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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`STRYKER CORPORATION,
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner
`_________
`
`Case IPR2014-01535
`Patent 6,280,456 B1
`
`DECLARATION OF NEIL J. SHEEHAN
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`
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`STRYKER EXHIBIT 1002, pg. i
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`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
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`IPR2014-01535
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`ORTHOPHOENIX EXHIBIT 2011
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`IPR2014-01519 Page 1 of 84
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`Declaration of Neil J. Sheehan
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`TABLE OF CONTENTS
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`INTRODUCTION............................................................................................. 2
`I.
`BACKGROUND AND QUALIFICATIONS ........................................................... 3
`II.
`DOCUMENTS CONSIDERED IN FORMING MY OPINIONS ............................... 4
`III.
`BACKGROUND OF THE ART ........................................................................... 5
`IV.
`BRIEF DESCRIPTION OF THE 456 PATENT .................................................... 17
`V.
`PERSON OF ORDINARY SKILL IN THE ART .................................................... 21
`VI.
`CLAIM CONSTRUCTION ............................................................................... 22
`VII.
`VIII. CLAIMS 1-10 OF THE 456 PATENT ARE ANTICIPATED OR OBVIOUS IN
`VIEW OF THE PRIOR ART ............................................................................. 24
`A.
`Comparison Of Claims 1-4 To Pathak ............................................... 26
`B.
`Comparison Of Claims 1-7 To Pathak And Reiley ............................. 34
`C.
`Comparison Of Claims 1-7, 9 And 10 To Reiley And Andersen ......... 45
`D.
`Comparison Of Claims 1-10 To Reiley And Valley ............................. 55
`E.
`Comparison Of Claims 1-8 To Reiley And Antoshkiw ........................ 66
`SECONDARY CONSIDERATIONS ................................................................... 75
`CONCLUSION .............................................................................................. 75
`
`IX.
`X.
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`I.
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`Declaration of Neil J. Sheehan
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`I, Neil J. Sheehan, declare as follows:
`
`1.
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`INTRODUCTION
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`I have been retained as an expert witness on behalf of Stryker
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`Corporation (“Stryker”) for the above captioned inter partes review (“IPR”). I am
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`being compensated for my time in connection with this IPR at my standard
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`consulting rate, which is $600.00 per hour, plus expenses. My compensation is
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`not dependent upon the outcome of this matter.
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`I understand that the Stryker petition for IPR concerns U.S. Patent No.
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`2.
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`6,280,456 (“the 456 patent”) (Ex. 1001) and requests that the United States
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`Patent and Trademark Office (“USPTO”) cancel claims 1-10 of the 456 patent. I
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`further understand that the 456 patent is currently owned by Orthophoenix, LLC
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`(“Orthophoenix”). I have also provided a Declaration for IPR2014-01519, a
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`related IPR of U.S. Patent No. 6,623,505 (“the 505 patent”), which is related to the
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`456 patent.
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`3.
`
`The 456 patent is generally directed to expandable structures, which,
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`in use, are deployed in interior body regions of humans and other animals. (Ex.
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`1001, 1:9-11.) The claims of the 456 patent describe a method employing a “tool”
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`with an expandable structure, such as a typical balloon catheter. (See, e.g. id. at
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`1:15-16 (“expandable structures, generically called “balloons,. . . ”); 16:6-22 (claim
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`Declaration of Neil J. Sheehan
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`1).)
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`4.
`5.
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`Throughout this declaration, the field of catheters carrying an
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`expandable or inflatable structure, such as a typical balloon catheter, is referred
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`to as the relevant field or the relevant art.
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`In preparing this Declaration, I have reviewed the 456 patent and
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`considered the documents cited in Section III, in light of the general knowledge of
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`a person of ordinary skill in the relevant art. In forming my opinions, I have relied
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`upon my experience as an engineer and consultant with extensive experience
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`with various medical devices – including catheter and balloon devices.
`
`BACKGROUND AND QUALIFICATIONS
`
`II.
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`6. My field of expertise in this matter is medical products or devices. A
`7.
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`copy of my current Curriculum Vitae is attached, providing a comprehensive
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`description of my academic and employment history, among other things.
