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`EXHIBIT 10
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`TO THE DECLARATION OF BRIAN J. NISBET
`IN SUPPORT OF DEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OR, IN THE
`ALTERNATIVE, SUMMARY ADJUDICATION
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`

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`Electronic Acknowledgement Receipt
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`EFSID:
`
`Application Number:
`
`12929893
`
`95001888
`
`International Application Number:
`
`Confirmation Number:
`
`7222
`
`Title of Invention:
`
`SURGICAL ACCESS SYSTEM AND RELATED METHODS
`
`First Named Inventor/Applicant Name:
`
`7691057
`
`Customer Number:
`
`30328
`
`Filer:
`
`Stephen R. Schaefer/Leslie Smith
`
`Filer Authorized By:
`
`Stephen R. Schaefer
`
`Attorney Docket Number:
`
`20330.0002.RX057
`
`Receipt Date:
`
`Filing Date:
`
`TimeStamp:
`
`04-JUN-2012
`
`09-FEB-2012
`
`18:54:08
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`Application Type:
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`inter partes reexam
`
`Payment information:
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`Submitted with Payment
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`I no
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`File Listing:
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`Document
`Number
`
`Document Description
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`File Name
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`File Size( Bytes)/
`Message Digest
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`Multi
`Part /.zip
`
`Pages
`(ifappl.)
`
`1
`
`Oath or Declaration filed
`
`13958-0076RX1-Dec132-
`Youssef.pdf
`
`1594425
`
`87905ce9ee02284e2de4c6803cda69d 1 a93
`93227
`
`no
`
`9
`
`Warnings:
`
`Information:
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`Appx00356
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`

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`369008
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`2
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`13958-0076RX1-Reply.pdf
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`yes
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`End
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`Amendment/Req. Reconsideration-After Non-Final Reject
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`Applicant Arguments/Remarks Made in an Amendment
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`Claims
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`Reexam Certificate of Mailing
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`1
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
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`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
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`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 0), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
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`Appx00357
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`Attorney's Docket No.: 13958-0076RX1
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Patent No.: 7,691,057
`Inventor(s): Miles et al.
`Serial No.:
`10/759,811
`
`Control No. : 95/001,888
`Art Unit
`3993
`Examiner : Beverly Meindl Flanagan
`Conf. No. : 7222
`SURGICAL ACCESS SYSTEM AND RELATED METHODS
`
`Title
`
`Mail Stop "Inter Partes Reexam"
`Central Reexamination Unit
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-14 50
`
`DECLARATION OF DR. JIM YOUSSEF UNDER 37 C.P.R. 1.132
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`I, Dr. Jim Youssef of Durango, Colorado, declare that:
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`1. I am an orthopaedic surgeon board certified by the American Board of Orthopaedic Surgery
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`and fellowship trained in spine surgery. I received my medical degree from the University of
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`California in 1991. I performed my orthopaedic surgery residency at Dartmouth-Hitchcock
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`Medical Center in Lebanon, New Hampshire from 1992-1996. I was chief resident of
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`Orthopaedic surgery at the VA Medical Center in White River Junction, Vermont from 1995-
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`1996. Subsequently, I did my spine fellowship training at the University of California, Davis
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`Medical Center from 1996-1997. I have been a practicing spine surgeon for the last fifteen years.
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`2. Since 2000, I have been the Medical Director of Spine Service at the Mercy Regional
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`Medical Center in Durango, Colorado. I am the co-founder of Spine Colorado, a
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`multidisciplinary comprehensive center focused on spine care. There I have an active surgical
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`practice directed at the treatment of degenerative spine diseases and spinal injuries, which
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`includes, among other things, spine surgery to the cervical and thoracolumbar regions of the
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`spine. I have twice received Achievement Awards from the American Academy of Orthopaedic
`
`Surgeons. I am a founding member of the Society of Minimally Invasive Surgery, board member
`
`of the Society of Lateral Access Surgery ("SO LAS"), and the co-chair of the education
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`committee for this society. I am a member of the American Orthopaedic Association, a
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`leadership society in Orthopaedic surgery.
