[00:00:00] Speaker 04:
All right, our final case for oral argument today is 23-2338, Inray McClay.

[00:00:08] Speaker 04:
Mr. McClay, please proceed.

[00:00:09] Speaker 01:
Thank you, Your Honor.

[00:00:12] Speaker 04:
Am I saying your name right, McClay?

[00:00:13] Speaker 01:
You are, Your Honor.

[00:00:14] Speaker 01:
Very good.

[00:00:14] Speaker 01:
Thank you.

[00:00:17] Speaker 01:
I may have pleased the court.

[00:00:17] Speaker 01:
I'm Bart McClay, and I'm here representing the appellant, Dr. Matthew McClay.

[00:00:22] Speaker 01:
Disappeal in relation.

[00:00:24] Speaker 01:
Sorry?

[00:00:24] Speaker 01:
In relation.

[00:00:25] Speaker 01:
He is actually my twin brother.

[00:00:29] Speaker 01:
Your Honor, if I could, I'd like to frame the legal issues here by telling you first what Dr. McClay set out to do and what he thought it would work.

[00:00:37] Speaker 01:
This invention that we're talking about is a pharmaceutical drug.

[00:00:41] Speaker 01:
He was born in response to an unparalleled virus in recent history.

[00:00:45] Speaker 01:
Dr. McClay knew a lot about RNA viruses, which includes the coronavirus.

[00:00:50] Speaker 01:
And he also knew a lot about ribavirin, an antiviral drug used for four decades.

[00:00:55] Speaker 01:
Dr. McClay knew oral and intravenous use of ribavirin had safety issues.

[00:00:59] Speaker 01:
And he also, they had struggled

[00:01:02] Speaker 01:
that drug had struggled to get the drug to the disease in that form.

[00:01:06] Speaker 01:
But ribavirin aerosol was safe.

[00:01:09] Speaker 01:
It was used with children with RSV.

[00:01:12] Speaker 01:
But he knew that his peers may have doubts about the success of it because SARS included a protein called exonucleus.

[00:01:21] Speaker 01:
And that exonucleus could remove ribavirin in SARS.

[00:01:24] Speaker 01:
It doesn't exist in RSV.

[00:01:26] Speaker 01:
So while ribavirin aerosol worked there, they might suspect it wouldn't work here.

[00:01:31] Speaker 01:
But Dr. McClay knew more than that because he knew that from data and information and from his own study in 30 years plus and working in pulmonary work, he knew that the exonuclease could be overwhelmed if there was a sufficient amount.

[00:01:46] Speaker 01:
He had been one of the co-authors of a article, Gilbert and McClay.

[00:01:51] Speaker 01:
They had determined that when you use aerosolized ribavirin, you had multiple ways to get to the same location, but you could deliver a very significant amount of ribavirin.

[00:02:03] Speaker 02:
Do I remember correctly?

[00:02:05] Speaker 02:
That amount was 10%.

[00:02:07] Speaker 01:
There was three different ways to get there, Your Honor.

[00:02:10] Speaker 01:
2%, 6%, and 10% were all free ways to get to about the same deposit in the lower airways.

[00:02:16] Speaker 01:
So either in the range that had been picked, there was a range for the use of bribery.

[00:02:21] Speaker 01:
Three different ways you could get that.

[00:02:23] Speaker 00:
How does that square with enablement of up to 50%?

[00:02:27] Speaker 01:
Up to, sorry?

[00:02:28] Speaker 00:
How does that square this Gilbert and McCray 2%, 6%, and 10%

[00:02:35] Speaker 00:
How does that square with the enablement issue of up to 50% of ribavirin that's called for and claimed 20?

[00:02:43] Speaker 01:
Right.

[00:02:43] Speaker 01:
The way it would work this way, Your Honors, first of all, is ribavirin and water put together, obviously.

[00:02:50] Speaker 01:
And then it's going to be inhaled, so it has to be aerosolized.

[00:02:53] Speaker 01:
And then it has to run through a nebulizer.

[00:02:55] Speaker 01:
So all parts of what I just said are part of the claim, part of claim 20.

[00:03:00] Speaker 01:
So when we start with 49% ribavirin at that level,

[00:03:04] Speaker 01:
You're going to evaluate how much water would be combined to be aerosolized and then to be inhaled and then put through a nebulizer.

[00:03:12] Speaker 01:
And it's going to change.

[00:03:14] Speaker 01:
There could be some inoperable embodiments, as this court uses in United Therapeutics, or some refinements that might need to be made.

[00:03:22] Speaker 01:
We're talking about this isn't a genus claim where we're looking at whether or not there's a full scope of multiple different types of antibodies or other

[00:03:32] Speaker 01:
Proteins that might be this is a single claim ribavirin and water used together to be aerosolized inhaled and pushed through a nebulizer It turns out that we identify that that Gilbert and McClay identifies three ways ten two percent six percent ten percent But there could be new nebulizers in the future.

[00:03:49] Speaker 01:
They're ultrasonic nebulizers and

[00:03:51] Speaker 01:
that we understand that are out there that may allow for a greater or higher level that the point of the the point of the percentage was not to say this is the precise amount but what it was to say is that there's going to be a ribavirin water combination that's going to have to have more water than ribavirin and then it's going to have to be used during this process the entire claim has to be considered from our standpoint and that includes making it aerosolized and allowing for inhalation

[00:04:21] Speaker 00:
I'm just having trouble with seeing that the prior art, the 2%, 6%, and 10% is a long way away for less than 50% right of air and more than 50% water.

