[00:00:00] Speaker 04:
Target case, December 18, 1497.

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D. Braun Nelson, an AG, against Becton Dickinson in company.

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Mr. Bernstein.

[00:00:11] Speaker 00:
Good morning, Your Honor.

[00:00:24] Speaker 00:
Good morning.

[00:00:25] Speaker 00:
May I just grab some water, please?

[00:00:26] Speaker 04:
Yes, please, of course.

[00:00:35] Speaker 00:
May it please the court?

[00:00:40] Speaker 00:
Scott Bornstein for Appellants v. Braun.

[00:00:42] Speaker 00:
The issue before the court today is whether the district court erred in construing the phrase needle-protected device as a means-plus-function term pursuant to 112.6.

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By way of background, there are seven patents at issue from two families.

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The patents all use the word needle-protected device in the asserted claims.

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And the patents generally relate to catheter insertion devices for inserting an IV catheter into the vein of a patient.

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And what was acknowledged at the time was when you would draw the needle from the patient after insertion, the needle tip could be problematic to the healthcare workers.

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And so they developed what's called a needle protective device, which was known to persons of skill and the art at the time, which would protect the tip of the needle from needle stick injuries.

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And then also a novel valve, which would prevent blood from flowing out of the catheter after the needle was withdrawn.

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And we contend that needle protective device was incorrectly construed as 112-6 for several reasons.

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First, the limitation doesn't include the word means, and as this Court is well aware, when the word means does not appear in a phrase, a presumption occurs that means plus function should not exist.

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And whereas here, there was evidence presented, and we believe substantial evidence presented, by persons of skill in the art, in particular Mr. Meist, our expert, as well as prior art that he relied upon and articles that he relied upon.

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We believe that it was a clear error for the Court

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to conclude.

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We've also said that word device is a classic nonce word.

[00:02:07] Speaker 01:
Well, your honor.

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And then the question is, does the term needle protective connote sufficient structure to those skilled in the art?

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And so as I understand what happened here is the judge below looked around the specification for understanding as to the meaning of

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needle protective device and did not see the term used in the specification and didn't see it defined in the prosecution history.

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And so then everyone had to resort to extrinsic evidence to try to figure out whether this term needle protective device is a term of art, an established term of art in the field that skilled artisans would look at and understand in their mind that

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that there is some class of structures that relate to this term, needle-protective device.

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Your Honor, I agree with you in part, and respectfully disagree in part, and of course I'll explain.

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I don't agree that device necessarily is a nonce word.

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It can be that the cases have determined that in instances where there's not sufficient support, either in the intrinsic record or the extrinsic record, it can be so construed.

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We contend that in this particular instance, needle-protective device, when viewed as a

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and also in the context of the surrounding language in the claim is not a nonce word, and it did connote specific terminology to a person of skill in the art.

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And we relied, and actually the IPRs, and we submitted a citation of supplemental authority just a few weeks ago, where three IPR decisions on the same patents and suit construed that same term needle protective device to not be subject to 112.6.

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And so I understand the arguments were a little different, and the evidence was also a little different before the board compared to what Judge Andrews had here.

[00:03:58] Speaker 01:
Well, I understand what happened below.

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There was no argument from your side that any of the claim language helps define what is meant by needle protective device.

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So let me answer your question, and there's several parts to the answer, so if I may.

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The evidence was the same.

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In other words, the intrinsic evidence was the same.

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Mr. Mice testified, our expert, at the district court and also presented expert testimony before the board.

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They presented expert testimony from Mr. Griffith, the same expert, that presented testimony both below and at the PTAB.

[00:04:33] Speaker 01:
Right.

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But am I wrong in recalling that your side agreed that there wasn't anything in the claim, the text of the claims themselves, that helped support the idea of what it must mean to be a needle protector?

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So this is going to sound sort of like a lawyer's argument.

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But the answer to your question is we didn't agree that there was not sufficient structure in the surrounding claim language.

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We did agree, though.

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And admittedly, we agreed that we were not presenting that argument to the district court because we felt confident that there was sufficient evidence from a person of skill in the art that they wouldn't understand that term to connote a class of structure.

