[00:00:00] Speaker 03:
We will hear argument next in number 221896 in Gray Institute Pasteur.

[00:00:08] Speaker 03:
Mr. Arrigo?

[00:00:09] Speaker 03:
Is that Arrigo?

[00:00:10] Speaker 03:
Arrigo.

[00:00:12] Speaker 04:
Thank you.

[00:00:13] Speaker 04:
May I please report?

[00:00:15] Speaker 04:
Unexpected results are an integral part of the obviousness determination.

[00:00:20] Speaker 04:
Thus, as set forth in Graham v. Deere, unexpected results must be considered to determine whether Institute Pastora's claim method is obvious.

[00:00:30] Speaker 01:
In the context of looking at unexpected results, don't you have to look at the closest prior art and compare the claimed invention to the closest prior art?

[00:00:40] Speaker 04:
Yes, I think you certainly do need to compare it to the closest prior art.

[00:00:43] Speaker 04:
And the closest prior art in this particular case

[00:00:46] Speaker 04:
is methods, methods of use with morphine.

[00:00:52] Speaker 04:
Why morphine?

[00:00:54] Speaker 04:
Because morphine was, if you look, the declaration was submitted in this application.

[00:01:00] Speaker 01:
Why is that the closest priority?

[00:01:02] Speaker 01:
Why isn't the PCT from which the

[00:01:09] Speaker 01:
Patent that's being the comparison patent is drives its priority wanted to be reference for the claims here.

[00:01:18] Speaker 04:
Because the claims here are method claims.

[00:01:23] Speaker 04:
And if you look at the prior art, the method claims and the prior art never performed the method that we are claiming.

[00:01:32] Speaker 01:
But they did have the same

[00:01:36] Speaker 01:
It wasn't morphine, right?

[00:01:38] Speaker 04:
It was the other... It's exactly the same compound that we're talking about.

[00:01:41] Speaker 01:
It's the exact same compound.

[00:01:43] Speaker 01:
So why do I have to look at morphine instead of the exact same compound if the closest prior art is the exact same compound?

[00:01:50] Speaker 04:
Because it's not the closest prior art to the claimed invention.

[00:01:53] Speaker 04:
The claimed invention is a method.

[00:01:56] Speaker 04:
And if we take a look and compare the two applications, two applications are both from the Institute-Pastor, and we have a double patent issue here.

[00:02:07] Speaker 04:
The first application discovered opioid use, and it had pain, that you could treat pain with it, generally.

[00:02:21] Speaker 04:
That's fine.

[00:02:22] Speaker 04:
And treating pain is a good thing, but morphine was available.

[00:02:27] Speaker 04:
The problem with treating pain, and I think that's actually well laid out in the declaration, if you look at it in the prior part, one of the big issues with treating pain is pharmacodependence and tolerance.

[00:02:41] Speaker 04:
If you treat a patient with morphine, they get addicted to it.

[00:02:44] Speaker 04:
You need to use more of it.

[00:02:47] Speaker 04:
They have this tolerance and this pharmacodependence.

[00:02:50] Speaker 04:
It's difficult to get them off of morphine.

[00:02:52] Speaker 04:
So what we're looking for is a substitute for morphine.

[00:02:56] Speaker 04:
If you look at the earlier application, it says you can treat pain.

[00:03:00] Speaker 04:
It seems to go through some of the same receptors as morphine.

[00:03:04] Speaker 04:
So the expectation in the art was that it would be like morphine, that you'd have these problems.

[00:03:11] Speaker 04:
with pharmacodependence and tolerance.

[00:03:14] Speaker 04:
That was the expectation in the art.

[00:03:16] Speaker 04:
So if you think about the method of treating a person for seven days with a certain amount of it,

[00:03:24] Speaker 04:
over those seven days, the expectation, again, this is supported in the declaration, was that that person would develop pharmacodependence and tolerance.

