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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`BECTON, DICKINSON AND COMPANY,
`Petitioner,
`
`v.
`
`B. BRAUN MELSUNGEN AG,
`Patent Owner.
`____________
`
`Case IPR2017-01586 (Patent 8,328,762 B2)
`Case IPR2017-01587 (Patent 9,149,626 B2)
`____________
`
`REDACTED Record of Oral Hearing
`Held: September 26, 2018
`
`___________
`
`
`
`Before SCOTT A. DANIELS, MICHAEL L. WOODS, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`
`
`
`
`
`
`Case IPR2017-01586 (Patent 8,328,762 B2)
`Case IPR2017-01587 (Patent 9,149,626 B2)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`HEATHER M. PETRUZZI, ESQUIRE
`WILLIAM G. McELWAIN, ESQUIRE
`ALEXIS COHEN, ESQUIRE
`LAURA MACRO, ESQUIRE
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue, NW
`Washington, D.C. 20006
`Heather.Petruzzi@wilmerhale.com
`William.Mcelwain@wilmerhale.com
`Alexis.Cohen@wilmerhale.com
`
`NATALIE R. POUS, ESQUIRE
`OMAR A. KHAN, ESQUIRE
`Wilmer Cutler Pickering Hale and Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, New York 10007
`Natalie.Pous@wilmerhale.com
`Omar.Khan@wilmerhale.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`BARRY J. SCHINDLER, ESQUIRE
`Greenberg Traurig, LLP
`500 Campus Drive, Suite 400
`Florham Park, New Jersey 07932-0677
`SchindlerB@gtlaw.com
`
`JOSHUA L. RASKIN, ESQUIRE
`SCOTT J. BORNSTEIN, ESQUIRE
`Greenberg Traurig, LLP
`
`
`2
`
`
`
`Case IPR2017-01586 (Patent 8,328,762 B2)
`Case IPR2017-01587 (Patent 9,149,626 B2)
`
`
`MetLife Building, 200 Park Avenue
`New York, New York 10166
`RaskinJ@gtlaw.com
`BornsteinS@gtlaw.com
`
`and
`
`KEVIN WOEHR
`Danziger Str. 2
`Felsberg, Germany 34587
`
`
`
`
`The above-entitled matter came on for hearing on Wednesday,
`September 26, 2018, commencing at 10:05 AM ET, at the U.S. Patent and
`Trademark Office, Madison Building, 600 Dulany Street, Alexandria,
`Virginia, 22314.
`
`
`
`
`
`
`3
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`Case IPR2017-01586 (Patent 8,328,762 B2)
`Case IPR2017-01587 (Patent 9,149,626 B2)
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE KINDER: Good morning, everyone. I'm Judge Kinder, and
`
`with me remotely are Judge Daniels and Judge Woods.
`
`Before we get started today, we'll do a brief roll call.
`
`For petitioner, please?
`
`MS. PETRUZZI: Sure. Heather Petruzzi for petitioner. I'm joined by
`my colleagues Natalie Pous,
`
`William G. McElwain, Omar Khan, Alexis Cohen, and Laura Macro,
`all from WilmerHale.
`
`JUDGE KINDER: All right. Ms. Petruzzi, who will be arguing
`today?
`
`MS. PETRUZZI: I will.
`
`JUDGE KINDER: Okay.
`
`And for patent owner?
`
`MR. SCHINDLER: Good morning, Your Honor. For the patent
`owner, Barry Schindler will be arguing.
`
`In addition, because we're going to talk procedurally, Josh Raskin, my
`colleague, will be arguing the secondary considerations.
`
`JUDGE KINDER: Okay.
`
`MR. SCHINDLER: Potentially, he argues if we have questions on
`amended claims.
`
`And then I'd just like to introduce, Scott Bornstein is here, and the
`inventor, Kevin Woehr, is also here.
`
`JUDGE KINDER: All right. Thank you.
