`DEMONSTRATIVE
`EXHIBITS
`
`IPR 2014-00191
`U.S. Patent 7,837,736
`Claims 21, 22, 31-36
`Oral Hearing January 9, 2014, 10 A.M.
`
`
`BSI Exhibit 2006
`Zimmer Holdings, Inc. et al. v.
`Bonutti Skeletal Innovations
`LLC
`Trial: IPR2014-00191
`Page 1
`
`
`
`
`SOLE ISSUE IN THIS PROCEEDING:
`
`WHETHER PETITIONER HAS PROVEN, BY A
`PREPONDERANCE OF THE EVIDENCE,
`THAT CLAIMS 21, 22, AND 31-36 ARE
`ANTICIPATED BY WALKER
`
`
`
`
`
`(Paper 25, PO Resp., p. 2)
`
`Page 2
`
`
`
`Claim 22 of the ‘736 patent
`
`15. A device to replace an articulating surface of a first
`side of a joint in a body, the joint having first and second
`sides, comprising:
` a base component, including a bone contacting side
`connectable with bone on the first side of the joint, and a
`base sliding side on an opposite side of said base
`component relative to said bone contacting side;
` a movable component, including a movable sliding
`side, said movable sliding side being matably
`positionable in sliding engagement with said base sliding
`side, and an articulating side on an opposite side of said
`movable component relative to said movable sliding side,
`shaped to matingly engage an articulating surface of the
`second side of the joint;
` a protrusion extending from one of said base sliding
`side or movable sliding side, said protrusion substantially
`offset with respect to a midline of the first side of a joint;
` a recess sized to receive said protrusion, disposed
`in the other of said base sliding side or movable sliding
`side, said protrusion and recess matable to constrain
`movement of said first and second components relative
`to each other, thereby promoting movement of the joint
`within desired anatomical limits.
`
`(Paper 25, PO Resp., pp. 3, 7-8, Exh. 1001)
`
`
`22. The device of claim 15, wherein
`said protrusion is a pin, and said
`recess is a hole sized to receive said
`pin.
`
`Page 3
`
`
`
`CLAIM 22
`“15. . . . a protrusion
`extending from one of
`said base sliding side or
`movable sliding side,
`said protrusion
`substantially offset with
`respect to a midline of
`the first side of a joint;
`a recess sized to
`receive said protrusion,
`disposed in the other of
`said base sliding side or
`movable sliding
`side . . ..
`22. . . . wherein said
`protrusion is a pin, and
`said recess is a hole
`sized to receive said
`pin.”
`
`(Paper 25, PO Resp., pp. 7-8)
`
`Tibial platform 41includes an "upstanding stud 42",
`a "rail 48", and "a semicircular abutment 50 which is
`upstanding at the medial side of the platform."
`Meniscal component 44 includes a "slot 43" which
`receives the stud 42, "a recess 49" that engages
`with the rail 48, and "a recess or notch 51" which is
`"rounded."
`
`
`(Paper 25, PO Resp., p. 7)(citations omitted)
`
`
`Page 4
`
`
`
`A NOTCH IS NOT A HOLE OR CAVITY
`
`EVEN CONSIDERED UNDER THE BROADEST
`REASONABLE CONSTRUCTION STANDARD
`
`(Paper 25, PO Resp., p. 11 and p. 13, Exh. 2003)
`
`Page 5
`
`
`
`A NOTCH IS NOT A HOLE OR CAVITY
`
`EVEN CONSIDERED UNDER THE BROADEST
`REASONABLE CONSTRUCTION STANDARD
`“’notch’ and ‘hole’ are
`terms of ordinary usage in
`the English language”
`
`“a person of ordinary skill
`in the art at the time of the
`invention would
`understand that a notch is
`not a hole.”