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`I received my Bachelor of Science in Mechanical Engineering degree,
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`summa cum laude, from Villanova University in 1968. I was the recipient of their
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`1993 Alumni Achievement Award for my work in the medical device field. I took
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`graduate courses in the department of Engineering and Applied Physics at
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`Harvard University in 1968-1969. I also studied biology, biochemistry, and organic
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`chemistry at the University of California at Berkeley in 1974-1975.
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`Declaration of Neil J. Sheehan
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`I have nearly forty years of experience in medical device design and
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`development, with roles ranging from that of an individual contributor to that of a
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`Vice President of Engineering and Manufacturing.
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`I have been directly involved in the design, development, and
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`manufacture of medical devices since 1975, both as an employee and as a
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`consultant.
`
`8.
`9.
`10.
`11.
`III. DOCUMENTS CONSIDERED IN FORMING MY OPINIONS
`12.
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`I am a named inventor on 39 patents in the medical device field
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`covering a broad range of products.
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`In addition, I have designed, worked with, and consulted on
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`hundreds of medical devices, including catheter and balloon devices and devices
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`used in bone, and the like.
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`In forming my opinions, I have considered at least the following
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`documents:
`
`Exhibit
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`
`Description
`U.S. Patent No. 6,280,456 (“the 456 patent”)
`Curriculum Vitae
`WO 94/24962 (published Nov. 10, 1994) (“Pathak”)
`WO 95/20362 (published Aug. 3, 1995) (“Reiley”)
`U.S. Patent No. 4,706,670 (issued Nov. 17, 1987) (“Andersen”)
`U.S. Patent No. 5,766,151 (filed Jun. 7, 1995) (issued Jun. 16, 1998)
`(“Valley”)
`U.S. Patent No. 4,024,873 (issued May 24, 1977) (“Antoshkiw”)
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`Declaration of Neil J. Sheehan
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`Exhibit
`1008
`1009
`1010
`1011
`1012
`1013
`1014
`1015
`1016
`1017
`1018
`
`IV.
`
`Description
`U.S. Patent No. 5,480,400 (issued Jan. 2, 1996) (“Berger”)
`U.S. Patent No. 4,490,421 (issued Dec. 25, 1984) (“Levy”)
`U.S. Patent No. 5,108,404 (issued Apr. 28, 1992) (“Scholten 404”)
`U.S. Patent No. 5,547,378 (issued Aug. 20, 1996) (“Linkow”)
`U.S. Patent No. 5,849,014 (issued Dec. 15, 1998) (“Mastrorio”)
`U.S. Patent No. 281,043 (issued Jul. 10, 1883 to Finney)
`U.S. Patent No. 397,060 (issued Jan. 29, 1889 to Knapp)
`U.S. Patent No. 4,313,434 (issued Feb. 2, 1982 to Segal)
`U.S. Patent No. 4,562,598 (issued Jan. 7, 1986 to Kranz)
`U.S. Patent No. 5,372,138 (issued Dec. 13, 1994 to Crowley)
`European Patent No. 0405831 (published Jun. 7, 1995) (“Barbere”)
`
`BACKGROUND OF THE ART
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`13. Catheters carrying inflatable structures for deployment in interior
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`body regions
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`(including catheters employing an
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`inner and outer tube
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`configuration) have been used by physicians for many decades for a variety of
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`applications. For example, balloon catheters have been known for many years in
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`urinary and vaginal applications, in the vasculature for applications such as
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`angioplasty and stent delivery, and in bone for compressing cancellous bone and
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`adjusting fractures. U.S. Patent No. 281,043 (issued Jul. 10, 1883) discloses a
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`urinary catheter with an inflatable balloon attached to an inner and outer tube.
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`(See Ex. 1013, Fig. 3, 1:36-42, 2:90-3:4.) U.S. Patent No. 397,060 (issued Jan. 29,
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`1889) discloses a device with an expandable structure used to expand the folds of
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`the vaginal walls. (See Ex. 1014, Fig. 2, 1:25-2:62.)
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`14.
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`In addition, inflatable balloon catheters have long been used in
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`angioplasty. (See, e.g., Ex. 1009, 1:5-23.) Since the advent of angioplasty
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`catheters, angioplasty balloon catheters have been used to compress plaque
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`(including calcified lesions) in arteries and deliver stents. (See, e.g., id. at 1:19-23;
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`Ex. 1005, 1:11-14; Ex. 1003, 1; Ex. 1004, p. 3 ll. 22-30.)
