[00:00:00] Speaker 01:
Glycobiosciences.

[00:00:43] Speaker 01:
Please proceed, Mr. Schneider.

[00:00:45] Speaker 03:
Good morning.

[00:00:46] Speaker 03:
May I please report?

[00:00:48] Speaker 03:
After the briefs were filed in this case, the Supreme Court decided to have the pharmaceuticals versus Sandoz.

[00:00:54] Speaker 03:
There's a portion of that decision that I believe is extremely relevant to the issues on appeal.

[00:00:59] Speaker 03:
And that's the portion of the decision that appears at 135, Supreme Court Reporter, pages 840, 841.

[00:01:09] Speaker 03:
Even though Sandoz, or Teva or Sandoz as we call it, whichever way you identify it, is a claim construction case, it does indicate that when you are solely reviewing documents, claim construction is purely a matter of law.

[00:01:28] Speaker 03:
The reason I think that is important is that here, there is no dispute on the facts as to what the prior art document shows.

[00:01:39] Speaker 03:
This is not a situation such as Zirco where you're relying on patent office expertise.

[00:01:45] Speaker 03:
This is a situation where we are asking the court to read the document in context.

[00:01:52] Speaker 03:
Don't stop short in the middle of a sentence.

[00:01:54] Speaker 03:
Don't stop short in the middle of a paragraph.

[00:01:56] Speaker 03:
Read the patent in context.

[00:01:58] Speaker 03:
And when you do that, you get an entirely different reading compared to the findings from the Patents Trial and Appeal Board.

[00:02:12] Speaker 03:
It is no different, we submit, than if you were to read an encyclopedia and find all of the ingredients.

[00:02:18] Speaker 03:
That doesn't teach or motivate or suggest combining the teachings.

[00:02:25] Speaker 03:
At best, the components are old but in a different context, namely with a PGF or polypeptide growth factor.

[00:02:36] Speaker 03:
As a legal matter, that is insufficient.

[00:02:40] Speaker 03:
and we have identified the Kimberly Clark case and Gillette case on pages 15 and 16 of our brief for that proposition.

[00:02:48] Speaker 03:
Neither of those cases or that concept has been addressed by the director in the opposition brief.

[00:02:56] Speaker 03:
The position is that the primary document was not considered as a whole for everything that it teaches.

[00:03:07] Speaker 03:
Rather, they were snippet-taken.

[00:03:09] Speaker 03:
out of context, and in our reply brief, at pages seven and eight, we identify proposed findings F2 through 10, the letter F standing for the Think an Hour patent, in the proper context of what the Think an Hour invention is all about.

[00:03:28] Speaker 02:
We also propose... Is it your contention that the claim necessarily excludes PGA?

[00:03:39] Speaker 02:
that your claim excludes PGF?

[00:03:43] Speaker 03:
It does not exclude PGF.

[00:03:46] Speaker 03:
Because it's a comprising claim?

[00:03:47] Speaker 03:
Because it's an open-ended claim.

[00:03:49] Speaker 03:
But as we've identified and developed the argument in that context, because the claim was not rejected under 35 U.S.P.

[00:03:58] Speaker 03:
101 or 112 as being incomplete or not enabled, the claim must cover a two-component system.

[00:04:08] Speaker 03:
even though it's open and would cover three, four, or five, or many more component systems, it must cover a two-component system, and that is not disclosed in the Fincan-Albert Act.

[00:04:19] Speaker 01:
I don't understand that argument.

[00:04:22] Speaker 01:
Clearly, the claim must include at least a two-component system, because you've got

[00:04:28] Speaker 01:
non-ionic polymer and HA.

[00:04:30] Speaker 01:
So that's two components, but it's a comprising claim.

[00:04:32] Speaker 01:
Why can't there be additional components?

[00:04:34] Speaker 03:
Well, there can be in an infringing device.

[00:04:36] Speaker 03:
The scope of the claim is broader than two components, but the claim must also cover a two-component system.

[00:04:42] Speaker 01:
Well, if the scope of the claim is broader than two components, I agree with you that the claim could also cover a two-component system, but we're not talking about infringement.

