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The United States Court of Appeals for the Federal Circuit is now open and in session.

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Please be seated.

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Our first case today is number 2017-1178, American InnoTech versus United States.

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How do I pronounce your last name?

[00:00:34] Speaker 05:
My name is Daniel Ernsberger.

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Okay, Mr. Ernsberger, please proceed.

[00:00:50] Speaker 05:
Good morning.

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My name is Daniel Ernsberger.

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I represent American Inatech in this case.

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This

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is a patent infringement case involving a urine collection bag.

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This urine collection bag makes use of a very special kind of super absorbent polymer.

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This particular super absorbent polymer does a unique thing.

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It separates the incoming urine in the urine collection bag into two parts.

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The first part is a gel, which is sort of the expected result of the use of a super absorbent polymer.

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And the second part is an unsequestered liquid, which is the surprising part of the super absorbent polymer.

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That's why we call this

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a gelable hydrophilic material because it is not an ordinary super adsorbent polymer.

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It forms a gelled mass at the bottom of the bag and also it forms a liquid layer which is the unsequestered liquid and for 30 seconds they coexist in the bag.

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And after 30 seconds, it all becomes gel.

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So this is the temporary phenomenon when the gelling is still underway and not completed.

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Well, I don't think that's quite the way to say it.

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The prior art has gel that is sort of liquidy that goes to a solid gel.

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It's a transition.

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all prior art super absorbent polymers do.

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It forms a thin gel to a thick gel.

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This is different because it forms a gel at the bottom and floating on top is a liquid which is not part of the gel.

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It's physically separable.

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I have an exhibit, I'll show you that.

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This is the urine collection bag.

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The Air Force pilot goes on extended missions

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They eat lunch, sometimes dinner.

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They certainly urinate.

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They urinate into the top of the bag.

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It goes down through the funnel, mixes with the polymer.

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The polymer forms this gel at the bottom with the liquid floating on top.

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When the bag is finished used, it's closed.

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I want to illustrate the separation of the liquid from the gel.

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For that purpose, I brought a video clip from

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The defendant's expert.

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This is Mr. Richard Moran.

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He's the expert witness for the defendant.

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He is testing plaintiffs, the urine collection bag that is in this case.

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And he, at this point of the video clip... I'm sorry, when you say plaintiffs, that's in the case, it's not the accused's product.

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It's just your embodiment of your own patent.

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He is testing the accused's product.

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Oh, the accused's product.

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OK.

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And he is saying at this point in the video that the accused product does not leak.

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He says, I would have to say it does not leak.

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So it's doing what it's supposed to do.

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When the Air Force pilot is using the air inflection bag, you can turn it upside down, and it will not leak.

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And that's what he's saying in this part of the video.

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But to answer your question, what I really wanted to show you was that when he's turned this bag upside down,

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There are two parts.

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This white part, snowball-looking part, is the gel.

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That is the conventional thing that everybody thinks of when they say gel.

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Below it is a murky liquid that sits beside the funnel, at the bottom of the funnel.

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They are physically separated.

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When he turned the bag upside down, the liquid drained out of the gel and landed on the funnel down here.

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And is that an unsealed bag?

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Yes, this is unsealed.

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This is the bag, and it is open, and it remains open down here.

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So the fluid would like to just flow right down, but it's not flowing right down.

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That's the really remarkable thing about this.

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So there's two things that you need to understand about this to understand validity.

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The first thing is that there is a liquid that separates from the gel.

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If you look at all the prior art patents, you will see that there's a gel.

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It goes from a transition of soft gel to hard gel, but there's only one gel.

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There's no liquid.

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So if you look at the prior art inventions, if a person of ordinary skill of the art looks at those patents, they will make a bag

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without a funnel.

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You see, all the prior art patents have a gel with no separate liquid.

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And so they would say, okay, I have gels, no liquid, I don't need a funnel.

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And so the natural course, the expected course of an invention would be to form a gel here and no funnel because they don't need a funnel because there is no liquid.

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And so that is the first thing that is really important that you need to know about this patent.

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So am I remembering incorrectly or correctly that the prior art product, the Piddle Pack with Sponge, had a funnel?

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Yes.

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And then the Milspec B, or I don't know whether it was A or B, it doesn't matter, they were both prior, said,

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you can use a sponge or granular material.

