[00:00:00] Speaker 02:
Our next case is in, Ray Edward Tobinick.

[00:00:31] Speaker 02:
Mr. Hall?

[00:00:35] Speaker 02:
And I'll pronounce your name correctly.

[00:00:37] Speaker 02:
You have 15 minutes, and I guess there's no rebuttal here, so it's 15 minutes.

[00:00:45] Speaker 03:
Well, I'd like to talk about two topics, the first one being that Old Market did not possess the invention claimed in the interference at the time that its PCT application was filed.

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And then if I may reserve five minutes to

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to speak about a second topic, which is the problem that Ulmarker had the day the patent office declared two different interferences, one in which it was the junior party against Lee and one in which it was the senior party.

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I'd like to define some terms just to get us started.

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The claims use the term nerve condition mediated by nucleus pulposus.

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Nucleus pulposus is a cellular material that comes out of a herniated disc and it impinges on surrounding nerve tissue and causes pain.

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By two mechanisms, one is simple pressure and the other is that it releases a protein called TNF which hurts somewhat like the way hot sauce hurts, but it also causes inflammation.

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and the immune system reacts to inflammation, cellular leukocytes will find that area and they will get involved in releasing cytokines, including more TNF.

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And I'd just like to also point out in the record that the term mediate is defined on page A4746.

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So just to state it simply,

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Invention is about treatment of back pain by localized application of an antibody that binds TNF.

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My brief talks about Olmarker's series two experiments in which he took an antibody, mixed it with nucleus pulposus, and put it on the exposed nerves of a pig.

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This was a model for epidural treatment.

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That paper,

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It's called Ohmacher, 1998.

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And those experiments ended up in the priority documents and in the PCT application.

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The series two experiments failed, and there's a lot of material in the PCT saying so and drawing conclusions.

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And I just want to explain what they were trying to get at in that paper.

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No one had reached the conclusion yet that TNF

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is the only bad actor.

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There were other cytokines.

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And no one had reached the conclusion that local treatment works at all.

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Systemic, of course, is preferred for most medical treatments.

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So what, Omar, from 1998.

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So the board found that the descriptions of the series two results

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show that the inventors understood the therapeutic value or the therapeutic potential.

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You argued that they did not.

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Explain why the board erred in that determination.

[00:04:07] Speaker 03:
Well, the board erred by reading the conclusion sentence of that paper as broadly encompassing all of the different

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molecules that they had used, the doxycycline broad spectrum inhibitors of all cytokines and the antibody.

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But when you actually read it with understanding, you can see that they're really saying only the broad spectrum, the doxycycline, is what worked.

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And the others do not work.

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That's why they said inhibiting TNF and related substances, what they mean is cytokines.

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And we have

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expert testimony from Dr. Weinberger, from Dr. Richardson, from Dr. Clark saying that's exactly what this means.

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Was there contrary expert testimony on that point?

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The other side, the board relied on Dr. Anderson who we complained was not being fair, not being truthful and then they said well even if Dr. Anderson's testimony isn't accurate or reliable

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we can read it for ourselves.

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And so they read that for themselves.

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But if I could just point out that a subsequent paper by Olmarker and Aoki, and it's in the record at 2845, I quoted in the brief, it was not possible to draw any conclusion regarding which of these cytokines might be directly involved.

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That's talking about the Olmarker 1998 and the series two.

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And this is a factual issue, right?

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It's a factual question.

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Yeah.

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And so the question is whether there's substantial evidence to support the board's finding, right?

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I think there is not because they interpreted it for themselves and they discounted our expert testimony by saying that they found a contradiction between two of the experts and therefore they didn't need to listen to Dr. Weinberger.

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But when you look at the contradiction they point to,

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There's no contradiction, and I discussed that in the brief.

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They're talking about two totally different things.

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Now, if we disagree with you about your argument with respect to Dr. Anderson's testimony and find that the board did not err by considering that evidence, then is there substantial evidence to support the board's finding?

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It's wrong.

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It's just flat wrong.

