[00:00:00] Speaker 03:
Our case this morning is Intuitive Surgical v. Rex Medical, 2021, 1862.

[00:00:05] Speaker 03:
Mr. Katz, good morning.

[00:00:07] Speaker 03:
Good morning, Your Honors.

[00:00:12] Speaker 02:
May it please the Court.

[00:00:15] Speaker 02:
A person of ordinary skill in the art would have had reason to add an eye beam

[00:00:22] Speaker 02:
to any surgical stapler that has two jaws that clamp shut and have a stapling element that moves through those jaws.

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We know that because that's what Green 695 teaches.

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And in appendix 634, at column 1, lines 49 to 52, if you take that entire paragraph, Green explains

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that there is a problem with a stapler with two jaws, where the tissue and staples, when the staples are being formed, tends to push the jaws open.

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And I quote, this is column one, line 54, that tends to laterally distort the jaws, thereby hindering accurate stapling.

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Now, Green recognized this is a general problem.

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This is not a problem unique to Green 209.

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This is Green 695 talking generally about staplers that use two jaws.

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But McGuckin is different from Green, right?

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McGuckin is not different from Green 695 in this relevant respect.

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Like Green 695, McGuckin has two jaws that close upon tissue

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and has a movable staple element that runs through the jaws.

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So the configuration is different.

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But there's nothing in green 695 that suggests that that particular configuration matters.

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In fact, if you read the background of the invention of column one, just starting at lines three, what they talk about is that there are surgical staplers out there.

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And the features that are relevant is that they have two jaws.

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that pivot closed upon tissue, and there's a movable stapling element running through the jaws.

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And when you try to staple through the tissue, there tends to be a little distortion.

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That's what Green 695 teaches.

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And none of the distinctions that the district court points to have anything to do with the teachings of Green.

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And that's where the board's error was.

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that the board said, yes, there are differences between Green 209 and McGucket.

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But none of those differences affect what Green 695 teaches about the value of the I-beam.

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What Green 695 says is there is this problem of jaw distortion, generally in staplers,

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And then it says, we have a solution.

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And then that's in Appendix 634, Column 2.

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It starts at around Line 22 to 35.

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That paragraph says, if you have what they call shoes, which are the top of the eye beams, it will hold the eye beam closed

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at the point of stapling.

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And this is critical.

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The I-Beam provides localized support at the point of stapling.

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And I think this is best shown in our brief for the opening brief, page 45.

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We have a colored, annotated picture of figure 31 from Lugucka.

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But Mr. Katz, isn't what these references teach question of fact on which we owe deference to the board?

[00:03:48] Speaker 02:
uh... these references uh... do provide questions of fact the board here we believe was one no substantial evidence onwards there is no evidence defending the board ultimate conclusion which was a legal so by no means are we standing here asking this court to say our expert should have been chosen over their expert what we're saying is on the facts the board accepted is true

[00:04:15] Speaker 02:
they lose.

[00:04:16] Speaker 02:
On the facts the board accepted, and the facts are found in Appendix 97.

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And the first one is that there's this longitudinal stability of the, supposedly of the McGuckin stapler, because of the wide hinges.

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That's the critical element of the board's decision.

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The board says, at Appendix 97, we credit

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Rex Medical's expert that these hinges are wide and provide longitudinal stability.

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Now, on that issue, we don't dispute that.

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I'm not sure it's true.

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In fact, the hinges don't necessarily need to be wide.

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But even if we accept that the hinges are wide, we accept that, as their expert said, that creates

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a strong hinge, a stable hinge.

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Our expert doesn't dispute that.

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So that wasn't a resolving a disputed fact issue.

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What we're saying is, no matter how strong that hinge is, there could have been 20 hinges along that line, 30.

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It could have been one big solid hinge.

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None of that has to do with the relevant issue that Green 695 is talking about.

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Green 695 is saying the stapling action will tend to push the jaws open.

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And in the McGuckin configuration, its longitudinal stability has nothing to do with preventing the jaws from opening.

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And that's why I want to point your honors to figure 31.

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So the longitudinal stability aspect means that the hinge where the jaw pivots up is solid.

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Let's assume that's a perfect hinge.

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you can still push the jaws open from the stapling operation.

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And the hinge cannot prevent that at all.

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So the longitudinal stability in McGuckin is not material at all.

