[00:00:01] Speaker 05:
I know you need some time to clear out.

[00:01:39] Speaker 05:
We're ready when you are, sir.

[00:01:43] Speaker 04:
Good morning.

[00:01:44] Speaker 04:
May it please the court.

[00:01:46] Speaker 04:
Your honors, the board below committed reversible legal error by improperly weighing the evidence of obviousness and unrebutted objective indicia of non-obviousness.

[00:01:57] Speaker 04:
Specifically, the board mischaracterized the problem to be solved in terms of the inventor's own solution, making a questionable showing of obviousness appear strong in hindsight.

[00:02:09] Speaker 02:
In the red brief at 23, Hyperbranch notes that the evidence relied upon by INCEP to establish industry praise, the feature in the publication of orthopedics this week, copied an INCEP press release pretty much word for word

[00:02:27] Speaker 02:
What value does that have in establishing industry praise?

[00:02:31] Speaker 04:
That person that did that was an industry analyst.

[00:02:35] Speaker 04:
He had a reputation in the industry.

[00:02:37] Speaker 04:
He adopted as his own the accurate description that Incept had put forth.

[00:02:46] Speaker 04:
Had he not believed it, he would not have printed it and put it out in his magazine.

[00:02:51] Speaker 04:
That's why he had the value.

[00:02:52] Speaker 04:
Did he testify?

[00:02:54] Speaker 04:
Please, say your honor.

[00:02:55] Speaker 04:
I said, did he testify?

[00:02:57] Speaker 04:
No, your honor, he did not testify.

[00:02:58] Speaker 04:
So how do we know that?

[00:03:01] Speaker 04:
How do you know it?

[00:03:02] Speaker 04:
He had a reputation to uphold.

[00:03:06] Speaker 02:
Was there testimony about his reputation?

[00:03:08] Speaker 04:
No, there was not testimony of his reputation.

[00:03:10] Speaker 04:
And how can you say that to me?

[00:03:14] Speaker 04:
In the declaration of Dr. Sahani, which was submitted in support, he indicated that the analyst was very well known in the industry and had a reputation in the industry and that he would not have adopted it as its own if he did not believe it.

[00:03:31] Speaker 04:
He printed this in an industry magazine that was accepted by the industry and viewed by many people there with respect.

[00:03:40] Speaker 04:
The fact that he accepted INCEP's characterization was that he recognized that it was completely accurate.

[00:03:48] Speaker 02:
Now, as I was saying, additionally, in addition to... I mean, you're so far into speculation and lack of foundation.

[00:03:57] Speaker 02:
I'm not even going to ask any more questions about it.

[00:03:59] Speaker 02:
But if you can't answer me more fulsomely, that's fine.

[00:04:03] Speaker 04:
Well, I want to answer your question, Your Honor.

[00:04:07] Speaker 02:
But as I indicated, in addition to the industry praise, you had to- Take me to the page of the appendix where the affidavit is.

[00:04:19] Speaker 04:
The affidavit for Dr. Sahani, I believe, is

[00:04:26] Speaker 04:
I think it's $44.90.

[00:04:30] Speaker 04:
It's in paragraph 17 of his declaration.

[00:05:07] Speaker 01:
I think you want 28.

[00:05:10] Speaker 04:
Maybe not.

[00:05:20] Speaker 04:
Is that correct?

[00:05:21] Speaker 04:
Is it paragraph 15?

[00:05:27] Speaker 04:
Paragraph 28, Your Honor, at 4484.

[00:05:29] Speaker 02:
OK, where does that declaration state that the

[00:05:37] Speaker 02:
publisher was highly reputable or that he adopted the press release as his own?

[00:05:51] Speaker 04:
All right.

[00:05:51] Speaker 04:
The declaration doesn't show it, but his article, which is attached to it, lists what he did.

[00:05:59] Speaker 04:
If you can look at the appendix at 4813,

[00:06:08] Speaker 04:
That is the article that we're referring to.

[00:06:11] Speaker 04:
It's orthopedics this week, a very reputable article.

[00:06:15] Speaker 02:
You're not answering my question.