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`3. I have an active research department and I have participated not only in my own original
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`research, but in several clinical trials involving new technology. In addition, I founded a non-
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`Appx00358
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`profit organization focused on resources for medical collaboration. As a result of my academic
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`interests and publications, I have been invited to speak and participate in Grand Rounds at a
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`number of different hospitals throughout the United States and the rest of the world. I have given
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`over 120 presentations at various spine or orthopaedic societies related to spine maladies, spine
`
`treatments, spine surgery and my own research, written 16 peer reviewed articles related to spine
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`maladies, treatments, surgery and my own research, written numerous book chapters related
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`spine maladies and treatments, served as a course founder and course director at the Annual
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`Emerging Technologies Spine Education Summit since 2005, and served as faculty teaching
`
`Minimally Invasive Techniques for the Treatment of Thoracolumbar Spine Disorders in St.
`
`Louis, Missouri, along with numerous other courses. I have participated as faculty and course
`
`chairman for the annual AAOS Spine Surgery: State-of-the-Art Techniques and Science since
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`2005. In 2011, I co-authored a book chapter on Lateral Transpsoas Approach/Fusion on the
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`Advanced Reconstruction: Spine. I was also the co-editor for the Spine chapter in the
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`Orthopaedic Knowledge Update Volume 9. In addition, I currently serve on several editorial
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`boards and review committees, including the editorial board for Spine, The Journal of the
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`American Academy of Orthopaedic Surgeons, and the Spine Arthroplasty Society Journal.
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`Furthermore, I am a named inventor on at least 3 patents, several of which read on commercially
`
`available spine implants used in surgery today.
`
`4. I am not an employee ofNuVasive, Inc., but instead was engaged to provide my independent
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`analysis of the issues raised in the above-mentioned reexamination ofU.S. Patent No. 7,691,057
`
`("the '057 patent"). I received no compensation for this declaration beyond my normal hourly
`
`compensation based on my time actually spent studying the matter, and I will not receive any
`
`added compensation based on the outcome of the above-mentioned reexamination of the '057
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`patent.
`
`5. Based upon my knowledge and experience in this field, I am aware of the needs and the
`
`challenges orthopaedic surgeons face in performing spinal surgical procedures. I routinely
`
`perform and observe these spinal surgical procedures, and I am familiar with the various types of
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`access systems that are used during spinal surgical procedures, including dilator instruments and
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`retractor assemblies. I was a practicing spine surgeon prior to January 2003 and I am familiar
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`Appx00359
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`with the state of spinal surgery prior to the introduction ofNu Vasive Inc.'s products including
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`various inventive features as described in the '057 patent.
`
`6. I have reviewed the '057 patent, the pending claims in this reexamination proceeding, and the
`
`April4, 2012 Office Action in this reexamination proceeding. Also, I have reviewed the Branch
`
`reference (U.S. Patent No. 6,945,933), the Koros reference (U.S. Patent No. 5,928,139), the
`
`Michelson reference (U.S. Patent No. 5,772,661), the Tsou reference (U.S. Pub. No.
`
`2002/0077632), the Kelleher reference (PCT Pub. No. WOOl/37728), and the Kossman
`
`reference (Minimally Invasive Vertebral Replacement with Cages in Thoracic and Lumbar Spine,
`
`European Journal of Trauma 2001, 27:292-300), and I understand these alleged prior art
`
`teachings and what they would have suggested to a person of ordinary skill in the art prior to the
`
`filing of the '057 patent.
`
`7. Generally, based on my knowledge and experience in the field and my review of the prior art
`
`references, I believe that the '057 patent describes and claims significant inventions that have
`
`had a large impact on the medical community and patients with lower (lumbar) back problems.
