`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDICS, INC.
`Patent Owner
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2013-00206
`Patent 8,251,997
`
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S RESPONSE TO THE MOTION FOR OBSERVATION REGARDING
`CROSS-EXAMINATION OF DR. BRANTIGAN
`
`
`
`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
`
`Response to the Introduction
`
`This paper responds to Patent Owner’s motion for observation regarding cross-
`
`examination of Dr. Brantigan, filed Apr. 22, 2014. Patent Owner states in an introductory
`
`paragraph that it filed its observations about “Dr. Brantigan’s prior sworn testimony” “[i]n lieu
`
`of taking additional depositions.” However, Petitioner made Dr. Brantigan, and declarants
`
`Mr. Miles, Dr. McAfee, and Dr. Jacobson, available to Patent Owner for deposition. It was
`
`Patent Owner’s choice to comment on Dr. Brantigan’s prior testimony and to forgo a
`
`deposition in which Dr. Brantigan could explain that the supposed inconsistencies do not
`
`exist. Petitioner disagrees with Patent Owner’s characterization of Dr. Brantigan’s prior
`
`testimony as explained below.
`
`Response to Observation Nos. 1-3
`
`In Observation Nos. 1-3, Patent Owner discusses Dr. Brantigan’s prior testimony
`
`concerning Figures 10 and 11 of his ‘327 patent. This testimony and Dr. Sach’s
`
`mischaracterization of it, were addressed by Dr. Brantigan in his declaration at paragraphs
`
`15-17. There, as in his prior testimony, Dr. Brantigan explains that Figure 10 shows two
`
`implants inserted using two different approaches at two different levels of the spine and that
`
`Figure 11 shows the lower level implant of the two implants in Figure 10.
`
`While Patentee makes much of Dr. Brantigan’s candid testimony that some small
`
`aspects of these figures are not accurately drawn, Dr. Brantigan never wavered from his
`
`position that the top part of Figure 10 shows an implant inserted using a direct lateral
`
`2
`
`
`
`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
`approach. Dr. Brantigan has also been consistent in explaining that Figure 11 is not an
`
`illustration of the upper level of Figure 10, but rather Figure 11 shows the lower level of
`
`Figure 10 where the implant is inserted using an anterior approach. See Ex. 1041, page
`
`1514, lines 16-19, page 1515, lines 10-12, 19-23 (“A. THAT SHOWS TWO
`
`ILLUSTRATIONS. THE LEVEL AT THE TOP WAS INSERTED LATERALLY, AND THE ‘Z’
`
`SHAPE SHOWS A DIFFERENT WAY OF PUTTING IT IN.”). Dr. Brantigan’s testimony
`
`under cross examination at trial is entirely consistent with Dr. Brantigan’s statements in his
`
`declaration. Ex. 1031, ¶¶ 15-17. Patent Owner was afforded an additional opportunity to
`
`cross-examine Dr. Brantigan on these points, but chose not to, perhaps because the
`
`element numbering on Figures 10-11, as explained in paragraph 16 of Dr. Brantigan’s
`
`declaration, is so clearly consistent with his testimony.
`
`Response to Observation Nos. 4-6
`
`In Observation Nos. 4-6, Patent Owner references prior testimony by Dr. Brantigan
`
`discussing implant sizing with respect to the patient’s vertebral end plates. There is no
`
`contradiction with the declaration testimony of either Dr. Brantigan or Dr. McAfee. For
`
`example, in Exhibit 1041 at page 1495 lines 2-7, Dr. Brantigan testifies (with emphasis
`
`added):
`
`Q. AND IS THE LENGTH OF YOUR IMPLANT IN YOUR '327
`PATENT GREATER THAN HALF OF THE MEDIAL-LATERAL
`OR SIDE TO SIDE WIDTH OF THE VERTEBRA?
`
`3
`
`
`
`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
`A. WE TEACH THEM IT SHOULD BE SUBSTANTIAL OF THE
`ENTIRE LENGTH OF THE VERTEBRAE, YES.
`
`Similarly, in Exhibit 1041 at page 1483 lines 8-21 Dr. Brantigan elaborates on this point
`
`(with emphasis added):
`
`Q. HERE IT REFERENCES MEDIAL-LATERAL AND
`ANTERIOR-POSTERIOR DIMENSION AND SAME RATIO AS
`NORMAL VERTEBRAL BODIES; WHAT DOES THAT MEAN?
`A. THAT MEANS WHAT WE JUST TALKED ABOUT; THESE
`SHOULD SUBSTANTIALLY FILL THE ENTIRE DISC SPACE.
`THEY ARE SIZED AND SHAPED TO MATCH THE DISC
`SPACE. AS WE SAID, DIMENSION 28 TO 42 BY 42 MATCH
`THE NORMAL RATIO OF THE DEPTH TO THE WIDTH OF
`THE NORMAL VERTEBRAL BODIES.