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So if you were starting with the widely used Piddle Pack with sponge with a funnel, and as prices for super absorbent material came down and they became more familiar, why wouldn't you just use that in the same bag that you have the sponge in before, rather than saying, oh, I don't need the funnel, take it out?

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OK, let's go with that thought.

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I like that thought.

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Let's go with it.

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That's the second point I want to make here.

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The piddle pack is the same as this bag, except that it has a funnel, I mean a sponge here instead of the hydrophilic material.

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When water enters the sponge or urine enters the sponge, it drains out of the sponge

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and goes zooming right through this funnel.

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That's why the tram study was done.

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That's why they found that the urine collection bag, the benzel bag, was unsanitary and unsafe.

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They don't want urine splashing all over the cockpit.

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And so in the benzel product, this is a sponge.

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The urine goes in, the urine comes out, and it splashes all over the cockpit.

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That's just the way

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This same identical funnel works with a sponge.

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So the really remarkable thing about this patent is that it doesn't flow out.

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If a person of ordinary skill in the art were to look at the benzel bag, they'd say, it's going to flow out, because that's what it does.

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A PRAM study confirmed that.

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But this one doesn't.

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And that's what's really remarkable about this particular year in connection.

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But what about the fact that what the court relied on was benzel as modified so that instead of using a sponge, there would be the granulate material?

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Right.

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Let's talk about what the court relied on.

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The court, there were two attempts to prove how this worked.

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The first attempt was by the

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trial testimony.

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Mr. Richard Moran said that the reason why this works and the Benzel bag does not work, he said the reason why it works and the Benzel bag does not is because there's a change in viscosity.

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That's what he said in his pretrial statement at page

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Appendix 156.

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And in the appendix, in his pretrial statement, he says this works because there's a change in viscosity.

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But they never repeated that at trial.

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And the reason why he couldn't repeat it at trial is because there was no prior art to suggest that this will work, that the fluid will not flow right through.

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There is no prior art to say that the viscosity will change.

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There is no prior art to say that the change in viscosity will stop the fluid from going through.

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And so they couldn't say that at trial, and they didn't say that at trial.

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Now, to answer your question, how did the judge come to that conclusion?

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The way she did it is she misquoted the testimony.

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I would like you to look at appendix page 62.

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That's her testimony.

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I mean, that's her quote of the testimony.

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And in her quote of the testimony, appendix page 62, she says that the physical properties change, dot, dot, dot.

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And therefore, it doesn't flow out.

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However, the real, the complete testimony

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that she should have included without the dot dot dot says that physical properties change, but we don't know why.

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Even today, with 20-20 hindsight, we still don't know why this fluid does not flow out.

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Can I ask you, I understand the points that you're making today, but one of the problems with your argument is that maybe the claim that I don't see where this is claimed.

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The claim doesn't talk about turning it upside down and absolutely nothing will ever come out.

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It just talks about having particular structural properties, and those seem to be satisfied by the combination that was relied on by the trial court.

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In terms of that claim, it says prevent escape.

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It says that this particular structure prevents escape of the liquid.

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And so it gives structural elements, the pattern of the bag.

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And it gives the final structural element.

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And it gives the closure structural element.

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But throughout the claim, it says, as a result, it prevents escape.

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Preventing fluid from being expelled from the bag.

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Yes.

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OK.

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And there's two parts of the claim.

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One is preventing the escape before 30 seconds.

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And the other part is preventing escape after 30 seconds.

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The one claim element, the funnel prevents escape before 30 seconds.

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The full gelation prevents escape after 30 seconds.

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And then after the whole process is completed, then they seal the opening here.

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But yes, the claim is made that it is a functional prevents escape kind of product.

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And that's why it is so important.

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But what I would like you to do is compare the trial court's statement on page 62 to the claim construction hearing, which you quoted on page 105.

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And if you compare those two pages, you will see that by using three dots, the trial court eliminated the uncertainty that exists today as to why

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This happens.

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Mr. Ernsberger, you're using up your rebuttal time.

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Do you want to save any?

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I'll just run one more minute and then I'll be back.

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The other thing I wanted to say is that there is clear evidence of non-obviousness based on objective indicia.

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Defendant's expert says that

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This is in his report and a trial.

