IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re Patent of: Barry
`U.S. Patent No.: 7,670,358
`Issue Date: March 2, 2010
`Appl. Ser. No.: 11/027,026
`Filing Date: December 30, 2004
`Title:
`SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN
`THE AMELIORATION OF ABERRANT SPINAL COLUMN
`DEVIATION CONDITIONS
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`
`
`Attorney Docket No.: 108136.00038
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`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`DECLARATION OF DAVID POLEY REGARDING
`THORACIC PEDICLE SCREWS FOR IDIOPATHIC SCOLIOSIS VIDEO
`AND FREE HAND THORACIC SCREW PLACEMENT AND CLINICAL
`USE IN SCOLIOSIS AND KYPHOSIS SURGERY SLIDE PRESENTATION
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`
`1
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`Medtronic, Inc. MSD 1023
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`

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`1. My name is David Poley. I began working at Sofamor
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`Danek/Medtronic in 1997/1998 as Vice President, Marketing. In 2003, as Vice
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`President, Clinical and Strategic Development, my responsibilities included
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`advancing clinical research, evidence development and medical education.
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`2.
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`In 2003, I was responsible for organizing the Spinal Deformity Study
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`Group (SDSG) meetings, including an SDSG Scottsdale Meeting held at the
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`Sanctuary on Camelback Mountain in Scottsdale, Arizona, on April 10-13, 2003.
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`The SDSG is a multicenter group studying clinical outcomes in pediatric scoliosis
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`and related deformities, adult spinal deformities, and spondylolisthesis. The
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`members of this group, and other surgeons, attend and provide instruction at these
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`meetings. As with all SDSG meetings I was involved with, a binder containing
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`material related to the subject matter of the various presentations taking place at
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`the meeting was prepared for that meeting and distributed to all attendees without
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`restriction or obligation of confidentiality. A listing of the attendees at the April
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`2003 meeting in Scottsdale, Arizona, is shown on the agenda, a true and correct
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`copy of which is attached hereto as Appendix A. At least about 20 surgeons
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`attended this meeting and received these handouts.
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`3.
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`I understand that the Thoracic Pedicle Screws for Idiopathic Scoliosis
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`Video (the “Video”), having a copyright date of 2001, has been submitted as
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`Exhibit MSD 1002 in the above-referenced Inter Partes Review proceeding. I
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`2
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`have kept binders from all of the SDSG meetings I attended, including the April
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`2003 meeting in Scottsdale, Arizona, in a cabinet at the Medtronic facility in
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`Memphis, TN. True and correct copies of photographs of the binder from the
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`April 2003 meeting in Scottsdale, AZ, are attached hereto as Appendix B. As
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`shown in the photographs, the binder included, in an inside pocket, a CD
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`containing the Video.
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`4.
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`Although I am an employee of the Petitioner, no part of my
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`compensation is dependent on the outcome of this proceeding, and I have no other
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`interest in this proceeding.
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`5.
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`I hereby declare that all statements made herein of my own
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`knowledge are true and that all statements made on information and belief are
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`believed to be true; and further that these statements were made with the
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`knowledge that willful false statements and the like so made are punishable by fine
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`or imprisonment, or both, under Section 1001 of the Title 18 of the United States
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`Code.
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`Dated: November 16, 2015
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`By:
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`David W. Poley
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`3
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`

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`
`
`Appendices to Poley Declaration
`
`APPENDIX A: List of the participants at Spinal Deformity Study Group
`Scottsdale Meeting held at the Sanctuary on Camelback Mountain
`in Scottsdale, Arizona, on April 10-13, 2003
`
`
`APPENDIX B: Photographs of the binder prepared for the Spinal Deformity
`Study Group Scottsdale Meeting held at the Sanctuary on
`Camelback Mountain in Scottsdale, Arizona, on April 10-13,
`2003
`
`
`
`4
`
`

`
`APPENDIX A
`APPENDIX A
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`
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`
`5
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`

`
`SPINAL
`
`THE SANCTUARY - CAMELBACK MOUNTAIN
`
`- DEFORMITY
`STUDY GROUP:
`
`SCOTTSDALE, AZ
`APRIL 10-13, 2003
`
`POOLSIDE
`
`UPPER GARDEN
`
`VIEWS
`BALLROOM
`
`THURSDAY, APRIL 10TH
`
`Arrival / Check-in
`
`Welcome reception
`
`Adjourn
`
`FRIDAY, APRIL 11TH
`
`Continental breakfast
`
`Welcome by Co-Chairs - Betz, Bridwell, Lenke
`
`Study Group Operational Update
`
`Study Group Abstract/Publication Summary and Status - Betz
`
`Breakout into Study Group Working Sections (see page 2)
`- Adult Deformity Section -— (Four Peaks Room)
`-
`Pediatric and Adolescent Scoliosis Section -— Ongoing Studies
`(Views Ballroom)
`Objectives:
`- Update Ongoing Studies
`-
`Present and Discuss Abstracts and Publications
`
`- Review and Develop New Study Proposals
`- Note: Study Group Section Assignments are for the working
`breakout sessions only. All surgeons are encouraged to participate
`in any/all study projects within their interest
`
`Break
`
`VIEWS TERRACE
`
`Continued Breakout into Study Group Working Sections
`
`11:00 a.m.
`
`Spine Surgery Simulator ( S3 ) — Carl Eric Aubin, Hubert Labelle
`
`VIEWS
`BALLROOM
`
`Center of Gravity and Force/Pressure Plate Pilot Clinical Studies
`— Frank Schwab, Pierre Roussouly
`
`Lunch / Recreation — Lunch buffet in Upper Garden.
`Breezeway to bus transport.)
`
`(Golfers pick-up box lunch in Lobby
`
`6
`
`