[00:04:53] Speaker 01:
We're talking about obviousness and

[00:04:57] Speaker 01:
you know, when you're talking about anticipation or obviousness, if any point, the claim might cover a two-component system, a three-component system, a four-component system, and if any of those systems are identically disclosed in the prior art, you've got a 102 problem, right?

[00:05:10] Speaker 01:
I mean, it doesn't have to be all of them, just any of them.

[00:05:13] Speaker 01:
And the argument here is that there is Finkenauer, which discloses HA and a non-ionic polymer together.

[00:05:24] Speaker 03:
not together into alternate embodied.

[00:05:29] Speaker 01:
And therein is this part of the road if you will okay what about thinking our at about line of page for thinking our which would be J. A. three eighty one.

[00:05:43] Speaker 01:
Let's start around line forty ish.

[00:05:47] Speaker 01:
It's telling you that I'm going to totally garble all of these words.

[00:05:55] Speaker 03:
I'm going to garble these words.

[00:05:59] Speaker 01:
There's no chance I'm going to say these words properly.

[00:06:02] Speaker 01:
Page JA381 at line 40.

[00:06:08] Speaker 01:
See where I'm talking about?

[00:06:11] Speaker 01:
Glycosaminogenicans.

[00:06:14] Speaker 01:
Not even close, I'm sure of it.

[00:06:16] Speaker 01:
This is why I use initials.

[00:06:17] Speaker 01:
Yeah, I don't know what the initials are for that thing.

[00:06:19] Speaker 01:
So, okay.

[00:06:21] Speaker 03:
Here's for that, by the way, is GAG.

[00:06:23] Speaker 01:
GAG.

[00:06:24] Speaker 01:
The GAG may be used to enhance wound healing in combination with any other gel forming polymer.

[00:06:30] Speaker 01:
Yes.

[00:06:31] Speaker 01:
Right above it said the GA can be selected from a group consisting of HA, right?

[00:06:38] Speaker 01:
Yes.

[00:06:38] Speaker 01:
That's one of the things.

[00:06:40] Speaker 01:
Okay, so we've got HA at this point.

[00:06:43] Speaker 01:
and then you go down to the bottom at about page line 55, any further embodiment, the topical or incisional gel may comprise a cellulose derivative.

[00:06:55] Speaker 01:
preferred cellulose derivatives are HPMC, which I understand is a non-ionic polymer.

[00:07:02] Speaker 01:
Okay, so are you saying that those are totally discrete embodiments, that this embodiment, which can include a non-ionic polymer, doesn't include G, whatever, whatever, whatever?

[00:07:13] Speaker 03:
Yes, Your Honor, that's exactly the position that we are taking, and let me explain the reasons.

[00:07:19] Speaker 03:
First of all,

[00:07:22] Speaker 03:
In line 55, you have the word comprised, different from consisting over comprising, but still open-ended.

[00:07:28] Speaker 03:
It may comprise a non-ionic polymer, but it's a further embodiment.

[00:07:32] Speaker 03:
It's not the same embodiment.

[00:07:34] Speaker 02:
But it refers back to any other gel-forming polymer, correct?

[00:07:39] Speaker 03:
Absolutely.

[00:07:41] Speaker 03:
But the problem is, when you have, under KSR, the teaching, the motivation, the suggestion issue, how many

[00:07:53] Speaker 03:
What is the quantity of polymers?

[00:07:54] Speaker 03:
What is the quantity of non-ionic polymers?

[00:07:58] Speaker 03:
What is the quantity of regular or ionic polymers such as HA or all the other GAGs or PA which is polyacrylic acid?

[00:08:06] Speaker 03:
There are an enormous quantity of possible components to be used when you then look at the specific examples.

[00:08:18] Speaker 03:
Examples one through

[00:08:23] Speaker 03:
There's only five six examples in various tables you don't find two polymers

[00:08:32] Speaker 03:
You certainly don't find an ionic and a non-ionic polymer in any example.

[00:08:36] Speaker 01:
Well, but you do have this line that Judge O'Malley honed right in on that says the G-thing may be used to enhance wound healing in combination with any other gel-forming polymer.

