`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00444
`Patent 6,915,560 B2
`____________
`
`Record of Oral Hearing
` Held: March 15, 2018
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`
`
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, STACY B.
`MARGOLIES, Administrative Patent Judges.
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`Case IPR2017-00444
`Patent 6,915,560 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
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`
`
`
`
`
`
`CRAIG S. SUMMERS, ESQUIRE
`Knobbe Martens
`2040 Main Street, 14th Floor
`Irvine, California 92614
`949.760.0404
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`WALLACE WU, ESQUIRE
`Arnold Porter
`777 South Figuero Street, 44th Floor
`Los Angeles, California 90017
`213.243.4104
`
`
`
`
`The above-entitled matter came on for hearing on Thursday, March
`15, 2018, commencing at 1:00 p.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
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`Case IPR2017-00444
`Patent 6,915,560 B2
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`P R O C E E D I N G S
`- - - - -
`JUDGE TARTAL: We are here for a final hearing in inter partes
`review case captioned Edwards Lifesciences Corporation, Petitioner, versus
`Boston Scientific Scimed, Incorporated, Patent Owner, Case IPR
`2017-00444, concerning U.S. Patent Number 6,915,560 B2.
`Let me begin by introducing the panel. I'm joined by Judge Powell
`and Judge Margolies and I'm Judge Tartal. Can I please have the parties'
`appearances and we'll begin today with Petitioner.
`MR. SUMMERS: Good afternoon. My name is Craig Summers of
`Knobbe Martens. I'm here to present the argument today on behalf of the
`Petitioner, Edwards Lifesciences. With me today will be Josh Stole, my
`partner and my partner Christy Lee. I'd also like to introduce two in-house
`attorneys from Edwards Lifesciences who are here today. Keith Newberry,
`who is the vice-president and chief IP counsel of the company, and Ryan
`Lindsey, who's senior corporate counsel of intellectual property and
`litigation.
`JUDGE TARTAL: Good afternoon, Counsel, and welcome. Now for
`Patent Owner, who do we have appearing today?
`MR. WU: Wallace Wu, from Arnold Porter Kaye Scholer. With me
`is my colleague Nick Nyemah. Also with me are my colleagues Chantelle
`Gutrick, Ed Hong and Mark Cohen. Thank you, Your Honors.
`JUDGE TARTAL: Thank you. We set forth the procedures for
`today's hearing in our trial order and as a reminder, each party will have 40
`minutes of total time to present arguments in the case. Petitioner has the
`burden of proof and will go first. Patent Owner will then present opposition
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`arguments for the case, also argue its motion to exclude and if the Petitioner
`has reserved time, Petitioner will present arguments in reply to the case and
`any opposition to the motion to exclude.
`Finally, if Patent Owner has reserved time, it may present reply
`arguments, only with regard to the motion to exclude. Counsel, any
`questions in that regard for Petitioner?
`MR. SUMMERS: No, Your Honor.
`MR. WU: No, Your Honor.
`JUDGE TARTAL: For clarity of the transcript, when you refer to an
`exhibit on the screen, please state for the record the exhibit and page
`number, or for demonstratives, the slide number to which you are referring.
`We remind each party that under no circumstances are they to interrupt the
`other party while that party is presenting its arguments and demonstratives.
`We are aware that Patent Owner has filed objections to Petitioner's
`demonstratives. Patent Owner may address those objections during its time
`to argue today, if it so chooses, but we will reserve ruling on those
`objections at this time.
`Are there any additional questions on behalf of Patent Owner?
`MR. WU: No, Your Honor.
`JUDGE TARTAL: Any questions on behalf of Petitioner at this time?
`MR. SUMMERS: No.
`JUDGE TARTAL: Petitioner, would you like to reserve a certain
`amount of time of the 40 minutes for your later reply?
`MR. SUMMERS: Yes, Your Honor. We would like to reserve 12
`minutes for the reply rebuttal.
`JUDGE TARTAL: So that will begin you with 28 minutes. You may
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`proceed when you're ready, Counsel.
`MR. SUMMERS: Thank you. And, again, good afternoon. As
`shown in Slide, the '560 Patent is directed to an apparatus having movable
`blades or dies arranged to form an aperture in the shape of a polygon. The
`dies move inward to reduce the size of the aperture and they move outward
`to increase the size of the aperture.
