[00:00:01] Speaker 02:
The United States Court of Appeals for the Federal Circuit is now open and in session.

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God save the United States and its honorable court.

[00:00:10] Speaker 05:
Good morning, ladies and gentlemen.

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We have four cases on the calendar this morning, three patent cases, two of them from the PTAP and one from the commission, and a veterans case.

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The first case is Braccoe Diagnostics versus the ITC 20-1358.

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Mr. Davis.

[00:00:32] Speaker 00:
Good morning, Your Honor.

[00:00:33] Speaker 00:
May it please the court.

[00:00:34] Speaker 00:
This is Mark Davis for Appellant Braco Diagnostics.

[00:00:38] Speaker 00:
Absent questions from the panel, I will focus on the issues relating to the first door limitation and to the onboarding of the dose calibrator and rely on the briefs for the other issues.

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Turning first to the first door limitation.

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As shown on pages 40 and 41 of Braco's initial brief, claim one of the 869 patent requires, among other things,

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a first door that is not only accessible via an opening in the outer shell, but which is also configured to provide access to the first shielding compartment and to close over the first opening of that shielding compartment.

[00:01:17] Speaker 05:
Mr. Davis, aren't all the claim limitations in Klein except the onboard calibrator and Tate provides that?

[00:01:31] Speaker 00:
So no, Your Honor.

[00:01:33] Speaker 00:
First of all, the first door is not disclosing Klein because the generator access lid is not accessible via what the Commission found to be the opening in the outer shell.

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If you turn to page 47 of the initial brief of BRCA, you can see the picture of Klein showing the location where the Commission found the generator access lid to be.

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As you can see, it's on the top of the cart, on the outside of the cart on the top.

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But if you look at appendix page 6276, you'll see what the commission found to be the opening in the outer shell.

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And that opening is not on the top of the cart, it's on the side of the cart.

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And accordingly, one would not reach through an opening in the side of the cart to access

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a door that resides on the outside of the top of the cart.

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And if one were to reach up to do so, one could not then obtain access to the shielding compartment that is the generator compartment.

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Also, the generator access lid doesn't close over the opening to the shielding compartment.

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The commission found instead

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that the door, the generator access lid, closed over the other opening, the opening in the top of the shell.

[00:03:11] Speaker 02:
Council, can I ask?

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This is Judge O'Malley.

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I'm sorry.

[00:03:15] Speaker 02:
If we find that the generator access lid, as you argue, does not meet the first door limitation, would we have to remand, or is it possible for us to say that in light of other testimony that

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that error would be harmless?

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So actually, Your Honor, I would submit that it's certainly not harmless error because the Commission erred in finding an element of the claim satisfied when it was not.

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And the Commission did not make a finding in the alternative that it would have been obvious to add a door having the,

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the features that are required.

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That was the theory that was argued by Jubilant and by the staff that was fully briefed.

[00:04:08] Speaker 04:
Council, just to judge more, I thought I remembered the board expressly finding in light of Stone that such doors, Stone's testimony that such doors were in fact obvious.

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So if you look at Stone's testimony, he didn't actually, well, he said that he said that doors are common.

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But that falls far short of the required analysis for nuvasives.

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First of all, it only applies to the door.

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There was no analysis with regard to the door being accessible via the opening in the outer shell or that the door was positioned such that it would provide access to the generator compartment and to close over that compartment.

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Given the failure to address all of those additional requirements of the claim limitation, the commission failed as a matter of law, and Dr. Stone's obviousness analysis likewise fails as a matter of law.

[00:05:14] Speaker 02:
So let's just turn... This only applies to the 869 patent, right?

[00:05:18] Speaker 00:
Correct.

[00:05:19] Speaker 00:
Okay.

[00:05:20] Speaker 00:
Let's turn now to the...

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the dose calibrator and the motivations that the commission and the judge found with regard to moving the dose calibrator onto the cart.

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If you look, the motivations that the commission relied on are set forth at appendix page 96.

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And bear in mind, your honors, remember that both experts testified at trial that Klein itself

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does not teach any motivation to alter or align or combine it with other art.

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Despite that, the judge found, based on his own analysis that was not previously made known to the parties, that Klein did indeed provide three motivations.

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But the motivations that the judge found and that the commission relied upon were

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They were based on a misunderstanding of how the dose calibrator is used in Klein.

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The dose calibrator for Klein is only used once a day as part of the morning protocol to check for breakthrough.

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It is not used to monitor the dose provided to patients.

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Accordingly, if you look at the motivations that the judge pointed to,

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the ability to move the cart around during patient treatment, that desire for mobility actually teaches a way from putting the dose calibrator on the cart.

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Because when you do that, you need to shield everything.

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And it adds considerable weight to the cart, making it less mobile.

[00:07:13] Speaker 04:
So this is such more.

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I understand that on these points, you've raised an APA challenge.

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Is there evidence that you would have liked to have introduced on these points that you didn't have the opportunity to?

[00:07:31] Speaker 00:
Yes, Your Honor.

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There are evidence we could have pointed out.

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We could have clarified the judges and the commission's error with regard to the misunderstanding of the purported motivations of Klein.

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We could have submitted expert testimony with regard to the passages of Klein that were cited by the judge and relied upon by the commission.

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that would have shown that these related to issues that would not have motivated one to place the dose calibrator on the cart, but rather would have motivated one to keep it off the cart.

[00:08:07] Speaker 04:
We have in the appendices the briefs that were submitted before the commission where the staff raises the issue of client alone.

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Was that ever raised prior to the ALJ's initial decision?