[00:06:17] Speaker 02:
You know you're not answering my question.

[00:06:20] Speaker 04:
I don't see how you are.

[00:06:21] Speaker 02:
Really?

[00:06:22] Speaker 02:
Yes.

[00:06:22] Speaker 02:
What you stated to me previously was that the

[00:06:25] Speaker 02:
declaration of your witness established sufficiently that the publisher was A, highly reputable, and B, as a highly reputable person, adopted that press release.

[00:06:42] Speaker 02:
And I don't see it in here, and you're making a representation to me of that.

[00:06:47] Speaker 04:
Well, I believe it's there you honor all right I think it was well out and additionally you have the testimony of all the other neurosurgeons who testified in support of the FDA approval that this was had fulfilled a long-felt need and they didn't say anything about coloration in their

[00:07:05] Speaker 04:
All right, and your honor and that was another error by the board below they didn't have to according to this court's precedence Set in the WPIP versus Kohler case all right this the same issue came up all right it says the board had improperly discounted the evidence of industry praise long felt needs saying that it was that none of the evidence differentiated between a hydrogel with or without the visualization agent and

[00:07:32] Speaker 04:
All right, in WBIP Krohler, they said that proof of nexus is not limited to only when the objective evidence is tied to the supposedly new features of the invention.

[00:07:43] Speaker 04:
This court in Krohler categorically rejected the claim that objective evidence must be tied exclusively to claim elements that are not disclosed in a particular prior reference in order for the evidence to carry substantial weight.

[00:07:57] Speaker 02:
Yet, that's exactly what was- Key word there is exclusively, isn't it?

[00:08:00] Speaker 02:
I said the key word there is exclusively, is it not?

[00:08:06] Speaker 04:
No, the key word is in order to, it must be tied exclusively to the claim elements.

[00:08:10] Speaker 04:
That is correct.

[00:08:12] Speaker 04:
It only needs to be tied to the invention as a whole.

[00:08:15] Speaker 04:
And the question is, is there no question that the claims cover the duraseal product?

[00:08:20] Speaker 05:
But what was the novelty of this invention?

[00:08:23] Speaker 05:
It was all about visualization, was it not?

[00:08:26] Speaker 04:
The novelty of this invention was that it provided an effective dural sealant that could be used in situ

[00:08:36] Speaker 04:
to prevent leakage of fluids and adhesions.

[00:08:40] Speaker 04:
It's the invention as a whole.

[00:08:41] Speaker 05:
It has nothing to do with visualization?

[00:08:43] Speaker 04:
The visualization allowed the person using it, the doctor, to be able to put on a thickness of a predetermined thickness.

[00:08:53] Speaker 04:
Right.

[00:08:53] Speaker 05:
Isn't that what the essence of this invention is?

[00:08:56] Speaker 04:
Well, I hate to speak in terms of the essence of the invention, Your Honor.

[00:08:58] Speaker 04:
It was in solving the problem that the industry faced.

[00:09:02] Speaker 05:
But that had to do with the determining thickness.

[00:09:06] Speaker 05:
That's what this invention is geared to.

[00:09:08] Speaker 05:
It's geared towards introducing a die, right?

[00:09:13] Speaker 04:
It isn't just introducing the die, Your Honor.

[00:09:15] Speaker 04:
It is the whole combination of putting all these together and coming up with an effective dural sealant.

[00:09:22] Speaker 04:
that effectively closes the tissue and prevents leakage.

[00:09:27] Speaker 05:
But the prior art had everything other than the insertion of this dye, this visualization, right?

[00:09:34] Speaker 04:
The prior art did not have everything.

[00:09:37] Speaker 02:
Re reads on every aspect except that, does it not?

[00:09:41] Speaker 02:
Isn't it Re that reads on every aspect except the dye?

[00:09:44] Speaker 04:
Rhee has all the components to the hydrogel except the dot.

[00:09:48] Speaker 04:
That is correct.

[00:09:50] Speaker 04:
But it did not have the visualization agent.

[00:09:54] Speaker 04:
You needed to have the visualization agent.

