IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT AND TRIAL APPEAL BOARD
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`STRYKER CORPORATION
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`Petitioner
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`v.
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`ORTHOPHOENIX, LLC
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`Patent Owner
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`U.S. Patent No. 6,280,456 B1
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`____________
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`Case IPR2014-01535
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`DECLARATION OF GAMAL BAROUD, Ph.D.
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`ORTHOPHOENIX EXHIBIT 2018
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`BEFORE THE PATENT AND TRIAL APPEAL BOARD
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`STRYKER CORPORATION
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`Petitioner
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`v.
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`ORTHOPHOENIX, LLC
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`Patent Owner
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`U.S. Patent No. 6,280,456 B1
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`____________
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`Case IPR2014-01535
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`____________
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`DECLARATION OF GAMAL BAROUD, Ph.D.
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`I, GAMAL BAROUD, Ph.D. declare:
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`1.
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` In 1993, I earned a B. Eng. in Biomedical Engineering degree from the
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`University of Applied Sciences in Aachen in Germany. In 1995, I was awarded a
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`Msc. Eng. in Mechanical Engineering from the University of Technology of
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`Chemintz in Germany and in 1997, I was awarded a Ph.D. in Mechanical
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`Engineering from the University of Technology of Chemintz in Germany.
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`2.
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`From 1998 to 2000, I was a post-doctoral fellow at the Human Performance
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`Laboratory of the University of Calgary.
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`3.
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`From 2000 to 2003, I was a researcher and assistant professor at the
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`Department of Orthopedic Surgery at the McGill University.
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`4.
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`From 2003 to 2015, I have been a professor (a full professor since 2008) at
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`the Department of Mechanical Engineering at the University of Sherbrooke in
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`Quebec.
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`5.
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`Over the past fifteen years, I have supervised the work of 6 post-doctoral
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`researchers and 17 graduate students.
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`6.
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`From 2005 to 2010, I was selected to serve as Canada Research Chair in
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`Skeletal Reconstruction and Biomedical Engineering (Mandate 1).
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`7.
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`From 2010 to 2015, I have served as Canada Research Chair in Skeletal
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`Reconstruction and Biomedical Engineering (Mandate 2).
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`8.
`copy of my curriculum vitae is attached to this declaration.
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`I have published 58 articles in peer-reviewed scientific journals, 12 book
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`chapters, 112 scientific abstracts, and am a co-inventor on 26 patent patents. A
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`9.
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`Over the past ten years, I have organized three international meetings and
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`co-chaired two other conferences focused on bone augmentation procedures.
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`These meetings gathered the key industrial, scientific and medical experts in this
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`area.
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`10.
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`In connection with the preparation of this declaration I have read and
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`understood U.S. Patent No. 6,280,456 (“the ’456 patent”) (Ex. 1001), Stryker’s
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`Petition for Inter Partes Review and the references cited therein, including Valley,
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`(Ex. 1007), Reiley, (Ex. 1006), and the Declaration of Mr. Sheehan, Ex. 1002. I
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`have also reviewed the Patent Owner’s Response to the Petition as well as the
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`transcript of Mr. Sheehan’s Deposition, Ex. 2020.
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`11.
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`I am advised that in proceedings before the USPTO, the Patent Trial and
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`Appeal Board accords the claims of an unexpired patent their broadest reasonable
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`interpretation in view of the specification from the perspective of one of ordinary
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`skill in the art. I have been informed that the ’456 patent has not expired.
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`Therefore, in comparing the claims of the ’456 patent to the cited references Valley
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`and Reiley, I have given the claims their broadest reasonable interpretation in view
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`of the ’456 specification from the perspective of one of ordinary skill in the art.
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`12.
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`I am informed that the ’456 patent was based on an application filed on
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`August 15, 1997. I have therefore been advised that a reference qualifies as prior
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`art only if it disclosed or suggested the claimed invention of the ’456 patent prior
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`to August 15, 1997
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`13.
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`I have been informed that “a person of ordinary skill in the art” is a
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`hypothetical person to whom an expert in the relevant field could assign a routine
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`task with reasonable confidence that the task would be successfully carried out. I
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`have been informed that the level of skill in the art may be evidenced by references
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`published at or around the time of the filing of the patent under consideration.
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`14. Based on my experience, a person of ordinary skill in the art would have had
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`advanced training in mechanical and biomechanical engineering and would have
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`had specific experience with the mechanics and properties of bones as well as,
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`more specifically, with the field of bone augmentation. Bone augmentation
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`includes bone strengthening, increasing osseous dimensions, as well as
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`vertebroplasty and kyphoplasty.
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`15.