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So there needs to be a distinction between Klein alone and the motivation to alter Klein.

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So Klein alone was briefly raised by the staff, but the staff never pointed to anything in Klein that would motivate one to alter Klein.

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The motivations.

[00:08:45] Speaker 04:
Council, Council, you're not answering my question.

[00:08:47] Speaker 04:
My question was, I understand that the staff may have pointed to client alone in its brief before the commissioner, but I'm asking you now to focus on the timeframe prior to the initial decision by the ALJ, which in the appendices we have is the first time there's ever been a client alone.

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rejection, was that argument made either by the staff or by the petitioner prior to the ALJ's decision?

[00:09:18] Speaker 00:
The staff made a conclusory argument that it would also work with plan alone.

[00:09:26] Speaker 04:
When?

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When did they make that argument?

[00:09:29] Speaker 00:
In the post-hearing briefs, before the ALJ, but not in the pre-hearing briefs.

[00:09:36] Speaker 04:
Okay.

[00:09:37] Speaker 04:
Okay.

[00:09:37] Speaker 04:
Go ahead, continue.

[00:09:39] Speaker 00:
Okay.

[00:09:40] Speaker 00:
Sorry, Your Honor.

[00:09:41] Speaker 00:
With regard to operational simplicity, which the ALJ also found, you'll note in the ID, the initial determination, the ALJ says that that would avoid having to plug and unplug the dose calibrator every time a patient is treated.

[00:10:03] Speaker 00:
But again, you don't need to do that because the dose calibrator is only used

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once a day.

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So that operational simplicity doesn't apply.

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Now, Dr. Stone did simply opine without any analysis that it would only be natural when one was commercializing the cart to place the dose calibrator on the cart.

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But that goes against the compelling real-world evidence here

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Your Honor, I see that I'm into my rebuttal.

[00:10:43] Speaker 05:
Counsel, you can continue or save your time, whichever you wish.

[00:10:48] Speaker 05:
I'll just finish this point, Your Honor.

[00:10:51] Speaker 00:
So the record shows that for 30 years, the only commercially available product used a dose calibrator that was not on the mobile cart.

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And even today, the most popular commercial product

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still uses a dose calibrator that was not on the cart.

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Likewise, when the University of Ottawa, where Klein was, was giving advice to Jubilant with regard to how to commercialize the University of Ottawa device, they did not suggest putting the dose calibrator on the cart.

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They simply said, use different tubing so that you can hook up the system to any of the commercially available dose calibrators.

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And as the commission found, it was only after Jubilant learned of what BRCA was doing, remember the secondary consideration of copying, that they actually placed the dose calibrator on the cart.

[00:11:51] Speaker 00:
Thank you, Your Honors.

[00:11:52] Speaker 00:
I'd like to save the rest for rebuttal.

[00:11:54] Speaker 05:
We will do that.

[00:11:58] Speaker 05:
Ms.

[00:11:58] Speaker 05:
Morad for the commission.

[00:12:02] Speaker 03:
Good morning.

[00:12:03] Speaker 03:
May it please the court?

[00:12:05] Speaker 03:
The commission correctly determined that Jubilant and the staff established by clear and convincing evidence that the asserted claims are obvious over Klein alone and in combination with other prior art including tape.

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Substantial evidence supports the commission's findings that the prior art features or suggests every disputed and undisputed limitation and that there was motivation to combine the references

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Bracko impermissibly asked this court to reweigh the evidence of records and adopt Bracko's views as to that record.

[00:12:39] Speaker 03:
Ms.

[00:12:39] Speaker 04:
Morad, before you move into the merits of the obviousness arguments, I'd like you to start by addressing their argument that the commission's decision on Klein alone violated the APA.

[00:12:55] Speaker 03:
That is incorrect, Your Honor.

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First of all, I'd like to correct some statements made by

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Bracko's council about whether the argument was raised by the staff.

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The argument was absolutely raised by the staff before the ALJ and before the ALJ issued his initial determination.

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It was raised in the staff, at least in the staff post hearing brief.

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This is the first time I hear an argument that it was not raised in the pre-hearing brief.

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It is not allowed for parties

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to raise arguments for the first time in the post-hearing brief, and if that happened, Bracco should have pointed that to the judge.

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So the staff, before the ALJ issued his ID, argued that Klein alone rendered the asserted claims obvious.

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And the staff did that not only in a conclusory fashion, as Bracco's counsel is arguing, but he did it

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in the summary of analysis, but also in the plane element by element analysis.

[00:14:02] Speaker 03:
And for that, I will point you to 6.478 and 6.4.

[00:14:20] Speaker 03:
Oh, I'm sorry.

[00:14:24] Speaker 03:
Just a second.

[00:14:30] Speaker 03:
Yes.

[00:14:34] Speaker 03:
Appendix 6478, 6479, Appendix 6474, and Appendix 6464.

[00:14:42] Speaker 02:
Which volume?

[00:14:44] Speaker 03:
Volume 5, Your Honor.

[00:14:48] Speaker 04:
I'm sorry.

[00:14:49] Speaker 04:
Which page in particular represents the staff raising this argument?

[00:14:55] Speaker 03:
Hold on, Your Honor.

[00:14:56] Speaker 03:
Give me just one second.

[00:15:02] Speaker 03:
I just want to make sure.

[00:15:10] Speaker 03:
Appendix 6478, 6479.

[00:15:11] Speaker 04:
Okay, so 6478 is the staff post-hearing breach.

[00:15:19] Speaker 04:
Is that correct?

[00:15:20] Speaker 03:
That's correct.

[00:15:21] Speaker 03:
That is correct, Your Honor.