[00:04:35] Speaker 00:
I mean, we adopt claims with the PTO issues claims because there's a specific way to do something that achieves a specific result.

[00:04:45] Speaker 00:
Now, that doesn't mean within those parameters, that's the only way it can possibly ever be done.

[00:04:51] Speaker 00:
This seems so broad between zero and up to 49.999% rival baron and 50 plus anything percent water that it leaves such a gap between what has ever been done in the past and what might be done in the future that I don't know how you get to a level where you can say this is fully enabled.

[00:05:15] Speaker 01:
Your Honor, I would say that fully enablement obviously comes down to the inventor being able to, I'm sorry, a focita or a person's field in the art, making and using the invention.

[00:05:26] Speaker 01:
We're talking about pulmonitis and infectious disease specialists.

[00:05:29] Speaker 00:
And here's what they're going to do.

[00:05:30] Speaker 00:
Making or using it without undue experimentation.

[00:05:32] Speaker 01:
And there would be no one doing experimentation here, Your Honor, and here's why.

[00:05:36] Speaker 01:
They have to, you can't, I, respectfully, we can't just use one of the claims.

[00:05:40] Speaker 01:
The person skilled in the art is going to do this.

[00:05:43] Speaker 01:
They're going to look up, they're going to see that the specification claim says, right of iron and water, it's got to be aerosolized, it's got to be used for inhalation, and it's got to get through a nebulizer.

[00:05:52] Speaker 01:
They all know what those parameters are.

[00:05:55] Speaker 01:
These are things that a person skilled in the art would understand how to do it.

[00:05:59] Speaker 01:
There have been cases that talk about nebulizer dosage.

[00:06:02] Speaker 01:
I guess that language could have been used here.

[00:06:05] Speaker 01:
But it was simply to say, there is water and riboform that are going to be mixed, and that composition is then going to have to be used in this way.

[00:06:12] Speaker 01:
I don't think you can talk about one set of the claims and then ignore the rest of the claim and say there's no enablement.

[00:06:19] Speaker 04:
I understand there's a... But what evidence is there a skilled artisan would know how to figure out what the percentages are if beyond 2, 6, and 10 percent?

[00:06:29] Speaker 04:
I mean you've got up to 50 and you have, you know, six or seven articles cited in the spec about how

[00:06:35] Speaker 04:
Nobody thought that ribovirin would work to treat COVID.

[00:06:39] Speaker 04:
And you have no examples at all in the spec of it being used to treat COVID.

[00:06:43] Speaker 04:
And so what, I mean, how's the skilled artisan, what evidence is there a skilled artisan would know what things within the range without unto experimentation up to 50% are going to work?

[00:06:54] Speaker 01:
Sure.

[00:06:55] Speaker 01:
The way the skilled artisan would do this process is the way, probably, the post filing reference, Messina, did it.

[00:07:01] Speaker 01:
And that was that they would look at, there has to be a ribavirin and water combination, and that combination then has to be used with a nebulizer.

[00:07:11] Speaker 01:
They would look to the prior art, and if you even Googled this,

[00:07:14] Speaker 01:
at ribavirin aerosol with nebulizer for COVID SARS-CoV-2, you would come up, you would almost for sure come up and see the Gilbert and McClay prior art, and that prior art is what then teaches

[00:07:29] Speaker 01:
that 2%, 6%, and 10% will get you.

[00:07:33] Speaker 01:
It's one way to get you.

[00:07:34] Speaker 02:
That's one way to get you for influenza.

[00:07:36] Speaker 02:
Pardon me?

[00:07:36] Speaker 02:
Right, for influenza.

[00:07:37] Speaker 02:
Well, that's, I mean, just to be clear, that article is directed to influenza, right?

[00:07:43] Speaker 01:
The article has the title influenza on it, but the article actually is just about delivery of drugs.

[00:07:48] Speaker 02:
But it doesn't say, I understand.

[00:07:50] Speaker 01:
And it also talks about, well, the delivery of drugs in, sorry, no, I'm sorry.

[00:07:53] Speaker 02:
I just have a really simple question.

[00:07:55] Speaker 01:
OK, sure.

[00:07:55] Speaker 02:
When I read the article, it didn't say anything about COVID.

[00:07:58] Speaker 02:
Am I wrong?

[00:07:59] Speaker 01:
No, you're not.

[00:08:00] Speaker 01:
It didn't say anything about COVID, but it also talked about RSV.

[00:08:04] Speaker 01:
It talked about the parameters in the table, which were there, were for use of different types of viruses.

[00:08:12] Speaker 01:
And so when a person skilled in the art would be looking, they would look to those parameters in the table.

[00:08:19] Speaker 01:
And they would say, here's three different ways to get to the same result.

[00:08:24] Speaker 01:
It didn't have anything to do with what was at the bottom of the line.

[00:08:26] Speaker 02:
I have a different concern, though.

[00:08:27] Speaker 02:
Let me ask you mine, because this is the time we have for you to assuage me of my concerns I have.

[00:08:34] Speaker 02:
So this is my concern.

[00:08:36] Speaker 02:
My concern is that cases like Rasmussen, where we kind of somehow get utility somehow involved with enablement, and there's evidence from which a PET examiner could determine

[00:08:49] Speaker 02:
that the invention will not work for it to treat as recited in the claim.