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` By virtue of my advanced training in biomechanical engineering as well as
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`over twenty years’ experience conducting research in the biomechanics, the
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`development of injectable vertebral cement and the mechanics of the bone
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`augmentation procedure, I had and continue to have an understanding of the
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`capabilities of a person of ordinary skill in the relevant art at the time of the
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`invention of the ’456 patent. I have supervised and directed the training of many
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`such persons over the course of my academic career.
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`16. The ’456 patent describes a method for treating bone and a device or tool for
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`deployment into bone. According to the Summary of the Invention the method and
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`device are described as follows:
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`The method provides a tool comprising an outer catheter tube having a
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`distal end and an inner catheter tube extending within the outer
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`catheter tube and having a distal end region that extends beyond the
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`distal end of the outer catheter tube. The tool includes an expandable
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`structure having a proximal end secured to the distal end of the outer
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`catheter tube and a distal end secured to the distal end region of the
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`inner catheter tube. The distal end region of the inner catheter tube is
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`enclosed within the expandable structure. The method manipulates
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`the tool to introduce the expandable structure into bone while in a
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`generally collapsed geometry. The method causes the expandable
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`structure to assume an expanded geometry inside bone.
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`Ex. 1001 at 1:63-67; 2:1-9.
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`17. One embodiment of the tool or device is illustrated below in Figure
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`19.
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`Ex. 1001 at p. 10.
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`Figure 19 is in turn described as follows:
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`As FIG. 19 shows, the structure 110 comprises, when
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`substantially collapsed, a simple tube. To facilitate formation of
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`the inverted end regions 114 and bonded regions 116, a two-
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`piece catheter tube is provided, comprising an outer catheter tube
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`118 and an inner catheter tube 120. The inner catheter tube 120
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`slides within the outer catheter tube 118. The catheter tube 118
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`can, at its proximal end, be configured like the tube 50 shown in
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`FIG. 3, with a handle 51 made of, e.g., a foam material.
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`As FIG. 19 shows, during the manufacturing process, the inner
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`catheter tube 120 is moved a first distance d1 beyond the outer
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`catheter tube 118. In this condition, the proximal and distal ends
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`122 and 124 of the tubular structure 110 are bonded, without
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`folding over or tucking in, about the inner catheter tube 118 and
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`the outer catheter tube 120, respectively. The unfolded ends 122
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`and 124 of the tubular structure 110 can then be directly exposed
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`to conventional adhesive or melt bonding processes, to form the
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`bonded regions 116.
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`Id. at 10:17-41.
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`The expandable structure or balloon of the tool is introduced into bone
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`while in a generally collapsed geometry, and then is caused to assume an
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`expanded geometry inside bone. This expansion is illustrated in Figures 26 and
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`27.
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`Ex. 1001 at p. 14.
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`Figures 26 and 27 are described as follows:
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`[T]he enclosed length of catheter tube 600 provides an interior lumen
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`602 passing within the expandable structure 604. The lumen 602
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`accommodates the passage of a stiffening member or stylet 606 made,
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`e.g., from stainless steel or molded plastic material.
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`The presence of the stylet 606 serves to keep the structure 604 in the
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`desired distally straightened condition during passage through an
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`associated guide sheath 608 toward the targeted body region 610, as
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`FIG. 26 shows. Access to the target body region 610 through the
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`guide sheath 608 can be accomplished using a closed, minimally
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`invasive procedure or with an open procedure.
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`As shown in FIG. 27, the stylet 606 can have a preformed memory, to
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`normally bend the distal region 612 of the stylet 606. The memory is
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`overcome to straighten the stylet 606 when confined within the guide
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`sheath 608, as FIG. 26 shows. However, as the structure 604 and stylet
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`606 advance free of the guide sheath 608 and pass into the targeted
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`region 610, the preformed memory bends the distal stylet region 612.
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`… The prebent stylet 606, positioned within the interior of the structure
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`604, further aids in altering the geometry of the structure 604 in
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`accordance with the orientation desired when the structure 604 is
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`deployed for use in the targeted region 610.
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`Id. at 12:36-62.
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`There are 10 claims in the ’456 patent. Claim 1 is the only independent
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`claim; claims 1 and 2 are representative and reproduced below:
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`1. A method for treating bone comprising the steps of
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`providing a tool comprising an outer catheter tube having a distal end,
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`an inner catheter tube extending within the outer catheter tube
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`and having a distal end region that extends beyond the distal end of the
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`outer catheter tube, and an expandable structure having a proximal end
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`secured to the distal end of the outer catheter tube and a distal end
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`secured to the distal end region of the inner catheter tube, whereby the
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`distal end region of the inner catheter tube is enclosed within the
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`expandable structure,
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`manipulating the tool to introduce the expandable structure into bone
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`while in a generally collapsed geometry, and
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`causing the expandable structure to assume an expanded geometry
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`inside bone.
