Trials@uspto.gov
`571-272-7822
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`Paper No. 35
`Entered: September 12, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NUVASIVE, INC.,
`Petitioner,
`
`v.
`
`WARSAW ORTHOPEDIC, INC.,
`Patent Owner.
`____________
`
`Case IPR2013-00395 and IPR2013-00396
`Patent 8,444,696
`____________
`
`Held: July 31, 2014
`____________
`
`
`
`
`
`Before: SALLY C. MEDLEY, LORA GREEN, and STEPHEN SIU,
`Administrative Patent Judges.
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`MICHAEL R. HAWKINS, ESQUIRE
`
`
`STEPHEN R. SCHAEFER, ESQUIRE
`
`
`Fish & Richardson P.C.
`
`
`3200 RBC Plaza
`
`
`60 South Sixth Street
`
`
`Minneapolis, Minnesota 55402
`
`
`571-272-7822
`
`
`
`
`Paper No. 35
`Entered: September 12, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NUVASIVE, INC.,
`Petitioner,
`
`v.
`
`WARSAW ORTHOPEDIC, INC.,
`Patent Owner.
`____________
`
`Case IPR2013-00395 and IPR2013-00396
`Patent 8,444,696
`____________
`
`Held: July 31, 2014
`____________
`
`
`
`
`
`Before: SALLY C. MEDLEY, LORA GREEN, and STEPHEN SIU,
`Administrative Patent Judges.
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`MICHAEL R. HAWKINS, ESQUIRE
`
`
`STEPHEN R. SCHAEFER, ESQUIRE
`
`
`Fish & Richardson P.C.
`
`
`3200 RBC Plaza
`
`
`60 South Sixth Street
`
`
`Minneapolis, Minnesota 55402
`
`
`
`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
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`
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`THOMAS H. MARTIN, ESQUIRE
`
`
`WES MEINERDING, ESQUIRE
`
`
`Martin & Ferraro, LLP
`
`
`1557 Lake O’Pines Street, NE
`
`
`Hartville, Ohio 44632
`
`
`
`The above-entitled matter came on for hearing on Thursday,
`July 31, 2014, commencing at 2:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`JUDGE MEDLEY: Good afternoon. This is the hearing
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`for IPR2013-00395 and 396, between Petitioner NuVasive and Patent
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`Owner Warsaw Orthopedic. At this time we would like the parties to
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`please introduce themselves and who will be arguing for their
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`respective sides, beginning with Petitioner.
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`MR. SCHAEFER: Yes, I'm Steve Schaefer for the
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`Petitioner, NuVasive, and I'm lead counsel, I will be arguing the case,
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`and with me as back-up counsel, Michael Hawkins.
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`JUDGE MEDLEY: Thank you. And for Patent Owner?
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`MR. MARTIN: Good afternoon, I'm Tom Martin with
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`Martin & Ferraro, lead counsel for the Patent Owner, Warsaw, and
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`Patent No. 8,444,696
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`with me today is Wes Meinerding, with Martin & Ferraro as well, he's
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`back-up counsel. And with us handling the exhibits is Mr. Thomas.
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`JUDGE MEDLEY: You will be arguing for your side?
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`MR. MARTIN: Yes, sir.
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`JUDGE MEDLEY: As you know, per the June 27th
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`order from the Board, each party will have 60 minutes to argue for
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`both cases. Petitioner, you will proceed first, to present your case
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`with respect to the challenged claims and grounds for which the Board
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`instituted trial, and then Patent Owner, you will respond to Petitioner's
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`presentation, and Petitioner, you may reserve rebuttal time if you'd
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`like.
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`So, Petitioner, counsel for Petitioner, Mr. Schaefer, you
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`may begin, and would you like to reserve rebuttal time?
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`proceed.
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`MR. SCHAEFER: Yes, I'd like to reserve 20 minutes.
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`JUDGE MEDLEY: Twenty minutes, all right. You may
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`MR. SCHAEFER: May it please the Board, thank you.
