IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ZIMMER HOLDINGS, INC.
`
`ZIMMER, INC.
`Petitioners
`
`V.
`
`BONUTTI SKELETAL INNOVATION LLC
`
`Patent Owner
`
`Patent No. 7,837,736
`Filing Date: October 30, 2007
`Issue Date: November 23, 2010
`Title: MINIMALLY INVASIVE SURGICAL SYSTEMS AND METHODS
`
`Inter Partes Review No. Unassigned
`
`SECOND DECLARATION OF ARTHUR G. ERDMAN, Ph.D.
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 1
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ZIMMER HOLDINGS, INC.
`
`ZIMMER, INC.
`Petitioners
`
`V.
`
`BONUTTI SKELETAL INNOVATION LLC
`
`Patent Owner
`
`Patent No. 7,837,736
`Filing Date: October 30, 2007
`Issue Date: November 23, 2010
`Title: MINIMALLY INVASIVE SURGICAL SYSTEMS AND METHODS
`
`Inter Partes Review No. Unassigned
`
`SECOND DECLARATION OF ARTHUR G. ERDMAN, Ph.D.
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 1
`
`
`
`1, Arthur G. Erdman, declare and state as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`This declaration is the second declaration that I have provided in
`
`connection with US. Patent 7,837,736 (the ’736 patent). My first declaration
`
`(“First Declaration”) was provided in connection with inter partes review no.
`
`2014-00191 of the ’736 patent, and is dated November 21, 2013.
`
`I understand that
`
`inter partes review no. 2014—00191 has been instituted.
`
`2.
`
`This declaration supplements my First Declaration. Accordingly, I
`
`refer to portions of the First Declaration.
`
`3.
`
`My background and curriculum vitae, as provided in the First
`
`Declaration, are current and incorporated herein.
`
`II.
`
`DOCUMENTS AND INFORMATION CONSIDERED
`
`4.
`
`In performing my investigation in this matter and in forming my
`
`opinions herein, I have reviewed the documents set forth in my First Declaration,
`
`some of which include the following documents.
`
`-
`
`0
`
`-
`
`°
`
`-
`
`Bonutti US. Patent 7,806,896 (the “Bonutti patent”)
`
`Walker et al. US. Patent 5,755,801 (the “Walker patent”)
`
`Buechel et al. US. Patent 4,340,978 (the “Buechel patent”)
`
`Hood et al. US. Patent 5,370,699 (the “Hood patent”)
`
`Bahler et al. US. Patent 5,282,868 (the “Bahler patent)
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 2
`
`
`
`-
`
`Decision —Institution of Inter Partes Review, Case IPR2014-0019l
`(“Decision’)
`
`III. APPLICABLE LEGAL STANDARDS
`
`5.
`
`I understand that this declaration is being used in connection with an
`
`inter partes review proceeding before the Patent Trial and Appeal Board of the
`
`United States Patent Office. I understand that the issues presented in this inter
`
`partes review proceeding must be considered in View of certain applicable legal
`
`standards.
`
`I am not a lawyer. A summary of my general understanding of certain
`
`legal standards that I have used in forming my opinions expressed below,
`
`including, in particular, my general understanding of the legal concepts of
`
`“anticipation” and “obviousness,” is set out in my First Declaration.
`
`IV. DETAILED STATEMENT OF OPINIONS
`
`6.
`
`A detailed explanation of my additional opinions in this matter as well
`
`as the bases for these opinions is set forth below.
`
`I reserve the right to supplement
`
`my opinions based on any new information that is provided to me in this matter.
`
`7.
`
`In my First Declaration, I opined that certain references anticipated or'
`
`rendered obvious certain claims of the ’736 patent. This declaration supplements
`
`my opinions.
`
`A.
`
`The Bonutti Patent
`
`8.
`
`I note that claim 25 of the Bonutti patent depends from claim 15, and
`
`says that the device of claim 15 “further includ[‘es] means associated with said
`
`2
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 3
`
`
`
`protrusion to prevent a separation of said base sliding side and said moveable
`
`sliding side.” I have been told that this is a “means plus function” claim, and that
`
`under applicable legal standards covers structures disclosed in the patent that
`
`provide the stated function, and equivalents. It seems clear from the words of this
`
`claim that the filnction of the “means” is to prevent separation of the base sliding
`
`side of the base component relative to the movable sliding side of the movable
`
`component. I will assume for purposes of my opinions herein that this is
`
`effectively the same as preventing separation of the claimed base component, such
`
`as a the tibial tray of a tibial knee implant, relative to the claimed movable
`
`component, such as the meniscal bearing insert, of the knee implant. For
`
`convenience, I sometimes refer to this claim function as the “separation prevention
`
`function” in my opinions. In my opinion, the specification of the ’736 patent does
`
`not disclose any structure associated with a protrusion that provides this separation
`
`prevention fiinction, as required by claim 25.
