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

[00:00:01] Speaker 03:
Next case is Bracco Diagnostics versus Jubilant Drax Image 20-1696, Ms.

[00:00:11] Speaker 03:
Bookbinder.

[00:00:13] Speaker 01:
Thank you.

[00:00:14] Speaker 01:
And may it please the court, this is Julie Bookbinder for the appellant Bracco Diagnostics, Inc.

[00:00:19] Speaker 01:
As the court is aware, this appeal applies different standards to a different evidentiary record than the case that was just argued.

[00:00:26] Speaker 01:
I'm going to start out with the Riley reference that was not part of the ITC case.

[00:00:31] Speaker 01:
For all challenged claims in the 1448 IPR, the petition relied on Riley only for motivation to combine its teachings with the Klein and Tate references to disclose the claim limitation of a dose calibrator on a mobile cart.

[00:00:46] Speaker 01:
But the board found that Riley does not teach placing a dose calibrator on a movable cart.

[00:00:52] Speaker 01:
When the board then relied on Riley for another reason not in the petition and that we did not have an opportunity to address, concluding that the petitioner carried its burden to share that the claim limitation of a dose calibrator on board a mobile cart was obvious in view of Klein, Riley, and Tate, the board legally erred.

[00:01:12] Speaker 01:
Once the board concluded that Riley did not teach the only aspect that the petition relied on it for, Riley should not have been used.

[00:01:21] Speaker 01:
There is no reference in the record that teaches a sensitive dose calibrator used to take measurements across a wide range of radioactivity on board a mobile cart with a rubidium generator.

[00:01:33] Speaker 02:
The record evidence... Counsel, can I ask, are there any substantively meaningful differences between the specifications of the patents at issue in this appeal and those at issue in the ITC appeal?

[00:01:46] Speaker 01:
No, Your Honor, not in the specifications, but the claims are definitely different.

[00:01:51] Speaker 02:
Okay.

[00:01:51] Speaker 01:
So the record in the IPR includes evidence that actually discourages jostling the dose calibrator in any way.

[00:02:00] Speaker 01:
Given the objective evidence in our record, it was error to credit the conclusory testimony of an expert that it would have been obvious to add this type of sensitive device to a mobile cart where it could be subject to mechanical shock and vibration as well as high and variable background radiation from the rubidium generator.

[00:02:19] Speaker 01:
Jubilant, as the petitioner, did not carry its burden on this point.

[00:02:24] Speaker 01:
Even if Riley was considered, there is no motivation to combine Riley with Klein, which uses its dose calibrator for a different purpose.

[00:02:33] Speaker 01:
Klein's dose calibrator must make extremely sensitive measurements, including measuring a very high rubidium level and then a tiny amount of radioactivity from strontium.

[00:02:44] Speaker 01:
The radiation level from strontium that Klein's dose calibrator measures is about 30,000 times smaller than the radioactivity in the rubidium.

[00:02:55] Speaker 01:
Thus, the rubidium generator system in Klein needs to use the full range of sensitivity of the dose calibrator, making it especially important not to subject the calibrator to mechanical shocks.

[00:03:06] Speaker 01:
This is not the case in Riley because Riley's dose calibrator is only used to measure the dose.

[00:03:12] Speaker 01:
not to take multiple measurements for further calculations as in Klein.

[00:03:17] Speaker 01:
Tate also uses a dose calibrator for the same purpose as Riley, to measure the dose.

[00:03:23] Speaker 01:
This is undisputed as neither Riley nor Tate include a rubidium generator requiring breakthrough measurements to be sure that it is safe to use the system.

[00:03:33] Speaker 01:
The board's finding of motivation to combine Tate and Riley with Klein based on beneficial design choices that increase user convenience

[00:03:41] Speaker 01:
is legally insufficient and not supported by substantial evidence.

[00:03:45] Speaker 01:
In fact, a conclusory assertion of design choice was specifically found to be insufficient motivation for an obviousness determination in the fan dual decision that was affirmed by this court last year.

[00:03:56] Speaker 01:
Further, the Board's Sue Espante observation that a person of ordinary skill could just use a bigger cart is contradicted by the evidence from both sides and is not supported by substantial evidence.

