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 IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
` Case IPR2017-01590 (Patent 9,370,641 B2)1
`____________
`
`Record of Oral Hearing
`Held: September 21, 2018
`____________
`
`
`
`
`
`
`
`
`
`
`
`Before SCOTT A. DANIELS, MICHAEL L. WOODS, and ROBERT L.
`KINDER, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`1 We issue one Transcript and enter it in each proceeding.
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BECTON, DICKINSON AND COMPANY,
`Petitioner,
`
`v.
`
`B. BRAUN MELSUNGEN AG,
`Patent Owner.
`____________
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
` Case IPR2017-01590 (Patent 9,370,641 B2)1
`____________
`
`Record of Oral Hearing
`Held: September 21, 2018
`____________
`
`
`
`
`
`
`
`
`
`
`
`Before SCOTT A. DANIELS, MICHAEL L. WOODS, and ROBERT L.
`KINDER, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`1 We issue one Transcript and enter it in each proceeding.
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`WILLIAM G. McELWAIN, ESQUIRE
`ALEXIS COHEN, ESQUIRE
`HEATHER M. PETRUZZI, ESQUIRE
`MARK D. CAHN, ESQUIRE
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue, NW
`Washington, D.C. 20006
`William.Mcelwain@wilmerhale.com
`Alexis.Cohen@wilmerhale.com
`Heather.Petruzzi@wilmerhale.com
`Mark.Cahn@wilmerhale.com
`
`NATALIE R. POUS, ESQUIRE
`Wilmer Cutler Pickering Hale and Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, New York 10007
`Natalie.Pous@wilmerhale.com
`
`JEANNE P. LUKASAVAGE, ESQUIRE
`Becton, Dickinson and Company
`1 Becton Drive
`Franklin Lakes, New Jersey 07417
`
`
`
`
`2
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`BARRY J. SCHINDLER, ESQUIRE
`Greenberg Traurig, LLP
`500 Campus Drive, Suite 400
`Florham Park, New Jersey 07932
`SchindlerB@gtlaw.com
`
`HEATH J. BRIGGS, ESQUIRE
`Greenberg Traurig, LLP
`1200 17th Street, Suite 2400
`Denver, Colorado 80202
`BriggsH@gtlaw.com
`
`JOSHUA L. RASKIN, ESQUIRE
`SCOTT J. BORNSTEIN, ESQUIRE
`Greenberg Traurig, LLP
`MetLife Building, 200 Park Avenue
`New York, New York 10166
`RaskinJ@gtlaw.com
`BornsteinS@gtlaw.com
`
`KEVIN WOEHR
`Danziger Str. 2
`Felsberg, Germany 34587
`
`
`
`
`The above-entitled matter came on for hearing on Friday, September
`
`21, 2018, commencing at 1:05 PM ET, at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`
`
`
`3
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`P R O C E E D I N G S
`
`1:05 p.m.
`JUDGE DANIELS: Good afternoon, everyone. We are here
`today, we have three proceedings that are going to go on in this hearing, if
`I'm not mistaken, 2017-01588, 01589, and 01590. That sounds right? So
`now we have final written decisions due on different dates -- or the same
`date, but one is going to come up earlier than the other.
`Who will be speaking from petitioner?
`MR. McELWAIN: Your Honor, Bill McElwain from WilmerHale
`for petitioner.
`JUDGE DANIELS: Thank you. And who is with you at the table?
`MR. McELWAIN: With me is my associate Alexis Cohen,
`Heather Petruzzi, and I would like to introduce Natalie Pous, also from
`WilmerHale, Mark Cahn from WilmerHale and Jeanne Lukasavage from
`Becton Dickinson.
`JUDGE DANIELS: Thank you. For patent owner?
`MR. SCHINDLER: Good afternoon, Your Honors. We are going
`to be splitting this. So Barry Schindler will be doing the first part before we
`get to the amended claims. And my colleague, Heath Briggs, will be doing
`the amended claims. And I want to introduce who is with me. With me is
`the inventor, Kevin Woehr. You have heard that term a lot. I try to get it
`right, Woehr. With me is Josh Raskin and Scott Bornstein from my firm,
`Greenberg Traurig.
`JUDGE DANIELS: Just a couple of housekeeping matters while
`I've still got my notes up here, did you all have a way that you wanted to do
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`4
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`each of your cases -- let me ask petitioner first. Do you want to do each of
`your cases separately or do them all at once?
