UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MEDTRONIC, INC.
`Petitioner
`
`v.
`
`NUVASIVE, INC.
`Patent Owner
`
`
`Patent Number: 8,187,334 B2
`Issue Date: May 29, 2012
`
`
`Case No. IPR2013-00507
`
`______________________________________________________
`
`
`DECLARATION OF PATRICK MILES
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`
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`
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`
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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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`
`
`
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`1
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`NUVASIVE 2030
`Medtronic, Inc. v. NuVasive, Inc.
`IPR2013-00507
`
`NUVASIVE - EXHIBIT 2052
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`

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`patents assigned to NuVasive, many of which are related to NuVasive’s XLIF solution,
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`including lateral surgical method and systems.
`l have witnessed or studied hundreds of
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`spinal fusion procedures using the CoRoent XL interbody implants and other interbody
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`fusion implants, and I understand the design constraints and difficulties associated with
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`developing a new interbody fusion implant, especially one particularly suited for lateral,
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`trans-psoas lumbar surgeries.
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`I submit this declaration in support of NuVasive’s Patent Owner Response to
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`the inter partes review related to US. Patent No. 8,187,334 (“the ’334 patent”).
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`My testimony is based on my education and experience in the spinal
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`orthopedics field, including my work experience at Sofamor Danek from 1996 to 1999 and at
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`NuVasive from 2001 to present, my in depth experience with NuVasive’s XLIF solution and
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`the competitive landscape, and my personal knowledge and involvement in certain events.
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`The development of the XLIF solution at NuVasive began in 2001. The XLIF
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`systems and procedure were initially released at the North American Spine Society Annual
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`Meeting in late 2003. Our commercialization efforts continued after the 2003 NASS meeting
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`into 2004. The CoRoent XL family of interbody implants, used in XLIF procedures and
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`inserted into the spine from a direct lateral, retroperitoneal, transpsoas approach to the
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`lumbar spine, was commercially launched at NASS in 2004. The CoRoent XL implants
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`were the first commercially available lumbar interbody implants having a length greater than
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`40mm, a maximum width of 18mm, and designed for insertion for a direct lateral,
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`transpsoas approach to the lumbar spine.
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`Initially, NuVasive’s XLIF solution was met with substantial skepticism within
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`the spinal orthopedics community, including concern over the size of our implants. During
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`those early years, we put substantial resources into training the spinal community to
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`overcome that skepticism and show the spinal community that the XLIF solution was indeed
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`a safe and effective solution for spinal fusion especially in the lower lumbar region. We
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`have continued to improve the XLIF solution, specifically expanding its usability to treat a
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`wider array of spinal issues. Eventually, NuVasive’s success led to competitors in the
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`marketplace, the first of those being Medtronic Sofamor Danek with its “DLIF” surgical
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`technique and its Clydesdale lateral implants in the 2006/2007 timeframe—years after
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`NuVasive pioneered the market for lateral, trans-psoas interbody fusion surgeries with the
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`CoRoent XL implant. NuVasive currently has a patent infringement lawsuit pending in US.
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`District Court against Medtronic, accusing its DLIF system, including its Clydesdale
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`implants, of infringing NuVasive patents. Additional competitors have also entered the
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`market with lateral fusion solutions that incorporate many of the important innovations
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`developed by NuVasive. Those other companies include, among others, Globus Medical,
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`Inc. with its Lateral Lumbar lnterbody Fusion (“LLIF”) solution and transcontinental interbody
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`implants introduced in the 2010 timeframe. See id. NuVasive also has a patent
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`See Appendix A, p. 8.
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`See Appendix A, p. 7. The above information from Petitioner Medtronic confirms my
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`understanding that NuVasive pioneered the market for lateral, trans-psoas interbody fusion
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`surgeries with the CoRoent XL implant and that NuVasive was dominant participant in this
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`market for such lateral, trans-psoas interbody fusion implants for at least years 2004-2008.
