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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
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`SMITH & NEPHEW, INC.,
`Petitioner,
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`v.
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`CONFORMIS, INC.,
`Patent Owner.
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`IPR2017-00778
`IPR2017-00779
`IPR2017-007801
`Patent 8,062,302 B2
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`DECLARATION OF JAY D. MABREY, M.D., IN SUPPORT OF
`PETITIONER’S REPLY TO PATENT OWNER RESPONSE
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`
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`1 A word-for-word identical declaration is filed in each proceeding identified in
`the caption.
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`
`
`Smith & Nephew Ex. 1202
`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, & -780
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`
`
`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780
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`I, Jay D. Mabrey, M.D., do hereby declare:
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`1.
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`I am being compensated for my work in this matter and I am being
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`reimbursed at cost for any expenses. My compensation in no way depends upon
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`the outcome of this proceeding.
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`2.
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`In preparing this declaration, I considered the following materials:
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`a. The Declaration of Charles Clark (Ex. 2005) and the exhibits cited
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`therein; and
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`b. All other references identified herein.
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`3. My background, experience, and biographical details are available in
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`my previous Declarations, which I understand were submitted as Exhibit 1002 (in
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`IPR2017-00778 and -779) and Exhibit 1102 (in IPR2017-00780).
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`4. My understanding of the legal standards at issue in this case has not
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`changed since my previous declarations and is the same as is enumerated therein.
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`Ex. 1002 ¶¶20-28, Ex. 1102 ¶¶20-28. I remain unaware of any evidence that
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`would suggest that the claims of the ’302 patent would not have been obvious.
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`5. My opinion regarding the definition of a person of ordinary skill in the
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`art has not changed since my previous Declarations. Ex. 1002 ¶¶29-32, Ex. 1102
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`¶¶29-32. I understand that ConforMIS’s expert, Dr. Clark, has proffered an
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`opinion that a person of ordinary skill in the art would have included a resident in
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`orthopedic surgery, so long as that person had achieved 150 cases. Ex. 2005 ¶51.
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`1
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`While I disagree with Dr. Clark, my opinions would not change under his
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`definition.
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`I.
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`BACKGROUND
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`A. Technology
`6.
`In Paragraph 15 of his Declaration, Dr. Clark states that “[a] PCP
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`[primary care physician] will typically refer the patient to a general orthopedic
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`surgeon or an arthroplasty orthopedic surgeon, depending on the severity of the
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`degeneration [of the cartilage].” Ex. 2005 ¶15. I disagree with Dr. Clark’s
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`categorization of orthopedic surgeons as either “general” or “arthroplasty.” In my
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`experience, orthopedic surgeons often employed both arthroplasty and non-
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`arthroplasty solutions and would have had experience using both.
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`7.
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`In Paragraph 24, Dr. Clark states that Alexander “depicts a non-
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`operative preventative treatment.” Ex. 2005 ¶24. I disagree. Alexander discloses
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`the imaging techniques for assessing a patient’s articular cartilage for the purpose
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`of determining the appropriate treatment. Alexander specifically contemplates that
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`the treatment may be “joint replacement surgery” (e.g., knee arthroplasty). Ex.
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`1004, 42:10-16.
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`8.
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`In Paragraph 24, Dr. Clark states that “[p]reventative treatments are
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`usually prescribed and monitored by sports medicine orthopedic surgeons who do
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`not commonly perform knee arthroplasty procedures.” Ex. 2005 ¶24 n.2. I
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`2
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`disagree. Orthopedic surgeons would have had a wide range of experience with
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`different treatment options, including what Dr. Clark characterizes as “preventative
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`treatments” and arthroplasty. In my experience, I and my colleagues—as well as a
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`person of ordinary skill in 2001—regularly prescribed both “preventative
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`treatments,” as defined by Dr. Clark, and non-preventative treatments including
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`arthroplasty. For example, while I had performed numerous knee arthroplasty
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`procedures, I had also performed many knee arthroscopy procedures, which are a
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`form of preventative treatment, prior to 2002. A person of ordinary skill in the art
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`would have had extensive knowledge of the available preventative treatments and
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`would have considered them to be in that person’s area of expertise.
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`9.