`Q. THIS PORTION HERE THAT THE OPPOSING END
`FACES THE ADJOINING VERTEBRA -- I'M SORRY. THE
`RINGS ARE BOTTOMED ON THE OPPOSING END FACE OF
`THE ADJOINING VERTEBRA; WHAT IS THAT REFERRING
`TO?
`A. THAT MEANS THEY ARE VERY TIGHTLY FIT WITHIN
`THE DISC SPACE TO ACHIEVE STRONG AND SNUG
`FIXATION.
`Dr. Brantigan also testified that “[t]he bone of the end plate is very strong” (Ex. 1041,
`
`1495:20-25) and affirmed numerous times that the implants of his ‘327 patent are sized to
`
`sit on and bite into the end plates. See Ex. 1041, 1465:20-23, 1483: 2-21, 1491:3-4,
`
`4
`
`
`
`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
`1492:9-15, 1495:20-25, 1548:7-11. The difficulty, which Patent Owner attempts to portray
`
`as inconsistent testimony, is that there is no anatomic demarcation of the boundary between
`
`the vertebral end plate and apophyseal ring. This is particularly true in patients suffering
`
`from degenerative disk disease. See Ex. 1029 at ¶ 3. As such, Dr. Brantigan points out in
`
`his declaration exactly how his ‘327 patent describes the disclosed implants: that his
`
`implants are “generally shaped and sized to conform with the disc space between adjoining
`
`vertebrae in a vertebral column”; and that they “are bottomed on the hard bone faces or end
`
`plates of adjacent vertebrae and are generally oval shaped to conform with the general
`
`outline perimeter of the vertebrae.” Ex. 1031 at ¶ 21. All of this testimony is relevant
`
`because it is consistent with Dr. Brantigan’s testimony in his declaration and the disclosure
`
`of the ’327 patent. See Ex. 1031, ¶ 21. It is also consistent with Dr. McAfee’s testimony in
`
`his declaration that “the endplate is confluent with the apophyseal ring.” See Ex. 1029, ¶¶
`
`3, 73.
`
`Response to Observation No. 7
`
`In Observation No. 7, Patent Owner identifies Dr. Brantigan prior testimony regarding
`
`capillary growth. In Exhibit 1041 at page 1521 line 21 and page 1522, line 9, Dr. Brantigan
`
`twice tells counsel for Warsaw, who is conducting cross-examination, that he is
`
`mischaracterizing human anatomy. In Exhibit 1041 on page 1519, line 20 to page 1522,
`
`line 9, Dr. Brantigan attempts to explain capillary growth with respect to the ‘327 patent in
`
`greater detail to Warsaw’s counsel. Having been precluded by Warsaw’s counsel from
`
`5
`
`
`
`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
`explaining his position, counsel for NuVasive allowed Dr. Brantigan to provide that
`
`explanation on re-direct examination: “Q. I'LL DIRECT YOUR ATTENTION TO COLUMN
`
`FIVE, LINE 24 TO 29. WHAT HAPPENS WHEN THE RIDGES OF YOUR IMPLANT BITE
`
`INTO THE HARD END PLATE? A. THEY PENETRATE THE HARD END PLATE, AND
`
`THEY ARE EXPOSED TO THE CAPILLARIES OF THE BONE.” Ex. 1041 at 1548, lines 3-
`
`11.
`
`Once again, when read in its entirety, Dr. Brantigan’s trial testimony is entirely
`
`consistent with his declaration testimony. See Ex. 1031, ¶¶ 19, 20. This testimony is also
`
`relevant because it is also consistent with Dr. McAfee’s declaration testimony. See Ex.
`
`1029, ¶ 73.
`
`
`
`
`
`
`
`
`Date: May 9, 2014
`
`
`Customer Number 26171
`Fish & Richardson P.C.
`Telephone: (612) 337-2508
`Facsimile: (612) 288-9696
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
` /Stephen R. Schaefer, Reg. No. 37,927/
`Stephen R. Schaefer
`Reg. No. 37,927
`
`
`
`6
`
`
`
`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies that on
`
`May 9, 2014, a complete and entire copy of this PETITIONER’S RESPONSE TO THE
`MOTION FOR OBSERVATION REGARDING CROSS-EXAMINATION OF DR.
`BRANTIGAN was provided via email to the Patent Owner by serving the correspondence
`email addresses of record as follows:
`
`Thomas H. Martin
`Wesley C. Meinerding
`Martin & Ferraro, LLP
`1557 Lake O’Pines Street, NE
`Hartville, OH 44632
`
`Email: tmartin@martinferraro.com
`Email: docketing@martinferraro.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Diana Bradley/
`
`Diana Bradley
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(858) 678-5667
`
`
`
`
`
`
`
`7
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