[00:03:34] Speaker 01:
This case is an obvious mistype double patenting case, right?

[00:03:38] Speaker 01:
Do you agree, though, that the reference, the PCT reference that I was referring to before, that's actually wanting to be prior art in this case, right?

[00:03:48] Speaker 04:
Could it be used as a 102?

[00:03:50] Speaker 04:
It was not used as a 102.

[00:03:52] Speaker 01:
It's not, but it could be, right?

[00:03:54] Speaker 04:
I don't see any reason why it couldn't have been used as a 102.

[00:03:58] Speaker 04:
No, it's actually brought up in the record many times that we said this is not a 103 rejection.

[00:04:05] Speaker 04:
I don't think it changes the analysis at all, because again, you have to look at unexpected results.

[00:04:11] Speaker 01:
I don't know if it makes a difference, but I'm just thinking about it in terms of, again, this closest prior argument that you're making about how, because the claims, I guess, that are being compared to the claims at issue in this case,

[00:04:25] Speaker 01:
weren't a method.

[00:04:28] Speaker 01:
But it seems that there is some reference to method in the prior art reference.

[00:04:32] Speaker 01:
So that might be the closest part of it.

[00:04:35] Speaker 04:
But if you look at what's in the prior art, and is actually done in the prior art, it's treatment one time.

[00:04:43] Speaker 04:
There is no, it's a genus in the prior art.

[00:04:48] Speaker 04:
Treat pain.

[00:04:49] Speaker 04:
We're talking about a very specific species in our claim that has specific duration that has specific amounts being delivered to a person per day.

[00:05:00] Speaker 03:
I think I'm a little confused.

[00:05:03] Speaker 03:
Maybe you can help me.

[00:05:04] Speaker 03:
Yes.

[00:05:04] Speaker 03:
I thought you started off by saying for purposes of unexpected results you compare to the results of morphine.

[00:05:13] Speaker 03:
Now I hear I think I hear you saying the comparison is between

[00:05:18] Speaker 03:
the application claims here that are an issue and the 871 claim, which is not about morphine.

[00:05:24] Speaker 03:
It's about opiorpher.

[00:05:26] Speaker 04:
In terms of the claims themselves.

[00:05:28] Speaker 03:
Right.

[00:05:29] Speaker 03:
So for unexpected results, what's the comparison?

[00:05:33] Speaker 04:
Well, the comparison has to be to the closest prior art.

[00:05:36] Speaker 04:
If we look at the prior art, the prior art never used morphine.

[00:05:40] Speaker 03:
I'm sorry.

[00:05:40] Speaker 03:
Is the closest prior art the 871 claim?

[00:05:43] Speaker 04:
To figure that out, what do we compare it to?

[00:05:46] Speaker 04:
If we say that this patent is the closest prior art, it was never used in terms of the amounts.

[00:05:55] Speaker 03:
This patent, you mean the 871?

[00:05:58] Speaker 04:
Yes.

[00:05:59] Speaker 04:
If we talk about that prior patent, it was never used over a period of time.

[00:06:06] Speaker 04:
Pharmacodependence and tolerance, which are recited in the claim

[00:06:11] Speaker 04:
are not in the prior art.

[00:06:15] Speaker 04:
There was never any treatment over time in the prior art.

[00:06:19] Speaker 04:
All there is in the prior art is a broad claim that says, treat.

[00:06:24] Speaker 04:
And if you look at the examples in the prior patent, what you find is that all they did was they used this opioid one time with a mouse.

[00:06:36] Speaker 04:
and saw that it reduced pain.

[00:06:38] Speaker 04:
They didn't do any of the studies that they did in the later application, which is the one that we have on appeal here.

[00:06:47] Speaker 02:
Do you have the appendix with you on any change?

[00:06:50] Speaker 04:
I do.

[00:06:51] Speaker 04:
I do.

[00:06:51] Speaker 02:
On page 448, I'm looking at the Rouge decoration.

