[00:00:00] Speaker 04:
Our next counsel for argument is 21-1104, Garden Health v. Fadal.

[00:00:05] Speaker 04:
Mr. Rosato.

[00:00:08] Speaker 00:
Thank you.

[00:00:09] Speaker 00:
May it please the Court.

[00:00:10] Speaker 00:
The Board here found certain claims of the H2P patent obvious over the Schmidt reference, but it did so by erroneously construing the claim terms, ignoring its own fact findings, which were inconsistent with its own conclusions, and by

[00:00:27] Speaker 00:
also declining to meaningfully consider several pieces of key evidence of non-obviousness.

[00:00:33] Speaker 00:
And with the court's permission, I'll turn to the issue of claim construction with the term non-uniquely tagged.

[00:00:40] Speaker 00:
So here for this claim term, the board had initially identified in its institution decision an express definition for this term.

[00:00:49] Speaker 00:
The final written decisions were declined to apply that express definition and opted for an alternative broader construction.

[00:00:57] Speaker 00:
The first issue of the board's decision here is for their alternate construction, the decision really provides no justification as to why this adopted construction is consistent with the intrinsic evidence.

[00:01:12] Speaker 00:
There are no fact findings supporting that construction.

[00:01:15] Speaker 00:
In fact, the board makes a number of fact findings that are inconsistent with its adopted construction.

[00:01:21] Speaker 00:
And there are several.

[00:01:22] Speaker 00:
The first is the board makes a finding of fact.

[00:01:26] Speaker 00:
that the specification discusses unique tagging and describes that in a way where it encompasses tagging molecules such that all or nearly all are uniquely tagged.

[00:01:41] Speaker 00:
Then the board adopts a construction that encompasses precisely what the specification is discussing as unique tagging.

[00:01:51] Speaker 02:
I do think there's a bit of inconsistent language in the board's decision.

[00:01:55] Speaker 02:
But if I understand what you're saying is that Schmidt doesn't satisfy the non-uniquely tagged limitation because the barcodes together with the endogenous DNA

[00:02:17] Speaker 02:
results in unique tagging, right?

[00:02:20] Speaker 02:
Correct.

[00:02:20] Speaker 02:
And the question is whether in determining whether something is uniquely tagged, you can consider the endogenous DNA and the board is saying, no, that's not

[00:02:32] Speaker 02:
part of the identifier within the meeting of the claims.

[00:02:36] Speaker 02:
Did I get that right?

[00:02:39] Speaker 00:
Mostly.

[00:02:40] Speaker 00:
I would just clarify a few points on that.

[00:02:43] Speaker 00:
I would agree that Schmitt unquestionably requires unique identifiers in order to distinguish one molecule from the other.

[00:02:52] Speaker 00:
That's the only way in which Schmitt distinguishes molecules.

[00:02:56] Speaker 00:
The board's construction

[00:02:58] Speaker 00:
of non-uniquely tagged does require that the number of identifiers be less than the number of polynucleotides.

[00:03:06] Speaker 00:
The board also finds

[00:03:08] Speaker 00:
And this is another instance where the board's fact findings are inconsistent with their conclusions.

[00:03:12] Speaker 00:
The board makes multiple findings of fact, as stated plainly in Schmidt, that in this hybrid embodiment they're relying on of Schmidt, that it's the combination, as you mentioned, Your Honor, of endogenous shear sequence plus exogenous NMR that together

[00:03:30] Speaker 00:
you form this amalgamation.

[00:03:31] Speaker 02:
Schmidt does not have unique barcodes, right?

[00:03:34] Speaker 00:
Schmidt only has unique barcodes.

[00:03:36] Speaker 02:
Well, it depends what you mean by a barcode, but the only reason that Schmidt has a unique identifier for all fragments is because it relies on the added

[00:03:55] Speaker 02:
identifiers put at the, tacked onto the fragments together with the endogenous DNA of the fragments themselves, right?

[00:04:04] Speaker 00:
In the one embodiment the board's relying on this hybrid embodiment that is correct, Schmidt's identifier, and you're correct, I should use the term identifier because that's the term in the claims and it's the term used by Schmidt and the board's construction.