[00:09:56] Speaker 04:
That's right.

[00:09:56] Speaker 04:
They had to combine it with another piece of prior art, which the board did.

[00:10:00] Speaker 04:
And the art that they combined it to

[00:10:02] Speaker 04:
was art that was chemically different in different bioadhesives, and it was not known that you could take the colorants that they use to put it in a hydrogel being formed in situ to be able to effectively seal the tissue.

[00:10:22] Speaker 04:
And its dramatically beneficial effect of being able to control the application of thickness to obtain a water site seal was not appreciated prior to the invention by the inventors.

[00:10:34] Speaker 04:
In retrospect, in hindsight, if you form this question, as the board did, of merely looking to

[00:10:42] Speaker 04:
Is it just how do we add a dye to?

[00:10:47] Speaker 04:
Hydrogen that is that obviously appears simple however the genius of a lot of inventions is is that in in retrospect all right it may seem preordained But you have to look to what the problem was it was being solved there was a long-felt need out there to

[00:11:06] Speaker 04:
for a sealant that could effectively seal the dura tissue.

[00:11:12] Speaker 04:
And this, despite the fact that the co-seal, which is the prior art, the re-tissue, was commercially available years before the dura seal product.

[00:11:23] Speaker 04:
Yet it didn't solve the problem.

[00:11:25] Speaker 04:
It still had the evidence of all that unmet need only after the inventors did their work.

[00:11:32] Speaker 04:
and came up with a solution which had the visualization agent so that you could effectively seal the dura tissue in situ and create a watertight seal.

[00:11:47] Speaker 04:
That was only done after they did all the hard work of experimenting to show that you wouldn't have the problems caused by the unpredictability in this field.

[00:11:58] Speaker 04:
The invention was twofold.

[00:12:00] Speaker 04:
It was the discovery of the potential for the addition of a visualization agent to be markedly beneficial.

[00:12:06] Speaker 04:
And in the face of the unpredictability of the chemical and physiological arts, it was discovery that colorant could be added without interference with the formation of the hydrogel in situ, without interfering with the quick gel time that was required, without causing problems such as toxicity or lack of biocompatibility.

[00:12:29] Speaker 04:
Now, the board erred in assuming that very small amounts of visualization agent needed to be added to the rehydrogels.

[00:12:37] Speaker 04:
The amount of visualization agent needed to be added to the hydrogel system was unknown and unpredictable at that time.

[00:12:45] Speaker 04:
Bass disclosed a broad range going from 0.01% up to 50% by weight and that typically higher concentrations were needed.

[00:12:57] Speaker 04:
The working examples in Bass typically were 50 times greater than the minimum concentration.

[00:13:02] Speaker 04:
Now, concentration of dye needed to visualize the hydrogel in a situ and thereby control the thickness of the application to obtain the watertight seal could not be predicted.

[00:13:13] Speaker 04:
The extent to which the visualization agent would interfere with the intended hydrogel formation, either by chemical reaction, by steric hindrance due to the size of the bulk of the dyes, or because of low water solubility,

[00:13:27] Speaker 04:
or that it would slow the rate of gel formation or increase the toxicity or the lack of biocompatibility simply could not be predicted.

[00:13:37] Speaker 04:
The board's conclusion of ordinary predictability and motivation to combine and with a reasonable likelihood of success is especially egregious with respect to claim 10, which requires that the hydrogel form within five seconds of contact.

[00:13:53] Speaker 04:
The board took inconsistent positions with respect to RE500, disclosing biocompatible hydrogels and hydrogels that satisfy the five-second gel time.

[00:14:03] Speaker 04:
When considering biocompatibility, the board found that the tetraamino PEG in the RE500 would not be biocompatible.

[00:14:11] Speaker 04:
It would have to be modified to become marginally biocompatible with sulfur hydropeg.

[00:14:19] Speaker 04:
However, when the board relied on the Tetramino PEG and Re500 Table 6 as satisfying the 5-second gel formation time, thus the board relied on the same hydrogels for the fast gel time that the board had said elsewhere in its opinion could not be categorized as being bio-compatible.

