[00:00:00] Speaker 04:
will be your argument in in Ray Rajagopalan number twenty one nine five six Mr. Green.

[00:00:10] Speaker 00:
Good morning your honor.

[00:00:12] Speaker 00:
Morning.

[00:00:12] Speaker 00:
May it please the court.

[00:00:14] Speaker 00:
I am starting my discussion going to the patent claim one which is available within the inside first page of our

[00:00:28] Speaker 00:
conditional presentation.

[00:00:30] Speaker 00:
And I think it's important to take a look at this reasonably carefully, because it's quite specific in what is required by this claim.

[00:00:44] Speaker 00:
It requires, among other things, an effective amount of an organoleptic excipient.

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And there's been a list of those excipients that's shown.

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And it goes on to say that what needs to then be accomplished is in the context of this product that's referenced in this to be used in a reduction action that comprises alkaline metals, zinc, and phosphorus.

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So this is all a combination of what's actually required to exist in order to have

[00:01:25] Speaker 00:
this claim declared not patentable.

[00:01:30] Speaker 00:
Now, if we take a look at the opening brief, I guess the easiest way I can put this is I've read through this argument that the claim is not patentable.

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And to me, it's like an apples and oranges situation because the

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underlying alleged basis here for why it's not patentable goes to this combination of GMALDRA with Adams.

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And the GMALDRA discussions all then tie back to what's in, obviously, what was an application became a patent.

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So in GMALDA,

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background of it does not indicate much about anything as to what GMALVA actually did.

[00:02:33] Speaker 04:
But on this combination question, why aren't the several things that are in paragraph 52 of GMALVA quite strongly supportive of the board's finding?

[00:02:51] Speaker 04:
Am I remembering that that's the kind of key paragraph in which the

[00:02:56] Speaker 04:
opening sentence says, most of it is about causing a real unpleasant stink, but that opening sentence is about if you have enough of the odorant, you can actually inhibit the reduction, the chemical reaction, which is what your claim is about.

[00:03:18] Speaker 04:
And then later in the paragraph, while talking about the bad odor

[00:03:25] Speaker 04:
property.

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Nevertheless, it refers to specific odor and parenthesis standard flavorant and I thought it was undisputed that Adams says that what Adams is discussing is the most common flavorant and it is actually one that is within the compass of your claim one.

[00:03:49] Speaker 00:
You are correct with respect to atoms.

[00:03:52] Speaker 00:
I'd say if you read 52, appendix 641, what does it say?

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It says, well, OK, if you add, say, 100 parts of this lymphatic amine and the specific odorant, this inhibition can take place.

[00:04:14] Speaker 00:
What's a specific odorant?

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There's no discussion.

[00:04:18] Speaker 04:
Well, except what's three or four sentences later is where it says where a specific odorant, e.g.

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a standard flavorant, is used.

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And that's, of course, the second part of the discussion of 52.

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And that's using lower levels of the composition at that time.

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And that's where it says it can impart a strong odorant.

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But even in that case,

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What is the standard flavorant that's being used?

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But again, in that context, it's really not being used in the variation that's in the first part of paragraph 52, because that's very specific about using this larger amount of the amine being also hooked up then with the amount that they're suggesting here to be used for the specific odorant.

[00:05:15] Speaker 00:
But how does the person of ordinary skill in the art know what is supposed to be done in that case?

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What specific odor in order to achieve the, not just a smell, which is what is discussed at the bottom of 52, but what's not discussed at the top of 52.

[00:05:32] Speaker 01:
Uh, and paragraph, I'm sorry, go ahead.

[00:05:37] Speaker 01:
No, you go ahead.

[00:05:39] Speaker 01:
Just paragraph 53.

[00:05:41] Speaker 01:
Then follows up paragraph 52, this is reading in GMALVA, by referring to the odorant being volatile amines.

[00:05:52] Speaker 01:
So we're narrowing in on the category of specific odorants, i.e.

[00:05:59] Speaker 01:
standard flavorants or EG standard flavorants, who we're talking about amines.

[00:06:04] Speaker 01:
And one very conspicuous amine was identified as acetylpyrazine,

[00:06:11] Speaker 01:
Why isn't that close enough so that a person of skill in the art wouldn't understand that atoms plus geomalvo would teach that combination that is described in the patent or the application?

[00:06:26] Speaker 00:
Well, Your Honor, even if you went so far as to say that that would be the case to a person of ordinary skill in the art looking at that combination, it still doesn't get you up to what's up on 52.

[00:06:39] Speaker 00:
Because now here we're talking about a specific odorant, and there's no discussion then as to what is actually being used with respect to the initial step that they were talking about in 52, which is using that larger amount in that formulation.