`There are multiple uses for this apparatus, including as a crimper and
`as a blow molding tool. The variable size polygonal apertures shown in the
`'560 Patent were well-known in the prior art. As shown in Slide 4, we have
`examples from four prior art patents which show crimping apertures in the
`shape of a polygon, some go back as far as 1954, such as the Andrews
`Patent, in the upper left. So these patents show multiple uses for gripping
`objects, forming bars and so forth and this was very well-known in the prior
`art.
`
`Slide 6, please. Trial has been instituted on all challenged claims
`based on Section 103, in view of the Yasumi Patent, Fig. 8. Trail also has
`been instituted on a subset of those same claims under Section 103, based on
`Yasumi in combination with Morales.
`Slide 7 shows the disputed issues in this case. The first one is whether
`the preamble, a stent crimper is limiting. I'd like to turn to that argument
`first.
`
`Slide 9 shows Claim 1 from the '560 Patent. This is a representative
`claim and shows the preamble in dispute. Every challenged claim has this
`preamble.
`Slide 12. There are multiple reasons why the preamble is not limiting.
`First, the body of the claim recites a structurally complete invention. The
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`preamble of each claim could be deleted and it would not affect the structure
`of the invention. The body of the claim is completely understandable
`without reference to the preamble and Boston has not identified any
`structure supplied by the preamble, a stent crimper, that is important for the
`claim to be structural complete.
`Boston argues that the description of the term stent in the specification
`connotes structure, but the structure of a stent is irrelevant to the structure of
`a stent crimper. They're two completely different structures. The structure
`of a stent does not inform or determine the structure of a stent crimper.
`There are many different times of stent crimpers and I think we'll see some
`of those today when Boston presents its reply at argument.
`Slide 13. Next, the stent crimper preamble does not provide any
`antecedent basis. The body of the instituted claims does not contain the term
`stent crimper, so the preamble provides no antecedent basis for that term.
`Boston argues that Claim 36, which is not part of this proceeding,
`controls. That claim does recite the term stent crimper in the body of the
`claim, but the law is clear that a preamble can be limiting in one claim and
`not in another. Boston argues that Claim 36 should control so that we will
`be giving consistent meaning to the term stent crimper from one claim to the
`next and, therefore, avoid any inconsistency, but the meaning or construction
`of the claim is very different than whether that term is limiting.
`And that's what we're talking about here. We're not talking about
`having inconsistent constructions of stent crimper across the claims. We're
`just saying that it's not limiting and, if anything, Claim 36, which does recite
`the term stent crimper in the body of the claim, shows that Boston knows
`how to write a patent claim and make the preamble potentially limiting if it
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`wants to and it has not done that with of any instituted claims.
`Slide 14. Finally, Boston did not distinguish the prior art based on the
`preamble. Slide 14 shows several patents that were cited at various times by
`the patent examiner to reject the claims. None of the tools shown in these
`patents are stent crimpers and Boston did not argue for that patentability of
`any of the instituted claims on the ground that the preamble is limiting and
`thus distinguished these tools. In fact, the examiner repeatedly said the
`preamble was not limiting and Boston did not at any time dispute the
`examiner's position.
`JUDGE TARTAL: Is there any legal basis to why that would matter
`in this proceeding, whether or not Patent Owner disputed the preamble
`during prosecution and whether or not it was limiting or not?
`MR. SUMMERS: Yes, Your Honor. Go to Slide 11. There's a
`statement in there from the Catalina Marketing case which says: Statements
`of intended use or asserted benefits in the preamble may, in rare instances,
`limit apparatus claims, but only if the applicant clearly and unmistakably
`relied on those uses or benefits to distinguish the prior art.
`So it's our position that the term stent crimper is a statement of
`intended use and it's rare that it would be limiting, and thus the Catalina case
`is instructive by saying if don't argue the preamble to distinguish the prior
`art, then a statement of intended use like this is not limiting.
`In Slide 15, I just wanted to briefly address the cases that Boston cited
`in its Patent Owner response. Boston took the position that their cases that
`support the preamble being limited and that the '560 Patent is restricted to a
`stent crimper, but all the cases that Boston cited are distinguishable. In each
`of those cases the patents dealt with solving a particular problem in a
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`particular way with a picture invention. There was no broad disclosure of
`the structure that had multiple uses like the case here, so we think the cases
`that Boston cited are distinguishable.
`And the '560 Patent does not define the term stent crimper and it does
`not set forth in any detail in the specification the structural dimensions of the
`crimper, what kind of material it needs to be made out of, those details are
`not there, which is very distinguishable from the cases such as Corning
`Glass where there was complex equations disclosed for determining the
`structural dimensions of the optical wave guide in that case and its refractive
`index.