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He says, whether others copied the claims and invention in ways in favor of non-obviousness.

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And then he says, as a fact, that he looks to as important, although military specification permitted the use of gangrene or hydrophilic material, it appears the NYCIV only began making the Piddle Pack with powder after learning of the Inatech invention.

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And this is his words.

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Defendants expert is saying,

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This is objective evidence that weighs in favor of a finding of non-obviousness.

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Yes, I'll reserve the rest for everybody.

[00:15:03] Speaker 03:
Thank you, Mr. Fargo.

[00:15:18] Speaker 01:
Thank you, and may it please the court.

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The obviousness case that we presented is, I think this court has recognized, focuses on the structure of the accused device.

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It's that the holding is basically, if the claims cover the accused device, they'd be invalid for obviousness.

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We have also two alternative bases for affirmance I just wanted to mention.

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The court obviously doesn't need to get to them if it agrees that the decision of the trial court should be affirmed, but otherwise,

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There is also a failure of proof on a means plus function limitation and a claim construction issue, which was based purely on de novo, I'm sorry, on intrinsic evidence, so it's reviewable de novo, which also would lead to known non-infringement and the same result judgment for the government.

[00:16:09] Speaker 01:
A couple of things and obvious.

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Can I ask you about the portion of the

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obviousness analysis before one gets the secondary consideration.

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And my recollection is as follows, and tell me whether it's right or wrong or complicated.

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Anyway, make it correct.

[00:16:29] Speaker 04:
That the trial court said it was quite obvious to take the piddle back with sponge bag, which kind of is represented in the prior Art Benzel,

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and substitute for the sponge a super absorbent polymer.

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That by itself, without more, doesn't get to the limitation that I think the other side is focusing on.

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Such that flow of any unsequestered fluid within said bag back towards said funnel means acts to close said funnel means to prevent escape

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of said unsequestered fluid.

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And how does one and what does the evidence say and what did the trial court find about why it was obvious to meet that limitation?

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What the trial court specifically found was the B specification requires also some internal means of preventing escape of fluid.

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And that is the funnel means that is in the Benzel bag and in the Piddle Pack with sponge.

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It also found that specification required no more than 30 milliliters escape by virtue of having the fluid flow among the sides of the bag, which, by the way, is also disclosed in Benzel as a mechanism of preventing escape.

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And that requirement of 30 milliliters is in the B specification.

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So that's how it works.

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Where in the trial court's opinion does it say, and it would be obvious to meet this admittedly functional non-structural requirement, either, and I can imagine, you have an inherency argument, so that might be your answer.

[00:18:33] Speaker 04:
But first, start with what did the trial court specifically say about that claim element?

[00:18:38] Speaker 01:
Yes.

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It's at Appendix 64.

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And it says, Mill Spec B describes your containment bag with an opening or neck of the bag that incorporates means for preventing spillage.

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When the bag is inverted, shall not impede flow input.

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It then goes to the court's claim construction of no more than 30 cubic centimeters shall it

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shall escape," and then concludes, Mill B, spec B, discloses this exact limitation in its inverted leakage test.

[00:19:13] Speaker 01:
So that's where the court got there.

[00:19:15] Speaker 01:
Now, as you recognize, we also have the argument of inherency that basically this is a statement of intended result because this claim to structure.

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And the structure of the accused

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Piddle pack with powder results from the substitution of the super absorbent polymer.

[00:19:36] Speaker 04:
So did the evidence indicate and did the CFC find that, I guess those are two separate questions, that regardless of what particular super absorbent polymer you use, this property will inherently result

[00:19:57] Speaker 01:
I don't think it found it specifically for the Piddle Pack, but what the evidence does show, because we're talking about the same structure, is that when you make that substitution and the polymer we use, which is disclosed in Sherman, is sodium polyacrylate.

[00:20:18] Speaker 01:
And the trial court did note that the same polymer was disclosed in the prior art.

[00:20:24] Speaker 01:
as is used in the Piddle Pack with powder, as is described in the patent also.

[00:20:31] Speaker 01:
I do want to mention one thing.

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Appellate's counsel said that some special superabsorbent polymer is used.

[00:20:41] Speaker 01:
There's no testimony that that's the case.