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`Similarly, in Paragraph 28, Dr. Clark states that “[a]rthroplasty
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`orthopedic surgeons, as opposed to sports medicine orthopedic surgeons, typically
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`perform knee arthroplasty procedures.” Ex. 2005 ¶28 n.3. I disagree. As
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`discussed in ¶¶6-8 above, orthopedic surgeons would have had extensive
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`knowledge of all treatment options for diseased cartilage, including arthroplasty
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`options. A person of ordinary skill in the art would have had extensive knowledge
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`of the available arthroplasty treatments and would have considered them to be in
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`that person’s area of expertise.
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`10. Dr. Clark’s opinions also ignore that the person of ordinary skill in the
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`art includes an engineer having a bachelor’s degree in biomedical engineering who
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`works with surgeons in designing cutting guides and who has had at least three
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`years of experience learning from these doctors about the use of such devices in
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`joint replacement surgeries. Ex. 2005 ¶¶50-51. Such a person would have been
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`experienced in the design of instruments (as in Radermacher) and would have been
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`interested in methods of assessing the condition of the cartilage and the bone,
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`obtaining measurements of each (as in Alexander), for the design and manufacture
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`of patient-specific devices.
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`11.
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`In Paragraphs 32-33, Dr. Clark describes a knee arthroplasty
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`procedure using an intramedullary rod, as shown below:
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`Ex. 1036, Fig. 4. In my experience, a person of ordinary skill typically would not
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`remove any articular cartilage before using the cutting guides. Rather, I and other
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`surgeons with whom I practiced simply pressed the cutting guide against the
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`4
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`natural surface of the femur—including articular cartilage—before making the
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`cuts. I never experienced any difficulty making the initial cuts accurately or
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`correctly due to the presence of the articular cartilage, nor did I hear of any other
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`surgeons experiencing such difficulty. This is because the articular cartilage, even
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`if diseased or damaged, does not meaningfully compress or deform when a cutting
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`guide is placed against it. A person of ordinary skill in the art would have
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`understood that there was no problem associated with using a conventional cutting
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`guide that abutted diseased or damaged articular cartilage.
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`B. Dr. Clark’s “Summary of Opinions”
`12.
`In Paragraphs 46-48, Dr. Clark provides a summary of his opinions.
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`For the reasons set forth in my prior declaration, and for the reasons discussed in
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`detail below, I disagree with Dr. Clark’s opinion. In particular, I disagree with his
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`assertions that:
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`Radermacher discloses a patient-specific template that matches bone
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`only and not the cartilage (Ex. 2005 ¶48);
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`Alexander is a “disparate reference” that “only reiterates that MRI
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`imaging would have provided information about cartilage surfaces”
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`(id.); and
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`A person of ordinary skill would not have modified Radermacher’s
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`template to match the cartilage surface (id.).
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`5
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`C. Asserted Prior Art
`i. Alexander
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`13.
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`In Paragraph 55, Dr. Clark states that “Alexander is not directed to
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`knee arthroplasty, knee resection, or tools used in knee arthroplasty or knee
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`resection procedures, such as individual templates or cutting guides.” Ex. 2005
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`¶55. Dr. Clark suggests that Alexander’s disclosure is limited to assessing the
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`condition of cartilage for purposes of “preventative options.” Id. I disagree.
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`Alexander expressly states that the cartilage imaging disclosed therein is used to
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`“guide the choice of therapy, e.g. . . . joint replacement surgery.” Ex. 1004, 42:10-
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`16. Therefore, Alexander is directed to assessing the condition of cartilage for all
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`treatment options, including arthroplasty. I also disagree with Dr. Clark’s
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`characterization of the use of “joint replacement surgery” as “in passing.” Ex.
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`2005 ¶55. A person of ordinary skill in the art would have understood that
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`Alexander is directed to assessing the condition of cartilage for, among other
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`things, treatment by arthroplasty.
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`14.
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`In Paragraph 55, Dr. Clark states that “[t]he imaging techniques
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`discussed in Alexander would be used quite early in the clinical diagnosis and
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`treatment of a patient with knee pain and cartilage degeneration. They would be
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`applicable to patients with substantial, intact natural cartilage and designed for
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`early-stage assessment and adjustment to postpone more invasive treatments.” Ex.
