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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`____________
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`Case IPR2014-01433
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`U.S. Patent No. 6,241,734 B1
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`DECLARATION OF GAMAL BAROUD, Ph.D.
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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 IPR2014-01433
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`U.S. Patent No. 6,241,734 B1
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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 from the Applied
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`Sciences of University of Aachen in Germany. In 1995, I was awarded a MSc.
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`Eng. in Mechanical Engineering from the University of Technology of Chemintz
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`in Germany and in 1997, I was awarded a Ph.D. in Mechanical Engineering from
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`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 the present, I have been a professor (and a full professor since
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`2008) at the Department of Mechanical Engineering at the University of
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`Sherbrooke in 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 the 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 2022.
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`9.
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`Over the past ten years, I have organized three international conferences and
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`co-chaired two other conferences focused on bone augmentation procedures.
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`These conferences gathered the key industrial, scientific and medical experts in
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`this 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. 6,241,734 (“the ’734 patent”) (Ex. 1001), Stryker’s
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`Petition for Inter Partes Review (the “Petition”) as well as the references cited
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`therein, including, Deramond, Ex. 1003, Kuslich, Ex. 1009, and the Declaration of
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`Dr. Jensen, Ex. 1002. I have also reviewed the Patent Owner’s Response to the
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`Petition as well as the transcript of Dr. Jensen’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 (“PTAB”) accords the claims of an unexpired patent their broadest
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`reasonable interpretation in view of the specification from the perspective of one of
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`ordinary skill in the art. I have been informed that the ’734 patent has not expired.
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`Therefore, in comparing the claims of the ’734 patent to the cited references,
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`Deramond and Kuslich, 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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`12.
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`I am informed that the ’734 patent is based on an application filed on August
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`14, 1998. I have therefore been advised that a reference qualifies as prior art only if
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`it disclosed or suggested the claimed invention of the ’734 patent prior to August
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`14, 1998.
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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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`Based on my experience, I agree with Dr. Jensen that the level of ordinary skill in
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`the relevant art at the time of the invention would be as follows: a person of
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`ordinary skill in the art relating to the subject matter of the ’734 patent “would
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`be a physician or a biomedical engineer with a number of years of experience,
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`e.g., three to five years, in the field of orthopedic technology or minimally
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`invasive surgery and, in particular, minimally invasive radiological procedures.”
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`Ex. 1002 at ¶13.
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`14.
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` Furthermore, at least by virtue of my advanced training in biomedical
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`engineering as well as over 20 years’ experience conducting research in
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`biomechanics, and in injectable cements for bone strengthening and augmentation,
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`which not only refers to increase in osseous dimensions by addition of material or
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`tissue but also includes verterbroplasty and kyphoplasty. I had and continue to
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`have an understanding of the capabilities of a person of ordinary skill in the
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`relevant art at the time of the invention of the ’734 patent. I have supervised and
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`directed many such persons over the course of my career.
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`15. The ’734 patent discloses and claims systems and methods for delivering
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`material into bone through a cannula. The ’734 patent describes an apparatus for
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`introducing material into bone through a subcutaneous cannula (Ex. 1001 at 2:3-5).
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`The apparatus includes a delivery device, such as a syringe, for conveying the
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`material at a “low delivery pressure.” Id. at 2:5-10. The pressure at which the
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`liquid is expressed from the syringe is no greater than about 360 psi. Id. The
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`apparatus can also include a nozzle, which can be advanced through the cannula to
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`deliver the material through a nozzle terminus into the bone. Id. at 2:11-13. The
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`nozzle can be coupled to the delivery device through a threaded connector. Id. at
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`10:45-46. The material to be injected can include a bone cement, auto- or allograft
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`tissue or a synthetic bone substitute. Id. at 3:13-17. One embodiment of the
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`apparatus is illustrated below in Figures 25 and 26 from the ’734 patent.
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`Ex. 1001 at p. 15.
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`The Figure is described as follows:
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`The injection nozzle 106 connects by a threaded connector
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`114 to the end of the syringe 1049 (see also Fig. 25). In the
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`illustrated embodiment, the nozzle 106 is made from a
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`generally flexible, inert plastic material, such as polyethylene
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`or another suitable polymer. Alternatively, the nozzle 106 can
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`be made from a generally rigid plastic or metal material. The
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`injection nozzle 106 is sized to be advanced through the
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`cannula instrument 30 (see Fig. 26).
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`Ex. 1001 at 10:43-53.
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`Optionally, the apparatus includes a tamping instrument.
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`Ex. 1001 at p. 17.