`
`(Paper 25, PO Resp., p. 12, Exh. 2001,
`Schoifet Decl., pars 39-44)
`
`(Paper 25, PO Resp., p. 11 and p. 13, Exh. 2003)
`
`Page 6
`
`
`
`A NOTCH IS NOT A HOLE OR CAVITY
`
`STANDARD: BROADEST REASONABLE CONSTRUCTION
`CONSISTENT WITH THE SPECIFICATION
`The distinction between notches and holes or cavities is also borne out
`in the specification of the '736 patent.
`
`"[t]he drill 128 is utilized to form a hole 130 in the center of the
`intercondylar notch in the distal end portion 124 of the femur 126 in a
`known manner. The drill 128 is used to form the hole 130 while the leg
`70 is in the orientation illustrated in FIGS. 2 and 3. "(Col. 17, ll. 24-30).
`The hole 130 and notch are illustrated in the figures:
`
`
`(Paper 25, PO Resp., p. 11 and
`p. 13, Exh. 2003)
`
`(Paper 25, PO Resp., pp. 13-14)
`
`Page 7
`
`
`
`A NOTCH IS NOT A HOLE OR CAVITY
`
`EVEN CONSIDERED UNDER THE BROADEST
`REASONABLE CONSTRUCTION STANDARD
`
`Notch: a v-shaped cut
`
`Hole: a cavity in a solid
`
`Cavity: a hollow . . . a
`hole … a hollow area
`within the body
`
`(Exh. 2002, American Heritage
`Dictionary, pp. 1237, 862, 306
`(1992), Paper 25, PO Resp., p. 12)
`
`(Paper 25, PO Resp., p. 11 and p. 13, Exh. 2003)
`
`Page 8
`
`
`
`A NOTCH IS NOT A HOLE OR CAVITY
`
`EVEN CONSIDERED UNDER THE BROADEST
`REASONABLE CONSTRUCTION STANDARD
`Walker refers to component
`51 as "a recess or notch 51"
`which is "rounded“
`
`
`
`
`
`
`
`
`
`Walker thus uses the term
`"notch" in accordance with
`its ordinary meaning: “a v-
`shaped cut” that has been
`"rounded.”
`
`(Paper 25, PO Resp., p. 12)
`
`(Paper 25, PO Resp., p. 11 and p. 13, Exh. 2003)
`
`Page 9
`
`
`
`A NOTCH IS NOT A HOLE OR CAVITY
`
`EVEN CONSIDERED UNDER THE BROADEST
`REASONABLE CONSTRUCTION STANDARD
`
`In Joy MM Delaware, Inc. v. Cincinnati Mine Machinery, Co., 497 Fed. Appx. 970, 973, 2012 U.S. App. LEXIS
`23027 (Fed. Cir. 2012), the court found "The term [indentation] has a commonly accepted meaning that does not
`include a hole. See Webster's Third International Dictionary (1993) (defining 'indentation' as 'an angular cut' or 'a
`notch' or 'a small surface depression'); Oxford English Dictionary (2d ed. 1989) (defining 'indentation' as a 'cut,
`notch, or angular incision')."
`
`In Sunbeam Products, Inc, v. Hamilton Beach Brands, Inc., 2010 U.S. Dist. LEXIS 85281, *19 (E.D. Va. 2010),
`the Court explained "[a]s differentiated from the narrower disputed claim term 'drinking cap having a drinking
`hole' (which is necessarily a subset of 'drinking cap') discussed infra, a 'drinking cap' includes not just a cap with
`a hole through which a person may drink. It also includes a cap with a notch or other portion cut out so that the
`cap itself does not have a hole, but that the user has an opening through which to drink when the cap is
`affixed." (Emphasis added).
`
`In Ex parte David E. Anderson, Appeal 2011-012922, 2013 Pat. App. LEXIS 7274 (Pat. App. 2013), the Board
`noted that the "Examiner's proposed modification to Shin includes modifying the windshield to have slots or
`notches instead of holes." (Emphasis added).