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`So, we're here on two IPRs on U.S. patent 8,444,696, the
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`'696 patent. The first IPR proceeding, that's IPR2013-00695, involves
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`claims 1 to 6 of the '696 patent, and the second one, IPR2013-00696,
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`involves claims 7 to 13.
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`So, for claims 1 to 6, we have two independent claims, 1
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`and 4. These are claims to a fusion implant device. They're wider
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`than they are tall. That's kind of distinguishing between claim set 1
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`through 6 and 7 to 13.
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`IPR2013-00395 and IPR2013-00396
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`These -- importantly, these implants have convex bearing
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`surfaces, ratchetings and at least one opening through the implant.
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`Two main grounds for this set that have been instituted,
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`they are the Senter grounds and then secondly they are the Michelson
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`grounds. Michelson's earlier patent, the '037 patent, and I'll talk about
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`both of those grounds.
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`The second IPR for claims 7 to 13, these involve the
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`insert and rotate claims. These are a specific type of implant that is
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`inserted and rotated 90 degrees. These claims also have the same
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`features that are in claim 1 and 4 of the convex bearing surfaces, as
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`well as ratchetings and the openings. So, those are the important
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`points.
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`As this Board knows from the lateral method patent that
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`we talked about two months ago, this case is similar in that it involves
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`spinal fusion implants, and just by way quickly of background, these
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`are a spinal fusion procedure, you remove the disc, put an implant in
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`place, and then bone grows between those two adjacent vertebra. You
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`don't end up with any movement between those two vertebra, as you
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`would with a natural disc, but you relieve problems such as pain in the
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`legs and the like.
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`So, the implant does two things: It provides structural
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`support to space apart the two adjacent vertebra, and it does facilitate
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`bone growth between the two vertebra.
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`So, I want to talk briefly about the '696 patent in general.
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`This is a patent that was granted just a little over a year ago, and it's
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`Patent No. 8,444,696
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`the great, great, great, great, that's four greats, grandchild of a 1995
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`application through a long series of continuations. That original 1995
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`application, as we describe in our petition, was a CIP of, in fact, the
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`specification that is the Michelson '037 patent. So, that 1988
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`Michelson '037 patent was the prior -- was the ultimate priority
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`document to the application filed in 1995, which is a CIP.
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`That's actually an important point, because you'll see if
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`you compare the two, there's a lot of similarities between these two,
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`and that is, in fact, why the '037 patent is part of -- is one of our main
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`grounds on claims 1 to 4.
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`We also talk in our petition about the prior
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`re-examination action on the '430 patent, the immediate parent of the
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`'696. As explained in our petition -- I'm sorry, the '430 claims, like
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`the '696 claims, claim a spinal fusion implant with convex upper and
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`lower bearing surfaces. Dependent claims in that patent got to the
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`anti-expulsion features, or ratchetings, and also got to the openings
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`through the implant. Ultimately, Warsaw sued NuVasive on that '430
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`patent, and in turn, NuVasive brought the Inter Partes Re-Examination
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`on that '430 patent.
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`In that action, despite the fact that much of that art was of
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`record, the CRU, in the re-exam, found numerous grounds upon
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`which these convex claims were invalid on the prior art, and
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`ultimately, Warsaw abandoned its efforts on that.
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`Meanwhile, while that re-exam was going on, Warsaw
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`obtained the '696 patent. So, that's why I say in our petitions, this was
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
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`déjà vu all over again, it seemed like we were re-litigating the same
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`issue that we had before.
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`So, let me talk now about claim -- all of the independent
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`claims 1, 4 and 10, generally. The claims have a lot of words.
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`They're probably at least a paragraph long, if not longer, but very little
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`structure.
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`According to Warsaw, and its expert, and you can find
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`this in their Patent Owner response at pages 5 to 8, that's the Patent
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`Owner response in the 395 case, the invention that's claimed in the
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`'696 boils down to a combination of three things: The convex bearing
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`surfaces, the ratchetings and the openings. It's a spinal fusion implant
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`that has those combined features.