[00:08:56] Speaker 02:
And there's, in that circumstance, where the PTO says, we see a person of ordinary scale in the yard would not know that this would work, and you haven't shown how it would work, and that is sufficient for enablement.

[00:09:11] Speaker 02:
And Rasmus said, why isn't that something that applies here?

[00:09:15] Speaker 01:
Okay.

[00:09:16] Speaker 01:
Thank you for your question, Your Honor.

[00:09:18] Speaker 01:
First of all, as to it not working, the examiner here, and then the board picked up on several of the articles, the references, they were all about oral and intravenous not working.

[00:09:29] Speaker 01:
The Tong article, appendix 400, Liu article, 386, Barnard article, appendix 415, these were all about oral and intravenous use not working.

[00:09:39] Speaker 02:
When it came down, when it came to... And these were all in the application itself.

[00:09:45] Speaker 01:
Yes, and they were referenced in the specifications, yes.

[00:09:49] Speaker 01:
In the specifications.

[00:09:51] Speaker 02:
And the specification characterizes them, right?

[00:09:54] Speaker 02:
Yeah, it characterizes... They say it's use... Ribovirin's use in treating COVID-19 is not expected by skilled pulmonologists and infectious disease specialists to be successful in treating COVID-19.

[00:10:07] Speaker 02:
That sentence doesn't have all these limitations that you're now imparting in it, right?

[00:10:11] Speaker 01:
Well, the actual references themselves, which are also in the appendix, do indicate that they were for oral and intravenous.

[00:10:18] Speaker 01:
The article from Farron, which is in specification paragraph 9, that talked about the exonuclease.

[00:10:25] Speaker 01:
And that has nothing to do with the safety issue, which is what some of those oral and intravenous use cases do have.

[00:10:31] Speaker 01:
This had just simply a utility.

[00:10:33] Speaker 01:
Could it remove it or could it not?

[00:10:35] Speaker 02:
In what?

[00:10:37] Speaker 02:
In the section of your specification in the written description, maybe the preferred embodiment of the invention, is there some sentence or something that says, we discovered that with respect to a nebulizer or that this would, ribovirin is

[00:10:59] Speaker 02:
effective and will work.

[00:11:01] Speaker 01:
I mean, where is there... Paragraph 14 of the specification says that this drug will be used that will reduce.

[00:11:08] Speaker 01:
The discovery here was that... Did you say paragraph 14?

[00:11:12] Speaker 01:
14, yes, Your Honor.

[00:11:14] Speaker 01:
It says, in fact, that the drug will use.

[00:11:17] Speaker 01:
It was a surprising discovery and that it will result in two things.

[00:11:20] Speaker 01:
reduction of the viral load of SARS-CoV-2, and second, that it would also reduce or prevent SARS.

[00:11:27] Speaker 01:
So it's directly telling the person skilled in the art.

[00:11:30] Speaker 01:
Yes, there is this background.

[00:11:32] Speaker 01:
There is these disparaging remarks.

[00:11:34] Speaker 01:
There is these negative histories.

[00:11:35] Speaker 02:
But there is... So I'm to read this language about delivered to the lungs of the COVID-19 infected patient, that that means it's an aerosol.

[00:11:45] Speaker 01:
Well, it is referenced elsewhere in the claim, of course, that this is a ribavirin aerosol.

[00:11:54] Speaker 02:
Paragraph 14 doesn't say it.

[00:11:56] Speaker 01:
Paragraph 14 may not say it, but the specifications as a whole, I think, would indicate that this was relating to the aerosol ribavirin delivery.

[00:12:05] Speaker 02:
And it says there's a surprising discovery that any one of ribavirin and that several other drugs or any combination thereof

[00:12:13] Speaker 02:
would be effective.

[00:12:14] Speaker 01:
Well, there was some characteristics that were similar between them.

[00:12:18] Speaker 01:
But today, we're here on claim 20 and ribavirin specifically.

[00:12:21] Speaker 01:
But I do want to answer you on restlessness.

[00:12:23] Speaker 02:
Where does it say in the specification that the reason why this is effective is because the exonuclease would be overwhelmed by using an aerosol with a large amount of riboflavin?

[00:12:37] Speaker 01:
Does it say that?

[00:12:38] Speaker 01:
It doesn't say it specifically, Your Honor.

[00:12:40] Speaker 01:
It's implied by reference, again, reading as a whole is what we would tell you.

[00:12:45] Speaker 01:
And also then, of course, reading the claim, along with the prior art,

[00:12:49] Speaker 01:
From Gilbert and the clay which shows it overwhelmed, but I want to address Rasmussen Rasmussen of course was about a drug finasteride.

[00:12:56] Speaker 01:
I believe that was being promoted for Some type of cancer.

[00:13:01] Speaker 01:
I think it was colon cancer or prostate cancer and

[00:13:04] Speaker 01:
And the court there said, in support of the board, there was no evidence that this drug has any relationship to prostate cancer.

[00:13:13] Speaker 01:
There was no evidence in the prior at all.

[00:13:15] Speaker 01:
And it went on to say, and there was no data, no information to suggest that.

[00:13:20] Speaker 01:
And so it was those two things together, the prior art and the fact that there was no data on it, that prevented that, that said, the court said, you know, there's no shown utility here.

[00:13:30] Speaker 01:
This, we can't see it at all.

[00:13:32] Speaker 01:
But in the case of, in the case of Bruinthal, the opposite was true.