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`2. A method according to claim 1 wherein, when assuming the
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`expandable geometry, the expandable structure compacts cancellous
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`bone.
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`Id. at 16:6-26.
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`18.
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`I have also been advised that the present Inter Partes Review (“IPR”)
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`proceeding has been instituted to review the patentability of (i) claims 1-10 of U.S.
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`Patent No. 6,280,456 (the “ ’456 patent”) as obvious under 35 U.S.C. § 103(a) over
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`Valley (Ex. 1006) and Reiley (Ex. 1004). Decision, Institution of Proceedings,
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`Paper No. 7, at 19.
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`19. The balloons in Valley are designed to operate at peak pressures much lower
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`than those encountered in compressing cancellous bone. For example, the peak
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`inflation pressure of the balloon in Valley is shown as 35 psi. Ex. 1006 at 21:1-4.
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`In contrast, the balloon described in the ’456 patent is designed to withstand
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`pressures up to 250-500 psi. Ex. 1001 at 13:1-5. In my experience, such pressures
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`are routinely used to compress cancellous bone.
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`20. Mechanically, the peak inflation pressure, measured at the proximal port
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`112, is composed of two sub-pressures, the interior static pressure in the balloon
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`and the dynamic pressure, which results from forcing the inflation solution through
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`the considerably thin and considerably extended annular conduit formed between
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`the inner tube 102 and outer tube 104, in the catheter connected to the balloon. The
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`dynamic pressure is the transient component in the inflation pressure. Therefore,
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`during the inflation process, the pressure inside the balloon in Valley is
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`significantly less than the inflation pressure at the proximal inflation port 122. Ex.
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`1006 at 21:24-33, referencing FIG. 5A, reproduced below.
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`Ex. 1006 at p. 5.
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`21. Pressures less than 35 psi, the transient peak inflation pressure noted in
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`Valley, with the balloon pressures then ranging between 10-12 psi (Ex. 1006 at,
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`21: 1-5) are insufficient to compress cancellous bone effectively. Pressures
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`typically required to compress various types of cancellous bone as shown in the
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`table from Page 51 of the book titled "Mechanical Testing of Bone and the Bone
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`Implant Interface". ISBN. 0-8493-0266-8. Exhibit 2020. The ultimate strength
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`(MPa) is the maximum stress that a material can withstand while being loaded to
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`failure. A 1-MPa ultimate strength is 145.03 psi. Osteoporosis and other diseases
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`weaken the cancellous bone. In my own measurements on osteoporotic vertebrae, I
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`found the cancellous bone strength to be in the range of 1.9 to 5.2 MPa,
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`corresponding to approximately 275 to 750 psi.
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`22. Valley states that “[t]he balloon should be inflated… to a pressure sufficient
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`to prevent migration of the balloon into the root whilst not being so high as to
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`cause damage or dilatation of the aortic wall.” Ex. 1006 at 5:45-50. In fact, at the
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`pressure specified in the ’505 patent, 250-500 psi, the balloon in Valley will most
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`likely rupture or be punctured by individual trabeculae of the cancellous bone.
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`In mechanics, the balloon structures of Valley are known as “thin-walled pressure
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`vessels”. The circumferential stresses, σ, acting within the wall of a thin balloon
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`vessel, which is pressurized internally, are derived as follows:
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`rt
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`σ= p ⋅
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`Wherein p is the internal pressure in psi, r and t are the radius and thickness of the
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`€
`pressure vessel, respectively. Valley disclosed “A balloon length of about 40 mm
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`and diameter of about 35 mm is suitable in humans” (Ex. 1006 at 6:36), and “The
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`wall thickness of the molded balloon 210 in its deflated state is typically about
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`0.090-0.130 mm” (Ex. 1006 at 21:65). The stronger balloon in Valley features a
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`thickness of 0.13 mm. Accordingly, the stresses that develop the balloon wall can
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`be estimated as follow:
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`σ = 250 −500
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`] psi ⋅
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`0.5 ⋅ 35 mm
`0.13 mm = 250 −500
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`σ= 33,653.84 -67,307.69
`] psi
`[
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`] psi ⋅134.61
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`€
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`€
`Valley (Ex. 1006) discloses, among others, the following materials for the balloon.
