[00:00:00] Speaker 04:
The case for argument today is 2017-2402, Virginia's versus Bass.

[00:00:27] Speaker 04:
All right, please proceed, Mr. Bennett.

[00:00:48] Speaker 01:
Good morning, Your Honors.

[00:00:49] Speaker 01:
May it please the court, John Bennett, for the appellant for Seniors Covey.

[00:00:53] Speaker 03:
You stayed on page 42 of the blue brief

[00:00:55] Speaker 03:
Pseudo showed an 11-fold increase in particulate contamination levels associated with closures treated with silicone to those associated with closures untreated.

[00:01:07] Speaker 03:
At Table 1, though, Pseudo reports that the peeling quality number for the siliconized stopper is 680.

[00:01:16] Speaker 03:
Based on Table 1, Pseudo reports finding a total of 680 particles of 10 micrometers

[00:01:24] Speaker 03:
of water for the silicone oil-treated stopper.

[00:01:28] Speaker 03:
Isn't that below the safety limits of both U.S.

[00:01:31] Speaker 03:
pharmacopoeia and the British pharmacopoeia, which allowed for 3,000 particles for a container of less than 1,000?

[00:01:39] Speaker 01:
That is what the board found, Your Honor, and we're not contesting that finding.

[00:01:43] Speaker 01:
But the point remains that the board's motivation analysis should not have been limited to whether or purely whether these individual references

[00:01:53] Speaker 01:
exceeded certain regulatory limits.

[00:01:54] Speaker 01:
Okay.

[00:01:55] Speaker 01:
Let me direct you to some calculations.

[00:01:59] Speaker 03:
Your expert, Dr. Davis, asserted that Pseudo reports a finding of 680 particles of 10 micrometers per milliliter of water for the silicone oil-treated stopper.

[00:02:13] Speaker 03:
His calculation is off by a factor of 300, isn't it?

[00:02:18] Speaker 01:
If, first of all, I should point out that Dr. Feinberg

[00:02:21] Speaker 01:
petitioner's expert initially agreed with our analysis that that was a per milliliter number.

[00:02:26] Speaker 01:
I think the reference is a bit unclear as to whether that is or not.

[00:02:30] Speaker 01:
But again, we're not contesting the board's finding on that particular point.

[00:02:35] Speaker 01:
But again, Your Honor, the point remains that whether or not this exceeds a particular regulatory limit, the person of skill still would not have been motivated

[00:02:46] Speaker 01:
to adopt packaging that would have increased the particulate load for this product.

[00:02:51] Speaker 03:
Let me ask you some more questions about these calculations.

[00:02:55] Speaker 03:
Dr. Davis' analysis of the particulate data resulting from the immersion of 10 stoppers into a container of water did not account for the fact that the number of particulates shed from 10 stoppers would have been 10 times the number of particulates shed from the single stopper in a container, right?

[00:03:16] Speaker 03:
So it's off by another factor of 10.

[00:03:19] Speaker 01:
Again, we're not contesting the board's finding on that.

[00:03:23] Speaker 03:
So you agree that Dr. Davis's calculations are essentially worthless?

[00:03:28] Speaker 01:
No.

[00:03:30] Speaker 01:
Again, I think that Dr. Feinberg, again, agreed with the per milliliter number that we had proposed below.

[00:03:37] Speaker 01:
And it does remain clear, if you look at pseudo, I think the plain teaching is that siliconized stoppers

[00:03:45] Speaker 01:
were producing a much higher number of particulates in the solution that was tested than non-siliconized stoppers.

[00:03:52] Speaker 02:
And I think, again, whether you agree with a particular... Would Dr. Davis be off by more than a factor of 10?

[00:03:58] Speaker 01:
Oh, sure.

[00:03:59] Speaker 02:
Because those experiments, you were submerging the hole stopper, 10 hole stoppers in the solution.

[00:04:07] Speaker 02:
And in practice, you would never have a situation where the entire rubber stopper is submerged.

[00:04:14] Speaker 02:
inside the vial, right?

[00:04:17] Speaker 01:
Again, we're not contesting, Your Honor, that the numbers as found on the board were incorrect or off.

[00:04:23] Speaker 02:
I'm just correcting Brother Wallach then.

[00:04:25] Speaker 02:
It's not just a factor of 10.

[00:04:27] Speaker 03:
Well, it's 10 times 300 times the other mistakes, too.