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`Specifically, the surgical methods and tools described in the '057 patent are not only minimally
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`invasive and safe, but provide for maximum access to a surgical site that enables the use of
`
`conventional tools and techniques, and therefore minimizes the problems that may arise when
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`less skilled surgeons attempt lateral lumbar surgery. For example, claim 17 of the '057 patent
`
`describes a surgical method for accessing the lumbar spine along a lateral, trans-psoas path,
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`wherein the method involves the use of dilator-based distraction assembly in combination with a
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`retraction assembly having a plurality of retractor blades, the retractor blades are introduced in a
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`closed position and thereafter placed in an open position, and a fixation element is releasably
`
`engaged with at least one of the retractor blades to secure that blade to the spine. This
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`combination was new, unorthodox, and innovative to me when I first saw them implemented in
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`NuVasive's MaXcess system and related Extreme Lateral Interbody Fusion ("XLIF") surgical
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`procedure that was released in the Fall of2003, and there was nothing like that on the market at
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`the time. In fact, at the time I was deeply interested in innovative surgical techniques, yet I
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`continued to use traditional surgical techniques rather than the method claimed by the '057
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`patent because I did not believe that lateral, trans-psoas approach to the lumbar spine could be
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`done safely and reproducibly as traditional surgical approaches to the spine due to the presence
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`Appx00360
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`of the lumbar plexus within the psoas muscle, thus increasing the risk of neural injury to the
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`patient when performing such procedures. Spine surgeons at the time had long known that
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`traditional approaches for spinal surgery, such as anterior approaches and posterior approaches,
`
`were far from ideal. But it was not until Nu V asive commercialized a lateral approach with the
`
`XLIF and MaXcess, which implemented the inventions of the '057 patent, that surgeons were
`
`provided with a viable, and in fact superior, surgical approach that addressed the shortcomings of
`
`the traditional approaches. While it may seem logical to approach the spine laterally (from the
`
`side), it is by no means an easy task. To perform a lateral, trans-psoas approach to the lumbar
`
`spine safely and reproducibly required the advent ofNu Vasive inventions, such as those
`
`described and claimed in the '057 patent. There is no doubt in my mind that to a person of
`
`ordinary skill in the art having full knowledge of the state of the art in 2003, and general
`
`knowledge of the problems associated with lumbar spinal fusion procedures, the inventions set
`
`forth in the claims of the '057 patent at issue in this reexamination (namely, independent claim
`
`17 and dependent claims 18-22 and 24-27) were not obvious.
`
`8. The term "trans-psoas" is a term well known within the spinal surgery community, and
`
`means going through the psoas muscle. By contrast, an approach that retracts the entire psoas
`
`muscle in an anterior-to-posterior direction is not, within the medical community and among
`
`those of skill in the art, considered to be a "trans-psoas" path or approach. That would be a
`
`"retracted psoas" approach.
`
`9. In addition, the '057 patent also describes and claims the use of nerve monitoring in
`
`connection with the above described access features, for example, at dependent claims 19 and
`
`27. This was an integral and important innovation in the context of a lateral, trans-psoas
`
`approach to the lumbar spine. Due to the presence of numerous nerve roots (the lumbar plexus)
`
`running through the psoas muscle, the use of nerve monitoring is a further technique to ensure
`
`the lateral, trans-psoas surgical approach avoids nerves in the psoas muscle, and thus contributes
`
`to the safe and reproducible nature of the Nu V asive lateral solution that it provides to spinal
`
`surgeons. Neuromonitoring is a key element in the '057 patent and in the XLIF procedure.
`
`Neuromonitoring allows surgeons to safely and reproducibly perform the XLIF procedure with
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`few complications related to neural injury to the patient. This has allowed the procedure to gain
`
`widespread acceptance, whereas without this innovative advancement, the ability to perform the
`
`Appx00361
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`XLIF would have higher rates of complications and thus less adoption by the spine surgery
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`community.
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`10. With respect to the specific rejections of the '057 patent claims, based on my knowledge and
`
`experience in the field and my review of the prior art references, I do not believe that they teach
`
`the inventions as are set forth in claims 17-22 and 24-27 of the '057 patent. For example, with
`
`respect to the Branch and Koros references, I believe that if a device combining the guide tubes
`
`of Koros were to be added to the retractor portions of Branch, that combination would result in a
`
`device that would be dangerous when used in conjunction with a dilator. For example, the
`
`addition of the guide tubes would prevent the retractor of Branch from closing completely
`
`around the dilator during insertion. Instead, the retractor would be partially open where it could
`
`likely damage the surrounding tissues during insertion, or allow for tissue or nerves to creep
`
`beneath the retractor blades, thus restricting appropriate visualization of the disc space.
`
`Allowing for nerves to creep beneath the retractor blades has a higher probability of resulting in
`
`neural deficit. This is particularly inappropriate if one were to use such a modified retractor in
`
`an application where it is inserted along a trans-psoas path as with the '057 patent, because in
`
`such an application the retractor device must be designed to minimize any potential of damage to
`
`the psoas tissue and to avoid the nerves. Therefore, one of ordinary skill in the art would not use,
`
`even today, Branch's retractor as modified according to the Office action in an application where
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`it is introduced along a trans-psoas surgical path. The Koros reference itself does not teach the
`
`use of its retractor blades in conjunction with dilators, likely because the tubular guides along
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`Koros's retractor blades would interfere with any guided delivery of the blades along such
`
`dilators. One of ordinary skill in the art would not add the guide tubes in such a situation, in
`
`which they would defeat the purpose of being able to insert the retractor by running it closely
`
`along the outside of the largest dilator.
