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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`COOK GROUP INCORPORATED
`and COOK MEDICAL LLC,
`Petitioners,
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`v.
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`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`IPR2017-00435 (Patent 9,271,731 B2)
`IPR2017-00440 (Patent 9,271,731 B2)
`____________
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`Record of Oral Hearing
`Held: September 17, 2018
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`BEFORE JAMES T. MOORE, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
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`IPR2017-00435 (Patent 9,271,731 B2)
`IPR2017-00440 (Patent 9,271,731 B2)
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
`DOMINIC P. ZANFARDINO, ESQ.
`JEFFRY M. NICHOLS, ESQ.
`JASON W. SCHIGELONE, ESQ.
`Brinks Gilson & Lione
`455 N. Cityfront Plaza Drive
`Suite 3600
`Chicago, Illinois 60611
`
`
`ON BEHALF OF PATENT OWNER:
`DAVID A. CAINE, ESQ.
`Arnold & Porter Kaye Scholer
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306
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`--and--
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`JEFFREY MARTIN, ESQ.
`Arnold & Porter Kaye Scholer
`250 West 55th Street
`New York, New York 10019
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`The above-entitled matter came on for hearing on Monday,
`September 17, 2018, commencing at 1:30 p.m., at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`IPR2017-00435 (Patent 9,271,731 B2)
`IPR2017-00440 (Patent 9,271,731 B2)
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`P R O C E E D I N G S
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`JUDGE KINDER: Good afternoon, everyone. I'm
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`Judge Kinder, and with me today are Judge Tartal and Judge
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`Moore on the far end. Today we're calling two proceedings for a
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`supplemental hearing in IPR2017-435 and IPR2017-440, both
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`involving patent number 9,271,731.
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`This is -- as I mentioned, this is a supplemental hearing,
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`so it's -- we have already had an initial hearing. We also note that
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`these two cases have not been consolidated or joined, but just like
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`this morning's proceeding, they involve overlapping issues, so we
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`are going to argue them both together. But as I think the parties
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`want, we are going to separate the '435 and '440 issues out as
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`needed.
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`Each party will have 60 minutes of time, and because
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`the Petitioner bears the burden, the Petitioner will go first, and
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`then can reserve time for rebuttal, much like this morning,
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`however you prefer.
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`So at this point, I want to get a roll call of who's here for
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`Petitioner.
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`MR. ZANFARDINO: Good afternoon, Your Honors.
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`For Petitioners Dominic Zanfardino and Jason Schigelone.
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`JUDGE KINDER: All right, thank you.
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`For Patent Owner?
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`MR. CAINE: Good afternoon, Your Honors. David
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`Caine and Jeffrey Martin, and, again, our paralegal Shantell
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`Gutrick, and our client, Denise Lane, our client representative.
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`JUDGE KINDER: All right, thank you.
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`Again, some of the same rules as this morning. When
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`you get up to argue, please make sure that you give your name
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`and then which proceeding the argument is either directed to or in
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`response to, just so when we're going back through the transcript,
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`we can see those clear delineations of when you switch and who
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`If there are no questions at this time, we will proceed
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`with Petitioner, I believe on the '435 case first.
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`MR. ZANFARDINO: Thank you, Your Honors.
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`Dominic Zanfardino on the '435 case, and I should have also
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`introduced my other co-counsel from this morning, Jeff Nichols,
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`and then the client representative, Jack Hunt, and then an
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`observer from my firm, Alex Wang.
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`Okay, so first the '435. The newly instituted grounds
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`are grounds 3 and 4. Ground 3 presents the issue of whether what
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`the parties call Malecki embodiment 2 anticipates the claims that
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`are listed here on slide number 4, and then ground 4 presents the
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`issue of whether that same embodiment in Malecki 2 would
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`render obvious certain claims listed on slide 4.
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`IPR2017-00435 (Patent 9,271,731 B2)
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`So I am going to jump ahead a few slides here to slide
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`number 12 to re-orient the Board as to what Malecki embodiment
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`2 is. My colleague touched upon it a little bit this morning, but I
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`just want to make sure we all understand what it is.
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`Malecki embodiment 2 is a clamp, and the way it works
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`is there are two jaws. One is referred to as a fixed jaw, 308B.
