[00:00:00] Speaker 02:
Were you pleased to have sitting with us this morning as a visiting judge, the Honorable Beth Freeman of the Northern District of California?

[00:00:11] Speaker 02:
Thank you for sitting with us, Judge Freeman, and welcome.

[00:00:14] Speaker 02:
Thank you.

[00:00:16] Speaker 02:
We have four cases on the calendar this morning.

[00:00:19] Speaker 02:
Two from the PTAB, one from the Claims Court, one from the District Court.

[00:00:27] Speaker 02:
Two from the District Court and one from the Claims Court.

[00:00:31] Speaker 02:
That and one of the PTAB cases are being submitted on the briefs and not being argued.

[00:00:39] Speaker 02:
So our first case is Edward Neister versus Eden Park, illumination, et al.

[00:00:49] Speaker 02:
2024-1374.

[00:00:51] Speaker 02:
Ms.

[00:00:51] Speaker 02:
Parsons.

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

[00:01:01] Speaker 00:
Abby Parsons from the law firm of Arnold and Porter on behalf of counsel for repellent, Mr. Ed Meister.

[00:01:08] Speaker 00:
May it please the court?

[00:01:11] Speaker 00:
This panel must reverse the board's final written decision of obviousness, because there is not a shred of evidence in the record showing the use of 222 nanometer light on skin.

[00:01:25] Speaker 02:
Well, what there is is the claims recite, specifically, 222 and 282.

[00:01:31] Speaker 02:
And both are in the references.

[00:01:33] Speaker 02:
And one of the references describes use with skin.

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And this isn't an anticipation case.

[00:01:40] Speaker 02:
It's obviousness.

[00:01:42] Speaker 02:
So why isn't it fairly simple?

[00:01:46] Speaker 00:
It's not fairly simple, Judge Laurie, because this is a very unpredictable art.

[00:01:51] Speaker 00:
And let's look at the specific combination that petitioners set forth.

[00:01:55] Speaker 00:
The first reference, the Eckert reference, you're right, it talks about the use of UV on skin.

[00:02:01] Speaker 00:
It only discloses, it has a very broad statement in paragraph 31 that says any light capable of disinfection can be used in this invention.

[00:02:12] Speaker 00:
Any light.

[00:02:13] Speaker 00:
But if this reference taught the use of 222 or 282 nanometer on skin, this would be a 102 case.

[00:02:21] Speaker 00:
Petitioners knew that it didn't support that teaching.

[00:02:25] Speaker 00:
and we have to look to Sosnin for the use of 222 or 282 wavelengths.

[00:02:31] Speaker 00:
But what Sosnin is missing

[00:02:34] Speaker 00:
is the use of skin of any kind.

[00:02:37] Speaker 03:
But that doesn't matter.

[00:02:38] Speaker 03:
This is not, as you say, a 102 case.

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This is a 103 case.

[00:02:44] Speaker 03:
And so you combine the references, one which teaches the use of light on skin and one which uses the different range.

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And the board found a skilled artisan would combine those to find this range can be used on skin.

[00:02:58] Speaker 03:
You don't have to find skin in the second reference that has the range.

[00:03:01] Speaker 03:
Again, that would be 102.

[00:03:04] Speaker 03:
So I don't understand what your argument is in saying nobody shows this range on skin.

[00:03:10] Speaker 03:
They don't have to in a single reference for an obviousness case.

[00:03:14] Speaker 03:
Are you attacking motivation to combine these two?

[00:03:20] Speaker 00:
Yes, we're attacking motivation to combine, but let me first talk about the prima facie case that is not disclosed by even the combination of Eckerd and Sosnian.

[00:03:28] Speaker 00:
Because under this court's Raytheon decision, which we described in the blue brief at page 27, that the combination must enable the entire invention.

[00:03:40] Speaker 00:
So we had some debate in the briefs about whether the rule of 112 applies for obviousness.

[00:03:46] Speaker 00:
I'll agree that Ms.

[00:03:47] Speaker 00:
Craning had the better argument that reference itself doesn't have to be self-enabling.

[00:03:53] Speaker 00:
So Eckert, we know, doesn't teach 222 or 282 on skin.

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So we have to look at what Saaz then teaches.