`
`11. Based on my knowledge and experience in this field and my review of the Koros reference, I
`
`believe that one of ordinary skill in the art prior to the filing of the '057 patent, and even today,
`
`would recognize that the surgical device taught by Koros is designed to be suited for a trans(cid:173)
`
`peritoneal anterior abdominal approach, as Koros teaches, and not a lateral trans-psoas
`
`retroperitoneal approach, as the '057 patent describes and claims. This conclusion is
`
`corroborated by the description in Koros that the retractor "is inserted in the incision to hold
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`Appx00362
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`organs ... [and] arteries ... out of the way," (Koros at 1 :37-40), and by the illustration of Figure 6
`
`in Koros, which is consistent with a retractor positioned as in a primarily anterior approach.
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`Therefore, I believe that a surgeon of ordinary skill would not look to the devices and description
`
`ofKoros for teachings suitable to a lateral, trans-psoas approach.
`
`12. Based on my knowledge and experience in this field and my review of the Branch reference,
`
`I believe that a person of ordinary skill in the art prior to the filing of the '057 patent would not
`
`have read Branch to teach that the devices and methods it describes are appropriate for a trans(cid:173)
`
`psoas approach. In addition, prior to NuVasive's innovations including those described in the
`
`'057 patent, spinal surgeons were aware of the dangers associated with splitting the psoas
`
`muscle, and would not have used a retractor as described in Branch in such an approach to the
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`spine. Instead, one of ordinary skill would have recognized the Branch device as appropriate for
`
`use in a conventional anterior trans-peritoneal approach.
`
`13. The Office Action identifies in Kossman a reference to splitting the psoas muscle, and asserts
`
`that "Kossman thus demonstrates that spinal surgery using a lateral, trans-psoas approach was
`
`well-known in the art," Office action at p. 5. Based on my knowledge and experience in the
`
`field and my review of the prior art references, this statement does not accurately reflect the
`
`understanding of one skilled in the art, as explained below.
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`14. Contrary to the assertion in the Office Action, having reviewed Kossman, I believe that one
`
`of ordinary skill in the art would have interpreted Kossman's description as referring to blunt
`
`dissection of unusually large psoas muscles in only a few cases. Prior to the filing of the '057
`
`patent, this technique would not have been accomplished with the use of dilators and retraction
`
`blades, but would have been most safely achieved with the use of the surgeon's fingers or a blunt
`
`instrument. Blunt dissection is not equivalent to dilation and retraction, and the ability to safely
`
`split a muscle using blunt dissection does not imply that trans-psoas dilation and retraction can
`
`be safely performed. Without NuVasive's innovations as reflected in the '057 patent, one of
`
`ordinary skill would not have seen the teaching of Kossman as permitting a surgeon to create an
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`operative corridor with a retractor such as that disclosed by Branch.
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`Appx00363
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`15. Further, the teaching of Kossman would not have been sufficient to enable a surgeon of
`
`ordinary skill to perform spinal surgery using a trans-psoas approach. The problems associated
`
`with impinging the nerve roots are well-known, and Kossman does not identify a surgical
`
`technique or other method to avoid or overcome these problems. Thus, prior to the filing of the
`
`'057 patent, a surgeon of ordinary skill would not be enabled to perform a trans-psoas procedure
`
`based on the teachings of Kossman, as the inherent dangers to the existing nerves in the psoas
`
`were well known.
`
`16. I have reviewed the Michelson reference, which teaches a cannula-based access method (not
`
`retractor based), and further teaches the use of a pair of prongs 149, 150 that extend from an
`
`access cannula and penetrate into the vertebral bone (not the disc). (This is shown, for example,
`
`in Figures 6-10.) First, I do not view cannula based access systems at all relevant to the design
`
`of split-blade retractor based access systems. In fact, cannula-based access systems such as that
`
`shown in Michelson would be extremely difficult to use, in that surgical operations performed
`
`through that tube would be very difficult and would require specialized tools. Moreover, a
`
`cannula system would require the use a larger cannula in order to insert an adequately sized
`
`implant, which would necessarily result in a larger incision, and a higher risk of neural deficit.