[00:06:56] Speaker 02:
Yes.

[00:06:57] Speaker 02:
It seems to me that it's important to be able to establish

[00:07:10] Speaker 02:
point right?

[00:07:14] Speaker 04:
Yes, I believe that's the the filing date 2008.

[00:07:17] Speaker 02:
So if you look at Appendix 85, there is here a declaration that Orby Orkin was known to have these unexpected results in 2007.

[00:07:40] Speaker 02:
If you look at page 85, page 37 of the PCP, it says that Rougeau disclosed to the public in 2007 that these unexpected results can be expected.

[00:08:00] Speaker 04:
Which page?

[00:08:04] Speaker 02:
Page 85 of the appendix.

[00:08:21] Speaker 02:
Those are 2007.

[00:08:23] Speaker 02:
And then it's referring to the formalin test.

[00:08:30] Speaker 02:
And if you look at the H71 patent in column 32, you see the formalin test was in 2003.

[00:08:38] Speaker 02:
I was just wondering when these unexpected results were discovered.

[00:08:46] Speaker 04:
The unexpected results are all in the application.

[00:08:49] Speaker 02:
I understand what you're talking about.

[00:08:51] Speaker 02:
I'm just a simple-minded person.

[00:08:53] Speaker 02:
I see that your case turns on being able to have these unexpected results not known in 2008.

[00:09:00] Speaker 02:
And you just agreed that is necessarily so.

[00:09:05] Speaker 02:
And yet, in the same appendix you give me, it said, we knew about this in 2007.

[00:09:12] Speaker 02:
I think we need to look at what the filing dates are specifically of the patent and the application.

[00:09:45] Speaker 04:
I'm not sure what the formalin test was specifically.

[00:09:48] Speaker 02:
Well, let me go to page J614, which is the 871 patent.

[00:09:55] Speaker 02:
And it describes, Roger was describing the results of the formalin test in 2003, which is five years before 2008.

[00:10:08] Speaker 04:
Well, there were tests with the mouse version

[00:10:11] Speaker 04:
of the opiorphine and the human version, which there may be some distinction in terms of which test you're talking about.

[00:10:17] Speaker 02:
Well, don't you think it's important for us to be able to figure out when these unexpected results were discovered?

[00:10:24] Speaker 03:
Well, I think that if you look at the declaration, it is saying... The appendix page 614, which is column 32 of the 871,

[00:10:36] Speaker 03:
seems to be specifically discovering, talking about a formalin test with rats.

[00:10:41] Speaker 03:
Right.

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

[00:10:45] Speaker 04:
I'm not sure that the formalin test really has anything to do with the pharmacodependence and the tolerance.

[00:10:52] Speaker 03:
Well, that's why I don't want to read it.

[00:10:55] Speaker 03:
Specifically.

[00:10:55] Speaker 03:
Right, but that transacted appendix 85.

[00:11:05] Speaker 03:
So it's referred to three analytical models, including the formal test of the oophren is capable of inducing the maximum analgesic effect.

[00:11:14] Speaker 04:
Right, that's a test for pain.

[00:11:16] Speaker 03:
I'm sorry, induced pain.

[00:11:19] Speaker 03:
And these results without inducing any of the major adverse effects of morphine, namely antiperistaltic effect, the pharmacodependence effect, and the tolerance effect with a site 2007.

[00:11:32] Speaker 04:
Right, and I think that that's this application.

[00:11:36] Speaker 03:
Proceedings of the Fourth International Peptide Symposium, I assume that was a public in Australia.

[00:11:46] Speaker 02:
I have those proceedings.

[00:11:52] Speaker 03:
It would have been helpful, I'm going to add, if you had the paper versions, we'd be losing many fewer seconds.

[00:11:58] Speaker 02:
Yes.

[00:12:00] Speaker 02:
I just want to

[00:12:01] Speaker 02:
concerned because it looked to me like there was a disconnect between page 85 of the record and page 428 of the record.