[00:15:22] Speaker 03:
That's the claim element by element analysis for the shielded well on board the cart.

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And it starts at the bottom of 6478.

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While the client system has an off-board dose calibrator, it was obvious to install the dose calibrator on any platform of the cart along with the generator shielding compartment.

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They cite Dr. Stone's testimony.

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And then the last sentence after the paragraph that follows the first picture on Appendix 6479,

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They say the integrated cart having the onboard dose calibrator is also topped by Tait and Integos.

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So the combination with Tait was an additional argument that the staff relied on.

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But Klein alone was properly raised by the staff here in the claim element by element analysis, but also on Appendix 6474 in the summary of the analysis again

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arguments about client alone.

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And Appendix 6464, the initial argument, all the asserted claims are invalid as obvious in view of the client alone or in combination with other prior arguments.

[00:16:44] Speaker 04:
Now, where on 6474 does the staff raise this argument?

[00:16:49] Speaker 03:
So again, on Appendix 6474,

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The client system includes each of these components but places them off the cart.

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That's after subheading two.

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And the last sentence, the evidence demonstrates it would be obvious that the dose calibrator of the client system could be moved onto the cart.

[00:17:17] Speaker 03:
It's again discussing flying alone.

[00:17:20] Speaker 04:
And that's why... I have a... This is such more.

[00:17:24] Speaker 04:
I have just an educational question.

[00:17:27] Speaker 04:
What is the staff's role in this dispute?

[00:17:32] Speaker 04:
How does the staff function in a dispute between two parties between the ICC?

[00:17:40] Speaker 03:
So the staff is an independent party before the commission.

[00:17:46] Speaker 03:
The commission's rules, 19 CFR 210.3, define the staff as a party.

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And the staff's role is to represent the public interest.

[00:18:01] Speaker 03:
In the Lanham case, which we cited in our brief, the court recognized the staff as a party.

[00:18:10] Speaker 03:
And the staff can raise invalidity

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challenges in the investigation before the commission.

[00:18:18] Speaker 04:
So it is understood or accepted that the staff can raise entirely different or new arguments that weren't in the petition, is that correct?

[00:18:30] Speaker 03:
I'm sorry.

[00:18:32] Speaker 03:
The staff did not raise an argument that wasn't in the petition.

[00:18:36] Speaker 04:
Well, no, Council.

[00:18:37] Speaker 04:
The petition never said Klein alone could result in obviousness.

[00:18:41] Speaker 04:
So the staff did raise a new issue that wasn't in the petition.

[00:18:44] Speaker 03:
I'm sorry.

[00:18:45] Speaker 03:
Which petition are you discussing?

[00:18:47] Speaker 03:
Are you discussing Bradford's petition to the commission or the staff's petition to the commission?

[00:18:58] Speaker 04:
I'm sorry, counsel, I meant before the ALJ.

[00:19:01] Speaker 04:
I shouldn't have used the word petition.

[00:19:06] Speaker 04:
So the staff can raise new arguments for invalidity before the ALJ that were not raised by the opposing party, like jubilance?

[00:19:19] Speaker 03:
Well, the staff is a party that participates from the beginning of the investigation.

[00:19:24] Speaker 03:
And the staff represents the

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the public interest.

[00:19:28] Speaker 03:
The staff can raise its own issues.

[00:19:30] Speaker 03:
The staff properly can raise invalidity issues, and they did so properly.

[00:19:35] Speaker 02:
But they never did so before the hearing, though, did they, Counsel?

[00:19:39] Speaker 03:
That is incorrect, Your Honor.

[00:19:41] Speaker 03:
This is the first time that I hear BRCAO saying that they didn't raise it before the hearing.

[00:19:46] Speaker 03:
There is no evidence of that in the record.

[00:19:48] Speaker 03:
If they raised it in the post-hearing brief,

[00:19:51] Speaker 03:
They, for sure, they should have raised it in the pre-hearing brief as well, because the commission rules do not allow arguments raised for the first time in the post-hearing brief.

[00:20:02] Speaker 03:
And there was no argument by Bracco before the ALJ or before the commission that there was an argument that was new raised in the post-hearing brief that was not raised in the pre-hearing brief.

[00:20:17] Speaker 02:
Okay, so wait.

[00:20:18] Speaker 02:
First, I have two questions before you sit down.

[00:20:20] Speaker 02:
So you're saying,

[00:20:22] Speaker 02:
It was raised in a pre-hearing brief, and yet the only thing you've pointed it to is the post-hearing brief.

[00:20:28] Speaker 03:
That's correct, Your Honor, because the... Then why is that not in the Joint Appendix?

[00:20:35] Speaker 03:
The argument that Graco made was that the ALJ did not raise the argument before the... I'm sorry, that Graco made is that the staff didn't raise the argument before the ALJ.

[00:20:49] Speaker 03:
And we pointed to evidence that the staff did.

[00:20:52] Speaker 02:
Right.

[00:20:53] Speaker 02:
Again, again.

[00:20:54] Speaker 02:
Wait, council, can you just answer my question?

[00:20:56] Speaker 02:
You point, the only thing you've pointed us to is the post hearing brief.

[00:21:01] Speaker 02:
Are you saying that there is another brief pre hearing where the staff raises this?

[00:21:07] Speaker 03:
Um, I'm saying that, uh, because Blackwood did not say.

[00:21:13] Speaker 03:
Okay.

[00:21:13] Speaker 02:
It's a yes or no question.

[00:21:15] Speaker 02:
Yes or no?

[00:21:17] Speaker 03:
Your Honor, the pre-hearing is not part of this appendix.