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`Case IPR2017-01586 (Patent 8,328,762 B2)
`Case IPR2017-01587 (Patent 9,149,626 B2)
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`So we're calling two IPRs today; case number IPR 2017-01586
`
`involving U.S. Patent 8,328,762, and case number IPR 2017-01587, with
`Patent 9,149,626.
`
`The petitioner is Becton, Dickinson and Company. And the patent
`owner is B. Braun Melsungen AG.
`
`And again, the IPR is going to be similar to the ones last week that we
`had involving the same parties. The oral argument today is going to start
`with one hour of total argument time per side. We do have another hearing
`in this room right after, so we may have to make sure we're a little bit
`punctual. We can't give you a whole lot of extra time today.
`
`The petitioner will go first to present its case and may reserve rebuttal
`time. Patent owner will go next and present its case. The patent owner has a
`motion to amend, so they also get -- you can have sufficient rebuttal time
`covering that, and also your motion to amend.
`
`There are remote judges. I'm the only one actually physically here
`today, so it's very important that you refer to the slide number when you're
`referencing the slide.
`
`The second thing I had was, we talked about sealing the courtroom
`because some of the demonstratives do have confidential information.
`
`Unfortunately, we haven't issued an order yet on your motions to seal
`which are pending, so -- you know, we've looked at them and skimmed
`them, but we haven't had time to fully consider that.
`
`What I would advise is, if you can refer to the exhibits and the line
`and page number and refer more generally to the confidential material.
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`If there's a situation where you do need to get into confidential
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`material that you don't want disclosed publicly, then you can present it at
`that time and we can deal with the courtroom.
`
`As a question, are there any parties in the courtroom -- or in the trial
`room right now that are not parties to this -- that are on confidentiality
`order?
`
`MR. SCHINDLER: Your Honor, Mr. Woehr.
`
`So to understand the confidentiality issue, it's mainly the petitioner's
`documents are confidential. And so that's the issue that we have with
`inventor being here and presenting those documents.
`
`So the suggestion was that we do all of the case in chief without the
`commercial success, which is where the confidential documents are, and I'll
`talk about timing, and then we do at the end the commercial success slides.
`
`I think that was the agreement between petitioner and patent owner, so
`that way we didn't have to stop. We could then -- Mr. Woehr would leave at
`that time, and we would do the commercial success.
`
`JUDGE KINDER: If there are no objections from my panel, I think
`that's a pretty good recommendation. And I don't see any objections from
`my panel members, so that would be fine.
`
`Again, make sure you leave sufficient time. There are a lot of issues
`with secondary considerations that we've been diving into, so make sure you
`leave sufficient time for that.
`
`MR. SCHINDLER: So let me talk about timing, Your Honor.
`
`JUDGE KINDER: All right. Go ahead.
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`MR. SCHINDLER: So we propose -- on our side, we propose 35
`
`minutes that we do, essentially, the prior art, and then 20 minutes for
`commercial success.
`
`JUDGE KINDER: So 20-minute rebuttal.
`
`MR. SCHINDLER: No. 20 -- you would call rebuttal, and then five
`minutes rebuttal. 20 minutes of the commercial success part, which is still --
`
`MR. RASKIN: Just a minor correction to that, Your Honor. For the
`secondary considerations part, the agreement was that the patent owner
`would go first.
`
`MR. SCHINDLER: On the commercial success part.
`
`MR. RASKIN: We're thinking -- we're thinking 20 minutes total per
`side for the secondary considerations issues. 40 minutes per side on the
`prior art issues. And then within that 40 minutes, we would go first, the
`patent owner would go first for the secondary considerations, reserving some
`of that 20 minutes for rebuttal, and so forth.
`
`JUDGE KINDER: Okay. Ms. Petruzzi, do you have anything on
`that?
`MS. PETRUZZI: Yes. So what we were proposing is that we have
`
`our case in chief go first for about 30 minutes, then for our rebuttal and our
`response to the motion to amend we would propose around 20 minutes, and
`then have 10 minutes which would be our rebuttal, because we would be
`going second in the secondary considerations section.
