`571-272-7822
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`Paper No. 46
`Entered: February 5, 2015
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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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`MEDTRONIC, INC.,
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`Petitioner,
`v.
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`NUVASIVE, INC.,
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`Patent Owner.
`______
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`Case IPR2013-00506, 00507 and 00508
`Patent 8,361,156
`__________
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`Held: November 18, 2014
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`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C.
`SIU, Administrative Patent Judges.
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`The above-entitled matter came on for hearing on Tuesday,
`November 18, 2014, commencing at 1:15 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`IPR2013-00506, 00507 and 00508
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`JEFF E. SCHWARTZ, ESQ.
`SETH A. KRAMER, ESQ.
`MICHAEL COOPERBURG, ESQ.
`Fox Rothschild LLP
`The Executive Building
`1030 15th Street, N.W., Suite 380 East
`Washington, D.C. 20005
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`and
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`ON BEHALF OF PATENT OWNER:
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`RODNEY M. YOUNG, ESQ.
`CHAD A. HANSON, Ph.D., ESQ.
`JASON O. PICHE, ESQ.
`Medtronic, Inc.
`2600 Sofamor Danek Drive
`Memphis, Tennessee 38132
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`MICHAEL A. AMON, ESQ.
`STEPHEN R. SCHAEFER, ESQ.
`STUART NELSON, ESQ.
`Fish & Richardson P.C.
`12390 El Camino Real
`San Diego, California 92130
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`and
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`JONATHAN SPANGLER, ESQ.
`NuVasive, Inc.
`7475 Lusk Boulevard
`San Diego, California 92121
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`JUDGE MEDLEY: Good afternoon. This is the hearing
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`for IPRs 2013-00506, 507 and 508 between Petitioner Medtronic and
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`Patent Owner NuVasive. Per the October 20th order that you received
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`from the Board, each party will have 90 minutes of total time to
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`present arguments for the three cases.
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`Petitioner, you'll proceed first, to present your case with
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`respect to the challenged claims and grounds for which the Board
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`instituted trial for all three cases. And thereafter, Patent Owner, you
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`will respond and use up all of your allotted time, and then, Petitioner,
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`you may reserve rebuttal time if you wish.
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`At this time we would like the parties to please introduce
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`themselves, beginning with Petitioner.
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`MR. SCHWARTZ: Yes, Your Honor, my name is Jeff
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`Schwartz, I am joined by Seth Kramer, Mike Cooperberg and
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`Medtronic representatives Rodney Young, Jason Piche and Chad
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`Hanson.
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`JUDGE MEDLEY: Okay, thank you. And for Patent
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`Owner?
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`MR. SCHAEFER: Your Honor, I'm Steve Schaefer, lead
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`counsel for Patent Owner NuVasive, and with me is Michael Amon,
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`he's pro hac vice, representing NuVasive.
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`JUDGE MEDLEY: Okay.
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`MR. SCHAEFER: And Stewart Nelson, who is also a
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`back-up counsel. And with me is Jonathan Spangler, in-house counsel
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`for NuVasive.
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`JUDGE MEDLEY: Okay, great. And we did look over
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`the issues. Ninety minutes, we think, per side, seems a bit excessive,
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`if you will. So feel free to shave down anything . You know, an hour
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`per side would be great with us. We don't feel that we need much
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`more than that from the parties, but having said that, we did tell you
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`you had 90 minutes, so if you're prepared for that, that's fine, we just
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`want to throw that out. It won't hurt you to go less than 90 minutes. It
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`might even help.
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`(Laughter.)
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`JUDGE MEDLEY: So, with that in mind, Petitioner,
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`you may begin.
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`MR. SCHAEFER: Thank you, Your Honor, and may it
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`please the Board, we realize that this specific panel has heard from
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`both of these parties twice before on this technology, which is spinal
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`fusion implants and procedures, so I'm going to avoid repeating that
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`tutorial that you've already heard and are aware of, and try to focus,
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`instead, on specifically what these claims are about. The nuance
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`being that we're starting from a different time period. We're starting
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`from eight years in the future, in these prior IPRs that you heard
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`between the parties, we were looking at mid-1990s for when those
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`applications had been filed, and now we're looking at 2002-2003 for
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`when these applications were filed.