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And if you look at Dr. Anderson's... The question is, is there substantial evidence?

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I would say no.

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It's so wrong.

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And if you look at Dr. Anderson's treatment of that area, he uses ellipses, he puts words in that actually aren't there, and he's just changing the meaning.

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The first time this case was on appeal, it was a very similar situation where Dr. Anderson was changing the meaning of the written record, and this court found there was no substantial evidence.

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You know, we have the same situation.

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And if I could just point to some of the statements in the PCT application which show that the series two didn't work.

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On page 82699 talking about possibilities for how do you treat back pain

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One may therefore also consider the possibility of a selective blocker of TNF may not be sufficient to completely block the nucleus proposes induced effects.

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And that simultaneous block of other synergistic substances is necessary as well.

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They had not come to the conclusion that TNF alone was the important thing to block.

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And it's also important to realize that even if you have decided it's TNF,

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you still have to know whether it's the local TNF coming from nucleus pulposus that is causing all the pain, or is that attracting immune cells from the blood, which has more TNF.

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And that's what they say in the PCT in the next paragraph.

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The third explanation could be that the amount of TNF in the nucleus pulposus may well be enough to start the cascade locally in the nerve root.

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causing then aggregation and recruitment of systemic leukocytes.

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However, it is these leukocytes that have the major content of TNF and that systemic treatment in a sufficient dose is necessary to block the contribution from these leukocytes and thereby also blocking the events leading to nerve injury.

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What about the disclosure at A2698 where it says the lack of effects in certain animals could be based simply on

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the amount of antibodies in relation to the TNF model?

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That's right.

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They didn't have a solution.

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They didn't have a result.

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They are speculating about what might have gone wrong.

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And so it could not be verified experimentally.

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And they're thinking about what could be done, what could explain it.

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But ultimately, you can see in the PCT, they never answered that question.

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And they're still wondering whether it's TNF or the other cytokines.

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and whether it needs to be systemic treatment to block.

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Like I said, necessary, sufficient dose, systemic treatment, and sufficient dose necessary.

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So he did the experiment.

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He got a result that misled him and left him thinking that something else mattered.

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And you can see that in the initial claims.

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Then they, by the time the PCT entered the national stage, they saw Dr. Tobinic's patent application, saw what he was doing with local administration of TNF inhibitors, and said, well, I did that experiment, that series two, so I should get that invention.

[00:10:17] Speaker 03:
But the series two didn't work.

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He didn't say it worked.

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He didn't think it worked.

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He did many, Omar did many experiments later

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They were all systemic.

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They never repeated this.

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It was basically abandoned until they saw Tobinic's claims.

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Then they got that patent allowed, and then Tobinic copied those claims to get into this interference.

[00:10:43] Speaker 02:
You didn't mention that you were going to address the issues you raised with respect to inequitable conduct.

[00:10:50] Speaker 02:
Yes.

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Are you taking those back?

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Are you conceding?

[00:10:53] Speaker 03:
No, no.

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I'd like to discuss that.

[00:10:58] Speaker 02:
seems to me that what you point to as inequitable conduct, they're just mere differences of opinion.

[00:11:08] Speaker 01:
Well, what Dr. Cohen said... Can I ask this procedurally?

[00:11:14] Speaker 01:
You filed a motion for permission to put on an inequitable conduct case?

[00:11:19] Speaker 03:
That's correct.

[00:11:19] Speaker 01:
You have to... I don't...

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have you essentially submitted the case you would make in support of inequitable conduct along with the motion?

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Not the evidence itself.

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It was an outline of what the evidence would show and what the arguments are.

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So I have declarations by two experts using the word perjury in this context, but those have not been made of record yet.

[00:11:48] Speaker 01:
And if the board

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was right about obviousness in validity of your patent claims.

[00:11:58] Speaker 01:
Why is it necessary to reach this question?

[00:12:03] Speaker 01:
I understand you contest the premise.