[00:04:17] Speaker 00:
But Schmidt's identifiers are unquestionably unique for every molecule in the hybrid embodiment.

[00:04:23] Speaker 02:
Not if you put aside the endogenous DNA, right?

[00:04:26] Speaker 00:
But then it wouldn't be an identifier.

[00:04:28] Speaker 00:
It doesn't identify anything.

[00:04:29] Speaker 02:
That's the question, what's an identifier?

[00:04:31] Speaker 02:
If I understand what the board is saying, that the identifier does not include the endogenous DNA, but just the sequences that are tagged onto the end of the fragments, right?

[00:04:44] Speaker 00:
uh... the what the board says it's a two key fact-finding support makes a statement correct i don't think that's i think that the board did is is the in some fact-finding is correctly identified what is the identifier schmidt and then in drawing their conclusions they ignored that identifier and look to a portion

[00:05:04] Speaker 02:
But if the unique identifier were the sequences that were tacked on to the end of the fragments, then Schmidt does disclose non-unique identifiers, right?

[00:05:21] Speaker 00:
That's incorrect, Your Honor.

[00:05:22] Speaker 00:
Schmidt, that is not correct.

[00:05:25] Speaker 00:
Schmidt has, relevant to this appeal, two embodiments.

[00:05:29] Speaker 00:
Well, in every single embodiment of Schmidt, the identifier is unique.

[00:05:33] Speaker 02:
Schmidt tells us that... That's only because of the endogenous DNA, right?

[00:05:37] Speaker 00:
No, it's because of the diversity and the length and the characteristics of the identifier.

[00:05:42] Speaker 00:
The identifier is a sequence of DNA that's used to uniquely distinguish one molecule from the other.

[00:05:49] Speaker 00:
In some cases, Schmidt's identifier is in a long endogenous sequence.

[00:05:54] Speaker 00:
They give an alternative, this hybrid, where the identifier is a combination of endogenous sequence plus.

[00:05:59] Speaker 00:
In every single case, the identifier is a long sequence of

[00:06:03] Speaker 00:
a long nucleotide sequence where that sequence is used to identify.

[00:06:08] Speaker 02:
What I ask is to put aside the endogenous DNA in Schmidt, which in your view creates unique identifiers.

[00:06:16] Speaker 02:
Let's say that's not part of the identifier, that the only identifier is the sequence that's tacked on to the end of the fragments.

[00:06:27] Speaker 02:
Then Schmidt does disclose the use of non-unique identifiers, right?

[00:06:32] Speaker 00:
It doesn't.

[00:06:34] Speaker 00:
No, every single piece of... How could that be?

[00:06:38] Speaker 02:
I just don't understand why that's your position.

[00:06:41] Speaker 00:
Well, it's the position because that's what Schmidt tells us, right?

[00:06:46] Speaker 00:
They're using any sufficient amount, length of nucleic acid sequence

[00:06:55] Speaker 02:
order to uniquely identify every fragment Schmidt says that you're not accepting my hypothetical your hypothetical is put aside the endogenous DNA don't consider that as an identifier there's part of an identifier then Schmidt

[00:07:13] Speaker 02:
because it doesn't have a tacked on sequence that's unique to each fragment, has non-unique identifiers, right?

[00:07:24] Speaker 00:
If you're just considering the endogenous?

[00:07:26] Speaker 02:
No, if you're not considering the endogenous and just the added tag at the end of the fragment.

[00:07:32] Speaker 02:
Then it does show non-unique identifiers.

[00:07:36] Speaker 00:
It would be a non-unique piece.

[00:07:39] Speaker 00:
I disagree it would be an identifier.

[00:07:40] Speaker 02:
That's a question of what you mean by identifier.

[00:07:43] Speaker 00:
Exactly.

[00:07:44] Speaker 02:
If you include endogenous DNA, then Schmidt does not disclose non-unique identifiers.

[00:07:52] Speaker 02:
If you put aside the endogenous DNA, it does.

[00:07:55] Speaker 02:
It's that simple, right?

[00:07:56] Speaker 00:
Under your hypothetical, Your Honor, if the whole identifier is a long sequence and then we

[00:08:01] Speaker 00:
ignore three-quarters of it and ask, circle an arbitrary piece and say, is that possibly non-unique?

