?

[00:14:10] Speaker 03:
If we disagreed with you on claim construction, would we have to remand for additional fact findings on the obviousness determination?

[00:14:18] Speaker 01:
The normal procedure would be to remand under a new construction.

[00:14:21] Speaker 01:
Here, however, as we state in our brief, there are no undisputed facts for the board to find.

[00:14:29] Speaker 01:
The presence of clopidogrel resistance, poor responders, non-responders,

[00:14:34] Speaker 01:
are essentially admitted prior art.

[00:14:37] Speaker 01:
It's in the background of the invention.

[00:14:39] Speaker 01:
There were statements during the prosecution history that everything was known, that the existence of these non-responders, the metabolic pathway, and the fact that it was this formula for metabolite that was causing thus largely the side effects of clopidogrel was already known.

[00:14:57] Speaker 01:
So on the record, as Sun argued the motion,

[00:15:01] Speaker 01:
They didn't make this argument about the claim, the preambles not being given patentable weight.

[00:15:07] Speaker 01:
They gave them patentable weight and said it was known in the art.

[00:15:11] Speaker 01:
So if this court disagrees with the claim construction, a remand, I think, would be wasteful.

[00:15:17] Speaker 01:
And obvious this is a question of law that this court can make on the undisputed facts in the record.

[00:15:22] Speaker 05:
You're saying if it would be obvious to administer asoxo for any patient that needs it for thrombosis, given that

[00:15:31] Speaker 05:
it was known in the art already that clopidogrel didn't work for certain people.

[00:15:36] Speaker 05:
It would be painfully obvious to administer S-oxo to that subpopulation.

[00:15:40] Speaker 01:
That's right, Your Honor.

[00:15:41] Speaker 01:
And that's what Sun said in their motion.

[00:15:43] Speaker 01:
In fact, they were going the next step.

[00:15:44] Speaker 01:
It was obvious to treat it to these patients, and in fact, to all patients, because the metabolic pathway happens in everyone.

[00:15:52] Speaker 01:
So to the extent you're giving a metabolite downstream of clopidogrel, it would be effective in all patients to treat.

[00:16:00] Speaker 01:
thrombosis and embolism.

[00:16:02] Speaker 03:
And I'm going to ask your opposing counsel on the other side of the coin, which is, if we agree with you, do we have to go anywhere else?

[00:16:11] Speaker 01:
If you agree with the board's claim construction, Kumar doesn't make any separate argument for the obviousness decision for the independent claims or a number of the dependent claims.

[00:16:22] Speaker 01:
It's just the claim construction redox.

[00:16:24] Speaker 01:
The board made a claim construction and then didn't give patentable weight to the patient populations.

[00:16:29] Speaker 01:
So there's no separate error in the obviousness decision.

[00:16:32] Speaker 01:
There's dependent claims 14 through, 10 through 14 and 16 that they make a separate argument for in terms of the board's reliance on routine experimentation.

[00:16:43] Speaker 01:
So that would be separate from the claim construction.

[00:16:47] Speaker 01:
I don't, that argument I think was just, they did make the separate, they made the claim construction argument again for those claims and then said the board erred in using routine experimentation.

[00:16:58] Speaker 01:
But there's not an error in using routine experimentation.

[00:17:01] Speaker 01:
When you have a known dosage range for clopidogrel, the claim seven says you will use less of the ex-oxo clopidogrel.

[00:17:10] Speaker 01:
And the board affirmed that for claim seven.

[00:17:13] Speaker 01:
So the effective amount of the ex-oxo is less.

[00:17:17] Speaker 01:
And then the specific dosages in the dependent claims then would be a matter of routine experimentation.

[00:17:23] Speaker 01:
And that's a question of fact review for substantial evidence.

[00:17:26] Speaker 01:
That's correct, Your Honor.

[00:17:27] Speaker 01:
So we could return to the claim construction argument.

[00:17:31] Speaker 01:
I don't believe the director has changed the claim construction argument.

[00:17:35] Speaker 01:
It's always been the board's construction gave partial effect to the treating and prevention of thrombosis and embolism.

