Trials@uspto.gov
`571-272-7822
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` Paper No. 42
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`Entered: June 11, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`CONFORMIS, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00510
`Patent 7,981,158 B2
`____________
`
`
`
`Before PATRICK R. SCANLON, JAMES A. WORTH, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`571-272-7822
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` Paper No. 42
`
`Entered: June 11, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`CONFORMIS, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00510
`Patent 7,981,158 B2
`____________
`
`
`
`Before PATRICK R. SCANLON, JAMES A. WORTH, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`IPR2017-00510
`Patent 7,981,158 B2
`
`
`I.
`
`INTRODUCTION
`A. Background
`Smith & Nephew, Inc. (“Petitioner”) filed a Petition requesting an
`inter partes review of claims 1–65 (“the challenged claims”) of U.S. Patent
`No. 7,981,158 B2 (Ex. 1001, “the ’158 patent”). Paper 1 (“Pet.”).
`ConforMIS, Inc. (“Patent Owner”) filed a Preliminary Response. Paper 7
`(“Prelim. Resp.”). We instituted an inter partes reviews of challenged
`claims 1–65, across four grounds of unpatentability, pursuant to 35 U.S.C.
`§ 314. Paper 9 (“Dec. on Inst.”).
`After institution, Patent Owner filed a Response (Paper 16 (“PO
`Resp.”)) to the Petition, and Petitioner filed a Reply (Paper 22 (“Pet.
`Reply”)). Additionally, with our authorization, Patent Owner filed a list of
`purportedly improper arguments contained in Petitioner’s Reply (Paper 29),
`to which Petitioner responded (Paper 35). Patent Owner also filed Motions
`for Observation on the Cross-Examinations of Garry E. Gold, M.D.
`(Paper 31) and Jay D. Mabrey, M.D. (Paper 32), to which Petitioner
`responded (Papers 37, 38).
`A consolidated oral hearing was held on March 13, 2018, between this
`proceeding, IPR2017-00511, and IPR2017-00373, and a transcript of the
`hearing is included in the record. Paper 41 (“Tr.”).
`We issue this Final Written Decision pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73. For the reasons set forth below, Petitioner has shown
`by a preponderance of the evidence that challenged claims 1–65 are
`unpatentable.
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`B. Related Proceeding
`The parties identify the following matter related to the ’158 patent
`(Pet. 1; Paper 3, 2):
`ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT
`(D. Mass.).
`
`C. The ’158 Patent
`The ’158 patent, titled “Patient Selectable Joint Arthroplasty Devices
`
`and Surgical Tools,” issued July 19, 2011, from U.S. Patent Application No.
`12/135,603, filed June 9, 2008. Ex. 1001. The ’158 patent discloses a
`surgical template that conforms to the surface of a patient’s patella, wherein
`the template includes a guide aperture that directs movement of a surgical
`instrument, e.g., a drill or saw. Id. at (57), 70:53–56. Specifically, the ’158
`patent explains that the template is designed by obtaining images of the
`patient’s joint, and using those images to construct the device. Id. at 70:43–
`48. Figure 22 is reproduced below, for example.
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`Figure 22 depicts “surgical tool 410 having one surface 400 matching the
`geometry of an articular surface of the joint . . . [and] aperture 415 in the tool
`410 capable of controlling drill depth and width of the hole and allowing
`implantation or insertion of implant 420.” Id. at 78:60–65.
`
`The ’158 patent also explains that when planning a total knee
`arthroplasty, “[t]he resections should be made to enable the installed
`artificial knee to achieve flexion-extension movement within the MAP-plane
`and to optimize the patient’s anatomical and mechanical axis of the lower
`extremity.” Id. at 69:27–31.1 Accordingly, “axis and alignment information
`of a joint or extremity can be included when selecting the position of the . . .
`cut planes, apertures, slots or holes on the template.” Id. at 76:64–67. These
`axes may be identified by, e.g., CT, MRI, or CT scout scans. Id. at 77:1–10.
`
`Illustrative Claims
`D.
`Of the challenged claims, claims 1 and 38 are independent,
`illustrative, and reproduced below.