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In fact, if you look at figure 31, and again, at page 45, our brief is, it's annotated.

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We've drawn a circle around where the knife is.

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And you see the tissue in green draped into the jaws.

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There is nothing at that location to provide the localized support that the I-Beam provides.

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Nothing.

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The hinges are on the opposite side.

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And while you will likely hear Rex Medical talk about the lifting arm, the lifting arm is way over here on this other side.

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And the board didn't rely on the lifting arm, by the way.

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So the board made no fact finding about the value of the lifting arm.

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But the key here is that in the circle we show on page 45 of our brief, there is no localized support.

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There is nothing to stop distortion of the jaws at that place.

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And that's what the benefit of the eye beam is.

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That's exactly what green 695 teaches, that where you're stapling, where you're pushing up, you want to hold those jaws in place.

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You want to have a local clamp, which effect is what the eye beam is, holding that in place.

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How did the board reach its conclusion?

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We actually don't know.

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The board may have fundamentally misunderstood McCuckin.

[00:07:39] Speaker 02:
I don't know.

[00:07:40] Speaker 03:
You're not saying it was intuitive.

[00:07:42] Speaker 02:
Exactly, we're not saying it was intuitive.

[00:07:46] Speaker 02:
Well, I think McGuckin's intuitive.

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I'm not sure what the board said was intuitive.

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But the key here is that the longitudinal stability just has nothing to do.

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There's nothing in the record that supports that decision.

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Their expert never says, because you have two wide hinges that provide longitudinal stability, therefore McGuckin does not need NIBE.

[00:08:09] Speaker 02:
Yes, Your Honor.

[00:08:11] Speaker 00:
Did you ever argue before the board that McGuckin-Stakler suffers from vertical and lateral instability?

[00:08:17] Speaker 02:
Absolutely, Your Honor.

[00:08:18] Speaker 02:
Yes, we did.

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We discussed that numerous times.

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Now, starting in the petition, we discussed the issue of stability with regard to 695, and we started with regard to the green 209.

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So you have to understand the structure of the petition.

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The petition started with Green 209.

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We did Ground 1.

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And then we weren't going to repeat everything for Ground 3.

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So in Ground 1, we discussed and Dr. Nodell described how Green 695 describes this vertical and lateral instability of pushing their jaws open.

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We cited this testimony I just went over, or excuse me, the record of Green Columns 1 and 2, Columns 1 and 2 of Green.

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And the key here is none of those arguments that we made with regard to ground one were particular to green 209.

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And that's fundamental.

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We argued that green 695 provides this teaching that it solves a distortion problem.

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We never said there was any particular synergy with green 209.

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So then later, in ground three, we said the line which Rex Medical repeats often in their brief,

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For all the same reasons we just discussed, McGuckin is obvious too, because McGuckin also has two jaws that close and has a stapling element that runs through.

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We didn't have to say anything more.

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Now, when they brought up their arguments, we, of course, then, in our reply, made those very statements.

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And so we had Dr. Nodell-Arts for a supplemental declaration, discusses those issues at appendix 2149 to 2150.

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He also discusses anvil deflection issues at 2459 to 2460.

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So Dr. Noel Dell came back in his supplemental declaration and said, you know, of course there are these issues in McGucket.

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We assumed it in our petition.

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We said all the same reasons apply.

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here is why.

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The key is because they still have the exact same effect of the tissue in the staples pushing the jaws open.

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In addition, if you look at the oral argument discussion, which my colleague Ryan O'Connor handled, that portion from McGuckin at appendix 2876, he specifically makes this argument.

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So I know they have a waiver argument, but there is no waiver here.

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I mean, he said right at the oral hearing before the P tab, there's a tendency in McGuckin to have the jaws pushed open, and that's why you use the IB, the very argument we're making here.

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And I believe another relevant issue we should point out is the issue of lightweight materials.

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Green says two things.

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One is there is a tendency for the staple to distort the jaws.

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And then in particular, it's a tendency to do that if you make your materials lightweight and disposable.

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The thinner the material, the more it will tend to distort and bend.

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And that's what Green teaches.

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And then we said,

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That's also a good reason to modify both Green 209 and McGuckin.

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And the interesting thing here is the board agreed with us on Green 209.

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So the board is already on record agreeing that Green 695 does suggest

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adding an I-beam to handle lightweight materials.