`
`In Ex parte YI YANG et al., Appeal 2009-006608, 2009 Pat. App. LEXIS 9281, * 15 (Pat. App. 2009), the Board
`found "Fulkerson teaches what a person of ordinary skill in the art would interpret as a 'notch.' A 'notch' is not a
`'hole' as required by the claims, when the claims are reasonably read in view of Appellant's Specification figures."
`
`(Paper 25, PO Resp., pp. 15-16)
`
`Page 10
`
`
`
`A NOTCH IS NOT A HOLE OR CAVITY
`
`EVEN CONSIDERED UNDER THE BROADEST
`REASONABLE CONSTRUCTION STANDARD
`
`Dr. Erdman: "[i]t would be a matter of
`routine engineering and design choice
`at the time of the Bonutti patent
`invention to replace the recess 51 with
`a hole or slot . . .." (emphasis added).
`(Exh. 1005, par. 47)
`
`Dr. Schoifet: “A person of ordinary skill
`in the art at the time of the invention
`would understand that a notch (like
`notch 51 of Walker) is not the same as
`a hole or cavity because they are
`common terms with a common
`understanding within the medical field.”
`(Exh. 2001, par. 39)
`(Paper 25, PO Resp., pp. 10, 12)
`
`Page 11
`
`(Paper 25, PO Resp., p. 11 and p. 13, Exh. 2003)
`
`
`
`Petitioner’s Reply Brief:
`
`Patent Owner:
`
`For instance, a dictionary, which the
`Patent Owner relies upon, defines
`“cavity” as “[a] hollow; a hole” and
`defines “hole” as “[a] cavity in a solid.”
`Thus, the dictionary uses these terms
`interchangeably, as do the Patent
`Owner and its expert. Recess 51 of
`Walker plainly meets this dictionary
`definition: it is hollow. Indeed, Patent
`Owner’s expert agreed with as much.
`(“Q. Do you agree recess 51 contains
`a hollow area? A. I do.”)”
`
`(Paper 30, Reply Brief, p. 7)(citations omitted)
`
`Cavity: a hollow . . . a hole
`… a hollow area within the
`body
`
`Hole: a cavity in a solid
`
`(Exh. 2002, American Heritage Dictionary, pp. 306, 862
`(1992), Paper 25, PO Resp., p. 12)
`
`Page 12
`
`
`
`Petitioner:
`“As confirmed by the cross-examination of Patent Owner’s expert, Dr.
`Scott D. Schoifet, however, Patent Owner has not applied the broadest
`reasonable interpretation in light of the specification (37 C.F.R.§
`42.100(b)) to these terms. See e.g., Ex. 1022 at 97:19-21 (defining
`cavity); 137:18-19 (defining hole)”.
`(Paper 30, Reply Brief, p. 1)
`
`Dr. Schoifet:
`Q. And what's a cavity?
`A. Would be a hole with
`dimensionality.
`(Ex. 1022 at 97:19-21)
`
`Q. What is it?
`A. The notch, if you look at
`that, if I -- the hole is circular,
`it's contained; and the notch is
`open, it’s not contained.
`(Ex. 1022 at 137:16-20)
`
`
`
`Dictionary:
`Notch: a v-shaped cut
`
`Cavity: a hollow . . . a
`hole … a hollow area
`within the body“
`
`Hole: a cavity in a solid
`
`(Exh. 2002, American Heritage Dictionary,
`pp. 1237, 306, 862 (1992), Paper 25, PO
`Resp., p. 12)
`
`Page 13
`
`(Exh. 1001, Exh. 2001, par. 41)
`
`
`
`736 Patent:
`
`15. A device to replace an articulating surface of a first side of a joint in a body,
`the joint having first and second sides, comprising: ….
`a recess sized to receive said protrusion, disposed in the other of said base
`sliding side or movable sliding side, said protrusion and recess matable to
`constrain movement of said first and second components relative to each other,
`thereby promoting movement of the joint within desired anatomical limits.
`
`22. The device of claim 15, wherein said protrusion is a pin, and said recess is a
`hole sized to receive said pin.
