Paper No. ___
`Filed: January 7, 2015
`
`Filed on behalf of: Zimmer Holdings, Inc. & Zimmer, Inc.
`By: Naveen Modi
`
`Joseph E. Palys
`
`Paul Hastings LLP
`
`875 15th Street, N.W.
`
`Washington, D.C. 20005
`
`Telephone: (202) 551-1700
`
`Facsimile:
`(202) 551-1705
`
`E-mail:
`naveenmodi@paulhastings.com
`
`
`
`josephpalys@paulhastings.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`
`ZIMMER HOLDINGS, INC.
`AND ZIMMER, INC.,
`Petitioner
`
`v.
`
`BONUTTI SKELETAL INNOVATIONS LLC,
`Patent Owner
`
`__________________
`
`Case IPR2014-00191
`Patent No. 7,837,736
`__________________
`
`PETITIONER’S DEMONSTRATIVE EXHIBITS
`
`

`

`Inter Partes Review of
`
`Case No. IPR2014-00191
`
`U.S. Patent No. 7,837,736
`
`Oral Hearing: January 9, 2015
`
`

`

`Background
`
`

`

`
`
`El‘dman Declaration, Ex. 1005 at 10
`
`
`Fibula
`
`Rkht Hanan Knee Joint
`
`
`
`

`

`Fig. 89
`
`1264
`
`1256
`
`1262
`
`
`
`’736 Patent, Ex. 1001 at Fig. 89
`
`
`
`
`
`1266/
`
`1 270
`
`

`

`Addit ionall
`
`The arrangement
`ofthe post and recess can be switched so that bearing insert
`1296 is provided with the post and superior surface 1302 is
`provided with the recess.
`
`736 Patent, Ex. 1001 at 101:28-34
`
`,~1290 Implant
`r\?gggins Insert
`$1292 Tibial Componen‘
`.~
`
`1291.
`Tray
`
`t300 Plate Member
`
`—O
`
`Lateral
`Side
`
`Erdman Declaration, Ex. 1005 at 27
`
`in the occurrence
`.
`.
`.
`.
`of rotation motion between bearing insert 1296 and both
`femoral and tibial tray components 1292. However. ttnlike
`prior art mobile bearing knee implants that rely on a post
`mechanism to control the rotational movement. the articulat-
`
`.
`Flg . 90
`(3""0‘a‘edl
`_
`_
`
`:
`
`1308 RECESS
`4306 Post
`?_,.
`I
`l
`I
`I
`
`‘
`
`Upper Bearing Surface
`of Bearlng Insert
`.nferl:r$Urface
`0f Bearing “150111304
`Superior Surface1302
`of Plate Member
`Axis of Medial-tateral
`Centerline
`
`‘
`
`_
`
`Central MS of /
`Spike
`’
`
`I
`
`l “298 Spike
`
`ing surfaces are not flat. Rather. superior surface 1302 oftibial
`tray 1294 and interior surface 1304 ofbearing insert 1296 are
`matin_ curved surfaces.
`
`’736 Patent, Ex. 1001 at 101:35-43
`
`

`

`Petitioner asseits that Walker discloses a mobile bearing prosthesis that
`
`includes every limitation of claims 15-22, 26-28 and 31—36. Pet. 28 (citing Ex-
`
`1005 W 45-69); see also id. at 28-35 (claim chart)- Having reviewed Petitioner’s
`
`assertions and the cited portions of the record, we are persuaded that Petitioner has
`
`demonstrated a reasonable likelihood of prevailing on its contention that Walker
`
`anticipates claims 15-22, 26-28 and 31-36 of the ’736 Patent.
`
`0 Board instituted review of claims 15-22, 26-28, and 31-36 based on
`Walker:
`
`- Remaining claims-at-issue: 21, 22, and 31-36
`
`Institution Decision, Paper No. 12 at 12
`
`0 Patent Owner filed a statutory disclaimer with respect to claims
`15-20 and 26-28
`
`Disclaimer in Patent under 37 C .F.R. § 1.321(a), Ex. 2005
`
`