[00:13:36] Speaker 01:
There was some prior art that suggested a relationship between the drug and the disease.

[00:13:41] Speaker 01:
And this court did not require any testing or experiments or anything at all and said that because of that relationship and because there was pharmacological activity that would be generated, that was enough to withstand the practical utility prong of Section 101.

[00:13:59] Speaker 02:
I hear you.

[00:14:00] Speaker 02:
Well, let me ask you this question.

[00:14:01] Speaker 02:
In a circumstance where I am supposed to review underlying fact findings for substantial evidence,

[00:14:08] Speaker 02:
How do I distinguish this case from Rasmussen?

[00:14:10] Speaker 02:
Because I feel like maybe you're asking me to reweigh the fact findings made by the PTO.

[00:14:17] Speaker 02:
You know, with the finding, for example, that a person of Ordinaries County wouldn't think it would work.

[00:14:23] Speaker 01:
Well, the fact-finding, the factors that were identified by the board here were just a few.

[00:14:29] Speaker 01:
There was, you know, there's eight wand factors and they identified just a couple.

[00:14:32] Speaker 01:
One of them was that the art was unpredictable.

[00:14:38] Speaker 01:
which from our perspective it's it's not when you take the specification as a whole and you say there's going to be in the claim together with the prior art you have an aerosolized right of iron that's going to be working with a deep deposit into the lung there's a procedure of

[00:14:53] Speaker 01:
that had been identified prior to 2008.

[00:14:56] Speaker 01:
We're looking at some references to show its danger, but Gilbert and McClay specifically found in that article, and there are others, that says aerosolized ribavirin does not suffer from the same problems of oral and intravenous ribavirin.

[00:15:10] Speaker 01:
And the skilled person in the art would find that, and they would reconcile those ideas and understand that, of course, aerosolized ribavirin has been used for decades with children.

[00:15:20] Speaker 01:
And so that would not be a fair, you know, so aerosolized ridement is different.

[00:15:25] Speaker 01:
And maybe Dr. McClay.

[00:15:26] Speaker 02:
So you're distinguishing Rasmussen with unpredictability of the time.

[00:15:30] Speaker 01:
Well, and also the other ground that they really talked about there was, let's see, what was it?

[00:15:38] Speaker 01:
It was, one second.

[00:15:41] Speaker 04:
Well, they're- OK, we're well into all your time, all your bottle time.

[00:15:45] Speaker 04:
I'll restore some of our bottle time, but let's hear from the government.

[00:15:47] Speaker 01:
OK, thank you, Your Honor.

[00:15:57] Speaker 03:
Good morning, your honors, and may it please the court.

[00:16:00] Speaker 03:
The board correctly found Representative Claim 20 not enabled.

[00:16:04] Speaker 03:
McClay's application with multiple citations says at the time of filing, a person of ordinary skill in the art would not have expected ribavirin to be successful in treating COVID-19.

[00:16:17] Speaker 03:
And I'll note that statement did not distinguish between oral IV versus inhalation, and that the skilled pulmonologist, who is someone who would know about

[00:16:27] Speaker 03:
aerosolizing a drug would not expect the drug ribavirin to have worked in COVID-19.

[00:16:36] Speaker 03:
McClay's specification then admittedly puts out a hypothesis that ribavirin would be successful in treating COVID-19, but provides no data, experimental, analytical, or otherwise, that has any efficacy or use against SARS-CoV-2.

[00:16:56] Speaker 03:
So the board's decision should be preferred.

[00:16:58] Speaker 04:
My problem with that is that, I mean, I feel like it's to some extent slipping the burden on its head.

[00:17:05] Speaker 04:
They've put forward a claim that says that this is effective.

[00:17:13] Speaker 04:
Suppose that instead of up to 50%, it said 2%.

[00:17:16] Speaker 04:
Suppose there were a claim, 2%, 6%, and 10% effectiveness.

[00:17:22] Speaker 04:
And it turns out it is effective, right?

[00:17:24] Speaker 04:
That's the other thing.

[00:17:25] Speaker 04:
Maybe they didn't know that at the time, but it does turn out that it works.

[00:17:29] Speaker 04:
So what's the problem with that?

[00:17:31] Speaker 04:
I mean, make and use for its intended purpose.

[00:17:34] Speaker 04:
I suppose it was a very specific claim, not up to 50%, so we're not talking about a range.

[00:17:40] Speaker 04:
But here is a specific, concrete, narrow composition.

[00:17:44] Speaker 04:
to be used in a method of treatment.

[00:17:46] Speaker 04:
I mean, because one of my problems with Rasmussen is it says, and then choose a therapeutically effective amount, right?

[00:17:51] Speaker 04:
Like, what does that even mean?

[00:17:53] Speaker 04:
But here we've got a nebulizer, we've got aerosol, we've got combining the active ingredient with water.

[00:18:00] Speaker 04:
We have a lot of specificity around the method of treatment here that didn't exist in Rasmussen.

[00:18:07] Speaker 04:
And it works.

[00:18:09] Speaker 04:
So what happens now?

[00:18:11] Speaker 03:
I mean, I think I see the difference in those facts.

[00:18:15] Speaker 03:
It's just the problem is all that enablement, getting the specific amount and using the nebulizer with the ribavirin to treat COVID-19.

[00:18:26] Speaker 03:
At the time of filing, no one thought it would work.