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But if I may, during questioning on oral argument, so in the briefing itself, we acknowledged that we were not making that argument.

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that there was sufficient structure in the surrounding claim language.

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No question about that.

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But then upon questioning from the judge during oral argument, we did in fact argue that there was structure.

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So the judge, and I'll get to that in just a moment, specifically during oral argument upon questioning from the judge in several different instances, and I'll direct the court to appendix 323 at lines 18 through 20 where counsel indicated, quote,

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We believe we have strong arguments as to why there's sufficient structure as to all three terms.

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It was a three, I should say.

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And what he's referring to there is there were three terms that were at issue at the district court that were all attempted to be construed by BD as means plus function, though they didn't have the word means in it.

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So what counsel's arguing is needle protective device plus these other two terms were structural.

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And he went on at appendix 325, lines 10 through 22, where he responded to the judge.

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So the issue is simple, Your Honor.

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Does the term needle protective device refer to structure to one skilled in the art?

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It does, and this is not means plus function limitation.

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So here's claim 11.

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Here is a representative claim from the where Zerby's pet.

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That's one of the two families at issue.

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And we highlighted towards the bottom of the slide the term needle protected device.

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The claims go on to describe where the needle protected device is located.

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It states from the needle tip to the in the ready position and movable

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relative to the needle tip at least in part distally of the needle.

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And then further in appendix 326, lines 5 through 10, counsel continued by arguing, but it needs to be spaced from the needle tip.

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It needs to be movable relative to the needle tip in the ready position.

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It has to be at least in part distally of the needle tip.

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Those are very specific limitations about this particular needle protective device.

[00:07:09] Speaker 04:
So what happened?

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Why would the result be different?

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whether it's means plus function or not.

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In both cases, you just look at the spec and there it is.

[00:07:18] Speaker 00:
Well, Your Honor, we would assert that when you look to the spec under means plus function, you're limited to the embodiments and equivalents thereof that are described in the specification.

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There was nothing in the file history, as Judge Chen correctly pointed out, that addressed the meaning of needle protective device.

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And so there would be no limitation.

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There's no prosecution history estoppel.

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that would require needle-protected device to be limited to just the specific embodiment of embodiments in the specification.

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So why would that result be any different?

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Well, the result would be different, Your Honor, respectfully, because if it is construed as means plus function, then it's limited to the embodiments in the specification.

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I'm equivalent.

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And equivalent, that's right.

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Well, I still don't understand why it would be different.

[00:08:00] Speaker 00:
Well, Your Honor, Mr. Mice presented several declarations to the district court.

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He was the expert for B Braun.

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And he indicated that there was a number of different embodiments that a person of skill in the art would understand to fall within the family of needle-protected devices.

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And so if you were to construe a needle-protected device broadly, as the PTAB did, for example, the PTAB construed it to be a device configured to prevent unintended needle sticks, which is precisely what we contended to the district court the term should mean, which would have a broader meaning, we believe,

[00:08:35] Speaker 00:
the construction that was ultimately doubted by the court.

[00:08:38] Speaker 02:
One aspect, I think, of what Judge Newman was just asking you about might be framed this way.

[00:08:47] Speaker 02:
In the pages you were reading from the transcript where you're pointing, and you now do in your brief a little bit, to other claim elements with structural features as supporting the notion that this language, needle-protective device, is self-structural.

[00:09:06] Speaker 02:
It seems to me the other language helps only to the extent that you can say, if you treat this language, needle protective device, as means plus function, and just pull in the two different things in the spec, that that other language in the claims wouldn't make sense.

[00:09:27] Speaker 02:
But if it does make sense, if all that other structural language

[00:09:31] Speaker 02:
makes sense even with the butterfly clip and the other thing, whatever.

[00:09:34] Speaker 00:
The spring clip is what it was referred to.

[00:09:38] Speaker 02:
Then it seems to me the other structural language in the claim doesn't add to the persuasiveness of an argument that needle protective device is itself structural.

[00:09:52] Speaker 02:
You know, I understand.

