[00:00:04] Speaker 07:
It all comes down to certain circumstances.

[00:00:13] Speaker 07:
No, because there's a separate element because you have to recognize the district board.

[00:00:32] Speaker 07:
Oh, I'm sorry.

[00:00:34] Speaker 07:
I'm not sure, because my view is that under this court's case law, the question is whether it would instruct the direct inquiry.

[00:00:42] Speaker 07:
And so the salient inquiry is whether the physician regards it as a recommendation to do genotyping, not whether a judge needs it.

[00:00:48] Speaker 01:
OK, the next case is number 162228, XY LLC against ABS Global.

[00:00:56] Speaker 01:
Again, Mr. O'Neill.

[00:00:58] Speaker 06:
Thank you again, Judge Newman.

[00:00:59] Speaker 06:
Kurt O'Neill, and may it please the court, Kurt O'Neill for the appellant XY.

[00:01:06] Speaker 06:
Your honors, the board found

[00:01:11] Speaker 06:
all challenge claims obvious over the combination of Seidel and Salisbury.

[00:01:16] Speaker 06:
That was in error because of erroneous claim construction.

[00:01:20] Speaker 06:
Separately, the board found only some of the claims obvious over the Fugger reference.

[00:01:26] Speaker 06:
The board there left intact the artificial insemination sample claims 25-27.

[00:01:33] Speaker 06:
And I'd like to confine my comments today to the more comprehensive ground of invalidity

[00:01:40] Speaker 06:
namely the combination of Cytolin and Salisbury, which was based, as I said, on the improper claim construction.

[00:01:47] Speaker 06:
Namely, the board erred in construing the selected sperm sample of claim one in a manner that required only one viable cell after the freezing and thawing process, the freezing step being step E of this method claim.

[00:02:04] Speaker 06:
The board erred in several different ways in arriving at that result.

[00:02:09] Speaker 06:
And the key way the board did that is to fail to look at specification, which describes a selected sperm sample that is suitable for what is called standard or conventional in vitro fertilization or artificial insemination.

[00:02:24] Speaker 06:
There was much evidence as to what a standard sample is for in vitro fertilization.

[00:02:30] Speaker 04:
I mean, the specification in column 11, line 34 says the frozen selected sperm sample, the invention is suitable for use

[00:02:38] Speaker 04:
in any method in which sperm is used.

[00:02:42] Speaker 04:
And the ICSI method calls within that, doesn't it?

[00:02:47] Speaker 06:
Your Honor, my answer is that a sperm sample, which is sorted by machine into populations, is not used and would never be used in the example given by the board, which was something called ICSI.

[00:03:01] Speaker 06:
That's a procedure which we acknowledge is sometimes referred to as an IVF procedure.

[00:03:07] Speaker 06:
But the procedure involves finding one viable claim under a microscope and taking it into a syringe and then injecting

[00:03:14] Speaker 06:
that signals sperm cell through a hypodermic needle.

[00:03:18] Speaker 02:
But ICSI is a conventional fertilization method.

[00:03:21] Speaker 02:
It is not, Your Honor.

[00:03:22] Speaker 06:
There is much evidence to the contrary.

[00:03:24] Speaker 06:
I'm excited for you here.

[00:03:26] Speaker 06:
But our expert went into some detail that this is highly nonstandard and unconventional, because it literally involves finding one viable cell under a microscope and taking it into the hypodermic needle.

[00:03:37] Speaker 06:
This patent, the disclosure, is entirely consistent.

[00:03:40] Speaker 06:
What we're doing here is using a machine to sort large volumes of cells.

[00:03:44] Speaker 02:
For in vitro?

[00:03:45] Speaker 02:
Or for artificial insemination?

[00:03:49] Speaker 06:
Both, your honor.

[00:03:50] Speaker 06:
In vitro in the sense of placing the selected sperm sample in a petri dish, right, with an egg so that the sperm cells, they're mobile and so they swim and one will eventually penetrate it.