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And that's at appendix 45 to 46, where they said, our lightweight material argument is, quote, reasonably supported, unquote, by Dr. Nodell, and then on the following page, and by Green 695.

[00:12:13] Speaker 00:
If McGuckin and Green 209 are different sizes, how is the board supposed to determine that there is a motivation to combine for the same reasons as in Ground 1?

[00:12:24] Speaker 02:
Well, the short answer is they aren't different sizes.

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So McGuckin has no size specification in it.

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Green does mention that it does use a 60 millimeter staple cartridge.

[00:12:43] Speaker 02:
McGuckin's staple length cartridge is probably roughly that or more.

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There's nothing in the record on the precise length.

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But there's no dispute that McGuckin has no dimensions in it.

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In fact, their experts admitted that McGuckin has no dimensions.

[00:13:01] Speaker 00:
Did the experts say that the maximum width of McGuckin was 50?

[00:13:05] Speaker 02:
Yeah, our experts said McGuckin could be as high as 50.

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Not maximum, but could be as high as.

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So the only evidence in the record, and that's based on our expert testifying about the types of instruments that McGuckin's talking about,

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is that it can have varying lengths.

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All staplers come in different sizes.

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But McGuckin could be as high as 50, he said.

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Now, Green discloses a 60-millimeter cartridge.

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But that's not the only disclosure.

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Green wasn't limited to 60-millimeter.

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And we have evidence in the record, and specifically we disclose that staple cartridges could be as small as 30 millimeters.

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And so McGuckin

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is actually larger than some staplers of the type similar to green.

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In fact, that's at Milliman.

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And we cite it in our brief at page.

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I have it tagged here.

[00:14:07] Speaker 03:
Council, your time is almost up.

[00:14:10] Speaker 03:
And you wanted to save some rebuttal time.

[00:14:12] Speaker 02:
We will save what rebuttal time.

[00:14:13] Speaker 03:
Why don't we give you two minutes of rebuttal time, and then you can answer that question.

[00:14:17] Speaker 03:
Thank you.

[00:14:19] Speaker 01:
May it please the court.

[00:14:36] Speaker 01:
As the court has pointed out in its questioning, the sole issue before this court is whether there is substantial evidence to support the board's fact-finding.

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on petitioners' failure to show a person of ordinary skill would have been motivated to redesign McGuckin to add elements from Green 695 to render the challenge claims obvious.

[00:15:01] Speaker 01:
The board, having reviewed the briefing, weighed the factual evidence, made credibility determinations, correctly determined that petitioner failed to carry his burden.

[00:15:14] Speaker 01:
The board found that Dr. Nodal's attempt to redesign and reconstruct the shape and length of McGuckin's jaws for the proposed combination was a bridge too far, relying improperly on hindsight bias.

[00:15:32] Speaker 01:
Instead, the board credited Mr. Durgan's expert testimony, citing paragraphs from Mr. Durgan's declarations, including paragraphs 132, 133,

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135, showing that McGuckin already had existing features providing alignment and stability.

[00:15:53] Speaker 01:
Because there's been some discussion today about the contours of the board's four pages of analysis, I'd like to invite the court to join me at the relevant portion of the board's final written decision at appendix 95 to 98 so I can respond to some of the points made.

[00:16:11] Speaker 01:
Appellate started this argument by saying that a person of ordinary skill would have had a motivation to add an eye beam to any surgical stapler.

[00:16:21] Speaker 01:
But it's important to note on Appendix 95 where the board's final decision describes the proposed modification.

[00:16:30] Speaker 01:
At the top, the board writes, petitioner proposes to modify McGuckin's ninth portion 76 to include the upper portion of an eye beam and to modify McGuckin's first and second jaws to include an internal passageway in opening.

[00:16:47] Speaker 01:
The easiest way to see the proposed modification is to look at appendix 514,

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which is Dr. Nodal's declaration, where he shows composite figures in which he proposes adding the upper shoes from Green 695, shown in yellow, into the knife of McGuckin, shown in blue, and creating entirely new channels from Green 695, shown in green, into the jaws of McGuckin.

[00:17:16] Speaker 01:
This is a classic example of using hindsight as a roadmap to reconstruct the claimed invention.

[00:17:24] Speaker 01:
Weighing the credibility of the competing expert testimony, the board correctly rejected Dr. Nodal's testimony as using hindsight.

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The second argument is that Appellant, during his oral argument, focused on the localized support and the hinges discussed in the final written decision.

