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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC.
`Petitioner
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`v.
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`NUVASIVE, INC.
`Patent Owner
`---------------------------------------
`
`Case IPR2013-00506
`Patent 8,361,156
`---------------------------------------
`
`
`
`PETITIONER’S NOTICE OF SUPPLEMENTAL
`EVIDENCE IN RESPONSE TO PATENT OWNER’S
`OBJECTION TO EVIDENCE UNDER 37 CFR § 42.64(B)(1)
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`MSD 1183
`IPR2013-00506
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`IPR2013-00506
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`Petitioner Docket No. 108136.00029
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`Petitioner Medtronic, Inc. (“Petitioner”) submits this Notice of Supplemental
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`Evidence in response to Patent Owner’s Objection to Evidence Under 37 C.F.R.
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`§ 42.64(b)(1), dated September 12, 2014. In response to Patent Owner’s
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`objections, Petitioner submits excerpts from the transcript of the Deposition of Dr.
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`Hansen A. Yuan, taken August 22, 2014. While Petitioner does not agree with the
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`objections set forth by Patent Owner, this supplemental evidence provides further
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`authentication of Exhibits 1154-1156.
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`Petitioner once again reminds Patent Owner that 37 C.F.R. § 42.64(b)
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`requires that evidentiary objections “must identify the grounds for the objection
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`with sufficient particularity to allow for correction in the form of supplemental
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`evidence.” Many, if not all, of Patent Owner’s objections contain only conclusory
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`references to the Federal Rules of Evidence and thus do not provide the required
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`particularity. At a minimum, Patent Owner should supply the paragraph number
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`related to each ground of objection related to the Declaration of Loic Josse (Exhibit
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`1116) and the Second Declaration of Dr. Richard A. Hynes (Exhibit 1157),
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`otherwise it is virtually impossible and incredibly burdensome for Petitioner to
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`correct any alleged evidentiary concerns with these documents. Petitioner thus
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`reserves all rights to respond to any further explanations Patent Owner is allowed
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`to provide regarding its evidentiary objections.
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`IPR2013-00506
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`Petitioner Docket No. 108136.00029
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`Dated: September 26, 2014
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`Respectfully submitted,
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` /Jeff E. Schwartz/ d
`Jeff E. Schwartz, Reg. No. 39,019
`Fox Rothschild LLP
`1030 15th Street, NW
`Washington, DC 20005
`Tele: 202-696-1470
`Fax: 202-461-3102
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`Attorneys for Petitioner
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`IPR2013-00506
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`Petitioner Docket No. 108136.00029
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on the 26th
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`day of September 2014 a complete and entire copy of “Petitioner’s Notice of
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`Supplemental Evidence in Response to Patent Owner’s Objection to Evidence
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`Under 37 CFR § 42.64(B)(1)” was provided via email to the Patent Owner by
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`serving the following email addresses:
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`schaefer@fr.com
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`hawkins@fr.com
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`Electronic service was used with the agreement of the Patent Owner’s counsel.
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`Dated: September 26, 2014
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`
` /Jeff E. Schwartz/ d
`Jeff E. Schwartz, Reg. No. 39,019
`Fox Rothschild LLP
`1030 15th Street, NW
`Washington, DC 20005
`Tele: 202-696-1470
`Fax: 202-461-3102
`
`Attorneys for Petitioner
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`Yuan, M.D., Hansen A.
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`August 22, 2014
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`1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,361,156 B2
`Issue Date: January 29, 2013
`Case IPR2013-00506
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,187,334 B2
`Issue Date: May 29, 2012
`Case IPR2013-00507
`---------------------------------------------------
`MEDTRONIC, INC.,
` Petitioner,
` -vs-
`NUVASIVE, INC.,
` Patent Owner.