`MR. McELWAIN: I think what we've agreed is we'll do the
`case-in-chief, all three IPRs together. Then there will be a response to that
`and they will present their motion to amend. Then I will come back with
`rebuttal and response to motion to amend.
`MR. SCHINDLER: That's the way we put the slides together, in
`one composite of all three IPRs, so hopefully it will flow in that way.
`JUDGE DANIELS: And do you want to -- we also now have a
`sur-rebuttal, right? I’ve got to make sure I'm keeping up with our rules too.
`MR. SCHINDLER: So I would like to just talk about timing and
`what we are thinking on our end, and then they can speak on their end. So
`because we have 100 minutes, we are looking at approximately 60 minutes
`that we would like to do as our case-in-chief and then rebuttal 40 minutes.
`JUDGE DANIELS: Okay. And how about, same thing, about
`60 minutes?
`MR. McELWAIN: That sounds fine.
`JUDGE DANIELS: The timer that I have here just gets away from
`me. I figured maybe you would go for 60 minutes, so I programmed it with
`60 minutes. So we'll start there.
`MR. SCHINDLER: Your Honor, can I ask another housekeeping
`question. For some of us 100 minutes may be a problem with bathroom
`breaks, so can we talk procedurally when we want to do that?
`JUDGE DANIELS: Sure. We were chatting about this before.
`When would you like to break? We can break at the hour quickly.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`5
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`MR. McELWAIN: Whatever suits people. Might be when one
`lawyer sits down, that would be a time to have a break.
`MR. SCHINDLER: That would be appreciated if we could do
`that. It's going to take a little time to set up anyway, so could we do it at that
`time?
`
`JUDGE DANIELS: Certainly. No problem.
`JUDGE KINDER: Yeah, quick five minutes.
`MR. SCHINDLER: Thank you very much.
`JUDGE DANIELS: Sure. Just be patient with me. I had
`computer issues this morning, and everything is fine. It just takes me a
`minute to get everything back up. We have our timer. The court reporter is
`all set.
`
`Good morning, this is our final hearing for IPR2017-01588, which
`relates to U.S. patent 8,460,247, IPR2017-01589, which relates to patent
`8,597,249, and IPR2017-01590, which relates to patent 9,370,641.
`Petitioner is Becton, Dickinson and Company, and patent owner is B. Braun
`Melsungen -- how do I pronounce that?
`MR. SCHINDLER: Melsungen.
`JUDGE DANIELS: Thank you. I'm Judge Daniels. This is Judge
`Kinder in the room with you, and Judge Woods is on the video from Dallas.
`If he asks a question, we need to make sure we are speaking into the
`microphone so that he can hear us. And please, for his sake, he can't see any
`of the demonstratives that we see in here, so just make sure -- because I'm on
`that receiving end sometimes, just make sure you say what slide you are on.
`It's really helpful.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`6
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`You all have entered demonstratives as well as the updated
`demonstratives, right? So those are the latest ones. We didn't talk about
`expunging the old ones at all. It doesn't matter at this point. We can or not.
`Each of you have asked for -- you have 100 minutes. We've divided that up,
`60 minutes to start, essentially. I'll keep the time right here. Petitioner has
`the burden, so you will go first. Patent owner, then you'll have, as you
`discussed before, you'll have the opportunity to present your response in
`rebuttal and then we have a sur-rebuttal. I'll give you a warning a couple
`minutes before you come towards the end. If you need a couple minutes,
`just ask. That's not a problem.
`We probably don't need to remind you not to interrupt. There's no
`speaking objections, so don't interrupt the other party. If you have an
`objection, we can talk about it before we adjourn the hearing, but usually
`that's not too much of a problem in here.
`The one thing I did want to talk with you all about is these motions
`to seal, which we have a number of, and you all seem to have reached an
`agreement on how we conduct this hearing. We are very dis-inclined to stop
`this proceeding and usher people in and out. I looked at some of the motions
`to seal, and some of them relate to -- on both sides seem to relate to just the
`fact that they are stamped confidential or confidential in the underlying
`District Court litigation. I'm reluctant to close this hearing for anything. So
`what I'm going to suggest we do is if you come to a part in your
`demonstratives -- the demonstratives at least for this hearing were not filed
`with motions to seal, right?