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But we must remember, as Judge Cunningham pointed out, that we need to look at how the petition framed the issue which led to the board's decision.

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The entire analysis that petitioner and Dr. Nodal provided for the alleged motivation to combine is three paragraphs at appendix 435 to 437

[00:18:07] Speaker 01:
in which Dr. Nodal focused on the combination of green 209 and green 695 in the context of ground 1.

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Then when Dr. Nodal got to McGuckin, ground 3, the ground at issue here, Dr. Nodal simply provided one conclusory sentence the same reasons would have applied.

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And that's appendix 513.

[00:18:34] Speaker 01:
The board considered the way Petitioner framed its arguments and rejected Dr. Nodal's testimony.

[00:18:41] Speaker 01:
The board credited Mr. Jurgen's testimony and found expressly that the differences between McGuckin and Green 209 would have led a person of ordinary skill to different results, that the design of Green 209 and McGuckin were fundamentally different.

[00:19:02] Speaker 01:
Green 209 has elongated alligator jaws with one pivot point at one far end, whereas McGuckin is fundamentally different.

[00:19:13] Speaker 01:
It has a U-shaped clam shell with two widely spaced hinges on the longitudinal side.

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It was already sufficiently stable.

[00:19:23] Speaker 01:
Thus, the board making a credibility determination credited Mr. Gergen's testimony.

[00:19:29] Speaker 01:
Petitioner thus failed to show

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A person of ordinary skill would have been motivated to look outside of McGuckin to completely redesign McGuckin to arrive at the claimed invention.

[00:19:41] Speaker 01:
Because there's substantial evidence to support the board's decision, we respectfully request an affirmance.

[00:19:47] Speaker 01:
I'm happy to answer any questions the court may have.

[00:19:50] Speaker 01:
Otherwise, I'm happy to cede or yield the remainder of my time.

[00:19:55] Speaker 03:
Thank you, counsel.

[00:19:57] Speaker 03:
Mr. Katz has two minutes for rebuttal.

[00:20:03] Speaker 02:
Thank you, Your Honors.

[00:20:07] Speaker 02:
So the fact that instruments such as green and others can be smaller than 60 millimeters can be found in Appendix 2151, where Milliman talks about 30-millimeter standard cartridge size.

[00:20:22] Speaker 02:
And interestingly, that 30-millimeter instrument had an IV.

[00:20:26] Speaker 02:
So there's nothing in Green 695 about the elongated, not elongated.

[00:20:32] Speaker 02:
That is not the teaching of Green 695.

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So Rex Medical is trying to rely on distinctions that are not pertinent to the actual reference and the teaching we're relying on.

[00:20:44] Speaker 02:
Again, this is not a dispute between experts.

[00:20:47] Speaker 02:
It's not a he said, she said situation.

[00:20:50] Speaker 02:
Green 695 provides these precise teachings we're talking about.

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It tells us when the eye beam is useful.

[00:20:58] Speaker 02:
And it's useful to prevent distortion to the laterally pushing up of the jaws and the distortion.

[00:21:07] Speaker 02:
On the redesign-reconstruct point, again, as we point out brief, that was based on looking at McGuckin's drawings and thinking they were drawn to scale clearly.

[00:21:17] Speaker 02:
The board didn't use those words, but Dr. O'Dell never proposed reconstructing McGuckin.

[00:21:23] Speaker 02:
What he said is, McGuckin could come in all shapes and sizes.

[00:21:26] Speaker 02:
It does not provide dimensions.

[00:21:27] Speaker 02:
That is not a reconstruction.

[00:21:30] Speaker 02:
And if you look at the record, the board did not credit what they just claimed the board credited Dr. Jergens for.

[00:21:39] Speaker 02:
Or excuse me, Mr. Jergens.

[00:21:40] Speaker 02:
They credited Mr. Jergens for the unremarkable point that if you have two wide hinges, you have a longitudinally stable hinge.

[00:21:49] Speaker 02:
The board never made any finding that those hinges somehow then make the whole device so stable that it wouldn't benefit from an IV.

[00:21:59] Speaker 02:
He, of course, made that conclusion, but then appointed the hinges, and it doesn't follow.

[00:22:05] Speaker 02:
There's no expert testimony to support what the board did as we laid out.

[00:22:08] Speaker 03:
Thank you, counsel.