[00:04:00] Speaker 04:
I want to come back to my question.

[00:04:02] Speaker 04:
I read you a sentence from column 11.

[00:04:04] Speaker 04:
Frozen selected sperm sample invention is suitable for use in any method in which sperm are used.

[00:04:11] Speaker 04:
And why isn't

[00:04:12] Speaker 04:
an ICSI method within that sentence.

[00:04:15] Speaker 06:
Well, you don't use a sample.

[00:04:17] Speaker 06:
Remember, what's claimed here is a selected sperm sample for the kind of in vitro fertilization referred to as ICSI.

[00:04:26] Speaker 06:
It is a single cell, not a sample for that cell.

[00:04:30] Speaker 06:
Samples are placed in, as I said, for IVF in the future.

[00:04:33] Speaker 04:
It's not a sample.

[00:04:33] Speaker 04:
Why is it a sample?

[00:04:34] Speaker 04:
Why isn't it a sample?

[00:04:38] Speaker 06:
Because, Your Honor, it's not separated into a discrete population based on a property and then established from that population a sample, as is called for by the claim.

[00:04:50] Speaker 02:
I guess the phrase in column 11 that Judge Dyke is pointing to, you know, the invention is suitable for use in any method in which sperm are used.

[00:05:02] Speaker 02:
It sounds very broad.

[00:05:05] Speaker 06:
I'd say you have to read that in the context of the rest of the specifications.

[00:05:09] Speaker 06:
They're talking about a sample, not a sperm cell.

[00:05:11] Speaker 06:
There's no report here in the specification of sorting one sperm cell.

[00:05:15] Speaker 06:
In fact, that would be unnecessary.

[00:05:19] Speaker 02:
What about the board's additional ruling at 830 where it said, even if we're talking about something that's a much larger sample,

[00:05:30] Speaker 02:
in the claim beyond a single viable sperm cell.

[00:05:35] Speaker 02:
The combination here of the references more than meets that.

[00:05:39] Speaker 02:
That's the whole point of the Seidel reference, which is to produce and collect a significant sample of the sperm to be used that then can be subsequently frozen.

[00:05:53] Speaker 02:
I mean, the board did come up with that alternative holding, and so you have to also

[00:05:59] Speaker 06:
win on that one as well

[00:06:20] Speaker 06:
It will work.

[00:06:23] Speaker 06:
What the expert said, if you read her entire answer, is this is what is taught to us by the 425 patent.

[00:06:30] Speaker 06:
She did not say that a person skilled in the art would have that understanding at the time of the invention.

[00:06:36] Speaker 02:
So now, as I understand it, we're moving over to the question of whether it be obvious to freeze the samples produced by CIDL.

[00:06:48] Speaker 02:
Yes, Your Honor.

[00:06:48] Speaker 06:
Yes.

[00:06:49] Speaker 02:
OK.

[00:06:49] Speaker 02:
And then now we have the freezing prior art Salisbury, which makes it clear from decades ago that people were freezing sperm all the time.

[00:07:02] Speaker 02:
And then as I understand it, your primary argument is, well, CIDL teaches a way from the idea of freezing the resulting collected sperm using the CIDL method, CIDL slash Johnson method.

[00:07:17] Speaker 02:
Maybe I'll call it that.

[00:07:18] Speaker 02:
What is your best statement from the CIDL reference that should have convinced the board that you should not ever freeze these samples?

[00:07:38] Speaker 06:
Your Honor, the best statement is the one discussed extensively at oral argument, which is that Seidel says that he tried chilling these samples and shipping them over a distance, and when they arrived, they failed.

[00:07:50] Speaker 06:
That's not freezing.

[00:07:52] Speaker 04:
That's not freezing.

[00:07:53] Speaker 06:
No, Your Honor, but it is.

[00:07:55] Speaker 02:
I'm talking about there are a lot of columns in this Seidel reference.