`
`
`(Paper 8, Corr. Pet., pp. 38-40, Paper 25, PO Resp., pp. 7-8, Exh. 1001)
`
`Petitioner:
`
`"Patent Owner also argues
`that what is actually
`described and depicted in
`Figure 2 of Walker is a
`notch. Response at 11-12.
`But Walker only once refers
`to item 51 a notch. In this
`instance, Walker is written in
`the alternative: 'recess or
`notch.' Ex. 1002 at 4:26-28
`(emphasis added). In all
`other instances, Walker
`refers to item 51 as a recess.
`Id. at 4:30-33; 6:29-33. And
`as described above, recess
`51 meets the broadest
`reasonable construction of a
`'hole' or 'cavity.'”
`(Paper 30, Rep. Br., p. 9)
`
`
`Page 14
`
`
`
` Petitioner’s Reply Brief:
`
`• Dr. Schoifet confirmed
`that “[i]n the context of
`this patent [a] hole or
`cavity is [a] recess.” Ex.
`1022 at 133:23- 25.
`
`(Paper 30, Reply Brief, p. 8)
`
`Dr. Schoifet:
`Schoifet Trans., Exh.
`1022: 133:23-25:
`• “In the context of this
`patent the hole or
`cavity is the recess.”
`
`Schoifet Decl.:
`• “In the embodiment of
`Figure 90, the bearing
`insert 1294 includes a
`recess 1308 in the
`form of a hole or
`cavity . . ..”
`• “In the embodiment of
`Figures 88-89, the
`bearing insert 1268
`includes a recess in
`the form of a dovetail
`shaped groove 1288”
`Page 15
`
`(Paper 25, pp. 3, 5, Exh 2001, pars 20, 25, 26).
`
`
`
`Claim 21 of the ‘736 patent
`
`15. A device to replace an articulating surface of a first
`side of a joint in a body, the joint having first and second
`sides, comprising:
` a base component, including a bone contacting side
`connectable with bone on the first side of the joint, and a
`base sliding side on an opposite side of said base
`component relative to said bone contacting side;
` a movable component, including a movable sliding
`side, said movable sliding side being matably
`positionable in sliding engagement with said base sliding
`side, and an articulating side on an opposite side of said
`movable component relative to said movable sliding side,
`shaped to matingly engage an articulating surface of the
`second side of the joint;
` a protrusion extending from one of said base sliding
`side or movable sliding side, said protrusion substantially
`offset with respect to a midline of the first side of a joint;
` a recess sized to receive said protrusion, disposed
`in the other of said base sliding side or movable sliding
`side, said protrusion and recess matable to constrain
`movement of said first and second components relative
`to each other, thereby promoting movement of the joint
`within desired anatomical limits.
`
`(Paper 25, PO Resp., pp. 7-8, 18, Exh. 1001)
`
`
`
`
`
`
`
`
`21. The device of claim 15, wherein
`said protrusion and recess engage to
`permit relative rotation of said base
`sliding side and said movable sliding
`side about an axis of said protrusion.
`
`Page 16
`
`
`
`CLAIM 21
`“21. [a protrusion
`extending from one of
`said base sliding side or
`movable sliding side,
`said protrusion
`substantially offset with
`respect to a midline of
`the first side of a joint;
`a recess sized to
`receive said protrusion,
`disposed in the other of
`said base sliding side or
`movable sliding
`side] . . ., wherein said
`protrusion and recess
`engage to permit
`relative rotation of said
`base sliding side and
`said movable sliding
`side about an axis of
`said protrusion.
`
` "[r]otation of the meniscal component 44 about an
`axis X at the edge of the tibial platform is controlled
`by [the] abutment 50." (Walker, col. 4, ll. 23-25)
`(emphasis added).
`
`"notch 51" is "rounded as shown to allow
`approximately 2 mms movement in an anterior and
`posterior direction." (Walker, col. 4, ll. 26-29).
