Trials@uspto.gov Paper 64
`571-272-7822 Entered: July 2, 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
`
`________
`
`Cases IPR2013-00206 and IPR2013-00208
`Patent 8,251,997 B2
`________
`
`
`RECORD OF ORAL HEARING
`
`Held: June 5, 2014
`
`
`
`Before: SALLY MEDLEY, LORA M. GREEN, STEPHEN SIU,
`Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Thursday, June 5, 2014 at 1:00 p.m,
`
` in Courtroom A at the U.S. Patent and Trademark Office, 600 Dulany Street, Alexandria,
`
`Virginia.
`
`
`
`
`571-272-7822 Entered: July 2, 2014
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`________
`
`Cases IPR2013-00206 and IPR2013-00208
`Patent 8,251,997 B2
`________
`
`
`RECORD OF ORAL HEARING
`
`Held: June 5, 2014
`
`
`
`Before: SALLY MEDLEY, LORA M. GREEN, STEPHEN SIU,
`Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Thursday, June 5, 2014 at 1:00 p.m,
`
` in Courtroom A at the U.S. Patent and Trademark Office, 600 Dulany Street, Alexandria,
`
`Virginia.
`
`
`
`
`
`
`
` 1 APPEARANCES:
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` 2 ON BEHALF OF THE PETITIONER:
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` 3 FRANK SCHERKENBACH, ESQ.
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` 4 Fish & Richardson P.C.
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` 5 One Marina Park Drive
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` 6 Boston, Massachusetts 02210
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` 7 617-542-5070
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` 8
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` 9 STEPHEN R. SCHAEFER, ESQ.
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` 10 Fish & Richardson P.C.
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` 11 3200 RBC Plaza
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` 12 60 South Sixth Street
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` 13 Minneapolis, Minnesota 55402
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` 14
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` 15 ON BEHALF OF THE PATENT OWNER:
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` 16 LUKE L. DAUCHOT, ESQ.
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` 17 NIMALKA WICKRAMASEKERA, ESQ.
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` 18 Kirkland & Ellis LLP
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` 19 333 South Hope Street
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` 20 Los Angeles, California 90071
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` 21
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` 22 THOMAS H. MARTIN, ESQ.
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` 23 Martin & Ferraro LLP
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` 24 1557 Lake O'Pines Street, N.E.
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` 25 Hartville, Ohio 44632
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`Cases IPR2013-00206 and IPR2013-00208
`Patent 8,251,997 B2
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` 1 P R O C E E D I N G S
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` 2 (1:00 p.m.)
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` 3 JUDGE MEDLEY: Good afternoon.
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` 4 This is th e hearing for IPR2013 -00206 and 00208
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` 5 between Petitioner, NuVasive, and Patent Owner, Warsaw
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` 6 Orthopedic.
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` 7 Before we proceed, we would like to memorialize on
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` 8 the record that a conference call was held on June 4th
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` 9 between counsel for the respective parties and the Panel.
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` 10 The purpose of the conference call was to discuss
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` 11 certain objections the Petitioner had with resp ect to Patent
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` 12 Owner's demonstratives that were filed on June 3rd.
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` 13 During the call the Panel ruled that the Patent
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` 14 Owner could not rely on slides 12 and 14 of its June 3rd
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` 15 demonstrative, and we further encouraged the parties to work
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` 16 out their differences regarding Petitioner's remaining
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` 17 objections to Patent Owner's June 3rd demonstrative.
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` 18 Just prior to noon today t he Board received
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` 19 another set of Patent Owner's demonstratives. We assume that
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` 20 this set replaces the June 3rd demonstratives and we plan to
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` 21 exclude the June 3rd demonstratives, if that is amenable to
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` 22 everyone.
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` 23 MR. DAUCHOT: That's fine, Your Honor.
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` 24 JUDGE MEDLEY: Okay. Are there any remaining
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` 25 issues regarding the demonstratives?
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` 1 MR. SCHERKENBACH: No, Your Honor.
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` 2 MR. DAUCHOT: No.