`1. A method of generating a patient-matched surgical tool,
`the method comprising:
`obtaining first image data associated with at least a
`portion of a joint of a patient;
`obtaining second image data associated with at least a
`portion of the joint;
`deriving an electronic model of at least a portion of the
`joint using at least the first image data;
`creating a surgical tool using, at least in part, the
`electronic model;
`
`
`1 The ’158 patent explains that “[t]he biomechanical axis may extend from a
`center of a hip to a center of an ankle,” and “[t]he anatomic axis 1920 aligns
`5–7˚ offset Ɵ from the mechanical axis in the valgus, or outward, direction.”
`Id. at 10:66–67, 69:1–3; see also id. at Fig. 21A.
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`surface
`includes a contact
`tool
`the
`wherein
`substantially matched to a corresponding surface of the
`joint and a guide for directing movement of a surgical
`instrument; and
`wherein the position or orientation of the guide relative
`to contact surface is adapted at least in part based on
`information derived from the second image data.
`
`38. A method of making a patient-matched surgical tool, the
`method comprising:
`obtaining first image data associated with at least a
`portion of a joint of a patient;
`obtaining x-ray image data associated with at least a
`portion of the joint;
`determining from the x-ray image data at least one of
`an anatomical and mechanical axis associated with the
`joint;
`creating a surgical tool based at least in part on the first
`image data and the x-ray image data;
`wherein the surgical tool includes a contact surface
`substantially matched to a corresponding surface of the
`joint and a guide for directing movement of a surgical
`instrument, the guide having a predetermined orientation
`based at least in part on the determined axis.
`Ex. 1001, 119:10–26, 120:54–121:2.
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`E. Applied References
`Petitioner relies upon the following references:
`Radermacher, WO Publication No. 93/25157 A1, filed
`June 17, 1993, published December 23, 1993 (“Radermacher,”
`Ex. 1003);
`Alexander et al., WO Publication No. 00/35346 A2, filed
`December 16, 1999, published June 22, 2000 (“Alexander,”
`Ex. 1004);
`Woolson, U.S. Patent No. 4,841,975, filed April 15, 1987,
`issued June 27, 1989 (“Woolson,” Ex. 1031);
`Radermacher et al., Computer Assisted Orthopaedic
`Surgery With Image Based Individual Templates, 354 CLINICAL
`ORTHOPAEDICS AND RELATED RESEARCH 28 (Carl T. Brighton
`ed., 1998) (“CAOS,” Ex. 1033);
`Edmund Y.S. Chao & Franklin H. Sim, Computer-Aided
`Preoperative Planning in Knee Osteotomy, 15 THE IOWA
`ORTHOPAEDIC JOURNAL 4 (Steven M. Madey et al. eds., 1995)
`(“Chao,” Ex. 1084); and
`Junichi Arima et al., Femoral Rotational Alignment,
`Based on the Anteroposterior Axis, in Total Knee Arthroplasty in
`a Valgus Knee, 77 A THE JOURNAL OF BONE AND JOINT SURGERY
`1331 (Henry R. Cowell et al. eds., 1995) (“Arima,” Ex. 1085).
`Pet. 20.
`Petitioner also presents the Declaration of Jay D. Mabrey, M.D.
`(“the Mabrey Declaration,” Ex. 1002), the Declaration of Jay D. Mabrey,
`M.D. in Support of Petitioner’s Reply (“the Mabrey Reply Declaration,”
`Ex. 1202), and the Declaration of Garry E. Gold, M.D. in Support of
`Petitioner’s Reply (“the Gold Declaration,” Ex. 1211).
`Patent Owner presents the Declaration of Christopher M. Gaskin,
`M.D. (“the Gaskin Declaration,” Ex. 2001), the Declaration of J. Bruce
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`Kneeland, M.D. (“the Kneeland Declaration,” Ex. 2003), and the
`Declaration of Charles R. Clark, M.D. (“the Clark Declaration,” Ex. 2005).
`
`F. Asserted Grounds of Unpatentability
`We instituted inter partes review based upon the following grounds
`(Pet. 20; Dec. on Inst. 30):
`References
`CAOS, Woolson, and Alexander
`
`Basis
`§ 103
`
`Claims Challenged
`1–3, 5–7, 11–14, 19–28,
`30, 31, 33–35, 37–41, 45,
`46, 51–56, 58, 59, 61–63,
`and 65
`
`4, 29, 32, 36, 57, 60, and
`64
`
`8–10 and 42–44
`
`§ 103
`
`§ 103
`
`CAOS, Woolson, Alexander, and
`Radermacher
`
`CAOS, Woolson, Alexander, and
`Chao
`
`CAOS, Woolson, Alexander, and
`Arima
`
`
`§ 103
`
`15–18 and 47–50
`
`II. DISCUSSION
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable interpretation in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Tech.,
`LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, we
`generally give claim terms their ordinary and customary meaning, as
`understood by a person of ordinary skill in the art in the context of the entire
`patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
`Cir. 2007).
