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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`Case IPR2014-‐01519
`Patent 6,623,505 B2
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`____________
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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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`
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`Case IPR2014-‐01519
`Patent 6,623,505 B2
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`____________
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`DECLARATION OF GAMAL BAROUD, Ph.D.
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`ORTHOPHOENIX EXHIBIT 2018
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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 from the University
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`of Applied Sciences in Aachen in Germany. In 1995, I was awarded a MSc. Eng.
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`in Mechanical Engineering from the University of Technology of Chemintz in
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`Germany and in 1997, I was awarded a Ph.D. in Mechanical Engineering from the
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`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, where I head the Biomechanics Laboratory.
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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.
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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 patents. A copy of
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`my curriculum vitae is attached as Exhibit 2019. Over the past ten years, I have
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`organized three international conferences and co-chaired two other conferences
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`focused on bone augmentation procedures. These conferences gathered the key
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`industrial, scientific and medical experts in this area.
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`9.
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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. 6,623,505 (“the ’505 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), Andersen (Ex. 1005) and the Declaration of Mr.
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`Sheehan (Ex. 1002). I have also reviewed the Patent Owner’s Response to the
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`Petition as well as the transcript of Mr. Sheehan’s Deposition (Ex. 2020).
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`10.
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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 ’505 patent has not expired.
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`Therefore, in comparing the claims of the ’505 patent to the cited references,
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`Valley, Reiley and Andersen, I have given the claims 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.
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`11.
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`I am informed that the ’505 patent is based on an application filed on August
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`15, 1997. I have therefore been advised that a reference qualifies as prior art only
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`if it disclosed or suggested the claimed invention of the ’505 patent prior to August
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`15, 1997.
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`12.
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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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`13. 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 more
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`specifically, with the field of bone augmentation. Bone augmentation includes
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`bone strengthening, increasing osseous dimensions as well as verterbroplasty and
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`kyphoplasty.
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`14.
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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 biomechanics, the
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`development of injectable vertebral cement and the mechanics of bone
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`augmentation procedures, 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 ’505 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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`15. The ’505 patent describes a device for deployment into bone. Ex. 1001 at
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`1:66-67; 2:1-8. The overall structure of the device is described as follows:
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`The device comprises an outer catheter tube having a distal end. An
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`inner catheter tube extends at least in part within the outer catheter
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`tube and has a distal end region that extends at least in part beyond the
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`distal end of the outer catheter tube. An expandable structure has a
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`proximal end secured to the outer catheter tube and a distal end secured
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`to the inner catheter tube. The expandable structure extends outside
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`and beyond the outer catheter tube and at least partially encloses the
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`inner catheter tube.
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`One embodiment of the device is illustrated below in Figure 19.
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`4
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`Id.
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`Ex. 1001 at p. 10.
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`Figure 19 is described as follows:
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`As FIG. 19 shows, the structure 110 comprises, when substantially
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`collapsed, a simple tube. To facilitate formation of the inverted end
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`regions 114 and bonded regions 116, a two-piece catheter tube is
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`provided, comprising an outer catheter tube 118 and an inner catheter
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`tube 120. The inner catheter tube 120 slides within the outer catheter
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`tube 118. The catheter tube 118 can, at its proximal end, be configured
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`like the tube 50 shown in FIG. 3, with a handle 51 made of, e.g., a foam
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`material.
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`Id. at 10:19-29.
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`16. The device is sized and configured for passage within a cannula into bone
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`when the expandable structure is in a collapsed condition. Id. at 2:9-11. The
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`cannula or guide sheath 608 of the device is illustrated in Figures 26 and 27.
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`Id. at p. 14.
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`17. 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
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`612…The prebent stylet 606, positioned within the interior of the
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`structure 604, further aids in altering the geometry of the structure
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`604 in accordance with the orientation desired when the structure 604
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`is deployed for use in the targeted region 610.
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`Id. at 12:36-62.
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`18.
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`In embodiments encompassed by claims 7 and 11, the device is “adapted and
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`configured to compress cancellous bone upon inflation of the inflatable structure in
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`bone.” Structures corresponding to this feature are illustrated in Figure 19
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`discussed above as well as in Figures 17, 18 and 20, shown below.
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`Ex. 1001 at p. 10.
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`19.
