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Our next case this morning is number 221137 in Roche Diabetes Care.

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OK, Mr. Brockland.

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May it please the court.

[00:00:10] Speaker 02:
Good morning.

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My name is Gene Brockland.

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And together with Jennifer LaCroix, we represent Appellant Roche Diabetes Care, whose application for a patent on a glucose monitoring device was improperly rejected, we believe, for obviousness.

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asking that this court reverse and remand the board's decision finding that claims 25 through 45 are rendered obvious in light of Nagakawa and in view of Buller, a finding that we believe is clearly erroneous.

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We ask the court keep in mind three key points from the prior art.

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First, Nagakawa is completely silent about regarding adding

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adjuvants and particularly a gelling agent to its reagent.

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Second, Nagakawa nonetheless requires that its reagent forms a liquid phase reaction system with rapidly diffusing reactants.

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And third, Buller provides, Buller the secondary reference, provides no guidance as to which adjuvants would enhance which reagent properties.

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In light of those points, we believe the board erred in finding obviousness, because there was simply no reason to pluck a gelling agent from bowler and add it to the reagent of Nagakawa.

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And second, doing so would render Nagakawa unsatisfactory for its intended purpose.

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Furthermore, the board committed reversible error when it shifted the burden to Roche

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to establish that combining a gelling agent from Buller with the reagent of Nagakawa would not work.

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That's not Rocha's burden in this case.

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The patent office bears the burden.

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Did you provide evidence to that effect?

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Evidence to the fact of it being unsatisfactory for its intended purpose.

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We believe, Your Honor, that the evidence is simply there on its face, that a gelling agent gels.

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And there was no reason for the examiner to pluck that gelling agent from a laundry list of adjuvants, where you've got 11 different adjuvants that are listed.

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And one of them is a gelling agent.

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And by the plain language of a gelling agent,

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Its purpose is to- What do you mean by clean on its face?

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Sounds to me like this is attorney argument, not evidence.

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Well, Your Honor, I think that words, I think it's more than attorney argument.

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I think that words have a plain meaning.

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And the plain meaning of a gelling agent is something that gels.

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Evidence is required to establish that a gelling agent gels.

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This is a substantial evidence case.

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It is, Your Honor.

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So we're looking for evidence.

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I understand that, Your Honor.

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And you're right that this is a substantial evidence case.

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But there is simply no evidence that a gelling agent would be satisfactory or help in Nagakawa.

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And there has to be some reason.

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There has to be some reason for one skilled in the art to pluck the gelling agent out of this laundry list of adjuvants.

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And there was simply no reason.

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I don't understand that.

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I mean, Bueller says a gelling agent is an adjunct that has benefits.

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It's not plucking it out from a list.

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It's in the list.

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It is in the list, Your Honor.

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It is being desirable and helpful.

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The problem with Bowler is it just says that adjuvants generally are helpful for reagents.

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That's all Bowler really says.

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It doesn't say how the adjuvants would help the reagent or what impact the adjuvants would have.

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You want to use examples of how they can be helpful, right?

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It gives examples, but the examples are very vague, your honor.

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And for instance, it lists, among that list, it includes coloring agents.

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It's unfathomable to me that a coloring agent could possibly be of any benefit in Nagakawa.

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And so that- It makes it easier to read the test results.

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But that's not what Nagakawa is all about.

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Nagakawa is all about.

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It doesn't have to be what Nagakawa is about.

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It's, Mueller says, that's a benefit to using some of these agents.

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That's correct, Your Honor.

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But the purpose of Nagakawa is to speed analysis time.

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And so the question is.

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But that's not Nagakawa's sole objective, right?

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It's not just speed.

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There are other objectives there, too.

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Accuracy and stability, I think, are also listed.

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You're right, Your Honor, that there are other objectives to Nagakawa.

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But the main objective of it, I believe, on a fair reading is that it's about reducing analysis time.

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And that's why it talks about the framework for the physical structure.