[00:04:10] Speaker 01:
The board's failure to analyze the teachings in the record, Riley, Klein, didn't Morocco agree that it could just use a bigger part?

[00:04:22] Speaker 01:
Yes, your honor, at the oral hearing.

[00:04:24] Speaker 01:
We agreed that hypothetically a bigger cart could be used, but that was never anything suggested in the petition and is also contrary to the experts having... Counsel, you didn't make an APA challenge in this case.

[00:04:36] Speaker 00:
Nowhere in your brief.

[00:04:37] Speaker 00:
So stop talking about what was raised in the petition and not because you didn't challenge it.

[00:04:41] Speaker 00:
Either way, you're making this up an oral argument for the first time.

[00:04:44] Speaker 00:
When a party actually agrees to something in the oral argument, I find it difficult to conclude the board then erred in holding that.

[00:04:55] Speaker 01:
Understood, Your Honor.

[00:04:56] Speaker 01:
We argued in our briefing that the board improperly relied on Riley after finding that Riley did not contain the movable cart teaching that the petitioner relied on it for.

[00:05:08] Speaker 01:
But I'll move ahead to another point, which is that the board legally erred in its obviousness analysis in the 1448 IPR by considering Riley or Tate because the board incorrectly compared the prior art references to each other

[00:05:23] Speaker 01:
rather than to the patents at issue when performing an analogous art analysis.

[00:05:29] Speaker 01:
This was addressed in the 1448 written decision at APX 33 to 38, but the decision did not include a complete or proper analysis of comparing the references to the patent at issue.

[00:05:42] Speaker 01:
If the board had applied the law properly, the analysis would have shown that Tate and Riley are not analogous to the patents at issue.

[00:05:50] Speaker 01:
Now, we do understand that it is a high hurdle to reverse on the basis of non-analogous art, but this is truly the case.

[00:05:58] Speaker 01:
During both tests for the analogous art analysis, the field of endeavor or pertinent to the particular problem of the challenge patents, neither was analyzed correctly by the board.

[00:06:09] Speaker 03:
First... But they all relate to computerized PET infusion systems.

[00:06:15] Speaker 03:
They're not in different fields.

[00:06:18] Speaker 01:
So Your Honor, we respectfully argue that they are in different fields because the field is more specific than PET radioactive infusion.

[00:06:26] Speaker 01:
The field of these patents is specifically rubidium generator systems.

[00:06:32] Speaker 01:
And neither Tate nor Riley have anything to do with rubidium generator systems.

[00:06:38] Speaker 01:
And you couldn't use those systems with a rubidium generator.

[00:06:42] Speaker 03:
Doesn't Tate mention rubidium?

[00:06:46] Speaker 01:
Tate mentions rubidium.

[00:06:47] Speaker 01:
in one sentence in the background, which was acknowledged by petitioner's expert, Dr. Stone, in his deposition.

[00:06:56] Speaker 01:
Hate could not be used with a rubidium system, a generator system.

[00:07:02] Speaker 01:
Similarly, with respect to the pertinent to a particular problem of the challenge patents, it was legal error for the board not to properly identify and compare the problems to which the challenge patent and the prior art release.

[00:07:20] Speaker 01:
In addition to these errors in the board's obviousness analysis in the 1448 IPR.

[00:07:24] Speaker 00:
So does the patent itself actually say that this invention is directed to systems that generate and infuse radiopharmaceuticals?

[00:07:37] Speaker 00:
I'm looking in particular at column one, line 25.

[00:07:40] Speaker 00:
So the patent itself defines what it's directed to much more broadly than just rubidium generators, doesn't it?

[00:07:49] Speaker 01:
So respectfully, Your Honor, we need to include generate, and that is a key component that the board omitted in its analogous art analysis.

[00:07:58] Speaker 01:
Neither Tate nor Riley generate any radiopharmaceuticals on their system.

[00:08:04] Speaker 01:
They are only infusion systems where they take a radiopharmaceutical, generate it elsewhere, measure it out very carefully, and infuse it into a patient.

[00:08:14] Speaker 01:
The patents relate to a completely different sort of system, where the radiopharmaceutical has to be generated on the actual system, and it's being infused to the patient while they're undergoing the PET scan, because the half-life of rubidium is so short that you have to do it at the same time.