[00:12:07] Speaker 01:
You presented a lot of issues and part of the challenge, at least for me here, has been to understand

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what the logical relationship among the various issues is, or whether one like that one I mentioned might be dispositive if it went against you.

[00:12:21] Speaker 03:
Well, the issue of who invented first is really what I was talking about with series two.

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I want to show that on the merits, Tobinic should win.

[00:12:30] Speaker 01:
And secondly... Why does it matter if your claim's invalid?

[00:12:36] Speaker 03:
The claims would be valid if the series...

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PCT were properly interpreted and series two was understood to be a failure that did not give them possession of the invention.

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In other words, their local claims would be new matter and Tobinic would win.

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So the inequitable conduct issue also goes to the reliability of Anderson in this case, not just Cohen.

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because they both said the same ridiculous thing.

[00:13:12] Speaker 02:
If we find that the board was correct in its determination concerning inventorship, does the rest of your case fall?

[00:13:22] Speaker 03:
I don't understand the use of the term inventorship.

[00:13:24] Speaker 03:
Oh, you mean who was first to invent?

[00:13:25] Speaker 03:
Correct.

[00:13:27] Speaker 03:
Please repeat.

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Does your case fall?

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If.

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If we say that the board was correct.

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If we find that the board was correct.

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We affirm on that issue.

[00:13:36] Speaker 03:
On the merits?

[00:13:36] Speaker 03:
Yes, yes.

[00:13:39] Speaker 00:
Do you know why Ohmarker is not here today?

[00:13:46] Speaker 03:
Well, I think that they are worried that you would ask them questions like, well, why isn't the Lee application prior art, pronunciation prior art, and how would you distinguish it?

[00:14:01] Speaker 03:
Because it shows TNF inhibitors

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treating CNS conditions, which means spinal cord conditions, systemically.

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And one thing to understand about Olmarka's position in the beginning of all this is that even though Tobinic has only local treatment with TNF, Olmarka has systemic claims using nonspecific inhibitors as well as local claims that they basically copied from seeing Tobinic.

[00:14:33] Speaker 00:
So it's not as if

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something has been settled or anything like that?

[00:14:38] Speaker 00:
No.

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And why they wouldn't participate in the appeal at all?

[00:14:40] Speaker 03:
No, that's right.

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They withdrew because they're in an untenable position, at least that's my supposition, that, you know, I mean, basically the way their patents still exist, their patents would have been canceled already by further fact that Dr. Cohen said essentially the nucleus pulposus does not mediate any pathologies or conditions of the spinal cord.

[00:15:06] Speaker 03:
And that's absurd.

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And they were trying to preserve their systemic claims for treating nucleus pulposus mediated conditions.

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And their claim, basically what they were trying to do was conceptually add a limitation to the claim

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such that the nucleus propulsus would only affect the peripheral nervous system, which would be the nerve roots coming out.

[00:15:35] Speaker 02:
So here the other side didn't show up.

[00:15:37] Speaker 02:
Yeah.

[00:15:37] Speaker 02:
No breeze.

[00:15:38] Speaker 02:
They're not here today.

[00:15:39] Speaker 02:
How should we treat that?

[00:15:41] Speaker 02:
And what's the legal basis for your answer?

[00:15:48] Speaker 03:
I think it should be treated as an unopposed.

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My brief should be treated as an unopposed brief.

[00:15:55] Speaker 03:
I mean, I can't.

[00:15:58] Speaker 02:
And what's the legal basis for that?

[00:16:00] Speaker 02:
I mean, we don't have a default type provision in our rules.

[00:16:05] Speaker 03:
You know, the solicitor was invited to join, and he did not intervene.

[00:16:13] Speaker 03:
Without explanation, I think, although I can say I was talking to people about what happens in situations like this and what does it mean, and it means that they felt the board had a say.

[00:16:26] Speaker 03:
the board had their say and just let it go with that.

[00:16:31] Speaker 03:
Okay.

[00:16:31] Speaker 02:
Mr. Hall, I think we understand your argument.

[00:16:33] Speaker 02:
Thank you very much.