`JUDGE MARGOLIES: Counsel, what statements in the patent itself
`support your argument for why the preamble is not limiting?
`MR. SUMMERS: I'm going to show you that right now. That's our
`next Slide 16. We have some excerpts here from the '560 Patent that we
`believe support our position that the '560 Patent is not limited to a stent
`crimper, but rather recites what Boston calls an inventive apparatus that has
`multiple and diverse uses.
`The first excerpt shows using this inventive apparatus to reduce the
`size of a medical device. The second excerpt talks about using the so called
`invented apparatus to crimp a medical device. The next one talks about
`using this apparatus as a variable size balloon mold.
`JUDGE MARGOLIES: Counsel, just for the record, can you say the
`column number and line number of the excerpts you're relying on.
`MR. SUMMERS: Yes, certainly. For the first excerpt it's '560 Patent,
`column 2, lines 48 through 55. The next excerpt about crimping a medical
`device is at column 3, lines 16 through 18.
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`The next excerpt about using the apparatus as a variable sized balloon
`mold is at column 3, lines 36 through 38. And, finally, using the apparatus
`and incorporating it into a blow molding tool is found at column 8, lines 65
`through 67. And all these citations are from the '560 Patent, and they're also
`on the slide for your convenience as well, Your Honor.
`Slide 17. What does Boston say about all these other uses. In
`Boston's Patent Owner response they relegated these other uses to a
`footnote. In the footnote they say that the specifications acknowledgment of
`other uses of a stent crimper does not alter the fact that the '560 Patent was
`directed to stent crimping, but the '560 Patent does not acknowledge other
`uses of a stent crimper. As we just saw, it acknowledges other uses of a so
`called inventive apparatus for things other than stent crimping. Boston
`completely ignores these other uses and perhaps they'll explain them today,
`but up to this point, they've been ignored. I next want to talk about the
`operatively engaged limitation of the claims.
`JUDGE TARTAL: Can I ask, does your ground turn on whether or
`not the preamble is limiting. In other words, do you have any argument that
`the claims challenged are obvious regardless of whether or not the preamble
`is limiting?
`MR. SUMMERS: Yes.
`JUDGE TARTAL: Can you explain?
`MR. SUMMERS: Yes. Whether or not preamble is limiting, so if the
`preamble is not limiting, Yasumi discloses each and every limitation of the
`claim. And this would be a single reference obviousness position.
`At the time we filed the petition, we weren't sure if the Board was
`going to agree with that, so we made our basis under 103(a). If the preamble
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`is limiting, we think Yasumi, with the knowledge of a person of ordinary
`skill in the art, that you could use pliers to crimp stents would look to
`Yasumi as an obvious solution to crimping a stent uniformly with that
`polygonally shaped aperture of Yasumi.
`JUDGE MARGOLIES: Where do you make that argument in your
`petition?
`MR. SUMMERS: We make that argument at pages 11 through 14,
`pages 46 through 47, I believe, and pages 82 through 85.
`So in the first citation I gave you, we talk about in the background of
`the art, how pliers are used to crimp stents. The second citation deals with
`how Yasumi is analogous and pertinent to the problem being solved. And
`the last citations to pages 81 to 85 deal with additional reasons why a person
`of skill would be motivated to use Yasumi. And I have slides on that, too, as
`well.
`
`Getting back to your question. If the preamble is limiting and for
`some reason the Board feels that Yasumi is not the kind of plier-like device
`that a person of skill would use to crimp a stent, we also have the Morales
`patent, which would be available to show some of the other limitations
`where the stent crimper -- where the term stent is used in some of the claims.
`That's the subset ground two.
`Let's go to Slide 19. Claim 1 of the '560 Patent shows the disputed
`limitations operatively engaged to the dies at distinct connection locations.
`I'd like point out that the claim only requires operative engagement by one
`stationary end wall and not two. It just says at least one of the stationary end
`walls.
`Slide 20, please. In this next series of slides, we're going to
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`demonstrate how in the Fig. 8 embodiment Yasumi side plates are
`operatively engaged to the movable pieces.
`Boston contends that there's insufficient disclosure in Yasumi
`regarding how these parts are connected together, the moveable pieces and
`the end walls, but we think Boston is not applying the level of ordinary skill
`in the art that would be brought to a reading and understanding of Yasumi.
