UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`
`Petitioner
`
`v.
`
`LORI FERRELL, CPA, CGMA
`
`DECLARATION OF
`
`WARSAW ORTHOPEDIC, INC.
`
`Patent Owner
`
`Patent Number: 8,444,696
`
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT
`
`HAVING ANATOMIC BEARING SURFACES
`
`Case IPR2013-OO395
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`US. Patent and Trademark Office
`PO. Box I450
`
`Alexandria, VA 223 l 3- 1450
`
`EXHIBIT
`EVARSA‘WZUN
`
`IPRZfllS—OUSS'S
`
`NuVasive, Inc. v.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`
`Petitioner
`
`v.
`
`LORI FERRELL, CPA, CGMA
`
`DECLARATION OF
`
`WARSAW ORTHOPEDIC, INC.
`
`Patent Owner
`
`Patent Number: 8,444,696
`
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT
`
`HAVING ANATOMIC BEARING SURFACES
`
`Case IPR2013-OO395
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`US. Patent and Trademark Office
`PO. Box I450
`
`Alexandria, VA 223 l 3- 1450
`
`EXHIBIT
`EVARSA‘WZUN
`
`IPRZfllS—OUSS'S
`
`NuVasive, Inc. v.
`
`
`
`I,M ofW hereby declare and
`
`state as follows:
`
`INTRODUCTION
`
`1. My name is Lori Ferrell, CPA, CGMA.
`
`2.
`
`I currently work in the Finance Department at Medtronic, Spinal
`
`and Biologics. I have worked for Medtronic in the Finance Department since 2007.
`
`Prior to 2007, I worked as SAP Manager for 14 years in the Bryce Corporation. I
`
`am a Certified Public Accountant and a Chartered Global Management Accountant
`
`as designated by the American Institute of Certified Public Accountants.
`
`3. My present capacity is as Financial Consultant in the Finance
`
`Department. Pursuant to this role, I have access to current and historic sales data
`
`for selected Medtronic Spinal and Biologics products, including the Clydesdale®
`
`Spinal System Implants.
`
`4.
`
`I was asked to provide total sales of Clydesdale® Spinal System Implants
`
`as identified in the attached brochure (Appendix A) since inception of the product.
`
`5. Total sales of the Clydesdale® Spinal System Implants from inception to
`
`present are at least $80 million.
`
`6. Total sales of the Clydesdale® Spinal System Implants for Fiscal Year
`
`2013 were at least $15 million.
`
`7.
`
`I declare that all statements made herein of my own knowledge are true
`
`
`
`And that all statements made on information and belief are believed to be true; and
`
`further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code.
`
`DATED: April 10, 2014
`
`By: W
`
`
`
`APPENDIX A
`
`
`
`CLYDESDALE®
`Product Information
`
`Spinal System
`
`The CLYDESDALE® Spinal System is used for
`patients diagnosed with degenerative disc
`disease (DDD) at one or two contiguous
`levels from L2 to S1. These DDD patients may
`also have up to Grade I spondylolisthesis
`or retrolisthesis at the involved levels.
`DDD is defined as discogenic back pain
`with degeneration of the disc confirmed
`by history and radiographic studies. These
`patients should be skeletally mature and
`have had six months of non-operative
`treatment. These implants may be implanted
`via a minimally invasive lateral approach.
`
`The CLYDESDALE® Spinal System is designed
`to be used with autogenous bone graft to
`facilitate interbody fusion and is intended
`for use with supplemental fixation systems
`cleared for use in the lumbar spine.
`
`
`
`CLYDESDALE® Spinal System | Product InformatIon
`
`Product Features
`
` » Bullet-nose design aids distraction
`during insertion
`
` » Convex shape for anatomical fit with
`patient anatomy
`
` » Larger surface area allows for greater
`contact with bone**
`
` » Angular teeth to grip end plates for
`expulsion resistance
`
` » Tantalum markers allow radiographic visualization
`for placement verification
`
` » 6 degree lordosis (non-lordotic implant available)
`
` » 40mm, 45mm, 50mm, 55mm, and 60mm lengths*
`
` » There are some risks associated with minimally
`invasive spine surgery, including transitioning
`to a conventional open procedure, neurological
`damage, damage to the surrounding soft tissue,
`and, where used, instrument malfunction. Other
`risks associated with implants used include device
`migration, loss of spinal curvature, correction,
`height, and/or reduction.
`
`* 60mm length only available in the lordotic design.
`
` ** Compared to CAPSTONE™ Spinal System.
` *** Height measurements do not include angular teeth,
`which add a total of 1mm to implant height.