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`So, let's talk about each one of those in turn. Convex
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`upper and lower bearing surfaces. So, the '696 patent discloses a lot
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`of embodiments that don't have convex surfaces, they have flat
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`surfaces. But, indeed, they disclose one embodiment that does have
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`these convex surfaces in figures 13 to 17.
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`So, if we can put up figure 14, this, of course, in the
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`institution decision, is the figure that's copied there, has upper and
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`lower surfaces, 313 -- 312 is generally referring to the upper bearing
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`surface, and the lower convex bearing surface is the region below that.
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`So, indeed, the '696 patent does, in fact, disclose that.
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`You will note that this embodiment doesn't have any openings
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`through the implant, it doesn't have any ratchetings on those convex
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`surfaces. This is the only convex embodiment disclosed in the patent.
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`IPR2013-00395 and IPR2013-00396
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`And importantly, nowhere in the '696 patent is there any
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`explanation about the advantages of a convex implant when it's
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`inserted into a patient having conforming, concave endplates. And
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`this is important, it makes sense, because as Dr. Brantigan explained
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`in paragraph 10 of his first declaration, there's -- he cites to six
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`different references there that show this very well-known feature in
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`1995 of upper and lower convex bearing surfaces.
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`And despite the fact that the '696 patent doesn't talk about
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`the advantage of these bearing surfaces, much of the prior art does,
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`such as the Kim reference, the Wagner reference, these references all
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`talk about the advantages of having that convexity, and it really boils
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`down to two things: It provides us added stability to keep the implant
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`in place after implantation, it helps to prevent -- it's, in essence, in a
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`concave portion of the endplate, and that convexity allows it to
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`prevent from being moved. Secondly, it actually helps in distributing
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`loads placed on the implant by the adjacent vertebra. So, that's what
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`the prior art talks about, although the '696 patent doesn't.
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`Secondly, ratchetings, or angled teeth, as Warsaw, or
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`Medtronic, its operating company, talks about this feature in
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`connection with its Clydesdale implant. These ratchetings were also
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`well known in 1995. Of course, they're shown in figures 8 -- figure 9
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`of the '696 patent. This, of course, is not a convex implant. It is a flat,
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`but it has the ratchetings, and as the specification describes, the
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`specification, that is the '696, the ratchetings facilitate introduction of
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`the implant into the disc space, and you understand that we have an
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
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`implant insertion tool at the trailing end, which is on the right of this
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`figure 9, of the '696 patent. That implant insertion tool is pushing it
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`into the disc space, and the ratcheting design prevents backout.
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`That very same feature, of course, is described in
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`Brantigan's '035 patent filed seven years before the priority date of the
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`'696. And if we can throw up the Brantigan '035 figures 18 and 19,
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`figure 18 and 19 there, we see we have the same feature in
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`Dr. Brantigan. He has what they call nubs, but it's the same deal.
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`This implant is inserted -- this one happens to be a posterior implant,
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`it's inserted from the back end, and those nubs help prevent backout.
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`That's what's described, in fact, in the Brantigan specification at the
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`paragraph from page 20 to 21, as we describe in our petition. Same
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`exact feature, facilitates introduction into the implant space, and
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`prevents backout.
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`And then, finally, the third feature of the three main
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`features, the opening, the claims recite at least one opening into and
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`through the spinal implant for bone growth through the implant. This
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`is also well known long before the 1995 priority date. This was
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`present in anterior implants, or implants inserted from the front, as we
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`know from the Michelson '037 patent, it's also present in posterior
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`implants, the Brantigan '035.
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`And I want to mention one thing, you'll see a lot of
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`discussion in the '696 patent about lordotic implants, or this wedge
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`shape of the implant. It's a big part of the '696 spec. It's only in one
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`of the claims, claim 7, it is not a big part of Warsaw's contentions, but
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`this -- if you compare, for example -- I should back up a second and
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`talk a little bit about the spine. The spine is actually a curved thing. It
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`curves from the tail bone forwardly, that's called a lordosis, that
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`forward curvature, in the thoracic spine, which is around your rib
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`cage, it's called kyphosis, or kyphotic, it's bending outwardly, and
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`then back in the neck it curves forwardly again. That lordosis causes
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`the disc space to be taller at the front of the implant than it is in the
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`back of the implant.