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`In their pre-institution papers, neither party proposed any claim terms
`
`for express construction. See generally Pet.; Prelim. Resp. Nonetheless, in
`our Decision on Institution, we determined it prudent to construe the phrase
`“surface of the joint,” which appears in independent claims 1 and 38. Dec.
`on Inst. 6–7. In their post-institution papers, neither party addresses our
`construction of this term.
`Our review of the ’158 patent reveals that a patient’s “articular surface
`can comprise cartilage and/or subchondral bone” and that the customized
`device “can have a surface and shape that will match all or portions of the
`articular cartilage, subchondral bone and/or other bone surface and shape.”
`Ex. 1001, 6:56–58, 70:43–50. This is consistent Dr. Mabrey’s testimony:
`In a healthy knee, the lower end of the femur and the upper end
`of the tibia are covered by articular cartilage. The layer of bone
`directly beneath the articular cartilage is called “subchondral
`bone.” In arthritic joints, some of the articular cartilage is often
`worn or torn away, resulting in a surface that is partially articular
`cartilage and partially exposed subchondral bone.
`Ex. 1002 ¶¶ 36, 85 (asserting “a person of ordinary skill in the art would
`have understood that ‘a corresponding surface of the joint’ recited in
`Claim 1 includes bone surface, particularly when the cartilage is worn out”).
`
`Accordingly, we maintain our construction of “surface of the joint” as
`“the surface of an articulating bone that includes cartilage and/or exposed
`subchondral bone.”
`We determine that no other claim term requires express construction.
`See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999).
`
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`B. Principles of Law
`A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations, including (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of skill in the art; and (4) objective evidence of
`nonobviousness.2 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`When evaluating a combination of teachings, we must also “determine
`whether there was an apparent reason to combine the known elements in the
`fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re
`Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Whether a combination of
`elements produces a predictable result weighs in the ultimate determination
`of obviousness. Id. at 416–417.
`“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016). The burden of persuasion never shifts to Patent Owner.
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015). To prevail, Petitioner must support its challenge by a
`preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`
`2 Patent Owner does not provide evidence regarding objective evidence of
`nonobviousness. See generally PO Resp.; see also Pet. 75.
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`We analyze the challenges presented in the Petition in accordance
`with the above-stated principles.
`
`C. Level of Ordinary Skill in the Art
`In determining whether an invention would have been obvious at the
`time it was made, we consider the level of ordinary skill in the pertinent art
`at the time of the invention. Graham, 383 U.S. at 17.
`Petitioner relies upon the testimony of Dr. Mabrey in contending that
`a person of ordinary skill in the art would be “an orthopedic surgeon having
`at least three years of experience in knee arthroplasty surgery” or “an
`engineer having a bachelor’s degree in biomedical engineering (or closely
`related discipline) who works with surgeons in designing cutting guides and
`who has at least three years of experience learning from these doctors about
`the use of such devices in joint replacement surgeries.” Pet. 19 (citing
`Ex. 1002 ¶¶ 29–31). Dr. Mabrey bases his opinion on his experience as a
`surgeon in the 1990/2000 timeframe. Ex. 1002 ¶ 31.
`Patent Owner contends that Petitioner’s position is incomplete,
`because it does not include “experience with and an understanding of
`imaging technologies,” or access to a person having such experience or
`understanding, such as a radiologist. PO Resp. 18.
`Based on our review of the ’158 patent and the types of problems and
`solutions described in the ’158 patent and cited prior art, we agree with
`Patent Owner that a person of ordinary skill in the art also would have
`experience with, or an understanding of, surgical imaging technologies, or
`would have access to such a person, in addition to the qualifications
`articulated by Petitioner. We also note that the applied prior art reflects the
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`appropriate level of skill at the time of the claimed invention. See Okajima
`v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`Furthermore, even under Patent Owner’s articulation of the
`appropriate level of skill in the art, a person of ordinary skill need only
`possess experience with, and an understanding of, imaging technologies (or
`access to such a person), and need not possess a degree in imaging
`technology, as suggested by Patent Owner’s argument. PO Resp. 19–21.