[00:17:41] Speaker 01:
The board expressly says that the preamble gives some basis for construing the effective amount, then said that the patient populations were just the context, and did its best with not seeing steps in the claim, didn't add the additional steps of administering clopidogrel,

[00:17:57] Speaker 01:
And also, as your honors have noticed, they said there's no effective amount for the treatment of a clopidogrel resistance, because giving the metabolite doesn't change the fact in the world about that patient's clopidogrel resistance.

[00:18:10] Speaker 01:
So unless this court has any other questions, we'll yield the rest later in my time.

[00:18:15] Speaker 05:
Mr. Bretschneider was arguing about how the preambles talk about in terms of a patient in need.

[00:18:21] Speaker 01:
Yes.

[00:18:22] Speaker 05:
In need thereof.

[00:18:23] Speaker 05:
And so I think his point is that that phrase is some kind of hook to bring in the subpopulation of patients that are resided in these preambles.

[00:18:36] Speaker 05:
So what do you have to say about that?

[00:18:38] Speaker 01:
I think that hook suffers from the same problem of the effective amount argument.

[00:18:43] Speaker 01:
That is true.

[00:18:44] Speaker 01:
There are patients who are in need of a reduction or alleviation of a poor response to clopidogrel.

[00:18:50] Speaker 01:
But the administration step here of administering the metabolite doesn't solve that problem.

[00:18:57] Speaker 01:
There's no reduction or elimination of the poor response to clopidogrel.

[00:19:02] Speaker 01:
Those patients are still clopidogrel resistant.

[00:19:04] Speaker 01:
They just now can take the metabolite and have a treatment for thrombosis or embolism.

[00:19:10] Speaker 01:
That's what's chemically happening in the body with the metabolite stopping platelet aggregation.

[00:19:17] Speaker 01:
I think claim 30 is a little bit more straightforward than the preamble to claim 1, where it's just a method for treating clopidogrel resistance.

[00:19:26] Speaker 01:
And there's nothing about administering esoxoclopidogrel that treats that patient's clopidogrel resistance.

[00:19:35] Speaker 05:
When it just comes to these subpopulation recitations and claims, I guess I'm

[00:19:44] Speaker 05:
concerned.

[00:19:45] Speaker 05:
Is it the PTO's view that they're never given patentable weight and they're always just some kind of contextual, atmospheric?

[00:19:58] Speaker 05:
I guess what I'm trying to figure out is we now know more and more each day that certain subpopulations of the human race are at proclivity for this disease, that disease, or more resistant to that drug, or more open to

[00:20:13] Speaker 05:
a healthy response to a different drug.

[00:20:16] Speaker 05:
So why, there's got to be some instances where patient population does matter and not only merely is throat clearing language, but it's actually a key point of the claim, prevention.

[00:20:32] Speaker 01:
I think that absolutely could be the case.

[00:20:34] Speaker 05:
It's not on the facts of this case, but in fact- Do you have an example off the top of your head where it would actually matter and work?

[00:20:41] Speaker 01:
We could change the facts of this case if there was evidence in the patent that the patient population to our poor resistors of clopidogrel, in fact, had a response to S-oxo or to drug X. Doesn't matter what the drug is.

[00:20:54] Speaker 01:
that it treated them at a certain effective rate.

[00:20:58] Speaker 02:
Well, like different dosages.

[00:21:00] Speaker 02:
Like different dosages, right.

[00:21:01] Speaker 02:
For example, if you found certain patients resistant to certain things required a higher or lower dosage of this to have the same level of effectiveness, that would be a great subpopulation limitation that was meaningful, right?

[00:21:11] Speaker 01:
Right.

[00:21:12] Speaker 01:
You're correct, Your Honor.

[00:21:14] Speaker 01:
I think that's the point I was trying to make, is if those people in need of the treatment for reducing clopidogrel had a different effective amount, that treating to that patient population would inform the administration steps.

[00:21:28] Speaker 01:
So it would change the administration steps.

[00:21:30] Speaker 02:
I just have a curiosity to make sure I understand something right.

[00:21:32] Speaker 02:
In the treatment using exoxo to treat thrombosis or embolisms,

[00:21:40] Speaker 02:
Isn't that true for patients regardless of whether they are clopidogrel resistant?