[00:14:39] Speaker 04:
The board attempted to justify this, saying that one skilled in the art could have decreased gel formation times by adjusting the pH.

[00:14:51] Speaker 04:
Well, obviously this requires what one of the ordinary skill in the art would have been motivated to do with the expectation of success, not what could have been done.

[00:15:02] Speaker 04:
The combination of the Re587 and methylene blue fails because it fails to consider the poor water solubility effect of the methylene blue.

[00:15:12] Speaker 04:
Re itself specifically discloses that the addition of compounds having poor solubility impedes reaction times.

[00:15:21] Speaker 04:
The one skilled in the art would not have a reasonable expectation that the Re-587 and methylene blue would deal with a hydrogel suitable to coat the tissue and a suitable visualization agent, let alone within the five seconds required by claim 10.

[00:15:38] Speaker 05:
I just want to let you know that you're into your rebuttal time.

[00:15:41] Speaker 05:
So you might want to pause here at the other side.

[00:15:46] Speaker 05:
Thank you.

[00:16:02] Speaker 03:
May it please the court, the petitioned claims in this case cover a trivial improvement over the prior art surgical tissue adhesives and sealants.

[00:16:13] Speaker 03:
The only point of novelty in the claims is the combination of an off-the-shelf commercially available dye with a hydrogel that was known effective as a surgical tissue coating or sealant.

[00:16:28] Speaker 00:
But isn't that exactly the problem?

[00:16:31] Speaker 00:
It's an off-the-shelf glue.

[00:16:33] Speaker 00:
It's an off-the-shelf dye.

[00:16:35] Speaker 00:
And all of a sudden, when these inventors

[00:16:40] Speaker 00:
make this combination, put these components together hadn't been done before.

[00:16:45] Speaker 00:
It turns out to displace everything else to achieve industry praise, sales, and all of the other indicia of success.

[00:16:57] Speaker 00:
If it were so obvious, what took so long?

[00:17:01] Speaker 00:
I mean, why were all these other inferior systems in use for so many decades if this was so obvious?

[00:17:10] Speaker 03:
Your Honor, the facts you describe are not the facts of this case.

[00:17:15] Speaker 03:
The facts in this case are that there is an express teaching in BAS and C that you can improve a surgical tissue adhesive or sealant by adding a dye to improve its visualization, to aid in its placement, engaging in its thickness.

[00:17:32] Speaker 03:
That express teaching was an express motivation

[00:17:36] Speaker 03:
to improve a hydrogel, such as the rehydrogels, in the same way that other polymeric tissue coatings had been improved.

[00:17:44] Speaker 03:
You ask about the praise in the record in this case, but this court's precedents have made clear that praise and other secondary considerations evidence must be tied to what is both claimed

[00:17:58] Speaker 03:
and what's novel in the claims.

[00:18:01] Speaker 03:
And the merits of the invention were not addressed in any of the statements of praise or need.

[00:18:07] Speaker 03:
The statements in the record concerning

[00:18:10] Speaker 03:
and need go only to the watertight sealing characteristics of the hydrogel.

[00:18:16] Speaker 03:
And it's undisputed that the hydrogel, whether clear or colored, may be an effective watertight seal.

[00:18:23] Speaker 03:
The problem with INCEP's evidence of non-obviousness in this case, as the board correctly found,

[00:18:30] Speaker 03:
was that the evidence that was offered of praise and long felt need went only to a watertight sealant.

[00:18:37] Speaker 03:
Now you ask why it was that there was success.

[00:18:41] Speaker 03:
It's important to keep in mind here that Incept sought approval for one indication, which is to seal the brain tissue or dura after surgery.

[00:18:52] Speaker 00:
No, I agree.

[00:18:53] Speaker 00:
The sealant is available, but that's not the accused product.

[00:18:58] Speaker 00:
What's being used or copied is the sealant combined with the dye as these inventors taught.

[00:19:07] Speaker 00:
If the dye has nothing to do with it, why is it so essential in order to compete to include the dye?

[00:19:17] Speaker 03:
Your Honor, it's not essential.