`So in Slide 20 we show the movement pieces in green and the fixed
`handle in blue, which has two stationary side plates 27-1 and 27-2. In Slide
`21 we introduce the movable handle, which is shown in purple. That has a
`frame at its base with guide grooves 39 shown in red and within those guide
`grooves the movable pieces are fitted. The movable pieces have projections
`40 which are also outlined in red that fit within those guide grooves.
`Slide 22 we're now introducing the setting piece 32 also shown in
`blue. The setting piece has two circular projections, one on the forward
`facing side and another one on the rear side that is not shown. The circular
`projection 33-1 fits within the hole 28-1 of the side plate. The rear circular
`projection on the setting piece fits within the circle recess 38 of the frame,
`which is in purple. So these three pieces, the movable pieces, the movable
`handle and the setting piece are now engaged with each other.
`And Slide 23, we're now going to introduce the two support discs 41
`and 42. Let's talk about disc 42 first. Boston's expert, Dr. Solar, contends
`that this disc is not engaged with a side plate. Again, we think he's not
`applying the level of skill in reaching that conclusion. The support disc 42
`fits within the hole 28-2 of the side plate and it also fits within a circular
`recess of the fame in purple. You can't see that circular recess but we've
`outlined it with the dashed line.
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`There's also an annular flange 70 on the support disc that prevents it
`from going all the way through the hole. The support disc 41 at the bottom,
`is a little larger than the hole 28-1 on that other side plate and it fits up
`against it.
`If we look at Slide 24, we introduce the drive pins and the screws.
`The drive pins go through -- there's one for each hole in each of these
`components that go through the holes in the disc 42, the elongated holes and
`the movable pieces, through holes in the setting piece and through holes in
`the disc 41, then the screws are connected to those drive pins and everything
`is now coupled together. Everything is engaged. We'll have some cites
`from Yasumi, too, to support that. In this way, every component is
`connected to another component.
`Now we're going to see how all of this operates to reduce the size of
`the aperture in Slide 25. In Slide 25 we have created an exploded view of
`Fig. 8. The red dashed line show the common crimping axis of this tool.
`We've also introduced a new component in red called the adjust cam.
`To use the tool, an operator will grab the movable handle and move
`towards the stationary fixed handle. The setting piece also moves along with
`it until the setting piece hits the adjust cam in red. When that happens,
`Yasumi teaches that you can continue to bring the movable handle closer to
`the fixed handle and because the pins are stopped, they don't move anymore,
`they don't rotate around that axis anymore because they've been stopped by
`the setting piece, which they go through, now for the movement of the
`movable handle forces the movable pieces against those drive pins and they
`slide inwardly to close the aperture. And we've got all the components in
`blue that are stationary, so you can see those do not move when the adjust
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`cam is contacted by the setting piece, but the purple movable handle does
`continue to move.
`The next series of slides, 26, 27 and 28, we have citations to Yasumi,
`excerpts that show how the movable pieces move by relative rotation of
`those handles 37 and 26, how they're coupled together.
`Slide 27 specifically talks about the setting piece and how it stops
`moving when it engages the fixed handle and then bringing the handles
`closer together causes the movable pieces to close the aperture.
`And Slide 28 we also have an excerpt that talks about the setting piece
`hitting that adjust cam and stopping movement of the setting piece and thus
`fixing those pins, just like in Fig. 3. In fig. 3 the pins are fixed because
`they're connected to the guide base. Yasumi Fig. 8 just fixes the pins in a
`different way, when the setting piece hits the adjust cam.
`Slide 29. Boston alleges that Yasumi's disclosure is insufficient. We
`don't think the problem is with the disclosure of Yasumi as being
`insufficient. We think the problem is that Boston is not applying the level of
`ordinary skill in the art and also because Dr. Solar had some difficulty
`understanding. Dr. Solar is Boston's expert. So as you can imagine, this
`was subject to cross-examination at his deposition.
`In Slide 30 in one exchange we asked Dr. Solar about how the setting
`piece and the movable handle worked together and he candidly admitted he
`had a difficult time understanding how the setting piece actually worked. He
`said it again, he had a difficult time.
`Slide 31. In another exchange, we asked him again about the setting
`piece in the movable handle and he said it's not clear how it works. There's
`not enough description to really understand what's going on there.