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`Another is referred to as a pivotally mounted jaw, 310B. Now,
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`it's hard to see, the numbering is small, but to the left of the jaws
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`that are open on the left side, you can see a -- what's called an
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`actuator housing, and that bears reference numeral 324B.
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`And the way that works is there is a separate device,
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`called a clamp positioner, that I believe you all are familiar with,
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`that sort of acts like a socket wrench. It fits over 324B, this
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`actuator housing, and it runs along a set of threaded -- there's a
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`bunch of -- there's some threads here on this jaw extension, 320B,
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`and as you rotate that actuator housing 320B, you either advance
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`it proximally or distally.
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`And when you advance it proximally -- I'm sorry,
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`distally, there's a shoulder portion that's referred to as 325B on
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`that actuator housing, 324 -- I'm sorry, it's 325, that's on 324B,
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`and it starts to push that jaw closed. And then as you rotate in the
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`opposite direction and start pulling that actuator housing 324B
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`back, that jaw -- that top jaw, 310B, can spring back open,
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`because there is a spring sitting there somewhere -- and our
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`expert talks about that -- that is disclosed but not illustrated,
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`okay?
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`So the question, going back to slide 6, is whether that
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`Malecki embodiment 2 anticipates claim 1 and claim 12. Claims
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`1 and claim 12 are identical. The only difference is there's an
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`additional paragraph or limitation at the end of claim 12 that
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`doesn't appear in claim 1 that is not material to the issues that are
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`being discussed today.
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`In slide number 6, we have highlighted or underlined
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`the two limitations that Boston Scientific argues are not present in
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`Malecki embodiment 2. The first is that there's a closed -- well,
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`the claim requires an open configuration and a closed
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`configuration, and I'll jump over to that here in slide 9.
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`There's an open tissue receiving configuration in which
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`the first and second arms are separated from one another by a
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`distance selected to receive tissue therebetween. So, in essence,
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`those two arms -- those two jaw arms, they're spaced apart.
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`There's an -- there's another configuration that's referred to as the
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`closed configuration in which the first and second arms are
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`moved inward to capture the tissue received therebetween.
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`So --
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`JUDGE KINDER: I think the big issue here, and it's
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`kind of -- it's a pretty simplistic issue, is what point of reference --
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`when it says "moved inward," what's our point of reference?
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`MR. ZANFARDINO: So thank you for the question,
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`because that really is the issue, and I think it is a very simple
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`issue. Now, our position is simply this. The point of reference in
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`the Board's institution decision, the Board said that the arm 308B
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`is fixed and thus not able to move inward as required by the claim
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`language. And then -- and Your Honors went on to say Petitioner
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`did not adequately explain how the first and second arm moved
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`inward in relation to the clip when the embodiment relied on
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`states that 308B is fixed and, therefore, not movable. Our
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`position is simply this, that the point of reference are the two clip
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`arms.
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`JUDGE KINDER: So when we say "in relation to the
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`clip," you think we got that wrong?
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`MR. ZANFARDINO: I think you got that wrong in
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`part. So, in other words, obviously the clip -- the clip arms are
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`part of the clip, right? And so when you're saying "in relation to
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`the clip" -- I'm sorry -- yeah, "in relation to the clip," it's not
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`entirely clear, at least it wasn't entirely clear to us, what you
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`meant there.
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`What we -- what we think you may have meant -- but I
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`don't want to put words in your mouth -- is that the point of
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`relation are the two clip arms with respect to one another, because
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`look at the two configurations that we're talking about. We're
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`talking about an open tissue receiving configuration, and all it
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`says is there's a distance between those two arms. They are
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`separated from one another. There's no act of actually someone
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`reaching out and spreading them apart. They just need to be --
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`have a distance between them.
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`The closed configuration is now relating itself back to
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`the open tissue receiving configuration and saying, well, there's a
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`different state, if you will, of these two arms in which those first
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`and second arms are moved inward to capture tissue. In other
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`words, the space that exists in the open tissue receiving
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`configuration is less than the space that exists in the closed
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`configuration, so that the arms are moved inward -- go ahead.
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`JUDGE KINDER: But, I mean, claim -- the first part is
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`configuration. There's nothing about distance or separation
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`amount. It's an action of they have to be capable of being moved
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`inward, first and second arms are moved inward to capture the
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`tissue. So to me you're kind of saying the closed configuration
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`should relate back and you have to look at the first limitation, and
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`I'm just not fully understanding that argument.