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`15. With the increase in angioplasty and stent procedures there has been
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`a proliferation of balloon catheter designs. Skilled artisans contemplating the
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`design of a balloon catheter would have considered angioplasty and other
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`cardiovascular catheters. As one patent explained, “[b]alloon catheters are not
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`limited in their use to the relief of arterial stenosis but have been found useful in
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`many medical applications involving not only insertion into blood vessels but also
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`involving insertion into a variety of body cavities.” (Ex. 1009 at 1:19-23.)
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`Specifically, with the advent of balloon-assisted vertebroplasty, or
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`vertebral kyphoplasty, in the late 1980s,1 it became well known (and even the 456
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`patent specification recognizes) that balloon catheter designs originally conceived
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`1 Balloon-assisted vertebroplasty is a procedure involving injecting bone cement
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`16.
`
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`into a vertebral body after creating a cavity in the bone using a balloon catheter.
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`(See, e.g., Ex. 1010 (U.S. Patent No. 5,108,404 (issued Apr. 28, 1992)).)
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`for cardiovascular purposes could be used in bone. (Ex. 1001 at 1:14-21 (“The
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`deployment of expandable structures into interior body regions is well known.
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`For example, expandable structures, generically called ‘balloons,’ are deployed
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`during angioplasty to open occluded blood vessels. As another example, U.S. Pat.
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`Nos. 4,969,888 and 5,108,404 disclose apparatus and methods the [sic] use of
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`expandable structures for the fixation of fractures or other osteoporotic and non-
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`osteoporotic conditions of human and animal bones.”), 4:27-44; Ex. 1004 at p. 4 ll.
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`21-25, p. 5 ll. 29-33.)
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`17.
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`The Pathak publication (see table in ¶ 12 for identification of
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`references described by name), which disclosed balloon catheters used for
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`implanting polymeric materials in the form of a stent, focused on cardiovascular
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`applications but also explained how the catheter could be used “[i]n other
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`therapeutic applications, (i.e., trachial [sic], urinary, bronchial, bone lumens and
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`the like) . . . .” (Ex. 1003 at 15) (emphasis added.) Additionally, Linkow, which
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`disclosed an inflatable balloon used to create a cavity into which bone fragments
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`are inserted for fusing with each other and surrounding bone, explained that
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`“[t]here are catheters used for balloon angioplasty which are ideal for use in the
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`present invention.” (Ex. 1011, Abstract, 4:46-47.) Likewise, Mastrorio described
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`creating a cement plug in a bone cavity by using an angioplasty balloon catheter.
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`(Ex. 1012, 3:10-13 (“In an exemplary embodiment, the conduit [] and inflatable
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`body [] are provided by a catheter of the type useful
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`in angioplasty
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`18.
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`procedures.”).)
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`Indeed, Reiley disclosed using a balloon catheter to compress
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`cancellous bone in vertebral applications and for addressing bone fractures in
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`long bones. (Ex. 1004 at Abstract, p. 6 ll. 17-21, p. 19 ll. 17-35, pp. 24-28.) Reiley
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`disclosed “[a] balloon (10) for use in compressing cancellous bone and marrow
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`(also known as medullary bone and trabecular bone) against the inner cortex of
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`bones whether the bones are fractured or not.” (Id. at Abstract.) As such, it was
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`known to a person of ordinary skill that when the expandable structure assumes
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`the expandable geometry it will exert an interior force upon the surrounding
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`cortical bone. (Id. at p. 6 ll. 17-26, p. 10 ll. 30-34.)
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`19. Reiley taught advancing a catheter with a balloon at its distal end
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`through a cannula in order to compress cancellous bone upon expansion of the
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`balloon in, for example, the vertebra (as shown in Figure 2 of Reiley). Reiley also
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`praised the design of balloon catheters used in angioplasty, including the
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`Andersen design (see Figure in ¶ 20 below), which it described as a “coaxial
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`catheter with inner and outer tubing . . . .” (Id. at p. 4 ll. 21-25.) After discussing
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`the current state of the art regarding angioplasty balloon catheters, Reiley
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`disclosed what was well known in the art, i.e., that “[c]urrent medical balloons
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`can compress bone . . . .” (Id. at p. 5 l.29; see generally id. at p. 3 l. 13 – p. 5 l. 33.)
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`Additionally, Reiley discloses conveying material into a cavity, including bone
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`cement. (Id. at p. 2 ll 25-29; p. 11 ll. 15-23.)
