`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`ZIMMER HOLDINGS, INC.
`ZIMMER, INC.
`Petitioners
`
`v.
`
`BONUTTI SKELETAL INNOVATIONS LLC
`Patent Owner
`
`Patent No. 7,806,896
`Filing Date: November 25, 2003
`Issue Date: October 5, 2010
`Title: KNEE ARTHROPLASTY METHOD
`
`__________________
`
`Inter Partes Review No. Unassigned
`__________________
`
`DECLARATION OF ARTHUR G. ERDMAN, Ph.D.
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 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
`
`curriculum vitae is attached as Exhibit 1.
`
`2.
`
`Briefly, I have extensive background and knowledge in the field of
`
`orthopedic medical devices, including knee joint replacement implants. I also have
`
`extensive background and knowledge in the area of computer-based CAD/CAM
`
`systems in connection with medical devices. Since 2001, I have been Chair of the
`
`Design of Medical Devices Conference, one of the world’s largest premiere
`
`medical devices conferences, that 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. This list includes documents
`
`relating to knee replacement implants and procedures that I reviewed on
`
`1
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 2
`
`
`
`connection with my earlier declaration regarding the Bonutti U.S. Patent
`
`7,837,736.
`
`• U.S. Patent No. 7,806,896 (the “Bonutti patent”)
`
`• PCT Publication No. WO 93/25157 (the “Radermacher PCT
`Publication”)
`
`Radermacher et al., Computer-Integrated Orthopaedic Surgery:
`Connection of Planning and Execution in Surgical Intervention (the
`“Radermacher Article”)
`
`••
`
`• U.S. Patent No. 4,567,885 (the “Androphy Patent”)
`
`• U.S. Patent No. 6,068,658 (the “Insall Patent”)
`
`• U.S. Patent No. 4,421,112 (the “Mains Patent”)
`
`• Bonutti U.S. Patent No. 7,837,736
`
`• Walker U.S. Patent No. 5,755,801
`
`•
`
`Insall U.S. Patent No. 6,319,283
`
`• Zimmer Mbk Mobile Bearing Knee brochure
`
`• Zimmer Mbk Intramedullary Instrument Surgical Technique guide
`
`• Zimmer Micro-Mill Instrument Surgical Technique guide
`
`• Zimmer MBK Mobile Bearing Knee Implant & Instrument Order Form
`
`• Zimmer surgical technique guide entited “NexGen Complete Solution –
`Epicondylar Instrumentation Surgical Technique for Legacy Posterior
`Stabilized Knee” (the “NexGen Epi technique guide”)
`
`• Zimmer surgical technique guide entited “casey total knee,” (the “Casey
`technique guide”)
`
`2
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 3
`
`
`
`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
`
`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
`
`3
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 4
`
`
`
`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
`
`claimed invention.
`
`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 understand that the question of whether
`
`4
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 5
`
`
`
`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,
`
`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
`
`5
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 6
`
`
`
`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
`
`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,
`
`6
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 7
`
`
`
`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
`
`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
`
`7
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 8
`
`
`
`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
`
`Bonutti patent is August 28, 2001. Below I use terms such as “the 2001 timeframe
`
`and “the time of the invention” to mean a date on or before August 28, 2001.
`
`III. DETAILED STATEMENT OF OPINIONS
`
`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.
`
`13.
`
`Person of Ordinary Skill in the Art
`
`In my opinion, a person of ordinary skill in the art at the time of the
`
`invention would have had at least a bachelor’s degree or equivalent in a relevant
`
`8
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 9
`
`
`
`area such as mechanical or biomedical engineering and at least several years of
`
`experience in a field relating to joint implants, at least some of which would
`
`involve hip or knee implants. Such a person would also have had experience with
`
`computer-based design and manufacturing (i.e. CAD/CAM) systems.
`
`B.
`
`14.
`
`Knee Joint Anatomy and Kinematics
`
`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
`
`joint. The knee joint is a complex structure that accommodates a number of
`
`different motions or articulations. The primary articulation is the hinge-like
`
`motion between the femur and tibia when the leg moves between its straight
`
`(extended) position and its bent (flexed) position. A second articulation is the
`
`sliding motion of the patella along the femur during leg extension and flexion. The
`
`knee joint also accommodates a limited amount of relative axial rotation between
`
`the femur and tibia. These and other components of the knee joint, as well as the
`
`kinematics of the motion, can be described with reference to the following
`
`illustrations of a 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
`
`9
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 10
`
`
`
`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. While human bones
`
`generally have complexly shaped surfaces, the surface contours from the condyles
`
`and the trochlear groove create an especially complex surface at the distal end of
`
`the femur that will be unique to each individual.
`
`
`
`10
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 11
`
`
`
`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.
`
`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
`
`from the lateral condyle of the femur to a generally central proximal region on the
`
`11
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 12
`
`
`
`anterior side of the tibia. The PCL extends from the medial condyle of the femur
`
`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
`
`the articulating surfaces of the medial femoral condyle and corresponding medial
`
`12
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 13
`
`
`
`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).
`
`21.
`
`In general, knee replacement surgery consists of replacing the
`
`damaged surfaces of the knee with metal and plastic components configured as
`
`13
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 14
`
`
`
`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.
`
`22.
`
`The knee implant includes a tibial component and a femoral
`
`component. The femoral component replaces the medial and lateral condylar
`
`surfaces of the patient’s natural femur. The tibial component replaces the
`
`meniscus and proximal surface of the patient’s natural tibia.