`

`15. A device to replace an articulating surface ofa first side
`of a joint in a body" the joint having first and second sides
`comprising:
`a base component. including a bone contacting side con-
`nectable with bone on the first side of the joint. and a
`base sliding side on an opposite side of said base com-
`ponent 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
`zu'ticulating side on an opposite side of said movable
`component relative to said movable sliding side. shaped
`to matingly engage an articulating surface ol'the second
`side of the joint:
`
`Erdman Declaration, Ex. 1005 at 27V
`
`Um, 393mg Sudace
`0’ Beamg "‘55"
`Inferl:r Surface
`°f Beam New“
`
`Fig. 90
`(annotated)
`
`.
`
`,
`
`A~1290 Implant
`
`5
`
`‘.
`
`1308 Recess
`
`Bear“ Insert
`l>1292 Tibial Component
`
`z?#322122223'3MMQ306Poétfl/figi»
`Vii—I:
`
`Ax" “mm““3"“
`Centedine
`Med.a._
`Side
`
`-extending from oneol‘said base sliding side or
`movableslidingside,saidprotrusionsubstantiallyoffset
`
`with respect to a midline of the lirst side 0 l‘ a joint:
`- 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 move-
`ment ol‘said lirst and second components relative to each
`other, thereby promoting movement of the joint within
`desired anatomical limits.
`
`2]. The device ol'claim 15. wherein—
`
`_of said base slidini
`
`side and said movable sliding side
`
`22. 'Ihe device ofclaim 15. wherein
`and
`
`1300 Plate Member
`_.Lateral
`Side
`.298
`.
`I
`Spike
`
`Cemgglifiisof/ ’
`
`

`

`mating post or mating cavity offset from at least one of
`the medial-lateral centerline and the anterior- osterior
`
`centerline of said tibial trav.
`
`32. llte knee arthroplasty device ofclaim 31. wherein said
`post or mating post is offset medially from a medial-lateral
`centerline of said tibia] tray.
`
`33. The knee arthroplasty device of claim 31. wherein said
`mating cavity or mating post of said tibial tray insert is offset
`medially from a medial-lateral centerlitte of said tibial tray
`insert.
`
`34. 'llte knee artltroplasty device ofclaim 31. wherein the
`tibial tray has a keel with a central axis. and wherein said post
`or cavity of said tibial tray is offset from the central axis of
`said keel.
`
`35. 'llle knee arthroplasty device ofclaim 31. wherein the
`tibial tray has a keel with a central axis. and wherein said
`mating post or mating cavity of said tibial tray insert is offset
`frotn the central axis of said keel.
`
`36. The knee arthmplasty device of claim 31. wherein a
`proximal surface of said tibial tray insert includes a mound
`interposing a medial condyle receiver and a lateral condyle
`receiver.
`
`31. A knee anhroplasty device. comprising:
`a tibial tray including a lower distal surface and an upper
`roxitnal surface. said proximal surface having either.
`b said post or cavity oil'set from at least
`one of a medial-lateral centerline and an anterior-poste-
`rior centerline of said tibial tray;
`a tibial tray insert en 3a weable with said roxinial surface
`and havin
`
`’736 Patent, Ex. 1001 at 115:56-58; 116:1-16
`
`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.
`
`’736 Patent, Ex. 1001 at 115:35-55
`
`

`

`the ode of the tibial platform is controlled by
`
`FIG. 2c shows the manner in which
`
`and then the stud '
`
`Walker, Ex. 1002 at 4:22-33
`
`lelal Platform 41
`Upper Surface
`0f Tibial Platform
`
`Posterior ,Stud 42 Slot 43
`/
`
`_ A recess or notch 51 is fonned in the
`corresponding portion of the meniscal component and is
`rounded as shown to allow approximately 2 mm movement
`in an anterior and postedor direction.
`
`Erdman Declaration, Ex. 1005 at 28
`
`Meniscal Component
`Movement Path
`
`Meniscal
`Component44
`
`51 Recess
`
`\
`
`50 Abutment
`
`Fl 9 . 2
`Laterall Medial
`(Annotated)
`Side I Side_’
`Medial Lateral
`
`Anterior
`
`Centerline
`
`

