IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`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.
`
`WMT 1027-1
`
`
`_________________
`
`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.
`
`WMT 1027-1
`
`
`
`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
`
`WMT 1027-2
`
`
`
`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
`
`WMT 1027-3
`
`
`
`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
`
`WMT 1027-4
`
`
`
`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
`
`WMT 1027-5
`
`
`
`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
`
`WMT 1027-6
`
`
`
`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
`
`WMT 1027-7
`
`
`
`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
`
`WMT 1027-8
`
`
`
`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
`
`WMT 1027-9
`
`
`
`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
`
`WMT 1027-10
`
`
`
`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
`
`WMT 1027-11
`
`
`
`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
`
`WMT 1027-12
`
`
`
`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
`
`WMT 1027-13
`
`
`
`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
`
`WMT 1027-14
`
`
`
`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
`
`WMT 1027-15
`
`
`
`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
`
`WMT 1027-16
`
`
`
`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
`
`WMT 1027-17
`
`
`
`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
`
`WMT 1027-18
`
`
`
`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
`
`WMT 1027-19
`
`
`
`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
`
`WMT 1027-20
`
`
`
`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
`
`WMT 1027-21
`
`
`
`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
`
`WMT 1027-22
`
`
`
`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
`
`WMT 1027-23
`
`
`
`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
`
`WMT 1027-24
`
`
`
`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
`
`WMT 1027-25
`
`
`
`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 reduction).
`
`40.
`
`It was common during surgical procedures at the time of the invention
`
`to sterilize and reuse certain instruments. For example, to would be common for
`
`surgical sites to sterilize instruments such as retractors, scalpels and rongeurs that
`
`had been used during a surgical procedure, and to provide those sterilized
`
`instruments for use during subsequent surgical procedures. Similarly, certain knee
`
`implant system specific instruments, such as the femoral and tibial cutting guides
`
`and alignment guides, and the provisional components, discussed above, can be
`
`sterilized following use, and reused during subsequent procedures.
`
`25
`
`WMT 1027-26
`
`
`
`41.
`
`It is also well known that medical instruments could be packaged in
`
`sterile form for single use applications. Instruments of these types were disposed
`
`of after their use during a surgical procedure. For example, relatively inexpensive
`
`instruments or instruments that are not well suited to cleaning and sterilization
`
`(e.g., sharps and catheters) were often packaged for single use application.
`
`Furthermore, since, for example, they would have no further effe
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