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`MR. ZANFARDINO: Well, so -- so you have -- there's
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`two configurations. We all agree on that. One is an open tissue
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`receiving configuration, and one is a closed configuration. Now,
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`if we knew nothing else other than what an open tissue receiving
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`configuration is and a closed configuration was, we would have
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`said, okay, one's open and one's closed. What does exactly those
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`configurations represent? We don't know.
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`But the claim goes on to give you additional language,
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`additional explanation, right? It's telling you that -- because
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`already this claim, remember, has identified in antecedents that
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`arms are separated from one another by a distance selected to
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`receive tissue therebetween. It doesn't really care what the tissue
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`is, doesn't know what the tissue is. There just has to be some
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`space. So we're -- the patent -- the claims decided to refer to that
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`configuration as a configuration in which two arms are spaced
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`apart.
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`JUDGE TARTAL: Okay. Then what does the word
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`"inward" mean? I mean, you wouldn't need it if they were just
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`moved to capture the tissue. "Moved inward," what does that
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`mean?
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`MR. ZANFARDINO: Well, so, I suppose you could
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`imagine a set of clips where you might capture tissue where a
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`closed configuration has clip arms moving in a different
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`direction. I don't know if I'm stating this very well, but you could
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`imagine where you would trap -- so, for example, you would trap
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`tissue. You would be closing something by trapping tissue
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`against something else, as opposed to --
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`JUDGE TARTAL: Or it's a hole and the arms open
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`inside the hole.
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`MR. ZANFARDINO: Something like that, exactly.
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`JUDGE TARTAL: But in this instance, the claim says
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`"are moved inward." So inward relative to what?
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`MR. ZANFARDINO: Inward relative to one another.
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`So, in other words, you have two clip arms, but you're not
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`requiring -- in other words, there's not a method of use. This is an
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`apparatus claim. It's not -- there's no method of use that's
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`requiring a user to do something, right? It's describing a state. So
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`you have a state in which you have separation between clip arms,
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`and you have another state, the closed configuration state, in
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`which the two arms -- the first and second arms are moved
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`inward, but that doesn't mean necessarily that you moved both
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`arms. That's the point.
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`JUDGE MOORE: I'm having trouble with that.
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`MR. ZANFARDINO: I understand.
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`JUDGE TARTAL: Looking at your slide 12, I think,
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`why shouldn't we view the fixed clip arm 308B as defining a state
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`relative to what's labeled the jaw extension and it being fixed to
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`the jaw extension? Why isn't the construction of the claim
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`language something that would require both of the two clip arms,
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`labeled 310B and 308B, to move relative to one another and
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`distinct from the jaw extension itself? I think the fact that it's
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`labeled a fixed clip arm is what we may have some trouble
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`understanding outside of a frame of reference that isn't tied to
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`what you have labeled as the jaw extension itself.
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`MR. ZANFARDINO: And I understand -- I
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`understand, but it's about relative movement, and so it's -- so, in
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`other words, you could look at -- on slide 12, for example, you
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`could look at the clip in the configuration that's on the left, and
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`you could look at the clip that's in the configuration on the right.
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`claim on -- I mean, the clamp that's shown on the right in Figure
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`12, that's in the closed configuration. The claim -- the clamp on
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`the left is in the open configuration, right?
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`But now let's just assume you didn't know anything
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`the clamp that was on the left. How do you know if that's in the
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`open tissue receiving configuration or in a closed tissue receiving
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`configuration unless you know more about how much that clamp
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`is going to close, what is it you're trying to capture? And so the
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`claim uses language -- if I can go back to it -- to go beyond just
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`saying open and closed configurations, to tell you about distances
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`IPR2017-00435 (Patent 9,271,731 B2)
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`And why we think the Malecki patent supports that --
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`and I'll just go right to the slide. The bottom -- I'm looking at
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`slide 13 right now, and at the -- what Malecki said about this
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`embodiment, right, embodiment number 2, it says, "Thus,
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`slidable movement of the actuator housing 324B" -- which is this
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`element right here that I'm putting the pointer on, that's the
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`element that advances proximally and distally as a result of
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`rotation, it says, "The slidable movement of the actuator housing,
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`324B, and consequently shoulder 325B, moves the jaws," plural,
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`"moves the jaws between the open and closed positions." It
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`doesn't say "moves the upper jaw." It doesn't say "moves jaw
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`310B."