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And we know from this court's precedent that for obviousness, we're not just looking at individual disclosures.

[00:04:05] Speaker 00:
You have to look at the reference for all that it teaches.

[00:04:08] Speaker 00:
That's this court's Arctic Cat decision in Ray applied materials.

[00:04:13] Speaker 01:
Well, is Arctic Cat really something you can still rely on?

[00:04:18] Speaker 00:
I'm not sure I understand your question.

[00:04:21] Speaker 01:
Well, I think in the opposition brief that it was argued that this court has walked away from the Arctic Cat factors.

[00:04:28] Speaker 01:
and use as a different standard.

[00:04:31] Speaker 00:
Understood, Your Honor.

[00:04:32] Speaker 00:
So applied materials and the general principle that both parties recognize is that for obviousness, you have to look at the entire reference.

[00:04:39] Speaker 00:
What a person of skill would have understood from that reference.

[00:04:41] Speaker 00:
We start from the principle in Eckert that in paragraph 5, Eckert himself says, common knowledge says you don't use UV light on skin.

[00:04:51] Speaker 00:
That's the premise from which Eckert comes from and every other argument.

[00:04:56] Speaker 00:
This sounds like a teaching away argument.

[00:04:58] Speaker 00:
Well, the board made a specific finding discrediting an argument of teaching away.

[00:05:04] Speaker 00:
We're not challenging that here.

[00:05:06] Speaker 00:
We understood those findings are reviewed for substantial evidence.

[00:05:10] Speaker 00:
The finding of the board that lacks substantial evidence is on page 28 of the final written decision, where the board says that Sosnan

[00:05:23] Speaker 00:
Right in the middle of the first full paragraph, sosmin suggests using eczema lamps to selectively kill bacteria without damaging skin.

[00:05:32] Speaker 00:
And it cites to figures eight and nine of sosmin.

[00:05:35] Speaker 00:
So if we look at what figures eight and nine of sosmin are, those are two tests, one of which is using 222 nanometer in E. coli.

[00:05:45] Speaker 00:
And another is 282 nanometer light, also in E. coli.

[00:05:51] Speaker 00:
If you look at those, E. coli is not skin.

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That is clear.

[00:05:57] Speaker 00:
Sazmin then uses that data and tries to compare it to two other tests that come from different media.

[00:06:04] Speaker 00:
using two other wavelengths of 206 nanometers and 282 nanometers to make a comparison.

[00:06:10] Speaker 01:
But it seems like you're looking for Saznan to anticipate.

[00:06:14] Speaker 01:
And you're not combining Eckhart and Saznan and drawing the reasonable combination.

[00:06:21] Speaker 00:
I appreciate the question.

[00:06:23] Speaker 00:
We have to look at what the person of skill in the art would have looked at Saznan for that very purpose.

[00:06:27] Speaker 00:
And what would they have thought?

[00:06:29] Speaker 00:
Saznan itself,

[00:06:31] Speaker 00:
says that a Cho cell, that's a Chinese hamster ovary cell, that was the only cell that was being tested other than E. coli in that study.

[00:06:39] Speaker 00:
So a Chinese hamster ovary cell, even Sosman characterizes that as a fibroblast.

[00:06:45] Speaker 00:
Petitioner's expert, Mr. Lawal, the only evidence that he says that Sosman supports skin from a person of ordinary skill in the art, he says a Cho cell is a proxy for a mammalian cell.

[00:06:59] Speaker 00:
That sleight of hand is important.

[00:07:02] Speaker 00:
A mammalian cell, there are more than 200 different kinds of mammalian cells in a human.

[00:07:10] Speaker 00:
Skin is one of those 200 kinds.

[00:07:13] Speaker 01:
So you're again arguing that the appellee's expert was incredible.

[00:07:18] Speaker 01:
But that's not what we're looking at here.

[00:07:20] Speaker 00:
I actually am not arguing.

[00:07:22] Speaker 01:
Well, you did argue it in your brief.

[00:07:23] Speaker 00:
I did.

[00:07:24] Speaker 00:
I did.

[00:07:25] Speaker 00:
And I agree that that is not the substantial evidence test, Your Honor.

[00:07:29] Speaker 00:
What the finding of the board that lacks substantial evidence is the expert doesn't say that Saznan teaches skin.