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But even at that point, where is it that a person of ordinary skill in the art is to understand that this is going to work?

[00:07:10] Speaker 00:
There's nothing in this entire specification of Gia Malva that shows that any of this took place in the way of any actual showing.

[00:07:20] Speaker 00:
Not there.

[00:07:21] Speaker 01:
So your argument is that Gia Malva is not enabled?

[00:07:24] Speaker 00:
It's not at all from the standpoint of dealing with this issue in the scope of claim one.

[00:07:31] Speaker 00:
It's not there.

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And if you look at it.

[00:07:34] Speaker 02:
As I understand it, you didn't present any expert declarations or other evidence that would indicate how and why there could be problems or there very likely would be problems with using many different kinds of odorants

[00:07:54] Speaker 02:
at sufficiently high levels in order to inhibit this kind of a reaction.

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Am I right?

[00:08:00] Speaker 00:
There is none submitted in this situation.

[00:08:04] Speaker 00:
That is true.

[00:08:04] Speaker 00:
I agree with that.

[00:08:07] Speaker 02:
My question is why isn't what is contained here sufficient to make a prima facie case of obviousness that in

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in that respect would then mean it would be your turn to rebut that prima facie case with whatever evidence that you could marshal to explain away the theory behind the prima facie case.

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Well, I think the patent application of GMALVA actually speaks for itself from that standpoint because it goes through and uses terms like it can inhibit this or inhibit that.

[00:08:50] Speaker 00:
But at the end of the day, it's not there.

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There is nothing in that at all that states that if you use any of these formulations, that it's actually going to work.

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The inhibit is something that is this line out there.

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And if you look at what they did do, and maybe this would help, if you take a look at what occurs in the

[00:09:19] Speaker 00:
Let's see, the section dealing with the conversion.

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So the extraction, it's like it's a APX642.

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And we've got the extractions of the pseudoepithelium using a steam distillation that's taking place.

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in that formulation or in that testing that's done, you've got exhibits 2, 3, 4, and 5.

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Out of those, you do find there's actually one amine in there that's being used.

[00:10:04] Speaker 00:
And all they're doing here is an extraction.

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It's not doing any type of a,

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anything other than the extraction.

[00:10:18] Speaker 00:
So in other words, it's not taking a position from the standpoint of what occurs in this section to show that there was anything that was done that actually inhibited the transaction or the transmission of the pseudo effort and switching around so that you're getting your methamphetamine.

[00:10:43] Speaker 00:
I mean, that's not going on.

[00:10:44] Speaker 01:
Well, the inhibition, I take it, is the interference with the process of reducing the pseudo effort.

[00:10:53] Speaker 01:
That is what we're talking about in the inhibition, I take it, as opposed to the isolation.

[00:10:58] Speaker 00:
Yeah, the inhibition, that's right.

[00:11:00] Speaker 01:
Yeah, right.

[00:11:04] Speaker 01:
Paragraph five of GMALVA talks about interfering with efforts to produce illegal drugs.

[00:11:11] Speaker 01:
And then paragraph 17,

[00:11:13] Speaker 01:
more specifically says, the additive inhibits reduction of the sympathomimetic and or its derivatives.

[00:11:23] Speaker 01:
Isn't that saying exactly what it is that the inhibition is all about?

[00:11:32] Speaker 01:
Preventing the reduction of the pseudoephedrine?

[00:11:36] Speaker 00:
If we're looking at 7, sorry.

[00:11:39] Speaker 01:
5 and 17 are the two paragraphs

[00:11:42] Speaker 01:
that seemed to me to be pertinent here.

[00:11:48] Speaker 01:
And then 46 as well, talking about interference with the reduction to methamphetamine by competing.

[00:11:55] Speaker 01:
Here's the specific mechanism, competing with pseudoepiderm for the reducing agent.

[00:12:00] Speaker 01:
That seems to be about as complete a description of the reaction as would be necessary, don't you think?

[00:12:12] Speaker 00:
Yeah, when you're looking at the GMALVA inhibition reduction, like, for example, 17.

[00:12:17] Speaker 00:
In some embodiments, the additive inhibits reduction of the sympathetic amines, e.g.

[00:12:24] Speaker 00:
psilopithrin, and or its derivatives.

[00:12:27] Speaker 00:
OK, it says that.

[00:12:29] Speaker 00:
I agree with that.

[00:12:31] Speaker 01:
And 46 then describes the reaction in some detail.

[00:12:38] Speaker 01:
About four lines down in paragraph 46, five lines down.

[00:12:47] Speaker 00:
OK, made 46 where it starts with these additives.