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`20. Also, even prior to and certainly by the 1990s, catheters having two
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`concentric tubes with the inner tube (shown in green below) extending distally
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`beyond the outer tube (shown in red below) and an inflatable structure such as a
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`balloon (shown in blue below) distally attached to the inner tube and proximally
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`attached to the outer tube (as claimed in the 456 patent) were standard and well-
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`known in the art. As shown below, and as will be discussed in greater detail,
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`Pathak (published in 1994), Andersen (issued in 1987), Antoshkiw (issued in 1977),
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`Valley (filed in 1995, issued in 1998), and Barbere (issued in 1995) (Ex. 1018)
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`disclose such catheters in various applications including bone, as well as an
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`expandable structure that was introduced into bone while in a generally collapsed
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`geometry and that was caused to assume an expanded geometry once inside the
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`bone. The 456 patent acknowledged that “[t]he deployment of expandable
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`structures into interior body regions is well known.” (Ex. 1001 at 1:14-15.)
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`21. One of the earlier catheter design references, Antoshkiw, issued on
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`
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`May 24, 1977. (See Ex. 1007.) Antoshkiw discloses a multi-component flow
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`directed balloon catheter system for use in the determination of physiological
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`parameters in the vascular system. (Id. at Abstract, 1:5-14.) Antoshkiw discloses
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`a balloon catheter assembly with “an inner tube 24 [shown in green] having an
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`open distal end 26 and an open proximal end 28.” (Id. at 3:17-18, 1:30-32.) A
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`concentric outer tube 30 (shown in red) is positioned “so that the inner tube 24
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`extends distally and proximally from the ends of the outer tube 30.” (Id. at 3:19-
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`23.)
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`22.
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`“An inflatable balloon portion 38 [shown in blue] is attached to both
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`
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`the inner and outer tubes.” (Id. at 3:28-29.) Like other prior art catheters, “[t]he
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`distal end 40 of the balloon portion is affixed to the outer surface of the distal end
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`of the inner tube and the proximal end 42 of the inflatable portion 38 is attached
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`to the outer surface of the distal end of the outer tube 30.” (Id. at 3:29-33.) “By
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`sealing both ends of the balloon portion 38 to the tubes 24 and 30, an inner
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`chamber 44 is formed in the balloon portion with the only access to inner
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`chamber 44 being through the annular passageway 36 between the tubes.” (Id.
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`at 3:40-44, 1:32-37.) “[T]o inflate the balloon portion 38, a suitable inflation
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`medium such as a gas like air or carbon dioxide or a liquid can be passed in a
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`conventional manner through the opening 34 at the proximal end of outer tube
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`30, through annular passageway 36 and into chamber 44 to thereby expand the
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`flexible balloon 38 . . . .” (Id. at 3:45-51; see also id. at 3:24-27, 3:40-44.)
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`23. Antoshkiw discloses that the proximal and distal ends of the balloon
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`are capable of being inverted. (See, e.g., id. at Figs. 2-3.) Antoshkiw teaches that
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`“the inflated balloon 38 can be altered in configuration, as desired, by merely
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`shifting the relative axial position between inner tube 24 and outer tube 30 as
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`depicted in FIG. 3 [see red arrow] where the inner tube has been withdrawn
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`rearwardly toward the outer tube thereby causing the affixed balloon to deform
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`outwardly into engagement with the walls of the vessel 22.” (Id. at 3:53-59; see
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`also id. at 1:26-29, 1:47-52.)
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`
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`used
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`in the human vascular system, the catheter assembly has various
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`24. Antoshkiw further discloses that, although the catheter is primarily
`25. Valley provides another example of balloons with the proximal and
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`applications and can be utilized “in other areas of the body.” (Id. at 2:6-14.)
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`distal ends of the balloon inverted. (Ex. 1006 at 25:27-42; See also Ex. 1017 at Fig.
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`18d.) For example, Valley discloses such a balloon at Figure 8C:
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`It was also known that the inner catheter tube and the expandable
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`structure could be more compliant than the outer catheter tube, among other
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`
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`26.
`27. Moreover, prior to the 456 patent, inflatable balloons had been used
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`variations. (Ex. 1006 at 21:40-47, 26:67-27:6; Ex. 1005 at 2:17-19.)
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`to create cavities in bone by compressing cancellous bone. U.S. Patent No.