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`The key difference there is that we're able to rely on the
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`patents that you were looking at in those other IPRs as prior art to
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`NuVasive's patents, and so that's a key difference between the
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`arguments that you heard before. And going into it, my intention is to
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`just summarize what the initial claims are about, talk about the prior
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`art, and then get right into what the grounds are and what the art
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`shows.
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`So, if we can have claim 1 of the '156 patent, this patent
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`pertains specifically to the 506 IPR, and in general, what claim 1 is
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`describing is a spinal fusion implant, a device, it generally requires
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`antimigration elements on the top and bottom. It has an aperture, as
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`you can see, that's generally elongated, so its length is greater than its
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`width. It has -- it's made up of radiolucent material, and so therefore
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`the claim requires some markers so that you can see where the implant
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`is once you've implanted it.
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`This particular claim requires two markers in the center
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`of the implant. So, if you want to see where the middle is once you
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`put it in the patient, you can see by putting two markers in the middle.
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`Additionally, it's elongated, so the length is greater than
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`the width. And the maximum width is on the medial plane, or in the
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`middle of that implant.
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`If you could put claim 1 of the '334 patent up. The '334
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`patent is the subject of both the 507 and the 508 IPRs. This is a claim
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`that's very similar to what you just saw with the '156 patent, so I'll just
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`talk about the differences.
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`One of the differences in the '334 patent is that it requires
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`a length that is greater than 40 millimeters, which, as you'll see, is also
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`required in the '156 patent in dependent claim 5. It also requires that
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`not only is the length greater than the width, but it's a length that's two
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`and a half times greater than the width. And as we'll see, all of the
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`primary references show that.
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`The other nuance is that it requires three radiopaque
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`markers. So, where the '156 had two in the middle, the '334 requires
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`three, one at each end, essentially one in the proximal wall and the
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`distal wall and one in what's called the central region.
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`So, now, the other thing that I did want to emphasize is
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`that these are device claims. They're not method claims, and so the
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`approach is largely irrelevant, which way the implants come in. The
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`claim doesn't require them to come in in any particular manner, and,
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`in fact, the specification specifically says that the implants are
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`designed for a number of different approaches, including posterior,
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`anterior, posterior-lateral or anterior-lateral, which are basically at an
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`angle from the back or from the front.
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`And other than that, just generally, Your Honor, a point
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`to be made is that there's really nothing new here. We have primary
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`references that essentially show all of these elements with some minor
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`exceptions, which are the markers being in the middle, which we have
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`a secondary reference that explicitly shows that, to the extent that it's
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`not intuitively obvious, that if you wanted to see the middle, you
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`would put a marker. If you want to see how the middle is oriented,
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`you put two markers, so you can compare the two images on x-ray.
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`Similarly, the dimensions of this implant, nothing new
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`there, because we know from the Michelson teachings that Michelson
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`teaches an implant that's greater than 40 millimeters long, and it
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`teaches a width that is approximately 18 millimeters wide, which is
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`required in the dependent claims in both of these patents.
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`So, introducing the prior art itself, first we have what
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`as the Synthes implant, and the Synthes implant, if we could put up a
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`couple of the images from the 506 petition. The Synthes implant has
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`the antimigration elements on the top and bottom. It has a distal wall
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`with side walls, a proximal wall, which is a front and back and sides.
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`It also includes radiopaque markers on each of the ends. And I'm
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`getting a little bit ahead of Mike, and I apologize, Mike.
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`Next we have the Telamon implant, which is very similar
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`to the Synthes implant. It is also an elongated implant, so the length is
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`greater than the width. It is made of a radiolucent material, just like
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`the Synthes implant is. And, in fact, both of these implants have a
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`length that is two and a half times greater than the width.
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`They have apertures for fusion that goes from the top to
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`the bottom. Those apertures are elongated, which is the length is
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`greater than the width. They have ridges on the top and bottom. They
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`have visualization windows, as you can see from the side, on both
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`sides, so that you can see fusion as it's growing from top to bottom.
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`And the Telamon implant has a threaded hole at the end for purposes
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`of interfacing with an inserter.
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`The third primary reference that we have is the Frey
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`reference, and this derives from a published patent application. The
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`Frey reference, just like with Telamon and Synthes, is a spinal fusion
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`implant.