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`So, if we're looking at the lumbar spine here, the lower
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`spine, the back of the patient would be to the right, and the front of the
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`patient would be to the left, as shown in figure 7A here of the '696
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`patent.
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`So, you'll see all this discussion about the implant of the
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`'696 being designed to fill that disc space, it's really to prevent this.
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`That has nothing to do with any issues in this case, except, of course,
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`claim 7, and, of course, there we have the Steffee reference, which is
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`sort of informally referred to as the Steffee RAM. The Steffee RAM
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`is a lordotic implant, and we'll talk about that in connection with the
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`insert and rotate claims.
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`So, I want to turn now to the Senter grounds in particular.
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`And here we have the issue of claim construction with respect to the
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`upper and lower convex bearing surfaces. This is actually in all the
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`independent claims, but it really only relates to the Senter grounds.
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`In the petition, as this Board may recall, we had offered
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`an interpretation that the claim convexity need not be the entire length
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`IPR2013-00395 and IPR2013-00396
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`of the implant, the Board agreed with that, invited Warsaw to inform
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`the Board if it wanted that changed, Warsaw provided a claim
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`interpretation, I don't think it changes that issue. They provide
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`something else, which is that not only does the implant -- the
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`convexity need not be the entire length of the implant, but that it must
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`conform to a natural endplate. There's no basis of that in the claim.
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`The claim is silent. It talks about a convexity.
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`If we look at claim 1, column 13, lines 38 to 42, we see --
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`38 to 42 -- we see that the claim recites that the upper and lower
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`bearing surfaces have portions proximate to each of said first and
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`second sides and being convex along the entire length of said upper
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`and lower bearing surfaces, there. It doesn't say anything that the
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`convexity has to conform to some patient. There's nothing like that in
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`the claim, and it's created from whole cloth by Warsaw and its expert.
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`And furthermore, if one does interpret the claim to require a convexity
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`that's in conformance with a natural endplate, because different
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`patients will have different endplates, if I were to put an implant on
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`the table here, and it had certain convexity, one wouldn't know
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`whether it meets the claims or not.
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`JUDGE GREEN: Now, what if using that -- you have
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`lower bearing surfaces, doesn't it have to be bearing something, so
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`doesn't that mean that it has to bear the implant? I mean not the
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`implant, but the vertebral endplate? I mean, doesn't that to a certain
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`extent support that interpretation by Patent Owner?
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`MR. SCHAEFER: And it does, in fact, bear something.
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`If we compare in the claim where we talked about other bearing
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`surfaces, as Your Honor knows, there are multiple claimed bearing
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`surfaces. We have the terminal parts that also have bearing surfaces.
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`Here we say that the bearing surface actually engages the endplate.
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`And I think it's on the part of the claim in the prior page, right there.
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`We have a first bearing surface is adapted to bear against the portion
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`of the first endplate.
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`So, when we're talking about those bearing surfaces, it
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`specifically says that it's adapted to bear against those endplates.
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`When we're talking about the convex upper and lower surfaces,
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`however, there's no such language. It doesn't say that it has to bear
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`against endplates or anything else. It's silent. It just says it has to be
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`convex.
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`JUDGE GREEN: But if it's not bearing against the
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`endplates, what would it be bearing against?
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`MR. SCHAEFER: Other -- the Senter patent, for
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`example, involves moving -- removing part of it. There are things
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`underneath the endplate that it would bear against, it's not like it's a
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`hollow bone inside there.
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`So, in that sense when we get to Senter, which, as this
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`Board knows from the institution decision, the Senter implant does
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`have a center region that is convex, and there's no dispute that it's
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`convex, the only dispute is whether it meets this claim limitation. We
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`say it doesn't meet that claim limitation.