[00:18:29] Speaker 03:
And those are persons of skill in the art who know about Dilbert and McClay's prior art, who know that it sets them to treating.

[00:18:36] Speaker 04:
It doesn't matter if no one thought it would work.

[00:18:38] Speaker 04:
if without undue experimentation they could figure out it did.

[00:18:41] Speaker 04:
And here, if the claim, especially if it was limited the way I said, 2%, right?

[00:18:46] Speaker 04:
I want to stick with my hypothetical.

[00:18:48] Speaker 04:
I don't think Rasmussen applies because I think that it doesn't matter.

[00:18:53] Speaker 04:
I mean, every invention has to be non-obvious, right?

[00:18:56] Speaker 04:
So in order to have a claim, it's got to be non-obvious, which means, by definition, people in the skilled art didn't necessarily think of it before or think it would work necessarily.

[00:19:06] Speaker 04:
And that's why you invented something.

[00:19:08] Speaker 04:
So if it's very specific, and by the way, I'll also add this, this is an originally found claim.

[00:19:13] Speaker 04:
This isn't a continuation with a later filed claim.

[00:19:17] Speaker 04:
So it is possible for claims to be self-enabling because they're part of the specification.

[00:19:23] Speaker 04:
And when I say it's an originally filed claim, for my own clarification purposes for the record, I'll say it was a dependent claim that was turned into an independent claim.

[00:19:30] Speaker 04:
So it's not originally filed identically word for word, but all of the relevant limitations were present in the way it was filed originally.

[00:19:38] Speaker 03:
I think the problem, even if the claim is to, let's say, a 1% use of

[00:19:43] Speaker 03:
liquid ribavirin is.

[00:19:45] Speaker 03:
There's nothing in this specification that actually says that shows that ribavirin has any utility against COVID-19.

[00:19:56] Speaker 03:
But who cares?

[00:19:56] Speaker 04:
Doesn't undue experimentation kick in?

[00:19:58] Speaker 03:
But this court, Rasmussen's and also 318 patent litigation after Rasmussen says that there has to be some showing of use in order for you to be able to make and use an invention.

[00:20:10] Speaker 03:
And if there's no shown utility,

[00:20:11] Speaker 03:
then you can't have shown someone how to make use of the invention.

[00:20:14] Speaker 04:
Okay, suppose that this inventor actually did use it at 2% and it helped, you know, 100 people, but he didn't put all that in the spec.

[00:20:21] Speaker 04:
At the time, he didn't put it in the spec.

[00:20:22] Speaker 04:
He just put the claim in the spec.

[00:20:24] Speaker 04:
Oh my gosh, that is great invention.

[00:20:26] Speaker 04:
I know people said it wouldn't work, but it does use it here.

[00:20:30] Speaker 04:
Use it at this particular level.

[00:20:31] Speaker 03:
So if you had that post-filing information and said, look, in fact, my 2% aerosolized ribovarin works,

[00:20:41] Speaker 03:
And you would present that evidence to the board that could show that there was enablement at the time of those claims.

[00:20:48] Speaker 04:
Why?

[00:20:48] Speaker 04:
Because enablement is for the vantage point of a skilled artisan.

[00:20:51] Speaker 03:
Well, I said it could.

[00:20:52] Speaker 03:
It could show that it was enabled, as long as it shows enablement at the time of filing.

[00:20:58] Speaker 02:
Why do we inject utility into enablement?

[00:21:02] Speaker 02:
Why is that?

[00:21:03] Speaker 02:
Because utility usually falls under 101, right?

[00:21:06] Speaker 02:
So I'm also struggling with, I see, I know we did it in Rasmussen.

[00:21:13] Speaker 02:
But maybe it made more sense there.

[00:21:16] Speaker 02:
But why is it that, as a policy matter, we should say, we're going to treat the PTO like the FDA, and you need to have, in some circumstances, where a person of ordinary skill in the art wouldn't think the invention might work, you're going to have to actually prove it?

[00:21:33] Speaker 03:
I would push back a little.

[00:21:37] Speaker 03:
We're not requiring you to lead to the level of safety and efficacy that you've shown it works in people.

[00:21:42] Speaker 03:
in vitro and in vivo animal studies can show utility under this court's case law.

[00:21:48] Speaker 03:
So there's no requirement to show safety.

[00:21:49] Speaker 04:
But you think they have to do something?

[00:21:51] Speaker 04:
Like, you think they have to show, in their specifications, some actual experiments?

[00:21:57] Speaker 03:
No, they have to show some use.

[00:22:00] Speaker 03:
And so I'm just going to get back to Judge Solis with why we put 101 in here.

[00:22:04] Speaker 02:
So the use that they've shown is using this aerosol

[00:22:10] Speaker 02:
Let's again assume it's just, well, let's forget about the up to 50% issue, but the claim itself says using this inhaler, using it as an aerosol to treat COVID, right?

[00:22:25] Speaker 02:
And I think we can all agree that a person of ordinary skill in the art could make that happen.

[00:22:31] Speaker 02:
You're right.

[00:22:32] Speaker 02:
You could do those steps.

[00:22:35] Speaker 02:
But the only question is whether it has utility, whether it actually would treat someone with COVID.

[00:22:41] Speaker 02:
Right.

[00:22:41] Speaker 02:
And why should that be an enablement issue?

[00:22:45] Speaker 03:
As this court said in Rasmus's and in 318 patent litigation, in order to show so that you can make and use an invention, there has to be a use.