[00:12:08] Speaker 04:
I don't think there is.

[00:12:09] Speaker 02:
I think that it's... I know, but facially there is, because 45 says we discovered these unexpected results 2007.

[00:12:21] Speaker 04:
Yes, and I think that's part of this application, that those were incorporated into this application when it was filed.

[00:12:29] Speaker 04:
as opposed to being in the earlier application.

[00:12:31] Speaker 04:
I think it's after the filing date of the patent itself.

[00:12:36] Speaker 04:
So those results are not in the patent.

[00:12:37] Speaker 04:
So I don't think there's any inconsistency.

[00:12:40] Speaker 04:
I'd have to run through and look at all of the data, and that would certainly take some time to do.

[00:12:44] Speaker 04:
But I think that we have unexpected results.

[00:12:46] Speaker 03:
You're into your repeal time analysis.

[00:12:51] Speaker 04:
Let me say that.

[00:12:51] Speaker 04:
OK.

[00:12:53] Speaker ?:
Thanks.

[00:13:05] Speaker 00:
May it please the court.

[00:13:07] Speaker 00:
The board correctly determined that Representative Claim 35 is unpatentable for offices typed over patenting over the claims of the 871 patent.

[00:13:17] Speaker 00:
I would like to turn you to APPX 530, where the examiner discussed the unexpected results at issue here.

[00:13:25] Speaker 00:
The examiner explained that the so-called undisputed facts that the appellant pointed to only demonstrates the beneficial effects of opioid orphan

[00:13:34] Speaker 00:
as compared to morphine.

[00:13:37] Speaker 00:
And perhaps maybe that was unexpected, but Appellant failed to demonstrate that these benefits are unexpected as compared to the closest pride arc, which, as your honors have recognized, are the claims of the 871 patent, which also do recite treating pain with opiorphin.

[00:13:55] Speaker 00:
And the board and the examiner found that because the

[00:14:01] Speaker 00:
application, not only claims that describes dosages that overlap with those of the pending claims, that treating a patient with the same compound for the same pathology would result in the same types of properties of not inducing pharmacopendence.

[00:14:19] Speaker 03:
So can I ask you this question?

[00:14:21] Speaker 03:
It seems to me there are two different ways of formulating it.

[00:14:25] Speaker 03:
I think you'll briefly use both of the different ways of formulating

[00:14:31] Speaker 03:
the comparison.

[00:14:32] Speaker 03:
One is to say that what is claimed here, which is a particular negative effect, was true of the prior art too.

[00:14:47] Speaker 03:
And the other is to say, well, once you've narrowed the steps, there will be slightly additional

[00:14:59] Speaker 03:
constraints on the dosage and the length of time and the dailiness that whatever the effects are of this were also the effects of the previous one and that second way of saying it doesn't require anybody to have appreciated those facts at the earlier time.

[00:15:22] Speaker 03:
How do we think about that?

[00:15:25] Speaker 00:
So both of those are true and

[00:15:28] Speaker 00:
No matter what.

[00:15:29] Speaker 03:
So you're not contending that the board found or the examiner found that it was recognized at the time of the 871 that there would be an absence of pharmacodependence and an absence of tolerance?

[00:15:44] Speaker 00:
We did not contend that, Your Honor.

[00:15:45] Speaker 00:
We simply said that because there was no patentable distinction between the claims of the 871 patents.

[00:15:53] Speaker 00:
and the claims that are pending today, that any resulting pharmacodependence or tolerance in a patient would have been expected from both of those, or would have been the natural result of both of those method claims being practiced.

[00:16:10] Speaker 03:
Suppose it were the case that the narrowing of the class of steps

[00:16:28] Speaker 03:
the beneficial lack of tolerance, lack of pharmacodependence was an important reason to narrow to those particular set of constraints.

[00:16:44] Speaker 03:
Would the analysis be different?