`
`JUDGE KINDER: Okay. All right. You might have -- this is a little
`different than what we're used to so you might have to remind me during.
`
`MR. SCHINDLER: Definitely.
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`JUDGE KINDER: And make sure you also keep your own time. I'll
`
`keep time up here, but make sure you keep time as far as how you're
`splitting it.
`
`MR. SCHINDLER: Yes, Your Honor.
`
`JUDGE KINDER: All right? All right.
`
`I think we are ready to begin. And I believe, Ms. Petruzzi, you said
`30 minutes initial time, correct?
`
`MS. PETRUZZI: Yes, that's correct.
`
`JUDGE KINDER: All right. Let me set that before you begin.
`Whenever you're ready.
`
`MS. PETRUZZI: Okay. Good morning.
`
`JUDGE KINDER: Good morning.
`
`MS. PETRUZZI: Turning to Slide 2.
`
`Today we are here to talk about obviousness in view of the '626 and
`the '762 IPRs, as well as a motion to amend that concerns both obviousness
`as well as written description, and then, as we just discussed, secondary
`considerations at the end.
`
`Turning to Slide 3. The patents here are directed to well-known IV
`safety catheters. And I just want to take a moment to orient us to what these
`devices look like.
`
`Very quickly, if we look on the slide, this is -- this is the --
`
`JUDGE KINDER: Slide 3?
`
`MS. PETRUZZI: I'm sorry?
`
`JUDGE KINDER: Slide 3?
`
`MS. PETRUZZI: Slide 3.
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`This is the IV catheters that are in the specification in the Raines (sic)
`
`patents, and that's what we call the '762 and the '626 patents here, so you
`might hear me refer to them that way.
`
`On the top we have the device in the ready-to-use position in Figure 1.
`What you see is the catheter hub in red. Distal, or towards the patient, you
`have a light blue catheter. And then proximal to the catheter hub, or towards
`the user or clinician, you have a yellow needle hub.
`
`Attached to the yellow needle hub is a green needle. It extends from
`the needle hub, through the catheter hub, through the catheter, and out the
`distal end of the device.
`
`You also have a royal blue valve --
`
`JUDGE KINDER: Is the -- is the valve in the patent --
`
`MS. PETRUZZI: Mm-hmm.
`
`JUDGE KINDER: -- it says it has a slit, and it shows examples of the
`slit, I think 7B.
`
`How is that -- is that sealed at the beginning before it actually is
`pushed through?
`
`MS. PETRUZZI: So in the Rains patents, Your Honor, it starts -- the
`claims require the device is in a ready-to-use position.
`
`In the ready-to-use position, the needle, which is in green here, is
`already extending through the valve. So it's already extending through the
`valve, and so there already has been an opening.
`
`Once that device is placed in the patient, what would happen is, is the
`needle would go in, the catheter would be threaded in, and then the needle
`hub and the needle would be withdrawn.
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`As that needle is being withdrawn, it would then close the royal blue
`
`valve to prevent any blood from flowing out the back of the catheter hub.
`And then it would reopen when you attached a male Luer, such as a syringe
`or something like that, to push fluids into the patient.
`
`So the male Luer would come in the back of the catheter hub -- you
`can see it in Figure 2 -- since it's open, and it would push the actuator
`forward, and that would penetrate the valve again and reopen the valve again
`so that you could have fluid flow through.
`
`So because this is in a ready-to-use position, the valve is always open,
`shall we say.
`
`JUDGE KINDER: So the slits in the valve, though, at the beginning,
`at the -- before manufacture, before it's being put into use, there's a couple
`descriptions in the specification that talk about the slits "starting from the
`middle and extending radially over a short section forming elastic flaps
`therebetween which can be expanded by the hub needle."
`
`Are those slits essentially all the way through the material, or could
`they be halfway through, or is it not explicit in the patent?