[00:09:52] Speaker 02:
So is there something in these other structures in the other claim language

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that's sort of incompatible with the spring clip and... You know, I wouldn't necessarily say, Ron, there's anything that's incompatible with the spring clip.

[00:10:07] Speaker 00:
What I would say is, if you limit the claim to spring clip, as the BD is certainly attempting to do, then that would definitely narrow it more so than the plain and ordinary meaning of the term as we had proposed.

[00:10:21] Speaker 00:
And I'll give you examples, Ron.

[00:10:23] Speaker 01:
Can you explain an ordinary meaning that you proposed below?

[00:10:26] Speaker 00:
Sure.

[00:10:26] Speaker 00:
It's a device configured to prevent unintended needle sticks.

[00:10:30] Speaker 01:
Okay.

[00:10:31] Speaker 01:
So that covers anything that prevents needle sticks.

[00:10:37] Speaker 00:
So great question, Your Honor.

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And that was something that BD had pointed out.

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They argued in their briefs that, for example, rubber gloves would suffice under that definition.

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But the answer is it doesn't, because you have to look at the term in context.

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And so when you look at the term in context,

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you know that it has all these other structural limitations.

[00:10:53] Speaker 01:
Any component attached to the catheter assembly that can prevent needle sticks?

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If it met all the other limitations of the claim, I would agree with that.

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But I would point out, Your Honor, that even BD in its brief.

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I guess that my concern is that's breathtakingly broad and undefined.

[00:11:15] Speaker 01:
And that's not quite the same thing as

[00:11:19] Speaker 01:
you know, an ordinary skill artisan would imagine a certain set of structures and components that can, that can be a needle protective device that we're looking at it from a different angle, which is anything and everything that can, that can serve this function.

[00:11:38] Speaker 00:
Let me, let me see if I can help your honor, because Mr. Meist supplied an answer to that.

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Mr. Meist identified specific structures that he believed fell within the category of needle protected device.

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paragraph 90 of his declaration in appendix 1943 to 1944.

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And in it, he identified protective shields, retractable needles, among other structures that would fall within the class of needle-protected devices.

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And Judge Shen, just to point out and to further amplify the answer, BD also admitted in its brief, there's not a question here, a legitimate question about what falls within this category, because these were devices or structures that were known.

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And so BD admitted in its district court clamp instruction brief,

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I'll direct the court respectfully to page 1690 of the appendix, that there was a, quote, wealth of prior art teaching almost limitless configurations for protecting health care workers from accidental needle sticks.

[00:12:30] Speaker 00:
And then they listed the types, including caps, needle guards, and retracting needles.

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So this isn't really as broad as one may suspect, because persons of skill in the art understood what was referred to.

[00:12:42] Speaker 01:
And Your Honor.

[00:12:43] Speaker 01:
But I guess then there's a nexus question, which is,

[00:12:48] Speaker 01:
term that you appear to have coined, needle protective device, why should we conclude that it encompasses anything and everything that can serve this function?

[00:13:01] Speaker 01:
Just the fact that there were a number of, I'll just call them safety mechanisms in a generic way, that could protect against needle sticks.

[00:13:10] Speaker 01:
Why do we have to read or find that

[00:13:15] Speaker 01:
Judge Andrews clearly erred in concluding that needle protective device wasn't so established as a coined term to skilled artisans that it means anything and everything that prevents needle sticks.

[00:13:28] Speaker 00:
Sure.

[00:13:28] Speaker 00:
Well, in addition to Mr. Meist's two declarations, he also relied upon articles and prior references, and specifically... We're talking about the British Journal?

[00:13:36] Speaker 00:
The 508 patent was what I was going to feature first, and then also the British Journal.

[00:13:40] Speaker 01:
Well, your briefing below didn't really feature the 508 patent.

[00:13:43] Speaker 01:
It featured the British Journal.

[00:13:45] Speaker 00:
Actually, it featured both, Your Honor.

[00:13:46] Speaker 00:
I'll direct the court.

[00:13:46] Speaker 01:
You're talking about the string site to the 508?

[00:13:49] Speaker 00:
What I'm referring to, and if you give me a moment, Your Honor, I'll get to it.