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`The tamping instrument 108 is made from generally rigid, inert
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`plastic or metal material… The purpose of the tamping
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`instrument 108 is to displace the residual material out the distal
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`end 36 of the cannula instrument 30 and into the cavity, to
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`thereby fill the cavity without exerting undue pressure within the
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`bone. The tamping instrument 108 thereby serves to clear
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`residual material from the cannula instrument 30, to assure that
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`the desired volume of material is delivered into the cavity.
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`Ex. 1001 at 11:17-50.
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`The apparatus can also include a cavity-forming instrument, illustrated
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`below.
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`Ex. 1001 at p. 5.
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`As Fig. 4A shows, the group 16 includes an instrument 76, which is
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`deployed through the cannula instrument 30 to a location inside
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`bone (see Fig. 20). When so deployed, the instrument 76 serves to
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`form a cavity in cancellous bone…The distal end 82 of the
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`instrument 76 carries an expandable structure 86. In the illustrated
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`embodiment, the expandable structure 86 is made from a
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`polyurethane or an elastomer (e.g., silicone or nylon) material. The
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`structure 86 has been preformed to possess a desired shape by
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`exposure to heat and pressure, e.g., through the use of conventional
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`thermoforming techniques.
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`Ex. 1001 at 8:27-53.
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`16.
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`I have been advised that claims may be found unpatentable as anticipated if
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`a single prior art reference discloses each limitation of the claim, either expressly
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`or inherently. I understand a limitation to be inherently disclosed only if it is
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`necessarily present in the reference.
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`17.
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`I understand that claims 15, 16, 19 and 20 are alleged to be anticipated by
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`Deramond. Petition at pp. 11-17. However, Deramond does not disclose any
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`pressures explicitly. Furthermore, to the extent that delivery pressures in
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`Deramond can be calculated, Deramond fails to disclose delivery pressure of
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`cement such as polymethylmethylacrylate (PMMA) in vertebral augmentation
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`procedures of no greater than 360 psi.
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`18. Specifically, Dr. Jensen states that “mean maximum pressure of a 1- cc
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`syringe is about 360 psi. Ex. 1002 ¶ 40. Dr. Jensen also says that “syringes with a
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`volume of 1 cc or greater” have delivery pressures less than 360 psi. For the
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`following reasons, I disagree.
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`19. Dr. Jensen cites to Krebs et al. (Ex. 1012, “Krebs”) as supporting her
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`argument. Krebs is based on work done in part from my group and I am a co-
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`author on that paper. I draw a very different conclusion from Dr. Jensen about
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`delivery pressure cement of PMMA in Deramond. Krebs discloses a delivery
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`pressure for injection of cement or polymethylmethacrylate (PMMA) into bone,
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`using a 5-cc syringe of up to 3214 kPa, which equates to
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`approximately 466 psi (0.145 *3,214 kPa). Krebs further discloses an average
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`delivery pressure in a normal 5 cc syringe having a syringe nozzle of 1704 ± 597
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`kPa, which corresponds to a pressure range of 160.52 to 333.65 psi, allowing for a
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`variation of about one standard deviation.
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`20. The cross-sectional area, A, of a 5-cc syringe equals
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`where the diameter d of the 5-cc syringe is 12.50 mm. Accordingly, A equals
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`122.71 mm2.
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`21. The delivery force generated by the physicians can be calculated based on:
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`In accordance with above equation, the average delivery force, with a 67-percent
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`confidence interval, is in the range of 209 ± 73 N. This is the force a physician
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`typically generates in the bone augmentation procedures.
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`22. Krebs used an 8-gauge needle in his experiments. Compared to a 10 or 15-
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`gauge needle used in Deramond, an 8-gauge needle is larger in diameter, i.e., has a
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`larger bore. This means if the physician uses 15-gauge or 10-gauge instead of the
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`8-gauge needle, it will not get any easier, i.e., the average delivery force needed to
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`deliver the cement will not be smaller than those reported by Krebs et al.
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`23. Specifically, the diameter of a 2 or 3-cc syringe is 8.6 mm. The cross
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`sectional area in the barrel of a 2 or 3 cc syringe is 58.09 mm2. In this regard, it is
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`important to note that the 2 and 3 cc syringes are typically the same barrel size
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`(cross sectional area) with the only difference being the graduation/marking.
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`Accordingly, the delivery pressure that a physician can generate in 2 or 3-cc
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`syringe is 521.69 ± 182 psi, and can reach pressures of up to 984.45 psi for the
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`maximum forces/pressures reported in Krebs et al.
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`24. The diameter of 1-cc syringe is 4.85 mm, resulting in a cross section of
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`18.47 mm2. Therefore, the delivery pressure generated in the 1-cc syringe is in the
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`range of 1640.76 ± 575.24 psi.