`
`MS. PETRUZZI: I think it's not explicit in the patent. And another
`thing I just want to draw your attention to is the fact that it is true that in
`Figure, for example, 6, you see 7B, which are the slits, but in the '626 patent,
`which is the patent that requires a slit in the claim, that's just a single slit, it's
`not a plurality of slits, and so I just wanted to make sure that that was clear.
`
`JUDGE KINDER: Yeah. I'm reading from the specification.
`
`MS. PETRUZZI: Mm-hmm.
`
`JUDGE KINDER: The specification also talks about the radial slit
`7A -- we're looking at Figure 6 --
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`MS. PETRUZZI: Mm-hmm.
`
`JUDGE KINDER: -- "are designed such that the ready position" --
`
`"such that in the ready position, the flaps, 7B, are bent radially upwards."
`
`What does that mean? Does that mean that the slit has a hole,
`essentially, all the way through because the flaps can be bent radially
`upwards?
`
`MS. PETRUZZI: So what -- I think what's happening in there, the
`design, when you have radial slits -- which, again, is not required by the
`claim here -- but when you have radial slits in their specification, they are
`designed so that they will flex in a certain direction when they open.
`
`Because as you can imagine, when you have three slits -- right? -- so
`that's what you have in Figure 6, those create three flaps. And so when the -
`- when anything is penetrating through that valve, the flaps move, and so
`instead of having them sort of crinkle in different directions, they're saying
`they're designed to move in a direction.
`
`JUDGE KINDER: I understand that, but I guess my question was, are
`the flaps essentially -- or the slit all the way through the material at that
`time?
`MS. PETRUZZI: I think at the point of manufacture we don't know.
`
`I think once something is inserted into them, then you have to have an
`opening through this valve, and so at that point there is an opening that goes
`all the way through the valve. Otherwise, you couldn't insert the needle in
`the ready-to-use position, which is what the claims require.
`
`JUDGE KINDER: Thank you. You can get back on --
`
`MS. PETRUZZI: Sure. Okay.
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`And so I just wanted to finish with Figure 2, and I think we were
`
`almost there. But essentially what happens is when you insert this catheter
`into a patient, the catheter is threaded into the patient, and then you want to
`remove the needle. So you pull back on the needle hub, the yellow needle
`hub, and as you pull back on the yellow needle hub, a couple things happen:
`
`The needle is withdrawn. As the needle passes through the royal blue
`valve, the valve will close to prevent blood from flowing through the
`catheter. And what you also see is that the spring clip here, which is the
`needle protective device, that's in orange. It's biased outward by the needle.
`
`So when the needle passes through the spring clip, that spring clip will
`close and protect the tip of the needle, which is what you see in Figure 2.
`
`And so this is in the protected position. And then you, as I -- as I
`indicated, you would have a male Luer, something like a syringe filled with
`fluids, and that would come in and push the actuator distally, which would
`open the valve again and allow fluid to flow into the patient, which is the
`intended purpose of the catheter.
`
`JUDGE DANIELS: Ms. Petruzzi, there is a -- obviously, when we
`get to it, we're going to talk about the prior art in a moment, but this -- this
`spring clip here, this spring clip only acts radially. In other words, it only
`sort of goes from an extended position to a -- to an unextended position to
`protect the needle tip when the needle is extracted from the -- from the
`catheter hub, correct?
`
`MS. PETRUZZI: I think I understand your question. And yes, it is
`biased open. So you would see it biased open, and then once it's no longer
`biased, it would spring closed.
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`And it might be helpful if you have a copy of the '762 patent in front
`
`of you. It might be helpful to see it this way.
`
`So if you look in Figure -- in the figures – in particular if you look at
`Figure 4 -- and just let me know when you have that.
`
`JUDGE DANIELS: Yeah, I've got it.
`
`MS. PETRUZZI: Perfect. Okay. So what you see here is you see the
`back of the actuator in 10B. So you see that the actuator is -- in this patient,
`in this configuration is not actually solid in the back -- right? -- it's not
`actually a cylinder. It has these two pieces. And the spring clip sits actually
`in the openings. So it's sitting in the open sections.