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`5,108,404
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`(1992)
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`to
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`Scholten
`
`discloses methods
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`in which a
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`physician can form a cavity in bone –
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`including vertebral bones – by
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`inflating a balloon and compacting the cancellous bone. Specifically, Scholten 404
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`describes “forming an incision in the body and penetrating the bone having the
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`fracture with instruments including a guide pin and a cannula, drilling the bone
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`marrow of the bone . . . following which an inflatable device, such as an
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`expandable balloon, is inserted in the cavity and inflated. The expansion of the
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`balloon causes a compacting of the bone marrow against the inner surface of the
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`outer cortical wall of the bone to be treated to further enlarge the cavity.” (Ex.
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`1010 at 2:9-19, Fig. 21 (reproduced above).) Similarly, Reiley discloses an
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`improved balloon for use in compressing cancellous bone. “The main purpose of
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`the balloon is the forming or enlarging of a cavity or passage in a bone, especially
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`in, but not limited to, vertebral bodies.” (Ex. 1004 at Abstract, Fig. 2 (shown to
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`the right).) In fact, Reiley acknowledged that using balloons to compact
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`cancellous bone was already known in the art.
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`(Id. at p. 1 l. 20 – p. 3 l. 9.) The claimed
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`inventions of Reiley simply sought to improve
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`the effectiveness of the compaction by
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`incorporating additional engineering features into the balloons. (See, e.g., id.)
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`28. A person of ordinary skill in the art looking to design a balloon
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`catheter for bone applications would consider both bone and vasculature related
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`prior art. As Levy explains, “[b]alloon catheters are not limited in their use to the
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`relief of arterial stenosis but have been found useful in many medical applications
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`involving not only insertion into blood vessels but also involving insertion into a
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`variety of body cavities.” (Ex. 1009 at 1:19-23; see also Ex. 1003 at 15; Ex. 1011 at
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`Abstract, 4:46-47; Ex. 1012 at 3:10-14; Ex. 1004 at Abstract, p. 19 ll. 17-35, pp. 24-
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`28.)
`
`29.
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`It was not uncommon for practitioners and inventors to look at
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`angioplasty balloon catheters to solve problems related to the treatment of bone.
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`U.S. Patent No. 5,547,378 (1996) to Linkow, a patent disclosing an inflatable
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`balloon used to “create[] additional bone” in a sinus cavity, notes that “[t]here are
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`catheters used for balloon angioplasty which are ideal for use in the present
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`invention.” (Ex. 1011 at Abstract, 4:46-47.) Likewise, U.S. Patent No. 5,849,014
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`(1998) to Mastrorio describes creating a cement plug in a bone cavity by using an
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`angioplasty balloon catheter that presses against the interior bone wall. (Ex. 1012
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`at 3:10-14 (“In an exemplary embodiment, the conduit [] and inflatable body []
`
`are provided by a catheter of the type useful in angioplasty procedures.”).)
`
`30. Moreover, prior to the 456 patent, it was known that angioplasty
`
`balloon catheters could be used to compress bone. Reiley taught that catheter
`
`assemblies as claimed in the 456 patent (i.e., with an inflatable balloon distally
`
`attached to an inner tube and proximally attached to an outer tube) were well-
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`known in the art (Ex. 1004 at p. 4 ll. 21-33 (citing Ex. 1005, Andersen)) and that
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`IPR2014-01519 Page 16 of 84
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`Declaration of Neil J. Sheehan
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`31.
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`these assemblies could compress bone. (Ex. 1004 at p. 5 l. 29.)
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`There are many other examples of inflatable balloons being used
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`inside bone cavities. (See, e.g., Ex. 1015; Ex. 1016; Ex. 1008.) The Segal patent
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`involves a method of inserting a deflated flexible bladder (balloon) into the
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`medullary cavity of a bone, inflating the bladder (balloon) so as to conform to the
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`shape of the medullary canal, sealing the opening used to insert the bladder,
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`unsealing the opening after the fracture has
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`healed, and removing the bladder. (Ex. 1015 at
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`Abstract, 1:4-11, 1:55-2:13, Fig. 3 (reproduced
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`to the right).) The Kranz patent disclosed a
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`joint prosthesis for insertion in a bone cavity comprising a hollow, inflatable
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`“pressing member” for inflation and conforming to the walls of the bone cavity.