[00:07:37] Speaker 03:
The board doesn't have to teach skin.

[00:07:40] Speaker 03:
The other one teaches light to disinfect skin.

[00:07:44] Speaker 03:
Saznan just teaches a range for disinfectant.

[00:07:48] Speaker 03:
It's the combination of the two that show skin and range.

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And so whether Saznan teaches skin or not is irrelevant.

[00:07:57] Speaker 03:
If you're arguing that no

[00:07:59] Speaker 03:
skilled artisan would look to Skosnian for the range, then that's a different argument.

[00:08:05] Speaker 03:
That's a motivation to combine argument.

[00:08:07] Speaker 03:
It's not a disclosure argument.

[00:08:10] Speaker 00:
I appreciate that.

[00:08:10] Speaker 00:
And there is a motivation to combine argument based on Eckert's range.

[00:08:14] Speaker 00:
The board did get it wrong in saying there was a generic disclosure in Eckert of a range of wavelengths that were acceptable.

[00:08:23] Speaker 00:
In Eckert, paragraph 70, Eckert talks about the use of UV

[00:08:29] Speaker 00:
transmitting band-aids.

[00:08:32] Speaker 00:
And in that paragraph, it says a xenon flashbulb showing a range of between 220 and 310 nanometers could penetrate a certain type of polyethylene band-aid by 80%.

[00:08:45] Speaker 00:
That is a very specific disclosure about a xenon bulb and its penetration of a band-aid.

[00:08:52] Speaker 00:
From that one mention of those numbers, 220 to 310, the board grabs that as a general disclosure of a range of acceptable wavelengths that could be combined.

[00:09:04] Speaker 00:
A person of skill would not have read that teaching.

[00:09:07] Speaker 00:
Eckhart does not offer that as a general teaching that those wavelengths are acceptable.

[00:09:12] Speaker 01:
But didn't the board reject that argument saying that your client had argued this too narrowly on Eckhart?

[00:09:20] Speaker 00:
The board did reject the argument that

[00:09:23] Speaker 00:
Eckert taught only two embodiments.

[00:09:26] Speaker 00:
And below at the P tab, we had argued that only two embodiments were enabled by Eckert.

[00:09:33] Speaker 00:
They really focused on what was available at the time of the patent application, which was back in 2003.

[00:09:39] Speaker 00:
At that time, we had 254 nanometer light commonplace.

[00:09:45] Speaker 00:
Those were used in tanning beds.

[00:09:46] Speaker 00:
Those lamps were everywhere.

[00:09:47] Speaker 00:
All the art in this case talks about that.

[00:09:50] Speaker 00:
No one was even aware of a 222 nanometer light.

[00:09:53] Speaker 00:
And if Eckert would have been aware of it, he might have said something else besides that.

[00:09:58] Speaker 00:
But the only disclosure that the board grabs onto is those numbers.

[00:10:02] Speaker 00:
Those numbers are meaningless in the context of Eckert.

[00:10:05] Speaker 02:
But those are key to the claim.

[00:10:09] Speaker 00:
They are a key to the claim, and it's a key element that's missing.

[00:10:12] Speaker 00:
So in the combination of Eckhart and Sosnian, you get skin from Eckhart, and then you look at Sosnian to replace these two lamps.

[00:10:22] Speaker 00:
It doesn't make sense to a person of skill in the art at that time to say, how could I make the teachings of Eckhart safer for the use on skin?

[00:10:30] Speaker 00:
Sausman doesn't do anything to encourage the person of skill that those tests would show you that it was more safe.

[00:10:37] Speaker 00:
If anything, those are focused on mammalian cells.

[00:10:41] Speaker 00:
Safety is not a specific requirement of the claims.

[00:10:44] Speaker 00:
Safety comes into play because the petitioner's combination of Eckert with Sausman, Eckert is the treatment of UV, the treatment of skin using UV.

[00:10:56] Speaker 00:
And a person of skill in the art taking that disclosure for all it teaches under 103 would know that safety, you have to do that in a safe way.

[00:11:06] Speaker 00:
Otherwise, it impacts your reasonable expectation of success.

[00:11:10] Speaker 00:
And what's key for this argument, Your Honors, to reverse it?