`
`So you have on one -- in one plane -- right? – you would have the
`actuator, and the other you have the spring clip. And so as the needle passes
`through that spring clip, which is sitting in that plane, is going to close, as
`you said, radially, but in that inward direction, and then pull out on the
`needle tip.
`
`JUDGE DANIELS: Are these -- are these -- is this -- let's see. It's the
`valve actuating element that's put in the valve itself, are those what -- I can't
`remember which party was referring to it, but it -- maybe it's just a general --
`maybe it's just a general nomenclature.
`
`Is this the blood control mechanism to prevent – is that what "blood
`control" means?
`
`MS. PETRUZZI: I think in this context for these proceedings, when
`the parties are referring to "blood control" -- or when Braun is referring to
`"blood control", and then when we are, as well, we are referring to the
`combination of the valve and the valve actuator. The valve to prevent blood
`from flowing out the back of the catheter hub, and the actuator to penetrate
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`the valve to allow fluid flow. So those work in concert here, and I think
`that's what they're talking about for blood control.
`
`But as -- and I'm not sure if you're alluding to this, and I know we'll
`get to it when we get to secondary considerations, but this is also something
`to consider because, for secondary considerations, that has to be tied to the
`claims and not to general concepts. And so I'm not sure if that's where
`you're going with this, but we will talk about that when we get to the
`secondary considerations.
`
`JUDGE DANIELS: Are you also going to talk about -- I think you
`have -- and I'm assuming it's in both cases -- a -- you raised it, at least in the
`'762, that there is a District Court claim construction that's different from
`ours.
`MS. PETRUZZI: Yes.
`
`JUDGE DANIELS: I'm assuming you're going to get to that? That's
`
`fine, we can wait.
`
`MS. PETRUZZI: Let's -- let's go to Slide 4.
`
`Slide 4 is the claim construction, and there is one term that is at issue
`in these IPR proceedings.
`
`At the top, we see the Board's construction in its decision on
`Institution. That is the construction that we applied in the rest of the
`proceedings is the Board's construction, but we maintain that the proper
`construction here is a means plus function construction. That that is what
`was given by the District Court here. We do believe that the Board is bound
`by that determination.
`
`But nevertheless, we also believe that it is the correct interpretation
`because, as our expert explained, and as is in our petition, we believe that the
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`term "needle protective device" does not connote enough structure --
`sufficient structure to a person of ordinary skill in the art that the device term
`is like a means terms under the Williamson line of cases, and that we have to
`look then to the specification under In Re Donaldson for the same function
`or the same or an equivalent structure.
`
`JUDGE KINDER: Was the District Court decision --
`
`JUDGE DANIELS: I don't know if I'm happy with that -- sorry. Go
`ahead.
`
`JUDGE KINDER: I was just going to ask if the District Court
`construction is under appeal?
`
`MS. PETRUZZI: It is under appeal, briefing is completed, and we're
`waiting for our hearing date.
`
`JUDGE KINDER: Go ahead, Judge Daniels.
`
`JUDGE DANIELS: I think the problem I'm having with it, of course,
`we have -- and I want you to talk a little about it here -- we have a
`presumption. There's no means language here. And there is -- albeit --
`albeit the term "protected" is -- doesn't give us a lot of -- those of us who are
`not of ordinary skill in the art here -- in the art of catheter devices such as
`this -- I think that that – that may not be particularly descriptive, but I'm also
`concerned that it is descriptive enough along with what's in the rest of the
`claim because -- because of the presumption and because of the -- the
`testimony we have here from declarants, and my concern -- this isn't either --
`it's not enough, or it's not means, it's not, you know, simply a device. Can
`you talk (inaudible) about it a little bit?
`
`MS. PETRUZZI: Sure. I'd be happy to.
`
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`So I think that "device" is, in this context, we would say it is announce
`
`word, and that "needle protective" really just describes function.