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`The fact that these structures designed and constructed for compression
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`of cancellous bone is reflected in the specification as follows:
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`FIG. 17 shows another improved expandable structure 80 having a
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`geometry mitigating the tradeoff between maximum compaction
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`diameter and effective compaction length. Like the
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`structure 70 shown in FIG. 16, the structure 80 in FIG. 16 includes a
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`middle region 82 of BODYDIA and end regions 84 extending from
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`the middle region to the bonded regions 86, at TUBEDIA. As the
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`structure 70 in FIG. 16, the end regions 84 of the structure 80 make
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`a non-conical diameter transformation between BODYDIA and
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`TUBEDIA. In FIG. 17, the predefined radial sections r1 and r2are
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`each reduced, compared to the radial section r1 and r2 in FIG. 16.
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`As a result, the end regions 84 take on an inverted profile. As a
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`result, the entire length L2 between the bonded regions 86 becomes
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`actually less than the effective length L1 of maximum diameter
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`BODYDIA. …
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`The structures 70 and 80, shown in FIGS. 16 and 17, when
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`substantially inflated, present, for a given overall length L2, regions
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`of increasingly greater proportional length L1, where maximum
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`cancellous bone compaction occurs.
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`Furthermore, as in FIG. 17, the end regions 84 are inverted about the
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`bonded regions 86. Due to this inversion, bone compaction occurs in
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`cancellous bone surrounding the bonded regions 86. Inversion of the
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`end regions 84 about the bonded regions 86 therefore makes it
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`possible to compact cancellous bone along the entire length of the
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`expandable structure 80.
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`FIG. 18 shows another embodiment of an improved expandable
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`structure 90. Like the structure 80 shown in FIG. 17, the
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`structure 90 includes a middle region 92 and fully inverted end
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`regions 94 overlying the bond regions 96. The
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`structure 80 comprises, when substantially collapsed, a simple tube.
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`At least the distal end of the tubular structure 80 is mechanically
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`tucked or folded inward and placed into contact with the catheter
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`tube 98. As shown in FIG. 18, both proximal and distal ends of the
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`tubular structure are folded over and placed into contact with the
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`catheter tube 98. The catheter tube 98 can, at its proximal end, be
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`configured like the tube 50 shown in FIG. 3, with a handle 51 made
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`of, e.g., a foam material. …
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`The inverted end regions 94 of the structure 90 achieve an abrupt
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`termination of the structure 90 adjacent the distal end 104 of the
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`catheter tube 98, such that the end regions 94 and the distal catheter
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`tube end 104 are coterminous. The structure 90 possesses a region of
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`maximum structure diameter, for maximum cancellous bone
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`compaction, essentially along its entire length. The
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`structure 90 presents no portion along its length where bone
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`compaction is substantially lessened or no cancellous bone
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`compaction occurs.
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`Ex. 1001 at 9:24-67; 10:1-14.
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`FIGS. 19 and 20 show another embodiment of an expandable
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`structure 110. As FIG. 20 shows, the structure 110 includes a middle
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`region 112 of maximum diameter BODYDIA and inverted end
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`regions 114, which overlie the bonded regions 116. …
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`Once the bonded regions 116 are formed, the inner catheter
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`tube 120 is moved (see arrow 130 in FIG. 20) to a distance d2
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`(shorter than d1) from the end of the outer catheter tube 118. The
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`shortening of the inner tube 120 relative to the outer tube 120 inverts
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`the ends 122 and 124. The inversion creates double jointed end
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`regions 116 shown in FIG. 20, which overlie the bonded
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`regions 116. The relative position of the outer and inner catheter
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`tubes 118 and 120 shown in FIG. 20 is secured against further
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`movement, e.g., by adhesive, completing the assemblage of the
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`structure 110.
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`The double jointed inverted ends 114 of the structure 110 in FIG. 20,
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`like single jointed inverted ends 94 of the structure 90 in FIG. 18,
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`assure that no portion of the catheter tube protrudes beyond the
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`expandable structure. Thus, there is no region along either
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`structure 94 or 114 where cancellous bone compaction does not
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`occur. Like the structure 90 shown in FIG. 18, the
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`structure 110 in FIG. 20 presents a maximum diameter for maximum
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`cancellous bone compaction essentially along its entire length.
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`Ex. 1001 at 10:15-59.
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`20. Claims 1, 3 and 5 are representative.
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`1. A device for deployment into bone comprising an outer catheter
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`tube having a distal end, an inner catheter tube extending at least in
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`part within the outer catheter tube and having a distal end region that
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`extends at least in part beyond the distal end of the outer catheter tube,
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`an inflatable structure having a proximal end secured to the outer
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`catheter tube and a distal end secured to the inner catheter tube, the
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`inflatable structure extending outside and beyond the outer catheter
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`tube and at least partially enclosing the inner catheter tube, and a flow
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`passage between the outer and inner catheter tubes communicating
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`with the inflatable structure and adapted to convey an inflation
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`medium into the inflatable structure to inflate the inflatable structure.