[00:11:14] Speaker 03:
So now we're onto a third argument against obviousness.

[00:11:16] Speaker 03:
We started with no disclosure.

[00:11:18] Speaker 03:
Then we got motivation to come on.

[00:11:20] Speaker 03:
Now we're no reasonable expectation of success.

[00:11:23] Speaker 00:
That's true.

[00:11:23] Speaker 00:
And I'll be very brief.

[00:11:25] Speaker 00:
How we know there's no reasonable expectation in 2003.

[00:11:27] Speaker 00:
In 2021.

[00:11:29] Speaker 03:
What was the board's findings on reasonable expectation?

[00:11:33] Speaker 00:
The board rejected the argument of reasonable expectation of success.

[00:11:39] Speaker 00:
But again, this is the hole in the substantial evidence of no teaching of skin.

[00:11:44] Speaker 00:
It all comes back to Sosnan teaching skin.

[00:11:47] Speaker 00:
And I'll say one brief thing.

[00:11:48] Speaker 03:
The problem with your argument is that Sosnan doesn't teach skin.

[00:11:51] Speaker 03:
It seems irrelevant to me because they didn't look to Sosnan for the skin.

[00:11:55] Speaker 03:
They looked at Eckhart for the skin.

[00:11:58] Speaker 03:
They only looked to Sosnan for the range.

[00:12:01] Speaker 00:
Under this court's Raytheon decision, you have to look at both prior art references to enable the combination.

[00:12:08] Speaker 00:
We know that Eckhart could not have taught 222 on skin, which is the entire claim.

[00:12:12] Speaker 00:
And so you have to look at both.

[00:12:15] Speaker 00:
And when you look at both,

[00:12:16] Speaker 00:
We have to look at sosmin for the skin piece using those specific wavelengths.

[00:12:20] Speaker 00:
And it's just not there.

[00:12:22] Speaker 00:
It's not substantial evidence.

[00:12:23] Speaker 00:
The panel should reverse.

[00:12:25] Speaker 02:
You enter your rebuttal time, which you can save or use.

[00:12:29] Speaker 00:
I would like to reserve it.

[00:12:30] Speaker 00:
Thank you, Judge.

[00:12:31] Speaker 02:
We will save it for you.

[00:12:51] Speaker 04:
Good morning, Your Honors, and may it please support Casey Crane from Fish and Richardson on behalf of the FLEs.

[00:12:58] Speaker 04:
As we've just heard, appellant in this case points to no errors of law.

[00:13:03] Speaker 04:
Instead, what they're asking this court to do is to disregard the extensive findings of fact at the floor beneath the law, which really amounts to more than substantial evidence.

[00:13:13] Speaker 04:
In doing so, they ask this court to disregard the evidence that is plain on the face of the prior art, and they ask this court to reweigh that evidence and to reweigh the credibility of both parties' experts.

[00:13:27] Speaker 03:
What is the substantial evidence to support the board's conclusion that you would look to Sausson for the range and that you would combine it with Eckhart?

[00:13:36] Speaker 04:
Yes.

[00:13:37] Speaker 04:
So the substantial evidence is in Eckhart at paragraph 31, which is at appendix site 1795.

[00:13:45] Speaker 04:
And at that paragraph, it expressly says,

[00:13:49] Speaker 04:
that this invention effort can be used with any of the light that is shown to disinfect, including narrow-spectrum wavelength lamps.

[00:13:59] Speaker 04:
Those are the same things as the eczema lamps that snoznin uses.

[00:14:04] Speaker 04:
A person of ordinary school in New York will look to snoznin because snoznin has the same motivation as Eckhart in looking at whether specific wavelengths of light can be used to differentially attack bacteria versus mammalian cells.

[00:14:19] Speaker 04:
In doing so, snoznin uses both 222 and 282 nanometers of light.

[00:14:25] Speaker 04:
Now I've heard my friends say that the entire claim is 228 years.

[00:14:30] Speaker 04:
It's not.

[00:14:31] Speaker 04:
The claim claims 282 and 222.

[00:14:34] Speaker 04:
any alternative.

[00:14:35] Speaker 04:
So setting apart that there may not have been apples-to-apples comparison at 222 nanometers, there was at 282 nanometers.