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`See Appendix A, p. 7. Moreover, since 2008, based upon my knowledge and experience in
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`product marketing and development for spine surgery, I believe that in all of the years since
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`NuVasive pioneered the market for lateral, trans-psoas interbody fusion surgeries with the
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`CoRoent XL implant (2004 through 2013), NuVasive was, and continues to be, the
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`dominant participant in this market for such lateral, trans-psoas interbody fusion implants.
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`See also Appendix A, p. 17 (showing that Petitioner Medtronic’s projections for years 2009-
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`2013 correctly predicted that NuVasive’s CoRoent XL implant for NuVasive’s XLlF solution
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`would continue to be the market leader for interbody revenue).
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`Additionally, the above information above information from Petitioner
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`Medtronic confirms the fact that the “lnterbody Revenue” for NuVasive’s CoRoent XL
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`implant for NuVasive’s XLlF solution accelerated rapidly (refer to p. 7 of Appendix A). For
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`example, after NuVasive pioneered the market for lateral, trans-psoas interbody fusion
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`surgeries with the CoRoent XL implant, NuVasive’s revenues associated with CoRoent XL
`
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`implants in 2006 was more than 295% greater than those from 2005 (the first full year of
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`sales).
`In another example, NuVasive’s revenues associated with CoRoent XL implants in
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`2007 was more than 302% greater than those from 2006. Or, taking a longer view of the
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`growth in revenue associated with CoRoent XL implants, NuVasive’s revenues associated
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`with CoRoent XL implants in 2013 was more than 3,900% greater than those from 2005.
`In
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`sum, in the years since NuVasive pioneered the market for lateral, trans-psoas interbody
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`fusion surgeries with the CoRoent XL implant, the total CoRoent XL implant revenues from
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`2005 through 2013 totaled hundreds of millions of dollars, which (based upon my
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`knowledge and experience in product marketing and development for spine surgery) is
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`considered to be a tremendous commercial success and which I believe to be greater than
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`any other competitor lateral, trans-psoas interbody implant in this market (e.g., Medtronic
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`Clydesdale implant, Globus Transcontinental implant, and others).
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`11.
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`I hereby declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true; and
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`further that these statements were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of
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`the Title 18 of the United States Code and that such willful false statements may jeopardize
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`the validity of the application or any patents issued thereon.
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`Dated: May 21, 2014 ~-By:
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`Patrick Miles
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`DLiF is for every surgeon.
`Not new - been around for sometime'
`Minimally Invasive but Powerful
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`Access option from T6 to L5!
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`Pull through power (NIM , fixation , bio ... )
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`Vital opportunity for representative differentiation
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`High growth market!
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`New MedEd Strategy Implemented
`NIM & Patient Positioning incorporated
`Clydesdale Downclass
`Sales Trainings
`Regional Sales Meetings
`Advanced DLiF Trainings held regionally
`New Tech Rep focus product
`NIM rep alignment
`Captured -18% of market share since launch
`High Def Animation available
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`1 I Dnve 40% of sales force to sell Clydesdale by end of FY11
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`capStone
`PEEK Rods
`sextant
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`2 Perform 30,000 DLiF levels by end of FY12
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`abcc¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ñúDEFGHHIFd Ke
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`Recommendations
`1. DLiF Dilators are in the pathway
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`2. Immediate Focus on Navigated Dilators, Lateral Plate, NEMO, and Next
`Gen Implant
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`Key Question: How to get projects too small to even be considered a project
`(e.g. Long Throw Extender, Longer Knife, 40mm Clydesdale) across?
`
`3. How fast can we push things dangling at the finish line across? [Longer
`knife/bipolar, 40mm Clydesdale, "MAST Deformity" OR Long Throw
`Extender, Clydesdale Bone]
`
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`Develop best In class sales and surgeon training outlets
`along the entire learning curve CONTINUUM
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`T"T1Ing
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`Marketing Budget
`(S)
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`Create AWARE.NE.SS ollhe Medtromc DLiF offering and
`the strength 01 the complete solution
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`TU11Ing
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