`
`(Paper 25, PO Resp., pp. 7, 18, Exh. 1002)
`
`Page 17
`
`
`
` Petitioner:
`"While its expert contends that
`abutment 50 allows for translational
`movement of meniscal component 44
`in the anterior-posterior direction, he
`does not dispute that such movement
`guides meniscal component in an arc
`about abutment 50. Ex. 1022 at
`67:5-20."
`(Paper 30, Rep. Br., p. 14)
`
`Claim 21:
`15. A device . . . comprising: . . .said
`protrusion and recess matable to
`constrain movement of said first and
`second components relative to each
`other . . ..
`
`21. The device of claim 15, wherein
`said protrusion and recess engage to
`permit relative rotation of said base
`sliding side and said movable sliding
`side about an axis of said protrusion.
`(Paper 25, pp. 7-8, 18, Exh. 1001)
`
`Schoifet Transcript:
`Q. So it's your sworn testimony that the rail
`provides for rotation, yet you're unable to
`tell us that abutment 50 guides rotation?
`A. My testimony is that the rail will guide
`rotation. The abutment allows translational
`movement; and there is an axis of rotation
`in the platform. That axis of rotation will
`be positioned -- will be guided by the
`abutment 'cause it allows the translational
`motion, but it is not – the axis is not in the
`abutment. It's a complicated answer. I'm
`sorry it is, but this is a complicated
`structure.
`(Ex. 1022 at 67:5-20)
`
`Page 18
`
`
`
`Claim 31 of the ‘736 patent
`
`31. A knee arthroplasty device, comprising:
` a tibial tray including a lower distal surface
`and an upper proximal surface, said proximal
`surface having either a post or a cavity, said
`post or cavity offset from at least one of a
`medial-lateral centerline and an anterior-
`posterior centerline of said tibial tray;
` a tibial tray insert engageable with said
`proximal surface and having a mating second
`cavity if said tibial tray has a post, or a
`mating post if said tibial tray has a cavity,
`said mating post or mating cavity offset from
`at least one of the medial-lateral centerline
`and the anterior-posterior centerline of said
`tibial tray, wherein said mating cavity is
`adapted to receive at least a portion of said
`post, or said mating post is adapted to be
`received in at least a portion of said cavity;
` wherein said tibial tray insert rotationally
`moves with respect to said tibial tray, about
`said post, when the device is used within the
`body such that the rotation of the tibial tray
`insert is asymmetric with respect to at least
`one of the medial-lateral centerline and the
`anterior-posterior centerline of said tibial tray.
`
`Tibial platform 41includes an "upstanding stud 42", a
`"rail 48", and "a semicircular abutment 50 which is
`upstanding at the medial side of the platform." Meniscal
`component 44 includes a "slot 43" which receives the
`stud 42, "a recess 49" that engages with the rail 48, and
`"a recess or notch 51" which is "rounded."
`
`
`
`
`
`
`
`
`
`
`
`
`”Rotation of the meniscal component 44 about an axis
`X at the edge of the tibial platform is controlled by [the]
`abutment 50."
`
`"notch 51" is "rounded as shown to allow approximately
`2 mms movement in an anterior and posterior
`direction."
`
`(Paper 25, PO Resp., pp. 8-9, Exh. 1001)
`
`
`(Paper 25, PO Resp., pp. 7, 18, Exh. 1003)
`(citations to Walker omitted)
`
`Page 19
`
`
`
`Petitioner:
`
`Indeed, Figure 1 of another
`reference discloses a
`structure similar to abutment
`50 of Walker and refers to
`the structure as a post. See
`Ex. 1003 at Fig. 1, 3:14-18
`(describing item 32 as a
`“post”). When given a copy
`of Fig. 1 of Exhibit 1003,
`however, Dr. Schoifet
`refused to testify as to this
`figure (see Ex. 1021). See,
`e.g., Ex. 1022 at
`109:3-114:11. And when
`asked whether item 32 in
`Fig. 1 is a post, he “was
`unable to comment on that
`as an expert witness.” Id. at
`114:5-11.