`
`9.
`
`At paragraphs 39—44 of the First Declaration I discuss certain features
`
`of the tibial component 1292 shown in Fig. 90 and described in columns 101 and
`
`102 of the Bonutti patent. Specifically, I noted that the tibial component includes a
`
`tray 1294 and a bearing insert 1296. The upper or superior surface 1302 of the tray
`
`1294 is provided with a projection, or post, 1306 that cooperates with a recess
`
`1308 located on and extending into the bottom or inferior surface 1304 of the
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 4
`
`
`
`bearing insert to permit rotation of the bearing insert with respect to the tibial tray.
`
`I also noted that the Bonutti patent states that the post 1306 is offset toward the
`
`medial compartment of the knee.
`
`10.
`
`The post 1306 and recess 1308 of the tibial component shown in Fig.
`
`90 of the Bonutti patent will constrain the motion of the bearing insert 1296 to
`
`rotational motion with respect to the tibial tray 1294. By so doing, the post and
`
`recess prevent certain other forms of movement between the bearing insert and the
`
`tibial tray. For example, with reference to Fig. 90, the post and recess will prevent
`
`movement of the bearing insert with respect to the tibial tray in a direction parallel
`
`to the medial-lateral axis of the tray. Similarly, the post and recess will prevent
`
`movement of the bearing insert with respect to the tibial tray in a direction parallel
`
`to the anerior—posterior axis of the tray.
`
`11. However, the description of the implant shown in Fig. 90 and
`
`described at column 101 , line 6 through column 102, line 4, has no express
`
`description of structures associated with post 1306 that provide a separation
`
`prevention function, as I understand is required by claim 25. For example, I see
`
`no description of any structures associated with post 1306 that would prevent the
`
`bearing insert from separating from the tibial tray. Nor do I see any description of
`
`a dovetail joint structure (which I discuss in greater detail below) in connection
`
`with the description of the implant shown in Fig. 90.
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 5
`
`
`
`12.
`
`For purposes of this declaration, I have been asked to assume that in
`
`the ’736 patent, the structure associated with the protrusion that performs the
`
`separation prevention function is the shape of the post 1306 and its equivalents.
`
`In
`
`addition, I have been asked to assume that alternatively, a dovetail joint and its
`
`equivalents also perform the separation prevention filnction of the ’736 patent.
`
`13. With respect to a dovetail joint, I have reviewed the description of the
`
`mobile bearing implant 1250 shown in Figs. 88 and 89 and described at column 99,
`
`line 35 through column 101, line 5. This bearing implant has a tibial tray 1266
`
`with what is referred to as a track 1276 on its upper or superior surface 1274, and a
`
`bearing insert 1268 having what is referred to as a groove 1286 in the lower or
`
`inferior surface 1284. The track 1276 is an elongated member with a trapezoidal
`
`shaped cross section, and it extends in an anterior—posterior direction down the
`
`medial—lateral center of the tray. Similarly, the groove 1286 is an elongate slot or
`
`void with a trapezoidal shaped cross section, and it extends in an anterior—posterior
`
`direction down the medial-lateral center of the bearing insert. The sizes of the
`
`track and groove are such that they mate, and cooperate so that sliding motion of
`
`the bearing insert relative to the tray occurs substantially in the anterior—posterior
`
`direction.
`
`(See, e. g,, column 99, line 64 through column 100, line 24). I also note
`
`that “[a]lthough a single track 1276 is shown centrally located, track 1276 can be
`
`located elsewhere along superior surface 1274 and/or more than one track can be
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 6
`
`
`
`used (e.g. two lateral symmetrically placed tracks).” (Column 99, line 66 — column
`
`100, line 2). Based on my understanding of this description, the alternative track
`
`structures will enable sliding motion substantially in the anterior—posterior
`
`direction.
`
`14. Although not expressly identified as such in column 99, line 35
`
`through column 101, line 4, mating trapezoidal cross section shaped structures
`
`such as the track 1276 and groove 1286 are commonly referred to as “dovetail
`
`joint” structures. As evidence of this common terminology, I note that the Bonutti
`
`patent refers to a similarly shaped slot 1190 on the bottom of the tray 1186 shown
`
`in Fig. 80 as having a “dove-tail shape.” (Column 98, lines 1-5). In fact, it appears
`
`that the use of dovetail joint structures to hold bearing inserts onto tibial trays of
`
`tibial prosthesis components was well known before the invention of the Bonutti
`
`patent. As I discuss in detail below, the Hood patent, Bahler patent and Buechel
`
`patent all disclose what are expressly called dovetail joint structures for this
`
`purpose.