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` 3 JUDGE MEDLEY: We appreciate the parties willing
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` 4 to work it out and not to involve us beyond what was
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` 5 necessary.
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` 6 At this time we would like the parties to please
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` 7 introduce counsel, beginning with Petitioner.
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` 8 MR. SCHERKENBACH: Thank you, Your Honor.
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` 9 Good afternoon. Frank Scherkenbach of Fish &
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` 10 Richardson on behalf of Petitioner, NuVasive.
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` 11 Also, Stephen Schaefer is with me and may address
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` 12 certain discrete issues depending on whether they come up.
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` 13 JUDGE MEDLEY: Okay. Counsel for Patent Owner.
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` 14 MR. DAUCHOT: Good afternoon, Your Honor. Luke
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` 15 Dauchot on behalf of the Patent Owner .
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` 16 And with me here today is Nimalka Wickramasekera,
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` 17 who will be sharing the argument. And with us as well today
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` 18 is Tom Martin, lead trial -- or lead counsel.
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` 19 JUDGE MEDLEY: Okay. Thank you.
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` 20 As you know, per our May 9 order from the Board
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` 21 each party will have 60 minutes of total time to present
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` 22 arguments for the two cases.
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` 23 Because the two cases involve the same patent with
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` 24 similar issues, Petitioner, you will proceed first to state
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` 25 your case with respect to all of the challenged claims and
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`Patent 8,251,997 B2
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` 1 grounds for which the Board institute d trial for both cases.
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` 2 And thereafter, Patent Owner, you may have time to
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` 3 respond to the presentation for both cases.
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` 4 Petitioner, you may reserve rebuttal time if you
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` 5 would like.
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` 6 So we will begin with the Petitioner. And would
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` 7 you like to reserve rebuttal time?
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` 8 MR. SCHERK ENBACH: I would, Your Honor. I would
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` 9 like to reserve 20 minutes.
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` 10 JUDGE MEDLEY: Okay. Thank you.
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` 11 MR. SCHERKENBACH: Thank you.
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` 12 I structured my remarks today around what
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` 13 Petitioner sees is three primary points of dispute or
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` 14 assumptions that underlie many of the discrete issues that
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` 15 remain between the parties.
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` 16 One of those is regarding Jacobson and whether it
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` 17 teaches lateral or posterolateral approach in either
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` 18 discectomy or fusion.
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` 19 That issue underlies many of Warsaw's other
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` 20 arguments. So I wil l deal with that one first.
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` 21 Just by way of a brief introduction, obviously in
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` 22 its decisions instituting this proceeding, the Board, of
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` 23 course, agreed preliminarily that Jacobson was lateral an d
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` 24 not posterolateral. We think the plain teaching of Jacobson
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` 25 is clear on this issue.
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` 1 We have submitted the declaration from Dr.
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` 2 Jacobson himself who has weighed in on that issue and says,
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` 3 yes, it is lateral, not posterolateral. Dr. McAfee agrees.
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` 4 The only evidence in the record in substance going
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` 5 the other way is Dr. Sachs, and we will talk about that.
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` 6 The second, I think, overarching issue pertains to
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` 7 what we see as Warsaw's attempt to reconstrue substantially
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` 8 full transverse width. This is a term in the claims that the
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` 9 Board construed.
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` 10 We asked the Board to construe it and the Board
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` 11 did so. And yet, as I understand the Patent Owner's response
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` 12 and the respon sive declaration of Dr. Sachs, in substance
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` 13 they are now arguing for an additional limitation having to
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` 14 do with the apophyseal ring, and that in particular any
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` 15 implant has to rest both ends on the apoph yseal ring.
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` 16 That I think is a de facto end run around your
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` 17 claim construction. It also, we submit, is not supported by
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` 18 any of the intrinsic or extrinsic evidence, and I would like
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` 19 to comment on that.
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` 20 The third overarching issue has to do with the
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` 21 teachings of two of the other primary references, the
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` 22 Brantigan '327 patent and the Michelson '247 patent, and in
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` 23 particular whether those references disclose implants that
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` 24 would be in substance long enough, under the Court's proper
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` 25 claim construction, substantially the full transverse width.