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`Now, Frey only pertains to the 507 IPR, so only to the
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`'334 patent. It is also made of a radiolucent material. It has a length
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`that is greater than the width and, in fact, is more than two and a half
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`times greater than the width. It has fusion apertures from top to
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`bottom that allow bone growth to go through. It has threaded holes at
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`the end, and as you can see, it has radiopaque markers, so you can see
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`the proximal wall, the distal wall, and the center region from those
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`three radiopaque markers. It also has -- I'll take my laser pointer -- it
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`also has visualization apertures on both of the side walls for purposes
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`of being able to see the fusion growth.
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`As to the -- oh, one of the other things to point out about
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`the Frey reference is that it specifically discloses approaches that
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`include posterior, what's called a transforaminal approach, or an
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`angled posterior approach, but also a lateral approach, an
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`anterior-lateral approach, and this, Your Honor, is from the
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`specification, paragraph -- I believe 140. It includes a posterior-lateral
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`approach, transforaminal, and it also includes anterior-lateral, lateral
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`and anterior approaches.
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`So, it explicitly discusses that the Frey implant can be put
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`in in any number of ways. The other thing to note, in comparison to
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`the Synthes and Telamon implants, is that those references don't limit
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`any particular approach.
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`Now I'm going to move to a brief introduction of the
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`secondary references, the first one being Michelson, which the Board
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`is, no doubt, intimately familiar with from previous IPRs, and we're
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`going to pull up a couple of representative figures that are referred to
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`in the 507 petition at page 54 and 55. These figures show that
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`Michelson as well is an elongated implant, it's a spinal fusion implant,
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`it's made of a non-bone material, it has a length greater than its width,
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`and, in fact, as we'll get into, it explicitly discusses long embodiments,
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`that is from 30 to 50 millimeters with 42 millimeters being a preferred
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`length greater than 40 millimeters, and it also discusses approximately
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`18 millimeter widths, both in the discussion in the '973 patent, and
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`also by incorporation by reference to other patents that are discussed
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`within the '973 patent.
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`And in addition, it also discusses a lordotic shape, which
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`may become relevant for purposes of some of our discussion.
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`Finally, the last secondary reference and the second
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`secondary reference is Baccelli. Baccelli, just like all of the other
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`references, is a spinal fusion implant. It, like Frey, Telamon and the
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`SVS-PR, is made of a radiolucent material. It has ridges on top and
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`bottom. It has an aperture to allow bone growth to go from the top to
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`the bottom. It has apertures at the end for purposes of interfacing with
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`a tool, and most importantly, for purposes of our obviousness
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`combination, for the markers, is that it has four markers, one on each
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`of the distal and proximal wall, and two in the middle.
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`So, for purposes of the '334 patent, that's discussed as the
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`central region. For purposes of the '156 patent, it has two on the
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`medial plane, and those are equidistant from the proximal wall.
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`Now I'm going to go straight into the '156 patent and talk
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`about how the art actually shows what that claim requires. As I
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`mentioned, for purposes of the 506 petition, the primary references are
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`the Telamon reference and the SVS-PR. Both of these references
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`show all of the elements of claim 1 with the exception of the location
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`of the two markers. They all have antimigration elements, they're all
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`made of radiolucent material, they all have a length that's greater than
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`the width, they all have a maximum width in the center of the implant,
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`and they both have two radiographic markers. But admittedly, those
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`two markers are on the ends, the distal wall and the proximal wall.
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`They are not located in this -- in the medial plane -- in the center.
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`So, for purposes of obtaining that claim element, we
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`believe that it is intuitively obvious that if someone of skill in the art
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`wants to see the center of the implant, where it's located, how it's
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`positioned, where it's oriented within the spinal column, you just put a
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`marker in the middle. If you want to see how it aligns, how it may be
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`positioned or even migrates, once it's been implanted, you put two.
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`Then you can see how the two images compare.
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`There's nothing new here. These are well-known
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`features. And, in fact, the specification merely discusses the fact that
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`the markers are provided to show the progress of the implant, to show
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`how it's been placed within the body. That's a well-known attribute of
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`markers. And, in fact, it's entirely common sense and entirely
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`predictable, there's nothing unexpected about putting markers in the
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`middle and then knowing where the middle of the implant is when
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`you take an x-ray.