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`6
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`2005 ¶55. I disagree. A person of ordinary skill in the art would have understood
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`that the imaging described in Alexander would be useful to evaluating all patients
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`requiring treatment for diseased or damaged knees, including patients who have
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`substantial damage to their natural cartilage and require knee arthroplasty. In fact,
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`Alexander discloses using its process to evaluate the cartilage of a patient with full
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`thickness cartilage defects, as shown in Figure 22B below:
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`Ex. 1004, Figs. 22A-B. Alexander explains that the 2D MRI in Fig. 22A
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`“demonstrates a full thickness cartilage defect in the posterior lateral femoral
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`condyle (arrows)” and that, in the corresponding 3D cartilage thickness map in Fig.
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`22B, “[t]he cartilage defect is black reflecting a thickness of zero (arrows)[.]” Id.,
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`31:5-11. According to Dr. Clark, such full thickness cartilage defects and exposed
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`subchondral bone represent Grade 4 cartilage degeneration, which would make the
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`patient a candidate for arthroplasty treatment. Ex. 2005 ¶17 (“Grade 4 – full
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`thickness cartilage wear with exposed subchondral bone (bone-on-bone).”), ¶18
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`(“Arthroplasty treatments are usually reserved for patients with grade 4 cartilage
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`degeneration.”). Therefore, Alexander is not limited to assessing cartilage in
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`patients “with substantial, intact natural cartilage” or “early-stage” assessments as
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`Dr. Clark contends. Rather, Alexander is directed to assessing the articular surface
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`of all patients, including those with late-stage (grade 4) cartilage degeneration for
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`purposes of planning treatment, including knee arthroplasty.
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`15.
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`In Paragraph 57, Dr. Clark states that “[i]n the case of a cartilage
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`defect, the prognosis of the defect may be determined to guide the choice of
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`subsequent treatment including, e.g., physical therapy, joint injection, arthroscopic
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`debridement, and cartilage transplants.” Id. ¶57. Dr. Clark ignores that the
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`subsequent treatment may also include knee arthroplasty, as expressly disclosed by
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`Alexander. Ex. 1004, 42:10-16.
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`16.
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`In Paragraph 58, Dr. Clark states that Alexander “describes one of
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`ordinary skill as ‘someone having an advanced degree in imaging technology’” and
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`opines that “this further shows that Alexander would not have been a reference
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`considered by one of ordinary skill in the art” in this case. Ex. 2005 ¶58 n.5; see
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`also id. ¶137. I disagree. First, Alexander makes clear that “someone having an
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`advanced degree in imaging technology” is only one example of a person of
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`ordinary skill in the art with respect to the specific disclosure of that reference. Ex.
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`8
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`1004, 15:24-25 (“one of skill in the art, e.g. someone having an advanced degree in
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`imaging technology” (emphasis added)). Second, the level of ordinary skill in the
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`art contemplated by Alexander is irrelevant to its usefulness to one of ordinary skill
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`in this case. I, and others of ordinary skill in the art under my definition and Dr.
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`Clark’s definition, were well able to understand the relevant disclosure of
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`Alexander and would have been easily able to combine its disclosure with other
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`references cited herein to achieve the alleged invention recited in the ’302 patent.
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`While the mathematical details of Alexander’s imaging processes may have been
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`directed to those in the imaging field, Alexander’s disclosure of cartilage mapping
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`and using such imaging/mapping to treat patients was directed squarely to those of
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`ordinary skill in this case—surgeons—to determine whether knee arthroplasty was
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`necessary and thereby guide the choice of treatment.
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`17.
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`In Paragraph 61, Dr. Clark states that “[o]ne of ordinary skill would
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`have employed the monitoring and treatment procedures disclosed in Alexander in
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`order
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`to avoid or delay
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`the knee
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`replacement surgery addressed by
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`Radermacher[.]” Ex. 2005 ¶61. I disagree. Alexander expressly discloses that the
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`imaging process described therein may guide the choice of treatment, which
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`includes knee replacement surgery. Ex. 1004, 42:10-16. Thus, a person of
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`ordinary skill in the art would have used Alexander’s cartilage imaging and maps
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`9
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`to evaluate the condition of the articular surface for all patients, including those
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`needing knee arthroplasty.
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`ii. Radermacher
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`18.
