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U.S. PATENT NO. 5,099,531
`
`Claim 105
`vs.
`U.S. Patent No. 6,008,433 (EX1007)1
`and
`U.S. Patent No. 5,298,254 (EX1008)2
`and
`U.S. Patent No. 5,609,635 (EX1004)3
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`1 U.S. Patent no. 6,088,433 to Stone entitled, “Osteotomy Wedge Device, Kit and
`Methods for Realignment of a Varus Anuglated Knee” is hereafter referred to as
`“Stone” or “the ‘433 patent.”
`2 U.S. Patent no. 6,088,433 to Prewett et al. entitled, “Shaped, Swollen
`Demineralized Bone and its use in Bone Repair” is hereafter referred to as
`“Prewett” or”the ‘254 patent.”
`3 U.S. Patent no. 5,609,635 to Michelson entitled, “Lordotic Interbody Spinal
`Fusion Implants” is hereafter referred to as “Michelson ‘635” or “the ‘635 patent.”
`GLOBUS MEDICAL, INC.
`EXHIBIT 1010
`IPR2015-to be assigned
`(Globus v. Bonutti)
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`‘531 patent Claim 105 vs. the ‘433 patent, the ‘254 patent, the ‘635 patent
`
`An apparatus for
`use in changing
`the spatial
`relationship
`between first
`and second
`bones which are
`interconnected
`at a joint in a
`patient's body,
`said apparatus
`comprising
`
`The ‘433 patent (EX1007) discloses:
`• The ‘433 patent discloses a
`device, and kit and methods for
`realigning varus angulated
`knees, but also may be used for
`realigning any malaligned bone.
`EX1007 at 2:59-61 and FIG.
`3C.
`
`The ‘254 patent (EX1008)
`discloses:
`• The ‘254 patent discloses a
`spinal implant including bone
`wedges 8 used as
`intervertebral support blocks
`inserted between adjacent
`vertebrae. EX1008 at 6:65-
`7:13; FIGs. 5 and 6.
`• A wedge 8 is inserted
`between adjacent vertebrae 9
`and 10 in a spinal column 11
`in place of an intervertebral
`disk that has been removed. More specifically, FIG. 6
`illustrates insertion of the wedge 8 in the direction of arrow
`A. Id.
`
`The ‘635 patent (EX1004) discloses:
`• The present invention is directed to interbody spinal fusion
`implants having a structural configuration that provides for
`the maintaining and creating of the normal anatomic angular
`relationship of two adjacent vertebrae of the spine to
`maintain and create spinal lordosis. EX1004 at Abstract.
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`a wedge
`member which
`is movable into
`the joint
`between the first
`and second
`bones,
`
`
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`
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`The ‘433 patent (EX1007) discloses:
`• The implantable device has a substantially wedge-shaped
`body 110 having two angularly offset intersecting principal
`surfaces 112, 114. The principal surfaces 112,114 intersect at
`a vertex 121 at insertion end 120 and extend about a
`principal plane 122 extending midway between surfaces 112,
`114 from the vertex 121 at the insertion end 120 to a drive
`surface 126 at a drive end 118. The principal plane 122
`contains a drive axis 116. The drive surface 126 extends, at
`least in part, in a direction transverse to the principal plane
`122. The drive surface 126 is adapted to receive a force in the
`direction of the drive axis 116 towards the insertion end 120.
`EX1007 at
`5:27-40; FIG.
`1A.
`• The wedge body
`is configured
`and
`dimensioned for
`insertion
`between upper and lower
`portions of a bone joined at a
`lateral portion. EX1007 at 7:14-
`31.
`
`The ‘254 patent (EX1008)
`discloses:
`• The ‘254 patent teaches a spinal
`implant including bone wedges 8
`used as intervertebral support blocks inserted between
`adjacent vertebrae. EX1008 at 6:65-7:13; FIGs. 5 and 6.
`• A wedge 8 is inserted between adjacent vertebrae 9 and 10 in
`a spinal column 11 in place of an intervertebral disk that has
`been removed. More specifically, FIG. 6 illustrates insertion
`of the wedge 8 in the direction of arrow A. Id.
`
`The ‘635 patent (EX1004) discloses:
`• A spinal implant where the upper and lower surfaces are
`disposed in a converging angular relationship to each other
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`such that the implants of the present
`invention have an overall "wedged-
`shape" in an elevational side view.
`EX1004 at Abstract and FIG. 3.
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`The ‘433 patent (EX1007) discloses:
`• See EX1007 at 5:27-40; FIG. 1A, as shown
`below.
`
`first major side surface (112)
`thick end portion (126)
`
`edge (121)
`
`thin end portion (120)
`
`second major side surface (114)
`
`minor side surface
`
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`said wedge member having a
`thin end portion,
`
`a thick end portion,
`
`a first major side surface
`which extends from the thin
`end portion to the thick end
`portion,
`
`a second major side surface
`which intersects the first major
`side surface to form an edge at
`the thin end portion and
`extends from the thin end
`portion to the thick end
`portion, and
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`a minor side surface which
`extends between said first and
`second major side surfaces
`and tapers from said thick end
`portion to said thin end
`portion,
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`said wedge
`member
`having a
`plurality of
`passages
`which extend
`between said
`first and
`second major
`side surfaces
`for enabling
`bone to grow
`through said
`wedge
`member.
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`The ‘433 patent (EX1007) discloses:
`• By way of example, the principal surface 112 can be formed of
`a porous material which allows bone cells to grow within and
`throughout the pores. EX1007 at 6:31-36.
`• The body 110 of
`the device can
`be hollow and,
`accordingly,
`materials such
`as ground
`cancellous bone
`can be packed
`inside. EX1007
`at 7:9-14 and FIG. 2B.
`• A plurality of holes on the principal surface can facilitate
`packing of material within the body 110. Id.
`
`The ‘635 patent (EX1004) discloses:
`• The present invention is directed to interbody spinal fusion
`implants having a structural configuration that provides for the
`maintaining and creating of the normal anatomic angular
`relationship of two adjacent vertebrae of the spine to maintain
`and create spinal lordosis. EX1004 at Abstract and FIG. 1.
`• The upper and lower surfaces are disposed in a converging
`angular relationship to each other such that the implants of the
`present invention have an overall "wedged-shape" in an
`elevational side view. EX1004 at Abstract.
`• The implant 100 is hollow and comprises a plurality of
`openings 115 passing through the
`upper and lower surfaces 112 and
`114 and into a central hollow
`chamber 116. The openings 115
`provide for bone growth to occur
`from the vertebrae through the
`openings 115 to the internal
`chamber 116. EX1004 at 6:56-61 and FIGs. 1, 2 and 8.
`• The fusion enhancing material that is packed within the
`chamber 116 of the implant 10 serves to promote bone
`ingrowth between the implant 100 and the adjacent vertebrae.
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`Once the bone ingrowth occurs, the implant 100 will be a
`permanent fixture preventing dislodgement of the implant as
`well as preventing any movement between the adjacent
`vertebrae. Id. at 7:32-38.
`• Referring to FIGS. 8-12, an alternative
`embodiment of the lordotic interbody
`spinal fusion implant of the present
`invention, generally referred to by the
`numeral 200, is shown. The implant 200
`has a similar overall configuration as the
`implant 100 described above. In the
`preferred embodiment, the implant 200
`is solid and comprises a plurality of
`channels 215 passing from the upper surface 212 to the lower
`surface 214 through the implant 200. The channels 215
`provide for bone ingrowth and facilitate the incorporation of
`the implant 200 into the spinal fusion mass. Id. at 8:20-29.
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