[00:08:03] Speaker 02:
Which statement in the 920 patent

[00:08:07] Speaker 02:
That tells me that the board lacked substantial evidence when it found that the Seidel reference does not teach away as you urged the board to find.

[00:08:23] Speaker 06:
That is the example three of Seidel, Your Honor, and it bridges columns 16 through 17.

[00:08:31] Speaker 02:
OK.

[00:08:32] Speaker 06:
What page are they in?

[00:08:35] Speaker 02:
A71, A72.

[00:08:37] Speaker 07:
I apologize, Your Honor, I've lost it.

[00:08:54] Speaker 02:
I think you said column 16, carrying over to 17.

[00:08:57] Speaker 06:
Yes, I'm bridging column 16 through 17.

[00:09:00] Speaker 06:
And there is an explicit statement there that he did attempt to chill these samples down and shift them.

[00:09:07] Speaker 02:
OK.

[00:09:07] Speaker 02:
Do you have?

[00:09:08] Speaker 07:
Right.

[00:09:15] Speaker 07:
And he also did.

[00:09:17] Speaker 02:
All right.

[00:09:18] Speaker 02:
Do you have a quote?

[00:09:19] Speaker 07:
I do.

[00:09:20] Speaker 07:
The passage that was focused on the oral argument before the board was that, and I'm at column 17, lines 8 through 16.

[00:09:50] Speaker 06:
And there it's reported in response to Judge Dyke's question I acknowledge it doesn't say freezing But this is an instance in which he is reporting that he subjected these samples to the further stress of cooling and shipping and that At the distant end.

[00:10:10] Speaker 02:
Can you give me the quote?

[00:10:12] Speaker 02:
Where's the quote?

[00:10:14] Speaker 06:
of 29 females inseminated with sperm cool to 5c that's a column 10 and

[00:10:19] Speaker 06:
And then if you read through that, he reports a significant decrease in fertility from those samples.

[00:10:29] Speaker 02:
I don't see him saying that.

[00:10:31] Speaker 02:
It says of 29 females inseminated with sperm cooled to 5 degrees Celsius during shipping, 14 were pregnant at four weeks of gestation.

[00:10:44] Speaker 06:
And he characterizes these as drastic fertility decreases.

[00:10:49] Speaker 04:
But it's a result of the delay.

[00:10:51] Speaker 04:
The record is clear that delay.

[00:10:54] Speaker 04:
in using the sperm results in degradation.

[00:10:57] Speaker 04:
It's not that they were cooled and therefore didn't work.

[00:11:01] Speaker 04:
It's that they took more time to use them.

[00:11:05] Speaker 06:
Well, Your Honor, I'm not disputing the finding of fact.

[00:11:09] Speaker 06:
Our evidence was to the contrary.

[00:11:11] Speaker 06:
My point is the board rejected XY's arguments of this lack of expectation of success.

[00:11:20] Speaker 06:
by saying that your own expert said that sperm cells will survive freezing and that we know that this will work.

[00:11:33] Speaker 06:
What our expert says is that this is what is taught to us by the 425.

[00:11:39] Speaker 04:
Does any expert say that Seydel teaches that the cooling causes the degradation of the sperm?

[00:11:46] Speaker 06:
They say in general that further stresses cause degradation.

[00:11:51] Speaker 06:
That would include cooling, shipping.

[00:11:53] Speaker 02:
There were other prior references where there was a sorting method done to sort out sperm cells and then freezing them.

[00:12:02] Speaker 06:
Well, of course, ABS characterizes it that way, but the undisputed evidence was that those samples or sorting techniques did not actually work to effectively sort the same thing.

[00:12:10] Speaker 04:
So what if they didn't work?

[00:12:13] Speaker 04:
They may not have worked to sort, but the sperm survived the stresses of the sorting methods when they were frozen, right?

[00:12:19] Speaker 05:
Yes, Dr. Retina.

[00:12:21] Speaker 04:
That's what their evidence showed, right?