[00:21:20] Speaker 03:
I agree with you.

[00:21:21] Speaker 02:
But I do not... So it's not in the pre-hearing?

[00:21:24] Speaker 03:
Can you just answer my question?

[00:21:26] Speaker 02:
Is it in the pre-hearing brief?

[00:21:28] Speaker 02:
I believe it is in the pre-hearing.

[00:21:30] Speaker 02:
So you're saying it is, but you didn't submit it to the record, in the record?

[00:21:35] Speaker 03:
That's correct, Your Honor.

[00:21:37] Speaker 02:
Okay, my second question, my second question, and I think again this could be a yes or no answer,

[00:21:43] Speaker 02:
that the pages that you cited as to at JA 6475 and the other pages you cited as to never mentioned the various motivations to move the system onto the cart that the ALJ relied upon.

[00:22:00] Speaker 02:
Isn't that right?

[00:22:01] Speaker 03:
This is in part correct and in part incorrect.

[00:22:08] Speaker 02:
Well, the only motivation that the staff mentions

[00:22:11] Speaker 02:
is that Bracco's patent got the inventive idea from some users of its own system.

[00:22:18] Speaker 02:
But those aren't the motivations that the ALJ relied on.

[00:22:22] Speaker 03:
At Appendix 6479, Your Honor, the staff states that Dr. Stone noted that if someone were looking to commercialize a version of the client system,

[00:22:38] Speaker 03:
It only makes sense to place those system components on a single unit or a single cart.

[00:22:45] Speaker 03:
Fighting Stone's testimony, I believe this is Appendix 1165 and 1165.

[00:22:50] Speaker 02:
OK, so only makes sense is an expert opinion?

[00:22:58] Speaker 02:
Again, that's not that those aren't the motivations, the specific motivations that the ALJ relied on.

[00:23:04] Speaker 02:
Is it?

[00:23:05] Speaker 03:
Well, this is the second one, the operational simplicity.

[00:23:08] Speaker 03:
And he relied on the same testimony.

[00:23:10] Speaker 03:
And then Jubilant also raised the argument that having to roll the cards back to the hot lab every morning was inconvenient.

[00:23:24] Speaker 03:
So the mobility argument was also raised by Jubilant.

[00:23:28] Speaker 04:
Can I ask one additional question, please?

[00:23:33] Speaker 04:
My question is 554C, which is the provision they cite in the blue brief and in the gray brief, requires not just notice and an opportunity to be heard, namely briefing, but it requires an opportunity to present facts.

[00:23:51] Speaker 04:
So did, can you please respond to whether Braco had an opportunity to submit evidence on this, these particular motivations that the ALJ found?

[00:24:06] Speaker 04:
And if so, when?

[00:24:07] Speaker 04:
When, what is the time after which the evidentiary record is closed?

[00:24:15] Speaker 03:
Before the commission, they have the opportunity to file a petition raising all the objections they have to the ALJ's initial determination.

[00:24:29] Speaker 03:
And so in their petition, they could have and should have told the commission that they needed the records to be reopened or they needed

[00:24:39] Speaker 03:
I just want to be clear.

[00:24:42] Speaker 04:
Let me just be clear so I understand factually.

[00:24:45] Speaker 04:
Is it true that they're not permitted to submit new evidence before the commission?

[00:24:50] Speaker 03:
They are not permitted to submit new evidence without asking for permission to ask such evidence, but they could have asked for permission.

[00:25:02] Speaker 02:
What rule allows them to ask, gives them the opportunity to reopen the record?

[00:25:09] Speaker 03:
Your Honor, I'm not aware of any particular rule allowing them to ask for permission to reopen the records.

[00:25:20] Speaker 03:
But the parties, they do that in practice before the commission filing motions for leave.

[00:25:25] Speaker 03:
And also under the APA, the commission, the APFS, the commission with the authority to hear evidence if the parties

[00:25:37] Speaker 03:
ask to reopen the record, they could do that even before the commission, or they could ask for remand to the ALJ.

[00:25:44] Speaker 04:
Just to be clear, Braco asserts that they are not permitted to submit new evidence before the commission.

[00:25:52] Speaker 04:
Is that correct?

[00:25:53] Speaker 04:
Is the record closed once it leaves the ALJ?

[00:25:57] Speaker 03:
It is true that the record closed, that they are not permitted to, on their own,

[00:26:07] Speaker 03:
submit additional evidence, but they can ask the commission for leave to do that.

[00:26:14] Speaker 04:
Yes, but respectfully, that's like asking for a motion for reconsideration.

[00:26:18] Speaker 04:
And you know what?

[00:26:19] Speaker 04:
We never fault people who weren't given an opportunity to present evidence.

[00:26:24] Speaker 04:
because they didn't ask for reconsideration or a new opportunity to do so.

[00:26:30] Speaker 04:
If the commission closes the record and then makes a decision on a basis that wasn't something they had the opportunity to submit evidence on, they're allowed to appeal it to us.

[00:26:40] Speaker 04:
They don't have to ask for reconsideration before the agency.

[00:26:46] Speaker 04:
I mean, do you see some problem with that?

[00:26:48] Speaker 04:
Is there some law that you could point me to that would suggest that my understanding of the law is incorrect?

[00:26:53] Speaker 03:
Well, under the APA, 557B, the APA vests the commission with the authority to hear evidence as if it was presented for the first time.

[00:27:09] Speaker 03:
They can do that.

[00:27:10] Speaker 03:
I don't believe it's a motion for reconsideration.

[00:27:13] Speaker 03:
They have not asked the commission to reopen the record.