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`Materials
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`Elastomers (EL)
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`Polyurethane (PU)
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`Polyethylene Terepthalate (PET)
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`Typical strength (psi)
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`1,000 - 7,000
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`6,500 - 33,000
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`6,000 - 13,000
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`Source (http://endura.com/material-selection-guide/#26)
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`Nylon
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`12,400 – 27,000
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`Source (http://www.plastic-products.com/spec1.htm)
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`Latex and silicone-based polymers are typically weaker than PET
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`Even when applying the lower pressure threshold of 250 psi, and with no safety
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`factor assumption, the stresses of 38,461.52 psi exceed the strength of materials
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`specified in Valley.
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`23. The balloon in Valley is designed for operating in a soft environment, that of
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`vasculature pre-existing, and all of the teachings in it are specific to vascular
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`applications. Ex. 1006 at 5:29-67; 6:1-10. For example, the catheter is designed
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`with a soft, atraumatic tip. Ex. 1006 at 47:25-30. Additionally, the balloon in
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`Valley is formed from elastomeric materials are by nature soft and comparatively
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`atraumatic when pressed against an anatomic structure such as a blood vessel. Ex.
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`1006 at 21:32-46.
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`24. The balloon in the ’456 patent is designed to create a cavity which allows for
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`compaction of the cancellous bone that is relatively uniform such that the
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`cancellous bone is compacted in as many directions as possible and in a manner
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`respecting the symmetry of the bone to be compacted. Ex. 1001 at 7:26-34 (“The
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`symmetric compaction of cancellous bone 32 in the interior volume 30 that a
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`centered cavity provides also exerts more equal and uniform interior forces upon
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`cortical bone 32, to elevate or push broken and compressed bone”); Id. at 10:51-59
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`(“no region along either structure 94 [in FIG. 18] or 114 [in FIG. 20] where
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`cancellous bone compaction does not occur;” and “cancellous bone compaction
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`essentially along its entire length”); Id. at 8:12-26 (contrasting the nonuniform
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`compaction achieved by a conventional structure). With respect to Fig. 17, upon
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`inflation the balloon expands to compact cancellous bone along the entire of the
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`expandable, including the ends. Id. at 9:45-51. This relatively uniform compaction
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`for example along the entire length of the balloon is illustrated below in figures
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`drawn from the ’505 patent.
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`Ex. 1001 at p. 10.
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`25. Thus, the balloon of the ’456 patent creates a cavity of predictable geometry
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`and volume where cement can be injected in a safe and effective manner. A
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`person of ordinary skill reading the ’456 patent would know that if the geometry of
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`the cavity in the cancellous bone is in any manner unpredictable, i.e., there is a
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`portion of the cavity which is not predictably expanded, the cement can extravasate
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`in multiple directions like fingers of a glove which makes monitoring of the
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`volume injected difficult and increase the risk of leakage from the cavity.
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`26. The contrast between the expansion of the balloon in the ’456 patent and the
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`balloon in Valley (Ex. 1006) can be illustrated below in a figure taken from Valley.
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`Ex. 1006 at p. 12.
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`27.
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`It is shown in this figure that the Valley dilatation balloon does not form a
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`plastic or permanent cavity in the biological tissue but rather is inflated against the
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`aorta to prevent migration or dislodgement of the inflated balloon 660’. “The
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`balloon should be inflated to a pressure sufficient to prevent regurgitation of blood
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`into the aortic root and to prevent migration of the balloon into the root whilst not
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`being so high as to cause damage or dilation to the aortic wall. An intermediate
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`pressure of the order of 350 mmHg, for example, has been proven effective”, Id. at
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`5:46-52. Other Valley figures are to the same effect. In addition, if the Valley
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`balloon is placed in the cancellous bone, if not ruptured, will escape the hard
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`cancellous bone by deforming/expanding into regions of least resistance in the
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`cancellous bone (such as pre-existing cancellous cavities or fracture lines). This
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`effect may lead to enlarging these pre-existing cancellous cavities in unpredictable
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`fashion, and thus increasing the risk of uncontrolled cement filling, increasing the
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`risk of adverse leaks, and also rendering the augmentation ineffective. Of great
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`relevance is that the strength of cancellous bone is higher in the vertical or gravity
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`direction than the other two Cartesian directions. In other words, if the expandable
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`balloon structure is not sufficiently rigid and uniform as discussed above, the
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`balloon structure will expand laterally more than vertically, and the shape of the
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`cavity becomes again unpredictable. My conclusion is that the occlusion balloon,
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`as specified in Valley, is very unlikely to form, if any, a bone cavity of relevance
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`or a predictable shape.
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`28.
