Trials@uspto.gov
`571-272-7822
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` Paper No. 47
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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 IPR2017-00511
`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. 47
`
`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 IPR2017-00511
`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
`
`
`
`IPR2017-00511
`Patent 7,981,158 B2
`
`
`I.
`
`INTRODUCTION
`A. Background
`Smith & Nephew, Inc. (“Petitioner”) filed a Petition requesting an
`inter partes review of claims 66–81 (“the challenged claims”) of U.S. Patent
`No. 7,981,158 (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 66–72
`and 81, pursuant to 35 U.S.C. § 314. Paper 9 (“Dec. on Inst.”).1
`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 two
`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, IPR2017-00510, and IPR2017-00373, and a transcript of the
`hearing is included in the record. Paper 41 (“Tr.”).
`
`
`1 Pursuant to the U.S. Supreme Court’s decision in SAS Institute, Inc. v.
`Iancu, 138 S. Ct. 1348 (2018), we issued an Order modifying our Decision
`on Institution to include the challenge to claims 73–80, for which we
`originally denied institution. Paper 42. However, the parties filed—and we
`granted—a joint motion to limit the Petition to only the challenge to claims
`66–72 and 81. Papers 44, 45. Accordingly, we do not treat claims 73–80 in
`this Decision.
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`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 66–72 and 81 are
`unpatentable.
`
`B. Related Proceedings
`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 69:27–31.2 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 are identified by, e.g., CT, MRI, or CT scout scans. Id. at 77:1–10.
`
`Illustrative Claims
`D.
`Challenged claims 66, 69, 72, and 81 are independent. Independent
`claim 66 is illustrative and is reproduced below.
`66. A method of creating a patient-specific instrument for
`implanting an orthopedic implant in or about a joint of a patient,
`the method comprising:
`creating a patient-specific surgical instrument based at
`least in part on first and second image data sets,
`wherein the first image data set is of a type that is different
`from the second image data set, and the second image data set is
`x-ray image data;
`wherein the surgical instrument has a patient-specific
`surface that is derived from at least the first image data and that
`
`
`2 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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`substantially matches a corresponding surface portion associated
`with the joint; and
`wherein the surgical instrument has a guide that is oriented
`relative to the patient-specific surface based on information
`derived from the second image data set.
`Ex. 1001, 122:9–24.
`
`E. Applied References
`Petitioner relies upon the following references:
`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); and
`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).
`Pet. 21.
`Petitioner also relies upon the Declaration of Jay D. Mabrey, M.D.
`(“the Mabrey Declaration,” Ex. 1102), 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
`Kneeland, M.D. (“the Kneeland Declaration,” Ex. 2003), and the
`Declaration of Charles R. Clark, M.D. (“the Clark Declaration,” Ex. 2005).
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`F. Asserted Grounds of Unpatentability
`We instituted inter partes review based upon the following ground
`(Pet. 21; Dec. on Inst. 27; see supra n.1):
`References
`Basis
`CAOS, Woolson, and Alexander
`§ 103
`
`Claims Challenged
`66–72 and 81
`
`
`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).
`
`In the Petition, Petitioner stated that no terms required construction;
`however, Petitioner provided a construction of “articular surface of [a]
`joint,” which appears in independent claim 81. Pet. 20. Accordingly, we
`determined it prudent to construe this phrase, as well as similar language in
`claims 66, 69, and 72 (“surface portion associated with the joint,” “surface
`contours of at least a portion of a surface of or near a joint”). Dec. on Inst.
`5–7. In their post-institution papers, neither party addresses our construction
`of these terms.
`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
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`articular cartilage, subchondral bone and/or other bone surface and shape.”
`Ex. 1001, 6:56–58, 70:43–50. This is consistent with 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. 1102 ¶ 36; see also id. ¶¶ 68–71 (asserting “to a person of ordinary skill,
`the broadest reasonable interpretation of ‘articular joint surface’ in light of
`the specification is ‘the bone surface and/or cartilage surface of an
`articulating portion of a joint’), ¶ 113 (asserting “a person of ordinary skill in
`the art would have understood that ‘a corresponding surface portion
`associated with the joint’ recited in Claim 66 includes bone surface,
`particularly when the cartilage is worn out”).