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` 1 And so that's the last major point I would like to
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` 2 comment on.
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` 3 So if I may let me start with Jacobson.
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` 4 And there are var ious sources on this issue.
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` 5 Obviously the most important one is the Jacobson reference
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` 6 itself.
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` 7 And without rehashing everything in the papers on
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` 8 that, there are a couple of p articularly important points I
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` 9 submit on that.
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` 10 Jacobson is Exhibit 1004. Can we put up figure 3
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` 11 of Exhibit 1004, please, and then the text of columns 5, 1
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` 12 through 8.
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` 13 Essentially all of the figures in Jacobson --
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` 14 while they are pulling that up -- show a lateral approach, a
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` 15 direct lateral approach, the patient on their side in what is
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` 16 described as the lateral decubitus position, which is where
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` 17 the patient is completely on their side and bent in such a
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` 18 way as to expose the space between the vertebra distracted so
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` 19 that access in a direct lateral f ashion is facilitated.
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` 20 Here is figure 3. It is one of the figures from
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` 21 Jacobson. You can actually look at almost any figure in
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` 22 Jacobson and you will see the same fundamental arrangement of
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` 23 a direct lateral approach.
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` 24 In this particular -- can we go back to the other
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` 25 figure just for one second? I just wanted to point out in
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` 1 figure 3, and in various other figures you will start to see
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` 2 some of the surgical instruments that Jacobson used in his
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` 3 particular procedure.
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` 4 All of them, as you will see, are oriented
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` 5 vertically in these figures, patient on his or her side. The
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` 6 head would be over here on the left.
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` 7 And Jacobson describes coming, making an incision
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` 8 and coming through the side of the patient while the patient
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` 9 is on their side.
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` 10 There is explicit description of this in -- now I
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` 11 can go to column 5, lines 1 through 8 of Jacobson, and it
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` 12 talks about passing the cannula, which is ultimately the
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` 13 working channel instrument in Jacobson.
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` 14 A cannula is passed laterally through the body
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` 15 while the patient is in the lateral decubitus position.
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` 16 "While."
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` 17 The reason this has taken on some increased
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` 18 importance is because, as I understand it, Dr. Sachs in his
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` 19 responsive declaration says, well, it was not uncom mon in the
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` 20 art to start with the patient in this lateral decubitus
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` 21 position and then roll them slightly in one direction or the
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` 22 other as the procedure actually occurred.
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` 23 And whether that is true or not, and perhaps in
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` 24 Dr. Sachs' experience it is, that isn't what Jacobson
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` 25 teaches. There is no rolling of the patient. There is no
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` 1 repositioning of the patient either described in the spec or
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` 2 shown in the figures.
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` 3 This patient is in the lateral decubitus position
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` 4 and the procedure proceeds with the patient in that position.
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` 5 Now, we can look at, as I said, other figures. We
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` 6 can put up figure 5, for example, of Jacobson. And you will
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` 7 see, with reference to the working channel, figure 5, here is
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` 8 the cannula through which the procedure is actually going to
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` 9 be performed in a direct lateral position.
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` 10 It is actually in this one inside the speculum.
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` 11 The speculum will be r emoved and you do the work through the
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` 12 cannula.
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` 13 Just to jump ahead a little bit to one of Warsaw's
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` 14 arguments, I may come back to it in more detail if necessary,
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` 15 they say, wel l, this could be posterolateral because you
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` 16 aren't seeing the other view.
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` 17 The view is not only anterior -posterior, which
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` 18 this is, but sort of the end view of the patient so you can't
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` 19 tell from this figure whether this cannula is tilted in some
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` 20 way so that it would be other than sort of straight up and
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` 21 down.
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` 22 And we submit that actually you can because in all
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` 23 of these figures, the way they are drawn, you have, for
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` 24 example, a straight line at the bottom of this cannula. It
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` 25 is not an oval. Okay.