`Moreover, Dr. Mabrey’s experience aligns with our assessment of the
`appropriate skill level. See Ex. 1002 ¶¶ 4–9, 16–19, 43–57 (discussing
`personal and industry use of imaging); Ex. 1202 ¶¶ 16, 18, 19 (“I have been
`formally trained on various forms of medical imaging, including x-ray, CT,
`MRI, and fluoroscopy in connection with both my orthopedic surgery
`residency and my decades-long practice as an orthopedic surgeon at four
`major academic medical centers.”).
`
`D. Obviousness over the Combined Teachings of
`CAOS, Woolson, and Alexander
`Petitioner contends that claims 1–3, 5–7, 11–14, 19–28, 30, 31, 33–35,
`37–41, 45, 46, 51–56, 58, 59, 61–63, and 65 of the ’158 patent are
`unpatentable as obvious over the combined teachings of CAOS, Woolson,
`and Alexander. Pet. 21. For reasons that follow, we determine Petitioner
`has demonstrated that the challenged claims are unpatentable by a
`preponderance of the evidence.
`1. Overview of CAOS (Ex. 1033)
`CAOS is a paper titled “Computer Assisted Orthopaedic Surgery with
`Image Based Individual Templates.” Ex. 1033, 28. CAOS explains that
`“accurate placement of implant components with respect to the individual
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`mechanical axis of the leg is essential.” Id. at 31. Accordingly, CAOS
`discloses the design and manufacture of individual customized templates for
`use in, e.g., knee replacement surgery, wherein the templates are formed
`from three-dimensional reconstructions of bone structures, extracted from
`CT image data. Id. at 29. Additionally, CAOS explains that “topograms
`could be used to identify the bone axis.” Id. at 31. “[G]uides for drills,
`saws, chisels, or milling tools are adaptable or integrated into these
`individual templates in predefined positions for different types of
`interventions.” Id. at 29.
`2. Overview of Woolson (Ex. 1031)
`Woolson is titled “Preoperative Planning of Bone Cuts and Joint
`Replacement Using Radiant Energy Scan Imaging.” Ex. 1031, [54].
`Woolson discloses using “radiant energy scan imaging to determine the
`position of a bone-cut-defining guide relative to the bone to be cut,”
`preferably for knee replacement surgery. Id. at 1:9–15. Woolson explains
`that long-term surgical success requires aligning a reconstructed knee joint
`with the bone’s mechanical axis. Id. at 1:26–36. Conventionally,
`radiographs were taken to define this axis. Id. at 1:37–62. In Woolson’s
`preferred embodiments, CT scans are taken to define the mechanical axis so
`that cuts can be made perpendicular to that axis. Id. at 4:13–44, 5:9–16,
`7:62–67, Figs. 1, 2A, 2B.
`3. Overview of Alexander (Ex. 1004)
`Alexander is titled “Assessing the Condition of a Joint and Preventing
`Damage” and relates to “the use of [joint] assessment in aiding in prevention
`of damage to the joint or treatment of diseased cartilage in the joint.”
`Ex. 1004, 1:15–17. More specifically, Alexander discloses a joint
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`assessment method in which an image of cartilage is obtained, preferably by
`magnetic resonance imaging, and converted into a three-dimensional
`degeneration pattern, from which the degree of degeneration in the cartilage
`can be evaluated. Id. at 2:25–27. Alexander further discloses that a loss in
`cartilage may be determined through use of, for example, a “3D . . .
`thickness map.” Id. at 3:8–9; see also id. at 14:16–21.
`4. Analysis of Independent Claim 1
`Petitioner contends that the combined teachings of CAOS, Woolson,
`
`and Alexander would have rendered claim 1 obvious to a person of ordinary
`skill in the art. See Pet. 22–39.
`
`Patent Owner contends that claim 1 would not have been obvious “for
`substantially the same reasons as claims 3, 4, 7–9, 24, 26, and 38–65.” PO
`Resp. 44. However, Patent Owner’s arguments with respect to those claims
`rest upon Patent Owner’s contention that it would not have been obvious to
`modify CAOS to incorporate x-ray or MRI image data, as taught by
`Woolson or Radermacher, respectively. Id. at 21–44. As discussed herein,
`Petitioner’s contentions with respect to claim 1 do not rely on incorporating
`x-ray or MRI image data. Pet. 22–39. Therefore, Patent Owner’s arguments
`are not responsive to Petitioner’s contentions. Nonetheless, it remains
`Petitioner’s burden to demonstrate that claim 1 would have been obvious, by
`a preponderance of the evidence.