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`(Ex. 1016 at 1:48-57, 3:26-29, 5:25-37 (claim 1), 6:29-39 (claim 16).) The Berger
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`patent also disclosed an inflatable balloon used in a bone cavity to apply a
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`compressive force across a fracture site to enhance the stability of the fractured
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`bone and promote osseous healing. (See, e.g., Ex. 1008.)
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`In summary, balloon catheters of the type claimed in the 456 patent
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`had a long history of use in numerous applications, including the treatment of
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`bone. At the time of the 456 patent, a person of ordinary skill in the art who was
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`- 16 -
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`STRYKER EXHIBIT 1002, pg. 16
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`32.
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`ORTHOPHOENIX EXHIBIT 2011
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`trying to utilize an expandable structure in bone would have been aware of the
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`balloon catheters used in these numerous applications, or at least, would have
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`known to look toward existing vascular balloon catheter designs for a solution.
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`BRIEF DESCRIPTION OF THE 456 PATENT
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`V.
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`33.
`34.
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`The 456 patent (Ex. 1001) is entitled “Methods For Treating Bone,”
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`and discloses the design of expandable structures for use in bones or the
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`vasculature.
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`The 456 patent was filed on September 23, 1999, and claims priority
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`to U.S. Patent No. 5,972,015 (“the 015 patent”), which was filed on August 15,
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`1997. The 456 patent is directed to “expandable structures, which, in use, are
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`deployed in interior body regions of humans and other animals.” (Ex. 1001 at 1:9-
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`11.) Specifically, the specification of the 456 patent focuses on purportedly
`
`solving problems arising from using expandable structures such as balloons in
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`asymmetric applications.
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`The deployment of expandable structures into interior body
`regions
`is well known.
` For example, expandable structures,
`generically called “balloons,” are deployed during angioplasty to
`open occluded blood vessels. As another example, U.S. Pat. Nos.
`4,969,888 and 5,108,404 disclose apparatus and methods the [sic]
`use of expandable structures for the fixation of fractures or other
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`- 17 -
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`STRYKER EXHIBIT 1002, pg. 17
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`ORTHOPHOENIX EXHIBIT 2011
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
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`Declaration of Neil J. Sheehan
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`osteoporotic and non-osteoporotic conditions of human and animal
`bones.
`Many interior regions of the body, such as the vasculature and
`interior bone, possess complex asymmetric geometries. Even if an
`interior body region is somewhat more symmetric, it may still be
`difficult to gain access along the natural access of symmetry.
`(Id. at 1:14-26.)
`
`35.
`
`The 456 patent specification discloses that problems exist with
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`accessing the asymmetric geometries of the interior of the vasculature and bone
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`(Id. at 1:27-37) and that it can also be important to maximize the size and surface
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`area of an expandable structure when deployed in an interior body region. (Id. at
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`1:39-60.) The 456 patent specification purports to solve this problem with design
`
`features such as asymmetric balloon shapes tailored to the application. Examples
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`of such shapes are shown below:
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`- 18 -
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`STRYKER EXHIBIT 1002, pg. 18
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`ORTHOPHOENIX EXHIBIT 2011
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`Declaration of Neil J. Sheehan
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`36.
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`The specification also discusses balloons where the proximal and
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`distal ends of the balloon are inverted so that the balloon takes on a non-
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`spherical shape. (Ex. 1001 at 9:53-10:61.) An example of such a balloon (with
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`inverted ends 114) is shown in Figure 20 below.
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`37. While the specification focuses on designs to address the asymmetry
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`
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`issue, the specification identifies certain catheter designs for use in the claimed
`
`invention, including those that were known in the prior art. For example, as
`
`shown above, Figure 20 depicts a tubular balloon 110 bonded to the distal end of
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`an outer catheter tube 118 and to the distal end of an inner catheter tube 120.
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`(Id. at 10:16:31, 10:42-61.)
`
`38.
`39.
`
`The 456 patent has ten claims. Claim 1 is an independent claim.
`
`Claims 2-10 depend from claim 1.
