`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`
`ZIMMER HOLDINGS, INC.
`ZIMMER, INC.
`Petitioners
`
`
`
`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
`__________________
`
`
`DECLARATION OF ARTHUR G. ERDMAN, Ph.D.
`
`
`v.
`
`
`
`
`
`
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 1
`
`
`
`
`
`I, Arthur G. Erdman, declare and state as follows:
`
`1.
`
`I am currently the Richard C. Jordan Professor and the Morse Alumni
`
`Distinguished Teaching Professor of Mechanical Engineering at the University of
`
`Minnesota in Minneapolis, MN. I am also the Director of the Medical Devices
`
`Center at the University of Minnesota. I hold Ph.D. (1971) and M.S. (1968)
`
`degrees in Mechanical Engineering from the Rensselaer Polytechnic Institute, and
`
`a B.S. degree (1967) in Mechanical Engineering from Rutgers University. My
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`curriculum vitae is attached as Exhibit 1.
`
`2.
`
`Briefly, I have extensive background and knowledge in the field of
`
`orthopedic medical devices, including knee kinematics and knee joint replacement
`
`implants. Since 2001, I have been Chair of the Design of Medical Devices
`
`Conference, one of the world’s largest premiere medical devices conferences, that
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`is held annually at the University of Minnesota. I am an inventor on over 30 U.S.
`
`patents.
`
`I.
`
`DOCUMENTS AND INFORMATION CONSIDERED
`
`3.
`
`In performing my investigation in this matter and in forming my
`
`opinions, I have reviewed the following documents:
`
`• U.S. Patent No. 7,837,736 (the “Bonutti patent”);
`
`• U.S. Patent No. 5,755,801 (the “Walker patent”);
`
`• U.S. Patent No. 6,319,283 (the “Insall ’283 patent”);
`
`
`
`1
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 2
`
`
`
`
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`• U.S. Patent 6,068,658 (the “Insall ’658 patent”);
`
`• Zimmer Mbk Mobile Bearing Knee brochure (“Zimmer Mbk brochure”);
`
`• Zimmer Mbk Intramedullary Instrument Surgical Technique (“Mbk
`intramedullary technique guide”);
`
`• Zimmer Micro-Mill Instrument Surgical Technique guide (“Mbk Micro-
`Mill technique guide”); and
`
`• Zimmer MBK Mobile Bearing Knee Implant & Instrument Order Form
`(“Mbk order form”).
`
`II. APPLICABLE LEGAL STANDARDS
`
`4.
`
`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. However, the following is 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.”
`
`5.
`
`To anticipate a patent claim, I understand that the prior art must
`
`disclose each and every limitation of the claimed invention in a single prior art
`
`reference, either expressly or inherently. I further understand that the single
`
`reference must be enabling and describe the claimed invention sufficiently to have
`
`
`
`2
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 3
`
`
`
`
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`placed it in possession of a person of ordinary skill in the field of the invention.
`
`Stated differently, I understand that a single reference must describe the claimed
`
`invention with sufficient precision and detail that a person having ordinary skill in
`
`the art at the time of that invention would have been able to make the invention
`
`based on that reference without undue experimentation. To determine whether a
`
`potentially anticipatory prior art reference is enabling, I understand that the
`
`teaching of the reference must be considered together with the knowledge of one of
`
`ordinary skill in the pertinent art.
`
`6.
`
`I understand that even if there is not a single prior art reference that
`
`anticipates the claimed invention, the invention may still have been considered
`
`“obvious” in view of the prior art. I understand that this inquiry requires one to
`
`determine whether the invention would have been obvious to a person of ordinary
`
`skill back at the date or time of the invention. I understand that this analysis
`
`further involves the following factual inquiries: (1) the scope and content of the
`
`prior art; (2) the differences between the prior art and the claims at issue; (3) the
`
`level of skill in the pertinent art; and (4) objective evidence that may impact the
`
`obviousness analysis—which, I understand, is also known as secondary
`
`considerations—such as, for example, commercial success, long-felt but
`
`unresolved need(s), failure(s) of others, copying, or industry praise relative to the
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`claimed invention.
`
`
`
`3
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 4
`
`
`
`
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`7.