`
`And what we see is that the specification doesn't use the term "needle
`protective device" here. And our expert -- you're in good company. Our
`expert also doesn't -- this term doesn't connote any meaning to him, to a
`person of ordinary skill in the art at the time, of the invention here, which is
`2002, which is what we're talking about. The -- Braun has suggested that we
`should understand "needle protective device" to be "needle guard", but there
`is no indication that they are the same terms.
`
` And, in fact, in the parent application, the parent patent to the '762
`that's in the same family, they use the term "needle guard" in the claims.
`They knew how to use that term if that's what they wanted. That's not the
`term that they used here. They used the term "needle protective device".
`And that term does not have any meaning in – in the art.
`
`When we see there's been a little bit of sort of information going on
`about, you know, protective device, but, you know, in the cases where we
`actually have seen the term used, and it's not used routinely, it actually
`referred to the entire device.
`
`So the entire catheter insertion device would be a needle protective
`device because the entire point of the entire catheter insertion device would
`be to protect the needle, not the specific spring clip, as it is here.
`
`So we don't believe that there is any evidence in the record showing
`that the term "needle protective device" was understood to a person of
`ordinary skill in the art, we don't think that there's support in specification
`for the fact that the term "needle guard" should be read as a needle
`protective device. They're different terms. They could have used that term,
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`they didn't. And so we do believe that this is just a functional. It's just
`saying any old structure that could protect the needle, and that is not what's
`invented here.
`
`JUDGE DANIELS: "Needle guard" and "needle protective device"
`are not terms that would be understood to mean the same thing?
`
`MS. PETRUZZI: That's correct. That's correct.
`
`JUDGE DANIELS: Thank you.
`
`MS. PETRUZZI: Looking at Slide 5.
`
`Just to set the stage of where we are in the art. Okay? So by this time,
`the art recognized the need for blood control and for needlestick protection.
`Even Mr. Meyst, Braun's expert, admitted that by 2002, it was known to
`have devices with the blood control and needle stick protection.
`
`And that was because we were facing a time when you had the AIDS
`and the hepatitis epidemics. And so we had the OSHA guidelines, the
`blood-borne pathogen standards that happened in 1991, which called for a
`need to protect practitioners. We also had in two -- I believe it's 2000 -- yes
`-- the Needlestick Safety Prevention Act that recognized the need to have
`safer handling for these devices, and that included both needles systems or
`systems that protected the needle, as well as blood control to limit clinicians
`and practitioners' exposure to these blood-borne pathogens that could cause
`injury to them.
`
`BD had a product on the market in the 1990s. It's called a Saf-T-
`Intima. It had both blood control and needlestick protection. That was on
`the market in the '90s.
`
`As well, we see that there's prior art that discloses the combination.
`We've talked about Van Heugten here at length, but there were other prior
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`art references, and that's in the record that discloses that, including the
`Laundra (phonetic) reference, the Pike reference, and the Arnett reference,
`just to name a few.
`
`JUDGE KINDER: From an overview standpoint for the 1587
`proceeding, why wasn't Van Heugten used as an anticipatory reference
`alone?
`
`MS. PETRUZZI: Sure. So I think -- and maybe it helps to go to Slide
`8. I'm not sure if it does, but...
`
`The claims -- the claims in the '626 patent, which is the '87
`proceeding, require a slit.
`
`And so we took the, I think, conservative position that we use single-
`reference obviousness to say that it would have been obvious, in view of the
`Van Heugten disclosure, for a person of ordinary skill in the art to use a
`valve with a slit.
`
`The reason for that, there's three -- there's three disclosures in Van
`Heugten that we think are clear in rendering obvious a valve with a slit.
`
`One, of course, is the Reynolds disclosure, the second is the disclosure
`of a use of a duck-bill valve, which is known to have slits, and then the third
`is the fact that, even if this were a closed membrane, as Mr. Meyst, Braun's
`expert, admitted, when you're talking about hypodermic needles, which is
`what you're using in Van Heugten, that would actually cause a slicing of the
`material or a slit in the material, it wouldn't create a hole. And that's actually
`quite important because that same needle is also going to slice into your
`skin, and you wouldn't want to create sort of a hole that would create a plug
`of skin that could get into your vasculature.