[00:08:09] Speaker 00:
Under that hypothetical, that could be a non-unique piece.

[00:08:11] Speaker 00:
It's not an identifier.

[00:08:13] Speaker 00:
It'd be like trying to telephone somebody with an area code and having nothing of the rest of the phone number.

[00:08:20] Speaker 04:
Could I ask you to turn to your objective Indisha argument?

[00:08:24] Speaker 00:
Of course, Your Honor.

[00:08:26] Speaker 00:
So there, here the board

[00:08:32] Speaker 00:
aired in failing to consider evidence that went to both reasonable expectation of success as well as evidence that was submitted regarding objective and issue of non-obviousness.

[00:08:42] Speaker 00:
And I'll address those in turn.

[00:08:44] Speaker 00:
But for the issue of motivation with reasonable expectation, Gordon had submitted, among other evidence, five different peer-reviewed publications discussing challenges with cell-free DNA generally and criticizing Schmidt specifically when it came to cell-free DNA.

[00:09:02] Speaker 00:
One of those references, I don't have time to go through every one of them, but one example is the Parakas reference, which is discussed by both Gordon's expert and in the briefing at pages A626, 627, cited in Bloch quoted.

[00:09:18] Speaker 00:
But Parakas is discussing on the appendix sites for Parakas, 3293 in the appendix.

[00:09:26] Speaker 00:
is Parakis is discussing limitations and difficulties with conventional technologies, including sequencing platforms, library preparation protocols, as applied to cell-free DNA.

[00:09:36] Speaker 00:
On the very next page, 3294, Parakis is discussing the Schmitt method specifically and describes, goes on to provide a discussion that Schmitt had never been applied to cell-free DNA.

[00:09:51] Speaker 00:
It had recognized limitations.

[00:09:53] Speaker 00:
that would preclude its application to sell free DNA, and that skilled artisans didn't expect it to work.

[00:09:59] Speaker 04:
I asked you to move on to your objective consideration evidence, and none of that is fixed.

[00:10:04] Speaker 00:
I apologize, Your Honor.

[00:10:05] Speaker 04:
You have such a limit.

[00:10:06] Speaker 04:
You have less than two minutes left before you end your rebuttal time.

[00:10:08] Speaker 04:
So move to the argument I actually asked you.

[00:10:11] Speaker 00:
I thought you said evidence generally.

[00:10:13] Speaker 04:
I said your objective indigenous evidence.

[00:10:15] Speaker 00:
Objective evidence.

[00:10:16] Speaker 00:
So if I can finish that thought, that wasn't considered.

[00:10:19] Speaker 00:
With the objective indicia, there's still the issue of objective indicia evidence was submitted.

[00:10:25] Speaker 02:
Essentially, you didn't cite your expert, and you did.

[00:10:29] Speaker 02:
That's the argument.

[00:10:30] Speaker 00:
We did, yes.

[00:10:31] Speaker 00:
And the board's basis for disregarding it was we didn't cite our expert.

[00:10:34] Speaker 04:
OK, so that kind of sums it up.

[00:10:35] Speaker 04:
Probably doesn't need more argument than that.

[00:10:37] Speaker 04:
But I do have a question for you.

[00:10:38] Speaker 04:
How in the world did you find an expert named Quackenberg?

[00:10:42] Speaker 04:
I mean, I read that and I thought, is this a joke?

[00:10:46] Speaker 04:
Really?

[00:10:46] Speaker 04:
If this case goes to a jury, that's all they're going to think about.

[00:10:50] Speaker 00:
He's a compelling expert, Your Honor.

[00:10:53] Speaker 04:
OK.

[00:10:53] Speaker 04:
Well, yes.

[00:10:54] Speaker 04:
All right.

[00:10:56] Speaker 04:
Anything else?

[00:10:57] Speaker 01:
Was it Quackenbush's declaration, or was there a different name?

[00:11:00] Speaker 00:
It was Dr. John Quackenbush from Dean of Harvard Institute at Harvard.

[00:11:07] Speaker 01:
I thought when I was reading the declaration that you're urging us to say it was ignored, there was a different name on it, but I guess I'm wrong.