[00:13:59] Speaker 00:
So B. Braun cited the 508 patent in its claim construction briefing.

[00:14:03] Speaker 00:
That was at the joint claim construction brief at appendix 1753 through 1754.

[00:14:08] Speaker 00:
And then they also featured it during the oral argument at the Markman hearing.

[00:14:13] Speaker 00:
And that was at page 28, lines 1 through 12.

[00:14:16] Speaker 01:
I guess when I look at your joint brief, I see one citation in a string site, at the back of a string site, at A1754 to the 508 path.

[00:14:27] Speaker 00:
Understood.

[00:14:28] Speaker 00:
And is there anything else?

[00:14:30] Speaker 00:
In the briefing.

[00:14:30] Speaker 00:
In the briefing.

[00:14:31] Speaker 00:
I don't believe so.

[00:14:32] Speaker 00:
No, you're wrong.

[00:14:32] Speaker 00:
OK.

[00:14:33] Speaker 00:
And then during.

[00:14:34] Speaker 00:
Featured is strong word.

[00:14:36] Speaker 00:
Reference.

[00:14:37] Speaker 00:
Forgive me.

[00:14:37] Speaker 00:
I wasn't trying to overstate.

[00:14:38] Speaker 00:
It's reference.

[00:14:39] Speaker 00:
OK.

[00:14:39] Speaker 00:
Thank you.

[00:14:40] Speaker 02:
Why would the language in that help establish that the meaning of that phrase is something other than the meaning of a phrase, a device for protecting against needles?

[00:15:01] Speaker 02:
That is, if you have a patent and you title it needle protective device, it seems to me you haven't yet told the world

[00:15:08] Speaker 02:
that it is a name of a thing as opposed to a name of a class defined only functionally.

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

[00:15:16] Speaker 00:
Understood, Your Honor.

[00:15:17] Speaker 00:
So, for example, in the Five Elite patent, it actually recited that various protective devices of this kind, meaning needle-protected devices, are known.

[00:15:26] Speaker 02:
But why does that help?

[00:15:27] Speaker 02:
Well, the universe, the class of devices that serve the function will, of course, have members.

[00:15:34] Speaker 00:
Sure.

[00:15:35] Speaker 00:
And I think this is exemplary that there was a term that was known, needle protective device.

[00:15:39] Speaker 02:
Did your expert, by the way, ever say, here are a bunch of things that serve the function that are needle protective devices, and here are a bunch of things, or at least one thing, that serves the function that isn't a needle protective device?

[00:15:55] Speaker 02:
Because if you don't do that, then it seems to me the phrase is, you can't tell whether the phrase is simply referring to

[00:16:02] Speaker 02:
a purely functionally defined class.

[00:16:05] Speaker 00:
Sure.

[00:16:05] Speaker 00:
So I believe the answer to your question is he did in paragraph 90 of his declaration at page 1944 of the appendix identify structures that fell within the class.

[00:16:14] Speaker 02:
Right.

[00:16:14] Speaker 02:
What about the ones out?

[00:16:15] Speaker 00:
Yeah, I don't believe, yeah, I don't believe Judge Sorrento that he actually said, here are examples that are not within the class, in fairness.

[00:16:23] Speaker 00:
But I would also point out, and Judge Cheney referenced the 2003 British Journal of Nursing article.

[00:16:28] Speaker 00:
So that article, and

[00:16:30] Speaker 00:
They have raised the point that it's not prior art to all seven patents in suit.

[00:16:34] Speaker 00:
That is correct.

[00:16:35] Speaker 00:
It was prior art to the second family of patents, not the earlier family of patents.

[00:16:40] Speaker 00:
However, both parties acknowledge that the term needle-protected device should have the same construction across both families.

[00:16:46] Speaker 00:
And as this Court is aware, even if a later-in-time reference, it can be relied upon to show what the state of the art was earlier in time.

[00:16:54] Speaker 00:
And that's what we contend the British Journal of Nursing article does vis-a-vis the earlier family.

[00:17:00] Speaker 00:
And the reason why that article we believe is helpful is because it specifically references a definition for a needle-protected device.