`

`Furthen—
`
`pinfhole and posU'cavity are used in the claims. Claim 22 requires a pin and recites
`
`Patent Owner Resp, Paper No. 25 at 17
`
`— particularly in the context in which the ternls
`
`Patent Owner Resp, Paper No. 25 at 19
`
`Put simply.—
`
`— even considered under the broadest reasonable
`
`construction standard currently in place for inter panes review.1
`
`Patent Owner Resp, Paper No. 25 at 11
`
`

`

`Walker Discloses the Claimed
`
`“Pin99/“Post”
`
`

`

`15. A device to replace an articulating surface ofa first side
`oi'a joint in a body, the joint having first and second sides.
`Comprising:
`a base component. including a bone contacting side con-
`nectable with bone on the first side of the joint. and a
`base sliding side on an opposite side of said base com-
`ponent 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 ofthe second
`side of the joint;
`—extending front one ofsaid base sliding side or
`movable sliding side, said protrusion substantially o il‘set
`with respect to a midline o f 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 move-
`ment ol'said first and second components relative to each
`other, thereby promoting movement of the joint within
`desired anatomical limits.
`
`’736 Patent, EX. 1001 at 115:35-5 5
`
`22. 'lhe device ol‘claim 15. wherein—
`and said recess is a hole siIed to receive said pin.
`
`’736 Patent, Ex. 1001 at 114:5-27; 114:52-53
`
`31. A knee arthroplasty device. comprising:
`a tibial tray including a lower distal surface and an upper
`roximal surface. said proximal surface having either.
`_ said post or cavity ofTset from at least
`one of a medial-lateral centerline and an anterior-poste-
`rior centerline of said tibial tray;
`a tibial tray insert en a eable with said roximal surface
`and having
`
`mating post or mating cavity ofi‘sct 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 ol'said post. or said
`mating post is adapted to be received in at least a portion
`of said cavity:
`tray insert rotationally moves with
`wherein said tibial
`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.
`
`

`

`0 Definition of “Post”
`
`- Abutment 50 of Walker
`
`Amen'can Heritage Dictionary, Ex. 1023 at 1414
`
`Walker, Ex. 1002 at Fig. 2'
`
`Rotation of the meniscal component 44 about an axis X at
`the edic of the tibial platform is controlled by-
`
`— A recess or notch 51 is formed in the
`Walker, Ex. 1002 at 4:22-25
`
`._
`
`Fl 9 . 2
`
`

`

`SCOTT D. SCHOIFBT, M.D.
`
`comment on what that meaning is.
`
`And
`
`that's the meaning of abutment.
`
`It's
`
`something that‘s applying lateral
`
`pressure to that semi-circle.
`
`Q.
`
`what do you mean "that's
`
`applying lateral pressure to that
`
`semi-circle"?
`
`who's skilled in the art supposed to
`
`Schoifet Testimony, Ex. 1022 at 36: 1-18
`
`Q.
`
`So you're not able to tell
`
`us what an abutment is?
`
`A.
`
`What
`
`I was asked was
`
`in
`
`the -— in the language that's
`
`understood by an orthopedic surgeon
`
`Schoifet Testimony, Ex. 1022 at 35:17-25
`
`

`

`bearing insert 1296 with respect to tibial tray 1294." ('736 patent. Figure 90. col.
`
`101. 1128—31).
`
`-of Figure 90 is not located at "the center ofthe tibia". but
`
`rather. "is offset medially toward the medial compartment of the knee" ( fl , Figure
`
`The-cooperates with holex’cavity 1308 "to permit rotation of
`
`Schoifet Testimony, Ex. 1022 at 130:9-12
`
`f
`
`90- co]. 101. 11. 55-57).
`
`’736 Patent, Ex. 1001 at Fig. 90
`
`Patent Owner Resp, Paper No. 25 at 5
`
`9
`
`Q.
`
`You're not differentiating
`
`10
`
`between a post and pin for purposes of
`
`11
`
`12
`
`your opinions; right?
`
`A.
`
`Correct.
`
`