`
`Accordingly, we maintain our constructions of these phrases 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).
`
`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
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`(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.3 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).
`We analyze the challenges presented in the Petition in accordance
`with the above-stated principles.
`
`
`3 Patent Owner does not provide evidence regarding secondary
`considerations. See generally PO Resp.; see also Pet. 75.
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`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. 20 (citing
`Ex. 1102 ¶¶ 29–31). Dr. Mabrey bases his opinion on his experience as a
`surgeon in the 1990/2000 timeframe. Ex. 1102 ¶ 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. PO Resp. 17.
`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
`appropriate level of skill at the time of the claimed invention. See Okajima
`v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
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`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. 18–20.
`Moreover, Dr. Mabrey’s experience aligns with our assessment of the
`appropriate skill level. See Ex. 1102 ¶¶ 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 66–72 and 81 of the ’158 patent are
`unpatentable as obvious over the combined teachings of CAOS, Woolson,
`and Alexander. Pet. 22–56. 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
`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
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`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
`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
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`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 66
`Petitioner contends that the combined teachings of CAOS, Woolson,
`
`and Alexander would have rendered claim 66 obvious to a person of
`ordinary skill in the art. See Pet. 23–43.
`
`Patent Owner contends that claim 66 would not have been obvious.
`PO Resp. 20–42.4 For example, Patent Owner contends that it would not
`have been obvious to replace CAOS’s CT topogram with Woolson’s x-ray
`images because such a modification “would make obtaining CT . . . images
`technically infeasible” and would be “[n]onsensical.” Id. at 23, 31
`(emphasis omitted).
`
`After considering the parties’ arguments and evidence, we determine
`Petitioner has demonstrated that claim 66 is unpatentable by a
`preponderance of the evidence.
`
` Preamble
`Independent claim 66 recites “A method of creating a patient-specific
`instrument for implanting an orthopedic implant in or about a joint of a
`patient.” Ex. 1001, 122:9–11. 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 and are used for orthopedic surgery. See, e.g., Pet. 36–37 (citing,
`e.g., Ex. 1033, 28–31; Ex. 1102 ¶¶ 82–83).
`
`4 Patent Owner presents consolidated arguments for claims 66–71 and 81.
`PO Resp. 20.
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`We are persuaded by Petitioner’s contention. CAOS explains that a
`three-dimensional printer creates an “individual template” for use in surgery
`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, 30 (discussing implanting an orthopedic
`implant); Ex. 1102 ¶¶ 82–83.
` “creating a patient-specific instrument based . . .
`on first and second image data sets”
`Independent claim 66 recites “creating a patient-specific surgical
`instrument based at least in part on first and second image data sets.”
`Ex. 1001, 122:12–13. Petitioner contends that CAOS discloses utilizing CT
`image data—a “first image data set”—to create an individual template that
`fits exactly against the bone, wherein the template includes a tool guide.
`Pet. 23–25, 37–39 (citing, e.g., Ex. 1033, 28–31; Ex. 1102 ¶¶ 85–89).
`We are persuaded by Petitioner’s contention. CAOS explains that
`“[i]ndividual templates are customized on the basis of three-dimensional
`reconstructions of the bone structures extracted from computerized
`tomographic (CT) image data.” Ex. 1033, 29; Ex. 1102 ¶ 85.
`Petitioner also contends that CAOS teaches using topograms—a
`“second image data set”—to identify the bone’s mechanical axis and to
`position the template and tool guide accordingly. Pet. 25–26, 37–39 (citing
`Ex. 1033, 29, 31; Ex. 1102 ¶¶ 90–95). Further, Petitioner contends that
`Woolson discloses orienting tool guides based on x-ray or CT image data—
`also an “image data set”—to align a cutting path relative to a mechanical
`axis, to ensure long term surgical success. Pet. 28–29, 39–40 (citing, e.g.,
`Ex. 1031, Abstract, 1:27–57, 2:50–59, 4:7–26; Ex. 1102 ¶¶ 98–102).
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`Accordingly, Petitioner contends that the combined teachings of CAOS and
`Woolson teach the step of creating an instrument based on a first image data
`set (CT data, taught by CAOS) and a second image data set (topogram data,
`taught by CAOS, or x-ray or CT data, taught by Woolson). Id. at 29–30;
`Ex. 1102 ¶ 84. Petitioner also contends that it would have been obvious to
`modify CAOS to use image data to align cuts relative to a mechanical axis
`of the bone, as taught by Woolson, to ensure long-term surgical success. Id.