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`Moreover, Warsaw's narrow claim construction of
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`requiring this -- requiring the narrowness of -- that it conforms with
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`the endplate is inconsistent with the Board's holding that the Kim
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`grounds are redundant with the Senter grounds, because, of course, in
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`the Kim case, in the Kim reference, it, like many references, the
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`convexity is -- conforms with the endplate.
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`Now, this Board actually said those grounds are
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`redundant, but if they are not redundant, I think it's incumbent upon
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`Warsaw to explain, okay, if this ground, Senter, doesn't meet the
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`claim because this center region doesn't meet the convex limitation,
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`then why is it, then, that the Kim ground, which is exactly the same
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`combination, except that implant has a convexity that does, in fact --
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`is, in fact, described to rest on the endplate, why is that?
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`Warsaw doesn't address that. They didn't address that
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`and they don't have any answer for that, but at least, I think, we
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`deserve one statement as to why that ground is no longer redundant.
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`Now, there's -- I'm going to have to speed up here a little
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`bit.
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`There's basically two other arguments with respect to the
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`Senter combination. The -- and it really relates to modifying Senter,
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`the convex surface to have ratchetings. I think that's actually well set
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`forth in our reply in Dr. Brantigan's declaration, it's described right
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`there in detail why you would -- why one of skill in the art would
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`want a belt and suspenders approach, both features, the convexity and
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
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`the ratchetings provide stability in the disc space, and I think our
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`answer in our reply addresses that topic quite thoroughly.
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`And then the last argument by Warsaw has to do with
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`adding openings through the implant through Senter, based on the
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`teaching of many references, such as Brantigan, that show holes
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`through an implant, and again, I think this issue on the Senter grounds
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`is thoroughly explained in our reply brief, and in, also, the second --
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`the second Dr. Brantigan declaration.
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`So, with that I want to move to the second ground that's
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`been instituted on the first IPR, and that involves the Michelson '037
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`patent. Of course, our argument here is Michelson '037, filed in 1988,
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`discloses flat surfaces. Figure 1, there are, indeed, if we show figure
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`1, there are holes through the implant. It meets all the limitations of
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`the claim except two things, the convex upper and lower bearing
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`surfaces, and ratchetings on those upper and lower convex bearing
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`surfaces.
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`NuVasive's position is that adding those convex upper
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`and lower bearing surfaces to that design would have been obvious to
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`a person of skill in the art in 1995, after this period of seven years had
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`lapsed in which there is at least six references showing convex
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`surfaces. One of those being Wagner. And if we could show Wagner,
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`figure 6, Wagner actually shows -- Wagner shows flat implants, and it
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`actually shows convex implants. Like the '696 patent, Wagner is
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`similar in that sometimes it's flat, sometimes -- let's move to figure 7, I
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`think it is. This is the one that is the convex embodiment, and Wagner
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
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`actually describes it can be convex in different directions, front to
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`back and side to side. And interestingly enough here, this is a belt and
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`suspenders approach. You have the motion prevention by virtue of
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`the convexity of the implant, and you also have these pyramid
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`structures.
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`So, by 1995, our position is that this was in the toolbox
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`of implant designers, and one of skill in the art would have modified
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`Michelson '037 in view of these teachings of Wagner to obtain the --
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`to obtain the advantages described in both of these patents.
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`Warsaw's arguments boil down to two things: Its
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`primary argument is that Warsaw asserts the '037 being flat is
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`intended to treat a different type of patient, as compared to Wagner,
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`which is a convex implant for a patient that still has that concavity in
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`the endplate. That argument is flawed for two main reasons: First,
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`Michelson '037 says it's universally applicable and describes no such
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`limitations that were invented by Dr. Branch on this. In fact, on page
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`7, at lines 18 to 23 -- actually, I'm sorry. It's the same quote.
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`This is from the '037 patent, this is in Dr. Brantigan's
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`second declaration where the Michelson '037 patent teaches that the
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`disclosed implant device, "Will fit any patient, anywhere throughout
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`the spine, in any vertebral disc space, and without alteration of that
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`inner space, regardless of its natural size or shape."