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`JUDGE KINDER: But aren't they talking about
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`proximal and distal movement?
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`MR. ZANFARDINO: No. It says "moves the jaws
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`between the open and closed positions."
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`JUDGE KINDER: But you are still moving proximally
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`or distally between an open and closed position. Doesn't -- I don't
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`see a frame of reference there when it's talking about radially
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`inward movement, such as -- I think the claim limitation requires
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`the first and second arms to move inward to capture the tissue,
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`which to me seems like a different point of reference. We're
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`talking about radial movement, and here I think we're talking
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`about -- correct me if I'm wrong -- but I think we're talking about
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`essentially in and out, distal and proximal. Am I wrong on that?
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`MR. ZANFARDINO: I think you are wrong on that,
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`Your Honor, and the only reason I say that is because we're
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`spinning -- we're -- so --
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`JUDGE KINDER: I'm sorry, it says "slidable
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`movement."
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`MR. ZANFARDINO: Right, "slidable movement of the
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`actuator housing." That's this 324B right here.
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`JUDGE KINDER: Yeah.
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`MR. ZANFARDINO: Right? So that is sliding
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`distally -- well, it's rotating -- this refers to it as sliding, but it's
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`rotating, right? And it's rotating -- imagine that's -- it could be
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`anything. It could like a socket or a nut or something, but it's
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`turning on a set of threads, and as it's advancing, it's going to hit
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`that jaw that's straight up, and it's going to start closing it
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`downwardly, so to -- to look like what is shown on the right side
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`in slide 13, right?
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`JUDGE KINDER: Correct, but -- I agree fully that
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`308B, the bottom arm, is moving under that description, but the
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`question is, is it moving inwardly, in a radial movement moving
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`inward? I think when you're bringing it in, you're still moving it,
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`but I just don't see how that's inward movement. So I certainly
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`understand your point here in that both of them are moving, and it
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`says both jaws move, but is the movement inward in any way?
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`MR. ZANFARDINO: But I don't -- I don't think -- see,
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`maybe I'm misunderstanding him, but I don't think in the way
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`Malecki describes this embodiment that those jaws are moving
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`along an axis, sort of away and towards the user, right?
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`JUDGE KINDER: Okay.
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`MR. ZANFARDINO: It's -- it's -- imagine, if you will,
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`you're about to close a clamp on a piece of tissue. You have now
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`got those two jaws in a position where you want to -- you've
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`identified the tissue that you want to close on, and you've targeted
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`the tissue. Now you want those jaws to just come straight down
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`onto that tissue. You don't want to be worrying about either the
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`tissue -- the jaw's starting to move toward or away from the tissue
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`as you're closing them.
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`You know, imagine if you were -- any type of tissue
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`that you might be trying to clip, you have now targeted that
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`tissue, and all you're trying to do is bring the jaws together over
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`that particular tissue. If you have got a system where you're also
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`not only moving the jaws in this dimension, which is axially
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`around that pivot, but also they're moving longitudinally, which I
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`think you're referring to as sort of in and out, and now you have
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`got this thing moving in multiple dimensions in space, and that
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`makes it more difficult to do the targeting.
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`As I read this, this is acknowledging that there is
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`relative movement here, but this is our position. I mean, it isn't
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`really much more complicated than that.
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`JUDGE TARTAL: Is there anything, Counsel, in the
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`'741 patent that supports your position? In other words, supports
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`the notion that an arm that's fixed to the remainder of the
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`apparatus is still moving inward relative to an arm that's -- that's
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`not fixed to the apparatus?
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`Is this purely -- is there anything in the specification
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`that supports your argument I guess is my question.
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`MR. ZANFARDINO: I don't recall any specific
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`examples or any descriptions, but I don't recall -- I can't recall at
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`the moment, I'm sorry. It may come to me in a second. So that's
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`our position.
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`Now I'll go back to slide 6. We talked about the move
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`inward limitation. The other element that Boston Scientific says
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`is missing from Malecki embodiment 2 is this idea that there's an
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`opening element engaging inner walls of the first and second clip
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`arms, so --
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`JUDGE KINDER: Did we address that limitation?
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`MR. ZANFARDINO: I don't think so, no. No, no, I
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`think once you got far enough on the move inward limitation, you
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`thought that was -- mooted everything else.