`
`After considering the arguments and evidence of record, we determine
`Petitioner has demonstrated that claim 1 is unpatentable by a preponderance
`of the evidence.
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` Preamble
`Independent claim 1 recites “[a] method of generating a patient-
`matched surgical tool.” Ex. 1001, 119:10–11. Petitioner contends that
`CAOS discloses the subject matter recited in the preamble because CAOS
`teaches manufacturing individual templates that are molded to the shape of
`an individual bone surface. See, e.g., Pet. 33 (citing, e.g., Ex. 1033, 28–29).
`We are persuaded by Petitioner’s contention. CAOS explains that a
`three-dimensional printer creates an “individual template” by “mold[ing] the
`shape of small reference areas of the bone surface automatically into the
`body of the template,” such that it forms an “exact fit to the bone.”
`Ex. 1033, 28.
`
` “obtaining first image data”
`Independent claim 1 recites “obtaining first image data associated
`with at least a portion of a joint of a patient.” Ex. 1001, 119:12–13.
`Petitioner contends that CAOS teaches this limitation because CAOS
`discloses obtaining CT image data. Pet. 22–23, 33–34 (citing, e.g.,
`Ex. 1033, 29–32, 34, 37).
`We are persuaded by Petitioner’s contention. CAOS explains that
`“templates are customized on the basis of three-dimensional reconstructions
`of the bone structures extracted from computerized tomographic (CT) image
`data.” Ex. 1033, 29, 31 (obtaining CT images of the knee).
` “obtaining second image data”
`Independent claim 1 recites “obtaining second image data associated
`with at least a portion of the joint.” Ex. 1001, 119:14–15. Petitioner
`contends that CAOS teaches this limitation because CAOS discloses taking
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`topograms of the joint to identify a bone axis. Pet. 23, 34 (citing, e.g.,
`Ex. 1033, 29–32, 34).
`We are persuaded by Petitioner’s contention. CAOS explains that in
`conjunction with a “total knee replacement,” “topograms could be used to
`identify the bone axis.” Ex. 1033, 31.
`During oral argument, Patent Owner argued that a topogram is not
`“second” image data, different from the “first,” because both are taken by a
`CT machine. Tr. 41:7–42:8. This argument was not made in the Patent
`Owner Response and, thus, is waived. Paper 10, 3 (“[A]ny arguments for
`patentability not raised in the [patent owner] response will be deemed
`waived.”); Tr. 45:1–45:22, 57:14–59:12.3
`Nonetheless, the evidence of record demonstrates that CT images and
`topograms are different image data, i.e., “first” and “second” image data.
`See, e.g., Ex. 1202 ¶ 26 (“[A] CT topogram is an x-ray obtained from a CT
`scanner. After obtaining a topogram x-ray, subsequent scans may be taken
`to obtain CT image slices. . . . The topogram x-ray and CT image are two
`different types of image data sets that are viewed separately on a computer
`monitor and used independently in clinical practice.”); Ex. 2003 ¶¶ 18 (“The
`CT scanner takes two scans—the CT topogram and the series of CT images.
`. . . The resulting CT topogram is a low-resolution, projection image.”), 19
`
`3 Patent Owner argues that the Board did not institute an asserted ground of
`unpatentability relying on CAOS’s CT data as “first image data.” Tr. 57:17–
`58:12. Patent Owner is incorrect. See Dec. on Inst. 12 (“Petitioner contends
`that CAOS obtains first image data associated with a patient’s joint, as
`required by claim 1, because CAOS discloses obtaining CT image data. At
`this stage of the proceeding, we are persuaded by Petitioner.” (emphases
`added) (citation omitted)). Petitioner’s proposed modification to replace CT
`with MRI image data relates to claim 4, not claim 1. Id. at 22–24.
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`(“For the second scan, the scanning table moves slowly through the rotating
`bore of the gantry. . . . [T]he source is rotated around the patient’s anatomy
`to produce views from many angles. A computer is used to construct the
`various views into a full cross-sectional image of the patient’s anatomy.”);
`PO Resp. 11–12.