`at 29 (citing Ex. 1031, 1:26–36; Ex. 1102 ¶ 103). Petitioner argues that this
`modification would have been use of a known technique to improve a
`similar procedure in a predicable way. Id. at 29–30.
`We are persuaded by Petitioner’s contentions. In addition to the first
`image data discussed above (CT image data), CAOS also teaches that
`“topograms [second image data] could be used to identify the bone axis.”
`Ex. 1033, 31; Ex. 1102 ¶¶ 90–92. Although CAOS does not state explicitly
`that the axis identified by the topogram is used to create the patient-specific
`template, e.g., to position the template relative to the contact surface,
`Petitioner has shown that Woolson teaches using x-ray or CT image data to
`align surgical cuts relative to a mechanical axis. Ex. 1031, 1:27–57, 2:28–
`59, 4:13–26; Ex. 1102 ¶ 92. For example, Woolson teaches that prior art
`systems used a “preoperative radiograph of the femur in order to determine
`the angle between the anatomical and the mechanical axes of the femur for
`proper orientation of the femoral cutting guide,” such that “[t]he proximal
`tibia is cut perpendicular to the mechanical axis of the tibia by adjusting the
`tibial cutting guide in relation to the knee and ankle joints.” Id. at 1:41–58;
`Ex. 1102 ¶¶ 92–104.
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`Petitioner’s rationale and evidence establish that the proposed
`modification to CAOS’ surgical technique would have been obvious to a
`person of ordinary skill in the art, because the proposed modification would
`have been expected to provide a more successful surgery, as taught by
`Woolson. Pet. 29–30; Ex. 1031, 1:26–36 (“[A]ll total knee implantation
`systems attempt to align the reconstructed knee joint in the mechanical axis
`. . . . [T]his results in the placement of the total knee prostheses in a common
`mechanical axis which correspondingly is highly likely to produce a
`successful long-term result.”), 2:28–40; Ex. 1102 ¶¶ 102–104. Moreover,
`we are persuaded that using, in CAOS’s method, second image data to
`determine the proper orientation of a patient-specific surgical instrument’s
`guide relative to a mechanical axis is merely the use of a technique that has
`been employed to improve one knee arthroplasty procedure (Woolson’s) to
`improve a similar knee arthroplasty procedure (CAOS’s) in the same
`predictable way. Ex. 1102 ¶ 103.
` “x-ray image data” and
`“different” types of image data
`Independent claim 66 also recites that “the second image data set is x-
`ray image data,” and “the first image data set is of a type that is different
`from the second image data set.” Ex. 1001, 122:14–16.
`Petitioner contends that it would have been obvious to use “x-ray
`imaging in place of [CAOS’] topograms” because topograms “are similar to
`two-dimensional CT scout images [and] are an alternative to x-ray image
`data.” Pet. 30 (citing Ex. 1102 ¶ 105), 41–42. Petitioner also contends that
`Woolson discloses using x-ray image data to determine a mechanical axis
`and to orient cutting paths relative to that axis. Id. at 30 (citing, e.g.,
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`Ex. 1031, Abstract, 1:26–50, 2:28–59, 6:5–7:67; Ex. 1102 ¶ 106).
`Therefore, according to Petitioner, “it would have been obvious to modify
`CAOS to use x-ray image data in place of topograms,” because this would
`be a “‘simple substitution of one known element for another.’” Id. at 30–31
`(citing Ex. 1102 ¶ 106; quoting KSR, 550 U.S. at 417).
`In the Response, Patent Owner argues that a person of ordinary skill
`in the art would have recognized that CAOS’s method was successful
`because its two data sets—CT images and CT topograms—are “intrinsically
`co-registered.” PO Resp. 2, 15, 23, 25. Patent Owner explains that “[c]o-
`registration is the process of aligning two or more images so that
`corresponding pixels or voxels representing the same object may be
`integrated or fused.” Id. at 14. According to Patent Owner, “a CT topogram
`is required to plan the start and end points of the CT images. Because the
`CT topogram is taken on the same CT scanner seconds before the CT images
`are taken, the resulting CT images are intrinsically co-registered with the CT
`topogram.” Id. at 15 (citing Ex. 2003 ¶ 27; Ex. 1060, 6:34–46), 33.