[00:17:08] Speaker 00:
And in it, it defines needle-protected device as any product that can be used to protect health care workers from accidental needle stick or sharps injuries, other sharps injuries.

[00:17:17] Speaker 02:
But in terms of the weight of that evidence for the proposition that I think you have to establish, it seems to me when it says an NPR is defined as, it is

[00:17:30] Speaker 02:
not necessarily saying the world of the relevant technology here understands the word to mean this.

[00:17:40] Speaker 02:
It could just as easily and maybe even slightly more naturally be understood to be kind of acknowledging this is not a term the readership knows and we're now going to write something and as a shorthand we are going to define this term which it seems to me doesn't tell you very much about

[00:18:00] Speaker 02:
um, relevant understanding in the usage of, of the skilled artisan community.

[00:18:07] Speaker 00:
I understand your comment, your honor.

[00:18:09] Speaker 02:
And you do have to get to the level of saying Judge Andrew's factual finding about usage is clearly erroneous.

[00:18:17] Speaker 02:
So a little bit of evidence wouldn't seem to meet that.

[00:18:20] Speaker 00:
Well, your honor, um, we suggest we supplied evidence both in the form of the expert declarations.

[00:18:25] Speaker 00:
Of course, it doesn't matter what I think.

[00:18:27] Speaker 00:
It matters what a person of skill in the art thinks.

[00:18:29] Speaker 00:
And in this case, we did supply multiple declarations, which were credited, by the way, by the PTAB, when considering the exact same term.

[00:18:37] Speaker 00:
The other thing I would point out is, actually, before I even get to the argument about the surrounding claim language, if I still have time, I did want to point out that there were at least two clearly erroneous findings that we believe the district court made.

[00:18:51] Speaker 00:
One was the district court concluded that the prior art and articles referenced by Mr. Meis relied upon by Braun

[00:18:58] Speaker 00:
the filing date of some or all the patents at issue.

[00:19:01] Speaker 00:
And again, we point to the 508 patent, which preceded all seven patents at issue by several years, and also to the British Journal of Nursing article, which at least is prior art to one of the two families.

[00:19:13] Speaker 04:
Let's hear from the other side, and we'll save some rebuttal, John.

[00:19:16] Speaker 00:
Thank you.

[00:19:22] Speaker 03:
May it please the court, my name is Omar Khan, and along with Bill Lee, Bill McElwin, and Jeff Dattar, I represent BD in this appeal.

[00:19:29] Speaker 03:
Braun, at the district court, presented only a single factual issue to the district court, and that was whether the needle-protected device term had a commonly understood, established meaning in the art.

[00:19:39] Speaker 03:
The district court found that it did not, and that conclusion was correct, and certainly was not clearly erroneous.

[00:19:45] Speaker 03:
On appeal now, for the first time, Braun is presenting effectively a new case and is asking this court to make factual findings that it did not ask of the district court to make.

[00:19:55] Speaker 03:
We think those requests for new factual findings are waived, but even if the court were to consider them, the record evidence doesn't support those findings, certainly doesn't support the broad and incredibly expansive functional meaning that Braun wants to put forward and have in the court.

[00:20:11] Speaker 03:
What's important for the district court's conclusion

[00:20:14] Speaker 03:
is the context of what the court was looking at in the record.

[00:20:18] Speaker 03:
So the record was, as I think my friend on the other side acknowledged, was voluminous.

[00:20:23] Speaker 03:
There was two rounds of summer judgment briefing, three expert declarations, the court heard oral argument.

[00:20:29] Speaker 03:
The evidence before the court was that people in the industry and the field had been discussing mechanisms for needle stick prevention since the early 1980s.

[00:20:39] Speaker 03:
So there was a body of 40 years of literature that had been developed.

[00:20:44] Speaker 03:
And presumably, Braun canvassed that literature, as did we.

[00:20:47] Speaker 03:
And out of that entire literature, the parties put before the district court 70 references in connection with all of the claim construction disputes before the court.

[00:20:55] Speaker 03:
With respect to the needle-protected device limitations specifically, Braun put before the court eight references.