[00:04:32] Speaker 03:
It's the factor of Wellam's assessment.

[00:04:35] Speaker 01:
But again, I do think that the clear teaching from Pseudo, again, is that you have a much higher number of particulates from a siliconized stopper than a non-siliconized stopper.

[00:04:44] Speaker 01:
And as we've pointed out in our briefing, the question here should have been whether a person of skill would have been motivated to adopt packaging that would have increased the safety risk with this product, which was, again, an emulsion product that already had a number of globules in particular.

[00:05:04] Speaker 02:
Dippervan is an old product, right?

[00:05:08] Speaker 02:
It was already known to put it in a vial.

[00:05:11] Speaker 02:
It was already known to put Dippervan in a vial with a rubber stopper.

[00:05:14] Speaker 02:
And so your contribution to the youthful arts is putting a silicone on the rubber stopper.

[00:05:23] Speaker 01:
There was no evidence.

[00:05:25] Speaker 02:
I'm just trying to understand the context.

[00:05:27] Speaker 01:
That is that is the difference between what siliconized rubber stoppers.

[00:05:33] Speaker 02:
Right.

[00:05:33] Speaker 02:
I mean there were other.

[00:05:34] Speaker 02:
Many examples of siliconized rubber stoppers.

[00:05:37] Speaker 01:
Siliconized stoppers were known, but there is no evidence in the art, Your Honor, that they were ever used with a product like this.

[00:05:43] Speaker 01:
And there's very good reasons for that because, again, it's an emulsion product.

[00:05:48] Speaker 01:
It's different from your typical aqueous parenteral product.

[00:05:53] Speaker 01:
There was evidence in the art that it stripped silicone from packaging.

[00:05:57] Speaker 01:
And it had its own, putting aside whatever the regulatory, applicable regulatory limits were,

[00:06:03] Speaker 01:
It had its own limits, and this is from the Ferranati reference at A412, one of the combination references.

[00:06:12] Speaker 01:
It had its own limits on the number, size, distribution of particles, in particular, oil droplets, that were acceptable.

[00:06:20] Speaker 01:
Because again, it posed a risk to patients if you had too large and too many of these particles in the formulation because it could potentially cause embolism, which again was

[00:06:33] Speaker 01:
something that was known in the art.

[00:06:36] Speaker 02:
Is there a reason why both the United States and British pharmacopoeia standards focus only on 10 micrometer sized particles or 25 micrometer sized particles and doesn't address or seem concerned about particle sizes less than 10 micrometers?

[00:06:56] Speaker 01:
Right.

[00:06:57] Speaker 01:
And I think, again, for aqueous solutions, the concern was particle sizes that were larger because, again, the sphere

[00:07:03] Speaker 01:
that they could lodge in blood vessels and cause complications with patients.

[00:07:08] Speaker 01:
Now, the board essentially was unable to determine, based on the teaching of the various references that we pointed out, as to whether or not a person of skill could have expected combining the prior elements would actually meet these regulatory standards.

[00:07:25] Speaker 01:
If you look at page 19 of the board's decision, it basically says that

[00:07:30] Speaker 01:
It cannot discern from the prior teaching whether or not the product, this combination, would have met those standards.

[00:07:38] Speaker 01:
So in our view, that is an adequate basis upon which to find a reasonable expectation under cases like Honeywell.

[00:07:47] Speaker 01:
But the real problem, as we point out in our briefing, Your Honor, with what was done by the board below, or at least the primary problem,

[00:07:57] Speaker 01:
is its failure to address the sterilization issue that was admitted by a petitioner's expert and their counsel at argument, namely that if a person of skill were motivated to combine these elements, they would have to change the known sterilization method for the prior art product, Dippervan, which was known to be autoclaving, a method of applying steam heat, which was an efficient commercial process.

[00:08:24] Speaker 02:
Does your claim recite autoclaving?

[00:08:27] Speaker 02:
Has the sterilization technique required?

[00:08:31] Speaker 01:
No, but it does recite a sterile composition.

[00:08:36] Speaker 02:
Sure, and there were multiple ways of sterilization.

[00:08:39] Speaker 01:
Well, but again, the undisputed evidence below, Your Honor, was that A, prior art dipper van was autoclaved, and there were only two other means of sterilizing parental products that were known in the art at the time.