`
`Frida A ril 11"‘ - Stud Groun Section Breakout Assi - nments 8:00-11:00 am
`
`SPINAL DEFORMITY STUDY GROUP
`
`Attending:
`Sigurd Berven
`Fabien Bitan
`Keith Bridwell
`Cour-may Brown
`Ed Dawson
`Chris Dewaid
`John Dimar
`
`Darrell Hanson
`Chris Hamill
`Noriaki Kawakami
`11m Kuklo (1/2)
`Torn Lowe
`Steve Mardjetco
`Michael Neuwirth
`Stephen Ondra
`Pierre Roussouly
`Frank Schwab
`
`Se-II Suk
`Ensor Transfeldt
`
`Mark Weidenbaum
`
`Absent:
`
`Daniel Chopin
`Jean Dubousset
`
`Jean-Pierre Fatty
`Steve Glassman
`
`William Horton
`77m Hresko
`
`John Kostui/r
`
`Jim Ogilvie
`
`20 attendees
`
`LOCATION: VIEWS BALLROOM
`
`Surgeon Name
`
`Attending:
`Randy Belz
`John Braun
`
`Mohammad Diab
`John Dormans
`
`John Emans
`Kamal Ibrahim
`
`Charles Johnston
`
`Andy King
`‘Fm Kuklo (1/2)
`Hubert Labelle
`
`Larry Lenke
`John Lubicky
`Rick McCarthy
`Sergio Mendoza
`Andrew Merola
`
`Randy Puno
`Steve Richards
`
`Michael Vitale
`John Sanivark
`Dan Sucato
`
`Absent:
`
`Denis Drummond
`Serena Hu
`
`Peter Newton
`
`George Picettf
`David Raye
`Jim Sanders
`
`Paul Sponseller
`Jefi"rey flramson
`Stuart Weinstein
`
`new
`Agenda:
`— Prospective Study Update
`(30)
`—Bridwe||,
`— Revised Adult Outcomes
`Radike, PhDx
`Survey Forms (15)
`- Pre to Post Op Validation of <--Bridwell,
`SRS 22 vs. 30 (15)
`Bervin,
`Haffast
`
`-Bridwell,
`Radike
`
`— Radiographic / Outcomes
`Correlation Study (15)
`— Adult Radiographic
`Measurement Manual (15)
`- Adult Deformity X-Ray
`Positioning Study (15)
`- Prospective TPN Study (15)
`— Degenerative Scoliosis
`Prospective Study (15)
`— Center of Gravity and Force
`Plate Clinical Studies (30)
`
`Adult Radiographic
`Classification Study (15)
`- Future other studies
`
`-BEWETL
`(G|assrnan)
`-O'Brien:
`Kuklo, Hamill
`-~B|‘0W|1.
`(HOITON)
`-B|‘idWe"
`-~Be|'VEn
`
`—Schwab,
`Roussouly,
`Berthonaud
`--Schwab
`
`Section: Pediatric and
`Adolescent Scoliosis
`
`Section — Ongoing Studies
`
`Agenda:
`AIS Retrospective Study
`Update (30)
`PPSS Prospective Study
`Update (30)
`PPSS Database and
`
`Outcomes Surveys (30)
`Body and Spinal Physical
`Appearance Eva|uation(15)
`Radiographic Measurement
`Manuals (30)
`Digital Radiographic
`Measurement Software
`
`Development, Studies and
`Abstracts (45)
`
`— O'Brien
`
`-— Lenke
`
`— Richards,
`PhDx
`
`- Polly,
`(Sanders)
`- O'Brien
`
`- Kuklo,
`Schroeder,
`Trotter,
`Nycz
`
`7
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`