`MR. SCHINDLER: Yes, Your Honor.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`7
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`JUDGE DANIELS: So let's do this. I would rather have you all
`refer to them sort of with some euphemism. If you don't need to get into the
`details of the document, then there's no reason -- I don't see a particular
`reason to close this just because you want to refer to a document. I mean,
`the documents themselves are there. So if you really have a confidential
`subject matter that you want to talk about here today, we are going to have
`to have a discussion and maybe have an argument and some argument about
`that, because I looked through them. I see some stuff. I understand why you
`would want to keep it confidential, but some of it was just the name of the
`document itself. You can take some of your time if you want to argue the
`motions to seal if there's something you want to here, but I would suggest, if
`you can refer to it by the document number, that's how we usually handle it.
`We can look at it on the screen and see what you are referring to.
`Any questions, Judge Woods, on the motions to seal?
`JUDGE WOODS: No questions. Thank you.
`JUDGE DANIELS: With that, unless you all have any questions,
`I'm going to let petitioner begin.
`MR. McELWAIN: Thank you, Your Honors. Is the mic working?
`JUDGE DANIELS: Yes.
`MR. McELWAIN: For tall guys sometimes the microphone gets
`away from me. So if I'm not being heard, please don't hesitate to ask me to
`speak up.
`JUDGE DANIELS: We can hear you just fine here. It's just Judge
`Woods, hewill speak up if he can't.
`MR. McELWAIN: Let me reintroduce myself. My name is Bill
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`8
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`McElwain. I represent Becton Dickinson. I would ask Ms. Cohen to run the
`slides, so hopefully that will give me the discipline to announce the slide
`number so that Judge Woods can follow along.
`Slide 2, please. So as Your Honor indicated, there are three
`proceedings here involving three different patents. The patents are in the
`same family that has been referred to as the Zerbes family or the
`Woehr/Zerbes family. They share a common specification. I'm going to
`devote almost all my time to the '641 patent which presents issues that cross
`all three patents, and at the end I'll address the small issues involved in the
`'247 and the '249 patents.
`Slide 3, please. So to orient ourselves, this is Figures 13 and 14
`from the Zerbes patent, and it shows two different cross-sections of the same
`embodiment covered by the challenged claims. The key limitation and the
`key aspect of this embodiment that we have been talking about is the
`structure colored in purple which is referred to in the claims either as a tip
`protector housing or as a third housing. The tip protector housing surrounds
`a tip protector, which is the structure in red that's a spring clip that covers the
`needle after the needle is withdrawn.
`Next slide, please. This is claim 15, the independent claim of the
`'641 patent. And the limitation, the only limitation really at issue in these
`proceedings with respect to the '641 patent is the second-to-last limitation, a
`safety device covering the needle tip comprising a tip protector housing
`having a housing section positioned proximally of the proximal end of the
`catheter hub.
`While we have the claim up there, let's just go through the different
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`9
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`parts of it so we know where we are. The catheter hub, of course, is in the
`front there. I think it's labeled 32. The needle hub is all the way to the right.
`I think that's labeled 18. You see the valve, a particular type of valve called
`a skirt valve. That's labeled 46 right at the front. And then jumping to the
`last limitation, you have a valve opener which is certainly a plunger-like
`thing which under the force of a Luer lock will go into the valve and open
`the valve. None of those limitations are at issue. The only limitation at
`issue, as I said, is the safety device which in connection with the
`embodiment is the combination, I would say, of the safety clip and the tip
`protector housing.
`Next slide, please.
`JUDGE KINDER: When you say next slide, can you refer to the
`slide number. It helps our colleague and then also when we are looking at
`the record later.
`MR. McELWAIN: Apologies. Slide 5 we are on now, and this is
`just to orient us as to what the grounds are for the '641 patent. There are two
`grounds, Woehr in view of patent application Callaway and Woehr in view
`of a patent Villa.
`Let's go to the next slide, which is slide 6, and this is the Woehr
`application, a German application, the English translation of which is at
`Exhibit 1005. I believe the next slide gives the relevant -- colors the relevant
`portions of the structure disclosed in the Woehr German application and
`corresponds to the claims of claim 15. You see, as with claim 15, a catheter
`hub which, I believe, is 1, a needle hub which is 8, a valve which is colored
`in blue, which I'm not sure what the number of that is, a safety device which
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`is a tip protector, a metal safety clip, and a valve opener in purple there.
`So I do believe this is a truly undisputed fact with respect to all of
`the claims at issue in all of the patents, that Woehr discloses everything but a
`tip protector housing having a housing section positioned proximally for a
`proximal end of the catheter hub.
`Slide 8, please.
`JUDGE DANIELS: Could we look at just the slide with the '641
`picture on it, 3, I think.
`MR. McELWAIN: It was 4.