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`3. A device according to claim 1 wherein the inflatable structure is
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`adapted and configured to compress cancellous bone upon inflation of
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`the inflatable structure in bone.
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`5. A device for deployment into bone comprising an outer catheter
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`tube having a distal end, an inner catheter tube extending at least in
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`part within the outer catheter tube and having a distal end region that
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`extends at least in part beyond the distal end of the outer catheter tube,
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`an inflatable structure having a proximal end secured to the outer
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`catheter tube and a distal end secured to the inner catheter tube, the
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`inflatable structure extending outside and beyond the outer catheter
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`tube and at least partially enclosing the inner catheter tube, the
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`inflatable structure being sized and configured for passage within a
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`cannula into bone when the inflatable structure is in a collapsed
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`condition, and a flow passage between the outer and inner catheter
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`tubes communicating with the inflatable structure and adapted to
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`convey an inflation medium into the inflatable structure to expand the
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`inflatable structure.
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`Ex. 1001 at 16:5-35.
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`21. After reviewing the specification and the claims, I was asked to the meaning
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`of certain terms and phrases in the claims in accordance with their broadest
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`reasonable interpretation as it would be interpreted by a person of ordinary skill in
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`the art. In my view, the phrase “adapted and configured to compress cancellous
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`bone upon inflation of the inflatable structure in bone” means that the inflatable
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`structure is designed and constructed to compress cancellous bone. It is clear that
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`the inflatable structure must be designed and constructed to compress cancellous
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`bone upon inflation in a manner that creates a relatively uniform and predictable
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`compression in the cancellous bone (see discussion of Figures 17-20 below). In
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`any event, the phrase refers to structural features of the inflatable structure and not
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`merely to its use.
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`22. The term “bone” in the preamble and/or body of the claims requires that the
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`claimed device possess structure and properties compatible with, i.e., designed and
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`constructed for use in, bone. Without significant modification of both the
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`mechanical and structural properties of the balloons, bone catheters outfitted with
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`bone balloons cannot be used in blood vessels, nor can blood vessel catheters
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`outfitted with vascular balloons be used in bone. The bone and vasculature are
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`very different environments placing particular mechanical and material demands
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`on balloon structure and properties. In other words, the word “bone” provides a
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`structural context for the device and does not refer to end use of the device.
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`23. The dilatation balloons in Valley (Ex. 1007) are not “inherently capable of
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`compressing cancellous bone”. Institution Decision, IPR2014-01519 at p. 12,
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`Paper 7. The balloons in Valley are designed to operate at peak pressures much
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`lower than those encountered in compressing cancellous bone. For example, the
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`peak inflation pressure of the balloon in Valley is shown as 35 psi. Ex. 1007, 21:1-
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`4. In contrast, the balloon described in the ’505 patent is designed to withstand
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`pressures up to 250-500 psi. Ex. 1001, 13:1-5. In my experience, such pressures
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`are routinely used to compress diseased cancellous bone.
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`24. 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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`1007, 21:24-33, referencing FIG. 5A, reproduced below.
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`Ex. 1007 at p. 5.
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`25. 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. 1007, 21:
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`1-5) are insufficient to compress cancellous bone effectively. Pressures typically
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`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,
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`I 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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`26. 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. 1007, 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 structure of Valley is 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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`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. 1007 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. 1007 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 follows:
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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
`[
`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. 1007) 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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`27. The balloon in Valley is designed for operating in a soft environment, that of
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`vasculature, and all of the teachings in it are specific to vascular applications. Ex.
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`1007 at 5:29-67; 6:1-10. For example, the catheter is designed with a soft,
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`atraumatic tip. Ex. 1007 at 47:25-30. Additionally, the balloon in Valley is
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`formed from elastomeric materials by nature soft and comparatively atraumatic
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`when pressed against an anatomic structure such as a blood vessel. Ex. 1007 at
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`21:32-46.
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`28. The balloon in the ’505 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 7:24-31 (“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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`IPR2014-01519 Page 19 of 31
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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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`29. Thus, the balloon of the ’505 patent creates a permanent cavity of
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`predictable geometry and volume where cement can be injected in a safe and
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`effective manner. A person of ordinary skill reading the ’505 patent would know
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`that if the geometry of the cavity in the cancellous bone is in any manner
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`unpredictable, i.e., there is a portion of the cavity which is not predictably
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`expanded, the cement can extravasate in multiple directions like fingers of a glove,
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`which makes monitoring of the volume injected difficult and increases the risk of
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`leakage from the cavity.