`
`SATURDAY, APRIL 12"’
`
`Continental breakfast
`
`UPPER GARDEN
`
`SPINAL DEFORMITY STUDY GROUP
`
`Breakout into Study Group Working Sections (see page 4)
`-
`Spondylolisthesis Section — (Four Peaks Room)
`-
`Pediatric Scoliosis Section — New Study Proposals
`(Views Ballroom)
`Objectives:
`- Update Ongoing Studies
`-
`Present and Discuss Abstracts and Publications
`
`- Review and Develop New Study Proposals
`- Note: Study Group Section Assignments are for the working
`breakout sessions only. All surgeons are encouraged to participate
`in any/all study projects within their interest
`
`10:15 am
`
`Break
`
`10:30 am
`
`Adult Deformity Section Report
`
`— Bridwell
`
`11:00 am
`
`Pediatric and Adolescent Scoliosis Section Report — Lenke
`
`11:30 am
`
`Spondylolisthesis Section Report - Labelle
`
`12:00 am
`
`Summary, Future Plans — Belz
`
`VIEWS TERRACE
`
`VIEWS
`BALLROOM
`
`12:30 am
`
`Lunch I Recreation — Lunch buffet in Upper Garden.
`Breezeway to bus transport.)
`
`(Golfers pick-up box lunch in Lobby
`
`Group Dinner
`
`SUNSET PATIO
`
`SUNDAY, APRIL 13"‘
`
`Morning Departures
`
`8
`
`

`
`Saturday, April 12”‘ - Study Group Section Breakout Assignments (7:30-10:15 am)
`
`SPINAL DEFORMITY STUDY GROUP
`
`Section: Spondylolisthesis - Leaders
`
`LOCATION: FOUR PEAKS ROOM
`
`Surgeon Name
`
`Attending:
`Sigurd Berven
`Fabien Bitan
`
`Keith Bridwell
`
`Courtney Brown
`Ed Dawson
`Chris DeWa|d
`
`John Dimar
`Darrell Hanson
`
`Chris Hamill
`Noriaki Kawakami
`
`Hubert Labelle
`
`Steve Mardjetco
`Stephen Ondra
`Pierre Roussouly
`Frank Schwab
`Se-II Suk
`
`Ensor Transfeldt
`Mark Weidenbaum
`
`Absent:
`
`Daniel Chopin
`Jean Dubousset
`
`Jean—Pierre Farcy
`Steve Giassman
`
`William Horton
`77m Hresko
`
`John Kostvik
`Michael Neuwirth
`
`Jim Ogi/vie
`
`18 attendees
`
`Agenda:
`— Retrospective Pilot A, B and —Labe||e
`Normal Study Update (15)
`-Labelle,
`- Prospective Study A and B
`Berven
`Protocol Update (30)
`— Prospective Study PhDx
`Outcomes Surveys (30)
`— Spondylolisthesis Physical
`Appearance Assessment
`(15)
`— Manual Spondylolisthesis
`Measurements Study (15)
`— Isthmic Spondylolisthesis
`Treatment Options Study
`(15)
`— Pilot Study publications
`preparation (30)
`— Future/other studies (15)
`
`—Labe||e,
`PhDx/Haye
`—weidenbaum
`
`-Berven,
`O'Brien
`-Berven
`
`-Labelle
`
`-—Roussou|y
`
`wcmo~= news mi
`
`Surgeon Name
`
`I Attending:
`Randy Betz
`Fabian Bitan
`
`John Braun
`
`Keith Bridwell
`Mohammad Diab
`John Dormans
`
`John Emans
`Kamal Ibrahim
`
`Charles Johnston
`
`Andy King
`'l'Imothy Kuklo
`Larry Lenke
`Tom Lowe
`
`John Lubicky
`Rick McCarthy
`Sergio Mendoza
`Andrew Merola
`
`David Polly
`Randy Puno
`Steve Richards
`
`John Sanrvark
`Dan Sucato
`
`Mike Vitale
`
`Absent:
`Denis Drummond
`Serena Hu
`Peter Newton
`
`George Picetti
`David Raye
`Jim Sanders
`
`Paul Sponseller
`Jeffiey Thomson
`5 Weinstein
`
`Section: Pediatric
`Scoliosis - New Studies
`
`Agenda:
`— Infantile and Juvenile
`
`Idiopathic Study (30)
`— Anterior Endoscopic
`Correction Study (30)
`- Fusionless AIS Correction
`
`— Johnston
`
`—— Sucato
`
`— Betz, Braun
`
`Concepts (30)
`- Functional Evaluation of
`
`— Bitan
`
`Mobile Lumbar Segment
`after Fusion for Thoracic
`
`Scoliosis (30)
`— Prospective Bracing Study
`(15)
`— Orthoscan Pilot Study (15)
`— Future/other studies (15)
`
`— Mendoza
`
`— Lenke, Betz
`— tbd
`
`9
`
`

`
`10
`
`SPINAL DEFORMITY STUDY GROUP
`
`10
`
`

`
`11
`
`APPENDIX B
`APPENDIX B
`
`
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`11
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`

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`
`
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`
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