[00:22:55] Speaker 03:
And that's what incorporates utility into the enablement standard as a matter of law.

[00:23:00] Speaker 03:
And so the PTO, following that case law examiner cited 318 patent litigation, the board cited Rasmus's, that there's no data or analytical reasoning to connect

[00:23:14] Speaker 04:
So this is this is where I think the PTO is going way too far.

[00:23:16] Speaker 04:
I don't think there has to be data or analytical reasoning if the claim is in fact self enabling and very precise.

[00:23:22] Speaker 04:
You know the good argument you have with me is that 50 percent who knows where in that 50 percent.

[00:23:27] Speaker 04:
That's why I don't want to touch that argument because I think

[00:23:30] Speaker 04:
that the PTO is consistently over-broadly using 318 and Rasmussen, and I'm bothered by it.

[00:23:35] Speaker 04:
Because I think you'd suddenly think you're the FDA, and you're not the FDA.

[00:23:39] Speaker 04:
And I don't think they had to prove anything.

[00:23:40] Speaker 04:
I don't think they had to put it in their spec.

[00:23:43] Speaker 04:
I think they just have to teach someone how to make and use it.

[00:23:45] Speaker 04:
And I look at Rasmussen and those claims, and I don't think they teach someone how to make and use it because they say, go use a therapeutically effective amount.

[00:23:53] Speaker 04:
Well, that is just

[00:23:55] Speaker 04:
You know, that's like, go find something that curves it.

[00:23:57] Speaker 04:
Like that doesn't, you know, that isn't precise.

[00:24:00] Speaker 04:
And so I think that there's no utility because nobody knew how to get to a therapeutically effective amount in that case.

[00:24:06] Speaker 04:
So I think that those cases, while they use the word utility, they're still tethering that word to somebody being able to make and use without unto experimentation.

[00:24:16] Speaker 04:
used without undue experimentation, because a therapeutically effective amount has no constraints around it.

[00:24:22] Speaker 04:
And you might have that same argument here on the 50%.

[00:24:24] Speaker 04:
So don't think I'm not aware of that.

[00:24:28] Speaker 04:
But what I'm bothered by is this notion that there needs to be some degree of proof that they have actually used constructive reduction of practice is not necessary in patent law.

[00:24:39] Speaker 04:
I'm really bothered by the idea that they had to show in vivo or in vitro or in human or anything else.

[00:24:46] Speaker 04:
I don't think that's necessary.

[00:24:47] Speaker 03:
And I think what you heard counsel say today about the reasoning about how the endonuclease would be overwhelmed if you put it in a nebulizer and got it to the lungs would be some reasoning

[00:25:01] Speaker 03:
over the prior art as why it would have that use.

[00:25:04] Speaker 03:
And that would be sufficient if it were in the specification.

[00:25:07] Speaker 03:
And as this court said in Genetic versus Novo Nordis, you can't enable a claim by showing no teaching, no procedure for how to do it, and then just say it's in the prior art.

[00:25:17] Speaker 03:
What's novel about this claim is that they discovered they could use it with SARS-CoV-2.

[00:25:22] Speaker 03:
That's what's supposed to be novel.

[00:25:24] Speaker 03:
But they didn't even use the Gilbert McClay method

[00:25:29] Speaker 03:
in their specification.

[00:25:30] Speaker 03:
They're just saying, it's somewhere out there in the prior.

[00:25:33] Speaker 03:
It's enabled because people still need our approval.

[00:25:35] Speaker 02:
But they did claim it.

[00:25:36] Speaker 02:
You say they didn't use this method in the specification.

[00:25:40] Speaker 02:
But they did put the method in the claim, an originally filed claim, right?

[00:25:44] Speaker 03:
It's the claim that's currently.

[00:25:46] Speaker 02:
Yeah, that's right.

[00:25:48] Speaker 03:
I mean, it doesn't have, it doesn't.

[00:25:49] Speaker 02:
So I was just saying that that undermines your point, I think, because they didn't have to say, use the technique of the prior art.

[00:25:58] Speaker 02:
They could just say, here, here, we're claiming it, right?

[00:26:02] Speaker 02:
It's part of the original written description.

[00:26:04] Speaker 00:
So are you saying that the,

[00:26:06] Speaker 00:
disparity between the specification and the claim and the coronavirus or whatever it is here and the COVID-19 there, that the absence of alignment or connection is an important part of your case as to why there's no enablement?

[00:26:24] Speaker 03:
I mean, it's the connection between the prior art is teaching using this method with influenza A.

[00:26:30] Speaker 03:
and which the board found didn't correlate with.

[00:26:32] Speaker 00:
To me, the 800-pound gorilla is up to 50% that everybody wants to talk around.

[00:26:37] Speaker 00:
And we're talking around all the other things, too.

[00:26:39] Speaker 00:
But as long as we're doing that, I'm trying to figure how important to you is the differences or the lack of congruity between the spec and the claim language itself.

[00:26:51] Speaker 03:
I mean, the claim language as an original claim is part of the spec.

[00:26:56] Speaker 03:
I think the claim just says treating using this aerosolized ribavirin.

[00:27:02] Speaker 03:
the large percentage.

[00:27:03] Speaker 03:
And we could definitely talk about the large percentage because the board found it wasn't commensurate.

[00:27:08] Speaker 02:
Can I ask you a quick question first before you do that, which is, do you agree that our case law says that you don't need to have data in your specification?