[00:08:46] Speaker 01:
And the non-ionic polymer is another gel-forming polymer.

[00:08:50] Speaker 01:
And just a little bit down, it discloses non-ionic polymers.

[00:08:55] Speaker 01:
So why isn't that an expressed disclosure of HA plus a non-ionic polymer?

[00:09:03] Speaker 03:
As I said before, Your Honor, we believe that it is insufficient to suggest to one a coordinator's skill in the art, what are you combining?

[00:09:17] Speaker 03:
H.A.

[00:09:18] Speaker 03:
and a non-ionic polymer?

[00:09:20] Speaker 03:
Not necessarily, because at lines 40 and 41, once it hits any other gel-forming polymer, that doesn't tell you whether it's going to be part of the G.A.G.

[00:09:32] Speaker 03:
family or part of the non-ionic polymer family.

[00:09:35] Speaker 03:
They have different purposes.

[00:09:41] Speaker 03:
I would suggest that it's what we would call a gratuitous comment.

[00:09:44] Speaker 01:
It's there, but it doesn't teach you anything.

[00:09:50] Speaker 01:
thinks that you're saying something that had the patent office adopted, I would have said is not supported by substantial evidence.

[00:09:57] Speaker 01:
I think that your position, your argument is a reasonable one, but this is a prior art reference and what it teaches is a question of fact that we review for substantial evidence.

[00:10:10] Speaker 01:
We've got an office action that, you know, reviews or decides this issue in a way

[00:10:18] Speaker 01:
that is not the way you say, but I'm up against a substantial evidence standard.

[00:10:21] Speaker 01:
I'm not doing a de novo thing where I get to say, well, Mr. Snyder's interpretation of this disclosure, you know, actually resonates with me a little more than the other one.

[00:10:30] Speaker 01:
I've got the substantial evidence standard that I'm up against.

[00:10:33] Speaker 03:
Well, first of all, under the quotation from Teva that I read, I don't believe you are.

[00:10:39] Speaker 01:
Well, you know, just to be clear, you didn't even cite Teva anywhere in your briefs.

[00:10:42] Speaker 03:
Well, Teva was decided afterwards.

[00:10:45] Speaker 02:
But Teva is a different issue.

[00:10:47] Speaker 02:
Teva is talking about, and this has always been a little bit of an oddity in our case law, but Teva is talking about looking at the patent and the intrinsic evidence relating to what the claims of particular patents mean.

[00:11:01] Speaker 02:
what we're talking about here is what a prior art reference teaches and our and habit doesn't overrule our long-standing jurisprudence that says what a prior art teaches, even if it happens to be a patent, is a question of fact.

[00:11:17] Speaker 03:
Yes, but in the case this year in Ray, I'm ready to mispronounce this one, I's, I-M-A-S, 78th, 5th, 1250, authored by Judge Moore,

[00:11:27] Speaker 03:
You did go back and look at the prior art once you disagreed, it happens you disagree with the patent office on claim construction, but you did go back at the prior art and looked at the prior art and at page 1254 you reach the conclusion that you did not agree with the patent office on the interpretation of the prior art.

[00:11:44] Speaker 03:
So, reviewing the prior art is not something that's forbidden, it just has to be substantial evidence.

[00:11:51] Speaker 02:
Oh, of course it just has to begin.

[00:11:53] Speaker 02:
It's not forbidden, it's still a standard of review.

[00:11:55] Speaker 02:
In that case...

[00:11:58] Speaker 02:
We concluded that the prior art, that there wasn't substantial evidence supporting the Patent Office's interpretation of that prior art.

[00:12:08] Speaker 02:
So you have to convince us, not just that you have a reasonable position, but that there's no substantial evidence to support the alternative.

[00:12:16] Speaker 03:
Now the other part I would like to address briefly, and I realize I'm going into my rebuttal time.

[00:12:21] Speaker 03:
Claim six, which refers to the use of a drug.

[00:12:24] Speaker 03:
The PGF is not a drug.

[00:12:27] Speaker 03:
So the best we can say for the patent office decision is they found a drug, a specific drug, in another reference, and they say, well, we can substitute that teaching for the non-drug in the primary reference.