[00:11:16] Speaker 00:
No, it's Dr. Quackenbush, and that is his testimony is both cited and discussed at the page the board identified.

[00:11:22] Speaker 04:
OK, do you want to save the rest of your time for rebuttal?

[00:11:25] Speaker 00:
I do, and thank you.

[00:11:26] Speaker 04:
Yes, Ms.

[00:11:27] Speaker 04:
Craven.

[00:11:29] Speaker 03:
May it please the court?

[00:11:30] Speaker 02:
So on that last point, you got a bit of a problem.

[00:11:33] Speaker ?:
Sure.

[00:11:33] Speaker 03:
Of course, Your Honors.

[00:11:37] Speaker 03:
didn't consider the expert's testimony for the secondary considerations, that's true, because it didn't see the citation to the expert testimony for the nexus.

[00:11:47] Speaker 03:
And if we go to the patent owner's response, the page of the appendix, it's for secondary considerations.

[00:11:58] Speaker 03:
It starts at JA640.

[00:12:01] Speaker 03:
Which volume now?

[00:12:05] Speaker 03:
Line two.

[00:12:07] Speaker 03:
And so the last paragraph where it starts here is where they discuss the nexus.

[00:12:17] Speaker 03:
And that paragraph talks about the legal standard.

[00:12:22] Speaker 03:
It's well settled that there's a presumption of nexus for objective considerations when the patentee shows that the asserted objective evidence is tied to a specific product.

[00:12:30] Speaker 03:
That goes on to the next page.

[00:12:32] Speaker 03:
They have a citation to this

[00:12:33] Speaker 03:
court's case law, and then a C also.

[00:12:36] Speaker 03:
And that is their citation to their expert testimony.

[00:12:39] Speaker 03:
It's a block citation to all the paragraphs of Dr. Franklin Bush's evidence on secondary consideration.

[00:12:46] Speaker 04:
Is the C also exhibit 2025, paragraphs 156 to 166?

[00:12:52] Speaker 04:
Yes.

[00:12:53] Speaker 04:
It's not all of his testimony, right?

[00:12:55] Speaker 04:
It's 10 paragraphs of a very, very long expert report.

[00:12:58] Speaker 04:
So they just need to hone right in on specific paragraphs.

[00:13:02] Speaker 03:
That's fair.

[00:13:03] Speaker 03:
the block quotation to not only nexus but also long felt need and commercial success.

[00:13:09] Speaker 02:
The problem is that it's not just that site, it's later on that page, 641, as Dr. Krakenwisch explains, the garden 360 test embodies at least claim one out of the 822 plant.

[00:13:22] Speaker 03:
And there's no citation there, and the rest of the citations in that paragraph are to research articles, not to Dr. Quackenbook's, which is testimony.

[00:13:32] Speaker 04:
In multiple places, they have cited his testimony, but here they cite his testimony, and then they refer to his testimony explicitly, though without citation.

[00:13:42] Speaker 04:
Are you suggesting to me that that's not enough?

[00:13:45] Speaker 03:
To make them just look at it and address it?

[00:13:48] Speaker 03:
I mean, there is just the one citation.

[00:13:50] Speaker 03:
The rest are two references.

[00:13:52] Speaker 04:
But if your honors think that the board- Just the one citation and the sentence that uses his name.

[00:13:56] Speaker 03:
That is true.

[00:13:57] Speaker 03:
There is a sentence.

[00:13:58] Speaker 03:
There is no citation there.

[00:13:59] Speaker 03:
But if the board abused its discretion in not considering the testimony, then it would be a remand for the board to consider whether there was a nexus and the long felt need and commercial success in the first instance.

[00:14:11] Speaker 01:
But I asked a question about the remand.

[00:14:14] Speaker 01:
Sure.

[00:14:15] Speaker 01:
What happens on the remand?

[00:14:17] Speaker 01:
Where has the petitioner gone?

[00:14:21] Speaker 01:
Is the petitioner still involved at the PTO, or has the petitioner walked altogether?

[00:14:26] Speaker 03:
Well, the parties, it's my understanding the parties settled after appeal to this court.

[00:14:31] Speaker 03:
So the petitioner hasn't disappeared from the... We don't know the details of the settlement.