[00:14:45] Speaker 04:
And what Saussman clearly showed is that 282 was highly effective at disinfecting and killing E. coli bacteria cells while having very little impact on the mammalian show cells that are fiberglass cells that are often used as a mimic for the wound repair in epidemic testing.

[00:15:07] Speaker 04:
So the board correctly concluded from this, it will only be motivated to disinfect their skin with an eczema lamp taught by Sosnin, because Eckhart expressly invited a modification to do so.

[00:15:22] Speaker 04:
I also heard my friends say that this is an unpredictable art.

[00:15:26] Speaker 04:
There is no evidence below in this record to suggest that.

[00:15:30] Speaker 04:
I don't think it was even argued that it was an unpredictable art.

[00:15:34] Speaker 04:
Indeed, Eckhart discloses that wavelength of 220 to 310 nanometers, which covers both of the wavelengths here.

[00:15:43] Speaker 04:
It expressly uses 254 nanometer light, which was shown to be at high levels having damaging effects.

[00:15:51] Speaker 04:
But using ECHR, it acknowledges that there are benefits that outweigh the risk of UV light using the 254 nanometers.

[00:16:09] Speaker 04:
And the other point I wanted to make is that in Eckhart, I think that there is an over-reliance on the paragraph that pointed to that 220 in the three-ton range.

[00:16:18] Speaker 04:
And really, the focus of what our argument is is on the paragraph 31 that has that broader invitation to try other methods of sterilization, including the narrow-line wavelength lamps.

[00:16:33] Speaker 01:
And what is your response to Ms.

[00:16:35] Speaker 01:
Parson's argument that Saucinin doesn't teach use on skin?

[00:16:40] Speaker 04:
So I would agree that technically it does not apply on skin directly, but there is evidence that the board credited below from our expert, Mr. Lawal, that show cells in fibroblasts are often used as a proxy for human skin.

[00:16:55] Speaker 04:
And I'll go back to Your Honor's argument that was correctly made, that we don't need Sosne to teach disinfection of skin because we are combining it with Eckhart, which was expressly about disinfecting the skin.

[00:17:08] Speaker 01:
Well, the argument also was that Eckhart doesn't teach direct application to the skin because of the bandage.

[00:17:16] Speaker 04:
So I would say that's a misreading of Eckhart.

[00:17:18] Speaker 04:
There's a plain disclosure in Eckhart that the bandage can be removed for the UV light to be applied.

[00:17:24] Speaker 04:
And so this argument that the bandage somehow had to be transmissive of UV light is not the entire teaching of Eckhart, Your Honor.

[00:17:33] Speaker 04:
Thank you.

[00:17:34] Speaker 02:
Presumably there's some discovery in the fact that these wavelengths penetrate and damage the nucleic acids.

[00:17:45] Speaker 02:
The problem for the patent is these references, there are two references and someone else discovered that and neither reference is in the file of the patent examination.

[00:17:56] Speaker 04:
Yes, you're right.

[00:17:56] Speaker 04:
That's correct.

[00:17:57] Speaker 04:
I think one of the fundamental arguments here is that really, you know, my friend on the other side is asking a lot more of the prior art than what was even disclosed in the 642 patent.

[00:18:07] Speaker 04:
The 642 patent itself says more testing is needed to determine the exposure levels.

[00:18:13] Speaker 04:
It doesn't show us any testing on human skin for 222 or 282.

[00:18:19] Speaker 04:
So they're simply asking more of the prior art than even the inventor disclosed in his patent application.

[00:18:27] Speaker 02:
Anything further?

[00:18:29] Speaker 04:
Unless your honors have any other questions, I will yield the rest of my time.

[00:18:33] Speaker 02:
No one loses points by yielding any time.

[00:18:39] Speaker 02:
Ms.

[00:18:39] Speaker 02:
Parsons, you have some rebuttal time.

[00:18:47] Speaker 00:
I'll be brief.

[00:18:47] Speaker 00:
Three points.

[00:18:50] Speaker 00:
We heard from Dr. Cranning that petitioners rely on paragraph 31.

[00:18:55] Speaker 00:
for the general teaching that any light that can do disinfection is what was taught by Eckert.