[00:08:30] Speaker 01:
You have to generate, infuse, scan all together.

[00:08:39] Speaker 02:
When you're describing the technical field

[00:08:43] Speaker 02:
your patents at column one, lines 25 to 27, you don't mention rubidium or rubidium generator infusion systems, correct?

[00:08:57] Speaker 01:
We do mention generating.

[00:09:03] Speaker 01:
Just finding that column.

[00:09:08] Speaker 01:
The field, both the field of endeavor and the pertinent problem of these patents relate to generating the radiopharmaceutical, which neither Tate and Riley do.

[00:09:20] Speaker 01:
So turning to the anticipation issue that runs across all three of the IPRs, this relates to, and we can focus on Claim 21 in the 468 patent, the last two limitations.

[00:09:36] Speaker 01:
A computer configured to determine at least an activity of Strontium-82 and an activity of Strontium-85 in the eluate from the breakthrough activity data.

[00:09:46] Speaker 01:
And the computer further configured to prevent the patient infusion procedure if the activity of the Strontium-82 or the activity of Strontium-85 exceeds an allowable limit.

[00:09:59] Speaker 01:
Because it is undisputed that the petitions relied on anticipation by Klein for these limitations,

[00:10:06] Speaker 01:
The board should have decided whether Klein expressly discloses a computer that performs the claim in steps.

[00:10:13] Speaker 01:
Instead, the board erred in at least two ways.

[00:10:17] Speaker 01:
First, the conclusions are not supported by substantial evidence because Klein does not disclose these limitations.

[00:10:25] Speaker 01:
And second, the board erred by not relying on express disclosures.

[00:10:29] Speaker 00:
Council, Dr. Stone testified that a skilled artisan would understand Klein to be disclosing a computer preventing infusion once breakthrough is detected.

[00:10:38] Speaker 00:
In his declaration at 14-451, he says that expressly.

[00:10:45] Speaker 01:
However, neither Dr. Stone nor the board explained why a person of ordinary skill would understand that.

[00:10:53] Speaker 01:
There was just his conclusory statement with no explanation.

[00:10:58] Speaker 01:
And that's inadequate to support a finding of anticipation.

[00:11:06] Speaker 00:
Finally.

[00:11:07] Speaker 00:
I don't think that's right.

[00:11:09] Speaker 00:
Look at 14.160 to 161.

[00:11:11] Speaker 00:
Klein's daily flush and calibration enables the system only once the prerequisites, which include confirming no strontium breakthrough are completed.

[00:11:20] Speaker 00:
I mean, you may be right that the reference doesn't indicate that it is expressly

[00:11:26] Speaker 00:
going to prevent.

[00:11:29] Speaker 00:
But I mean, the reference is pretty darn close.

[00:11:34] Speaker 00:
And I'm not sure how I can find Dr. Stone's testimony that one would understand it to prevent in light of the way it's disclosed is not supported by substantial evidence.

[00:11:44] Speaker 00:
I mean, you've got a really high hurdle here.

[00:11:46] Speaker 00:
And you've got expert testimony that doesn't feel particularly conclusive to me in light of what's actually disclosed in the reference.

[00:11:54] Speaker 01:
I appreciate, Your Honor, but it's important to remember that the claim requires that a computer prevent the patient infusion procedure if the strontium level exceeds the allowable limit.

[00:12:07] Speaker 01:
And Klein simply does not disclose a computer doing that.

[00:12:12] Speaker 01:
I'll reserve my time for rebuttal.

[00:12:13] Speaker 01:
Thank you.

[00:12:15] Speaker 03:
Thank you, Ms.

[00:12:16] Speaker 03:
Bookbinder.

[00:12:17] Speaker 03:
Mr. Hales has 15 minutes.

[00:12:20] Speaker 04:
Thank you, Your Honor.

[00:12:23] Speaker 04:
Okay.

[00:12:23] Speaker 04:
We are now in the IPRs, but we have many of the same issues that we discussed in the prior session at the ITC, right?

[00:12:30] Speaker 04:
We have disputes over whether it's obvious to relocate the dose calibrator onto a movable cart.