`
`I also understand that throughout this analysis it can be important to
`
`identify a reason that would have prompted a person of ordinary skill in the
`
`relevant field to combine the prior art in the way the claimed new invention does. I
`
`also understand that it is appropriate to consider whether the person of ordinary
`
`skill in the art would have had a reasonable expectation of success in making the
`
`claimed invention based on the prior art. I also understand that the question of
`
`whether the art was predictable or unpredictable is also relevant to the obviousness
`
`analysis. For example, I understand that whether or not it would have been
`
`obvious to combine or modify prior art, and whether or not a person of ordinary
`
`skill would have had a reasonable expectation of success, may depend in part on
`
`whether the art in question was predictable or unpredictable.
`
`8.
`
`I understand that a prior art reference may be considered in assessing
`
`a patent claim’s obviousness if the reference discloses solving any problem or
`
`addressing any need addressed by the patent, or if the reference discloses
`
`information having obvious uses beyond its primary purpose that a person of
`
`ordinary skill in the art would reasonably examine to solve a problem or address a
`
`need addressed by the patent. I understand that a claimed combination of familiar
`
`elements according to known methods is likely obvious when it does no more than
`
`yield predictable results. I understand that when a work is available in one field of
`
`endeavor, design incentives and other market forces can prompt variations of it,
`
`
`
`4
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 5
`
`
`
`
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`either in the same field or a different one. I understand that if a person of ordinary
`
`skill in the art can implement a predictable variation of claimed subject matter,
`
`then the claim is likely invalid due to obviousness.
`
`9.
`
`I understand that an obviousness analysis need not seek out precise
`
`teachings directed to the specific subject matter of the challenged claim, and that
`
`the Administrative Law Judge and/or the Patent Trial and Appeal Board can take
`
`account of the inferences and creative steps that a person of ordinary skill in the art
`
`would have employed at the time of the alleged invention. I understand that it is
`
`often necessary to look to interrelated teachings of multiple prior art references; the
`
`effects of demands known to the design community or present in the marketplace;
`
`and the background knowledge possessed by a person of ordinary skill in the art,
`
`all in order to determine whether there was an apparent reason for the person of
`
`ordinary skill in the art to have combined elements in the manner claimed. I
`
`understand that any need or problem known in the field of endeavor at the time of
`
`the alleged invention or addressed by the patent-at-issue can provide a reason for
`
`the person of ordinary skill in the art to have combined elements in the manner
`
`claimed. I understand that one way in which a patent’s subject matter can be
`
`proved obvious is by noting that there existed at the time of invention a known
`
`problem for which there was an obvious solution encompassed by the patent’s
`
`claims. I understand that a person of ordinary skill attempting to solve a problem
`
`
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`5
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 6
`
`
`
`
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`will not be led only to those elements of prior art designed to solve the same
`
`problem. I understand that common sense teaches that familiar items may have
`
`obvious uses beyond their primary purposes, and in many cases a person of
`
`ordinary skill in the art will be able to fit the teachings of multiple prior references
`
`together like pieces of a puzzle. I understand that when there is a design need or
`
`market pressure to solve a problem and there are a finite number of identified,
`
`predictable solutions, a person of ordinary skill in the art has good reason to pursue
`
`the known options within his or her technical grasp. I further understand that, if
`
`this leads to the anticipated success, it is likely the product not of innovation but of
`
`ordinary skill and common sense and, as such, likely is obvious.
`
`10.
`
`I understand that someone assessing obviousness should be aware of
`
`and avoid the potential for distortion caused by hindsight bias and must be cautious
`
`of arguments reliant upon ex post reasoning. I understand that, before assessing
`
`the issue of obviousness, one must also consider certain objective factors—
`
`sometimes referred to as secondary considerations or indicia—which, if
`
`established, may indicate that the claimed invention may not have been obvious.