[00:19:18] Speaker 03:
And that's the problem with Incept evidence.

[00:19:21] Speaker 00:
Incept only... In that case, why infringe?

[00:19:24] Speaker 00:
There's then a clear path to acting in this business without infringing.

[00:19:32] Speaker 00:
But the choice has been made, according to the record, to make the product that is explicitly taught in this patent.

[00:19:42] Speaker 03:
Well, Your Honor, with respect to the question of why infringe, the only issue before the board, of course, since this is a PTAB case and out of an inter-parties review, was the obviousness of the claims.

[00:19:55] Speaker 03:
And on this record, we have undisputed evidence that the re-prior art references disclosed every limitation of the claims relating to hydrogels, and that Bass and C disclose every limitation relating to color and expressly teach the combination.

[00:20:11] Speaker 03:
The question here is, did the board err in applying the law or in its fact findings?

[00:20:17] Speaker 03:
And what we have is a record where the only two issues that were left for insects to argue, because it was such a strong obviousness case, were one, secondary considerations, and two, the issue of reasonable expectation of success.

[00:20:31] Speaker 03:
And the board properly applied the law on both of those issues, and its fact findings are subject to deference by this court.

[00:20:40] Speaker 03:
And what the record shows was that on the key issues, there were five buckets of evidence offered regarding secondary considerations.

[00:20:49] Speaker 03:
And the board found that the only one of those groupings of evidence that carried some weight of non-obviousness was the sales data.

[00:20:57] Speaker 03:
But it's important to keep in mind that at the point in time when those sales were generated, Incept was the only company on the market with an FDA-approved Dural Sealant.

[00:21:08] Speaker 03:
There was mention about the CoSeal product, and the question you posed was, why didn't CoSeal take those sales?

[00:21:15] Speaker 03:
CoSeal was approved for sealing vascular grafts for a completely different indication that dealt with vascular surgery and sealing up the stitch holes in veins and arteries after they had been patched up.

[00:21:29] Speaker 03:
And so CoSeal was on the market as a clear hydrogel sealant for a completely different purpose.

[00:21:36] Speaker 03:
The reason that

[00:21:37] Speaker 03:
CoSeal was not taking the Durall ceiling market was that they didn't have an FDA approval for that indication.

[00:21:45] Speaker 03:
And so the evidence in the case only shows some evidence of non-obviousness with respect to sales for a period in time when Incept was the only company on the market with an approved Durall ceiling.

[00:21:58] Speaker 03:
And this court has recognized that when a company is the only one on the market with an FDA approval,

[00:22:04] Speaker 03:
evidence of 100% market share is not entitled to very much weight.

[00:22:09] Speaker 00:
Is that what you... Just one question.

[00:22:14] Speaker 00:
Doesn't the record say that for surgical use, FDA approval is not required?

[00:22:21] Speaker 03:
Doctors are allowed to use products off-label.

[00:22:25] Speaker 03:
And there is some evidence in the record that other things, such as fibrin glues and cyanoacrylate compounds, were used.

[00:22:32] Speaker 03:
It also is clear in the record that the prior art cyanoacrylate compounds that were used included products that were colored blue.

[00:22:40] Speaker 03:
And that's the C reference that involves a cyanoacrylate sealant that's colored blue.

[00:22:46] Speaker 03:
And so the fact of including a dye to improve the visualization of a surgical tissue sealant or coating is something that was well established.

[00:22:57] Speaker 03:
It was known as an improvement that was desirable to make.

[00:23:02] Speaker 02:
Now, I'd like to- Is your FDA argument, approval argument, what you mean when you talk about untethered tube barriers to entry and other information in page 16 of your red brief?

[00:23:17] Speaker 03:
Your Honor, the argument that we're making is that the key problem with the evidence that was offered by INCEPT, as found by the board at pages 55 to 57 of the appendix, was that the evidence that was offered other than sales only went to characteristics of a hydrogel without distinguishing between colored or uncolored.

[00:23:41] Speaker 03:
A hydrogel, whether clear or colored, provides a watertight seal.