[00:21:02] Speaker 03:
Of all the 40 years of literature of the 70 references before the district court, only two references used the term at all.

[00:21:11] Speaker 03:
And both of those references use the term inconsistently with each other and with the claims.

[00:21:17] Speaker 03:
In light of the fact that there were no dictionaries, treatises, textbooks, in light of the fact that there's nothing in the intrinsic record, this court cannot be found to have committed clear error in weighing those two references and deciding that they were not probative on the core issue of whether the term needle-protected device had achieved status as a noun for established meaning.

[00:21:39] Speaker 01:
What if, hypothetically,

[00:21:40] Speaker 01:
This is a hypothetical.

[00:21:42] Speaker 01:
This specification said something different.

[00:21:45] Speaker 01:
What if it said, over the past number of decades, there's been a lot of research and development on mechanisms, safety mechanisms, that can help protect against needle sticks.

[00:21:58] Speaker 01:
And I'm going to coin a term, and I call it needle protective device.

[00:22:04] Speaker 01:
And by pointing that term, I am referencing all

[00:22:10] Speaker 01:
known ways of protecting against needle sticks.

[00:22:15] Speaker 01:
There could be a spring means that shoots out and covers the end point of the needle.

[00:22:19] Speaker 01:
There could be automatic retracting schemes to withdraw the needle back into the housing.

[00:22:25] Speaker 01:
There can be some other things too, some field elements of some kind.

[00:22:31] Speaker 01:
And when I say needle protective device, I'm referring to all of them.

[00:22:35] Speaker 01:
And then in the claim I go ahead and say,

[00:22:37] Speaker 01:
a catheter assembly having this, that, a valve, and a needle protective device.

[00:22:45] Speaker 01:
Would that kind of a claim term in the context of that specification cover any and all known ways of protecting against needle sticks up until the time of the filing date?

[00:23:01] Speaker 03:
That case is

[00:23:02] Speaker 03:
fundamentally different in two ways, and the answer... Just asking a question about my fact pattern.

[00:23:08] Speaker 03:
Right.

[00:23:08] Speaker 03:
So, in that very specific fact situation, first of all, needle-protected device, we contend would be a means plus function term subject to 112.6, and then there would have to be an inquiry into what the corresponding structures are that correspond to the now coined term needle-protected device.

[00:23:26] Speaker 03:
And if the disclosure in the specification corresponded to and had the requisite nexus to

[00:23:32] Speaker 03:
the coin term, then Braun would be able to establish that the neoprotective device limitation covered the corresponding structures plus equivalents under an illiterate infringement theory.

[00:23:45] Speaker 03:
But again, we focused on the disclosure.

[00:23:49] Speaker 03:
And here, the disclosure is completely different, because that's not the invention.

[00:23:54] Speaker 03:
So the invention here is the combination of the specific spring clip with their specific

[00:24:02] Speaker 03:
That's why the specification in this case doesn't talk about all the other shields and guards and caps and recessed needles and all the other things in the art that were known because the invention is highly, highly specific and directed to the specific combination of the sprinklet with their specific blood control valve.

[00:24:27] Speaker 03:
My colleague referred to the 508 patent

[00:24:31] Speaker 03:
On the 508 patent, again, context is incredibly important.

[00:24:35] Speaker 03:
On the 508 patent, again, as I mentioned, they put eight references before the district court on the needle protective device limitation.

[00:24:44] Speaker 03:
And the 508 patent appears only in a string citation in Ron's reply brief.

[00:24:52] Speaker 03:
So it doesn't appear in the opening brief.

[00:24:54] Speaker 03:
It appears in the reply brief.

[00:24:56] Speaker 03:
And it's in a string citation.

[00:25:00] Speaker 03:
their expert Dr. Meist also did not have the 508 patent in his opening declaration.

[00:25:06] Speaker 03:
It was in the rebuttal declaration.

[00:25:08] Speaker 03:
So what does he say about needle protective device in the rebuttal declaration?

[00:25:12] Speaker 03:
He says, I found a patent having the title needle protective device.

[00:25:18] Speaker 03:
That's it.