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`25. These pressure numbers of PMMA or cement injection are similar to those
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`found in Hayward et al. (Ex. 1011) (Jensen refers to Hayward in her declaration as
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`supporting her position, Ex. 1002 at ¶ 40). In the results section, Hayward et al.
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`(Ex. 1011) reported, “[s]maller syringes generated higher pressure of up to 600 psi
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`for a 1 mL syringe”, even when injecting a fluid less viscous than cement or
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`PMMA such as triamcinolone. Ex. 1011 at p. 381. A few lines below, Hayward
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`et al. stated that “the 1 mL and 3 mL syringes consistently generated high levels of
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`pressure (300-600 psi).” Id. These pressure-related statements in Hayward are also
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`reflected in the tables and figures of Hayward et al. Specifically, in Table 1,
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`Hayward et al. reported calculated pressures for the 1-mL syringe to be 472±256
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`psi (mean ± one standard deviation SD). In a normal distribution, 1 SD refers to
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`only 68 percent confidence interval around the mean value. This means that, with
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`68 percent confidence the measured pressure of delivery will be in the range 472-
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`256=216 psi to 472+265= 728 psi. This means that the maximum pressure
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`observed in Hayward can reach 728 psi.
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`26. Thus, based on the analysis that I have done as well as my own experimental
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`work with syringes of various sizes as well as my work with injectable materials
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`such as PMMA, the delivery pressures of PMMA or cement in a 2 or 3-cc syringe
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`into bone will greatly exceed 360 psi.
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`27. Therefore, the pressures in Deramond are not necessarily at or below 360 psi
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`and claim 15 cannot be anticipated by Deramond.
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`28.
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`I have been advised that the claims of a patent are obvious if the differences
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`between the subject matter . . . patented and the prior art are such that the subject
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`matter as a whole would have been obvious at the time the invention was made to a
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`person having ordinary skill in the art to which said subject matter pertains. In
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`analyzing obviousness, I understand that I should take into account: (1) the scope
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`and content of the prior art; (2) the differences between the prior art and the claims;
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`(3) the level of ordinary skill in the art; and (4) any objective evidence of
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`nonobviousness.
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`29. Dr. Jensen states that “Deramond discloses a coaxial embodiment where a
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`15-gauge needle is inserted into a 10-gauge needle with a stylet shown within the
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`15-gauge needle. (see Figure 4A.)” (Ex. 1002 at ¶ 71). Here, according to Dr.
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`Jensen, the 15-gauge needle acts as a nozzle, while the 10-gauge needle serves as a
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`cannula. Id.
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`Ex. 1003 at p. 5.
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`30. Given the disclosure of the reference, such an arrangement simply does not
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`work. Deramond itself states that the 10-gauge needle is 10 to 15 cm in length,
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`while the 15-gauge needle is 5-7 cm in length. Deramond, Ex. 1003 at p.2, right
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`col. Thus, if the 15-gauge needle is inserted into the 10-gauge needle in a coaxial
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`arrangement, the shorter 15-gauge needle cannot extend beyond the end of the
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`longer 10-needle (which would be required if the 15-gauge needle is to serve as a
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`tamping instrument as discussed below). In fact, Deramond shows the 15-gauge
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`needle in Fig. 4A likely being used as a biopsy needle, not a delivery needle to
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`convey material into the bone. There is no cement or any others filling materials,
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`neither in the needles or in the bone, shown in Fig. 4A.
`31. Dr. Jensen also states that “the stylet within the 15 gauge needle (shown in
`Fig. 4A) could be nested with the 15 gauge needle to form a tamping
`instrument for the 10 gauge cannula” to urge residual material from the cannula.
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`(Ex. 1002 at ¶ 72).
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`Stylet/Mandrel%dimensions%
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`8+g%needle%
`4.191%mm%
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`3.429%mm%
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`10+g%needle%
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`15+g%needle%
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`3.404%mm%
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`2.692%mm%
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`1.829%mm%
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`1.372%mm%
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`0.381%mm%
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`0.356%mm%
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`Stylet/mandrel%
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`Stylet/mandrel%
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`0.229%mm%
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`Source%(pg.%2520,%Machinery’s,Handbook,%29th%EdiEon,%ISBN+13:%978+0831129002%)%
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`32.
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`It is evident from the dimensions for 8, 10 and 15-gauge needles shown
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`above that if cement were extruded from a 15-gauge needle arranged coaxially
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`within a 10-gauge needle then PMMA could leak in the space between the 15-
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`gauge needle and the 10-gauge needle (compare the outer dimensions of the 15-
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`gauge needle, 1.829 mm, verses the inner dimension of the 10-gauge needle, 2.692
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`mm.