[00:12:23] Speaker 06:
That's what the evidence showed.

[00:12:25] Speaker 04:
Why isn't that substantial evidence?

[00:12:29] Speaker 06:
Your Honor, my response is that it's not consistent with the claim terminology, which is to actually successfully sort this out.

[00:12:36] Speaker 06:
And even though the position is that prior art shows an unsuccessful sorting technique followed by freezing, it cannot instill in any practitioner an expectation.

[00:12:48] Speaker 05:
Okay.

[00:12:48] Speaker 05:
Let's hear from the other side.

[00:12:54] Speaker 05:
And what I think I'm hearing is an argument that has teased us apart to the point of destruction of all meaning.

[00:13:02] Speaker 05:
The term in the label is moratorium.

[00:13:05] Speaker 01:
Mr. Trelo.

[00:13:06] Speaker 03:
Thank you, Your Honor.

[00:13:06] Speaker 03:
May it please the Court?

[00:13:08] Speaker 03:
I'd like to pick up with a point that Mr. O'Neill was making about Seidel and what he pointed to as the best example of teaching away.

[00:13:16] Speaker 03:
And he points to that example in Column 16 and 17.

[00:13:19] Speaker 03:
And he points in particular to the fact that

[00:13:24] Speaker 03:
In column 17, Seidel reports 41% were pregnant after 12 weeks or whatever it was, and he says that was a failure.

[00:13:33] Speaker 03:
But if you go to column 12 of Seidel, and I'll get the exact lines for you, near the bottom, lines like 55 to 60, he refers to 41% of the pregnancy rate as a good percentage of success.

[00:13:47] Speaker 03:
So what you see in Seidel with the cooling sample, the sample that was cooled,

[00:13:52] Speaker 03:
was a good percentage of success.

[00:13:54] Speaker 03:
And that is the best that they have as far as teaching away is concerned.

[00:13:59] Speaker 03:
The fact is that the 425 patent is a classic example of what KSR says is obvious.

[00:14:08] Speaker 03:
It combines two well-known techniques, uses them to perform the same functions each had always performed, and produces the precise result one would expect.

[00:14:18] Speaker 03:
XY in its reply criticizes the board for its supposed eagerness to reach an unfair result.

[00:14:24] Speaker 03:
But in fact, the board reached the only result it could.

[00:14:27] Speaker 03:
Now, Seidel, far from teaching away, as the board found, it gave rise to a reasonable expectation of success.

[00:14:36] Speaker 03:
We know, and it's undisputed, that unsorted sperm had been successfully frozen for decades.

[00:14:41] Speaker 03:
Salisbury taught that.

[00:14:43] Speaker 03:
Seidel reports,

[00:14:45] Speaker 03:
using his low stress sorting method, and remember Seidel is all about lower stress sorting methods, reports pregnancy rates for sorted and unsorted sperm cells that were not statistically significantly different from one another.

[00:14:59] Speaker 03:
So their equivalent success rates was sorted and unsorted.

[00:15:03] Speaker 03:
So you can freeze unsorted with a high likelihood of success.

[00:15:07] Speaker 03:
Seidel clearly would suggest you should have the same expectation of success

[00:15:12] Speaker 03:
with sperm that had been sorted, because it apparently hadn't been stressed enough to affect the pregnancy rate.

[00:15:17] Speaker 03:
And that stress is supposedly the big concern here.

[00:15:21] Speaker 03:
So there's absolutely no reason based on Seidel to think that freezing would have caused any more problems with sorted cells than it had decades earlier with unsorted.

[00:15:33] Speaker 03:
Also, as the court noted, the prior art was, and as the board noted, the prior art was full of examples of sorting techniques combined with freezing,

[00:15:42] Speaker 03:
producing viable sperm.

[00:15:44] Speaker 03:
Now, the board acknowledged that some of those techniques were not as effective, didn't reliably sort.

[00:15:50] Speaker 03:
But I think that's not really the point.