[00:27:17] Speaker 03:
They have not even identified any additional evidence that they would have wanted the commission to consider.

[00:27:25] Speaker 03:
And also, I mean, the commission made supplemental findings based on the combination that they had noticed and an opportunity

[00:27:39] Speaker 03:
to address the combination of clients with states.

[00:27:44] Speaker 04:
I'm sorry, one last question if you don't mind.

[00:27:46] Speaker 04:
I just need to understand the logistics and it's nowhere in this record.

[00:27:50] Speaker 04:
At what point before the ALJ is the record considered closed?

[00:27:55] Speaker 04:
Is the record considered closed as of the day of the hearing?

[00:27:59] Speaker 04:
Or when is the record, the proceedings before the ALJ, when is the record closed such that you don't, as a matter of right, have the ability to submit additional evidence?

[00:28:14] Speaker 03:
I believe that before the ALJ, I mean, as long as it's before the ALJ and before it goes to the Commission, I believe under

[00:28:24] Speaker 03:
the rules, they can ask the ALJ to reopen the records.

[00:28:29] Speaker 04:
I'm not asking you if they can ask to reopen.

[00:28:32] Speaker 04:
I'm asking when it closes.

[00:28:34] Speaker 04:
You don't need to reopen something until it closes.

[00:28:37] Speaker 04:
So when does it close?

[00:28:44] Speaker 03:
Before the commission, I believe that if they ask for permission, I suppose there is like a... I'm not asking for permission.

[00:28:52] Speaker 04:
Look, in every case, in every court in the country, discovery closes as of a certain date.

[00:28:58] Speaker 04:
Within the commission, there must be a procedure.

[00:29:00] Speaker 04:
I don't know why you're hiding it from me.

[00:29:02] Speaker 04:
No, no, no.

[00:29:05] Speaker 04:
Stop talking over me.

[00:29:06] Speaker 04:
There must be a procedure.

[00:29:08] Speaker 04:
When does the record close before the ALJ?

[00:29:12] Speaker 04:
Is it prior to the hearing, at the time of the hearing, after the post-hearing brief?

[00:29:17] Speaker 04:
When does the record close so that you can't just submit additional new evidence?

[00:29:23] Speaker 03:
I apologize.

[00:29:24] Speaker 03:
I thought you were asking me to point to a rule.

[00:29:27] Speaker 03:
But in terms of when the record close, I believe this is the procedural schedule that is

[00:29:35] Speaker 03:
presented to the ALJ and adopted by the ALJ, that would have a date for the close of discovery and a date for the close of expert discovery.

[00:29:48] Speaker 03:
So that would be before the hearing.

[00:29:53] Speaker 03:
I don't know when exactly, whether it's before they submit pre-hearing briefs or

[00:30:00] Speaker 03:
But I believe it's before the hearing, before the ALJ, and certainly before the ALJ issues the initial determination.

[00:30:07] Speaker 04:
But this court does not consider... My understanding, counsel, that in this case, the record before the ALJ was required to be complete at the time of the pre-hearing briefs, meaning no party was allowed to submit additional evidence

[00:30:26] Speaker 04:
after the pre-hearing briefs were filed.

[00:30:29] Speaker 04:
Is that correct?

[00:30:32] Speaker 03:
Absolutely, without leave, without asking for leave, yes.

[00:30:36] Speaker 05:
Thank you.

[00:30:37] Speaker 05:
Council, I think we have your argument.

[00:30:40] Speaker 05:
We'll now hear from Mr. Hales, and we'll give him seven minutes.

[00:30:43] Speaker 03:
Your Honor, can I say just one short thing about the first door?

[00:30:47] Speaker 05:
Very short.

[00:30:50] Speaker 03:
Because I just want to say that the argument that the first door was not

[00:30:57] Speaker 03:
accessible via the opening through the exterior shell.

[00:31:01] Speaker 03:
That was not an argument that Brattle raised in their opening brief.

[00:31:05] Speaker 03:
They made a different argument at page 43 of their brief that the first door is not accessible through the opening on the top surface of the cart, not the front surface of the cart.

[00:31:21] Speaker 03:
Additionally, I want to point to Appendix 33

[00:31:25] Speaker 03:
where the commission expressly found that doors are conventional and common and cited expert testimony in that regard.

[00:31:33] Speaker 03:
So there was an alternative finding that doors are obvious.

[00:31:36] Speaker 03:
Thank you, Your Honor.

[00:31:38] Speaker 05:
Thank you, Counsel.

[00:31:39] Speaker 05:
Mr. Hales.

[00:31:42] Speaker 01:
Yes, thank you, Your Honor.

[00:31:44] Speaker 01:
Good morning and may it please the court.

[00:31:46] Speaker 01:
Again, Bob Hales representing the Jubilant Companies.

[00:31:49] Speaker 01:
I guess that there's one takeaway that I would ask you to consider coming from today's proceedings is to please compare the Commission opinion and the breadth of its analysis and the number of different pieces of evidence that it cites to support its holdings to Bracco's briefs.

[00:32:06] Speaker 01:
You'll see there are large portions of the Commission opinion that are untouched by Bracco's appellate briefing.

[00:32:11] Speaker 01:
The two easiest ones to see are, for example, the Commission's KSR analysis

[00:32:16] Speaker 01:
And with respect to the first shielding component referenced in Appendix 20 to 23, there were two bases and BRCAO failed to appeal one of them, to challenge one of them.

[00:32:28] Speaker 01:
So there's a large body of evidence that the commission

[00:32:34] Speaker 01:
made its findings and based its findings on that are largely untouched by Bracco's appeal.