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`Our expert, Dr. Hynes, has testified in his declaration,
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`and it's not disputed, that these markers are well known, and have
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`been for a very long time, before the filing, for purposes of identifying
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`the location, position, orientation or migration of these implants. And,
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`in fact, NuVasive agrees in their response, they have indicated that
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`radiopaque markers have long been used on implantable medical
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`devices to show positioning.
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`So, they're admitting there's nothing new to having
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`markers. The suggestion is that there's something new to putting two
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`in the middle, but as we've seen, Baccelli shows two in the middle,
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`and, in fact, NuVasive's expert, Dr. Yuan, testified that there's nothing
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`unexpected about the result that you get when you put two markers in
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`the middle. You would have known, in 2002, that if you put a marker
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`in the middle, you would see the middle of the implant, and that if you
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`put two markers in the middle, you would see whether the markers
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`were aligned or not.
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`He said that they're not -- there's nothing unexpected
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`about that result, and we agree, there's nothing unexpected. It's
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`entirely predictable how two markers are going to act in the middle of
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`the implant.
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`So, now I'm going to move on to some of the dependent
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`claims. Some of them are not really being debated.
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`JUDGE MEDLEY: Before you move on?
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`MR. SCHWARTZ: Yes?
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`JUDGE MEDLEY: What about Patent Owner's
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`argument that adding two extra markers would cause confusion to the
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`surgeon?
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`MR. SCHWARTZ: Your Honor, there is no basis for
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`suggesting that adding two markers to the middle of an implant causes
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`confusion. As you can see from the Baccelli implant -- let's go back
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`to the Baccelli image.
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`Baccelli has four markers in it. NuVasive argues that
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`Baccelli is a small implant. It's not confusing in Baccelli to have four
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`markers. It wouldn't be confusing to put four markers in a larger
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`implant, which are what these primary references are. They would be
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`spaced apart further. They would not be confusing.
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`Now, admittedly, NuVasive points to some quotable
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`quotes from our expert during deposition, and we can deal with some
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`of that on rebuttal, but they're taken entirely out of context. And what
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`our expert was not saying, was that it's confusing in these
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`embodiments to have two markers in the middle. It's a simple
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`adjustment to what's shown in the primary references, Your Honor,
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`and plainly, for Frey, there's no reason to think that Frey is confusing
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`with what it teaches, and simply adding a fourth marker in Frey would
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`be no reason for confusion. And the same we believe is true for
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`purposes of the Synthes and the Telamon implants.
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`Let's go ahead and move to claim 2, which is not all that
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`different than claim 1, but simply requires that the markers in the
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`middle be equidistant, each of them the same distance from the
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`proximal end, which is shown in Baccelli.
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`Claim 3 simply requires the addition of a third and fourth
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`marker. So, if you're looking at the combination of claim 1 as adding
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`two markers from Baccelli, then you've got the original markers from
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`Telamon and Synthes at the ends, which is required from claim 3. If
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`you're looking at claim 1 as moving the markers that were already in
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`the implant to put them in the middle, then you add them at the end,
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`and that simply is common sense. If you want to see where the ends
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`are, you put a marker there. Because remember, you're looking at an
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`implant that's inside of a human body, and you look at an x-ray to see
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`how it's placed.
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`So, you don't have the opportunity to see it with your
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`eyes, so you have to rely on x-ray to see where it is. If you want to
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`know where the middle of it is, relative to the column, you put
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`markers in the middle. If you want to know where the ends are, you
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`put markers at the end.
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`And Baccelli shows you, it's not redundant, if you want
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`to have them at the end and in the middle, and there are other prior art.
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`I mean, Dr. Hynes referred to a number of prior art references. This is
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`not unusual to put multiple markers in an implant. It's known in the
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`prior art, and it's simple, it's predictable, it's entirely expected what
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`you're going to get when you put these markers in.
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`I'm going to move to -- hopefully move a little more
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`quickly, in deference to Your Honor's comment, claim 4 merely
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`requires that the markers go the entire height, we know that as well
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`from Baccelli, and we know that one would be motivated to do that if
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`they want that additional information on the orientation of the
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`implant.
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`Claim 5 is another claim that the parties are debating.
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`We believe that claim 5, and we have broken claim 5 into two
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`elements, actually, the first one is not really being debated. 5a, we
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`call it, simply requires an aperture in the proximal wall, and both
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`Telamon and Synthes show an aperture in the proximal wall.