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`33. Thus, a passage or annular lumen would exist between the outer surface of
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`the 15-gauge needle and the inner surface of the 10-gauge needle. Even assuming
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`for the sake of argument that a stylet occupied the entire internal space of a 15-
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`gauge needle as well as extended beyond the 15-gauge needle and beyond the 10-
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`gauge needle, the space between the 10-gauge and 15-needles would remain. Id. If
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`material such as PMMA were delivered through the 15-gauge needle, potentially,
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`the PMMA could leak backwards into the space between the 10- and 15- gauge
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`needles. Id. Thus, the 15-gauge needle together with the stylet could not be used as
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`a tamping device to effectively push material out of the 10-gauge needle (cannula)
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`because the material would back up into the annular space between the 10-gauge
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`needle and the 15-gauge needle. Id.
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`34. Moreover, if a 10-gauge needle were used to deliver PMMA, then the
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`operator would have to fill and empty the syringe close to 10 times in order to
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`deliver a 5 cc bolus of PMMA. This would likely result in hardening of the
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`PMMA during extrusion. Specifically, the inner diameter of the 10-gauge needle is
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`2.692 mm. If the cylindrical volume formed by the inner lumen of needle can be
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`written as follows:
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`V = A⋅ l = π
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`€
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`d2
`4 ⋅ l = 5.68 mm2⋅ l
`15
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`where A of 5.68 mm2 is the cross-section area of 10-guage needle, and l is the
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`length of the 10-guage needle. If l is 100 mm, the inner volume V of the 15-guage
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`needle is: V = 5.68 mm2 · 100 mm = 568 mm3.
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`35. With respect to Kuslich (Ex. 1009), “figures 5, 6, and 7B, Kuslich describes
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`an apparatus for introducing graft materials into bone through a subcutaneous
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`cannula 54: “bag 40 may be filled by packing the graft medium 52 through a guide
`tube 54.” (Ex. 1009, 9, 61-67.)”. Ex. 1002 at ¶166. However, figures 5 and 6
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`show a picture of an intervertebral disk not a bone. The intervertebral disk is
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`cartilaginous, not osseous.
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`Ex. 1009 at p. 3.
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`Ex. 1009 at p. 4.
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`36.
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`The bag, 40, referred to in Kuslich (Ex. 1009) is a fabric bag. Ex. 1009 at
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`7:1-61.
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`Ex. 1009 at p. 8.
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`37.
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`The bag, 40, is a porous implant, i.e., it allows for “ingress and egress” of
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`materials. Id. The bag does not form a cavity, but is inserted into a “previously
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`excavated space 44” and then this bag is compacted with material such as bone
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`chips or graft. Ex. 1009 at Abstract;7:26-27. The bag acts as a mechanical lifting
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`or spacer device positioned against the endplates of the intervertebral disk. When
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`inserted, the bag is packed with granules and forces the disk space open. Ex. 1009
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`at 9:24-40. The bag is designed to support physiological compressive loads
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`exceeding 1000 psi. Id. at 1:53. In fact, the scientifically correct way to refer to the
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`forces exerted on filler granules in the bag are compressive compaction forces, not
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`pressure. Id.
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`38.
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`The implanted bag once filled with bone chips or ganules has to be able
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`support the physiological compressive loads as specified above. Flowable bone
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`cement paste such as polymethyl methacrylate cannot be safely used to augment
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`the permeable bag. The cement paste would leak, if attempts are made to fill the
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`porous fabric bag. These leaks would extend beyond the intervertebral disk being
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`treated and likely cause severe adverse effects such as spinal nerve canal
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`compression, or potentially death if the PMMA cement paste enters the
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`cardiovascular system.
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`39. Kuslich teaches compacting the bone graft into the permeable bag and
`
`rendering it rigid. These high intra-tissue forces if applied inside the vertebrae
`
`18
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`ORTHOPHOENIX EXHIBIT 2021
`STRYKER CORPORATION v.
`ORTHOPHOENIX, LLC
`IPR2014-01433 Page 18 of 20
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`
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`would have disastrous consequences and would likely lead to cement leaks and/or
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`adverse effects on the patient. In short, Kuslich teaches with compacting the bone
`
`graft into the bag and rendering it rigid in a comparatively soft, yet restrained
`
`elastic environment of the intervertebral space in order to be able to withstand high
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`compressive load forces, not, as Dr. Jensen contends a “low pressure (e.g., under
`
`360 psi)… delivery [that] could be controlled.” Ex. 1002 at ¶164.
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`19
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`ORTHOPHOENIX EXHIBIT 2021
`STRYKER CORPORATION v.
`ORTHOPHOENIX, LLC
`IPR2014-01433 Page 19 of 20
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`
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`ORTHOPHOENIX EXHIBIT 2021
`STRYKER CORPORATION v.
`ORTHOPHOENIX, LLC
`IPR2014-01433 Page 20 of 20
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