[00:27:14] Speaker 03:
Yes.

[00:27:14] Speaker 03:
You could have the analytical reasoning.

[00:27:16] Speaker 03:
So if the reasoning that counsel has put in the blue brief and presented to you today is how you get from what they knew in the prior art and why they had failed to treat coronaviruses and SARS-CoV-2 specifically, if they had put in the specification

[00:27:32] Speaker 03:
all that reasoning.

[00:27:33] Speaker 03:
Well, now that you should use the nebulizer because that's what's going to get into the lungs and that's what's going to overwhelm the endonuclease.

[00:27:41] Speaker 04:
Why did they have to explain that?

[00:27:43] Speaker 04:
If the nebulizer was the big difference, right?

[00:27:46] Speaker 04:
If all of the prior art, even though they don't say it, was doing it intravenously,

[00:27:51] Speaker 04:
In the claim, which is part of the original specification, they're expressly saying, do this with a nebulizer.

[00:27:57] Speaker 04:
They're not claiming using bribo whatever it is in any form.

[00:28:01] Speaker 04:
They're saying just only with a nebulizer at this concentration.

[00:28:05] Speaker 04:
Why isn't that enough?

[00:28:08] Speaker 03:
But I think that

[00:28:10] Speaker 03:
So substantial evidence that the art was so unpredictable that pulmonologists didn't think it would work.

[00:28:17] Speaker 03:
They advised against using ribavirin.

[00:28:20] Speaker 03:
And there was no argument before the board that it was the inhalation versus the oral and the IV version that made the difference.

[00:28:27] Speaker 03:
So substantial evidence presented to the board was,

[00:28:31] Speaker 03:
that pulmonologists didn't think it would work, regardless of the administration.

[00:28:36] Speaker 04:
And all they're saying is- Do you think undue experimentation has no role to play in assessing the utility?

[00:28:45] Speaker 03:
I mean, the utility is some use for it.

[00:28:47] Speaker 03:
Here, there's also undue experimentation, because if you haven't shown a use for it, one of skill and the art doesn't even know where to start in terms of- No, that's not true, because this claim is really specific.

[00:28:57] Speaker 04:
Nebulizer, 50%, water.

[00:28:59] Speaker 04:
So you can't say one of skill and the art doesn't know where to start.

[00:29:01] Speaker 04:
Now, you could say one of skilled learners doesn't know where to start in the range of zero to 50%.

[00:29:05] Speaker 04:
But again, I'm trying to put that to the side because I have a problem with what the PTO is doing with this utility requirement enablement in general.

[00:29:12] Speaker 04:
So let's stick with suppose the claim was 2%, right?

[00:29:15] Speaker 04:
You can't say one didn't know where to start because that would be an incredibly precise, very narrowly defined thing.

[00:29:22] Speaker 04:
So are you saying undue experimentation has no role to play in utility because I don't see

[00:29:28] Speaker 04:
what undue experimentation there would be in this claim if it was directed to 2%.

[00:29:35] Speaker 03:
I think then it would just be the utility, the undue experimentation for doing a 2%.

[00:29:43] Speaker 03:
I'm not sure.

[00:29:46] Speaker 03:
You don't have an answer.

[00:29:47] Speaker 03:
I'm not sure.

[00:29:48] Speaker 03:
You don't have an answer.

[00:29:49] Speaker 03:
I think the board was relying on the fact that one of the skill in the art didn't think it would work.

[00:29:53] Speaker 03:
Yeah, but that's what I'm saying.

[00:29:55] Speaker 03:
I know.

[00:29:55] Speaker 04:
I think the board has dropped undo experimentation from that analysis, and it's wrong to do so.

[00:30:02] Speaker 04:
I think that the board needs to remember that enablement without undo experimentation is an always factor.

[00:30:10] Speaker 04:
And this little weird utility nub on enablement is not independent of the undo experimentation concept.

[00:30:19] Speaker 03:
It's hard to see how

[00:30:21] Speaker 03:
318 patent litigation and Rasmus says are requiring an undue experimentation.

[00:30:27] Speaker 03:
I mean, you can tie it to the therapeutically effective, but I think one of the claims was just to treating Alzheimer's in the 318, not necessarily finding a therapeutic amount for a dose.

[00:30:38] Speaker 03:
And in that case, the court did look to the fact that there was no known use for, I can't remember the specific name of the drug,

[00:30:48] Speaker 03:
in treating Alzheimer's disease.

[00:30:50] Speaker 04:
The one problem I have is in 318, I have to go back and look, but my best recollection is they weren't originally filed claims.

[00:30:58] Speaker 04:
Makes a big difference.

[00:31:00] Speaker 04:
Not part of the spec.

[00:31:03] Speaker 03:
I have to go back and look.

[00:31:05] Speaker 04:
I'm not positive, but that would make a big difference.

[00:31:08] Speaker 03:
I'm not sure how that makes a difference though, because it still is what 318 and the point of Rasmussen and 318 is, that someone's not just throwing out a hypothetical.

[00:31:18] Speaker 04:
And my clerk also said, by the way, actually 318 does use therapeutically effective amount in all the claims.

[00:31:22] Speaker 04:
OK, it does.

[00:31:23] Speaker 04:
So yeah, it's consistent with Rasmussen.

[00:31:25] Speaker 03:
I mean, I think both those cases characterize it as a treatment claim, not specifically looking at the therapeutically effective.