[00:23:46] Speaker 03:
Establishing that there was a need for a watertight sealant is just establishing a need for the prior art re-products.

[00:23:54] Speaker 03:
It's undisputed that the prior art included hydrogel surgical sealants that were uncolored for other purposes.

[00:24:02] Speaker 03:
And this court's presidents have acknowledged that when that's the case, whether they were on the market with an approval for the indication that INCEPT got is not the question that needs to be asked when the question of obviousness is addressed.

[00:24:15] Speaker 03:
I'd like to very briefly address and respond to each of the points that INCEP's counsel has made.

[00:24:20] Speaker 03:
There was reference to the importance of the indication for Durrell ceiling.

[00:24:25] Speaker 03:
I'd like to point out to the court that none of the claims in this case

[00:24:29] Speaker 03:
Recite or are limited to sealing the dura of the brain the claims are very broad and only cover a preparation of a hydrogel includes the hydrogel and the dye Only in column 8 in fact of the patent is there even a mention of one potential embodiment which includes Dural sealing turning to the predetermined thickness reference made by council for insect there are other claims in the patent that address the requirement of a particular thickness of application

[00:24:59] Speaker 03:
and discuss how the use of the dye can aid in that process.

[00:25:04] Speaker 03:
The claims here do not include that predetermined thickness limitation.

[00:25:09] Speaker 03:
There is a mention that the Bass and C dyes teach other chemically different tissue adhesives and sealants.

[00:25:16] Speaker 03:
That's inaccurate.

[00:25:17] Speaker 03:
Bass was found by the board to expressly incorporate the Nasa Duque reference, and it's undisputed that Nasa Duque's fibrin glues were a type of a hydrogel.

[00:25:27] Speaker 03:
Moving on to the question of hindsight, as we've mentioned in the briefs, in a case such as this one where the board made express findings that Bass and C expressly teach the improvement that's at issue here, that it was beneficial to add a dye to a surgical tissue sealant or adhesive,

[00:25:45] Speaker 03:
There isn't the problem with hindsight you might have in another case.

[00:25:49] Speaker 03:
And INCEPT has never been able to overcome that.

[00:25:51] Speaker 03:
Turning quickly to BAS, there was a mention that there was no starting point for BAS in terms of the concentration that the range was too large.

[00:25:59] Speaker 03:
As mentioned in both the petition and in Dr. Lohman's expert report, BAS claimed 40.

[00:26:04] Speaker 03:
Not only mentions methylene blue and endocyanine green, two of the three dyes that were relied upon by the board and its findings of obviousness

[00:26:14] Speaker 03:
But it claims that in a range of 0.01 to 10%.

[00:26:19] Speaker 03:
The BAS patent itself points the person of ordinary skill to use methylene blue and indosine 9 green at the 0.01% concentration.

[00:26:31] Speaker 03:
Turning to claim 10, I only heard argument, at least initially, about RE-500.

[00:26:36] Speaker 03:
I'd like to remind the court that the RE-587 patent was indisputedly biocompatible.

[00:26:42] Speaker 03:
It's important to note that the board found all the claims invalid four ways over four grounds.

[00:26:47] Speaker 03:
Two of the grounds were the RE-587 reference, admittedly biocompatible, instantaneous gel time.

[00:26:54] Speaker 03:
That's undisputed.

[00:26:55] Speaker 03:
The board reasonably found, based upon evidence,

[00:26:58] Speaker 03:
that a person of ordinary skill would expect success in adding a dye to an instantaneous gelling hydrogel of Re587, and that you'd easily get to a gel in less than five seconds.

[00:27:10] Speaker 03:
That's undisputed in the record.

[00:27:12] Speaker 03:
With respect to Re500, the only argument with respect to claim 10 is the alleged bulkiness and low water solubility of methylene blue.

[00:27:23] Speaker 03:
That issue is not a basis.

[00:27:26] Speaker 03:
for any finding of reversal, because Dr. Mays, Incep's own expert, conceded on cross-examination that Aldrich Chemical Company, during the prior art period, sold aqueous solutions of methylene blue as a dye at concentrations of 0.05%.