`JUDGE DANIELS: Either one of those is fine. This may
`eventually be a better question for patent owner, but how does the safety
`device -- it's in there by friction by the two nubs there inside it and then you
`have the spring clip inside of that. Is that a separate -- are they initially
`separate and then the needle is inserted and it goes through everything?
`MR. McELWAIN: So as you purchase the device, the needle is
`inserted in the catheter and you insert the catheter in the patient. So that's
`from a manufacturing standpoint how it works.
`When you withdraw the needle, it comes through the valve, and
`then when it reaches the back end of the tip protector housing, it creates kind
`of a frictional effect with that spring clip that snags that.
`JUDGE DANIELS: Snags that clip.
`MR. McELWAIN: And then as you pull it all the way out, the tip
`protector housing comes off it and with it, of course, the spring clip as well.
`JUDGE DANIELS: So is this when it's been pulled back, when
`the needle has been pulled back and engaged the spring protector and then
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`11
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`someone would grab the outside, is that your understanding, someone grabs
`the outside of that middle hub and just pulls it right out?
`MR. McELWAIN: Correct. There's no commercial embodiment
`of this, but either through the force of just pulling the needle hub back, that
`might be enough to take the tip protector housing off the catheter hub or
`grab the tip protector housing and just pull it off the catheter hub.
`JUDGE DANIELS: Thank you.
`MR. McELWAIN: If we could return to slide 8, we just discussed
`the fact that the only limitation missing from the Woehr German application
`is the tip protector housing. Tip protector housings were known in the prior
`art. I would say they are ubiquitous. In the record here are some of the
`patents that reveal a tip protector housing, including Callaway, Villa, which
`of course are the basis of the grounds that we'll talk about in depth.
`And if you go to next slide, which is slide 9, this is from the
`specification of the '641 patent or the specification of all the Zerbes patents
`where it states that a third housing may be incorporated to house the tip
`protector, and the third housing positioned between the catheter hub and the
`needle hub and then describes two patent applications where that is shown.
`Those are the Sircom and Menzi patents which are also in the prior art.
`So there's no dispute that a tip protector housing is in the prior art.
`It's admitted in the patent itself. Numerous references that show it. And so
`the only issue with respect to the '641 patent is would it have been obvious
`to add a tip protector housing to the Woehr device, to the teachings of the
`Woehr German application, would there have been a reason to add a tip
`protector housing.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`12
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`JUDGE DANIELS: So this is in the '641?
`MR. McELWAIN: Correct. That's column 12 near the top, I
`believe, line 19. There we go, line 19 to line 32.
`If we could turn to the next slide, now let's just talk about
`Callaway and Woehr. The structure of the way I'm trying to present this is
`to kind of try and lay out my prima facie case and respond to the arguments
`that I understand are to be made, but maybe they'll mix together. But first
`let's take a look at Callaway, which this is a -- in slide 9, a Figure 5 which is
`the two-catheter invention of Callaway which is a small catheter, a middle
`catheter, which is 21, inside a larger catheter 30. And the idea behind the
`basic invention of Callaway is this allows you, because you start out with a
`small tip that exceeds the front of the larger catheter, it allows you to get a
`larger catheter into a vein than you might be able to do if you were just
`dealing with a large catheter. That's the fundamental invention of Callaway
`not particularly relevant to the issues at hand.
`Slide 11, and this is Figure 9, and it shows -- on the right it shows
`the device expanded out with the large catheter in the front 30, the middle
`catheter in the middle 21, and the needle and needle hub on the right. The
`middle hub there, when it's referred to in Callaway, is a tip protector
`housing.
`Next slide, which is slide 12 --
`JUDGE DANIELS: Before you go there, can we go back to those
`pictures. So let me ask sort of the pragmatic question how this thing works
`again. So this one, Callaway in particular, has an inner and an outer
`catheter, and they both surround the needle; is that correct?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`13
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`MR. McELWAIN: That's correct. Maybe go to slide 10 and you'll
`see on the left the whole thing put together. And because the catheter, the
`middle catheter is a narrower dimension than the front catheter, that allows
`you essentially, I guess, sort of a telescoping-like ability to get in a small
`puncture and then a larger puncture and then retract them, and you'll have a
`larger catheter in the patient as a result.
`JUDGE DANIELS: And that larger catheter is the one that you
`see sitting in a patient sometimes in a hospital so they are not going -- I don't
`know what they call it, but going back in.