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`In Paragraph 66, Dr. Clark describes Radermacher as disclosing “an
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`individual template for engaging osseous (bone) structures during various surgical
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`procedures for resecting or repairing bone structures[.]” Ex. 2005 ¶66. He further
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`opines that “[o]ne of ordinary skill would have understood that ‘osseous’ refers to
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`‘bone.’” Id. ¶66 n.6; see also id. ¶117. I disagree to the extent that Dr. Clark
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`suggests that Radermacher refers only to engaging, resecting, and/or repairing
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`bone. While the term “osseous,” in and of itself, refers to bone, Radermacher’s
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`disclosure is not as limited as Dr. Clark suggests. Radermacher refers to the
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`“natural (i.e. not pre-treated) surface of the osseous structure intraoperatively
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`accessed by the surgeon.” Ex. 1003 at 12. A person of ordinary skill in the art
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`would have understood that an “osseous structure” refers to more than just the
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`bone; it would include tissues that are structurally attached to the bone and move
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`with it, such as articular cartilage. In the case of the distal end of the femur or
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`proximal end of the tibia, the “natural (i.e. not pre-treated) surface” of the “osseous
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`structure” is the articular surface, including both articular cartilage and any
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`exposed subchondral bone. That is also the natural surface that is “intraoperatively
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`accessed by the surgeon.”
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`10
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`19.
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`In Paragraphs 72-81 and 89, Dr. Clark refers to numerous portions of
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`Radermacher’s disclosure to suggest that Radermacher discloses matching only the
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`bone. I disagree because Radermacher is not so limited. Rather, Radermacher
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`discloses matching the “natural (i.e. not pre-treated) surface of the osseous
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`structure intraoperatively accessed by the surgeon.” Ex. 1003 at 12. A person of
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`ordinary skill would have understood that, when referring to an articulating joint,
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`the “natural (i.e. not pre-treated) surface of the osseous structure intraoperatively
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`accessed by the surgeon” would have been, for example, the articular surface of the
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`femur, which may include cartilage, bone, or a combination thereof, depending on
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`the condition of the patient’s joint surface. To be sure, in other areas of the body
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`addressed by Radermacher (e.g., vertebrae), no cartilage and no articular surface
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`would be present. But a person of ordinary skill in the art would have understood
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`the natural, not pre-treated surface of the knee joint to be the articular surface.
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`This is true even if “osseous structure” is understood, as Dr. Clark contends, to
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`mean “bone structure.” The natural, not pre-treated surface of the femur bone that
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`is intraoperatively accessed by the surgeon is the articular surface, which includes
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`cartilage.
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`11
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`II. RADERMACHER IN COMBINATION WITH
`ALEXANDER OR FELL AND WOOLSON
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`20.
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`I disagree with Dr. Clark’s conclusions in Paragraph 83, including
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`that:
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` “Radermacher does not teach a surgical instrument having an inner surface
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`that is substantially a negative of a diseased or damaged cartilage surface”;
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` “[A] person of ordinary skill would not have modified Radermacher’s bone-
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`matching template in view of Alexander”; and
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` “[O]ne of ordinary skill would not have (1) ignored Radermacher’s express
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`teaching of matching bone surfaces only []; (2) considered a disparate
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`reference (Alexander) that only reiterates that MRI imaging would have
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`provided information about cartilage surfaces; and then (3) modified the
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`individual template in Radermacher to include an inner surface that is
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`substantially a negative of a diseased or damaged cartilage surface with a
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`reasonable expectation of success.”
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`Ex. 2005 ¶83. I disagree for the below reasons.
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`12
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`A. Radermacher Teaches a Surgical Instrument Having an
`Inner Surface that Matches Cartilage
`21.
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`In Paragraph 84, Dr. Clark states that “Radermacher’s individual
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`template does not have an inner surface that is substantially a negative of a
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`diseased or damaged cartilage surface. . . . This is true regardless whether cartilage
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`is present in the joint or whether the preoperative imaging techniques in
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`Radermacher would show the presence of cartilage.” Ex. 2005 ¶84. For the
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`reasons discussed in ¶¶22-48 below, I disagree.
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`22.