[00:32:40] Speaker 01:
And I think there's a possibility of sort of a misunderstanding or a misconception if one were to focus solely on the pieces of evidence that Bracco challenges.

[00:32:49] Speaker 01:
I'm happy to discuss any of the elements that interest you.

[00:32:53] Speaker 01:
I was going to start with these first doors because Mr. Davis made an argument against them.

[00:33:01] Speaker 01:
This is an issue where

[00:33:03] Speaker 01:
There's actually different approaches taken by the staff and taken by jubilance when presenting that claim element and mapping it on to the evidence of record.

[00:33:13] Speaker 01:
The staff had taken the position that this generator access lid is sufficiently teaches the door and closes over the shielding compartments as required.

[00:33:24] Speaker 01:
viewing it from a perspective that closing over doesn't really require the shielding compartment to be enclosed, right?

[00:33:32] Speaker 01:
Viewing it from a perspective that the generator access lid does not have to, yeah, make a segmented, completely enclosed generator.

[00:33:42] Speaker 01:
The evidence that we presented and the argument that we presented was that doors are conventional and common in the ARC, and then it would have been obvious to place a door directly on the shielding that is provided by the client system.

[00:33:53] Speaker 01:
the lead rings that he calls the shielding, the generator shield.

[00:33:58] Speaker 02:
Right, so as to the first, as to the staff argument, you would concede that that's problematic since Dr. Stone actually said that Klein does not disclose the first-door limitation.

[00:34:11] Speaker 01:
Well, I think he, I mean, it wasn't the mapping that Dr. Stone used, right?

[00:34:16] Speaker 01:
When Dr. Stone was asked to compare it against the claim elements, he was not testifying in that manner.

[00:34:20] Speaker 01:
That's correct.

[00:34:21] Speaker 02:
He did testify as... Didn't he at JA 1211 and 12th that it doesn't, that Klein doesn't actually disclose the first door limitation, right?

[00:34:32] Speaker 02:
That's right.

[00:34:33] Speaker 01:
That's actually right.

[00:34:33] Speaker 01:
He said that.

[00:34:34] Speaker 01:
That's right.

[00:34:35] Speaker 01:
And then he had a statement that doors are conventional and common.

[00:34:38] Speaker 01:
They're everywhere that he had seen in his experience working with these radioactive materials.

[00:34:43] Speaker 01:
He's a guy with I think 15 years or so of experience working with radioactive materials.

[00:34:49] Speaker 02:
But did he ever take the next step to say that doors are common and doors that are shaped in the way that the first door limitation is, that that would be something that one of skill in the art would necessarily do?

[00:35:08] Speaker 02:
I mean, all I got from him was the general doors are common.

[00:35:14] Speaker 02:
It seems like there should have been another step.

[00:35:16] Speaker 02:
Well, that was.

[00:35:18] Speaker 01:
It was.

[00:35:18] Speaker 01:
It was discussed in context with the tape reference showing how pervasive they are.

[00:35:23] Speaker 01:
And now I'm going to try to find it in our brief.

[00:35:25] Speaker 01:
But he did explain that.

[00:35:28] Speaker 01:
So he explained, and this is on page 43 of our brief, that these are taught throughout the body of art that he was relying on and that these are standard and these are things that people would do.

[00:35:41] Speaker 01:
again, when taking this university cart, right, to something that's made by a master's student and turning it into a commercialized product.

[00:35:49] Speaker 01:
And so I think he did testify to that.

[00:35:52] Speaker 01:
In our view, our read of review of the commission's opinion, the commission was adopting both of those arguments.

[00:36:01] Speaker 01:
There's a statement, they rely on Dr. Stone at appendix 31, and that's in context with this generator access lid theory that staff had presented.

[00:36:09] Speaker 01:
And then the furthermore statement that's on Appendix 33 is, in our view, the Commission agreeing with our opinion that this is just natural stuff that people would provide in these kinds of systems.

[00:36:23] Speaker 01:
He explained, it's elsewhere, it's not cited in the commission opinion, he explained that the reason that they have these upward facing openings is so that when the thing is opened that radiation progresses upward and doesn't accidentally expose people who are approaching it from lateral sides.

[00:36:42] Speaker 01:
And then of course it's obvious to put a door on it to make sure that it's completely enclosed and to even enhance further the safety aspects of these kinds of things.

[00:36:51] Speaker 02:
So basically what you're arguing is that

[00:36:53] Speaker 02:
It was probably error for them to adopt the first position, but you think the error is harmless because they also made this alternative finding?

[00:37:02] Speaker 01:
There are these two alternative findings, and would you like to have the second one best?

[00:37:06] Speaker 01:
That's absolutely right.

[00:37:10] Speaker 01:
So it is, in our view, these are factual findings that are made by the commission, and they are supported by substantial evidence, not only the disclosures

[00:37:21] Speaker 01:
of Klein and Tate, but also the opinion of our expert who is somebody who was identified, I think the line that the ADLJ used was that it was undisputed that he has experience taking prototype devices to market, you know, commercializing medical devices and bringing them into commercial ready, market ready states.

[00:37:43] Speaker 01:
So that's where we are on the first door.

[00:37:45] Speaker 04:
Council, this is Judge Moore.

[00:37:46] Speaker 04:
I'd like you to turn to page 19 of your brief, please.

[00:37:51] Speaker 04:
At the bottom of your brief, you cite our Nike case.

[00:37:57] Speaker 04:
And you claim that it stands for the proposition.

[00:38:00] Speaker 04:
I'm quoting from your brief on the very bottom of page 19.