`Patent Number 8,187,334 B2
`Issue Date: May 29, 2012
`Case IPR2013-00508
`---------------------------------------------------
` Examination Under Oath of HANSEN A. YUAN, M.D.,
` held at 211 West Jefferson Street, Suite 21,
` Syracuse, New York, on August 22, 2014, before
` MARITA PETRERA, Registered Professional Reporter,
` and Notary Public in and for the State of New York.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`5
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`Yuan, M.D., Hansen A.
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`August 22, 2014
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`4
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` Index
`Witness Page
` Hansen A. Yuan, M.D.
` Examination by Mr. Schwartz 7
` Examination by Mr. Amon 272
` Examination by Mr. Schwartz 281
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` * * *
`
` EXHIBITS
`MSD
`Number Description Page
`Exhibit 1015 Posterior Lumbar Interbody 66
` Fusion Using Posterior Lateral
` Placement of a Single
` Cylindrical Threaded Cage
`Exhibit 1016 Document re: Premarket 74
` Approval extension for BAK
` Interbody fusion system
`Exhibit 1115 8,361,156 Patent 78
`Exhibit 1049 Declaration re: Case 81
` IPR2013-00506
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`August 22, 2014
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` EXHIBITS
`MSD
`Number Description Page
`Exhibit 1020 Medtronic OLIF25 Procedure 83
` Document
`Exhibit 1013 8,187,334 patent 95
`Exhibit 1050 Excerpt of Deposition of 125
` Richard Hynes, M.D.
`Exhibit 1051 Endoscopic Lateral Transpsoas 138
` Approach to the Lumber Spine
` Article
`Exhibit 1021 Medronic Sofamor Danek 172
` Butterfly Fusion System
` Surgical Technique brochure
`Exhibit 1031 European Patent number 204
` EP 1 290 985 A2
`Exhibit 1023 Alphatec Guided Lumbar 209
` Interbody Fusion Device
`Exhibit 1052 diagram 234
`Exhibit 1053 diagram 240
`Exhibit 1054 diagram 240
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`Yuan, M.D., Hansen A.
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`August 22, 2014
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`234
`with a depth at average of 38.6 and a 41 millimeter
`implant is not going to protrude 30 percent of its
`length, correct?
` A. That's correct.
` Q. Thank you, sir.
` A. Thank you.
` Q. Whew.
` MR. SCHWARTZ: Sir, I'm going to
` mark this as MSD 1052.
` (MSD Exhibit 1052, diagram,
` marked for identification, this date.)
` Q. Sir, I've handed you --
` MR. AMON: Could I have a copy,
` Counsel?
` MR. SCHWARTZ: It's the exact
` replica of the figure that's in his
` report.
` MR. AMON: It's been blown up?
` MR. SCHWARTZ: I'll get you a
` copy.
` MR. AMON: Thank you.
` MR. SCHWARTZ: Can I see it for a
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`235
` second, sir?
` THE WITNESS: Oh, sure.
` (Document handed.)
` MR. AMON: This was marked as
` 1032?
` MR. SCHWARTZ: 1052.
`EXAMINATION BY MR. SCHWARTZ:
` Q. You've been handed what's been identified
`as MSD 1052.
` A. Thank you.
` Q. Can we agree that's a proportionate
`representation of the figure that's in your report?
` A. Yes.
` Q. Okay, sir, I'm going to hand you cut-out
`of that exact implant which I invite you to put on
`top of it to compare the size. Is it the same size,
`sir?
` A. Yes.
` Q. Okay, sir.
` A. Sorry.
` Q. No. Now, sir, isn't it fair to say that
`even with your exaggerated implant, it will fit
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`Yuan, M.D., Hansen A.
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`August 22, 2014
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`236
`within that disk space?
` A. Would you want a spine surgeon to do the
`case on your back with that implant?
` Q. I'm not asking you that question, sir.
`I'm asking you does it fit within the disk space?
` A. It doesn't.
` Q. It's within the circumference of that disk
`space, sir?