[00:12:59] Speaker 01:
Yeah, about five lines down.

[00:13:01] Speaker 01:
That's the description of the reaction.

[00:13:07] Speaker 00:
OK, so what does 46 say?

[00:13:12] Speaker 00:
The additives can be further characterized by an ability to reduce the overall potency of the drug.

[00:13:18] Speaker 00:
Reduction in potency of the mixture can be affected by mere dilution alone or by interference with reduction to methylamine.

[00:13:29] Speaker 00:
OK?

[00:13:30] Speaker 00:
Interference with reduction.

[00:13:35] Speaker 01:
By competing with the pseudoephedrine for the reducing agent.

[00:13:40] Speaker 01:
That's the reaction that is at the core of this function, it seems to me.

[00:13:47] Speaker 00:
I would agree.

[00:13:48] Speaker 00:
What additive is it that's going to accomplish this?

[00:13:51] Speaker 01:
Well, I think that's where you go into paragraph 52 and paragraph 53.

[00:14:03] Speaker 01:
It doesn't say acetylpirazine.

[00:14:06] Speaker 01:
But of course, if it did, then this would be an anticipation case.

[00:14:10] Speaker 00:
Right, I would agree with that.

[00:14:12] Speaker 00:
Again, you have in 52, you have again the statement we just talked about that says that if you use the specific odorant, you'll get that.

[00:14:25] Speaker 00:
Now, there's no specific odorant that again is identified for use in 52.

[00:14:30] Speaker 00:
In fact, there's nothing in this entire specification that tells a pulse of what to do with this.

[00:14:37] Speaker 00:
other than how to deal with examples two, three, four, and five, which they do show, which has nothing at all to do with anything other than being able to take the product that contains the formulation as you need

[00:15:01] Speaker 00:
to be extracted.

[00:15:03] Speaker 00:
And it's extracted so you increase the amount of pseudoeferrin that's there, that it's coming out.

[00:15:11] Speaker 00:
But that's all that's happening.

[00:15:13] Speaker 00:
And it's going through.

[00:15:15] Speaker 00:
I see I'm missing my time on this.

[00:15:18] Speaker 00:
But it's going through a method that, again, has nothing to do with an inhibition.

[00:15:22] Speaker 00:
It's actually cleaning it out at that point in time so you have the pseudoeferrin.

[00:15:27] Speaker 00:
But there's nothing in it that teaches anything more than that.

[00:15:33] Speaker 04:
Mr. Green, why don't we hear from Mr. McBride and we'll restore your three minutes of repuddle time.

[00:15:41] Speaker 00:
I appreciate that.

[00:15:41] Speaker 00:
Thank you.

[00:15:42] Speaker 04:
Thank you.

[00:15:45] Speaker 03:
Good morning, Your Honors.

[00:15:46] Speaker 03:
May it please the Court.

[00:15:48] Speaker 03:
Your Honors, this case involves a fairly straightforward obviousness rejection based on the combination of two references, Giammalva and Adams, that involves a simple substitution.

[00:16:00] Speaker 03:
I think, as your honors have pointed out, Gia Malva does a fairly good job of describing the problem to be solved, which is preventing over-the-counter medications that contain pseudoephedrine from being misused to illegally convert the pseudoephedrine to methamphetamine.

[00:16:18] Speaker 03:
GMALVA describes two pathways.

[00:16:21] Speaker 03:
One is to create the bad odor, where you have the amine odorant in a small amount, and this other pathway where you add a larger amount of the amine odorant to

[00:16:32] Speaker 03:
actually chemically inhibit the reaction that converts the pseudoepidermine to the methamphetamine.

[00:16:39] Speaker 03:
I believe Rajagopalan's council conceded that GMALVA does disclose both of those pathways.

[00:16:47] Speaker 03:
And it's described as you pointed out in paragraphs five and 17 and 46 and also in paragraph 52.

[00:16:55] Speaker 03:
I'd also just like to point out that paragraph 52, in addition to

[00:17:00] Speaker 03:
to just pointing out the pathway that you can add this larger amount, it goes on to disclose the 100 parts additive to 100 parts of the pseudoephedrine is the ratio that would actually allow you to inhibit that reaction.

[00:17:18] Speaker 03:
And that is also consistent, if you look at Rajagopalan specification, in example one and also in table one, they give one ratio.

[00:17:27] Speaker 03:
They use a one mole of additive to one mole of the pseudoepidrin, and that's the only ratio they used.

[00:17:35] Speaker 03:
And so, GM all this, you know, disclosure of 100 parts additive to 100 parts pseudoepidrin is the same amount.