`
`15.
`
`As I discussed above, the dovetail joint track and groove of the mobile
`
`bearing implant described in connection with Figs. 88 and 89 will enable sliding
`
`motion of the bearing insert relative to the tibial tray in the anterior—posterior
`
`direction. These dovetail joint structures constrain movement of the bearing insert
`
`relative to the tibial tray to movement in the anterior—posterior direction. In
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 7
`
`
`
`particular, because of the shapes and mating nature of the dovetail structures on the
`
`bearing insert and tray, these dovetail structures will prevent separation of the
`
`bearing insert with respect to the tray.
`
`B.
`
`The Walker Patent
`
`16.
`
`The semicircular abutment 50 and semicircular recess 51 of the
`
`mobile bearing knee prosthesis shown in the Walker patent provide a separation
`
`prevention fiinction. Specifically, the abutment 50 and recess 51 will prevent
`
`separation of the meniscal component relative to the tibial platform when the
`
`meniscal component is moved in directions (e.g., in the medial or sideway
`
`direction in Fig. 2) that cause the semicircular edge surface of the recess 51 to
`
`engage the semicircular outer edge surface of abutment 50. For instance, Walker
`
`states that “the meniscal component can befitted to the tibial platform by engaging
`
`the abutment 50 in the recess 51 and then the stud 42 in its corresponding slot 43.”
`
`(Column 4, lines 30-34, emphasis added).
`
`C.
`
`The Buechel Patent
`
`17.
`
`The Buechel patent discloses a meniscal bearing knee replacement.
`
`Several of the drawing figures from the Buechel patent are reproduced below.
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 8
`
`
`
`FIG.32A
`
`Fl 6.328
`
`
`
`mssn‘r
`
`
`
`H7
`FORWARD
`'
`or
`J POSITION
`
`Fl G . l8
`
`’4'
`J—I—Z
`
`Fl G. l9
`4,—2.1
`I4]
`
`“’43
`
`I44
`
`’42
`
`18.
`
`As shown, the implant has a femoral component 111, a tibial platform
`
`component 116 and an intermediate tibial bearing component 117. The tibial
`
`platform 116 has tracks 148 and 153 that receive and partially constrain movement
`
`of the tibial bearing components 117. (Column 15 , lines 14—32). The bearing
`
`surface of the bearing component 117 has a “projecting dovetail surface” 144 that
`
`matingly engages the track surfaces. (Column 15, lines 14—21).
`
`19. As the knee is flexed slightly, the intermediate tibial bearing
`
`components 1 17 move rearward relative to the tibia (i.e., in the anterior-posterior
`
`8
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 9
`
`
`
`direction). Additional flexure produces a small additional posterior shift of the
`
`tibial bearing components 117. (Column 14, lines 19—27).
`
`D.
`
`The Hood Patent
`
`20.
`
`The Hood patent discloses a modular knee joint prosthesis. As
`
`shown in Figs 7, 8, 9 12 and 14 reproduced below, the tibial component 40 of the
`
`prosthesis includes a tibial tray 42 and a tibial insert 44. “A pair of longitudinally
`
`extending raised dovetails 54 and 56 extend above the surface 46 of the tray 42 and
`
`match cutout grooves in the distal or inferior surface of the insert 44 ....” (Column
`
`7, lines 27-31). “[T]he bosses 54, 56 and recess 57 act to retain a tibial insert 44
`
`which has matching dovetail shaped grooves cut in its inferior surface and a boss
`
`51 projecting from that surface that engages in the slot 57 when the dovetail bosses
`
`54 and 56 are fully inserted into the matching grooves 53, 55.” (Column 8, lines 1-
`
`6).
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 10
`
`
`
`
`
`E.
`
`The Bahler Patent
`
`21.
`
`The Bahler patent discloses a prosthetic arrangement for a complex
`
`joint such as a knee. As shown in Figs. 6C, 10A and 11 reproduced below, the
`
`second or tibial part 17 has two guide tracks 35 in the form of a dovetail.
`
`Intermediate parts 13 that have the condylar bearing surface 21 have coupling
`
`portions 15 that are dovetail shaped. (Column 9, lines 30—33 and 43—55; column
`
`10, lines 25— 36).
`
`10
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 11
`
`
`
`
`
`‘9'
`
`
` .5
`
`"/
`,.
`«a
`figfi n
`I.