`
`Such secondary considerations include: (1) Were products covered by the claim
`
`commercially successful due to the merits of the claimed invention rather than due
`
`to other, unrelated factors, such as, for example, advertising, promotion or
`
`marketing, salesmanship, or unclaimed features of the product?; (2) Was there a
`
`
`
`6
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 7
`
`
`
`
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`long-felt but unresolved need for a solution to the problem facing the inventors,
`
`which was resolved by the claimed invention?; (3) Did others try, but fail, to solve
`
`the problem solved by the claimed invention?; (4) Did others copy the claimed
`
`invention?; (5) Did the claimed invention achieve unexpectedly superior results
`
`over the closest prior art?; (6) Did others in the field praise the claimed invention
`
`or express surprise at the making of the claimed invention?; and (7) Did others
`
`accept licenses under the patent-at-issue because of the merits of the claimed
`
`invention? I understand that these factors are only relevant to obviousness if there
`
`is a connection, or nexus, between each of them and the claimed subject matter. I
`
`understand that, even if one could conclude that some of the above factors have
`
`been established, those factors should be considered along with all other available
`
`evidence when determining whether the claimed invention would have been
`
`obvious to the person of ordinary skill in the art at the time of the alleged
`
`invention.
`
`11.
`
`I also understand that the Patent Office gives claim terms their
`
`broadest reasonable construction or meaning during inter partes review
`
`proceedings. I have assumed for my analysis that the time of the invention of the
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`Bonutti patent is a time in or around July 2002.
`
`
`
`7
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 8
`
`
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`
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`III. DETAILED STATEMENT OF OPINIONS
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`
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`12. A detailed explanation of my opinions in this matter as well as the
`
`basis for my 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 manner.
`
`
`
`
`
`A.
`
`Person of Ordinary Skill in the Art
`
`13.
`
`In my opinion, a person of ordinary skill in the art at the time of the
`
`invention would have had an understanding of the kinematics of the human knee
`
`joint and experience developing knee joint replacement implants. Such a person
`
`would typically have at least a bachelor’s degree in a relevant area such as
`
`mechanical or biomedical engineering, and four or more years of experience in a
`
`field relating to joint replacement implants. At least some of the experience
`
`relating to joint replacement implants would involve knee replacement implants.
`
`
`
`
`
`B. Knee Joint Anatomy and Kinematics
`
`14. The human knee is a joint that joins the femur (upper leg or thigh
`
`bone) and the tibia (or shin bone, the larger of the two lower leg bones, the other
`
`being the fibula), and includes the patella (kneecap) which protects the front of the
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`joint. The knee joint is a complex structure that accommodates a number of
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`different motions or articulations. The primary articulation is the hinge-like
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`motion between the femur and tibia when the leg moves between its straight
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`(extended) position and its bent (flexed) position. A second articulation is the
`
`
`
`8
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 9
`
`
`
`
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`sliding motion of the patella along the femur during leg extension and flexion. The
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`knee joint also accommodates a limited amount of relative axial rotation between
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`the femur and tibia. These and other components of the knee joint, as well as the
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`kinematics of the motion, can be described with reference to the following
`
`illustrations of a right knee joint.
`
`
`
`15.
`
`In medical terminology, the front of the knee is referred as the anterior
`
`side, and the back as the posterior side. The inside of the knee (the side closest to
`
`the knee of the other leg) is referred to as the medial side, and the opposite and
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`outside is referred to as the lateral side. The bottom or distal end of the femur has
`
`two convex rounded regions known as condyles that are separated by a region
`
`known as the trochlear groove. The medial condyle is on the medial side of the
`
`joint, and the lateral condyle is on the lateral side of the joint.
`
`Femur
`(thigh bone)
`Posterior
`Side
`
`Lateral Condyle
`
`Trochlear Groove
`
`Lateral Side
`
`Fibula
`
`Quadriceps Tendon
`
`Patella
`
`Medial Side
`
`Medial Condyle
`
`Meniscus
`
`Patellar Tendon
`
`Anterior Side
`
`Tibia
`(shin bone)
`
`
`
`Right Human Knee Joint
`
`
`
`9
`
`
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 10
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`
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`Lateral View
`
`Left Human Knee Joint Posterior View
`
`
`
`
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`16. On the top or proximal end of the tibia are concave sockets or
`
`depressions. Disks of cartilage-like material known as menisci overlay the sockets.
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`The socket of the medial side of the tibia receives the medial condyle of the femur.