[00:25:19] Speaker 03:
He doesn't say anything else, and that's at

[00:25:23] Speaker 03:
2642, A2642, he doesn't say anything else about the 508 patent other than he found a patent that has a title.

[00:25:32] Speaker 03:
On that, and then at the argument, there was nary four lines of oral argument at A333 about the 508 patent, which was a throwaway to the preceding 25 minutes of discussion on the needle protective device limitation, much of which focused on the British nursing article.

[00:25:47] Speaker 03:
The district court on that record was not obligated to discuss it.

[00:25:50] Speaker 03:
It certainly considered it and rejected it and appropriately rejected it, but I think the fault that Braun places on the District Court and Judge Andrews for not addressing it is misplaced.

[00:26:00] Speaker 03:
It's really sort of Braun's own fault.

[00:26:02] Speaker 03:
With respect to the British nursing article, Judge Toronto, we think that the British nursing article is not authoritative for multiple reasons.

[00:26:14] Speaker 03:
for the fact that it states a definition that's coined for that particular article alone.

[00:26:19] Speaker 03:
It does not report to be stating an established meaning in the art.

[00:26:22] Speaker 03:
And, of course, it's inconsistent with the claim and the use of the term in the claim.

[00:26:27] Speaker 03:
So that's important for at least two reasons, the first being that the inquiry is about whether the term in the claim is means plus function and what the term in the claim means.

[00:26:39] Speaker 02:
It's inconsistent with?

[00:26:40] Speaker 03:
It's inconsistent because the definition in the British nursing article refers to products as a whole.

[00:26:47] Speaker 03:
So the British nursing article says, a NPD is a product that protects health care workers.

[00:26:54] Speaker 03:
And then it goes on to describe the products as a whole.

[00:26:58] Speaker 03:
On the facts of this case, that would be the catheter assembly that's set in the preamble.

[00:27:03] Speaker 03:
The way that needle-protected device is used in the claim is it's a component of the catheter assembly.

[00:27:08] Speaker 03:
The corresponding phrase

[00:27:10] Speaker 03:
for that component of a catheter assembly in the British nursing article is safety feature or safety mechanism.

[00:27:18] Speaker 03:
So the terms are being used inconsistently, which is relevant not only because we have to determine what the claim term means in the claim, but it also goes to show that there was no common understanding or established meaning that it was a coined term in both instances.

[00:27:36] Speaker 03:
With respect to the needle guard arguments, I won't address them at length.

[00:27:40] Speaker 03:
Really, Braun has to jump through incredible hurdles to get to the needle guard.

[00:27:45] Speaker 03:
It's not only the waiver issues, but even if we get past the waiver issues, it's incredible to imagine that the district court clearly erred on this record when the term needle guard is not in the claim at all.

[00:27:58] Speaker 03:
The only expert testimony on the term needle guard is from BD's expert.

[00:28:03] Speaker 03:
And BD's expert testified that the term needle guard has idiosyncratic functional and coined meanings in the art.

[00:28:09] Speaker 03:
And then there's of course the dependent claims that cast doubt on whether the term needle guarding and protected advice have the same meaning and we contend also then that the record evidence that they put before you is internally inconsistent.

[00:28:26] Speaker 03:
In sum, the district court cannot have clearly aired if when in the 40 years of literature and in the nearly 70 references that the parties put before the court

[00:28:36] Speaker 03:
There were only two non-authoritative references that even used the term, and they used the term inconsistently with each other and with the claims.

[00:28:45] Speaker 03:
If there are no more questions, I'll cede the rest of my time.

[00:28:48] Speaker 04:
Thank you, Mr. Cahn.

[00:28:54] Speaker 04:
Mr. Bornstein, you have a little time for rebuttal.

[00:28:56] Speaker 00:
Thank you, runner.

[00:28:57] Speaker 00:
Very briefly, I just want to point out that with respect to the question of whether or not the surrounding claim language,

[00:29:03] Speaker 00:
around needle protective device contains sufficient structure.

[00:29:07] Speaker 00:
That's a question of law.

[00:29:08] Speaker 00:
That's a question of law that presumably this court must look at de novo with a fresh look.