[00:38:05] Speaker 04:
that even in Interparte's review, the PTAP does not violate the APA by raising invalidity grounds not presented by the parties, so long as the grounds are based on record evidence and the parties had notice of those grounds and an opportunity to respond before the PTAP issues its final decision.

[00:38:26] Speaker 04:
Can you tell me where in the Nike case we held that because what you represent our holding of Nike to be would be completely the opposite of what it actually held and in fact would be in direct conflict with SAS as rendered by the Supreme Court and every

[00:38:45] Speaker 04:
post SAS decision and Nike came after SAS so it's not certainly not the case that Nike could have disregarded SAS and nor do I think it did.

[00:38:57] Speaker 04:
So I'm a little troubled that you would hold out to us that our Nike case stands for the proposition that the PTAB can rule on any ground as long as there's notice of an opportunity to be heard even if it wasn't presented by the party.

[00:39:14] Speaker 01:
I am struggling to get my hands on the case.

[00:39:18] Speaker 04:
Do you understand what the SAS decision held from the Supreme Court?

[00:39:23] Speaker 01:
I do.

[00:39:23] Speaker 04:
Do you understand that it held that the PTAB is never permitted to go outside the boundaries of the petition and make a decision on a ground that wasn't argued for in the petition?

[00:39:32] Speaker 01:
I do.

[00:39:33] Speaker 04:
So then how could our Nike case coming after SAS say the opposite?

[00:39:40] Speaker 01:
I understand the concern.

[00:39:43] Speaker 01:
It's probably an overstatement.

[00:39:45] Speaker 01:
I think the idea was the note is not... Well, it's actually a wrong statement.

[00:39:48] Speaker 04:
It's not an overstatement.

[00:39:49] Speaker 04:
It's the exact opposite of what the opinion actually holds.

[00:39:51] Speaker 04:
And just so you know, there's a tiny portion of Nike not actually on the pages you cite, which says limited to motions to amend because they are not any longer claims that fall within the petition itself.

[00:40:06] Speaker 04:
the PTAB can go outside the boundaries.

[00:40:09] Speaker 04:
But it says that after it makes it clear that they can never do that in a normal IPR because of SAS, because the Supreme Court said you can't do it in SAS.

[00:40:18] Speaker 04:
And then the case goes on, again, after the portion that you cited, not on the pages you cited, to say limited to a motion to amend, which isn't what was the subject of the petition at all.

[00:40:30] Speaker 04:
The PTAB can go outside those boundaries.

[00:40:32] Speaker 04:
But I don't welcome this kind of sloppiness in brief.

[00:40:37] Speaker 01:
I understand, Your Honor, and will not happen again.

[00:40:42] Speaker 01:
I guess we were looking at it from an APA's perspective, right?

[00:40:45] Speaker 01:
We're looking at it from a notice and an opportunity to comment perspective.

[00:40:50] Speaker 01:
But the point is taken.

[00:40:52] Speaker 04:
Well, the opinion in Nike, with these principles in mind, we conclude the board violated the APA's requirements dot, dot, dot, dot.

[00:41:00] Speaker 04:
So the Nike case speaks directly

[00:41:04] Speaker 04:
to the APA as well.

[00:41:06] Speaker 04:
But go ahead, please move on.

[00:41:09] Speaker 01:
Okay.

[00:41:09] Speaker 01:
So our point on the APA challenge was that these challenges that are being raised were being raised to the ALJ's findings, that they did have an opportunity to be heard on them and they agreed to it.

[00:41:23] Speaker 04:
Well, the Council doesn't being heard mean an opportunity to present evidence, especially on factual findings?

[00:41:31] Speaker 01:
Yes, I agree with that.

[00:41:33] Speaker 01:
I think that in this case, though, Bracco agreed with many of the findings that were made, right, were acknowledged these things.

[00:41:41] Speaker 01:
Klein does tout mobility.

[00:41:42] Speaker 01:
They said that at 6755.

[00:41:44] Speaker 04:
I don't think that Bracco agreed with the three different motivations articulated in the IELTS.

[00:41:49] Speaker 01:
I agree with you that he did not agree with the application of them, but the acknowledgement that Klein is interested in, you know,

[00:41:55] Speaker 01:
thinks that mobility is a consideration, that Klein is interested in operational simplicity.

[00:42:01] Speaker 04:
Yes, but as Bracco argued to us, it believed that these ALJ findings, which really do kind of come out of the blue, on motivation to modify Klein alone, are based on a misunderstanding, and they would have liked an opportunity to submit expert testimony to explain that.

[00:42:24] Speaker 01:
I understand that.

[00:42:25] Speaker 01:
They didn't proffer anything, right, until we get to the reply brief, but I do understand that point.

[00:42:30] Speaker 01:
I would point out that, again, there are, there's a host of different evidentiary sources that the commission opinion relied on, including, for example, Dr. Stone's testimony about taking things to market.

[00:42:43] Speaker 01:
Dr. Stone testified directly that it, and the mobility issue is one that actually the commission sort of,

[00:42:50] Speaker 01:
impliedly reverse the ALJ because the commission opinion, if you read it, talks about the difficulty of moving carts back to stationary dose calibrators, which is what Dr. Stone testified to directly and was presented directly.

[00:43:08] Speaker 01:
So even if there were a problem with these instances of motivation provided by the ALJ to which Bracco complains,

[00:43:17] Speaker 01:
There are other sources, again, that are untouched, largely, that the Commission based its findings on.

[00:43:25] Speaker 05:
Thank you, Counsel.