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`So what's clear about Malecki embodiment 2 is there is
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`a spring there. There's a torsion spring. It says it. It just says it's
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`not illustrated. So Dr. Nicosia's position is, okay, I know that this
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`reference discloses the existence of a torsion spring somewhere in
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`this device. What is that spring and what does it do? Because it
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`is expressly disclosed. That's why this is a 102 argument and not
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`a 103 argument, right?
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`And so he sees a few embodiments down that there's
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`another torsion spring, and as he sees it and as he has put in his
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`declaration, that torsion spring that you see in Malecki Figure 30,
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`that's the torsion spring that's being referred to with respect to
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`Malecki embodiment 2 that's in Figures 27, and just like that
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`torsion spring goes around a pivot point, so does the torsion
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`spring that is disclosed but not illustrated go around pivot point
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`316B.
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`There's no question there's a torsion spring there
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`somewhere. It's just not illustrated. He's saying that's where it's
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`at. And once it's placed there, just in the same manner that it
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`would be placed essentially in Figure 30B -- and I'm looking at
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`slide 16 right now -- you would have an opening element that
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`engages the inner walls of the clip arms.
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`So when you look at Figure 30B, for example, Boston
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`Scientific doesn't dispute that that torsion spring -- that particular
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`torsion spring in 30B, that it isn't an opening element, and they
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`don't dispute that what is shown in 30B is a torsion spring, which
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`is what's referred to in Malecki embodiment 2, and Boston
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`doesn't dispute that the torsion spring is mounted about a pivot, at
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`least in Figure 30B, and that that torsion spring doesn't engage
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`inner walls.
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`Now, what they do dispute is that -- does it engage inner
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`walls of the clip arms, right? Those are -- there are inner walls
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`that are being engaged, just not inner walls of the clip arms. So
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`Dr. Nicosia's view of all this is that spring that's in 30B, which is
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`the torsion spring that he believes is being referenced when
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`Malecki embodiment 2 says there's a torsion spring not shown --
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`let me see if I can find that -- that would engage the inner walls of
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`the clip arms in Figure 27B -- and I'm looking at slide 16 now --
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`in the same manner that the walls engage -- that the spring
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`engages the walls in Figure 30B, and those would be inner walls
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`of the clip arms.
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`You see, if you imagine the spring that's shown in
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`Figure 30B on the upper right, on slide 16, if you take that same
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`spring, you sort of have to flip it around, right, and then you have
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`to sort of place it over that pivot, 316B, and then it needs to
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`contact the walls, the inner walls of those clip arms to meet the
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`claim limitation.
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`Now, how do you do that? You have to have some sort
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`of arrangement that's similar to what's in Figure 30B, right?
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`JUDGE TARTAL: Why would you have to have that?
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`Why couldn't it be in one of a number of different locations and
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`still function as a torsion spring, whether it's the inner walls,
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`adjacent to the walls? Why is that the only possible scenario?
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`And does it need to be for your anticipation ground to prevail?
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`MR. ZANFARDINO: Well, it needs -- the claim
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`requires that the torsion -- well, in this case the opening element,
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`right, which is the torsion spring. The claim requires that it
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`engages the inner walls of the first and second clip arms. I can go
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`back to the claim language exactly, but -- an opening -- on slide 6
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`here, "an opening element engaging inner walls of the first and
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`second clip arms." So that torsion spring is serving as an opening
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`element. It just being an opening element isn't enough. If that's
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`all we had, we wouldn't have an anticipation argument, right?
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`We need the additional fact that it's engaging the inner walls of
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`the clip arms.
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`JUDGE TARTAL: So what is it that you have that
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`supports the notion that it must be engaging the inner walls, so
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`that it couldn't possibly be engaging anything but that?
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`MR. ZANFARDINO: Well, Dr. Nicosia's view is,
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`looking at slide 16, you would have the same arrangement. See,
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`that -- it's a little difficult to understand, and I'm not sure I
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`completely understand how it's shown in Figure 30B, but you can
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`see there's some sort of space or some kind of shelf or something
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`that extends along those arms of that clip that allow those legs, if
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`you will, of the torsion spring to be able to push up against the
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`jaws and open and close -- open them, right, bias them open. His
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`testimony is that would be the same arrangement that you would
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`find in 3 -- in 27B.
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`JUDGE KINDER: So let me get this straight just to
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`make sure. It describes using a torsion spring for embodiment 2.