[00:12:44] Speaker 03:
And again, I would submit that's a pure hindsight because it ignores the purpose of the PGF, the purpose of the drug.

[00:12:55] Speaker 03:
They are different.

[00:12:56] Speaker 02:
And you have to be certain that the HA- So your argument is that there's no motivation to combine the use of the drug in Piedavante with the PGF in Peking now.

[00:13:07] Speaker 02:
Combine or substitute?

[00:13:08] Speaker 03:
Or substitute for the PGF.

[00:13:09] Speaker 03:
Because you have to understand how does the HA interact and how does the second ingredient, whether it's a second polymer, ionic or non-ionic, how does that interact?

[00:13:19] Speaker 03:
And that was not developed by the board in its rejection, in its affirmance of the example.

[00:13:27] Speaker 03:
Thank you.

[00:13:28] Speaker 01:
Thank you, Mr. Snyder.

[00:13:29] Speaker 01:
We'll save the remainder of your time for rebuttal.

[00:13:31] Speaker 01:
Ms.

[00:13:31] Speaker 01:
Lynch?

[00:13:35] Speaker 02:
Can we start where he ended?

[00:13:37] Speaker 02:
Because I think that's the biggest difficulty I'm having, is that I understand that there are all these pieces and parts.

[00:13:47] Speaker 02:
But where does the motivation to combine a drug or to replace PGF with a drug

[00:13:54] Speaker 02:
for the PGF and Fincanara with the drug come from.

[00:13:57] Speaker 02:
I know that you cite Piedmonti primarily for that purpose, but what is the motivation to combine those two, or to substitute one for the other?

[00:14:07] Speaker 00:
Well, first of all, may I please record, first of all, claim one is representative.

[00:14:14] Speaker 00:
So there should be no arguments here about claim six, because claim one is representative, and like a lot of scientists didn't dispute that in their opening brief.

[00:14:22] Speaker 00:
But going beyond that, Petamonte actually talks about using HA plus a disinfectant and antibacterials.

[00:14:39] Speaker 00:
So also their argument that PGF is not a drug is also a new argument that was never made before the board.

[00:14:45] Speaker 00:
It was never made in their opening briefs.

[00:14:48] Speaker 00:
So what the examiner found though was that

[00:14:51] Speaker 00:
If it's a think-an-hour, it didn't disclose an antibacterial, but Pedimante does.

[00:14:58] Speaker 00:
A person of ordinary skill in the art, looking at these two references, both of which teach that HA is used to treat a dermatological condition, would think to use the antibacterial in Pedimante.

[00:15:11] Speaker 00:
That's where the substitution comes in.

[00:15:17] Speaker 00:
But going back to Representative Claim 1, which has really held us before this board today, is the board correctly concluded that Representative Claim 1 would have been obvious over three different combinations.

[00:15:30] Speaker 00:
Finconera and Valdacci, Finconera and Galena, Finconera and Yamamoto.

[00:15:35] Speaker 00:
Each one teaches treating a dermatological condition by topical application of a composition that includes a GAG and HA.

[00:15:44] Speaker 00:
and Finkenauer, like we already pointed to, specifically teaches to combine a GAG like HA with another gel-forming polymer.

[00:15:52] Speaker 00:
And it tells you why.

[00:15:53] Speaker 00:
It says to enhance the wound healing.

[00:15:55] Speaker 00:
Now, glycobiologist argues that the board erred because we didn't rely on references where HA was the primary ingredient.

[00:16:03] Speaker 00:
But as this court's already discussed, the claim is broad enough to include an additional ingredient

[00:16:10] Speaker 00:
in addition to HA and a non-ionic polymer.

[00:16:14] Speaker 00:
And actually, glycobio-scientists, they sued Nicomed using that exact construction, because Nicomed was using a composition that included HA, a non-ionic polymer, and an additional drug.

[00:16:26] Speaker 00:
So therefore, it was perfectly proper for the board to rely on references that included three ingredients.