`
`Similarly, the socket of the lateral side of the tibia receives the lateral condyle of
`
`the femur. The medial and lateral menisci are sometimes referred to as the
`
`meniscus, and protect the surfaces of the femur and tibia from rubbing on each
`
`other.
`
`
`
`17. Ligaments and tendons surrounding the knee joint provide stability to,
`
`and serve to limit movements of, the joint bones. The anterior cruciate ligament
`
`(ACL) and posterior cruciate ligament (PCL) stabilize the joint. The ACL extends
`
`
`
`10
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 11
`
`
`
`
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`from the lateral condyle of the femur to a generally central proximal region on the
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`anterior side of the tibia. The PCL extends from the medial condyle of the femur
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`to a generally central proximal region on the posterior side of the tibia. The medial
`
`collateral ligament (MCL) extends from the projection known as the medial
`
`epicondyle on the side of the medial condyle to the medial side on the proximal
`
`end of the tibia. Similarly, the lateral collateral ligament (LCL) extends from the
`
`lateral epicondyle to the lateral side of the tibia. The patella is held on the anterior
`
`side of the femur by the quadriceps and patellar tendons.
`
`
`
`18. As mentioned above, the knee joint can accommodate a relatively
`
`wide range of motion during flexion and extension of the leg. During the primary
`
`hinge-like bending motion, the articular surfaces of the medial and lateral condyles
`
`of the femur both roll and slide over the corresponding articular surfaces of the
`
`tibia, and the patella slides along the trochlear groove. The knee joint also
`
`accommodates a relatively limited amount of axial rotational motion between the
`
`femur and tibia (i.e., along the longitudinal axes of these bones). During this axial
`
`rotational motion the condyles of the femur move over the proximal end of the
`
`tibia.
`
`
`
`19. The knee joint is sometimes referred to as having three major
`
`compartments: the medial and lateral compartments and the patellofemoral
`
`compartment. The medial compartment is the region surrounding and including
`
`
`
`11
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 12
`
`
`
`
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`the articulating surfaces of the medial femoral condyle and corresponding medial
`
`side portions of the meniscus and tibia. Similarly, the lateral compartment is the
`
`region surrounding and including the articulating surfaces of the lateral femoral
`
`condyle and corresponding lateral side portions of the meniscus and tibia. The
`
`patellofemoral compartment is the area surrounding and including the articulating
`
`surfaces of the patella and the condyles and trochlear groove of the femur.
`
`
`
`C. Replacement Knee Joint Implants or Prostheses
`
`20. Damage to the natural knee caused by injury and/or disease such as
`
`arthritis can result in pain and the loss of knee joint function. Knee joint
`
`replacement with an implant or prosthesis, a surgical procedure known as
`
`arthroplasty, is commonly performed to decrease pain and restore knee function.
`
`Depending on the extent and nature of the damage, any one or all three of the knee
`
`compartments can be surgically replaced. For some patients, replacement of only
`
`one compartment (e.g., the medial compartment) may be sufficient to repair the
`
`damage. An arthroplasty procedure and implant for the repair of only one knee
`
`joint compartment is known as a unicompartmental arthroplasty (UKA). More
`
`commonly, all the knee compartments of the knee, or at least both the medial and
`
`lateral compartments, are replaced during a procedure known as total knee
`
`arthroplasty (TKA).
`
`
`
`12
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 13
`
`
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`
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`21.
`
`In general, knee replacement surgery consists of replacing the
`
`damaged surfaces of the knee with metal and plastic components configured as
`
`functional substitutes. A variety of different knee replacement implants are known
`
`and available. The illustrations below show one representative “total” replacement
`
`knee implant having features that are relevant for an understanding of the claims of
`
`the Bonutti patent that is the subject of this proceeding. These illustrations show
`
`the implant both alone and after implantation in a patient’s leg. The illustrated
`
`implant is configured to replace both the medial and lateral knee joint
`
`compartments.
`
`Femur
`
`Femoral
`Component
`
`Articular
`Surface
`
`Tibial
`Tray
`
`Tibial
`Component
`
`Tibia
`
`Post
`
`Replacement Knee Prosthesis
`
`Implanted Knee
`Prosthesis
`
`
`
`
`
`22. The knee implant includes a tibial component and a femoral
`
`component. The femoral component replaces the medial and lateral condylar
`
`
`
`13
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 14
`
`
`
`
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`surfaces of the patient’s natural femur. The tibial component replaces the
`
`meniscus and proximal surface of the patient’s natural tibia.