[00:20:45] Speaker 01:
It's sodium polyacrylate.

[00:20:46] Speaker 01:
There's nothing in the patent that really talks about any really special properties.

[00:20:51] Speaker 01:
It's described as sand wet.

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in the patent.

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And that's preceded by a statement that commercially suitable, commercially used superabsorbent polymers are regularly used in diapers, amongst other things.

[00:21:05] Speaker 01:
So there really isn't any testimony.

[00:21:09] Speaker 01:
With regard to the liquid layer, this is the process of gelation.

[00:21:14] Speaker 01:
There's no real chemical change.

[00:21:15] Speaker 01:
There's certainly no testimony that there was any.

[00:21:23] Speaker 01:
I think that our point, as we've said, is in terms of teaching, Sherman and the admissions made both in the patent and by the inventor and American and a text expert indicates that polymers were commonly used, particularly sodium polyacrylate, to absorb urine and to absorb liquid.

[00:21:51] Speaker 01:
Suggestion is in the B-Spec.

[00:21:54] Speaker 01:
Motivation is in the unrebutted testimony of Mr. Moran that by the time the invention was made, super-absorbent polymers, because of their widespread use in disposable diapers, had become cheaper than sponges.

[00:22:09] Speaker 01:
Clear economic motivation.

[00:22:13] Speaker 01:
The Jelza patent notes that they are preferable to sponges.

[00:22:18] Speaker 01:
They work better for absorbing urine

[00:22:20] Speaker 01:
There is no reference that teaches against.

[00:22:23] Speaker 04:
And that's in part because when you squeeze the bag, when you squeeze a sponge, the liquid comes out not true of the gel.

[00:22:30] Speaker 01:
Yes.

[00:22:30] Speaker 01:
The gel, say, has a statement that's similar to a statement in the Young patent on that advantage.

[00:22:40] Speaker 01:
So for these reasons.

[00:22:41] Speaker 04:
Can I ask you something?

[00:22:42] Speaker 04:
Sure.

[00:22:42] Speaker 04:
I know in a switch to the objective and issue.

[00:22:46] Speaker 04:
Yes.

[00:22:47] Speaker 04:
So it seems to me that the

[00:22:50] Speaker 04:
opinion of the trial court several times made an overstatement about a categorical principle that when the prima facie case, the arc-based side of the obviousness analysis, is strong, secondary considerations cannot overcome that.

[00:23:17] Speaker 04:
Most of what the opinion cites doesn't say that.

[00:23:22] Speaker 04:
One passage in one opinion has a sentence that can be read that way, but we've, I think, pretty consistently made a much more context-specific judgment.

[00:23:34] Speaker 04:
Is that an error that requires reconsideration?

[00:23:37] Speaker 01:
No, I don't think so.

[00:23:38] Speaker 01:
I think if you read fairly, and I'll agree with you, that you can find a passage

[00:23:44] Speaker 01:
here and there that seems to set up.

[00:23:45] Speaker 04:
Well, maybe just here.

[00:23:46] Speaker 04:
I'm not sure I found one except for one sentence in one.

[00:23:49] Speaker 01:
Yes.

[00:23:50] Speaker 01:
But if you take a look, I think as a whole, at what the trial court did, first it carefully considered objective evidence, it would be able not to.

[00:23:58] Speaker 01:
Second, it withheld a decision on whether or not the claims had been proven obvious until it had weighed and considered objective evidence.

[00:24:08] Speaker 01:
which is what I think the court requires.

[00:24:10] Speaker 01:
Certainly, even in a case like Beer v. Watson, where the panel of this court reversed the district court's finding of non-obviousness and held that they claim we've been obvious, the words prima facie are never used in that opinion.

[00:24:28] Speaker 01:
But what the court does after noting that, yes, there is objective evidence, it goes on to discuss the teachings of the prior art.

[00:24:37] Speaker 01:
in ways that indetermines the invention would have been obvious.

[00:24:40] Speaker 01:
And I think that's what the trial court does here as well.

[00:24:44] Speaker 01:
It takes a look at the objective evidence, which I would say is not compelling.

[00:24:50] Speaker 01:
There's some evidence of commercial success.

[00:24:53] Speaker 01:
It's a two-year span.

[00:24:54] Speaker 01:
There's no indication of how it stacks up in the marketplace.