` A. But if you look at this, posteriorly you
`are invading the spinal canal with that implant
`because the implant that we're putting in here is
`right in the space, and you're looking anteriorly.
`You've already penetrated all the annular ligaments
`and actually abutting against the vein.
` Q. Is it within the circumference of the
`vertebral body?
` A. No, just protruding. I would not do that
`case that way.
` Q. I'm not asking if you would do the case.
`I'm asking you does it fit within the circumference
`of the vertebral body?
` MR. AMON: Asked and answered.
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`August 22, 2014
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`237
` A. It is sitting on the rim and it's just
`protruding and it's dangerous.
` Q. So it's sitting on the rim. Where is it
`protruding?
` A. This is the vena structure and that's
`protruding, and that posteriorly is already in the
`spinal canal because the spinal canal comes down
`below.
` Q. Well, sir, the spinal canal is over here,
`right?
` A. No, no, that's where the nerves are.
`That's where the nerve structures are sitting, right
`in this whole space here. This is where your
`entrance point. No surgeon would leave the corner
`sticking out there.
` Q. Okay, sir. How about pointed in the other
`direction?
` MR. AMON: Can I have a copy of
` that one please, Mr. Schwartz?
` MR. SCHWARTZ: You want to take a
` break and make a copy? Want to take a
` break? We can take a break and make a
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`August 22, 2014
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`238
` copy. I'm trying to move this along.
` MR. AMON: No need to raise your
` voice, Mr. Schwartz.
` MR. SCHWARTZ: I'm not raising my
` voice, Counsel.
` MR. AMON: We'll get a copy at
` the next break.
` A. In an oblique implant, you don't want the
`implant sitting on the rim of the vertebral body.
`That's the reason why an implant of the size and this
`dimension that you're talking about cannot be used.
`EXAMINATION BY MR. SCHWARTZ:
` Q. But, sir, does it sit within the
`circumference?
` A. First of all, we don't know the dimension
`of this vertebral body and, secondly, we don't know
`here what the length is that we are measuring.
` Q. I'm just working from your picture, sir.
` A. My picture is an illustration. I don't
`have any numbers there to show that.
` Q. I understand.
` A. As I said to you, it's an illustration
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`239
`showing when a cage is too long, it will stick out
`through the anterior vertebral body, and whenever you
`have to take down the annulus at an oblique angle
`approaching from anywhere, posterior, posterolateral,
`there is risk.
` Q. Does it fit within the circumference, sir?
` A. It sits on the rim.
` Q. It's on the rim. It's not protruding.
` A. One corner is very close.
` Q. Very close but not protruding?
` A. Very close.
` MR. SCHWARTZ: Thank you, sir.
` Why don't we take a short break so we
` can make copies of this picture.
` MR. AMON: Why don't we keep
` going?
` MR. SCHWARTZ: Why don't we take
` a short break to make copies of this
` picture.
` (Whereupon, there was a pause in
` the proceedings.)
` MR. SCHWARTZ: This is MSD 1032,
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`240
` sir, I've handed you again just. So
` we're clear, MSD 1032. Counsel, your
` copy.
` MR. AMON: Thank you. And we
` should mark this second one MSD 1053?
` (MSD Exhibit 1053, diagram,
` marked for identification, this date.)
`EXAMINATION BY MR. SCHWARTZ:
` Q. The second one, sir, as we talked about is
`the implant that was sitting on the ground. And now
`I'm going to hand you what's going to be marked as
`MSD 1054.
` (MSD Exhibit 1054, diagram,
` marked for identification, this date.)
` Q. On MSD 1054, you see that implant, at
`least in your report, was slightly greater than
`40 millimeters, is within the translateral width of
`the implant but just barely so, right?
` A. By this drawing, which we have no proper
`delineation of size, as the illustration, yes.
` Q. Okay. And it's fair to say, referring
`back to Zhou, which you have in front of you, that
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