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`30. The contrast between the expansion of the balloon in the ’505 patent and the
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`balloon in Valley (Ex. 1007) can be illustrated below in a figure taken from Valley.
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`20
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`Ex. 1007 at p. 12.
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`31.
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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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`32. Mr. Sheehan presents the following analysis of the distal end of the outer
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`catheter tube in Andersen. Ex. 1005 at p. 4.
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`22
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`Ex. 1002 at p. 61.
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`The claim chart of the Sheehan Declaration also describes the figure in a similar
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`way. Ex. 1002 at p. 63.
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`33. Based on his description, the distal of the outer catheter tube, shown in red,
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`ends before the “balloon portion” designated as “I” in FIG. 4a of Andersen and
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`identified as such in the Andersen specification. Ex. 1005 at 5:41-47).
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`34. For the following reasons, I disagree with where Mr. Sheehan places the
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`distal end of the outer catheter tube. Andersen states that the distal end of the
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`catheter 4 is 25. Ex. 1005 at 5:27-29. The “inner catheter tube” is also referred to
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`as the “inner tube”. Ex. 1005 at 5:27-29. In my view, the outer tube corresponds to
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`number 4 in Fig. 4a, and the blue portion and red portions are a single continuous
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`piece, all constituting portions of the catheter shaft, i.e., the outer catheter tube.
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`35. The specification of Andersen supports my analysis. Looking at Figure 3(a),
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`the catheter shaft or outer tube is divided into three portions, a balloon portion I, a
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`movable shaft portion II and an immovable shaft portion III. Ex. 1005 at 4:53-60.
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`Ex. 1005 at p. 3.
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`The balloon portion, I, inflates when the catheter is inserted into the blood vessel.
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`Ex. 1005 at 2:36-39; 8:61-68. Andersen describes the catheter as a “coaxial
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`catheter with a flexible inner tubing and an outer tubing of a filament reinforced
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`elastomeric material.” Ex. 1005 at 2:17-18. This coaxial arrangement of the inner
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`and outer tubes is shown clearly in Figure 4a. The distal end of catheter has a
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`“hollow plastic tip” 22. Ex. 1005 at 5:25-30.
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`36. Although the specification does not explicitly label the outer catheter tube,
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`the only interpretation of FIG. 4 which makes sense, in light of both the
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`specification as well as the mechanics of the catheter, is that the red and blue
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`portions shown above form the outer tube. In other words, the specification uses
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`“shaft” interchangeably with “outer catheter tube” or “outer tube.” Thus, the outer
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`tube ends at the point designated by numeral 25, after the expandable portion I.
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`This interpretation of the figure also means that the expandable portion is not
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`anchored to the inner tube, but rather to number 22, which is the hollow plastic tip.
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`Accordingly, the expandable portion of the catheter does not and cannot extend
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`beyond the end of the outer tube.
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`37. Moreover, the fact that a hollow plastic tip extends beyond the end of the
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`balloon portion means that the balloon in Andersen cannot create a cavity which
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`allows for relatively uniform compaction of the cancellous bone as indicated by the
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`’505 patent. Ex. 1001 at 10:51-59. In other words, there is an area where the
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`catheter is positioned where compaction of cancellous bone could not physically
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`occur. In addition, the inflation pressure, measured at the proximal catheter end 20,
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`will only partially propagate to the expandable portion of the outer tube because of
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`the pressure loss in the considerably think and long annular conduit in the catheter.
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`38.
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`In my view, Reiley (Ex. 1006) 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 that
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`best supports the bone when appropriately filled. It does not teach
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`how to prevent balloons from being spherical when inflated, when
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`this is desired. Current medical balloons can compress bone but are
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`too small and generally have the wrong configuration and are
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`generally not strong enough to accomplish adequate cavity
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`formation in either the vertebral bodies or long bones of the body.
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`Ex. 1004 at p. 5, ll. 25-33.
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`39.
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`In its specification, Reiley specifically refers to Andersen, U.S. Patent
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`No.4,706,670 (Ex. 1005 at p. 4, ll. 23). Andersen cannot create a cavity which
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`allows for near uniform compaction of the cancellous bone, that best supports the
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`bone, as required by the ’505 patent. Ex. 1001 at 10:51-59. The ’505 patent
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`specifically states that it wants to avoid the uneven compaction of the bone shown
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`for the 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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`40. Specifically, the ’505 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
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