`
`
`
`23. As shown in these illustrations, the femoral component, which is
`
`typically formed of a biocompatible metal alloy, is shaped as a partial shell-like
`
`structure that has a back or bone-engaging surface and an opposite articular
`
`surface. The articular surface has a pair of spaced-apart and generally convex
`
`rounded portions that correspond to the shape of the medial and lateral condyles of
`
`a natural femur. The condylar portions of the articulating surface are separated by
`
`a surface portion having a shape that corresponds to the shape of the trochlear
`
`groove of a natural femur. The bone-engaging surface of the femoral component is
`
`formed from a number of generally planar regions (e.g., five in the illustrated
`
`implant) that extend generally tangentially with respect to an actuate path
`
`extending from the distal side to the anterior side and corresponding to the outer
`
`articulating surface, and intersect one another along the arcuate path. Femoral
`
`components sometimes have mounting structures on the bone-engaging side to
`
`help secure the component to patient’s femur. The illustrated femoral component,
`
`for example, has posts projecting from the bone-engaging side for this purpose.
`
`
`
`24. The tibial component is formed from two parts: a generally flat tibial
`
`tray and an articular surface that mounts to the tibial tray and functions as a
`
`replacement for the meniscus. Tibial trays are typically formed from metal alloy,
`
`
`
`14
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 15
`
`
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`
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`and sometimes have mounting structures to help secure the component to the
`
`patient’s tibia. The illustrated tibial component, for example, has a post that
`
`extends from the underside of the tibial tray for this purpose.
`
`
`
`25. The articular surface is typically formed from high molecular weight
`
`(i.e., high density) plastic material. The articular surface has a bottom surface that
`
`mounts to the tibial tray, and an opposite surface with a pair of spaced-apart and
`
`generally concave depressions that correspond to the shape of the sockets in the
`
`corresponding sides of the patent’s natural tibia. After the prosthesis is surgically
`
`implanted into the patient, the condylar surfaces of the femoral component engage
`
`and move in the depressions of the articular surface in much the same manner as
`
`the natural surfaces during flexion and extension of the patient’s leg. Although not
`
`shown in the illustrations above, the knee implant can also include a patellar
`
`component that similarly replaces the inside or femur-facing surface of the
`
`patient’s natural patella if the patellofemoral compartment is being replaced.
`
`
`
`26. Some knee replacement prostheses, known as “mobile bearing”
`
`devices, are configured with an articular surface that can move on the tibial tray,
`
`typically over limited ranges of motion, when implanted in the patient. This
`
`limited movement of the articular surface enhances the ability of the prosthesis to
`
`mimic the complex joint function of the natural knee, such as the axial rotation
`
`between the tibia and femur during bending.
`
`
`
`15
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 16
`
`
`
`
`
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`
`
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`D. Knee Arthroplasty Surgical Procedure
`
`27.
`
`I am not a surgeon and have not performed knee arthroplasty
`
`procedures. However, I have observed these surgical procedures and am familiar
`
`with the aspects of these procedures relevant to the joint implants that are the
`
`subject of this proceeding.
`
`28. The surgical procedures used to implant different knee implants can
`
`vary. Different knee implant vendors will offer different surgical instruments for
`
`use with their implants. Steps of the surgical procedures are within the discretion
`
`of the surgeon, and different surgeons may use different procedures to implant the
`
`same type of implant. For example, although the surgical instrument and
`
`procedure described below involve making the first femoral cut on the anterior
`
`surface of the femur, and referencing other femoral cuts to the anterior cut, other
`
`surgical instruments and procedures make the distal femoral cut first, and reference
`
`the subsequent femoral cuts to the distal cut.
`
`29.