[00:14:37] Speaker 01:
The settlement may have been that the petitioner takes a walk entirely forever.

[00:14:42] Speaker 03:
That is true.

[00:14:43] Speaker 01:
Yes.

[00:14:43] Speaker 03:
The board can proceed without a petitioner to consider this evidence and issue a final written decision.

[00:14:51] Speaker 01:
Who makes the arguments on behalf of the petitioner?

[00:14:54] Speaker 03:
Well, the petitioner has already made the arguments in their reply to the patent owner's response.

[00:15:00] Speaker 03:
So there are arguments before the board that address nexus.

[00:15:03] Speaker 01:
What happens if there are further questions?

[00:15:06] Speaker 01:
If they get past nexus, right, then the secondary considerations are up for grabs.

[00:15:13] Speaker 03:
That's right.

[00:15:13] Speaker 03:
And the petitioner makes arguments against long felt need and commercial success in their reply brief.

[00:15:19] Speaker 03:
So there are arguments for the board to assist.

[00:15:21] Speaker 01:
What's the practice been in the past?

[00:15:25] Speaker 03:
I think the practice has been in the past.

[00:15:27] Speaker 01:
Where there's been a remand where, for example, the petitioner has taken a walk.

[00:15:31] Speaker 03:
I'm aware of cases where they

[00:15:34] Speaker 03:
The parties ask for it to be dismissed, and the board dismisses the case.

[00:15:39] Speaker 03:
I am aware of cases where the board then goes on and issues another final written decision.

[00:15:45] Speaker 03:
Those are the options to the board, and they could ask.

[00:15:48] Speaker 03:
Right now, my understanding is not that there needs to be new briefing, because it's just that the board failed to consider evidence that was before it.

[00:15:56] Speaker 03:
So really, the only thing the board would need to do is consider that evidence, consider all the secondary considerations, and then

[00:16:04] Speaker 03:
right, a final written decision that determines obviousness in light of the secondary considerations.

[00:16:11] Speaker 01:
The record would be closed in terms of further submissions on the issue.

[00:16:15] Speaker 01:
I believe so.

[00:16:16] Speaker 01:
Unless the board asks, right?

[00:16:18] Speaker 03:
Unless the board asks, but my understanding is the complaint is that they didn't consider this evidence, not that there needs to be new evidence submitted for the secondary considerations.

[00:16:30] Speaker 04:
So then we can, the next issue is... You did really well with a tough set of facts there.

[00:16:38] Speaker 03:
Thank you, Your Honor.

[00:16:39] Speaker 03:
Go ahead.

[00:16:41] Speaker 03:
So then turning to Schmidt and whether Schmidt teaches non-unique tagging, what the board found, there's two real meanings of identifiers.

[00:16:50] Speaker 03:
And in the board's construction of

[00:16:54] Speaker 03:
unique identifiers, different identifiers for non-unique tagging.

[00:16:59] Speaker 03:
It emphasizes over and over again that that means the tag count, which is those extrinsic pieces of DNA that are ligated to the endogenous CF DNA molecules.

[00:17:10] Speaker 03:
And you can find this at JA25 in the board's final claim construction.

[00:17:17] Speaker 03:
And also in its discussion of Schmidt on JA36,

[00:17:23] Speaker 03:
where it talks about Schmidt's hybrid method because of the number of unique identifiers, i.e.

[00:17:28] Speaker 03:
the tag count of 65,536.

[00:17:30] Speaker 03:
The board is clear that when the identifier is the unique identifier for the non-unique tagging of the polynucleotides,

[00:17:38] Speaker 03:
It's referring to the tags, the barcodes, there's a number of different terms for it, but are those extrinsic pieces of DNA?

[00:17:46] Speaker 02:
Clearly would have to be because the whole purpose of the patent is to save money by cutting down on the number of tags that you're adding, right?

[00:17:53] Speaker 03:
That's right.

[00:17:54] Speaker 03:
They want to use fewer tags.

[00:17:56] Speaker 03:
So that you can then not, you can't uniquely identify all the polynucleotides in the sample unless you use the start and stop regions of the endogenous DNA.