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But not reduce the analysis time at the expense of accuracy or stability, right?

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You're right, Your Honor.

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Nobody wants to solely focus on analysis time at the expense of other important objectives.

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That's correct.

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And while I've got you, do you also agree that Nakakawa and Bueller are directed to the same field, glucose testing?

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Generally, they're directed to the same field.

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But the fact that they're just directed to the same field is insufficient to allow the board to shift the burden to Roche to combat

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I don't think you have much of an argument that they shifted the burden of references in there, which we find frequently in board decisions about.

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One, the patentee hasn't shown this or shown that.

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That doesn't, we've repeatedly said that that kind of language doesn't indicate a burden shifting.

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But I understand that, Your Honor.

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But I think the effect of what the court did, of what the board did, was say, you know, Rose, you have to come forward and rebut this.

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And I don't think that was the proper burden to place on Rose here.

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And I don't think that where the board failed and the examiner failed is to provide a reason.

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a reason that one skilled in the art would choose the gelling agent and have a reasonable opportunity of success.

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And that's what the case law does require, is that there be a reasonable opportunity of success.

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And there's nothing in Bowler to suggest that there would be a reasonable opportunity of success when one takes the gelling agent and combines it with the reagent.

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of Naga Kawa.

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Is this the viscosity argument that it actually slows down the Naga Kawa process?

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Well, there is a viscosity issue.

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But I think it's been discussed, perhaps, incorrectly in the briefing.

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The viscosity issue with Naga Kawa was talking about the viscosity of the sample, not of the reagent.

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And so it's not a matter of the viscosity of the reagent.

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In Nagakawa, they were concerned about the viscosity of the sample, the blood sample.

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And the problem with the gelling agent is that it is going to... I thought your argument was that the viscosity of the gelling agent slowed down the process of Nagakawa.

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that it didn't.

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Whereas a claim in advance of Niagara-Kawa was to speed up a reading, using a gelling agent that's got a high level of viscosity in it would actually slow it down.

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And therefore, Niagara-Kawa cannot be an appropriate prior reference.

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And perhaps I must misspoke, Your Honor.

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I do believe that the problem with the gelling agent is the high viscosity.

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And that is going to slow reaction time.

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I think my time is up, and I'll reserve the remainder for rebuttal.

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Thank you.

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Ms.

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Caprahan?

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Good morning, Your Honors, and may it please the court.

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I would only like to address a few points today.

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First, there is sufficient evidence here for the board to rely on that there was a motivation to add the gelling agent from Buller into Nagakawa's reagent layer.

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And that is expressed at 8 ppx 5 and 6 of the decision.

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Second, as to appellant's argument that adding a gelling agent would render Nagakawa unsatisfactory for its objective purpose, as the board properly found, the appellant here did not present any evidence in support of that argument.

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And further, the record evidence actually shows that adding gelling agents was known and conventional in the art, and that Nagakawa would work for its intended purpose.

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And third, the examiner here established its prima facie burden.

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And therefore, the board's decision was properly grounded in section 103 based on the combination of Buller and Akakawa.

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If there are no further questions, I will yield the rest of my time.

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Mr. Rocklin, anything further?

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Yes, just briefly, in rebuttal,

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Bowler simply says that adjuvants have benefits.

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And we don't dispute that, that adjuvants have benefits.

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But it does not express a preference for a gelling agent.

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And there's no reason to pick that gelling agent from a list of adjuvants that generally have benefits for reagents.

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one skilled in the art to sit down and look at Buller and say, out of this list of 11 adjuvants that generally have benefits for reagents, I'm going to choose gelling agents.

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There was no reason to do that and to look now and say that Buller renders Nagatawa obvious is simply hindsight.

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The board should not engage in hindsight.

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It has to be obvious on its face from the prior art.

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It simply was not obvious on its face that Buller, and particularly one specific adjutant out of 11 in Buller, should be added to the Nagakawa reagent.

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Thank you.

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Thank you.

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Thank both counsel.

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The case is submitted.