`
` “deriving an electronic model”
`and
`“creating a surgical tool using . . . the electronic model”
`Independent claim 1 recites “deriving an electronic model of at least a
`portion of the joint using at least the first image data” and “creating a
`surgical tool using, at least in part, the electronic model.” Ex. 1001, 119:16–
`19. Petitioner contends that CAOS teaches these limitations because CAOS
`discloses customizing templates based on three-dimensional reconstructions
`of CT data. Pet. 24, 34–36 (citing, e.g., Ex. 1033, 29–37, Figs. 1B–1C).
`We are persuaded by Petitioner’s contentions. CAOS explains that
`“templates are customized on the basis of three-dimensional reconstructions
`. . . extracted from computerized tomographic (CT) image data,” and
`CAOS’s Figures 1B and 1C depict the process of “computer assisted
`planning” on the electronic model. Ex. 1033, 29, Fig. 1B–1C. That model
`is used to create a surgical tool, which is generated by “a desktop computer
`controlled milling device . . . used as a three-dimensional printer.” Id. at 28.
` “the tool includes . . . a guide”
`Independent claim 1 recites “the tool includes . . . a guide for directing
`movement of a surgical instrument.” Ex. 1001, 119:20–22. Petitioner
`contends that CAOS teaches this limitation because CAOS discloses a tool
`guide for directing a saw or drill. Pet. 25, 36–37 (citing, e.g., Ex. 1033, 28–
`31, 34, 36–37).
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`We are persuaded by Petitioner. CAOS explains that “[m]echanical
`guides for drills, saws, chisels, or milling tools are adaptable or integrated
`into these individual templates.” Ex. 1033, 29.
` “the tool includes a contact surface”
`Independent claim 1 recites “the tool includes a contact surface
`substantially matched to a corresponding surface of the joint.” Ex. 1001,
`119:20–21. Petitioner contends that CAOS discloses matching the
`customized template to bone, which “‘fit[s] exactly on the bone.” Pet. 24–
`25 (quoting Ex. 1033, 29). Petitioner also contends that “[e]ven if
`ConforMIS attempts to argue that substantially matching the corresponding
`surface of the joint requires matching the cartilage surface, this would have
`been obvious” in light of Alexander’s disclosure of using CT or MRI to
`generate images of cartilage. Id. at 25–26 (citing Ex. 1002 ¶¶ 88–91;
`Ex. 1004, 14:16–21, 61:19–25, Fig. 18C). Petitioner contends that it would
`have been obvious to incorporate Alexander’s teachings into CAOS, such
`that the template would have included a contact surface substantially
`matched to a corresponding surface of the joint, whether that joint surface
`includes bone (in light of CAOS) and/or cartilage (in light of Alexander),
`because bone and cartilage are the only two surfaces to which the template
`could be matched, and selection between them is simply a design choice. Id.
`at 26–27 (citing Ex. 1002 ¶¶ 89–90, 154), 36–37.
`We are persuaded by Petitioner’s contentions. As discussed in
`Section II.A, supra, we construe “surface of the joint” as “the surface of an
`articulating bone that includes cartilage and/or exposed subchondral bone.”
`CAOS explains that “the position of the contact faces of the template [can be
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`adjusted] until they fit exactly on the bone.” Ex. 1033, 29. Thus, to the
`extent the surface of the joint includes bone, CAOS satisfies this limitation.
`To the extent the surface of the joint includes cartilage, alone or in
`conjunction with bone, we are persuaded that matching cartilage would have
`been obvious in view of Alexander’s teaching that CT or MRI—the same
`imaging techniques used by CAOS to generate the patient-specific tool—
`also generate images of cartilage. Ex. 1004, 14, 61 (“3D reconstruction of
`femoral and tibial bones . . . femoral cartilage . . . and tibial cartilage”);
`Ex. 1031, 29 (CT), 37 (MRI). We are persuaded by Petitioner’s undisputed
`contention that a person of ordinary skill in the art would have found it
`obvious to utilize Alexander’s teachings with CAOS, because bone and
`cartilage are the only two surfaces to which CAOS’s template could be
`matched. Pet. 26–27; PO Resp. 43; Ex. 1002 ¶¶ 89–90 (Dr. Mabrey opining
`that a person of ordinary skill in the art would have been motivated to
`combine CAOS and Alexander because, inter alia, bone and cartilage are the
`only surfaces to which the template could match and choosing between them
`“is simply a design choice and a matter of the surgeon’s preference”). Given
`CAOS’s teaching that the tool is customized to have an “exact fit to the
`bone,” we are persuaded that a person of ordinary skill in the art would have
`found it obvious for the tool’s surface to “exact[ly] fit” the joint surface,
`whether that surface includes bone, cartilage, or both, in accordance with the
`surgeon’s preference. Ex. 1002 ¶¶ 89–90.