`
`So we do think that there are three reasons why, but it is --
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`JUDGE KINDER: Okay. Yeah. So you answered my question about
`
`anticipation. It's the -- it's really the limitation with the slit.
`
`MS. PETRUZZI: Yes.
`
`JUDGE KINDER: And I understand that it may not have been
`explicitly set forth in Van Heugten, that's why we're here today, and this
`seems to be a very, you know, contentious term --
`
`PETRUZZI: Yes.
`
`JUDGE KINDER: -- but neither party has offered a precise definition
`for the term "slit".
`
`So what is petitioner's definition based upon the specification of what
`a slit should be?
`
`MS. PETRUZZI: Sure. So I think that we -- it's our position that a
`person of ordinary skill in the art would understand the meaning of the term
`"slit", that it gets its plain and ordinary meaning in this field. You know --
`
`JUDGE KINDER: So does a slit have to have a hole?
`
`MS. PETRUZZI: I think that in this context a slit is not a hole.
`Right? So when we think of a hole --
`
`JUDGE KINDER: Or an opening all the way through the material.
`
` MS. PETRUZZI: I -- so I -- I think it's our position that the opening
`eventually has to be all the way through the material because you have to
`insert the needle in it.
`
`To get to Independent Claim 11 in the '626 patent, it has to have a
`needle passing through it. It's in the ready-to-use position. So there has to
`be an opening that goes all the way through the valve when the needle is
`passing through it.
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`Whether that opening has to pass all the way through in a sort of
`
`prefabrication, you know, before you actually assemble this product, I don't
`think that that's clear in the specification, and it's certainly not required by
`the claim here.
`
`The claim only requires that when this needle is passing through, that
`the valve have a slit. There isn't anything here about a pre-manufactured
`slit, there's nothing here about how you manufacture this, and the -- the
`device -- the claim is directed to a product that has the valve -- I'm sorry --
`the needle passing through the valve.
`
`JUDGE KINDER: So the limitation -- the valve actuating element
`requires the nose section having a tapered end for pushing the valve open or
`to open the slit.
`
`Wouldn't that infer that it has to have an opening in a prefabricated
`position? I'm looking at Claim 11 of the '626 patent, the valve actuating
`element limitation.
`
`MS. PETRUZZI: So this is saying -- so I'm on Slide 8 for the remote
`judges, and it has the claim language on it.
`
`So the valve actuating element, it does have to have a nose section, it
`has to have a tapered end, and it has to push the valve to open the slit.
`
`But recall, that's not going to happen until after the needle has already
`been withdrawn from this device, at which point there is going to be an
`opening because the needle left an opening that's then sealed. And so the --
`the valve actuating element in this case will push through that slit that's
`formed.
`
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`There is no way that the valve actuating element could pass through
`
`the valve or the slit in the valve before the needle does. It's just not how
`these devices work.
`
`JUDGE KINDER: So we're talking about a point in time where the
`needle is withdrawn.
`
`MS. PETRUZZI: We -- we are talk -- in that particular instance, we
`are talking about a point in the time when the needle is withdrawn, because
`that's the only time where the back of the catheter hub is open so that you
`could have a male Luer come in contact with the actuator to actually distally
`push the actuator opening.
`
`Recall, when the needle is still there, you have the needle hub on the
`back of the catheter hub, so there's no way to push that actuator in a distal
`direction.
`
`JUDGE KINDER: So looking at the claim language for the valve
`which comprises a wall surface comprising a slit.
`
`MS. PETRUZZI: Yes.
`
`JUDGE KINDER: Does it make any difference here that they're
`claiming just the wall surface itself comprising a slit as opposed to the entire
`wall?
`MS. PETRUZZI: I don't think that it matters that they're claiming a
`
`wall surface -- I mean, potentially. Right?
`
`
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