[00:08:52] Speaker 01:
One was filtration.

[00:08:53] Speaker 01:
That, again, was not appropriate for this product because it's an emulsion.

[00:08:58] Speaker 03:
You're hanging your head on this because you have nothing else left.

[00:09:02] Speaker 03:
I'm sorry?

[00:09:02] Speaker 03:
I said you are hanging your head on this, which is not in the patent, because you have nothing else left.

[00:09:11] Speaker 03:
You're saying it's your principal argument?

[00:09:13] Speaker 01:
Well, we've made a number of arguments, Your Honor, but this is not our only one.

[00:09:20] Speaker 01:
but but what i don't think we are on this well uh... your honor again the the the the the points not just from sudo but from a multitude of other references that were that were relied on by dr davis and others men men are ma has the same errors doesn't it dr davis's calculations are just as wrong about that well uh... there there was no finding on that your honor and i i don't i don't believe that uh...

[00:09:50] Speaker 03:
The Metamock test measured the number of particulates shed from 10 stoppers immersed in 200 milliliters of solution.

[00:09:58] Speaker 03:
Dr. Davis didn't do any division there, did he?

[00:10:01] Speaker 01:
Well, that may be correct, Your Honor, but again... Well, it either is or it isn't.

[00:10:07] Speaker 01:
I will concede that point, but the issue remains, Your Honor, whether or not a person of skill would adopt packaging

[00:10:17] Speaker 01:
that was known to increase the particulate load with a product that was known to be sensitive to the number and distribution of particulates because it was an emulsion.

[00:10:27] Speaker 02:
When it comes to your auto-claiming argument, the problem I have is the specification of your own 010 patent.

[00:10:35] Speaker 02:
At column seven, line 31, if I can just read the sentence, the present invention's composition is a sterile aqueous formulation and is prepared by

[00:10:47] Speaker 02:
standard manufacturing techniques using, for example, as septic manufacture, sterile filtration, or terminal sterilization by autoclaving.

[00:11:01] Speaker 02:
So, to me, it just looks plain that this inventor has contemplated that all three of these different sterilization techniques are interchangeable and they all

[00:11:13] Speaker 02:
can be applied equally to the quote unquote present invention.

[00:11:16] Speaker 01:
So again, that's language from the specification.

[00:11:19] Speaker 01:
Yes, your patent.

[00:11:20] Speaker 01:
It's our patent, but that's not reflective of what's in the prior art, Your Honor.

[00:11:23] Speaker 01:
And it was undisputed, again, below at A2400 to 01 from Dr. Feinberg that you couldn't filter prior art Dippervan because it was an emulsion.

[00:11:35] Speaker 01:
The patent pertains to a range of different formulations.

[00:11:38] Speaker 02:
So you're saying the patent is

[00:11:41] Speaker 02:
Saying something that's false?

[00:11:42] Speaker 01:
No.

[00:11:43] Speaker 01:
I'm saying that there are formulations within the patent that are different.

[00:11:47] Speaker 01:
Again, the patent pertains to a range of different formulations, some of which may have been capable of being filtered.

[00:11:55] Speaker 01:
And this is a reference, again, to sterile filtration.

[00:11:56] Speaker 02:
Which ones would those be?

[00:11:58] Speaker 02:
You're saying that it's for sure it can definitely be used for other things that are not your particular claims in question here.

[00:12:04] Speaker 02:
Which ones are those?

[00:12:05] Speaker 01:
Well, there are a number of low-oil formulations, for instance, that are much different from the prior Dippervan product, which was a much higher oil content and emulsion.

[00:12:14] Speaker 02:
Does the patent explain that?

[00:12:16] Speaker 01:
It does.

[00:12:16] Speaker 02:
The patent seems pretty broad when it says the present invention can use any one of these three techniques.

[00:12:23] Speaker 01:
Your Honor, again, that's not from the prior art.

[00:12:27] Speaker 02:
It doesn't mean what it says is what you're saying.

[00:12:28] Speaker 01:
Now, I'm saying it pertains to

[00:12:32] Speaker 01:
a description of the invention, some of which does not pertain to the precise formulation that was known as Dippervan in the prior art.

[00:12:41] Speaker 01:
And again, it was undisputed that the prior art teaching was that you couldn't filter.

[00:12:47] Speaker 01:
So your only other option was something called aseptic manufacturing.