`
`In general, during a knee arthroplasty surgical procedure used to
`
`implant knee prostheses of the types described above, one or more of: (1) the
`
`femoral condylar surfaces, (2) any remaining menisci, and (3) the upper surface of
`
`the tibia are cut away, a process known as resection, and replaced with prosthesis
`
`components. For example, during a TKA procedure, the outer surface of both the
`
`medial and lateral femoral condyles and the upper surface of the tibia are resected
`
`
`
`16
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 17
`
`
`
`
`
`and replaced with femoral and tibial prosthesis components. A brief description of
`
`one representative surgical technique for this procedure follows.
`
`
`
`
`
`1.
`
`Resection of the Femur
`
`30. After making the incisions needed to provide access to the bones, a
`
`femoral alignment guide is mounted to the distal end of the femur. The femoral
`
`alignment guide is mounted to the end of an intramedullary rod that is inserted into
`
`the medullary canal. As shown below, a hole can be drilled through the bone on
`
`the distal end of the femur to provide access to the intramedullary canal.
`
`Femur
`
`Intramedullary
`Canal
`
`Intramedullary
`Rod
`
`Femur
`
`Femoral
`Alignment
`Guide
`
`Tibia
`
`
`
`Tibia
`
`
`
`31. The distal end of the femur is then resected to provide an outer surface
`
`
`
`
`
`shape that corresponds to the bone-engaging (inside) surface of the femoral
`
`component. During the illustrated surgical technique, the anterior side surface of
`
`the femur is resected first. As shown below, an anterior femoral cutting guide that
`
`has slots used to guide the cutting instrument is mounted to the femoral alignment
`
`
`
`17
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 18
`
`
`
`
`
`guide. The blade of the cutting instrument is inserted through the slots and guided
`
`by the slots during the anterior cut.
`
`Cutting Instrument Blade
`
`Anterior Side
`Of Femur
`
`Anterior Femoral
`Cutting Guide
`
`Guide Slot
`
`Femoral
`Alignment Guide
`
`
`
`32. The distal ends of both the medial and lateral femoral condyles are cut
`
`next in this technique. As shown in the illustrations below, during the distal
`
`femoral cuts the cutting instrument blade is guided by slots in a distal femoral
`
`cutting guide. The distal femoral cutting guide is positioned on the previously cut
`
`anterior surface of the femur using the femoral alignment guide as a positioning
`
`reference, and secured to the femur by pins.
`
`
`
`18
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 19
`
`
`
`
`
`Cutting Instrument Blade
`Distal Femoral Cutting Guide
`
`Mounting Pin
`
`Guide Slot
`
`Distal End of Femur
`
`Distal End
`of Femur
`
`Tibia
`
`Femoral Alignment Guide
`
`
`
`
`
`33. The final femoral cuts are made using a femoral finishing guide that is
`
`mounted to the previously cut distal surface of the femur. The femoral finishing
`
`cut guide is positioned with respect to the previously cut anterior surface and
`
`secured to the distal surface by pins. As shown below, the femoral finishing guide
`
`has guide slots for the posterior, posterior chamfer, and anterior chamfer cuts.
`
`Femoral Finishing Guide
`
`Anterior Chamfer
`Guide Slot
`
`Posterior Guide
`Slot
`
`Posterior Side Of Femur
`
`Anterior Cut
`Surface
`
`Pin
`
`Distal Cut Surface
`Posterior Chamfer
`Guide Slot
`
`
`
`19
`
`Cutting Instrument Blade
`
`Femoral Finishing Guide
`
`Anterior Cut
`Surface
`
`Anterior Chamfer Cut Line
`
`Posterior Chamfer
`Cut Surface
`
`Posterior Cut
`Surface
`
`
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 20
`
`
`
`
`
`34. Using the femoral finishing guide and the associated guide slots, the
`
`surgeon makes: (1) a posterior cut on the posterior side of the femur, (2) a
`
`posterior chamfer cut between the distal cut surface and the posterior cut surface,
`
`and (3) an anterior chamfer cut between the distal cut surface and the anterior cut
`
`surface. The completely resected femur is shown in the following illustration:
`
`
`
`
`
`2.
`
`Anterior
`Cut Surface
`
`Femur
`
`Distal Chamfer
`Cut Surface
`Distal Cut Surface
`Posterior Chamfer
`Cut Surface
`
`Trochlear Groove
`
`Posterior Cut Surface
`
`
`
`Resection of the Tibia
`
`35. The tibia is often resected using a cutting guide mounted to an
`
`
`
`
`
`extramedullary alignment device such as that shown in the illustrations below.