[00:31:31] Speaker 03:
And here also is the treating claim.

[00:31:34] Speaker 03:
But again,

[00:31:35] Speaker 03:
The last point I'll make is this is the 50%, and they have not enabled the full scope of that claim.

[00:31:42] Speaker 03:
That's what the board found, and they didn't even appeal that.

[00:31:45] Speaker 03:
So please ask the court to affirm the board's decision.

[00:31:48] Speaker 04:
Thank you for your argument.

[00:31:52] Speaker 04:
All right.

[00:31:53] Speaker 04:
Mr. McClay, you have some.

[00:31:55] Speaker 04:
We'll give you two minutes for a bubble time.

[00:31:57] Speaker 01:
Thank you, Your Honor.

[00:31:58] Speaker 01:
I want to address the breadth of the claim up front.

[00:32:00] Speaker 01:
I think it's notable that Juan's factor has breadth of the claim as factor number eight.

[00:32:05] Speaker 01:
That factor was not used.

[00:32:06] Speaker 01:
It was not cited by the board, by the examiner, or anybody.

[00:32:09] Speaker 01:
And I think that what they're trying to do here is, in effect, is make a written description argument.

[00:32:14] Speaker 01:
They're saying that that claim range

[00:32:17] Speaker 01:
is such that maybe the inventor didn't have possession of the invention.

[00:32:22] Speaker 01:
What this argument they're making is, in effect, a disguised written description argument.

[00:32:28] Speaker 01:
I also want to mention that the words full scope of the claim that's been used by Amgen and this court many times, that is not the same thing as the full range of a claim.

[00:32:39] Speaker 01:
A full scope of the claim has been used multiple times in the case law, referring to genus claims.

[00:32:45] Speaker 01:
And that makes a lot of sense.

[00:32:47] Speaker 01:
When it's a range of a claim, like you did in United Therapeutics, there could be inoperable embodiments within the claim.

[00:32:53] Speaker 01:
There was a whole group of patients in United Therapeutics that wasn't even covered at all by the claim.

[00:32:59] Speaker 01:
And the court said, look, there's refinements that can be made.

[00:33:02] Speaker 01:
There's inoperable embodiments that can be restricted.

[00:33:06] Speaker 01:
And all of those things can take place.

[00:33:09] Speaker 01:
So, I will also know that Messina, who was the post-filing reference, did exactly this.

[00:33:16] Speaker 01:
Dr. McClay did not need to be standing next to any pulmonologist or infectious disease person and say, hey, look, this is how you use, identify SARS-CoV-2.

[00:33:24] Speaker 01:
Here's how you use a nebulizer.

[00:33:26] Speaker 01:
Here are the limits of the nebulizer.

[00:33:28] Speaker 01:
Here's what you have to, none of those things would have to be taught to that, that this case is largely terms on the knowledge and ability

[00:33:35] Speaker 01:
of the person skilled in the art.

[00:33:37] Speaker 01:
And they would have all the information.

[00:33:39] Speaker 01:
In fact, United Therapeutics says exactly that.

[00:33:42] Speaker 00:
And I almost want, if I could quote it, is... But our written description and enablement, the twin brothers, they're different, but they're very, very close, and they're very, very

[00:33:52] Speaker 00:
the connected.

[00:33:53] Speaker 00:
I mean, how do you jump from one to the other?

[00:33:55] Speaker 00:
Between, I'm sorry, between the two.

[00:33:57] Speaker 00:
To me, written description and enablement are, like you and Dr. McCracken, twin brothers.

[00:34:02] Speaker 00:
Well, they're very closely related.

[00:34:04] Speaker 00:
And the line between them is sometimes hard to distinguish.

[00:34:07] Speaker 00:
And to come up here and say, no, this is really a hidden written description argument.

[00:34:11] Speaker 00:
It doesn't have anything to do with enablements.

[00:34:13] Speaker 01:
Yes, please.

[00:34:14] Speaker 01:
Fair comment.

[00:34:15] Speaker 01:
Not disingenuous, but.

[00:34:17] Speaker 01:
Judge Giltrap, fair comment on one point.

[00:34:19] Speaker 01:
But the fact is that this circuit has said repeatedly that written description and enablement are separate concepts, and they need to be dealt with separately, and has gone said that over and over.

[00:34:30] Speaker 01:
I just want to mention one thing.

[00:34:31] Speaker 01:
This is what United Therapeutics said.

[00:34:34] Speaker 01:
It said there, a person skilled in the art, and I would have, and I'm quoting now,

[00:34:37] Speaker 01:
information to limit the claims to operative embodiments and refinements without undue experimentation, then it is fully enabled.

[00:34:44] Speaker 01:
So if a pulmonologist, an infectious disease person, knows how to use a nebulizer, knows they have limits, would take ribavirin and water at some level, they know they have to have more water than ribavirin, and they're going to then, they're going to find a composition that works to get it through the nebulizer.

[00:35:01] Speaker 01:
All they really had to do was to go to Gilbert McClay and find three different ways they could get to the same deposit

[00:35:06] Speaker 01:
Two six and ten percent, but there may be other ways they didn't want to say there's no other nebulizer that could put more than ten percent in Dr. McClain knew that it might be more it could new nebulizer an ultrasonic nebulizer jet nebulizer, okay?

[00:35:20] Speaker 04:
All right, thank both council cases taking their submission