[00:15:52] Speaker 03:
The point is that their expert described these techniques as very stressful.

[00:15:57] Speaker 03:
But nonetheless, it was routine to use those techniques and then freeze and then have viable sperm.

[00:16:06] Speaker 03:
The issue here was not about effective sorting.

[00:16:09] Speaker 03:
Would the stress of sorting methods somehow lead somebody not to want to freeze?

[00:16:14] Speaker 03:
And clearly, that was not the case.

[00:16:16] Speaker 03:
I think it's worth noting also that in column four of the 425 patent, there's a list of what the inventor refers to as exemplary sex selection methods that could be used with the invention.

[00:16:29] Speaker 03:
Included in that list are two of the references that sort and freeze, Paracharya and Lang.

[00:16:35] Speaker 03:
Now, they're not identified by name, but if you look at the patent numbers,

[00:16:38] Speaker 03:
They're in the list of sorting methods that this inventor said could be used with his invention.

[00:16:44] Speaker 03:
You could sort using this technique and then freeze.

[00:16:47] Speaker 03:
And that practices his invention according to the specification.

[00:16:50] Speaker 03:
So there's absolutely no support for this notion that Seidel teaches away.

[00:16:55] Speaker 03:
And there also was a very clear expectation of success in combining these two prior art methods.

[00:17:01] Speaker 03:
The other thing to note, I think, and this is what the board was talking about, I think, in Appendix 30, the passage that Mr. O'Neill referred to, is that the motivation here, and it was undisputed that one of our ordinary skill would be motivated to combine sorting and freezing.

[00:17:16] Speaker 03:
And what's also undisputed and what the board was saying is that that is the invention.

[00:17:23] Speaker 03:
There is no modification.

[00:17:24] Speaker 03:
There are no adjustments.

[00:17:25] Speaker 03:
There are no technical obstacles to overcome.

[00:17:28] Speaker 03:
If the person of ordinary skill who was motivated to make this combination would have the invention.

[00:17:34] Speaker 03:
And that is about as clear a case as obviousness as you can get.

[00:17:37] Speaker 03:
Now let me turn, since Mr. O'Neill started with claim construction, let me turn to that.

[00:17:43] Speaker 03:
And I think the first point to note on that is that it doesn't matter.

[00:17:47] Speaker 03:
Because as I think Judge Chen, you pointed out, at appendix 31 and at appendix 30, the board notes that

[00:17:55] Speaker 03:
Even if we forget about ICSI and methods that need small numbers of sperm, the result is unchanged.

[00:18:04] Speaker 03:
And that's for all of the reasons that the board had already explained and that I just alluded to.

[00:18:08] Speaker 03:
No teaching away, clear encouragement in the prior art to do this.

[00:18:14] Speaker 03:
But besides that, the claim construction is correct.

[00:18:18] Speaker 03:
As the court noted, the specification says this invention can be used with any method.

[00:18:25] Speaker 03:
in which sperm are used.

[00:18:26] Speaker 03:
It refers to conventional methods such as artificial insemination and in vitro fertilization.

[00:18:32] Speaker 03:
There are expert characterized ICSI as a method of in vitro fertilization.

[00:18:38] Speaker 03:
And this notion that, well, you wouldn't need to sort, and you wouldn't have a sorted sample if you were using ICSI doesn't make any sense.

[00:18:48] Speaker 03:
A Johnson and Cran in their 1996 article identified ICSI as a fertilization method suitable for use with cells sorted using the Johnson technique.

[00:18:59] Speaker 03:
And the Fugger reference, which is the one that uses humans, the testing with humans, used the Johnson technique to sort cells and then use those cells in ICSI to produce sex-selected offspring.

[00:19:13] Speaker 03:
So there's just a disconnect in this argument that you wouldn't use sorting with ICSI.

[00:19:18] Speaker 03:
Of course you would.

[00:19:20] Speaker 03:
Any time you want to gender select the offspring, you're going to use sorting no matter what fertilization technique you use.