`

`As explained by Dr. Schoifet, in orthopedics—
`
`through) a hole cavity through the two devices (or bones), and-
`
`_y drilling (or passing
`
`Patent Owner Resp, Paper No. 25 at 17
`
`—or would an
`
`abutment reside within a hole or cavity as claimed. (Schoifet Decl_, pars. 45—46)-
`
`

`

`and then the stud 42 in its
`
`Walker, Ex. 1002 at 4:30-33
`
`corresponding slot 43.
`
`FIG. 2c shows the manner in which
`
`Walker, Ex. 1002 at Fig. 2c
`
`

`

`Walker Discloses the Claimed
`
`“Hole”/“Cavity”
`
`

`

`15. A device to replace an articulating surface 0 f a first side
`ol‘a joint in a body. the joint having first and second sides.
`comprising:
`a base component. including a bone contacting side con-
`nectable with bone on the first side of the joint. and a
`base sliding side on an opposite side of said base com-
`ponent 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 ofth second
`side of the joint:
`a protrusion extending from one ofsaid base sliding side or
`movable sliding side. said protrusion substantially offset
`with respect to a midline of the first side ofa joint:
`- 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 move-
`ment ofsaid lirst and second components relative to each
`other. thereby promoting movement of the joint within
`desired anatomical limits.
`
`’736 Patent, EX. 1001 at 115:35-5 5
`
`31. A knee arthroplasty device. comprising:
`a tibial tray including a lower distal surface and an upper
`roximal surface. said proximal surface having either.
`b said post or cavity offset front at least
`one ofa medial-lateral centerline and an anterior-poste-
`rior centerline of said tibial tray;
`a tibial tray insen en a eable with said roximal surface
`and havin
`
`said
`
`mating post or mating cavity oll‘set from at least one 01
`the medial-lateral centerline and the anterior- ostcrior
`
`centerline of said tibial trav.
`
`tray insert rotationally moves with
`wherein said tibial
`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.
`
`22. The device 0 l‘claim 15. wherein said rotrusion is a pin.
`and‘
`
`’736 Patent, Ex. 1001 at 114:5-27; 114:52-53
`
`

`

`. Definition of “hole” and “cavity”
`
`hole (hOJ) n.
`
`I. A cavity in a solid. 2.0. An opening or a
`American Helitage Dictionary, Ex. 2002 at 862
`
`- Recess 51 of Walker
`
`American Heritage Dictionaiy, Ex. 2002 at 306
`
`‘- A ’10"an
`coyoiofy (k3v'i-té) 71., pl -'ie$. AbbT. COVv
`hole. 2. A hollow area within the body. a sinus cavity 3. A
`
`Schoifet Testimony, Ex. 1022 at 5026-8
`
`Q.
`
`Do you agree recess 51
`
`contains a hollow area?
`
`A .
`
`I do .
`
`

`

`0.
`
`Do you agree that the
`
`ordinary and custonary meaning of the
`
`recess is an indentation or small
`
`hollow?
`
`THE WITNESS: .— I .
`
`Schoifet Testimony, Ex. 1022 at 96: 14-17, 20-21
`
`And _I-
`
`would be 0--
`
`Walker, Ex. 1002 at Fig. 2
`
`were to say a hole is an opening, would
`
`
`
`Schoifet Testimony, Ex. 1022 at 97: 19-21
`
`Q.
`
`And would you agree if I
`
`you agree?
`
`A.
`
`I would not agree in the
`
`sense they're not synonymous with each
`
`other.
`
`Q.
`
`And why -- and why is that?
`
`