[00:12:36] Speaker 04:
We have a dispute over whether Klein discloses a computer that performs this prevent operation.

[00:12:42] Speaker 04:
And this is the third set of eyes that has taken a look at this and come to the same conclusion based upon what is not identical but strongly overlapping sets of materials.

[00:12:54] Speaker 04:
With respect to the computer, we think these statements are crystal clear.

[00:13:01] Speaker 04:
They are well understood.

[00:13:04] Speaker 04:
This argument that we see from BRCA is more about, in our view, an in-hack verbal test, whether they use the exact same language as described in the claim.

[00:13:14] Speaker 04:
But when you have a statement, for example, on 14.186 that says the system software ensures that this daily protocol is followed and enables runs only after its prerequisites are met, that's something that a person of skill, you know, with or without expert testimony understands that we're not allowing these runs to perform.

[00:13:35] Speaker 04:
They are not enabled if the prerequisites are not met.

[00:13:38] Speaker 04:
So they are using just different language to say the exact same thing.

[00:13:42] Speaker 00:
Okay, Council, I agree with you on that.

[00:13:43] Speaker 00:
Why don't you move on instead and tell us why the references are in fact analogous.

[00:13:48] Speaker 00:
So focusing in particular on her claim that this is to generation, I mean every single claim in their patent says a generating system.

[00:13:58] Speaker 00:
So generation seems to be an important element.

[00:14:03] Speaker 00:
of this invention and her argument seems to be that the prior references don't fall into that analogous art.

[00:14:11] Speaker 00:
So why don't you go there?

[00:14:12] Speaker 04:
I'm happy to.

[00:14:13] Speaker 04:
Okay.

[00:14:13] Speaker 04:
So again, please review Bracco's brief and see how they explain that this happens.

[00:14:21] Speaker 04:
This rubidium generation system, it's 30 years old by the time that we get to the filing of these patents.

[00:14:27] Speaker 04:
The generation of the rubidium, that's 30 years old, right?

[00:14:30] Speaker 04:
The problem that BRCAO identifies, both in its patents and in its briefing, is that it's, you know, that they're elaborate and they're hard to set up and the maintenance and operation is complicated.

[00:14:40] Speaker 04:
Klein definitely speaks to that in the context of a rubidium system, but so does Tate and so does Riley and talks about, they answered those kinds of issues in, you know, in the domain of

[00:14:55] Speaker 04:
PET imaging general.

[00:14:57] Speaker 02:
General.

[00:14:58] Speaker 02:
But don't Kate and Riley's dose calibrators do something totally different than Klein's dose calibrator?

[00:15:07] Speaker 04:
That is correct.

[00:15:08] Speaker 04:
It is used in a different way.

[00:15:09] Speaker 04:
It's used in a way that's appropriate for that FDG medicine.

[00:15:12] Speaker 04:
That's correct.

[00:15:13] Speaker 04:
It's not the usage though.

[00:15:14] Speaker 04:
We're not proposing anywhere in our obviousness challenge to use the dose calibrator in any way that is different than Klein.

[00:15:23] Speaker 04:
I mean, Klein,

[00:15:24] Speaker 04:
does the dose calibration.

[00:15:26] Speaker 04:
Klein looks for the strontium, excess strontium levels.

[00:15:29] Speaker 04:
You know, Klein's dose calibrator does all of the things that are required to be performed in the claim.

[00:15:34] Speaker 04:
It just does it sitting on a shelf.

[00:15:36] Speaker 02:
And our point is that... So are you saying you don't even need to combine Klein with Tate and Riley?

[00:15:43] Speaker 02:
Because that's, to me, the weakest point in the board's analysis.

[00:15:50] Speaker 02:
Can I finish?

[00:15:51] Speaker 02:
I don't see how a skilled artisan

[00:15:54] Speaker 02:
would be motivated to combine those, Kate and Riley's dose calibrator so as to duplicate the activity counter already on client's cart.

[00:16:04] Speaker 04:
And we're not suggesting to duplicate the activity to counter.

[00:16:07] Speaker 04:
We're suggesting to keep those as is.

[00:16:09] Speaker 04:
All we're talking about is picking this device up and putting it on a cart in a way that is, you know, it simplifies life.