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`The claims disclose “a tool” comprising the following main
`
`components: “an outer catheter tube having a distal end,” “an inner catheter
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`- 19 -
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`STRYKER EXHIBIT 1002, pg. 19
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`ORTHOPHOENIX EXHIBIT 2011
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`tube extending within the outer catheter tube and having a distal end region that
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`extends beyond the distal end of the outer catheter tube,” “an expandable
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`structure having a proximal end secured to the distal end of the outer catheter
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`tube and a distal end secured to the distal end region of the inner catheter tube,
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`whereby the distal end region of the inner catheter tube is enclosed within the
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`expandable structure.” (Id. at 16:6-17.) Devices with an outer catheter tube, an
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`inner catheter tube, and an expandable structure of the same design and
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`arrangement disclosed in the 456 patent claims were well-known as of August 15,
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`1997, as discussed above in Section IV.
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`Independent claim 1 further discloses “manipulating the tool to
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`40.
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`41.
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`introduce the expandable structure into bone while in a generally collapsed
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`geometry” and “causing the expandable structure to assume an expanded
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`geometry inside bone.” (Id. at 16:18-22.)
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`The dependent claims of the 456 patent are generally directed to
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`additional known variations of the disclosed method set forth in claim 1. Claim 2
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`adds “wherein, when assuming the expandable geometry, the expandable
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`structure compacts cancellous bone.” (Id. at 16:23-25.) Claim 3 adds “wherein,
`
`when assuming the expandable geometry, the expandable structure compacts
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`cancellous bone and forms a cavity.” (Id. at 16:26-30.) Claims 4 and 5 set forth
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`- 20 -
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`STRYKER EXHIBIT 1002, pg. 20
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`ORTHOPHOENIX EXHIBIT 2011
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`the additional limitations that material is conveyed into the cavity and that the
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`“material comprises bone cement.” (Id. at 16:31-35.) Claims 6 and 7 set forth the
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`additional limitations that “wherein, when assuming the expandable geometry
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`the expandable structure exerts interior force upon cortical bone” and “wherein,
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`when assuming the expandable geometry, the expandable structure exerts
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`interior force upon cortical bone to move fractured cortical bone,” respectively.
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`(Id. at 16:36-43.) Claim 8 sets forth the additional requirement that “wherein the
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`proximal and distal ends of the expandable structure are inverted about the distal
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`end of the outer catheter tube and distal end region of the inner catheter tube,
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`respectively.” (Id. at 16:44-49.) Finally, claims 9 and 10 set forth the additional
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`limitations that “wherein the inner catheter tube is more compliant than the
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`outer catheter tube” and “wherein the inner catheter tube and expandable
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`structure are more compliant than the outer catheter tube,” respectively. (Id. at
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`PERSON OF ORDINARY SKILL IN THE ART
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`I understand that a person of ordinary skill in the art is a hypothetical
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`person who is presumed to be aware of all pertinent art, possesses conventional
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`wisdom in the art, and is a person of ordinary creativity. I understand that this
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`hypothetical person is considered to have the normal skills and knowledge of a
`
`- 21 -
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`STRYKER EXHIBIT 1002, pg. 21
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`VI.
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`16:50-55.)
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`42.
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`ORTHOPHOENIX EXHIBIT 2011
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`Declaration of Neil J. Sheehan
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`person in a certain technical field.
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`43.
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`I have been asked to analyze the 456 patent and the references
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`discussed herein from the perspective of such a person at the time of invention. I
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`understand that, for the purposes of this IPR, the date of invention is assumed to
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`44. A person of ordinary skill in the relevant art would have a mechanical
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`be August 15, 1997.
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`engineering degree, industrial design degree, or similar technical degree, or
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`equivalent work experience, and at least 5 years of working in the area of medical
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`device design, including experience with catheters carrying an expandable or
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`inflatable structure, such as a typical balloon catheter.
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`VII. CLAIM CONSTRUCTION
`45.
`46.
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`I understand that claim construction is the interpretation of the
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`meaning of patent claims. I also understand that claims in an IPR proceeding are
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`given their broadest reasonable construction.
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`I understand that many sources can be used to assist
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`in
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`47.
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`understanding the meaning of a claim including the claims themselves, the
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`specification, the prosecution history of the patent, as well as extrinsic evidence
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`concerning the meaning of technical terms and the state of the art.
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`I have been asked to review the claims and ascertain the meaning of
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`- 22 -
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`STRYKER EXHIBIT 1002, pg. 22
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`ORTHOPHOENIX EXHIBIT 2011
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`Declaration of Neil J. Sheehan
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`the claims from the perspective of one of ordinary skill in the art as of August 15,
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`1997. The meanings
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