`
`14
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 15
`
`
`
`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 posterior side to the anterior side and corresponding to the
`
`outer articulating surface, and intersect one another along the arcuate path.
`
`Because those planar regions of the femoral component do not match the natural
`
`shape of the distal end of the femur, the femur must be resected or cut so that the
`
`distal surface of the femur fits the bone-engaging surface of the femoral
`
`component, as described below in more detail. Femoral components sometimes
`
`have mounting structures on the bone-engaging side to help secure the component
`
`to the patient’s femur. The illustrated femoral component, for example, has posts
`
`projecting from the bone-engaging side for this purpose.
`
`15
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 16
`
`
`
`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,
`
`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.
`
`D.
`
`26.
`
`Knee Arthroplasty Surgical Procedure
`
`I am not a surgeon and have not performed knee arthroplasty
`
`procedures. However, I have observed these surgical procedures and am familiar
`
`16
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 17
`
`
`
`with the aspects of these procedures relevant to the joint implants and surgical
`
`instruments that are the subject of this proceeding.
`
`27.
`
`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 instruments 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. Thus, the order in which particular
`
`portions of the femur are cut and removed is largely dictated by the selected
`
`instrument set, which is often specific to the selected implants, and other aspects of
`
`the procedure including those within the skill set and discretion of the surgeon.
`
`28.
`
`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
`
`17
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 18
`
`
`
`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
`
`29.
`
`To access the bones forming the knee joint, the surgeon will make an
`
`incision through the patient’s skin. The edges of the incision are pulled apart (e.g.,
`
`by applying force through the use of retractors engaging the opposite edges of the
`
`skin, muscle and other tissue) to widen or expand the aperture into the operative
`
`areas of the knee. Making the incision and pulling apart the sides of the incision to
`
`widen the aperture into the patient is a common surgical practice, if not an inherent
`
`requirement for knee arthroplasty operations, and would have been inherent to a
`
`person of ordinary skill in the art from the references discussed below (as well as
`
`obvious). Furthermore, it was known at the time of the invention to minimize the
`
`size of the incision (e.g., to minimize devascularization, minimize damage to
`
`nerves and to minimize the physical appears of resulting scars).
`
`30. Once the surgeon has accessed the surgical site, he or she will resect
`
`the distal end of the femur to match the corresponding back surfaces of the femoral
`
`component. It is important that the femur be accurately cut so that the femoral
`
`component is properly located and oriented on the bone and fits properly. To
`
`ensure that the cuts are precisely made (e.g., properly located and aligned),
`
`surgeons typically use special surgical tools to align and guide the cutting
`
`18
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 19
`
`
`
`instrument (e.g., a saw blade). For example, in one common approach shown
`
`below, the surgeon drills a hole through the bone at the distal end of the femur to
`
`provide access to the intramedullary canal. An intramedullary rod is inserted into
`
`that hole, and a femoral alignment guide is mounted to the opposite end of the
`
`intramedullary rod.
`
`Femur
`
`Intramedullary
`Canal
`
`
`
`Tibia
`
`
`
`Intramedullary
`Rod
`
`Femur
`
`Femoral
`Alignment
`Guide
`
`Tibia
`
`31.
`
` With the intramedullary rod and femoral alignment guide in place, a
`
`cutting guide (i.e., an anterior femoral cutting guide) is mounted to the femoral
`
`alignment guide so that it is precisely placed with respect to the femur. That
`
`cutting guide has slots that guide a saw, mill, or other cutting instrument as it cuts
`
`the bone along a particular path. Specifically, the blade of the cutting instrument is
`
`inserted through the slots and slides along the surface of the slots during the
`
`anterior cut. The anterior surface of the distal end of the femur is cut during the
`
`anterior cut.
`
`19
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 20
`
`
`
`32.
`
`The distal ends of both the medial and lateral femoral condyles are cut
`
`next ( the distal cut) in this exemplary technique – though, as noted above, the
`
`order of the resecting cuts could easily be changed. 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 and
`
`aligned on the previously cut anterior surface of the femur using the femoral
`
`alignment guide as a positioning reference, and is secured to the femur by pins. In
`
`the illustrated procedure, the femoral alignment guide is removed after the distal
`
`femoral cutting guide is mounted to the anterior side of the femur.
`
`20
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 21
`
`
`
`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 and aligned with respect to the previously cut anterior
`
`surface and is 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.
`
`21
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 22
`
`
`
`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.
`
`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.
`
`Guide Slot
`
`Distal End of Tibia
`
`Tibial Cutting Guide
`
`Extramedullary
`Alignment Rod
`
`Tibia
`
`22
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 23
`
`
`
`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. As shown in the illustration, 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.
`
`3.
`
`Trial Reduction
`
`
`
`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
`
`23
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 24
`
`
`
`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
`
`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.
`
`24
`
`Zimmer Holdings, Inc. and Zimmer, Inc.
`Exhibit 1002 - 25
`
`
`
`5.
`
`Component and Instrument Packaging
`
`39.
`
`Implantable medical devices such as the knee joint implant
`
`components are typically packaged in sterile form. The surgeon or his or her
`
`assistant will usually open the packages for the selected components in the
`
`environment of the surgical procedure after the properly sized components have
`
`been determined (e.g., after the trial reduc