`

`What is described and depicted in Walker is a notch 51, not a hole or cavity.
`
`hich is "rounde ":
`
`Patent Owner Resp., Paper No. 25 at 12
`
`’736 Patent, Ex. 1001 at Fig. 90
`
`Additienally, superior surface 1302 is pro-
`vided with a post 1306 that cooperates with—
`]ocated on bearing insert 1296 to permit rotation of bearing
`insert 1296 with respect to tibial tray 1294.
`
`Fig. 90
`
`’736 Patent, Ex. 1001 at 101:28—31
`
`

`

`corresponding portion of the meniscal component and is
`rounded as shown to allow approximately 2 mm movement
`: uterior and . ten’or direction.
`
`Walker, Ex. 1002 at 4:26-29
`
`Walker, Ex. 1002 at 6:29-33
`
`(e) an abutment upstanding at one age 0
`platform which engages with-in one edge of the
`meniscal component
`thereby guiding and limiting
`movement of the meniscal component in an are around
`the abutment.
`
`FIG Zc shows -
`- manner in w c
`t-vemems
`ponent can be fitted to the tibial platform by engaging the
`abutment 50 in the- and then the said 42in its
`corres - . din slot 43.
`
`Walker, Ex. 1002 at 4:30-33
`
`

`

`Walker Discloses the Claimed
`
`Rotation “About an Axis of [a]
`
`Protrusion”/“Ab0ut [a] Post”
`
`

`

`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 con-
`nectable with bone on the first side of the joint, and a
`base sliding side on an opposite side of said base com-
`ponent 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 ofthe second
`side of the joint:
`_extending from one ofsaid base sliding side or
`movable sliding side. said protmsion substantially offset
`with respect to a midline of the first side ofa joint:
`- 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 move-
`ment ofsaid first and second components relative to each
`other, thereby promoting movement of the joint within
`desired anatomical limits.
`
`’736 Patent, EX. 1001 at 115:35-5
`
`31. A knee arthroplasty device. comprising:
`a tibial tray including a lower distal surface and an upper
`roximal surface. said proximal surface having either.
`said post or cavity offset from at least
`one of a medial-lateral ccnterline and an anterior-poste-
`rior centerline of said tibial tray;
`en a eable with said roximal surface
`
`said
`
`mating post or mating cavity offset from at least one of
`the medial-lateral ccnterline and the anterior-posterior
`centerline of said tibial tray. wherein said mating cavity
`is adapted to receive at least a portion ofsaid post. or said
`mating post is adapted to be received in at least a portion
`of said cavity;
`
`2]. The de ”ice of claim 15. wherein—
`_of said base sliding
`side and said movable sliding side
`
`’736 Patent, Ex. 1001 at 11425—27; 114:48-51
`
`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 centerlin * and the anterior-
`
`posterior centerline of said tibial tray.
`
`

`

`
`
`

`

`protrusion. Further, in Walker, there is no rotation about "an axis of said
`
`Patent Owner Resp, Paper No. 25 at 18
`
`A person of ordinary skill in the art at the time of the invention would
`
`understand Walker as describinga_ and would
`
`protrusion"bmus—
`
`Patent Owner Resp, Paper No. 25 at 19
`
`not consider that as being a rotation "about an axis of said protrusion" as claimed-
`
`(Schoifet Decl., pars. 51-53).
`
`

`

`Paper No. ___
`Filed: January 7, 2015
`
`Certificate of Service
`
`I hereby certify that on January 7, 2015, a copy of the foregoing Petitioner’s
`
`Demonstrative Exhibits was served by e-mail on the following counsel of record
`
`for Patent Owner, Bonutti Skeletal Innovations, LLC:
`
`Cary Kappel – ckappel@ddkpatent.com
`
`William Gehris – wgehris@ddkpatent.com
`
`David Petroff – dpetroff@ddkpatent.com
`
`Dated: January 7, 2015
`
`By:
`
`
`
`/Naveen Modi/
`Naveen Modi
`Reg. No. 46,224
`
`Counsel for Petitioner
`
`
`
`
`
`