[00:24:58] Speaker 01:
It's really just American Intertech selling one and perhaps not being

[00:25:04] Speaker 01:
more interested in selling their somewhat more expensive briefer leaf than restop.

[00:25:11] Speaker 01:
But it's that.

[00:25:12] Speaker 01:
The trial court did give some weight to long felt need.

[00:25:19] Speaker 01:
But it's not compelling.

[00:25:21] Speaker 01:
If you take a look at the Pram study out of 600 questionnaires, only 15 responses it really said, this is something we really need.

[00:25:30] Speaker 01:
That's not something that bespeaks a long felt need.

[00:25:34] Speaker 01:
And copying, in terms of copying, the only thing that was copied was the use of super-absorbent polymers to absorb and gel urine, something that had been done.

[00:25:46] Speaker 04:
But I thought that your basic theory is that if you take the old bag, replace the sponge with super-absorbent polymer, we've now arrived at the thing.

[00:25:56] Speaker 01:
I think that's exactly it.

[00:25:57] Speaker 04:
At the claimed invention.

[00:25:59] Speaker 04:
And yet that wasn't done for a long time.

[00:26:03] Speaker 04:
And that appears to have been copied.

[00:26:06] Speaker 01:
They're by one company.

[00:26:08] Speaker 01:
But in that George Martin case, which the trial court relies on, it indicates that you need more.

[00:26:16] Speaker 01:
There's several other features of the product that were not copied.

[00:26:22] Speaker 01:
And I should those kind of segue into two things I did want to discuss before I run out of time, which is also the closure mains issue.

[00:26:33] Speaker 01:
makes it clear that just performing the function isn't enough.

[00:26:38] Speaker 01:
The means plus function claim never covers just the function.

[00:26:44] Speaker 01:
And general reference, as we said, to the roll and fold closure being some kind of clamp also is insufficient.

[00:26:54] Speaker 01:
There had to be some comparison, and none was there.

[00:26:58] Speaker 04:
And the spec here has what?

[00:26:59] Speaker 04:
Ziploc plus?

[00:27:01] Speaker 01:
Ziploc plus a tubular clamp.

[00:27:03] Speaker 01:
sometimes referred to as a seal chip.

[00:27:05] Speaker 04:
And that one, the accused one, is just a roll and fold.

[00:27:10] Speaker 01:
The IMS case doesn't absolve American in an attack of the burden to show that a different structure in the accused device function isn't an equivalent thereof.

[00:27:23] Speaker 01:
One of the things, well the other thing I'd like to point out is the trial court's finding regarding the lack of nexus on commercial success tends to indicate that the Ziploc

[00:27:34] Speaker 01:
feature is important and distinct from roll and fold, substantially different.

[00:27:40] Speaker 01:
But the other thing I'd like to point out with respect to this issue is American Intertext's reliance on unsupported arguments to argue that somehow the roll and fold closure is interchangeable with either the zip lock or the seal tube.

[00:28:02] Speaker 01:
Also highlights the failure of proof.

[00:28:04] Speaker 01:
There's no testimony these were interchangeable.

[00:28:09] Speaker 01:
No witness called the roll and fold a rudimentary zipper lock.

[00:28:15] Speaker 01:
It's not clear how it would be.

[00:28:17] Speaker 01:
They're not the same national stock number.

[00:28:21] Speaker 01:
They have the same prefix, but the prefix for plumbing covers a number of items.

[00:28:26] Speaker 01:
Surely they can't all be interchangeable.

[00:28:32] Speaker 01:
So all of these things indicate really that there was no comparison.

[00:28:37] Speaker 01:
And if the court wishes to, it can affirm the judgment on that basis.

[00:28:42] Speaker 01:
Because it's not a fact issue.

[00:28:45] Speaker 01:
It's really something where they haven't shown.

[00:28:48] Speaker 01:
And no reasonable finder of fact could conclude that the roll and fold closure is an equivalent of either the zipper lock 43 or the seal tube 34.

[00:29:00] Speaker 01:
The other one that I'd

[00:29:01] Speaker 01:
I'd like to mention just in the last minute because another alternative basis is free from attachment.

[00:29:09] Speaker 01:
The claim structure, sides meeting at opposite edges suggest the edges are part of the side.