[00:17:43] Speaker 03:
that Rajagopalan is disclosing that works and is, you know, constitutes this effective amount that's going to result in less than 25% of the methamphetamine being created.

[00:17:56] Speaker 03:
And also if you look at paragraph 56, it makes another disclosure of the different amounts that you can use, the different ratios that you can use between the additive and the pseudoephedrine.

[00:18:08] Speaker 03:
And it says you can, that the most preferred amounts is a ratio

[00:18:13] Speaker 03:
2 to 1 to 1 to 2, and that's the ratio between the amine additive and the pseudoephedrine, and that's, you know, squarely within the range.

[00:18:23] Speaker 03:
It's consistent with the one-to-one ratio just disclosed in Rajagopal specification that results in this effective amount that can inhibit that chemical inhibition.

[00:18:34] Speaker 03:
And then if you turn to the motivation to look to atoms, there's a number of different guideposts in GMALVA.

[00:18:43] Speaker 03:
You know, first it talks about using a volatile amine odorant.

[00:18:47] Speaker 03:
It talks about using a specific odorant

[00:18:52] Speaker 03:
which it describes as a standard flavorant.

[00:18:56] Speaker 03:
If you look at atoms, it discloses a number of standard flavorants.

[00:19:02] Speaker 03:
It discloses specifically acetylpirazine as, you know, ingredient or flavorant number 24.

[00:19:09] Speaker 03:
That acetylpirazine happens to be disclosed by atoms the most commonly.

[00:19:15] Speaker 03:
used acetylpirazine flavorant.

[00:19:18] Speaker 03:
So I think that provides a strong motivation to make that combination.

[00:19:21] Speaker 03:
And then Adams also goes on to say that acetylpirazine is recognized as being generally recognized as a safe standard flavorant, which GMALVA also recognizes is a desired characteristic to use something that's generally recognized as safe.

[00:19:39] Speaker 03:
That's also consistent with Raja Gopalan specification.

[00:19:42] Speaker 03:
If you look at

[00:19:45] Speaker 03:
Rajagopalan spec at APPX23, it talks about how there's an enormous number of molecules that can be used and that would work.

[00:19:56] Speaker 03:
But one of the limiting factors is you want to use something that's generally recognized as safe.

[00:20:01] Speaker 03:
And GMALVA and Adams both disclosed that particular feature.

[00:20:06] Speaker 03:
So I think the combination is quite strong.

[00:20:10] Speaker 03:
There's a lot of evidence that supports that determination.

[00:20:13] Speaker 03:
And then on the counter side, there is no evidence of unexpected results.

[00:20:17] Speaker 03:
There's no teaching away evidence.

[00:20:21] Speaker 03:
Roger Goplin does make this long felt need argument, but as the board and the examiner found, it's unsupported by evidence.

[00:20:29] Speaker 03:
And even if you take that argument on the merits, he's talking about how the prior art was using these physical tamper resistant packaging.

[00:20:40] Speaker 03:
a method to avoid this, you know, illegal conversion to methamphetamine.

[00:20:46] Speaker 03:
And the problem solved was allegedly having this chemical inhibition.

[00:20:50] Speaker 03:
But as Raja Gopalan's counsel seemed to concede, Gia Malva discloses that particular feature.

[00:21:00] Speaker 01:
Mr. McBride, this is Judge Bryson.

[00:21:03] Speaker 01:
One thing that struck me, and I'd like you to comment on this, is that the examiner having, although,

[00:21:08] Speaker 01:
The examiner wrote quite a bit.

[00:21:12] Speaker 01:
She did not focus in on the inhibition of the reduction.

[00:21:18] Speaker 01:
Instead, she seemed to focus on the interference with the isolation part of the process, which, as I understand the chemistry here, was a quite different stage of the process from the reduction.

[00:21:34] Speaker 01:
It's step one as opposed to step two.

[00:21:37] Speaker 01:
Is there any, am I missing something in what the examiner did or did the board and your brief walk away from the analysis of the examiner?

[00:21:51] Speaker 03:
So I think the examiner, your correct examiner did focus more of their attention on the fact that by adding the amine odorants, you can create this bad smell and that bad smell

[00:22:04] Speaker 03:
even if you add the amine odorant in a much smaller amount, that's still going to deter people from doing this illegal conversion because it's going to tip off police, it's going to tip off potential buyers.

[00:22:19] Speaker 01:
But there was nothing in the examiner's office action that I saw that addressed the inhibition, i.e.

[00:22:30] Speaker 01:
the interference with the reduction part of the

[00:22:34] Speaker 01:
of the GMALVA disclosure, right?

[00:22:37] Speaker 03:
Well, the examiner did cite to paragraph 47 of GMALVA.