[00:16:48] Speaker 00:
Perhaps if a pellet had shown a superior type of

[00:16:54] Speaker 00:
property within the patient at a particular dosage for a particular duration.

[00:16:59] Speaker 00:
Perhaps then there could have been some criticality to that species within the broad genus that they claimed in the prior claims.

[00:17:06] Speaker 00:
But here, that simply wasn't shown.

[00:17:08] Speaker 00:
The only data that was shown was that in comparison to morphine, which is an entirely different product, that there was some unexpected showing of pharmacodependence.

[00:17:21] Speaker 03:
So the Rucho.

[00:17:23] Speaker 03:
Joe.

[00:17:25] Speaker 03:
Joe Joe Joe Joe Joe Joe Joe Joe Joe Joe Joe Joe Joe Joe Joe Joe Joe

[00:17:41] Speaker 03:
treatment regimen that also would fall within the broader genus of H71.

[00:17:47] Speaker 00:
That's correct.

[00:17:48] Speaker 00:
And there simply has been no showing of any unexpected results here.

[00:17:52] Speaker 00:
And the prior claims are pretty broad as appellant even concedes in both their opening and reply brief.

[00:17:59] Speaker 00:
And those broad claims, perhaps this property within the patient

[00:18:06] Speaker 00:
may have been exhibited even at different dosages and different ranges.

[00:18:09] Speaker 00:
So there simply isn't showing the criticality of the specific claims that are at issue here.

[00:18:15] Speaker 00:
And as the board and examiner found, there is no pathological distinction between these claims.

[00:18:22] Speaker 00:
And if there are no further questions, I yield the rest of the floor.

[00:18:49] Speaker 03:
which I guess certainly has struck me in this case, trying to figure out how one thinks about this inherency question with a previously unknown property and how that fits with a large body of case law about identifying species within earlier genus claims.

[00:19:10] Speaker 03:
Why isn't the government right here about it being critical that there's no criticality

[00:19:19] Speaker 03:
as to these particular properties of the particular narrowing of the actual steps of the method?

[00:19:26] Speaker 04:
Well, I think if you look at the case law in Ray Kaplan, if you start with a very large genus, the species within that genus are not necessarily obvious.

[00:19:38] Speaker 04:
You have to get to those species to start with.

[00:19:40] Speaker 04:
So that's really the first part of this that I think that the

[00:19:43] Speaker 04:
the PTO has simply waved their hands and said, well, it encompasses.

[00:19:47] Speaker 04:
And encompasses is not the law.

[00:19:49] Speaker 04:
Encompasses doesn't give you.

[00:19:51] Speaker 03:
I think the examiner in the court did more than that.

[00:19:54] Speaker 03:
It said, when you look at these particular numbers and think about what an average person weighs, this would actually, even if you were not thinking about these pharmacodependence and tolerance properties, a skilled artisan would readily get to these particular constraints.

[00:20:12] Speaker 04:
And that's where the unexpected results come in.

[00:20:14] Speaker 04:
And they have to be considered before reaching the conclusion of obviousness.

[00:20:19] Speaker 04:
And that's not what the PTO does.

[00:20:21] Speaker 04:
I mean, if you look at what the PTO says, it says that this is just like Baxter, mere recognition of a latent property in an obvious method.

[00:20:30] Speaker 04:
So they said it's an obvious method.

[00:20:33] Speaker 04:
And then they say, well, take a look at this.

[00:20:36] Speaker 04:
It's inherent in the obvious method.

[00:20:38] Speaker 04:
Of course it's inherent in the obvious method, our method, because they've already reached obviousness without looking at unexpected results.

[00:20:47] Speaker 04:
You have to look at the unexpected results first to figure out if it's obvious.

[00:20:51] Speaker 04:
If you don't, it's always, and unexpected results are always going to be inherent 100% of the time.

[00:20:57] Speaker 04:
because you've already reached obviousness before considering.