[00:16:16] Speaker 04:
You know, it's a user convenience thing, as Dr. Stone testified.

[00:16:19] Speaker 04:
In our view, I mean,

[00:16:21] Speaker 04:
In particular, Tate is an example of a device that's far more market ready than this design that was in a university environment.

[00:16:29] Speaker 04:
And it's an example of the kinds of things that people would do.

[00:16:32] Speaker 04:
And it's an example, I think, again, Dr. Stone testified that just placing something, you know, two pieces into a unitary system to make it easier as a product out in the marketplace, I think is,

[00:16:46] Speaker 04:
is substantial evidence right there and provides the motivation.

[00:16:49] Speaker 04:
And Tate shows that it can get done, right?

[00:16:52] Speaker 04:
It can get done.

[00:16:53] Speaker 04:
You can put a dose calibrator on a movable cart because Tate's did.

[00:16:58] Speaker 04:
Again, we're not talking about using it in the way that Tate says.

[00:17:00] Speaker 04:
We're talking about using it in the way that Klein says.

[00:17:03] Speaker 04:
And so that's the evidence that they relied on, the board.

[00:17:09] Speaker 04:
Let me get to the right part.

[00:17:12] Speaker 04:
I'm at the top of, actually the bottom of appendix 40 and going over to 41.

[00:17:16] Speaker 04:
It's a beneficial design choice that increases user convenience.

[00:17:20] Speaker 04:
They cite the stone.

[00:17:22] Speaker 04:
And again, Riley, Kate, and Klein all show that these components are really well known.

[00:17:28] Speaker 04:
The dose calibrator is a well known commodity device at this time.

[00:17:31] Speaker 04:
The Capentex CRC15 is something that's available.

[00:17:35] Speaker 04:
It's the gold standard product that's available to people of skill.

[00:17:41] Speaker 04:
And this is just reusing well-known things in their familiar ways as client disclosures, simply just in a different arrangement.

[00:17:52] Speaker 04:
The, with respect to the analogous argument directly, BRCAO complains that the board did not consider the 5-6-8, sorry, the 4-6-8 patent disclosures, but they absolutely did.

[00:18:03] Speaker 04:
That's at appendix 37.

[00:18:05] Speaker 04:
They discussed Klein, Reilly, and Tate together and then, you know, identified a need in the art identified by the 468 patent and then explained how Klein, Reilly, and Tate align with those needs.

[00:18:19] Speaker 04:
So, again, and they made factual findings that they are analogous at that level and they decided that that was sufficient.

[00:18:35] Speaker 04:
The other thing that I would like to point out is this idea of the determining.

[00:18:38] Speaker 04:
Ms.

[00:18:39] Speaker 04:
Finder talked about, oh, there's no disclosure of a computer that performs this determining step.

[00:18:44] Speaker 04:
That was a step that was not argued in BRCAO briefing.

[00:18:47] Speaker 04:
That's a step that came up in oral arguments and was identified, impliedly, as new.

[00:18:52] Speaker 04:
So if you go through, for example, the briefing, they argue about, at appendix, for example, 1051 through 1052, they argue this idea of the computer doesn't prevent illusions.

[00:19:05] Speaker 04:
If you look at Appendix 1429, Council Fabracco gets up in oral argument and says, hey, everyone agrees that the claim says computer event, but actually does more than that.

[00:19:15] Speaker 04:
And he talks about four steps and he goes into an elaborate discussion of four steps and how the prior art allegedly does not teach two of them.

[00:19:23] Speaker 04:
Does not teach the prevent step, but also doesn't teach the second determining step, which I think precedes it in the claim.

[00:19:29] Speaker 04:
I mean, that's a pretty good tip off that these are new arguments, that this determining step should have been argued separately in briefing and it absolutely wasn't.

[00:19:38] Speaker 04:
And the board was correct to find those arguments waived.

[00:19:44] Speaker 04:
I have, I think I've covered most of the things that I want to cover.

[00:19:49] Speaker 04:
I want to make sure, are there questions from the panel?

[00:19:54] Speaker 04:
This, oh, the other thing that I would point out is,

[00:19:57] Speaker 00:
Hey, Council, this is Judge Moore.