`(Paper 30, Rep. Br., p. 5, n. 3)
`
`
`Dr. Schoifet:
`
`
`Q. Dr. Schoifet, what is Zimmer
`Exhibit 1021?
`
`…THE WITNESS: I have no idea.
`(Ex. 1022, 109:10-16)
`
`
`Page 20
`
`
`
`Petitioner:
`
`
`
`Patent Owner’s own
`expert admitted that the
`drawings without more
`are insufficient to
`convey to a person of
`ordinary skill in the art
`that post 1306 is a “pin”
`or recess 130 is a
`“hole”/”cavity.” See, e.g.,
`Ex. 1022 at 142:16-25.
`
`(Paper 30, Rep. Br., p. 7, n. 4)
`
`
`Dr. Schoifet:
`
`
`
`
`Q. And how are you able to tell that here the axis is at
`the post?
`A. A person skilled in the art would know that with the
`pin and the post and the construct, that it would rotate
`around the axis.
`Q. Just from looking drawing you would know that?
`A. From reading the patent I would know that.
`
`(Exh. 1022, 142:16-25)
`
`
`Page 21
`
`
`
`Petitioner:
`
`
`
`Patent Owner’s own
`expert admitted that the
`drawings without more
`are insufficient to
`convey to a person of
`ordinary skill in the art
`that post 1306 is a “pin”
`or recess 130 is a
`“hole”/”cavity.” See, e.g.,
`Ex. 1022 at 142:16-25.
`
`(Paper 30, Rep. Br., p. 7, n. 4)
`
`
`Dr. Schoifet:
`
`26. In the embodiment of Figure 90, the bearing insert 1294
`includes a recess 1308 in the form of a hole or cavity which
`mates with a protrusion 1306 in the form of a post or pin. The
`hole or cavity 1308 extends from inferior surface 1304
`upward into the interior of bearing insert 1296, as indicated
`by the dashed lines depicting component 1308. The pin/post
`1306 cooperates with hole/cavity 1308 "to permit rotation of
`bearing insert 1296 with respect to tibial tray 1294."(Id ,
`Figure 90, col. 101, ll. 28-31).
`
`38. A person of ordinary skill in the art at the time of the
`invention familiar with the '736 patent specification and
`claims would understand that recess 1308, shown in figure
`90, is a hole or cavity. In particular, a person of ordinary skill
`in the art would recognize from figure 90 that the dotted line
`shows where the hole or the cavity is located in bearing insert
`1296, and if switched, the hole or the cavity could be located
`in the superior surface 1302. (Id. col. 101, ll. 28-34). In my
`experience, dashed lines are a common way to illustrate this.
`(Exh. 2001, Schoifet Decl., pars. 26, 38, Paper 25, PO Resp., p. 5)
`
`Page 22
`
`
`
`22. . . . wherein said protrusion is a
`pin, and said recess is a hole sized
`to receive said pin.
`31. . . . wherein said mating cavity is
`adapted to receive at least a portion
`of said post . . ..
`
`
`Abutment 50 Is Not a Pin or a Post
`a pin or post is not the same as an
`abutment, particularly when used in
`combination with a hole or cavity into
`which it is received as it is in the
`context of claims 22 and 31. In
`orthopedics a pin or post is typically
`used to fix or align one device (or
`bone) to another device (or bone) by
`drilling (or passing through) a hole
`cavity through the two devices (or
`bones). We commonly pin fractures
`or pin guides to bones. An abutment
`is not a pin. We would not use an
`abutment to fix align one device (or
`bone) to another device (or bone)
`nor does an abutment reside within a
`hole or cavity. A person of ordinary
`skill in the art of orthopedics at the
`time would not consider the
`abutment of Walker to be a pin or
`post as those terms are used in
`claims 22 and 31.
`Page 23
`(Paper 25, p. 17, Exh. 2001, par. 45)
`
`(Paper 25, pp. 8, 9, 12, 17)
`
`