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` 1 You are not seeing an oval shape there which would
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` 2 indicate either, in hidden line or otherwise, which might
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` 3 indicate that that cannula is at some other angle. It is
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` 4 shown in a strai ght line.
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` 5 And actually this point was made in Dr. McAfee's
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` 6 declaration. Perhaps a figure would be helpful. In
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` 7 paragraph 38, the second McAfee declaration, just try to make
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` 8 this point plain.
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` 9 Figure 6 in Jacobson shows a cross -section of the
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` 10 cannula. This is actually from Jacobson. And you can see
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` 11 that the cross -section shows, again, that the cannula is
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` 12 straight up and down direct lateral.
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` 13 If, indeed, Dr. Sachs' view were correct, and this
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` 14 were showing posterolateral, the cross -section wouldn't look
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` 15 like that.
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` 16 You may not have exactly what is shown on the
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` 17 right but you would have some other shape where the
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` 18 cross-section would look different if that were not a direct
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` 19 lateral procedure.
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` 20 So one other point on the intrinsic evidence
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` 21 relating to Jacobson, and, that is, this is a very early
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` 22 patent, early '80s patent. And I believe it is undisputed
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` 23 actually on this record that at that time there was no term
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` 24 of art that was direct lateral or true lateral. That came up
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` 25 later.
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` 1 At the time of Jacobson in the ear ly '80s the
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` 2 phrase was lateral, or posterolateral. And so it is not
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` 3 surprising that Jacobson didn't use a qualifier like direct
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` 4 or true or anything of the sort because it wasn't used in the
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` 5 parlance at that time.
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` 6 Dr. McAfee has testified to this. Dr. Jacobson
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` 7 has in his declaration. Dr. Sachs actually agreed in
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` 8 substance in deposition that the phrase direct lateral wasn' t
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` 9 in use at this time.
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` 10 Now, that is Jacobson itself or at least a
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` 11 highlight of the evidence from Jacobson itself.
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` 12 There is also these contemporaneous papers from
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` 13 Dr. Friedman, who describe the Jacobson procedure. All
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` 14 right. So it's not something that has been provided by
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` 15 anybody interested in the proceedings on one side or the
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` 16 other.
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` 17 Back in the day, Dr. Friedman, and perhaps we can
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` 18 put up, for example --
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` 19 MR. DAUCHOT: Your Honor, just a procedural
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` 20 question. We obviously have objections to that. And I
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` 21 assume they are reserved without the need for me to stand up
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` 22 and object as counsel here discusses it.
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` 23 JUDGE MEDLEY: Is that part of a motion to
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` 24 exclude, is that what you are saying?
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` 25 MR. DAUCHOT: It is, Your Honor. We have a motion
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` 1 to exclude on this as well as evidentiary objections as to
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` 2 the Friedman a rticles, among other items of evidence.
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` 3 I am happy to take those up after Mr. Scherkenbach
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` 4 has concluded.
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` 5 JUDGE MEDLEY: Right. You get to raise that when
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` 6 it is your turn.
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` 7 MR. DAUCHOT: So just for the record they are
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` 8 reserved?
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` 9 JUDGE MEDLEY: Right.
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` 10 MR. DAUCHOT: Thank you.
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` 11 JUDGE MEDLEY: Thank you.
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` 12 MR. SCHERKENBACH: So the Friedman article, I
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` 13 don't need to dwell on this, but we would submit they are
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` 14 particularly probative because they are from back at the
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` 15 time.
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` 16 This is from a disinterested surgeon, actually
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` 17 several surgeons, who explicitly say Dr. Jacobson taught me
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` 18 his lateral procedure.
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` 19 And they have, Dr. Friedman a nd others have
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` 20 published two papers, one is Exhibit 1036 and the other is
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` 21 1037 where, again, if you look at the figures and/or read the
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` 22 text, it is abundantly clear we are talking direct lateral or
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` 23 true lateral or whatever qualifier you would like to use.
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` 24 And these I think are particularly significant for
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` 25 another reason because you are looking at -- these are not
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` 1 anterior-posterior. These are looking at it along sort of
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` 2 the length of the patient, so cephalic and caudal view.