[00:27:45] Speaker 03:
Five times the concentration that Bass says is a preferred concentration to add as a dye, particularly for methylene blue.

[00:27:53] Speaker 03:
There's no question Dr. Mays, Incep's expert,

[00:27:56] Speaker 03:
conceded that the aqueous solution you could buy from methylene blue was in a dropper bottle, and you could put it into a solution, and it would turn the water blue.

[00:28:06] Speaker 03:
With respect to the question of steric hindrance or bulkiness, last issue I'd like to address.

[00:28:12] Speaker 03:
The board's fact findings here were quite clear.

[00:28:15] Speaker 03:
Dr. Lohmann, hyperbranch's expert, offered a calculation explaining that at Bass's concentration of 0.01%,

[00:28:25] Speaker 03:
The concentration of the electrophilic functional groups in the hydrogel precursor, the nucleophilic functional groups in the hydrogel precursor to the dye would be 1000 to 1000 to 1.

[00:28:37] Speaker 03:
And that even if you had some minor amount of steric hindrance, that the concentration of the functional groups was so much larger than the concentration of the dye,

[00:28:49] Speaker 03:
that no person of ordinary skill would have any expectation that gel time would be slowed meaningfully or that there would be an interference problem with the gel formation.

[00:28:59] Speaker 03:
In response, Dr. Mays conceded on cross-examination several important things.

[00:29:05] Speaker 03:
First, he emphasized that steric hindrance was a major problem, but the board found that testimony was speculative.

[00:29:12] Speaker 03:
Because while agreeing that concentration of the dye was important to consider,

[00:29:17] Speaker 03:
he conceded that he had not considered concentration effects in developing his opinions, and the reason why was pretty plain on the record.

[00:29:26] Speaker 03:
If he had considered concentration effects, it would have been clear, and he would have had to concede that at the very low concentrations necessary for a dye to color a hydrogel, there would be no interference, steric or otherwise.

[00:29:41] Speaker 03:
This is a case where the board, in a carefully reasoned 60-page opinion,

[00:29:47] Speaker 03:
methodically went through every issue, applied the law in accordance with this court's precedence, considered the totality of the evidence before reaching any decision on obviousness.

[00:29:59] Speaker 03:
There were no shortcuts here where the first three grand factors were used to establish a prima facie finding of obviousness.

[00:30:07] Speaker 03:
The board considered the totality of the evidence and on that totality found

[00:30:13] Speaker 03:
in a reasoned, carefully and lengthy decision that every single one of the claims was invalid four ways.

[00:30:21] Speaker 03:
And every issue raised by Incept in this appeal raises a substantial evidence review question other than the very preliminary question of whether the board recited and applied the law correctly on the question of secondary considerations.

[00:30:37] Speaker 03:
The board's findings were well supported by evidence and are entitled to deference by this court.

[00:30:42] Speaker 03:
Thank you.

[00:30:49] Speaker 04:
Oh, Your Honor, first of all, the WBIP versus Kohler case was not followed by the board.

[00:30:58] Speaker 04:
That case says you have to consider the invention as a whole.

[00:31:02] Speaker 04:
All of the praise, all of the long-felt need was to Duracell as a whole.

[00:31:07] Speaker 04:
There was never any praise, anything differentiated by saying that, hey, it's just because of the qualities of the hydrogel, such as the re-prior art that was out there.

[00:31:19] Speaker 04:
You have to look at the invention as a whole.

[00:31:20] Speaker 04:
It talked about Duracell.

[00:31:22] Speaker 04:
So it's improper for them to discount that.

[00:31:24] Speaker 04:
With regard to being praised and Longfellow Need being commensurate with the scope of the claims, the in-rate chuck case that we cite says you don't have to have exact commensurate with the scope.

[00:31:38] Speaker 04:
In that case, they had claims going to crops.

[00:31:40] Speaker 04:
There was commercial success with regard to corns and soybeans and praise, and that was sufficient.

[00:31:47] Speaker 04:
With regard to the RE587 and the Methylene Blue issue,

[00:31:50] Speaker 04:
He said you could have the aqueous solution of 0.05 that was for sale.