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`And, finally, in Slide 32, we asked him specifically, is the support disc
`42 engaged with the hole 28-2 in the side plate of the fixed handle. And his
`answer was there's no description that it's engaged. It just states that it's
`placed there. In our view that's a difference without a distinction. I think it's
`semantics in a sense. They are operatively engaged to each other as we saw
`the disc fits within the hole of the side plate.
`Slide 34. At one point Dr. Solar relied on fixation as a basis for there
`to be operative engagement. And here's an exchange where we asked, are
`you saying there need to be holes in the side plates of the Yasumi that
`correspond to the holes in the support disc. And Dr. Solar said for it to be
`operatively engaged, that's what I'm saying, yes. But as we just explained,
`Yasumi's side plate is operatively engaged to the movable pieces via
`multiple components. It's an indirect connection. And the '560 Patent does
`the same thing.
`In Slide 35 we show how the '560 patent operatively engages its
`blades to the non-rotating plate indirectly through three components. Slide
`36 shows the first component. It's the connecting link, 130 shown in red.
`Slide 37 shows the second component. It's a bearing block in dark blue,
`number 212. And the third component is shown at Slide 38. It's the linear
`slide shown in yellow.
`So Boston's argument that Yasumi's side plates are not operatively
`engaged is without merit and unpersuasive. Yasumi's side plates are
`operatively engaged to the dies by multiple components, just like the '560
`Patent.
`JUDGE MARGOLIES: Counsel, I believe you only relied on this
`figure in your reply, but could you make a statement or argument for the
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`other embodiments.
`MR. SUMMERS: Yes, I believe that's correct. All of the blades are
`connected to the stationary plates through multiple components. We made
`this argument in our reply brief in response to Boston's position that there
`had to be some kind of fixation or holes in the side plate.
`One other point, if you removed any of the components of Yasumi,
`take away any one of the ones we just described, the tool wouldn't operate.
`So if that connection isn't operative engagement, it's hard to imagine what
`would be.
`In Slide 29 Boston argues that the distinct connection locations must
`be on the stationary end plates, but there's no support for this argument and
`Boston's own expert testified that the distinct connection locations are on the
`blades. Slide 40 shows that testimony. We asked him that question. That's
`what he said. Yes, they're located on the blades.
`Now I'd like to talk about the inward/outward limitation of the claim.
`Slide 42 shows a representative claim, which requires the dies move inward
`to reduce the size of the aperture or outward to increase the size of the
`aperture.
`Let's turn to Slide 43 now. We've got Yasumi Fig. 3 on the left and 2a
`from the '560 Patent on the right. We've colored the dies so you can see
`them more clearly. We're going to show how these dies move inward to
`reduce the size of the aperture. And I would ask you to focus on the tip of
`one of these dies. Let's just take the red die, for example. Watch the tip of
`the red die of Yasumi as it moves towards the central aperture of Yasumi.
`Let's do the same thing with the '560 Patent. Let's look at the red die and
`watch the tip of the red die follow that radial line 126 that goes through the
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`center of the aperture.
`So the dies in Yasumi move inward in the exact same fashion as the
`'560 Patent and we have one more slide that shows that movement inward
`completely to zero. This is Slide 44. So there's clearly movement inward
`and outward according to the plain meaning of those terms as would be
`understood by a person of ordinary skill in the art.
`Let's go to Slide 47. Now if the Board does find that the preamble is
`limiting, it's our position that a person of ordinary skill would have been
`motivated to use Yasumi as a stent crimper. In Slide 47, what did a person
`of ordinary skill know. They know from these patents here, the Pinchasik,
`Dinh and Verbeek, that it was well-known to use pliers or ordinary pliers,
`plier-like devices, to crimp a stent.
`In Slide 48 we asked Dr. Solar, Boston's expert, if he knew, did
`people know to use pliers to crimp stents. He said, yes, they did. And then
`we asked him why didn't you say anything about that in your declaration.
`His answer was, I chose to express my opinions as I did. He really didn't
`have an answer. And we think the answer is because tools like Yasumi are
`very similar to what the examiner cited and what people of skill knew to use
`to crimp stents.
`We also know on Slide 49 that the examiner relied on prior like
`devices, just like Yasumi, to reject the claims during prosecution. The
`examiner recognized and relied on the Whitesell Patent and the Wilhelm
`Patent to reject the claims, taking the position that they were capable of
`crimping a stent, therefore, they were stent crimpers, even though none of
`the disclosure in the patents says that those were stent crimpers. And Boston
`did not dispute that position.