[00:16:32] Speaker 00:
But even if we were to accept glycobio-scientists' argument that we had to rely on

[00:16:38] Speaker 00:
references that only have two ingredients, the board did that as well.

[00:16:43] Speaker 00:
And if you look at Bellocchi, that teaches using a GAG alone, the G-A-G alone, to treat a dermatological condition.

[00:16:50] Speaker 00:
And it tells you that it's therapeutic.

[00:16:52] Speaker 00:
It tells you it restores and heals tissues, and it's effective agent in the recovery of wounds and lesions.

[00:16:58] Speaker 00:
And Gallina also teaches that H-A on its own is a

[00:17:03] Speaker 00:
pharmacistically active agent, even though it's used with urea.

[00:17:07] Speaker 00:
So a person of ordinary skill in the art, considering all of the teachings of the art, not portions of them, as they argue, would have had every reason to combine HA with the non-ionic polymer, either with or without an additional ingredient.

[00:17:22] Speaker 00:
And for these reasons, we ask that you affirm.

[00:17:25] Speaker 00:
Do you have any questions?

[00:17:27] Speaker 01:
Thank you, Ms.

[00:17:28] Speaker 01:
Lynch.

[00:17:29] Speaker 01:
Mr. Schneider, you have some rebuttal time.

[00:17:35] Speaker 03:
I returned to my opening comments about the scope of the claim.

[00:17:48] Speaker 03:
And I believe that because the claim must also be construed as covering two ingredients, notwithstanding that it's an open-ended claim and could include PGF,

[00:18:06] Speaker 03:
the interpretation of the primary reference to Pinkenauer is being taken out of context.

[00:18:11] Speaker 03:
Now I will say a second thing about claim one, and I may have spoken too quickly Judge O'Malley in response to your question.

[00:18:19] Speaker 03:
I'm not sure that the PGF is a component for therapeutic purposes, which is required by the claim.

[00:18:27] Speaker 03:
So I'm not sure claim one, even though there's no dispute it's an open-ended claim, I'm not sure the PGF provides that function.

[00:18:34] Speaker 02:
You did concede that claim one was represented, though, didn't you?

[00:18:38] Speaker 02:
Yes.

[00:18:41] Speaker 02:
And so your point is that PGF has no therapeutic property?

[00:18:47] Speaker 03:
I don't believe it has therapeutic property.

[00:18:49] Speaker 03:
It's not disclosed.

[00:18:50] Speaker 03:
Let me say that again.

[00:18:51] Speaker 03:
It's not disclosed.

[00:18:52] Speaker 03:
It has a therapeutic property encompassed by claim one.

[00:18:59] Speaker 02:
but if that's the case then your two ingredients such as HA and the non-ionic polymer would then be sufficient for purposes of the incisional wound healing?

[00:19:09] Speaker 03:
It would be and that is the comment made certainly in a footnote in our reply addressing both section 101 and section 112 the claim with just two ingredients must be sufficient otherwise

[00:19:25] Speaker 03:
It would have been rejected under 35 USC 101 or 112.

[00:19:35] Speaker 03:
I'm sorry, that footnote is in our opening brief.

[00:19:38] Speaker 02:
But if those two ingredients are sufficient in your claim and PGF has no therapeutic properties, then why aren't those two ingredients sufficient in Finkenau?

[00:19:58] Speaker 03:
The claim is topically applying a therapeutically effective dose of the gelled composition for treating the condition.

[00:20:09] Speaker 03:
Now, comprising means there can be other steps as well as saying there could be other ingredients.

[00:20:16] Speaker 03:
The claim is open in that regard.

[00:20:19] Speaker 03:
It does not tell us that the PGF or that there could be something else in it that doesn't provide the therapeutic function.

[00:20:29] Speaker 03:
The claim is directed to a therapeutically effective dose.

[00:20:34] Speaker 01:
Do you want to have a final thought?

[00:20:36] Speaker 01:
We're beyond our time.

[00:20:37] Speaker 03:
I am beyond.

[00:20:38] Speaker 01:
Thank you.

[00:20:39] Speaker 01:
Thank both counsel for their argument.

[00:20:41] Speaker 01:
The case is taken under submission.