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`So, here again, we have a universally -- allegedly a
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`universally applicable Michelson '037 patent, and now, on the other
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`hand, now we've got Wagner, who in 1992 teaches you're going to
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
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`have flat bearing surfaces or you can have convex bearing surfaces,
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`take your choice. And we will have anti-migration capability for belt
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`and suspenders on those bearing surfaces. And in view of that,
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`certainly in 1995, in view of Wagner, one of skill in the art would
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`know that Michelson '037 could be convex or it could be -- or it could
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`be flat.
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`Warsaw's second argument on this ground, on the
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`Michelson '037 grounds against claims 1 and 4 is that if the teaching
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`of Wagner were to include convex surfaces, if that were included in
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`the Michelson '037, the specific anti-migration mechanism of
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`pyramids of Wagner must also be adopted rather than the ratchets of
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`Brantigan '035. And specifically, Warsaw contends that Wagner's
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`pyramids provide anti-migration that is both front and back, and side
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`to side. But allegedly, the ratchetings, according to Warsaw, of
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`Brantigan '035 provide only front to back stability.
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`Well, that argument is simply flawed, and again, this is
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`actually an argument that we've fleshed out in some detail in our
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`reply, and in the Brantigan second declaration. Here we see that
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`Wagner is -- is pretty general about what could be on that bearing
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`surface. He says that they are three-dimensional features, and that it
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`provides anchoring effect on the implant's bearing surfaces.
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`It happens to give the example of pyramids, but
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`ratchetings were also another 3-D anti-migration feature that was
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`known at the time, and one of skill in the art would know that these
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`are interchangeable things.
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
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`The other point is that Warsaw argues that because
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`Brantigan is put in a hole with sides to prevent it from going back and
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`forth, therefore, the nubs that dig into the vertebra would not -- do
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`not -- are not what's providing back and forth movement. That's just
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`simply, I would submit, flawed logic, simply because there are two
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`things preventing the side to side movement doesn't mean the
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`ratchetings which dig into the bone don't also provide side to side
`
`movement. They do, in fact, prevent side to side movement.
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`Now, I guess the final point I want to make on this
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`ground involving Michelson '035 patent, if it were really something
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`tricky, or difficult, in 1995, to put ratchetings on a convex bearing
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`surface, you would think that somewhere in the '696 patent, there
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`would be some discussion of that. There's not.
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`14
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`So, all of Warsaw's arguments that say you can't -- one of
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`skill just wouldn't know how to combine these. Well, then you have
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`to look at the '696, we submit, and it's not described as being
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`17
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`combined there. So, they're putting us to a lot higher burden in the
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`18
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`prior art that we would submit is the backdrop of the '696. These are
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`all interchangeable features, and the whole disclosure of the '696
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`20
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`patent recognizes that, and that's why, in fact, you don't have any
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`21
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`disclosure of any embodiments that have a convex surface with
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`22
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`ratchetings on them.
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`23
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`I want to mention, I guess, move now, I'm going to stay
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`24
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`on the first IPR, but talk a little bit about the secondary considerations
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`that Warsaw does briefly mention for claims 1 and 6. They argue that
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
`
`the commercial success of its lateral implants, called the Clydesdale,
`
`support a finding of nonobviousness.
`
`I would submit that they just simply did not meet their
`
`burden. There's no claim-by-claim analysis. There's, in fact, the only
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`record evidence that's here of it is an accountant statement of what the
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`sales of that lateral implant have been, and, in fact, Dr. Branch, who's
`
`the expert, is not familiar with the Clydesdale implant, he provides no
`
`testimony on it, and when cross examined on it, he just simply was
`
`unfamiliar with it and didn't know whether it met the claims or not.
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`We described this in our reply briefly, we addressed the
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`issue and our arguments are there, I would submit that's a non-issue.
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`So, let me now spend the time I have, and I may take a
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`little longer than 40 minutes here, to talk about the IPR number two,
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`which are the insert and rotate claims. First let me give a little
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`15
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`background on what an insert and rotate implant is all about. These
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`16
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`are a posterior implant, inserted from the back, and if you remember
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`17
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`in my discussion about the lordosis of the spine, you remember that
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`18
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`the space in the disc is actually a little larger in the front, or the
`
`19
`
`anterior portion of the patient, than it is in the back.