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`5b, as we refer to it, requires, and I apologize, Mike, I'm
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`getting ahead of you. 5b requires the length greater than 40
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`millimeters, which as we saw, is in claim 1 of the '334 patent.
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`So then the question is, is it obvious, based on what we
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`know about Synthes and Telamon, to make them longer, because they
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`don't teach an implant that's greater than 40 millimeters. We believe
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`that it's intuitively obvious, based on the teachings of Dr. Michelson
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`in the '973 patent. Dr. Michelson explicitly says that you can make an
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`implant longer for purposes of getting greater stability and structural
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`support. NuVasive doesn't disagree with that proposition, and, in fact,
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`they cite to Michelson in their response for that exact same teaching.
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`So, Dr. Michelson teaches it, and explicitly teaches it for
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`purposes of putting something in laterally, or anterior laterally, so
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`putting it across a disc space or putting it at an angle coming in
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`anteriorly, and there's no reason why you wouldn't, based on the
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`teachings of Dr. Michelson, make Synthes or SVS-PR longer based on
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`the motivation to obtain a more stable structural construct.
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`And, in fact, Dr. Yuan, again, NuVasive's expert, agrees
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`that it's advantageous to provide for a large surface area for greater
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`structural support and proper spacing of the vertebrae.
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`And NuVasive, in their response, admit, and I'll wait for
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`you to catch up, Mike, this is in the response at pages 9 to 10.
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`NuVasive admits that it is desirable for implants to be large. We
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`agree with that. That there is a motivation to make implants larger.
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`And, in fact, they refer to Michelson as touting the importance of
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`length and width for creating a greater surface area of contact.
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`Desirable for an implant to be large, we agree with that, and that is the
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`motivation for combining Synthes and Telamon with Michelson.
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`I'm going to move on to claim 6. Claim 6 simply
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`requires a threaded aperture at the end of the implant for purposes of
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`mating with the inserter. Telamon has a threaded aperture, Synthes
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`would be obvious, in combination with any number of references,
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`including Michelson, or Baccelli, and NuVasive has not debated that
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`issue.
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`Claim 7 merely requires that the aperture is along the
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`central axis, parallel to the -- I'm sorry, the aperture has a central axis
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`that is parallel to the length. Both of Synthes and Telamon have an
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`aperture that has its central axis parallel to the length.
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`Claim 8 simply requires lateral grooves in the aperture --
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`I'll let you catch up. That's fine, Mike.
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`Claim 8 requires lateral grooves in the aperture. There's
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`no question that Synthes shows that, and that Telamon would have
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`that in combination with Michelson. This is a well-known feature
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`since the late '80s, since Dr. Michelson taught it, to have that lateral
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`aperture or lateral grooves extending from the aperture.
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`Claim 9, and, Mike, if you could pull up from the claim
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`chart the petition at page 29. Claim 9 is another element that's being
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`debated. Claim 9 merely requires that the maximum lateral width is
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`approximately 18 millimeters. Now, as the Board has recognized,
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`Michelson teaches an approximate 18-millimeter width. It also
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`incorporates by reference specific teachings of these types of implants
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`for an 18-millimeter width.
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`This is a well-known dimension for these types of
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`implants. It's a simple design choice that people would incorporate if
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`they were so motivated, and it is dictated by the anatomy. So, there's
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`nothing special about it. And we know, to the extent that we're
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`making the primary references slightly wider, Michelson teaches
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`making larger implants for greater stability and structural support, and
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`NuVasive agrees with that concept, although they don't necessarily
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`agree with that combination.
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`In fact, if we could pull up the NuVasive response at
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`page 57, NuVasive agrees that Michelson discloses a width of 18
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`millimeters. So, there's no debate about the fact that it's disclosed in
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`the art, and, in fact, that it's well known, and is a common size for
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`these types of implants.
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`Claim 10 -- no need to put something up on the board for
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`that -- simply requires that the implant is PEEK, Telamon explicitly
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`discusses PEEK, Synthes discusses a radiolucent material, which
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`PEEK is, and so it's either inherent within Telamon or Synthes to
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`describe that, or it's obvious in combination with Baccelli or any
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`number of references that we've talked about.
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`Claim 11, as we talked about before, requires
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`visualization apertures. Both of the primary references have these
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`visualization apertures in the side wall.