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`Is that correct?
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`MR. ZANFARDINO: Yes, but it says it's not shown.
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`JUDGE KINDER: And it's not shown, so what we're
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`doing -- would you agree, then, that 30B is a distinct
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`embodiment, but you're just using it as an example to say this is
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`how the spring would work in embodiment 2 as well?
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`MR. ZANFARDINO: Yes, but not an obviousness
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`context.
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`JUDGE KINDER: I understand, because it does say
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`embodiment 2 has a spring, but it just doesn't show where or how
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`it's positioned or --
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`MR. ZANFARDINO: Right, and his view is, as one of
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`ordinary skill in the art, I see another torsion spring and how it
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`works that is illustrated, and why would that be any different than
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`the one that's not illustrated here in Figure 27B. I mean, his
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`position is as simple as that.
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`JUDGE KINDER: So you're saying it discloses it,
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`but --
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`JUDGE ZANFARDINO It just doesn't illustrate it.
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`JUDGE KINDER: -- you have to kind of look at it
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`from the perspective of one of skill in the art that would know
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`you can put it in there the same way as embodiment 27 or --
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`MR. ZANFARDINO: Well, that's the --
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`JUDGE KINDER: -- 30? Then I don't understand why
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`this wasn't an obviousness position more than anticipation. It's
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`close, and I'm not saying I disagree with you, but what I'm saying
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`is it just seems more like an obviousness argument as far as
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`placement and positioning of the spring, because as Judge Tartal
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`mentioned, why not mount it on the outside walls or some
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`internal pivot point outside of the inner walls? So that's my
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`holdup here, is --
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`MR. ZANFARDINO: So we don't know why -- in
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`Malecki, we don't know why they didn't -- they elected not to
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`disclose, right? I mean, they say it's there, but they say it's not
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`disclosed. We don't know why. The most we know is that there
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`is another torsion spring, and it's disclosed in the fashion that's in
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`30B. So as far as Dr. Nicosia's concerned, that's the same
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`arrangement that's being disclosed -- not illustrated, but
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`disclosed -- in 30B.
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`And you're right, I mean, you know, you have got to
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`remember, our petition came in with several grounds, and we
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`could have had another ground -- a ground on 103, but we elected
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`not to do so, because this at least, to our experts, seemed fairly
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`clear, that this is what this disclosed.
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`JUDGE KINDER: I understand.
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`MR. ZANFARDINO: Unless Your Honors have any
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`other question on this, I'll move on.
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`Let me see. Okay, so I see I've already used half of my
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`time. Let me just -- I think that's all I want to do for now, so I
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`will cede my time on the '435. Thank you.
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`MR. CAINE: Your Honors, David Caine for the Patent
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`Owner on the '435 IPR.
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`I'd like to start with respect to the anticipation ground
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`by talking about what counsel for the Petitioners was talking
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`about, which is the plain language of the claim and the question
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`of how that plain language should be interpreted.
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`With respect to claim 1, there is several instances in the
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`claim that tell you that we're not talking about -- the claim is not
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`covering some kind of a relative movement of the clip arms, but
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`it's talking about a requirement of absolute movement of both clip
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`arms, and we'll -- and I'll point that out.
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`It starts with the clip being movable between an open
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`tissue receiving configuration in which the first and second arms
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`are separated from one another by a distance, et cetera, and a
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`closed configuration in which first and second arms are moved
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`inward. The claim is not saying "in which the first arm is moved
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`toward the second arm." It's saying "the first and second arms are
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`moved inward" to capture tissue. That is a plain way of
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`describing and capturing the idea that both arms have to move.
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`That was the basis for the DI denying -- initially denying
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`institution on these claims.
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`And if we go on --
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`JUDGE KINDER: Is there anything in evidence -- and
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`I don't recall, is there anything in the prosecution history about
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`why that limitation is in there?
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`MR. CAINE: I don't believe there's anything in -- the
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`prosecution history, I suspect, is in evidence, but I don't think
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`there's any discussion --
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`JUDGE KINDER: Okay.
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`MR. CAINE: -- and certainly none that Petitioners have
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`pointed out as limiting or somehow changing what this plain
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`language conveys.
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`JUDGE KINDER: That's fine.
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`MR. CAINE: And --
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`JUDGE KINDER: That's fine. I guess the follow-up
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`question -- and I'm sure you're going to get to it -- is what's