[00:43:26] Speaker 05:
Your time is up, and we'll hear from you again on the related subject matter in the next case.

[00:43:32] Speaker 05:
Thank you, Your Honor.

[00:43:33] Speaker 05:
Mr. Davis, we'll give you your full five minutes back.

[00:43:37] Speaker 00:
Thank you, Your Honor.

[00:43:38] Speaker 00:
I would like to address first Counsel's statement that the Commission implicitly reversed the ALJ with regard

[00:43:46] Speaker 00:
to the three motivations the ALJ found inclined.

[00:43:49] Speaker 00:
That is simply not true.

[00:43:52] Speaker 00:
If you look at appendix page 15 and 16, you will see where the commission says, the FID also correctly finds that several design incentives would have motivated a person of ordinary skill in the art to move the dose calibrator on board the cart, including mobility, operational simplicity, and minimizing radiation exposure to the operator.

[00:44:14] Speaker 00:
C, FID, site incline, et cetera, et cetera.

[00:44:18] Speaker 00:
There was no implicit reversal.

[00:44:20] Speaker 00:
There was an explicit adoption.

[00:44:23] Speaker 00:
Also, with regard to the passing reference regarding KSR, if you apply KSR here, it shows that there is no obviousness.

[00:44:42] Speaker 00:
There's for at least three reasons.

[00:44:44] Speaker 00:
One is the unrebutted evidence that when it comes to these types of sensitive machines, there are no small changes.

[00:44:51] Speaker 00:
You can see that at 1440 and 1925.

[00:44:55] Speaker 00:
Likewise, Drublin struggled for years to move the dose calibrator on board the cart, as shown at 1597, 98, and 1604.

[00:45:04] Speaker 00:
And the dose calibrator of Tate does not perform the same function as the dose calibrator used by Klein.

[00:45:13] Speaker 00:
And it appears that the commission's reliance on TATE was a misunderstanding of this difference.

[00:45:19] Speaker 00:
So the commission cited KSR for the proposition that if a technique has been used to improve one device and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.

[00:45:38] Speaker 00:
So TATE and Klein do not use dose calibrators in the same way.

[00:45:42] Speaker 00:
Kate uses a dose calibrator to measure the dose given to a patient.

[00:45:48] Speaker 00:
Klein already has a separate monitor that does that, that is on the cart.

[00:45:53] Speaker 00:
And there was no evidence submitted that the dose calibrator that is used purely for the purposes of the morning protocol and detecting breakthrough could even be used to measure the radiation dose given to a patient.

[00:46:09] Speaker 00:
And that's because rubidium has such a short half-life.

[00:46:13] Speaker 00:
Likewise, Tate does not even have a generator.

[00:46:17] Speaker 00:
So it uses a cyclotron, which is what Klein disparages and says is not as advantageous as the Klein device.

[00:46:30] Speaker 00:
And therefore, Tate cannot teach anything about testing for breakthrough and whether that should be done onboard a mobile cart

[00:46:40] Speaker 00:
when the testing of the radioisotope that is used in Tate is done at the cyclotron offsite.

[00:46:49] Speaker 00:
Your Honor, turning now to whether we actually made the arguments with regard to the first door.

[00:46:57] Speaker 00:
I would point your attention to appendix page 6757, where we talk about the motivations identified by the judge

[00:47:10] Speaker 00:
never having been raised by Jubilant or the staff.

[00:47:14] Speaker 00:
And we repeat that on 56, 57, and 58 as we talk about the three different motivations.

[00:47:22] Speaker 00:
We raised the issue with regard to the prejudice that it was caused to us in our petition to the commission.

[00:47:29] Speaker 00:
The commission did not address those arguments that we made to it.

[00:47:36] Speaker 00:
Also, just informationally,

[00:47:38] Speaker 00:
The record in this case closed on the final day of hearing.

[00:47:42] Speaker 00:
And the judge closed it.

[00:47:46] Speaker 00:
Jubilant cites in its brief two rules that it said would have provided us an opportunity to submit additional evidence.

[00:47:55] Speaker 00:
Both do not apply.

[00:47:56] Speaker 00:
One is for the judge to be able to reopen the record before he issues the ID.

[00:48:01] Speaker 00:
We had no notice with regard to these motivations until after the ID was cited.

[00:48:07] Speaker 04:
Yes, but you could have theoretically asked for the record to be reopened, right?

[00:48:12] Speaker 04:
When you pointed out to the commission that you were prejudiced by virtue of these new motivations being raised, you could have at that point.

[00:48:19] Speaker 04:
I'm not saying you had to, but you certainly could have.

[00:48:22] Speaker 00:
Well, Your Honor, what we did is we told, and as both Jubilant and the commission acknowledge, we pointed out the prejudice that was caused to us.

[00:48:35] Speaker 00:
And what we were seeking to do, rather than reopen the record, because again, this is an injunctive proceeding where we need injunctive release as soon as possible, we argued that it was error to rely on those new theories.

[00:48:49] Speaker 00:
And we were asking the commission to simply rely on the theories that were really raised.

[00:48:55] Speaker 00:
Now, when the commission decided that it wanted to go ahead, it would go ahead and rely on those new theories, its rules specifically state

[00:49:04] Speaker 00:
that it can reopen the record.

[00:49:06] Speaker 00:
But all that we are required to do is to point out it was error to do so.

[00:49:11] Speaker 00:
That we did.

[00:49:13] Speaker 05:
Thank you, counsel.

[00:49:14] Speaker 05:
We appreciate the arguments of all counsel and the case is submitted.

[00:49:19] Speaker 00:
Thank you, your honor.