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`In Paragraph 86, Dr. Clark states that I “minimiz[e] Radermacher’s
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`statement as to what surface is actually being referenced: the ‘osseous [bone]
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`structure.’” Id. ¶86. I disagree. I did not minimize this language. Rather, I
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`considered the entire sentence as a whole. A person of ordinary skill in the art,
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`reading the entire sentence and in the context of the knee joint, would have
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`understood that the “natural (i.e. not pre-treated) surface of the osseous structure
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`intraoperatively accessed by the surgeon” refers to the articular surface. Thus, a
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`person of ordinary skill would have understood that Radermacher’s individual
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`template matches the articular surface, which may include cartilage and/or bone.
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`23.
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`In Paragraph 86, Dr. Clark further states that the phrase “not pre-
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`treated” means only that the bone has not been cut, drilled, milled, or otherwise
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`altered, and is not a statement pertaining to the presence or absence of cartilage on
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`the joint. Ex. 2005 ¶86. Dr. Clark also states that “not pre-treated” is not
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`13
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`“necessarily” a reference to cartilage. Id. I disagree. First, if the bone has not
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`been cut, drilled, milled, or otherwise altered, then a person of ordinary skill in the
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`art would understand that the cartilage has also not been cut, drilled, milled, or
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`otherwise altered. Second, Radermacher describes the not pre-treated “surface” of
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`the osseous structure “intraoperatively accessed by the surgeon.” Ex. 1003 at 12.
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`Dr. Clark appears to ignore the context of the sentence. A person of ordinary skill
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`in the art would have understood that this entire sentence refers to the natural
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`surface as it is accessed by the surgeon. In the case of the femur or tibia, that
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`surface would include cartilage.
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`24.
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`In Paragraph 88, Dr. Clark states that “Radermacher states, quite
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`specifically, that the ‘individual template’ is created from the image data of bone
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`surfaces only.” Ex. 2005 ¶88. I disagree. Radermacher states that the negative
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`mold2 is of the “natural (i.e. not pre-treated) surface of the osseous structure
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`intraoperatively accessed by the surgeon.” Ex. 1003 at 12. Radermacher further
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`states that the negative mold “can” reproduce “a bone surface.” Id. Radermacher
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`2 The “negative mold” is the digital form of the template disclosed in Radermacher,
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`and they share the same patient-specific surface. Ex. 1003 at 15 (“the individual
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`template with the faces of the negative mold is set under mating engagement”)
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`(emphasis added), 12, 10.
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`never limits the negative mold, or the template based thereon, to a bone surface
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`only.
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`25.
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`In Paragraph 89, Dr. Clark also relies on the “parts of” language to
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`argue that a person of ordinary skill in the art would have understood Radermacher
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`to disclose a template that matches only the “bony parts.” Ex. 2005 ¶89. I
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`disagree. The “parts of” language does not refer to bony parts at all. Rather,
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`Radermacher discloses generating a mold of “parts of the individual natural (i.e.
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`not pre-treated) surface of the osseous structure intraoperatively accessed by the
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`surgeon.” Ex. 1003 at 12. A person of ordinary skill in the art would have
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`understood the phrase “parts of” to refer to the relevant portion of the osseous
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`structure, e.g., the articular surface (rather than the entire leg) in knee surgery, or
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`the femoral head in a hip replacement surgery. This “parts of” language would not
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`have been understood to distinguish between “bony parts” and non-bony parts as
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`Dr. Clark contends. Indeed, Dr. Clark’s interpretation would result in a sentence
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`that makes no sense because it would read: “[T]here is generated a three-
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`dimensional negative mold of [the bony] parts of the . . . surface of the [bone]
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`structure intraoperatively accessed by the surgeon.” Thus, a person of ordinary
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`skill would not understand the “parts” to be referring to the “bony parts.”
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`26.
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`In Paragraph 90, Dr. Clark states that “one of ordinary skill would
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`have understood that Radermacher’s individual template would include a ‘plurality
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`of geometrically non-abutting partial segments of a bone surface’ to account for
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`other structures and tissues, such as ligaments, tendons, and cartilage.” Ex. 2005
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`¶90. I disagree for several reasons. First, Radermacher discloses an embodiment
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`in which the patient-specific surface includes recesses, but Radermacher discloses
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`that such recesses are used to avoid other structures, such as the vertebrae shown in
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`Fig. 5. Ex. 1003 at 22, Figs. 4-5. Radermacher never discloses using such recesses
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`to avoid soft tissue such as ligaments, tendons, or cartilage.