`MR. McELWAIN: Yes. There's a robust dispute about what
`happens to the middle hub. But I don't think there's any dispute about when
`the dust clears, the front catheter is in the patient and additional devices can
`be attached.
`JUDGE DANIELS: If you're going to hit this later, I'm going to
`ask you a question that I have been thinking about which is -- and maybe
`you are going to get to this, but if I look at the figure on the right, if you pull
`out the needle there, it would be really strange if it engaged a spring tip
`protector inside that metal -- if it engaged a middle tip protector inside of
`that middle hub, it would be kind of funny, wouldn't it? It would be kind of
`flopping around there on the end?
`MR. McELWAIN: Sure. This is the exact teaching of Callaway.
`And why don't we go to paragraph 61, which is really the critical disclosure
`in Callaway. And if I could, maybe I'll just kind of walk through it sentence
`by sentence. So Figure 9 shows the catheter assembly with the needle safety
`device disclosed in this patent, the '630 patent. The '630 patent is another
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`14
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`patent of Mr. Woehr's, and it discloses the basic safety clip. We can see that
`on the next slide but don't need to look at it right now.
`Figure 9 illustrates how the catheter assembly could be integrated
`with an existing needle protection device. As patent owners show now,
`Figure 9 doesn't actually show the safety clip inside the middle. You have to
`take the text word for that. In Figure 9, the catheters and their hubs have
`been partially advanced off the needle. That's just describing Figure 9. And
`then it tells you the needle safety device includes a metal clip in the hub 21.
`21 is the middle hub of the inner catheter which upon withdrawal of the
`needle -- and I think this is a critical phrase: Upon withdrawal of the needle,
`the inner hub captures and contains the needle tip within the hub.
`JUDGE WOODS: I apologize, this is important to me and I'm
`glad you are discussing it. If I could please interrupt and ask a question.
`MR. McELWAIN: Please.
`JUDGE WOODS: So I understand the petitioner relies largely on
`this paragraph, Callaway's paragraph 61 for teaching that its hub 21 provides
`extra protection in addition to the metal clip from the needle's sharp tip. I
`also see this same paragraph as teaching two versions, one version in which
`the needle and attached clip could be withdrawn from hub 21, and a
`preferred version wherein the inner catheter hub 21 and needle remain
`attached together and are discarded together in a safe manner. So for clarity,
`which version, if any, does petitioner rely on?
`MR. McELWAIN: Well, of course we rely on the disclosure as a
`whole. But if I had to answer that question more directly, I would say the
`preferred version is the version most germane to this argument because it
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`15
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`clearly provides the motivation to add what I would call sort of a
`belts-and-suspenders approach to safety which is in addition to a needle clip,
`you have an extra hub or a tip protector housing that surrounds the needle
`clip.
`
`JUDGE WOODS: Thank you. And as a follow-up question, will
`you please reconcile that answer with Mr. Griffis's cross-examination
`testimony, specifically Exhibit 2050 at page 97, lines 11 to 25?
`Exhibit 2050 at 97, lines 11 to 25 where he states that he's not relying on the
`preferred version.
`MR. McELWAIN: Your Honor, I don't have that testimony
`particularly in mind. I can tell you what my fundamental answer would be,
`which is the answer I gave previously only partially in jest, which is that I do
`believe you look at the patent as a whole. And I suspect what he was talking
`about was I am relying on the teaching as a whole, which teaches a tip
`protector housing with respect to both embodiments. My argument would
`be that the preferred embodiment is the one most clearly germane to this
`particular proceeding.
`JUDGE DANIELS: Judge Woods, what page was that on?
`JUDGE WOODS: Well, in particular, Exhibit 2050 is, I believe,
`Mr. Griffis's cross-examination testimony. In particular, page 97, lines 11 to
`25.
`
`MR. McELWAIN: Again, I would have to look at that in context.
`I think in our petition, the sentence that we really focused on was the clip
`and hub protects users from the sharp tip of the needle. So that's the sort of
`direct motivation, the teaching of a hub that protects users from the tip of the
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`16
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`needle. The two additional sentences expand on that fundamental point.
`JUDGE WOODS: Thank you.