[00:21:46] Speaker 02:
That's correct, Your Honor.

[00:21:47] Speaker 02:
It's kind of like, in my simplistic way of explaining things, you could take Tylenol for a headache or you could get Advil for a headache.

[00:21:56] Speaker 02:
Maybe Tylenol's not so effective for some people.

[00:21:59] Speaker 02:
So those people could take Advil.

[00:22:00] Speaker 02:
Guess what?

[00:22:01] Speaker 02:
All the people could have taken Advil.

[00:22:02] Speaker 02:
What's the difference?

[00:22:04] Speaker 01:
That's correct, because the metabolite

[00:22:07] Speaker 01:
is then further metabolized in all patients to have the effect on platelets and treat or prevent.

[00:22:13] Speaker 02:
It's not, I guess the point I'm making, it's not like there's something special about the clopidogrel resistant people that makes exoxo better for them than it would have been for any other person it was necessarily administered for.

[00:22:27] Speaker 02:
And even if there is something like that, it's certainly not described in this patent or in these claims.

[00:22:32] Speaker 01:
That's correct.

[00:22:32] Speaker 01:
There's nothing in the record or any facts that that's the case.

[00:22:37] Speaker 02:
Thank you.

[00:22:39] Speaker 02:
Thank you.

[00:22:40] Speaker 02:
Mr. Bretschneider, you have some little time.

[00:22:42] Speaker 02:
Thank you, Your Honor.

[00:22:42] Speaker 03:
Just a couple of... So you're going to answer my question first, right?

[00:22:46] Speaker 03:
No.

[00:22:47] Speaker 03:
Do you agree that your obviousness arguments depend on your, on the pro-offer claim construction?

[00:22:52] Speaker 04:
I'm sorry?

[00:22:53] Speaker 03:
Do you agree that your obviousness arguments depend on the pro-offer claim construction?

[00:22:59] Speaker 04:
Oh, yes.

[00:23:00] Speaker 04:
I think that's, that goes without saying in a case like this.

[00:23:04] Speaker 04:
Just a couple of points.

[00:23:05] Speaker 04:
Point one.

[00:23:07] Speaker 04:
The director hasn't joined issues with the Janssen issue.

[00:23:11] Speaker 04:
Janssen is dead on point.

[00:23:13] Speaker 04:
And that's one thing.

[00:23:15] Speaker 04:
Another thing is, let's talk about the supposed substantial evidence.

[00:23:21] Speaker 04:
The most important testimony that is relied upon is an appendix 2079 to 2080, which is in the testimony of Dr. Gerbel, who is the expert used by Sun.

[00:23:34] Speaker 04:
Dr. Gerbel basically says,

[00:23:36] Speaker 04:
that it's a routine matter to determine dosages if you know what the desired therapeutic effect is.

[00:23:46] Speaker 04:
If you know what it is, then you can determine it.

[00:23:49] Speaker 04:
But as this court has said in cases like Honeywell versus Mexicum, just because something is routine doesn't make it unpatentable.

[00:23:57] Speaker 04:
Otherwise, the last sentence of 35 USC 103A

[00:24:00] Speaker 04:
that patentability will not be negative by the manner in which the invention was made.

[00:24:04] Speaker 04:
This is essentially of no consequence.

[00:24:08] Speaker 04:
Another point is let's look at what the board actually did here.

[00:24:13] Speaker 04:
The PENIX 25 right in the middle lines 13 through 15 crystallized the board's decision.

[00:24:21] Speaker 04:
We need not reach whether the intended use of overcoming clopidogrel resistance would have been obvious as the intended use does not confer patentability.

[00:24:31] Speaker 04:
That's wrong.

[00:24:32] Speaker 04:
We've explained why.

[00:24:33] Speaker 04:
We needn't belabor the point any further.

[00:24:37] Speaker 04:
And that, Your Honor, unless the Court has questions, concludes our presentation.

[00:24:41] Speaker 02:
Okay.

[00:24:42] Speaker 02:
I thank both counsels for their arguments.

[00:24:43] Speaker 02:
The case is taken under submission.