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` 3 And so, again, straight up and down. So this is
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` 4 the other view that is sort of orthogonal to the one that's
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` 5 shown in Jacobson itself, right.
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` 6 If this were posterior at all you would see these
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` 7 access instruments angle on e way or the other with respect to
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` 8 the vertical axis. You don't see that.
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` 9 Okay. And so certainly the combination of this
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` 10 Friedman -- these Friedman articles with Jacobson, you have
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` 11 got both views. They are contemporaneous. They are not
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` 12 colored or shaded in any way by people's interest in this
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` 13 proceeding. They show a direct or true lateral approach.
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` 14 Last point on Jacobson and then I want to get to
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` 15 the fusion aspect. And, that is, again, before we got
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` 16 embroiled in this situation and find ourselves before you,
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` 17 what did Warsaw itself say in its own patents on this issue
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` 18 of lateral versus posterolateral?
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` 19 We talked about this in our papers, and the bottom
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` 20 line is when Warsaw discussed Jacobson, specifically
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` 21 discussed Jacobson, it us ed the term lateral and not
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` 22 posterolateral.
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` 23 Now they are all saying it is posterolateral. But
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` 24 at the time -- here is Exhibit 1039. This is a patent
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` 25 assigned to Warsaw discu ssed in our papers. And it couldn't
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` 1 be clearer, I submit.
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` 2 In the background section, this is from column 2,
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` 3 lines 32 to 41 of Exhib it 1039, this is a Warsaw patent
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` 4 saying, for example, U.S. Patent Number 374 to Jacobson
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` 5 discloses a percutaneous lumbar discectomy using a lateral
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` 6 approach.
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` 7 Okay. Lateral, not posterolateral. And you know
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` 8 that is not an accident or sort of a rough approximation
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` 9 because in the very next paragraph this patent goes on to say
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` 10 there are other procedures, for example, Dr. Kamb in, who has
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` 11 a lot of patents in the field as well, and they disclose
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` 12 percutaneous decompression of herniated discs with a
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` 13 posterolateral approach.
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` 14 So it seems fairly clear to us that if Warsaw
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` 15 really believed Jacobson was posterolateral and not lateral,
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` 16 they would have described it in that way. They didn't.
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` 17 This is not an isolated example, as Dr. McAfee
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` 18 explained in his declaration, his second declaration,
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` 19 paragraph 41. There must be almost 30 patents that have this
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` 20 language, 30 Warsaw patents that use a consistent description
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` 21 of what Jacobso n shows.
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` 22 All right. So let me go on to the question of
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` 23 fusion. So with respect to Jacobson there is the issue of
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` 24 approach and there is the issue of what does it mean when
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` 25 Jacobson says you can use his approach for fusion, and does
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` 1 that necessarily mean or imply that there would be an implant
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` 2 used?
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` 3 And f irst of all, the patent itself, and, again,
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` 4 maybe we could go to Jacobson, Exhibit 1004, column 6, lines
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` 5 9 to 13. There isn't any dispute that Jacobson says you can
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` 6 use his approach for fusion, disc re alignment, fusion, or any
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` 7 other surgical or diagnostic procedure.
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` 8 I mean, generally speaking, Dr. Jacobson, his
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` 9 patent is about an approach. It is about a surgical approach
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` 10 to create a working channel through the spine.
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` 11 And once you are there you can do any number of
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` 12 things through that working channel, including fusion, which
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` 13 he explicitly says.
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` 14 Now, in the context of Dr. Jacobson's patent and
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` 15 in the context of the tools and instruments that he shows,
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` 16 Dr. McAfee is of the opinion that you would have to put an
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` 17 implant in there.
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` 18 It is not the sort of procedure where you are
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` 19 going to go in laterally, take out some or all of the disc,
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` 20 and then, if you are doing a fusion, not put an implant in
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` 21 that space.
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` 22 And there arose a subsequent dispute after Dr.