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`In my view, Reiley (Ex. 1004) does teach against using prior art balloon
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`catheter designs for bone. Specifically, Reiley states that the prior art:
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`does not teach the shape of the balloon which creates a cavity
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`that best supports the bone when appropriately filled. It does not
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`teach how to prevent balloons from being spherical when
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`inflated, when this is desired. Current medical balloons can
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`compress bone but are too small and generally have the wrong
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`configuration and are generally not strong enough to accomplish
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`adequate cavity formation in either the vertebral bodies or long
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`bones of the body.
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`Ex. 1004 at p. 5, ll. 25-33.
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`In its specification, Reiley specifically refers to Andersen, U.S. Patent No.
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`4,706,670 (Ex. 1005 at p. 4, ll. 23). Andersen cannot create a cavity which allows
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`for near uniform compaction of the cancellous bone, that best supports the bone, as
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`required by the ’505 patent. Ex. 1001 at 10:51-59. The ’505 patent specifically
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`states that it wants to avoid the uneven compaction of the bone shown for the
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`conventional (prior art) device depicted in Figure 15 of the ’505 patent.
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`Ex. 1001 at p. 9.
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`29. Specifically, the ’456 patent states that is wants to avoid uneven compaction
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`of cancellous bone.
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`Due to the geometry shown in FIG. 15, maximum cancellous bone
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`compaction does not occur along the entire length (L2) of the
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`conventional structure 56, as measured between the bonded ends 58.
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`Instead, maximum cancellous bone compaction occurs only along the
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`effective length (L1) of the cylindrical middle region 64 of the
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`structure 56, where the structure 56 presents its maximum diameter
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`BODYDIA. Cancellous bone compaction diminishes along the length
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`of the conical portions 62, where the structure's diameter
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`progressively diminishes. At the bonded ends 58, and portions of the
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`19
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`ORTHOPHOENIX EXHIBIT 2018
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`IPR2014-01535 Page 19 of 23
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`catheter tube 50 extending beyond the bonded ends 58, no bone
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`compaction occurs.
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`Ex. 1001 at 8:15-26.
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`30.
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`In contrast, the balloon in the ’456 patent is designed to create a cavity
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`which allows for near uniform compaction of the cancellous bone. Ex. 1001,
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`10:51-59. In other words, there is no area where the balloon is positioned in the
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`cancellous bone where compaction does not occur. Id. This near uniform
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`compaction along the entire length of the balloon is illustrated below in several
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`figures drawn from the ’456 patent and it is thus part of the structure of devices of
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`the ’456 invention that are designed and constructed to compress cancellous bone.
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`The near uniform cavity, once cement-filled, provides the vertical support for the
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`bone.
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`20
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`ORTHOPHOENIX EXHIBIT 2018
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`IPR2014-01535 Page 20 of 23
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`Ex. 1001 at p. 10.
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`31. Thus, the balloon of the ’456 patent creates a cavity of predictable and
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`uniform geometry and a controlled volume where a measured cement volume can
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`be injected in a safe manner for effective vertical support of the bone. If the
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`geometry of the cavity in the cancellous bone is in any manner unpredictable, i.e.,
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`there is a portion of the cavity which is not uniformly expanded, the cement could
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`flow in multiple directions like fingers of a glove which makes monitoring of the
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`volume injected difficult, increases the risk of leakage from the cavity, and renders
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`the vertical mechanical support of the bone ineffective.
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`21
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`ORTHOPHOENIX EXHIBIT 2018
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`IPR2014-01535 Page 21 of 23
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`32. Therefore, in my view, Reiley does teach not to use the balloon
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`structures seen in the prior art. Nor does the prior art, at least according to
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`Reiley, provide any guidance on how to design an appropriate balloon for
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`bone. This is true, especially, in view of the fact that Reiley clearly states
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`that: “[i]t can be concluded from the foregoing review of the prior art that
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`there is little or no substantive information on inflatable devices used to
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`create cavities in bone. It does not teach the shape of the balloon which
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`creates a cavity that best supports the bone when appropriately filled.” Ex.
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`1004 at p. 5, ll. 22-33. Thus, one of ordinary skill would not have combined
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`Reiley with Valley in order to design an appropriate balloon for compressing
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`cancellous bone.
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`33. For my efforts in connection with the preparation of this declaration, I have
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`been compensated at my regular hourly rate for this type of consulting activity. My
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`compensation is in no way dependent or contingent upon the outcome of these
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`proceedings or any other proceedings relating to the subject ’456 Patent.
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`22
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`ORTHOPHOENIX EXHIBIT 2018
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`IPR2014-01535 Page 22 of 23
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`ORTHOPHOENIX EXHIBIT 2018
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`IPR2014-01535 Page 23 of 23
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