[00:19:28] Speaker 03:
So if the court has no questions, just to wrap up, this is just two conventional methods used in a conventional way.

[00:19:35] Speaker 03:
And in fact, they had been used that way in the past.

[00:19:39] Speaker 03:
And they produce exactly the result one would expect.

[00:19:42] Speaker 03:
If the court has no questions, I'll yield the rest of my time.

[00:19:44] Speaker 04:
Well, they hadn't been used together in the past.

[00:19:47] Speaker 04:
Other sorting methods.

[00:19:48] Speaker 03:
Other sorting methods, right.

[00:19:49] Speaker 03:
Other sorting methods hadn't been used in the past.

[00:19:52] Speaker 03:
But there was a clear, and the board described it as routine, it was routine in the prior art to use sorting methods and then to freeze and to have viable sperm cells afterwards.

[00:20:03] Speaker 03:
Yes, Your Honor.

[00:20:05] Speaker 00:
Any more questions?

[00:20:07] Speaker 00:
Thank you, Mr. Trelo.

[00:20:10] Speaker 05:
Mr. O'Neill?

[00:20:11] Speaker 06:
To be brief, I want to make clear, in particular in response to your questions, that XY does not raise a point of error of lack of substantial evidence or clearly erroneous fact-findings here.

[00:20:26] Speaker 06:
Our two key points of error with respect to the combination of Seidl and Salisbury on the correct structure of the claim are the following.

[00:20:35] Speaker 06:
Number one, the board used an improper teaching away

[00:20:38] Speaker 06:
analysis.

[00:20:40] Speaker 06:
The board looked for an express mention of freezing incital.

[00:20:44] Speaker 06:
Finding none is that we're not going to pursue this further.

[00:20:48] Speaker 06:
That's contrary to this court's clear case law.

[00:20:53] Speaker 06:
that a teaching away can be implicit and that you need to evaluate the references at all.

[00:20:59] Speaker 06:
The partisan side that we relied on for teaching away is nowhere mentioned in the board's 30-some page decision clearly indicating that we didn't get a fair hearing on our teaching away evidence because the reference doesn't explicitly mention freezing and doesn't explicitly say you should not freeze things.

[00:21:20] Speaker 06:
Our second major point was that the board, under the proper claim construction, didn't do the analysis.

[00:21:26] Speaker 06:
And I go back again to page 30 of the appendix.

[00:21:29] Speaker 06:
This is the entirety of the board's analysis.

[00:21:32] Speaker 02:
Is it fair to say that column 12 describes a 41% rate of pregnancy as a good percentage of success?

[00:21:45] Speaker 06:
It expresses it as a

[00:21:49] Speaker 06:
Pregnancies.

[00:21:49] Speaker 06:
Yes.

[00:21:50] Speaker 05:
Declining with time out of the shipping container after having been chilled.

[00:21:58] Speaker 02:
And that's the exact percentage that came up in example three?

[00:22:04] Speaker 02:
Correct.

[00:22:04] Speaker 02:
Okay.

[00:22:06] Speaker 06:
As I've said, the entirety of the board's analysis on obviousness and more particularly expectation of success

[00:22:14] Speaker 06:
consists of three sentences at page 17 under the right construction, and those three sentences can get you there.

[00:22:20] Speaker 06:
In fact, one of those sentences is a heavy reliance to our own expert's testimony that if you use Cytol's disclosure and then freeze the cells, they will survive the process and produce a sufficient number to fertilize the eggs.

[00:22:35] Speaker 06:
The board used that very heavily.

[00:22:37] Speaker 05:
What the witness actually said is that the teachings of the 425 patent in suit teach us that our prior art, not anything in the prior art, our personal skill.

[00:22:50] Speaker 05:
That's all.

[00:22:52] Speaker 01:
Thank you.

[00:22:52] Speaker 01:
Thank you both.

[00:22:53] Speaker 01:
The case is taken under submission.