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` 23 McAfee was deposed, you see this in the papers, where they
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` 24 ask Dr. McAfee whether, in general, outside the context of
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` 25 Jacobson, could you have fusion occur without an implant?
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` 1 And the answer to that is of course. You all know
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` 2 that if you have broken a bone, a long bone, or you know
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` 3 someone who has broken a long bone. The doctor sets the bone
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` 4 and we all hope it fuses. And that's not happening with
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` 5 implants.
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` 6 Bones fuse all the time without implants . That's
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` 7 not the relevant question. And that's in substance what Dr.
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` 8 McAfee said in his deposition.
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` 9 He was not asked in deposition, in Jacobson do you
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` 10 think there could be fusion without an implant? In fact, he
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` 11 wasn't asked a single question about Jacobson in his
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` 12 deposition. So just to get to the front of that issue.
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` 13 As to what sorts of implants were allowed a t the
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` 14 time, there is a great deal of information in this record on
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` 15 that. This is early '80s.
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` 16 There were the most widely used implants for bone,
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` 17 various shapes and sizes, bon e dowels, bone fragments,
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` 18 autograft, meaning the patient's own bone, allograft, meaning
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` 19 bone from a donor of some sort.
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` 20 You have got the Crock paper and work on that.
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` 21 You have got Dr. McAfee talking about his own practice. You
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` 22 have got Dr. Jacobson in his declaration saying I did fusion
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` 23 using the procedure shown in my patent and I used bone dowels
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` 24 when I did that procedure .
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` 25 It was commonly done well before 1995. And, in
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` 1 fact, just to remind us all on sort of the state of the art
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` 2 of implants, just to s et the timetable, so Jacobson is early
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` 3 1980s. Okay.
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` 4 Right about that time there started to be a
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` 5 development of nonbone implants, distant issue in the case, I
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` 6 understand, wit h Dr. Bagby, one of the very early titanium
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` 7 cage implant patents.
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` 8 It was right around the same time. Bagby sort of
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` 9 starts off the cage rage, as it came to be called later on.
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` 10 And so between the early '80s and by the time of
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` 11 the priority date, the priority date of the '997 patent is
`
` 12 February 27, 1995. Okay. We are talking 13 -14 years down
`
` 13 the road before you eve n get to Patent Owner's filing date.
`
` 14 There have been an enormous amount of work done
`
` 15 and procedures done with implants of all kinds. And this is
`
` 16 explained in the record in detail so I am not going to relive
`
` 17 that. But I think it is very important background
`
` 18 information.
`
` 19 It explains why it isn't any stretch at all to
`
` 20 read, when you see fusion in Jacobson, to under stand that to
`
` 21 require or at least very likely use an implant.
`
` 22 And it also, I submit, and perhaps drives what the
`
` 23 next issue is that I want to get to, and that is why it is
`
` 24 that the Patent Owner is trying to put a gloss on your claim
`
` 25 construction of substantially full transverse width, that has
`
` 17
`
`
`
`Cases IPR2013-00206 and IPR2013-00208
`Patent 8,251,997 B2
`
`
`
`
` 1 this -- to do with the apophyseal ring.
`
` 2 That is all in service we believe of trying to
`
` 3 distinguish these many, many implants of all kinds that were
`
` 4 in the art.
`
` 5 And, you know, it is interesting, we can't really
`
` 6 point per se in the prior art to implants that are discussed
`
` 7 in the context of apophyseal ring. You won't see that
`
` 8 phrase.
`
` 9 But you won't see it in the '997 patent eit her.
`
` 10 It is not in the patent other than the claim. It is not in
`
` 11 the specification. It is never discussed, not shown in any
`
` 12 of the figures.
`
` 13 The Board's construction, the one we are working
`
` 14 with, is not about an apophyseal ring. Okay.
`
` 15 Your construction is that substantially the full
`
` 16 transverse width includes implants that are less than the
`
` 17 full transverse width by an insubstantial amount. Less than
`
` 18 the full width by an insubstantial amount.
`
` 19 And Warsaw did not explicitly challenge the
`
` 20 construction but
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