`
`Implant Dimensions and
`Radiographic Marker Locations
`
`Angled View
`
`Lateral View (Lordotic)
`
`Anterior Height = X***
`
`Posterior Height = X - 2mm***
`
`X = listed height of implant
`
`Axial View
`
`8mm
`
`3.5mm
`
`9mm
`
`18mm
`
`AP View
`
`5mm
`
`½ Length
`Length (40, 45, 50, 55, 60mm)*
`
`Height
`(8, 10, 12,
`14, 16mm)***
`
`
`
`CLYDESDALE® Spinal System | Product InformatIon
`
`Graft Volume and Surface Area
`
`Height × Length
`
`Graft Volume* (cc)
`
`6 degree
`
`0 degree
`
`8mm × 40mm
`10mm × 40mm
`12mm × 40mm
`14mm × 40mm
`16mm × 40mm
`
`8mm × 45mm
`10mm × 45mm
`12mm × 45mm
`14mm × 45mm
`16mm × 45mm
`
`8mm × 50mm
`10mm × 50mm
`12mm × 50mm
`14mm × 50mm
`16mm × 50mm
`
`8mm × 55mm
`10mm × 55mm
`12mm × 55mm
`14mm × 55mm
`16mm × 55mm
`
`8mm × 60mm
`10mm × 60mm
`12mm × 60mm
`14mm × 60mm
`16mm × 60mm
`
`1.40
`1.80
`2.30
`2.80
`3.30
`
`1.70
`2.22
`2.64
`3.37
`3.95
`
`2.09
`2.61
`3.27
`3.99
`4.66
`
`2.36
`3.15
`3.82
`4.80
`5.55
`
`2.72
`3.48
`4.15
`5.23
`6.12
`
`1.60
`2.10
`2.60
`3.00
`3.50
`
`2.02
`2.59
`3.17
`3.75
`4.33
`
`2.37
`3.05
`3.74
`4.43
`5.12
`
`2.74
`3.51
`4.31
`5.11
`5.90
`
`—
`—
`—
`—
`—
`
`Set Ordering Information
`CLYDESDALE® Spinal System Implants
`
`Part Number Description
`6° CLYDESDALE® Spinal System
`(SPS02156)
`2968840
`2968845
`2968850
`2968855
`2968860
`2968040
`2968045
`2968050
`2968055
`2968060
`2968240
`2968245
`2968250
`
`8mm × 40mm
`8mm × 45mm
`8mm × 50mm
`8mm × 55mm
`8mm × 60mm
`10mm × 40mm
`10mm × 45mm
`10mm × 50mm
`10mm × 55mm
`10mm × 60mm
`12mm × 40mm
`12mm × 45mm
`12mm × 50mm
`
`Part Number Description
`6° CLYDESDALE® Spinal System
`continued
`2968255
`2968260
`2968440
`2968445
`2968450
`2968455
`2968460
`2968640
`2968645
`2968650
`2968655
`2968660
`
`12mm × 55mm
`12mm × 60mm
`14mm × 40mm
`14mm × 45mm
`14mm × 50mm
`14mm × 55mm
`14mm × 60mm
`16mm × 40mm
`16mm × 45mm
`16mm × 50mm
`16mm × 55mm
`16mm × 60mm
`
`Part Number Description
`0° CLYDESDALE® Spinal System
`(SPS02157)
`2969840
`2969845
`2969850
`2969855
`2969040
`2969045
`2969050
`2969055
`2969240
`2969245
`2969250
`2969255
`
`8mm × 40mm
`8mm × 45mm
`8mm × 50mm
`8mm × 55mm
`10mm × 40mm
`10mm × 45mm
`10mm × 50mm
`10mm × 55mm
`12mm × 40mm
`12mm × 45mm
`12mm × 50mm
`12mm × 55mm
`
`Part Number Description
`0° CLYDESDALE® Spinal System
`continued
`2969440
`2969445
`2969450
`2969455
`2969640
`2969645
`2969650
`2969655
`
`14mm × 40mm
`14mm × 45mm
`14mm × 50mm
`14mm × 55mm
`16mm × 40mm
`16mm × 45mm
`16mm × 50mm
`16mm × 55mm
`
`
`
`MLITCLYDESBR10 ©2010 Medtronic Sofamor Danek USA, Inc. All Rights Reserved. IRN10790-2.0-03/0810
`
`Please see the package insert for the
`complete list of indications, warnings,
`precautions, and other important medical
`information.
`
`Autograft must be used with the product.
`
`www.medtronic.com
`
`Medtronic
`Spinal and Biologics Business
`Worldwide Headquarters
`
`2600 Sofamor Danek Drive
`Memphis, TN 38132
`
`1800 Pyramid Place
`Memphis, TN 38132
`
`(901) 396-3133
`(800) 876-3133
`Customer Service: (800) 933-2635
`
`For more information visit
`www.myspinetools.com
`
`
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