[00:22:42] Speaker 03:
which does disclose both of those pathways.

[00:22:46] Speaker 03:
And the examiner does cite about the office action to paragraph 56, specifically reciting to GM ALBA's disclosure of using the one-to-one ratio to achieve the effective amount that is claimed.

[00:23:03] Speaker 03:
So I think it is accurate to say that the examiner did talk about how the combination could create this odor that could deter

[00:23:13] Speaker 03:
The examiner also found that GMALVA in paragraph 56 disclosed adding this amine odorant in the amount that is claimed and the examiner pointed out that, you know, this is a composition claim and once you add that amine odorant of atoms in the amounts that's disclosed by GMALVA,

[00:23:35] Speaker 03:
you have the same composition.

[00:23:38] Speaker 03:
And, you know, that's all that's required to meet the claims.

[00:23:42] Speaker 03:
And they went on to say that, you know, in addition to what GM ALBA talks about, how they disclose this, the fact that adding in that amount is going to clinically inhibit the reaction.

[00:23:52] Speaker 03:
The examiner also pointed out that, and the board recognized that,

[00:23:56] Speaker 03:
Once you have that composition, any properties associated with that particular composition, such as inhibiting the chemical reaction, is necessarily going to flow from the fact that you have the same composition.

[00:24:09] Speaker 03:
And that's at least sufficient to shift the burden to the applicant to then attempt to show that that combination or that resulting composition would not have the claimed properties.

[00:24:21] Speaker 03:
And here, there doesn't seem to be any disputes or any allegations that the

[00:24:26] Speaker 03:
the composition resulting from the composition would have the, you know, the claim property of chemically inhibiting the conversion of pseudoepithrine to methamphetamine.

[00:24:41] Speaker 03:
Does that answer your question?

[00:24:43] Speaker 03:
Thank you.

[00:24:43] Speaker 04:
Mm-hmm.

[00:24:47] Speaker 04:
Brad, do you have anything else?

[00:24:51] Speaker 03:
No, I think that sums up the rejection.

[00:24:54] Speaker 03:
Unless there are any further questions from your honors, I'm happy to yield the rest of my time.

[00:25:01] Speaker 04:
Hearing none, we'll hear from Mr. Green for rebuttal.

[00:25:07] Speaker 04:
You have three minutes, Mr. Green.

[00:25:10] Speaker 00:
Thank you again.

[00:25:11] Speaker 00:
And I will just return to what I've said before, which is in this specification, there is a lot of talk

[00:25:20] Speaker 00:
about what could be done.

[00:25:22] Speaker 00:
And additives are certainly discussed.

[00:25:25] Speaker 00:
You're talking, for example, to paragraph 56.

[00:25:29] Speaker 00:
And it does talk about this wide range and how it can be used.

[00:25:34] Speaker 00:
But it doesn't say for what purpose.

[00:25:37] Speaker 00:
And I still have the position that there is nothing in this specification where they're taken alone.

[00:25:49] Speaker 00:
or in combination that gives you what is required by the claim, which is you have to be able to know what it is that's going to work in the formulation at what amount in order to obtain a reduction as is set forth in this claim.

[00:26:09] Speaker 00:
And there is nothing in here that shows any action of that sort where there's actually a reduction that's taking place.

[00:26:19] Speaker 00:
And I, again, go back to the only thing that's in the specification are the examples 2, 3, 4, 5, and 6.

[00:26:30] Speaker 00:
And there's only one of those that has an amine in it.

[00:26:33] Speaker 00:
And that's example 2.

[00:26:35] Speaker 00:
And in that situation, there was five times as much presence with respect to the pseudoephedrine than there was the ingredient that was being added to it.

[00:26:47] Speaker 00:
In this situation, there was no one-to-one ratio whatsoever that was used.

[00:26:52] Speaker 00:
And obviously, at that point, it was also not generating it for the purposes of converting it to methamphetamine.

[00:27:00] Speaker 00:
And without some basis for a post-it to look at this and understand what is happening or what would be needed in order to accomplish what is set forth and claim one of the pending applications,

[00:27:17] Speaker 00:
believe the policy totally without any understanding.

[00:27:21] Speaker 00:
That's our view.

[00:27:25] Speaker 04:
Okay.

[00:27:25] Speaker 04:
Thank you, Mr. Green.

[00:27:27] Speaker 04:
And thank you to Mr. Bride as well.

[00:27:31] Speaker 04:
The case is submitted.

[00:27:33] Speaker 04:
Thank you.

[00:27:36] Speaker 03:
The honorable court is adjourned until tomorrow morning at 10 a.m.