[00:29:13] Speaker 00:
And I'll cite the zero-click versus Apple case regarding questions of claim construction, including whether claim language invokes 35 USC section 112-6, the district court's determinations based on evidence intrinsic to the patent, which of course the surrounding claim language would be, as well as its ultimate interpretations of the patent claims

[00:29:32] Speaker 00:
are legal questions which you review de novo.

[00:29:35] Speaker 00:
And when you look to the actual language of the claims, and I'll give you as an example claim one of the 249 patent, which is an appendix 173, just by way of example.

[00:29:46] Speaker 00:
And admittedly, each of the 14 claims that are presently asserted that include the needle protective device limitation all have different types of structure.

[00:29:54] Speaker 00:
But the 249 patent claim one describes a needle protected device, but it goes on from there.

[00:30:00] Speaker 00:
It says the needle-protected device is spring-loaded in a ready-to-use position.

[00:30:05] Speaker 01:
Sorry, which claim?

[00:30:06] Speaker 00:
I'm sorry.

[00:30:07] Speaker 00:
Sir, I meant claim one of the 249 patent at appendix 173.

[00:30:09] Speaker 00:
So it requires that the needle-protected device is spring-loaded in a ready-to-use position, positioned proximally of the valve, and at least in part around the needle to prevent unintended contact with the needle tip in a protective position.

[00:30:26] Speaker 00:
So it's not the type of usage.

[00:30:29] Speaker 00:
It typically and of course I'm sure my counterpart and I looked at as many cases as we could find from this court that have interpreted means plus function limitations.

[00:30:37] Speaker 00:
And typically when you see means plus function limitations, it's a circuit with nothing else or a lever with nothing else.

[00:30:46] Speaker 00:
But it doesn't have all the structural features and operational features that are here.

[00:30:51] Speaker 00:
Claim 25 of the 762 pen, which is an appendix 94.

[00:30:54] Speaker 01:
I understand that all the claims were argued together, right?

[00:30:59] Speaker 01:
There wasn't a breakout of, okay, claim 44 of this patent says this, claim 17 of this other patent says that, as in relation to the recited needle protective device.

[00:31:15] Speaker 00:
You're right, Your Honor, with the limited exception that I read to you earlier from counsel when he was responding to questions from the court and identified a couple specific claims and limitations in those claims that he believed had structural limitations.

[00:31:27] Speaker 00:
But other than that, I agree with you.

[00:31:29] Speaker 00:
Claim 25 of the 7-6-2 patent, which is in Appendix 94.

[00:31:33] Speaker 00:
It's a dependent claim, and it reads the method of Claim 18 wherein the needle-protective device comprises a resilient portion made from a metallic material for moving the needle-protected device from a ready position to a protected position.

[00:31:47] Speaker 00:
So again, you see structure.

[00:31:49] Speaker 00:
It's a different structure than the previous one.

[00:31:51] Speaker 00:
And I would direct the court to the MIT versus Abacus software case, which is 462,

[00:31:57] Speaker 00:
F3rd, 1344, 1355.

[00:31:58] Speaker 00:
And there the court acknowledged, in the context of aesthetic correction circuitry, that where the claim language does not merely describe a circuit, it adds further structure by describing the operation of the circuit.

[00:32:13] Speaker 00:
This description of the operation of the circuit is sufficient to avoid 112-6.

[00:32:17] Speaker 00:
And I'll also leave you with the Inventio case, which is Inventio versus Theissenkrupp.

[00:32:22] Speaker 00:
And in that case, which was 649, F3rd, 1350,

[00:32:26] Speaker 00:
at 1359, the court interpreted the meaning of the phrase modernizing device.

[00:32:31] Speaker 00:
And it found that it was not subject to 112.6 because the claims delineate the components that the modernizing device is connected to and describe how the modernizing device interacts with those components, which we contend is precisely what the claims do in this case.

[00:32:47] Speaker 00:
Unless you have further questions, I have nothing further.

[00:32:51] Speaker 04:
Good.

[00:32:51] Speaker 04:
Thank you.

[00:32:52] Speaker 04:
Thank you both.

[00:32:53] Speaker 04:
The case is taken under submission.