`
`As a consequence, the cannula-based access system of Michelson is not something that is used in
`
`the marketplace for any lateral access to the spine. Cannula-based access has been used in
`
`anterior retroperitoneal approaches. In contrast, the use of retractors in lateral, trans-psoas
`
`lumbar access, if done safely and reproducibly using Nu V asive innovations, overcome the
`
`problems of cannula-based access systems.
`
`17. In addition regarding the Michelson reference, the Office Action asserts that "Michelson thus
`
`demonstrates that spinal surgery using a shim structure to penetrate into the targeted lumbar
`
`spinal disc is well known in the art," Office Action p. 9. However, a person of ordinary skill in
`
`the art would recognize that the fixed prongs of Michelson's access cannula penetrate and hold
`
`two adjacent vertebrae, thereby avoiding penetration of the intervertebral disc between the two
`
`vertebrae. The prongs 149, 150 ofMichelson, which are integrally fixed to the device, are not
`
`sized or positioned so as to be suitable to penetrating a lumbar disc, and a surgeon of ordinary
`
`skill would not use the prongs in this fashion. Instead, an extension member 148 of the access
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`cannula itself is inserted into the intervertebral space. This integral member 148 is not
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`Appx00364
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`equivalent to a releasable shim. Based on my knowledge and experience in the field and my
`
`review of the prior art references, I do not believe that one of ordinary skill would learn from the
`
`teachings of Michelson to add a releasable shim to the end of a retraction blade for penetration of
`
`the targeted lumbar spinal disc as claimed. Furthermore, if such fixation was placed into the
`
`adjacent vertebral bodies, and attached to the cannula as described in the Michelson reference,
`
`this would prevent any disc distraction, appropriate endplate preparation and create endplate
`
`fracture, therefore it would not be used as a method to perform a lateral interbody fusion.
`
`18. Furthermore, I believe that a person of ordinary skill would not consider the fixation screws
`
`of Koros to be analogous or compatible with the fixed prongs of Michelson. The fixation screws
`
`disclosed in Koros are manipulated at the proximal end due to their length, and are manipulated
`
`and fixed only after the blades are delivered. (See Koros at 6:42-49). In contrast, the integral
`
`prongs 149, 150 and extension 148 ofMichelson are mounted to the distal end of the outer sleeve
`
`and are affixed as part of the insertion of the sleeve. (See Michelson at 10:61-67). One of
`
`ordinary skill would not, even today, attempt to combine these two very different mechanisms in
`
`a single surgical device, and neither reference provides the guidance necessary for one of
`
`ordinary skill to combine them.
`
`19. Having reviewed Kelleher, I believe that the addition of Kelleher does not correct the
`
`deficiencies that I noted with Branch, Kossman, and Koros regarding a lack of any teaching that
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`would enable one skilled in the art to operate along a lateral, trans-psoas path. I have also
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`reviewed the Tsou reference, which does not mention the psoas muscles and is also not directed
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`to a lateral, trans-psoas surgical approach. Instead, one of ordinary skill would recognize Tsou
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`as teaching an antero-lateral trans-peritoneal approach.
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`20. Having reviewed each of the cited references collectively and in tum, it is my opinion based
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`on my understanding of the state of the art prior to the time the '057 was filed and my own
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`expertise as a spine surgeon that no combination of Branch, Kossman, Koros, Michelson,
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`Kelleher, and Tsou teach the surgical methods recited in claims 17-22 and 24-27 of the '057
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`patent and explained in its disclosure.
`
`Appx00365
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-10 Filed 01/18/20 PageID.22532 Page 12 of
` 12
`Case: 17-1666 Document: 41 Page: 221 Filed: 01/12/2018
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`PatentNo. :
`Control No.:
`Page
`
`7,691,057
`95/001,888
`9 of9
`
`Attorney's Docket No.: 13958-0076RX1
`
`21. I hereby declare that all statements made herein of my knowledge are true and that all
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`statements made on information and belief are believed to be true; and further that these
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`statements were made with the knowledge that willful false statements and the like so made are
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`punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States
`
`Code and that such willful false statements may jeopardize the validity of the application or any
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`patents issued thereon.
`
`Dated:
`
`June 4, 2012
`
`60769068.doc
`
`JimY~
`
`Durango, CO
`
`Appx00366
`
`