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`Claim 12 requires that the -- that's good enough -- that
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`the top and bottom surfaces are generally parallel, and as the Board
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`noted in instituting this proceeding, both of these references have
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`surfaces that are proximately in the same direction in at least some
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`aspect.
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`Claim 13 merely requires that the upper and lower
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`surfaces are angled for lordosis, and as the Board recognized, both of
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`these references also have an angulation to them in at least some
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`aspect.
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`Claim 14, we're back to talking about the fusion aperture.
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`The fusion aperture is required to be generally rectangular, and
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`generally oblong. NuVasive has not disputed that these references
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`have that shape for their fusion aperture.
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`Claim 19 -- and we can just leave this here, Mike -- claim
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`19 requires ridges, both of these implants -- Synthes implant as well --
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`has ridges.
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`Claim 20 merely requires that the ridges go along
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`perpendicular to the length. No dispute that these references both
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`have ridges that extend perpendicular to the length.
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`Claim 23 requires that the maximum width of these
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`implants at the end walls is smaller than the maximum width in the
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`medial plane. So, it's a little more narrow at the ends. And as you can
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`see, not a great picture, admittedly, but at the ends, the implant curves
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`in a little bit. So, and there's no dispute between us and NuVasive that
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`these primary references show that.
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`Claim 24 requires a maximum width that is wider than
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`the height. Or wider than a height. There is no dispute that both of
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`these references have a maximum width that is wider than the height.
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`Claim 25 discusses the aperture width being at least two times or
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`greater than two times the width of either of the walls, moving target.
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`And as you can see, Telamon explicitly has a wider width to its
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`aperture that is more than two times the width of either of the side
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`walls, and as the Board recognized, it would be obvious to combine
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`Synthes with Telamon for purposes of getting that wider width on the
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`aperture.
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`Claim 26 merely requires one marker that is shorter than
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`a height, and in both of these implants, there is at least one marker that
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`is shorter than a height, the maximum height being in the middle,
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`neither of the end markers extending beyond the surface, and so
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`plainly they are larger than or shorter than the height.
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`And then last but not least, for claim -- for the '156
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`patent, it requires osteoinductive material be put into that aperture,
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`and there's no dispute that both of these references show that.
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`So, I'm going to move straight into the '334, unless
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`there's any questions about the '156, and I'm going to try to avoid
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`talking too much about the two references we just showed, because
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`they show the same things for purposes of the redundant claims. I'm
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`not meaning that in a pejorative way.
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`And, so, if we could put up a representative figure of the
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`Frey reference, just to be able to show how it lines up. As we talked
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`about, both Telamon and Synthes have -- they're both fusion
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`apertures, or fusion implants, they have antimigration elements,
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`they're made of radiolucent material. They have a -- well, we've
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`talked about the length greater than 40 millimeters for purposes of
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`claim 5. It's the same analysis for purposes of claim 1 of the '334.
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`They all have a length that's at least two and a half times
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`the width, and there's no debate about that. They all have an aperture
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`that is longer than it is wide. And this claim, as I mentioned before,
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`requires three markers.
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`And, so, the first thing that I want to talk about is the
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`length of greater than 40 millimeters as it pertains to Frey, because
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`we've already talked about it for Synthes and Telamon. As it pertains
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`to Frey, as I mentioned, Frey explicitly talks about putting in an
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`implant laterally and anterior laterally.
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`We know that Michelson is directed to lateral and
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`anterior-lateral implants, and making them greater than 40
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`millimeters. So, it is intuitively obvious that if you wanted to put Frey
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`in, laterally or anterior laterally, based on the teachings in Frey, you
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`would look at Michelson to make it greater than 40 millimeters, based
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`on the preferred sizes in Michelson, for purposes of having greater
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`stability and structural support.
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`And then as we get to the markers, as I -- this is
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`essentially the same issue for markers when we talk about Synthes
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`and Telamon, although in claim 1, we're merely adding to what
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`Telamon and Synthes show, which is one marker on each end, and
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`we're putting one in the central region.
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`So, for the same reasons that you would add one or two
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`in the medial plane for claim '156, you could add one in the middle for
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`purposes of the '334, so that you could know, on x-ray, where the
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`middle is, as it aligns with whatever you're trying to align it with on
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`the x-ray.
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`Patent 8,361,156
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`For purposes of Frey, it has the three markers already in
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`it, and there's no dispute about that. I'm going to move on to claim 2,