[00:12:51] Speaker 01:
And again, the only motivation that was the basis of institution in this case was that you would adopt

[00:12:58] Speaker 01:
a siliconized packaging in order to improve the ease and efficiency of manufacturing.

[00:13:04] Speaker 01:
And again, it was undisputed below that you would need to change the sterilization method, and the only method to change it to would be this aseptic manufacturing, which would require an extraordinary amount of expensive and complicated precautions that you'd have to take and put into place in order to ensure that essentially an entire

[00:13:27] Speaker 01:
manufacturing facility was kept in a sterile, contaminant-free environment.

[00:13:34] Speaker 01:
That simply doesn't square with a motivation to improve the ease and efficiency of manufacturing, Your Honors.

[00:13:42] Speaker 01:
And it was undisputed, again, that the person of skill would need to do this in order to arrive at the prior combination.

[00:13:54] Speaker 01:
So in our view, that undisputed evidence, which was not addressed by the board, is problematic legal error under cases like the Polaris Industries case, which found that the board's failure to address undisputed evidence that would have discouraged the prior combination was a reason for vacating a board decision.

[00:14:15] Speaker 01:
I also want to touch a bit on the

[00:14:24] Speaker 01:
nature of the motivation analysis was applied in this case.

[00:14:27] Speaker 01:
Again, we've discussed this a little bit, Judge Wallach, about whether or not these... You're willing to your rebuttal time.

[00:14:33] Speaker 04:
Do you want to save any of it?

[00:14:35] Speaker 01:
I will save.

[00:14:36] Speaker 01:
Sorry.

[00:14:37] Speaker 01:
Thank you.

[00:14:45] Speaker 00:
Good morning, Your Honor.

[00:14:46] Speaker 00:
My name is Dr. Gregory Gonsalves and I'm representing J. Carl Bass and Eric Spangenberg.

[00:14:51] Speaker 00:
May it please the Court

[00:14:53] Speaker 00:
I just want to set a context for what this appeal is about.

[00:14:57] Speaker 04:
We know what this appeal is about.

[00:14:58] Speaker 04:
Why don't you just get to the merits and address this argument.

[00:15:02] Speaker 00:
Sure.

[00:15:02] Speaker 00:
And there's only a factual issue as to whether one of ordinary skill in the art would have combined the teachings of the prior art in order to achieve the claimed invention with a reasonable expectation of success.

[00:15:13] Speaker 00:
The standard of review of that is that, and this is the Paul Farmer case that I cited in the brief,

[00:15:21] Speaker 00:
The presence or absence of the motivation to combine references in an obviousness determination is a pure question of fact.

[00:15:30] Speaker 00:
The presence or absence of a reasonable expectation of success is also a question of fact.

[00:15:36] Speaker 00:
What a reference teaches and whether it teaches toward or away from the claimed inventions are questions of fact.

[00:15:43] Speaker 00:
And a finding is supported by substantial evidence if a reasonable mind

[00:15:48] Speaker 00:
might accept the evidence to support the finding.

[00:15:53] Speaker 00:
The board's finding that there was a motivation to combine the prior rot references is supported by much more than substantial evidence.

[00:16:01] Speaker 00:
The board reasoned that having considered the full trial record, they were persuaded that a person of ordinary skill in the out would have recognized the advantages of siliconizing rubber closures,

[00:16:15] Speaker 00:
such as ease or efficiency during manufacture would have had a reason to siliconize the bromobutyl rubber closure of Dippervan with the reasonable expectation of success.

[00:16:28] Speaker 00:
The Patent Owner presented no meaningful expert testimony to dispute the board's finding at Dr. Davis's deposition, which is at page 806 of the appendix.

[00:16:41] Speaker 00:
He's, I asked him,

[00:16:43] Speaker 00:
Do you yourself have experience in filling and packaging of pharmaceutical products?"

[00:16:47] Speaker 00:
And he said, no.

[00:16:49] Speaker 03:
He also conceded at page 93 that his calculations were wrong, because I went and got a copy of the death rule.

[00:16:57] Speaker 00:
That's also correct.

[00:16:58] Speaker 00:
And that goes to whether or not I supposedly made it and it was an undisputed admission that you would have had to have changed sterilization methods.

[00:17:08] Speaker 00:
I didn't make any such admission.

[00:17:09] Speaker 00:
That was one argument of several.