[00:19:59] Speaker 00:
I'm just going to give you a little friendly piece of advice.

[00:20:01] Speaker 00:
When you raise arguments during your time that weren't raised by the other side, you now open the door to them addressing them on rebuttal.

[00:20:09] Speaker 00:
Whereas if you hadn't addressed them, they wouldn't be able to.

[00:20:13] Speaker 00:
Like the last argument you just made where the board didn't just find for you on waiver, found for you on the merits, too.

[00:20:18] Speaker 00:
You know, it's just something to think about for the future.

[00:20:20] Speaker 00:
Bye.

[00:20:22] Speaker 04:
Thank you.

[00:20:24] Speaker 04:
OK.

[00:20:26] Speaker 04:
The last thing I would say is that throughout these proceedings, the board looked at our expert's declaration and found that it was eminently credible, found it corroborated materials and was corroborated by the materials that were of record.

[00:20:41] Speaker 04:
The same cannot be said for Bracco's expert.

[00:20:44] Speaker 04:
Dr. Pelt was identified in not only this proceeding but elsewhere as being, as offering conclusory opinions and his testimony was not accepted.

[00:20:55] Speaker 04:
by the board.

[00:20:57] Speaker 04:
Okay.

[00:20:57] Speaker 04:
That's what I have.

[00:20:58] Speaker 04:
Thank you very much.

[00:21:00] Speaker 03:
Thank you, Mr. Hales.

[00:21:01] Speaker 03:
Ms.

[00:21:01] Speaker 03:
Bookfinder has four minutes for rebuttal.

[00:21:05] Speaker 01:
Thank you, Your Honor.

[00:21:06] Speaker 01:
To touch on the point raised by council about whether we waived a limitation, as an initial matter, of course, it's petitioner's burden to show how the prior art discloses the limitation, and it would be inappropriate to shift that burden to the patent owner to first show that the prior art does not disclose that, but notwithstanding that principle, we did in our patent owner response address that the system has no knowledge of what the breakthrough

[00:21:36] Speaker 01:
determination is, and we went through this, and this is APX872 to 875 are an example of places where that came up.

[00:21:48] Speaker 01:
Then also to address the preventing a patient infusion if the strontium level exceeds the allowable limit, I would like to turn to APX14201, which is figure 3-15 of Klein.

[00:22:06] Speaker 01:
And this is the detailed flowchart of what the computer does for the daily protocol.

[00:22:14] Speaker 01:
The only portion of this that refers to anything having to do with breakthrough is the calibration run.

[00:22:20] Speaker 01:
And in fact, Petitioner Jubilant pointed to a smaller block diagram with just a box for calibration.

[00:22:26] Speaker 01:
So that is the portion of the daily protocol that they're relying on to disclose the claim limitation of a computer configured to prevent the patient infusion

[00:22:35] Speaker 01:
if the strontium exceeds an allowable limit.

[00:22:38] Speaker 01:
And there is nothing in this flowchart of the computer steps for determining the breakthrough or preventing the infusion if the strontium breakthrough value exceeds the allowable limit.

[00:22:51] Speaker 01:
It's simply not disclosed.

[00:22:53] Speaker 01:
My second point, or third, I believe Council just argued that

[00:23:01] Speaker 01:
If you move the dose calibrator onto Klein's cart, you're not using the dose calibrator as Tate says, which is precisely the reason that you can't move the dose calibrator onto the mobile cart in Klein.

[00:23:15] Speaker 01:
The dose calibrator has to be used to take a wide range of very sensitive radioactivity measurements that you do not have to take in Klein and that would not work properly

[00:23:28] Speaker 01:
excuse me, you don't have to take those measurements in Tate.

[00:23:32] Speaker 01:
And it would not work properly on Klein's cart because of the mechanical vibration and because of the high and variable background radiation caused by the generator, which is only in Klein and not in Tate and Riley.

[00:23:50] Speaker 01:
If the panel has no other questions, then I will cede my remaining minute.

[00:23:57] Speaker 03:
Thank you, counsel.

[00:23:58] Speaker 03:
You've both infused us with a lot of food for thought, and we'll take the case under submission.

[00:24:04] Speaker 03:
Thank you.

[00:24:06] Speaker 01:
Thank you.