`Fig.10A
`
`
`"35
`
`35
`
`Fig. 60
`
`I
`
`13
`
`17 #1 7
`
`
`
`
`ll
`
`
`*9.
`
`The Claims of the Bonutti Patent
`
`22.
`
`Claim 23 of the Bonutti patent depends from claim 15, and recites
`
`“wherein said protrusion is a dovetail pin and said recess is a dovetail tail, together
`
`forming a dovetail joint.”
`
`11
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 12
`
`
`
`23.
`
`Claim 24 depends from claim 24, and recites “wherein said dovetail
`
`joint is elongate, extends in a substantially anterior—posterior orientation, and
`
`enables anterior—posterior displacement of the base sliding side relative to the
`
`movable sliding side.”
`
`24.
`
`As I discussed above, claim 25 is a “means plus function” claim that
`
`depends from claim 15 and recites the device as “fiirther including means
`
`associated with said protrusion to prevent a separation of said base sliding side and
`
`said movable sliding side.”
`
`25.
`
`For the reasons expressed in my First Declaration (see, 6. g. , paragraph
`
`50), it is my opinion that the Walker patent anticipates claim 15.
`
`26. With respect to claim 25, as I noted above, I have been asked to
`
`assume that the shape associated with post 1306 and its equivalents are the
`
`structure that correspond to the claimed separation prevention function. Assuming
`
`that is the case, the Walker patent anticipates this claim. For the reasons discussed
`
`above, a person of ordinary skill in the art would have understood the Walker
`
`patent as teaching that the abutment 50 andrecess 51 are shaped and located to
`
`prevent separation of the meniscal component from the tray when the meniscal
`
`component and tray move with respect to one another in directions that cause the
`
`recess to engage the abutment. For these reasons, it is my opinion that claim 25 is
`
`anticipated by the Walker patent.
`
`12
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 13
`
`
`
`27. With respect to claim 23, for the reasons discussed above, the Buechel
`
`patent teaches the use of dovetail joint structures, including a dovetail pin and a
`
`dovetail tail, to provide constrained movement of meniscal components relative to
`
`the tray in mobile bearing knee implants. This function is the same function as that
`
`provided by the abutment 50 and recess 51 in the Walker patent.
`
`It was well
`
`known that dovetail joints could be used for this purpose in this application. The
`
`Walker patent and the Buechel patent also both relate to tibial knee implants, and
`
`in particular mobile bearing knee implants. It would have been obvious to a person
`
`of ordinary skill in the art (e.g., a matter of routine engineering and design choice)
`
`to substitute the dovetail joint structures of the Buechel patent for the abutment and
`
`recess of the Walker patent. Such a substitution would achieve the predictable
`
`result of providing constrained relative movement between the two components.
`
`Moreover, choosing features such as what structure to use to prevent separation
`
`would have been a mere design choice based on common sense. For at least these
`
`reasons, it is my opinion that claim 23 is obvious over the Walker patent in view of
`
`the Buechel patent.
`
`28.
`
`Claim 24 is obvious for the same reasons as claim 23. In particular,
`
`the dovetail joint disclosed in the Buechel patent is elongated, extends in a
`
`substantially anterior—posterior orientation, and enables anterior—posterior
`
`displacement of the base sliding side of the tray with respect to the movable sliding
`
`l3
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013- 14
`
`
`
`side of the bearing insert. For the reasonsdiscussed above, it would have been
`
`obvious to a person of ordinary skill in the art to substitute the dovetail joint of the
`
`Buechel patent for the abutment and recess of the Walker patent. Claim 24 is
`
`therefore obvious over the Walker patent in view of the Buechel patent.
`
`29.
`
`Turning again to claim 25, as I noted above, I have been asked to
`
`alternatively assume that a dovetail joint is the structure that corresponds to the
`
`claimed separation prevention function. Assuming as much, it is my opinion that
`
`claim 25 would have been obvious over the Walker patent in View of the Buechel
`
`patent. As I discussed above, the dovetail joint structure of the Buechel patent is a
`
`structure that provides a separation prevention function (e.g., in directions both
`
`parallel to and normal to the major surfaces of the components). For the reasons
`
`discussed above in connection with claims 23 and 24, it would have been obvious
`
`to a person of ordinary skill in the art to substitute the dovetail joint of the Buechel
`
`patent for the abutment and recess of the Walker patent. Claim 25 is therefore
`
`obvious over the Walker patent in view of the Buechel patent.
`
`****
`
`I hereby declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledge that willful false
`
`14
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 15
`
`
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under 18 U.S.C. § 1001.
`
`mom
`
`Date
`
`i 15% M- M
`
`Arthur G. Erdman
`
`15
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1013 - 16
`
`
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