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`27. Second, while Dr. Clark relies heavily on Radermacher’s “non-
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`abutting partial segments” language, Radermacher does not disclose using such a
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`surface when the template is for the knee. Rather, Radermacher discloses
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`matching a “cohesive region,” without any recesses (5):
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`16
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`Id. at 12, 30, Fig. 13c. Thus, a person of ordinary skill in the art would have
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`understood that Radermacher’s knee template does not include any recesses or
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`avoid cartilage.
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`28.
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`In Paragraphs 91-94, Dr. Clark recites various examples where
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`Radermacher discloses that the template is matched to the shape of the “osseous
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`structure” or set on the “bone surface.” Ex. 2005 ¶¶91-94. But that is because
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`Radermacher’s disclosure
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`is applicable
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`to various parts of
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`the body.
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`Radermacher’s template may be used “for any desired orthopedic interventions”
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`including the spine, hip, foot, knee, etc. Ex. 1003 at 9. A person of ordinary skill
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`in the art would have understood that Radermacher’s template would match bone
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`(where only bone exists) or articular cartilage (where articular cartilage exists)—
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`i.e., the natural, not pre-treated surface. While Radermacher generally refers to
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`placing the template on the bone surface, the only sentence in Radermacher that
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`specifically describes the characteristics of the surface onto which the template is
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`placed is the sentence that states that the template is placed on the natural, not pre-
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`treated surface that is intraoperatively accessed by the surgeon.
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`29.
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`In Paragraphs 95-99, Dr. Clark discusses several embodiments of
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`Radermacher in which the individual template is designed to rest on exposed, not
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`pre-treated bone. Ex. 2005 ¶¶95-99. These embodiments are consistent with my
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`opinion that Radermacher discloses matching the natural, not pre-treated surface.
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`17
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`The natural, not pre-treated surface of those particular anatomic structures exposed
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`by the surgeon would not include cartilage. Thus, the fact that the individual
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`template rests on bone there says nothing about whether it would rest on cartilage
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`where cartilage is present, such as in the knee joint.
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`30.
`
`In Paragraph 100, Dr. Clark states that, in Radermacher’s knee
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`embodiment, the template “avoids the cartilage.” Id. ¶100. I disagree, and there is
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`no support in Radermacher for this statement. Radermacher’s knee template
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`covers most of the end of the femur, is not designed with recesses (as is the
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`template in Figs. 4-5), and there is no indication that cartilage was avoided.
`
`31. Radermacher’s disclosure that “[t]he individual template 4 is set onto
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`the bone 17 in a defined manner” does not warrant the weight that Dr. Clark
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`ascribes to it. Id. (emphasis in original). Radermacher did not distinguish between
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`bone and cartilage. A person of ordinary skill would have understood
`
`Radermacher to be disclosing setting the individual template onto the bone surface,
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`which in the context of the knee joint, is the articular surface. That articular
`
`surface includes cartilage and exposed subchondral bone. Thus, a person of
`
`ordinary skill would have understood Radermacher to be disclosing setting the
`
`individual template on the articular surface of the femur bone, which would
`
`include cartilage.
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`18
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`
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`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780
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`32.
`
`In Paragraph 100, Dr. Clark states that “one of ordinary skill would
`
`have considered Radermacher’s description of the knee embodiment in the same
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`way as all of the other embodiments.” Id. I agree. However, I disagree with Dr.
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`Clark’s assertion that “Radermacher never once describes the contact surface,
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`applicable to numerous different bone structures, as contacting anything other than
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`bone, let alone cartilage.” Id. First, as Dr. Clark admits, see id. ¶121, almost all of
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`Radermacher’s embodiments are designed to contact anatomic structures that,
`
`when accessed by the surgeon, present only bone. Thus, it would be nonsensical to
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`expect Radermacher’s template to match anything other than bone for those
`
`embodiments. However, those embodiments would have told a person of ordinary
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`skill in the art that the template would match whatever surface is presented to the
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`surgeon upon opening the joint. In many cases, that surface would be only
`
`exposed bone. But in the case of the distal femur and proximal tibia, that surface
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`would include articular cartilage and any exposed bone. Second, Radermacher
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`does disclose matching cartilage because it discloses that the template matches the
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`“natural (i.e. not pre-treated) surface of the osseous structure intraoperatively
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`accessed by the surgeon,” which a person of ordinary skill in the art would have
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`understood to mean the articular surface in the case of the knee. Ex. 1003 at 12.