[00:18:07] Speaker 03:
So then you can group the polynucleotides into families for the amplified polynucleotides and determine then a mutation that is consistent in all those polynucleotides as opposed to a sequencing error or an amplification error.

[00:18:21] Speaker 03:
And this is exactly what the 822 patent teaches in what we've called the TAG plus embodiment

[00:18:27] Speaker 03:
where you use the non-unique tags, but then you use the start and stop regions of the endogenous DNA to provide a unique molecular identifier.

[00:18:38] Speaker 03:
And that's the word Schmidt uses, not the unique tag identifier, but the unique molecular identifier that would identify that molecule as the parent of all these amplified polynucleotides.

[00:18:54] Speaker 03:
There's terms that are then being used for different concepts.

[00:18:59] Speaker 03:
And the board found that Schmitz tags, non-uniquely tag, the polynucleotides in the sample in the hybrid method, and that that meets the limitations of the claim.

[00:19:11] Speaker 03:
If there's any questions about claim construction or the reasonable expectation of success, I'm happy to answer any questions.

[00:19:18] Speaker 03:
Otherwise, ask this court to affirm the board's decision.

[00:19:26] Speaker 00:
Thank you, Your Honor.

[00:19:27] Speaker 04:
At the start, I have to just channel Judge Laurie for a second.

[00:19:29] Speaker 04:
And Ms.

[00:19:31] Speaker 04:
Frazier will appreciate this.

[00:19:32] Speaker 04:
Your expert didn't duck the issue, did he?

[00:19:39] Speaker 04:
Sorry.

[00:19:40] Speaker 00:
I hope my expert doesn't listen to this hearing transfer.

[00:19:44] Speaker 00:
No, he did not.

[00:19:47] Speaker 00:
With that, just a few brief points, if I may, on the objective indicia.

[00:19:57] Speaker 00:
The court may already recognize this, but at 641, the discussion that begins Dr. Quackenbush explains is pointing to the very same pieces of evidence that Dr. Quackenbush lists in his claim chart.

[00:20:16] Speaker 00:
So this discussion actually maps with exactly what he's going through and explaining maps up in his claim chart.

[00:20:25] Speaker 00:
So there's consistency there.

[00:20:28] Speaker 04:
And you agree the right course of action is to vacate and remand?

[00:20:33] Speaker 00:
Well, certainly to vacate.

[00:20:35] Speaker 00:
There was a question on what happens on remand.

[00:20:40] Speaker 00:
And when there is no party left, the party that goes back is certainly going to ask for additional briefing because they'll have more to say.

[00:20:48] Speaker 00:
I'm not aware of a single case in which the board has continued on remand when parties have settled out.

[00:20:54] Speaker 00:
And there's nobody to oppose what Patent Owner's asking for.

[00:20:59] Speaker 00:
So I would expect a termination of the proceeding.

[00:21:06] Speaker 01:
With re- Just to clear the confusion I had about the name, was the claim chart done by Flaggenbosch?

[00:21:14] Speaker 00:
It was, Your Honor.

[00:21:15] Speaker 00:
That's at paragraph 159.

[00:21:17] Speaker 00:
If you want an A site, I can provide it.

[00:21:19] Speaker 00:
That's A4491.

[00:21:26] Speaker 00:
If I can turn to the issue of identifiers and non-unique tagging, I would point out there's important language of the claim.

[00:21:34] Speaker 00:
The claim in claim one is defining tagged parent polynucleotides as having two parts.

[00:21:43] Speaker 00:
Part one is the sequence from the DNA molecule.

[00:21:46] Speaker 00:
Part two is the identifier comprising one or more barcodes.

[00:21:50] Speaker 00:
So this is important language that stems from the claim, and that just doesn't line up with what we see in Schmidt.

[00:21:56] Speaker 00:
So I maintain the argument that Schmidt doesn't satisfy the claim construction, whether it's the express construction that's adopted or whether it's the board's construction.

[00:22:07] Speaker 00:
And with that, I have no further comment unless there are questions.

[00:22:12] Speaker 04:
We thank both counsels for this argument.

[00:22:13] Speaker 04:
The case is taken under submission.

[00:22:15] Speaker 00:
Thank you.