[00:31:57] Speaker 04:
Lee itself says that when you have something which has poor solubility, such as the methylene blue, it affects the reaction times.

[00:32:08] Speaker 02:
Where is that in the record, please?

[00:32:11] Speaker 04:
Yes, your honor.

[00:32:15] Speaker 04:
That is in...

[00:32:20] Speaker 04:
If you look at our blue brief at page 43, we cite to where that is in the record.

[00:32:28] Speaker 04:
It has the specifics on that page as to the columned in line numbers and where it said that specifically discloses additions of components having poor solubility impedes reaction time.

[00:32:42] Speaker 02:
You said re-mention methylene blue.

[00:32:44] Speaker 04:
I want to know where it is.

[00:32:47] Speaker 04:
No, re-talking about, not as mentioned, methyl and blue.

[00:32:50] Speaker 04:
It says that ones with having poor solubility.

[00:32:54] Speaker 02:
But methyl and blue doesn't necessarily have poor solubility.

[00:32:59] Speaker 02:
It comes in an aqueous solution, does it not?

[00:33:02] Speaker 04:
It can come in, that's correct, but it is in the record that it does have poor solubility.

[00:33:09] Speaker 04:
That's set forth itself in the 034 patent itself.

[00:33:13] Speaker 04:
That's in the appendix at 97.

[00:33:18] Speaker 04:
And it's in our reply brief at 25 and at footnote 36.

[00:33:23] Speaker 04:
Finally.

[00:33:24] Speaker 04:
This case affords the court an excellent opportunity to clarify the law on the treatment of objective condition of non-obviousness, to make clear that secondary considerations come second approach is improper as a matter of law.

[00:33:38] Speaker 04:
You shouldn't have an improper shortcut that converts three of the grant funds.

[00:33:44] Speaker 05:
Did you say we should clarify our law?

[00:33:46] Speaker 04:
Yes, I do, Your Honor.

[00:33:47] Speaker 05:
Well, don't you think, doesn't our law say we have to overturn our law?

[00:33:52] Speaker 05:
Because doesn't the law obviously allow?

[00:33:55] Speaker 05:
We've had hundreds of cases where you deal with the prima facie case of obviousness.

[00:34:01] Speaker 05:
And then, of course, before you reach an ultimate conclusion, you go to the secondary considerations.

[00:34:07] Speaker 05:
So are you asking us to overturn all of those cases?

[00:34:10] Speaker 04:
You have to make it consistent out there that the secretary of non-obviousness is not a rebuttal.

[00:34:20] Speaker 04:
All right.

[00:34:21] Speaker 04:
It is one of the four factors of RAM and has to be considered before you arrive at the obviousness conclusion.

[00:34:28] Speaker 05:
In the blue brief, we told you- Didn't the board here consider the secondary considerations before it arrived to this conclusion of obviousness?

[00:34:37] Speaker 05:
That's quite clear that it did, right?

[00:34:39] Speaker 04:
Well, Your Honor, I would tend to disagree with that.

[00:34:42] Speaker 04:
If you look under the blue brief at page six, where we cited what Judge Salward said,

[00:34:47] Speaker 04:
is that there is a strong case of obviousness.

[00:34:50] Speaker 04:
Secondary considerations don't rebut that.

[00:34:53] Speaker 04:
All right, that was the way that they followed in determining.

[00:34:58] Speaker 04:
First of all, they made the mistake of characterizing problems.

[00:35:01] Speaker 02:
They did a secondary considerations analysis, did they not?

[00:35:04] Speaker 04:
They did do a secondary considerations, a flawed one because they didn't follow WBIP versus Kohler.

[00:35:09] Speaker 04:
They discounted the secondary considerations contrary to that precedent.

[00:35:14] Speaker 04:
OK, we're out of time.

[00:35:15] Speaker 05:
Thank you.

[00:35:16] Speaker 05:
I'm going to thank both sides and the case is submitted.

[00:35:25] Speaker 05:
The next case for argument is 18-2207, Alleghen, vicious standards.