`
`
`
`20
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 21
`
`
`
`
`
`Guide Slot
`
`Distal End of Tibia
`
`Tibial Cutting Guide
`
`Extramedullary
`Alignment Rod
`
`Tibia
`
`
`
`
`
`36. The tibial cutting guide has a slot. The cutting guide is positioned on
`
`the alignment device so that the cutting instrument blade is guided by the slot to
`
`form the upper or proximal cut surface at the desired depth and angle as shown in
`
`the illustration below. Pins can be used to secure the cutting guide to the tibia.
`
`Also shown below is an illustration of the completely resected tibia. Although not
`
`shown in these illustrations, the inner surface of the patella will also be resected if
`
`the patellofemoral compartment is being replaced as part of the procedure.
`
`
`
`21
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 22
`
`
`
`
`
`
`
`
`
`Tibial Cutting
`Guide
`Cutting Instrument
`Blade
`
`Proximal Cut Surface
`
`Proximal End of
`Tibia
`
`Tibia Cut Line
`Pin
`
`Tibia
`
`3.
`
`Trial Reduction
`
`Alignment
`Rod
`
`
`
`Tibia
`
`
`
`37. Before the final components are implanted, temporary components,
`
`known as provisionals, are used to determine the proper size and position of the
`
`final components. During trial reduction, the proper size tibial and femoral
`
`provisionals, and the associated articular surface provisional, are selected and
`
`temporarily mounted onto the associated resected bones. The surgeon then
`
`evaluates the fit of the provisional components and the kinematics of the knee joint
`
`with these components. The tibial and femoral provisional components also serve
`
`as templates that enable the surgeon to properly position and form any holes in the
`
`bones that may be used to receive the mounting structures on the final components.
`
`Following the trial reduction process, the provisional components are removed.
`
`
`
`
`
`4.
`
`Component Implantation
`
`38. After the final components are chosen, they are mounted to the
`
`associated resected bones. The tibial tray of the tibial component is mounted to the
`
`proximal cut surface of the tibia. The femoral component is mounted to the
`
`
`
`22
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 23
`
`
`
`
`
`resected distal end of the femur. In addition to the fixation provided by mounting
`
`structures such as the posts that extend from the components into the bones,
`
`cement is sometimes used to secure the components to the resected surfaces. The
`
`articular surface is then mounted to the tibial component, between the tibial tray
`
`and the femoral component. The patellar component is placed on the resected
`
`surface of the patella if it is part of the procedure being performed. These steps are
`
`shown generally in the illustrations below. After all the prosthesis components
`
`have been implanted, the incision is closed.
`
`Femoral
`Component
`
`Femur
`
`Articular Surface
`
`Femoral
`Component
`
`Tibial
`Component
`
`Femur
`
`Articular
`Surface
`
`Tibial Tray
`
`Tibia
`
`Tibial Tray
`
`Tibia
`
`
`
`
`
`
`
`
`
`
`
`E.
`
`The Bonutti U.S. Patent 7,837,736
`
`39. The Bonutti patent describes a number of different joint replacement
`
`implants and related surgical procedures and instruments. The focus of the Bonutti
`
`patent disclosure is on devices and methods related to knee joints. The claims of
`
`the patent, however, are directed mobile bearing joint devices, and in particular to
`
`mobile bearing knee prostheses. Claims 15-28 and 31-37 are even more specific in
`23
`
`
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1005 - 24
`
`
`
`
`
`that they effectively claim a particular type or class of mobile bearing implants—
`
`implants that have a meniscal component configured to rotate or move with respect
`
`to the tray or base component in a manner that is asymmetric or offset from at least
`
`one of a medial-lateral centerline or an anterior-posterior centerline of the device.
`
`The Bonutti patent asserts that configuring the device in this manner recreates the
`
`natural pivoting motion of the knee (e.g., at column. 101, lines. 55-67).
`
`
`
`40.
`
`In claim 15, this mobile bearing joint configuration is claimed as
`
`including, inter alia: (1) “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;” and (2) “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