[00:29:16] Speaker 01:
In the accused device, just to make it clear, the open bottom where the slits are to allow urine to pass are attached to the edge of the bag.

[00:29:27] Speaker 01:
They're attached to the seam in the accused device.

[00:29:30] Speaker 01:
They're not that way

[00:29:32] Speaker 01:
I would suggest either in figure 8, which shows a clear internal line, or in figure 1 of the young patent.

[00:29:39] Speaker 01:
That's not the way.

[00:29:40] Speaker 01:
And free from attachment, the specification also refers to 16 and 18, which are first called the side edges as sides.

[00:29:50] Speaker 01:
So free from attachment of the sides, we think ought to have been construed to mean the open bottom is not attached to the seam as it is in the accused bag.

[00:30:01] Speaker 01:
In that case, there's no literal infringement.

[00:30:04] Speaker 01:
There is a festal presumption, because the claim was narrowed from space apart from the sides to free from attachment to the sides, that festal presumption has not been rebutted.

[00:30:17] Speaker 01:
And that rebut would mean there is no infringement on that alternative basis.

[00:30:22] Speaker 01:
So in sum, basically, if the claims were read on the accused product, it's a simple substitution for which there's no

[00:30:31] Speaker 01:
real downside.

[00:30:32] Speaker 01:
Nothing suggests against it.

[00:30:35] Speaker 01:
Making that substitution, the trial court properly credited the testimony of Moran and the evidence.

[00:30:42] Speaker 01:
No clear error has been shown.

[00:30:45] Speaker 01:
And for that reason, this case, the trial court's opinion ought to be affirmed.

[00:30:52] Speaker 03:
Thank you, Mr. Fargo.

[00:30:54] Speaker 03:
Mr. Ernstberger, we'll add one more minute to your rebuttal time.

[00:31:05] Speaker 05:
Yes, I think it's a key part of this case is to say that the inherent property of a super absorbent polymer is that it forms a gel.

[00:31:18] Speaker 05:
There's nothing inherent about super absorbent polymers that they form an unsequestered liquid.

[00:31:27] Speaker 05:
It's like looking up at the stars at night.

[00:31:31] Speaker 05:
You see

[00:31:31] Speaker 05:
lots of stars that are scattered in the sky and you can't tell the difference one from the other until someone points to that one and says it's supernova and that one that says it's a nova.

[00:31:42] Speaker 05:
The same is true here.

[00:31:44] Speaker 05:
All the polymers look alike until somebody says this particular polymer forms, splits the substance into an unsequestered liquid and a gel.

[00:31:57] Speaker 05:
Until Mr. Young said that,

[00:32:00] Speaker 05:
all the stars looked alike, all the polymers looked alike.

[00:32:04] Speaker 05:
If you look at the particular patent in this case, they talk about polyacrylates, sodium polyacrylates.

[00:32:17] Speaker 05:
But the one that was successful, the wetlock or whatever they called it, was a starch grafted polyacrylate.

[00:32:25] Speaker 05:
They use the word starch grafted when they talk about that.

[00:32:28] Speaker 05:
So he's saying that

[00:32:30] Speaker 05:
There is a difference.

[00:32:32] Speaker 05:
Not all polymers are the same.

[00:32:34] Speaker 05:
Some are different.

[00:32:35] Speaker 05:
And Mr. Young, when he invented this patent, said that this is different because for that 30-second window, there is a separation between the gel and the unsequestered liquid.

[00:32:50] Speaker 05:
Also, on the issue of infringement, there is a means for claim.

[00:32:58] Speaker 05:
And in means for claims,

[00:33:01] Speaker 05:
There is an issue of whether the physical structure is of little or no importance to the claimed invention.

[00:33:07] Speaker 05:
We can see Mr. Richard Moran showing us that the opening is of little or no importance to the invention because this works and the opening is wide open.

[00:33:21] Speaker 05:
This is the fiddle pack.

[00:33:24] Speaker 05:
It was designed, they claimed, to be sort of a ziplock.

[00:33:29] Speaker 03:
I thank both counsel for their arguments and the case is taken under submission.

[00:33:39] Speaker 05:
Thank you for attention to this case.

[00:33:41] Speaker 05:
Thank you very much.