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`33.
`
`In Paragraph 101, Dr. Clark concludes that “Radermacher shows the
`
`individual template mounted directly on a bone surface of the distal end of the
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`19
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`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780
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`femur . . . and . . . Radermacher does not show any cartilage in Figure 13c because
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`no other material or surface is illustrated between the femoral bone . . . and the
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`individual template[.]” Ex. 2005 ¶101. I disagree. Dr. Clark has misunderstood
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`Radermacher’s disclosure regarding the stippled surface texture. Radermacher
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`states that structure 17 is the “osseous structure” and that the template matches the
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`natural surface. E.g., Ex. 1003 at 12. Thus, Radermacher’s stippling in Figure 13
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`depicts the natural surface that is intraoperatively accessed by the surgeon in a
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`knee arthroplasty procedure, which includes both cartilage and bone, as discussed
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`above in ¶¶18-19, 22, 31-32. A person of ordinary skill would have recognized
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`that the stippling depicts the natural surface (including cartilage), precisely because
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`cartilage would be present but is not shown as a separate layer in Figure 13.
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`34.
`
`In Paragraph 102, Dr. Clark states that “diseased or damaged cartilage
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`is not as structurally sound of a surface on which to mount an individual template”
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`as compared to bone. Ex. 2005 ¶102. He states that diseased cartilage “is
`
`relatively weak and may be frayed.” Id. But diseased or damaged cartilage may
`
`have a wide variety of appearances and consistencies and is often just as
`
`structurally sound as bone. Indeed, during conventional arthroplasty procedures, I
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`routinely placed non-patient-specific cutting guides against my patients’ damaged
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`articular cartilage, and the surface did not indent, compress, or otherwise cause the
`
`cutting guide to be misaligned. In general, for purposes of placing a cutting guide,
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`20
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`
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`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780
`
`diseased or damaged cartilage is equally structurally sound as bone. Thus, in most
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`cases of diseased or damaged cartilage, a person of ordinary skill would have
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`understood that it is feasible to match a patient-specific surface such as
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`Radermacher’s to a cartilage surface “in a clearly defined position and with mating
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`engagement.” Ex. 1003 at 10. Such a choice would simplify and speed up surgery
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`relative to matching the subchondral bone only, which would either involve
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`matching less surface area of the osseous structure or would involve removing
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`cartilage. A person of ordinary skill in the art would certainly have been motivated
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`to choose to match cartilage rather than or in addition to bone, contrary to Dr.
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`Clark’s assertion.3
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`35. Dr. Clark’s reference to the “seaweed” appearance of cartilage during
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`knee arthroscopy, with the joint flooded with saline, is irrelevant to the inquiry at
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`3 Dr. Clark refers to bone as “non-compressible.” Ex. 2005 ¶102. It should be
`
`noted that a person of ordinary skill would have understood that cartilage is nearly
`
`as non-compressible as bone and that this would not be a distinguishing
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`characteristic of bone over cartilage. In general, cartilage compresses only a
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`microscopic amount that would be undetectable to a surgeon pressing a cutting
`
`guide (conventional or patient-specific) against it. In addition, in the case of a
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`template that matches both cartilage and bone, the bone-matching portion would
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`prevent the template from compressing the cartilage at all.
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`21
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`
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`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780
`
`hand for several reasons. See Ex. 2005 ¶102. First, in my experience, it is
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`extremely rare for a patient to have such damage to the femoral or tibial articular
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`cartilage.
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` Patellar cartilage sometimes has this appearance during knee
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`arthroscopy because the patella is subjected to lateral shearing forces when it
`
`dislocates. Indeed, the article upon which Dr. Clark relies relates to patellar
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`cartilage, not articular cartilage on the femur or tibia. Ex. 2009 at 634. A person
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`of ordinary skill in 2001 would have understood that the femoral and tibial
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`articular surfaces rarely, if ever, have this type of damage. Accordingly, this
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`characteristic would not prevent them from making a patient-specific device for
`
`those surfaces. Second, even if the femoral or tibial cartilage had been damaged in
`
`a similar manner such that it had a “seaweed” appearance during arthroscopy, it
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`would be irrelevant because knee arthroplasty, and the imaging used to plan knee
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`arthroplasty, does not involve flooding th
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