[00:19:02] Speaker 00:
As of 2013, the first reference I know of anywhere in the record that taught 222 on skin was 2013.

[00:19:10] Speaker 00:
And if you look at the blue brief on page 50, we refer to the IUVA article, each of which of the petitioners had a principal who was an author of that study.

[00:19:22] Speaker 00:
And on that, in the blue brief,

[00:19:24] Speaker 00:
We point to both a demonstrative from that paper that shows the penetration of skin that was known as of 2021.

[00:19:35] Speaker 00:
And we can see below that there's a quote from that study.

[00:19:38] Speaker 00:
Multiple recent studies of health effects from far UVC exposures of the eye and skin indicate that the wavelengths below about 230 nanometers are substantially safer than longer UVC wavelengths.

[00:19:51] Speaker 00:
And it cites papers ranging from 2013 to 2021.

[00:19:56] Speaker 00:
So we're talking about Eckert making a general disclosure in 2003 saying, anything that's known to disinfect is what I claim in my invention.

[00:20:05] Speaker 00:
So that's the first point.

[00:20:07] Speaker 00:
Secondly, Ms.

[00:20:10] Speaker 00:
Cranning points to Dr. Lawal's testimony to say that mammalian skin is a proxy for other things.

[00:20:18] Speaker 00:
If you look at Dr. Lawal's

[00:20:20] Speaker 00:
Excuse me, Mr. Lawal's supplemental declaration where this evidence comes from.

[00:20:25] Speaker 00:
He relies purely to support that sentence on his experience.

[00:20:31] Speaker 00:
He says, in my experience, Cho cells are a proxy for mammalian skin.

[00:20:38] Speaker 00:
This court has rejected and overturned the board for motivation to combine

[00:20:44] Speaker 00:
precisely where an expert offers only a conclusory Ipsa-Dixit statement.

[00:20:50] Speaker 00:
And that was this court's very recent decision, overturning the board in 2024, which came up after the party briefed this case.

[00:20:59] Speaker 00:
It was the Vitek.

[00:21:03] Speaker 00:
Give me one second.

[00:21:04] Speaker 00:
I'll give you that.

[00:21:05] Speaker 02:
Did you submit a 20HA letter citing that?

[00:21:09] Speaker 00:
I did not, Your Honor.

[00:21:11] Speaker 00:
I'll give you the citation in case you want to look at it.

[00:21:12] Speaker 00:
It's Vertec Vision International versus Assembly Guidance System, 97, F4, 882, 2024.

[00:21:22] Speaker 00:
So an unsupported expert declaration cannot support substantial evidence of the board's findings and should reverse.

[00:21:30] Speaker 00:
Finally, testing, there's an argument that's been raised in the brief that there's not more in the patent application than there is in the prior art.

[00:21:39] Speaker 00:
That argument is a red herring.

[00:21:40] Speaker 00:
This is a 103 case, not an enablement case of Mr. Nester's patent.

[00:21:44] Speaker 00:
But if you look at the specification for Mr. Nester, Figures 11 and Figure 14 show testing by Mr. Nester's own invention, the 222 nanometer light

[00:21:56] Speaker 00:
Granted, that was not done on skin.

[00:21:58] Speaker 00:
But if you look at the specification itself, we have several examples starting on columns 9 and 10 that walk through very specific methods of using that 222 nanometer light on skin.

[00:22:10] Speaker 00:
Also in columns two and three, Mr. Nester walks through precisely how DNA is denatured in a different way in each of the wavelengths at issue.

[00:22:22] Speaker 00:
254 attacks the amino acids, and 222 was surprisingly discovered to really denature by using dimers

[00:22:32] Speaker 00:
of the DNA proteins.

[00:22:34] Speaker 00:
So Mr. Kneeser has an in-depth understanding of his invention.

[00:22:40] Speaker 00:
He was the first one to put 222 or 282 nanometers on skin in a claim.

[00:22:46] Speaker 00:
And his patent is presumed valid.

[00:22:48] Speaker 00:
And it should be upheld by this panel.

[00:22:50] Speaker 02:
Thank you, counsel.

[00:22:51] Speaker 02:
Your time has expired.

[00:22:53] Speaker 02:
We appreciate both arguments.

[00:22:54] Speaker 02:
And the case is submitted.