[00:21:01] Speaker 04:
It's part of the obviousness analysis to get there.

[00:21:05] Speaker 04:
They have to be considered first.

[00:21:07] Speaker 04:
Otherwise, unexpected results would never get you anywhere.

[00:21:11] Speaker 04:
Here we have very good unexpected results.

[00:21:14] Speaker 04:
They are lining up almost perfectly with our claims in terms of the dosages that we used.

[00:21:21] Speaker 04:
And the PTO hasn't challenged any of the unexpected results whatsoever.

[00:21:26] Speaker 04:
In fact, they seem to agree with them.

[00:21:29] Speaker 04:
Perhaps they're unexpected with respect to morphine.

[00:21:32] Speaker 04:
And our position has always been morphine is the appropriate comparison.

[00:21:37] Speaker 04:
Because the prior artist is this giant genus, and no one within that genus ever did anything that would have shown this unexpected result.

[00:21:47] Speaker 02:
Are you suggesting that the unexpected results in this case should be

[00:21:52] Speaker 02:
considered and reflected in the prima facie case analysis of 103, but not as secondary considerations because they have been proven to be not improvements over the nearest prior arc.

[00:22:09] Speaker 02:
It looks to me like the nearest prior arc issue traps your unexpected results as secondary considerations.

[00:22:21] Speaker 04:
I don't think so.

[00:22:23] Speaker 04:
I think expectations come in at both levels, certainly.

[00:22:26] Speaker 02:
I think there's a difference between, I mean, I think your argument is basically that Honeywell suggests that you take a look at the unexpected results as part of the prima facie case.

[00:22:38] Speaker 04:
I think they have to be, you might be able to make a prima facie case, but that's not the end.

[00:22:43] Speaker 04:
You have to, to really get to the obvious, you have to look at the results.

[00:22:46] Speaker 02:
Where are you suggesting that we should

[00:22:52] Speaker 02:
in the 103 analysis in this case as part of the premeditation case or as part of secondary considerations after we have reached a premeditation case.

[00:23:03] Speaker 04:
I think you really, in this particular case, need to look at them at both levels because we're talking about expectations of the skilled artisan.

[00:23:10] Speaker 02:
But if the nearest prior artisan is the 871 patent and if it's so that the unexpected results were to be expected, we're in here

[00:23:20] Speaker 04:
Well, I don't think you could say that they are inherent I mean if this if this were if this were a straight anticipation Inheritance case why isn't there a 102 rejection?

[00:23:37] Speaker 04:
It's obvious yes

[00:23:39] Speaker 04:
Excuse me?

[00:23:40] Speaker 04:
The case is about obviousness, not about 102.

[00:23:43] Speaker 04:
They couldn't make, the PTO could not make a 102 rejection.

[00:23:47] Speaker 04:
So they're relying on obviousness.

[00:23:48] Speaker 04:
Once they do that, they have to take into consideration unexpected results, the expectations of the skilled artist in even reaching the factory and fisher case.

[00:23:58] Speaker 02:
How do you do it once you have decided that these unexpected results were inherent in the practice of the previous patent?

[00:24:06] Speaker 02:
If they were inherent... That's a finding in this page, correct?

[00:24:11] Speaker 04:
No, it's not.

[00:24:12] Speaker 04:
The inherency, if you look at it, it's mere recognition of a latent property.

[00:24:17] Speaker 04:
In other words, inherency in an obvious method.

[00:24:20] Speaker 04:
So they're reaching obviousness first, and then saying that our unexpected results are inherent not in the prior art, but in our method.

[00:24:30] Speaker 04:
And that's the wrong

[00:24:32] Speaker 04:
application of a law.

[00:24:33] Speaker 04:
That can't be done.

[00:24:34] Speaker 04:
I mean, I think all of the law that's been cited by either the PTO or by us would go against that result.

[00:24:46] Speaker 03:
Thanks very much.