[00:17:12] Speaker 00:
In fact,

[00:17:13] Speaker 00:
Most of the replies, several pages of my reply is directed toward any sterilization method that could be used, including autoclave.

[00:17:24] Speaker 00:
And it was directed to the mistake, after mistake, after mistake that Dr. Davis made when he reviewed the data.

[00:17:32] Speaker 00:
So there was no admission that you would have to change sterilization methods.

[00:17:37] Speaker 00:
Instead, I argued for several pages that

[00:17:41] Speaker 00:
The particulate contamination was well below the limits of the U.S.

[00:17:46] Speaker 00:
and British pharmacopoeia, and that Dr. Davis' arguments to the contrary were based upon a flawed analysis of the data.

[00:17:56] Speaker 00:
And you went over some of those things.

[00:17:58] Speaker 00:
I made it clear in the reply, pseudo.

[00:18:08] Speaker 00:
And then the other thing is that the board, as you know, has discretion to determine which expert they're going to find to be more credible.

[00:18:17] Speaker 00:
And they reviewed this, the entire record.

[00:18:20] Speaker 00:
They reviewed all of the mistakes that Dr. Davison made.

[00:18:24] Speaker 00:
And it's not surprising that over and over and over again, in the final written decision, they talk about these mistakes and then they say,

[00:18:34] Speaker 00:
we give credit to Dr. Feinberg's testimony and not to Dr. Davis' testimony because of these error after error after error.

[00:18:42] Speaker 00:
And so the accusation that the board did not consider the arguments made by patent owner is just false.

[00:18:50] Speaker 00:
There are numerous locations throughout the final written decision where the board did consider all of the arguments that were made by the patent owner, and it rejected them because they were based upon

[00:19:03] Speaker 00:
an improper analysis.

[00:19:07] Speaker 00:
Pseudo, as you indicated before, it's off by a factor of 300.

[00:19:11] Speaker 00:
And as you also indicated before, at APX 19, the board indicated that, you know, the particles that are 10 micrometers in diameter or larger were well below the pharmacopoeia standards of acceptable contamination

[00:19:31] Speaker 00:
And by the way, these pharmacopoeia standards, the British and the US, they were introduced by the patent owner.

[00:19:38] Speaker 00:
The patent owner said, look, these are the standards.

[00:19:42] Speaker 00:
And the data indicates that it exceeds, the contamination level exceeds it.

[00:19:46] Speaker 00:
But that's not the case when you look at the analysis.

[00:19:48] Speaker 00:
You find it's all flawed.

[00:19:51] Speaker 00:
They didn't even read the right number from pseudo.

[00:19:53] Speaker 00:
And then the analysis itself was all flawed.

[00:19:55] Speaker 00:
They didn't take into consideration that if you have 10 of them,

[00:19:58] Speaker 00:
It's going to have 10 times as more particulates.

[00:20:00] Speaker 00:
That forces and flexing.

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

[00:20:07] Speaker 00:
Again, CAPES and LOMAX, something that you haven't mentioned.

[00:20:11] Speaker 00:
The patent owner relied on CAPES and LOMAX, but those were syringes.

[00:20:18] Speaker 00:
And just from common sense, and as pointed out by Dr. Feinberg, the area in the inside of a cylinder is where the silicone exists.

[00:20:28] Speaker 00:
is much greater than the area on a stopper that's stuffed into a vial.

[00:20:34] Speaker 00:
And because you have more surface area that's been coated with silicone, you're going to get a higher number of particulates.

[00:20:46] Speaker 00:
It just doesn't transfer to a stopper that's put in a vial.

[00:20:50] Speaker 00:
That analysis was on page 22 of the joint appendix.

[00:20:57] Speaker 00:
Page 23 and 24 of the joint appendix, the board also considered the arguments that contaminants of five micrometers or less.

[00:21:07] Speaker 00:
You can assume we read it.

[00:21:09] Speaker 00:
Okay.

[00:21:09] Speaker 00:
So, and also the other point I'm trying to make is that the board did not misallocate the burden of proof for obviousness.

[00:21:19] Speaker 00:
It did mention that these three particular articles, Romberg, Thiss, and Minnurma, that the data was

[00:21:27] Speaker 00:
ambiguous, but it also at other locations of its final written decision, on page 19 for example, it said that the pharmacopoeia standard set forth the acceptable number of particles that are 10 micrometers in diameter or larger, and here the references referring to Romberg, Digis and Minerma, each report data that includes particles that are smaller than 10 micrometers.