` “the position or orientation of the guide . . . [is] based on
`information derived from the second image data”
`Independent claim 1 recites “the position or orientation of the guide
`relative to [the] contact surface is adapted at least in part based on
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`information derived from the second image data.” Ex. 1001, 119:24–26.
`Petitioner contends that CAOS teaches this limitation, or it would have been
`obvious in view of Woolson. Pet. 27–33, 37–38.
`Petitioner contends that CAOS uses topograms to align the template
`and its guide relative to the bone. Id. Specifically, CAOS explains that the
`template, including its tool guide, is fit exactly against the bone surface.
`Ex. 1033, 29. CAOS also explains that “accurate placement of implant
`components with respect to the individual mechanical axis of the leg is
`essential,” and “topograms could be used to identify the bone axis.” Id. at
`31. Thus, according to Petitioner, “CAOS teaches using second image data
`(topograms) to align the cutting guide relative to the contact surface of the
`[template], which serves as ‘a reference base’ for surgical work on the
`bone.” Pet. 29 (citing Ex. 1033, 31).
`Additionally, to the extent CAOS does not explicitly disclose this
`limitation, Petitioner contends it would have been obvious in light of
`Woolson’s disclosure of using image data (e.g., x-ray or CT) to orient a tool
`guide relative to the bone’s mechanical axis. Pet. 31–32, 38. Woolson
`explains that placement of a knee prosthesis along a mechanical axis “is
`highly likely to produce a successful long-term result.” Ex. 1031, 1:26–36;
`2:28–40, 4:13–26 (“cutting along a line 20 which is perpendicular to
`[mechanical] axis 14”), 4:27–29 (identifying mechanical axis from CT data).
`Petitioner argues, inter alia, that it would have been obvious to use CAOS’s
`topograms to orient the template’s cutting guide relative to the contact
`surface and the mechanical axis of the bone, as taught by Woolson, to
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`achieve long-term surgical success. Pet. 32 (citing Ex. 1002 ¶¶ 105–107).4
`According to Petitioner, this would have been use of a known technique to
`improve a similar procedure in a predictable way. Pet. 33.
`We are persuaded by Petitioner’s obviousness contention. Although
`CAOS does not state explicitly that the axis identified by the topogram is
`used to position the template and its guide relative to the contact surface,
`Petitioner has shown sufficiently that the combined teachings of CAOS and
`Woolson satisfy this limitation. Pet. 31–32; Ex. 1031, 2:28–40, 4:13–26.
`Petitioner has provided a sufficient rationale, supported by evidence of
`record, to demonstrate that a person of ordinary skill in the art would have
`found it obvious to use CAOS’s topogram to position CAOS’s template
`(and its guide) with respect to the contact surface and mechanical axis of the
`bone, as taught by Woolson, for the stated purpose of providing a more
`successful surgery. Pet. 32–33; Ex. 1031, 1:26–36, 2:28–40; Ex. 1002 ¶ 105
`(“This would ensure the accurate alignment of the knee prosthesis with the
`mechanical axis, which both Woolson and CAOS recognize is essential.”),
`¶ 107 (“[O]rienting the surgical tool guides in CAOS relative to the
`mechanical axis based on second image data would merely involve using a
`technique that has been employed to improve one knee arthroplasty
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`4 For claim 1, Petitioner does not propose modifying CAOS to use x-ray
`image data, as Petitioner contends regarding claim 38. See PO Resp. 44;
`compare Pet. 31–33 (regarding claim 1, “a POSITA would have understood
`that CAOS in combination with Woolson and Alexander discloses orienting
`the guide relative to the instrument’s contact surface based on second image
`data (e.g., topograms)”), with id. at 40–41 (regarding claims 3 and 38, “using
`x-ray image data in place of topograms to determine the mechanical axis and
`orient the cutting paths relative to this axis would have been obvious”).
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`procedure (Woolson’s) to impr
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