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`We also know from Slide 50 that Yasumi has broad disclosure. Here's
`an expert from Yasumi that talks about the polygonally shaped aperture and
`how it can be used as a press tool, which is another name for a crimper, and
`there's other uses described. So this tool has a lot of application. You can
`even use it as a control valve.
`JUDGE POWELL: So do you submit that it is a stent crimper then?
`MR. SUMMERS: Yes, we do. It is a stent crimper, just like the prior
`Whitesell and Wilhelm Patents that the examiner cited.
`JUDGE MARGOLIES: Did you say that in a paper submitted to us?
`MR. SUMMERS: It would be in our petition and in Mr. Sheehan's
`declaration at page 50 of the petition, Your Honor.
`And so in Slide 51, in light of all these teachings, we think a person of
`skill would have been motivated to use Yasumi as a stent crimper. It's a
`plier-like tool. It solves the same problem as the '560 Patent. And there's
`nothing unpredictable about this device. A person of skill would have a
`reasonable expectation of success in using a device like this to crimp a stent.
`To the extent necessary, I'd like to turn, briefly, to the Morales Patent.
`At page 55, we have some representative claims, Claims 11 and 17. These
`cite the categories of additional limitations that are at issue here. Claim 11
`and 19 and 35 talk about the stent being disposed about a medical balloon
`and a medical balloon being disposed about a catheter. In our view, these
`are conventional uses of a stent and really don't limit what the invention is, a
`crimping device or a blow molding tool device. Whether there's a stent in
`there doesn't limit that claim, in a sense it's an improper dependent claim.
`However, it's there. And the other category of claim here is of Claims 17,
`26, 34 and 39, and those just talk about having the stent being disposed
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`entirely within the aperture.
`JUDGE MARGOLIES: Counsel, I want to go back to the follow-on
`question I asked you and you pointed to page 50 of your petition, which says
`Yasumi is considered a stent crimper for purposes of analyzing validity of
`the challenged claims. What did you mean by for purposes of analyzing the
`validity? Is it not a stent crimper for other purposes?
`MR. SUMMERS: No, that's probably extraneous language we don't
`need. It's a tool that's capable of crimping a stent and doing a lot of other
`things, but it's clearly capable of crimping a stent and, therefore, it's a stent
`crimper. I think we were trying to follow what the Patent Office was saying
`here about a tool like this.
`And I'd also like to direct your attention, please, to pages 82 through
`85 of the petition, which also talk about why a person would be motivated to
`use Yasumi as a stent crimper. If you'd like, I can try to highlight a few of
`those sentences for you, if that would be helpful, but that's where you'll find
`it, Your Honor.
`I'm going to conclude with just saying that Boston really hasn't
`disputed any of these additional limitations and our remaining slides 56, 57
`and 58 show how Morales teaches each of these -- the limitations of these
`dependent claims, which are the subject of ground two. And with that I
`would like to save the rest of my time for rebuttal.
`JUDGE TARTAL: Thank you, Counsel. You have 40 minutes. Do
`you want to reserve any of that?
`MR. WU: Yes, I'd like to reserve five minutes for my time for
`argument on the motion to exclude.
`JUDGE TARTAL: You have 35 minutes for this portion of your
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`argument.
`MR. WU: Good afternoon, Your Honors. My name's Wallace Wu. I
`represent the Patent Owner, Boston Scientific Scimed. Petitioner has failed
`to carry its burden of proving by the preponderance of the evidence the
`challenged claims of that '560 Patent. They failed for many reasons. But
`before I get into the detail as to why they failed, I would like to step back
`and briefly examine the history of the stent crimper field.
`Slide 2 you see a picture of a stent on a journal publication from the
`late 1980s. It shows a tubular mesh-like metal structure that's mounted on a
`balloon catheter. Now when the balloon expandable stent was first
`introduced on the market, the stent and the balloon catheter were sold
`separately. So it was up the physicians to crimp the stent, either using a pair
`of hands or using a tool like a plier. But that didn't work because when you
`use hand crimping or plier-like device, it will result in non-uniform stent
`crimping. It could cause trauma to the vessel and also negatively affect the
`balloon itself and also the uniform expansion of the stent.
`Now in the early 1990s, medical device companies start to sell stents
`pre-mounted on the balloon catheters, so that trigged intense competition
`among medical device companies to develop stent crimping technologies.
`My client, Boston Scientific Scimed, and its predecessor Scimed, Inc.,