[00:21:49] Speaker 00:
The board went on to say that

[00:21:52] Speaker 00:
We are not persuaded that the data from the Nerges and Tidges would have discouraged a person of ordinary skill in New York.

[00:21:57] Speaker 04:
OK, well, you know what?

[00:21:58] Speaker 04:
We're just reading the board decision.

[00:22:00] Speaker 04:
We've all read it.

[00:22:01] Speaker 04:
Is there any other argument, if not?

[00:22:03] Speaker 00:
Well, the purpose of this was just the point that the patent owner's argument that the board did not consider their arguments as false.

[00:22:12] Speaker 00:
Because if you look at the final written decision, if you look at the reply that I wrote below, we did contest their arguments.

[00:22:18] Speaker 00:
The board did fully consider them.

[00:22:21] Speaker 00:
The only other point I'm trying to make is that, that I will make before I sit down, is that the levels of particulate contamination that's not recited in the claim, and also if you look at the soft copy of the patent and do a search for particulate contamination, you won't find one hit.

[00:22:39] Speaker 00:
It's something that was not even mentioned.

[00:22:44] Speaker 00:
Unless there are any questions, that would be all.

[00:22:46] Speaker 00:
Thank you, Your Honor.

[00:22:49] Speaker 04:
All right.

[00:22:49] Speaker 04:
Mr. Bennett, you have a little bit of rebuttal time.

[00:22:57] Speaker 01:
Your honor, Mr. Gonzales went through a number of things that the board addressed in its opinion, but it's not, I don't think it can be disputed, but it did not address this sterilization issue and the admissions that were made on the record regarding that issue.

[00:23:15] Speaker 01:
And I know there was some suggestion that the issue was not admitted, but I think if you look at the

[00:23:24] Speaker 01:
The declaration from Dr. Feinberg, paragraphs 23 to 24 of his declaration, as well as the admissions that were made by counsel below at the oral argument, it's clear that based on the teaching of references like the Thege 919199 patent and the Minerma reference.

[00:23:42] Speaker 03:
Incite us to a page where he made an admission that you believe is binding.

[00:23:57] Speaker 01:
The declaration references of A879 to 880, as well as if you look at 8311, which is the trial transcript.

[00:24:08] Speaker 01:
So again, in light of those admissions, we don't think it's possible for the board to have found that there would have been an improvement in the ease or efficiency of manufacture.

[00:24:17] Speaker 01:
And if I may, Your Honor, just touch on the obvious.

[00:24:19] Speaker 03:
Where's 8311 in the record?

[00:24:22] Speaker 03:
In the appendix?

[00:24:29] Speaker 03:
Give me a page, because I ordered the entire transcript.

[00:24:33] Speaker 01:
Okay.

[00:24:36] Speaker 01:
I have it as A311, Your Honor, as the trial transcript.

[00:24:40] Speaker 01:
Oh, I'm sorry.

[00:24:41] Speaker 01:
The declaration references A879-882.

[00:24:43] Speaker 01:
Oh, okay.

[00:24:45] Speaker 01:
Got it.

[00:24:46] Speaker 01:
And these were cited in our briefs.

[00:24:52] Speaker 01:
If I may just briefly touch on obvious to try, I want to make sure that it's clear that... That's not a concession at all.

[00:25:02] Speaker 03:
Now, is that a concession?

[00:25:03] Speaker 03:
He says, our response to that is, no, you won't only if you use one particular type of sterilization technique, and there are other sterilizations.

[00:25:11] Speaker 01:
That's precisely the point, though, Your Honor.

[00:25:13] Speaker 01:
And the follow-up question was, do you agree that you need to show that you need to change the sterilization method

[00:25:22] Speaker 01:
to substantiate a finding of obviousness based on this combination, and he said yes.

[00:25:29] Speaker 01:
So the point is that if you'd have to change from autoclaving an efficient, less expensive means to a more expensive, more complicated, more cumbersome means of sterilization like aseptic manufacturing, it undermines the entire rationale for combining the references in the first place.

[00:25:48] Speaker 04:
Okay, Council, we're way over your time, so that concludes our arguments for today.

[00:25:53] Speaker 04:
under submission.