`MR. McELWAIN: As long as we are on paragraph 61, let me
`respond to at least one argument now that I understand petitioner to make,
`which is this preferred version actually refers to an embodiment, the next
`embodiment discussed in the Callaway patent which is referred to as the
`Critikon embodiment by patent owner. And just from a matter of how you
`read a patent or a patent application, I think that's not a very convincing
`argument. If you look at the structure of the Callaway patent, it has a long
`section with no figures referenced at the beginning of each paragraph. And
`then when it gets into the figures, it marches through each figure. It says
`Figure 1 and explains what Figure 1 is up to, Figure 2 and explains what
`Figure 2 is up to, and then it gets to Figure 9 and explains what Figure 9 is
`up to. Then following that it goes to Figure 10 which is the Critikon version
`on which the patent owner relies. So it seems to me, just leaving everything
`else to the side, simple kind of grammar and the way things are written, that
`the one version and the preferred version of paragraph 61 very clearly is
`discussed in Figure 9 and the safety clip that is in the hub.
`JUDGE DANIELS: But there's no drawing -- there's no figure that
`shows -- there's no figure that shows the spring clip in the hub?
`MR. McELWAIN: That's correct, Your Honor.
`JUDGE DANIELS: Are we to assume that there would also be a
`structure in there that would keep -- capture or keep that spring clip in there?
`MR. McELWAIN: Yeah. Why don't we turn to slide 13 where we
`talk about that a little. So slide 13 is the '630 patent. And as we've
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`17
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`discussed before, the '630 patent is what's referred to in Callaway, and it has
`the spring clip that is identical to the Woehr patent.
`Interesting, the '630 patent, this is discussed in the Griffis
`declaration, refers to several prior art patents in its background section,
`including a patent of Gaba and a patent of Purdy, I believe. And both of
`those patents show a protective device within a housing. So I would say the
`'630 patent itself has information that would lead a person to a tip protector
`in a tip protector housing.
`JUDGE KINDER: From an evidentiary standpoint and the fact
`that paragraph 61 incorporates by reference the '630 patent, what difference
`does that make, the fact that it's actually incorporated by reference?
`MR. McELWAIN: I think it means for certain that the teaching as
`a whole is incorporated by reference. I think the particular sentence in the
`'630 patent is simply saying -- the next sentence is simply saying here is a
`spring clip that you can use in the middle hub of this device. I would not
`suggest that this is telling you anything about how to attach it within the
`spring clip, within the hub, but the rest of the specification clearly suggests,
`implies, tells a person of ordinary skill in the art that it is attached, because if
`it wasn't attached, then you wouldn't be able to have this preferred
`embodiment.
`JUDGE DANIELS: And here in the '630, it just pulls right out
`from being inside there?
`MR. McELWAIN: That's correct. That's an identical operation as
`Woehr, I would say.
`Let me take a look at Villa now, which is slide 15. Villa also
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`18
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`shows a tip protector housing. That's shown in purple on slide 15. These
`are Figures 7 and 8. In Villa you have these two clips. I think they are
`called tongues in Villa. When you withdraw the needle, there is this item, I
`think it's 23, which pulls back. I think it's called a blocking means, and
`allows the tongue to fold over the needle tip. Prior to that, the tongues are in
`contact with a needle. I don't believe it's disputed that Villa discloses a tip
`protector housing.
`Slide 16, please. So we went over this before. The petition stated
`and the institution decision found that Callaway gives a reason to add a tip
`protector housing to Woehr in this particular sentence that describes that the
`clip and hub protect users from the sharp tip of the needle. So a person of
`ordinary skill in the art would read that and understand that the hub would
`be used to protect the users from the sharp tip of the needle.
`And then if we go to slide 17, Villa discloses an additional
`advantage. Villa, of course, is about accidental needle sticks, and now that's
`shown, I think, in paragraphs 15 and 80. But in paragraph 63 and also I
`believe in paragraph 80, it expands on the notion that the tip protector
`housing serves the function of containing fluids inside the hollow body, as
`it's called in Villa, after the needle is withdrawn.
`One thing to consider when you think about these devices is the
`needle in this is a hollow cannula usually, and so there's a lot of blood
`involved as you withdraw the needle both on the needle and coming out of
`the needle. So one aspect of a tip protector housing is to contain fluids
`within it, which a simple spring clip, of course, is not going to do. And that
`is an express teaching of Villa.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`19
`
`
`
`Case IPR2017-01588 (Patent 8,460,247 B2)
`Case IPR2017-01589 (Patent 8,597,249 B2)
`Case IPR2017-01590 (Patent 9,370,641 B2)
`
`
`JUDGE WOODS: If I may ask another question, is it
`Mr. McElwain?
`MR. McELWAIN: McElwain, but I certainly answer to McElwain
`
`too.
`
`JUDGE WOODS: I apologize for butcherin
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