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`20
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`And, so, the idea, as it's described in the Steffee patent,
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`21
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`and if we could throw up the Steffee patent, figures 9 to 12, the idea
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`22
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`of an insert and rotate patent is it has a width that's less than its height.
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`23
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`So, you put it into the disc space from, again, the back, and you put it
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`24
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`in on its side, and then you rotate it 90 degrees.
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` 17
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
`
`
`1
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`2
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`3
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`4
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`6
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`7
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`8
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`9
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`So, here we see a description of that, starting with figure
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`9, one implant is put on one side. You will see here that you have to
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`avoid the spinal column, which is in the back. I have a pointer, this
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`space here. Well, actually, I don't want to -- the space between --
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`sorry, technical difficulties.
`
`This area right there is the spinal column. So, this is the
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`posterior part of the spine and this is the anterior column where the
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`discs are. The first implant is put in on one side of the column, on its
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`side, and then turned 90 degrees, the ratchetings or teeth, as they're
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`10
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`called, are on the top and bottom, and then you put in the second one,
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`11
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`on its side, turn it 90 degrees, and then you have both implants there.
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`12
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`So, that's what an insert and rotate implant is. In the '696
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`13
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`patent, that's similarly envisioned as the insert and rotate embodiments
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`14
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`that are introduced posteriorly. If we could put up figures 18 to 23 of
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`the '696 patent. This is one set of insert and rotate embodiments.
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`Here it is, this is its top surface, and its bottom surface, it's taller than
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`17
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`it is wide. Here it is, its width going in the space, smaller, and then
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`18
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`the patent -- the '696 patent, just like Steffee, describes that you turn it
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`19
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`90 degrees, and you have this height.
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`20
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`Now, this would be at the anterior part of the implant, the
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`21
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`forward part, so it's taller, and this would be at the back part. So,
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`22
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`conceptually, it's pretty much close to Steffee. Importantly, of course,
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`23
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`you don't see any convex bearing surfaces here, you don't see any
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`24
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`ratchetings. These insert and rotate embodiments don't have any of
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`25
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`that in it. And if we show the only other insert and rotate embodiment
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
`
`is on the next page of the figures, here's another one that shows, again,
`
`another version of the insert and rotate embodiment, has
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`anti-migration features that also were in the toolbox at the time of
`
`posts on a flat bearing surface, not a convex bearing surface. This,
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`again, is an insert and rotate implant, and is in figures -- this is figures
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`24 through 29 of the '696 patent.
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`So, if we get at, now, the claims, there's one claim
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`interpretation issue having to do with opening that relates to the
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`Steffee grounds. The claim recites, and let me put up the claim
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`1
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`language, can we put the claim -- this is from our claim chart, opening
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`is -- no, it's -- can we go to the patent, claim 7, the '696 patent, claim
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`12
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`7. Opening is down here.
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`13
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`The claim recites "an opening between said trailing face
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`14
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`and said insertion face and between said first and second sides to
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`15
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`permit for the growth of bone through said implant from the first
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`16
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`vertebra to the second vertebra." So, the structural part of the claim
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`17
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`that the opening be between the trailing face and the insertion face,
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`18
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`and between the first and second sides. Now, Steffee has holes
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`19
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`through from side to side, horizontal holes through the implant, not
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`20
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`disputed, bone grows through those.
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`21
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`The functional language in this, the intended use, is for
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`22
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`the growth of bone through said implant from the first vertebra to the
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`23
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`second vertebra. We would submit that we're talking about fusion
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`24
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`from the top vertebra to the second vertebra. The claim doesn't
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`25
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`require that these openings, or the opening through the implant be in
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`IPR2013-00395 and IPR2013-00396
`Patent No. 8,444,696
`
`communication with the top bearing surface or what have you, it just
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`simply provides an opening, bone grows through the implant, and
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`forms a fusion between that upper implant and
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