`Therefore, Patent Owner argues that one skilled in the art would not
`eliminate the intrinsic co-registration of a CT data set by replacing CT
`topograms with x-ray image data, because such a modification “would make
`obtaining CT . . . images technically infeasible” and would be “difficult,
`time-consuming, and often inaccurate.” See id. at 23–25, 28–31.
`Patent Owner also contends that “Petitioner provides insufficient
`reasons for completely deviating from CAOS’s successful method,” and that
`Petitioner does not identify shortcomings in CAOS’s method or
`improvements that would have motivated the proposed modification. PO
`Resp. 24–28. For example, Patent Owner argues that this modification
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`would require x-ray image data to be co-registered with CAOS’s CT data,
`which is “difficult, time-consuming, and often inaccurate, all of which
`would increase the risk of misalignment compared to CAOS’s use of CT
`images and a CT topogram.” Id. at 28 (citing Ex. 2003 ¶¶ 25–26, 59;
`Ex. 2005 ¶¶ 62–64, 66–71; Ex. 2022, 69:19–70:2).
`Additionally, Patent Owner contends that the Petition fails to explain
`how the proposed modification would be achieved, including how to
`reconcile differences in 2D (x-ray) and 3D (CT) images, imaging modalities,
`magnifications, projection angles, resolutions, and patient positions. Id. at
`28–31 (citing, e.g., Ex. 2022, 81:4–9, 91:19–92:18, 94:14–96:14, 98:5–23,
`107:13–109:9, 128:12–21, 139:25–141:25; Ex. 2003 ¶¶ 28–29, 59–61).
`Further, Patent Owner contends that the proposed modification is
`impractical. PO Resp. 31. For example, because topograms are used to plan
`the start and end points of a subsequent CT scan, Patent Owner argues that
`one “would not (and practically cannot) obtain CT images without first
`obtaining a CT topogram,” and an x-ray image would not provide the same
`type of information. Id. at 33. According to Patent Owner, this
`demonstrates that there is no motivation and no reasonable expectation of
`success in using an x-ray image instead of a CT topogram. Id. at 34.
`In its Reply, Petitioner contends that co-registration is not recited in
`the ’158 patent claims and, nonetheless, the ’158 patent specification
`demonstrates that “co-registration would not have been a problem.”
`Pet. Reply 3. Petitioner contends that Patent Owner is bound by its
`admission that a person of ordinary skill in the art would have appreciated
`that different types of image data can be combined, i.e., “co-registered,”
`without further describing any co-registration technique or details. Id. at 3–4
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`(quoting Ex. 1001, 34:32–33 (“As will be appreciated by those of skill in the
`art, imaging techniques can be combined, if desired.”); citing Ex. 1001,
`37:63–38:14 (example of combining x-ray with CT or MRI), 40:4–11
`(same), 40:16–18 (same)) (citing PharmaStem Therapeutics, Inc. v. ViaCell,
`Inc., 491 F.3d 1342, 1362 (Fed. Cir. 2007); Smith & Nephew, Inc. v. Rea,
`721 F.3d 1371, 1380–81 n.6 (Fed. Cir. 2013)).
`According to Petitioner,
`With no such disclosure [of co-registration] in the
`specification, only two possibilities exist. Either co-registration
`was within the ordinary skill, or the ’158 patent is not enabled
`under § 112. For purposes of obviousness, the Board presumes
`that the patent satisfies § 112, i.e., that co-registration was within
`the knowledge and skill of a POSITA.
`Id. at 4–5. Petitioner thus contends that Patent Owner cannot argue that co-
`registration of image data was “difficult, time-consuming, and often
`inaccurate,” while “at the same time, claim[ing] that very combination,
`without disclosing ‘how it was done.’” Id. at 5.
`Petitioner analogizes to the Federal Circuit’s decision in Smith &
`Nephew, Inc. v. Rea, in which the patent owner “argued that achieving
`compression with non-locking screws in conically tapered, partially threaded
`holes was unknown in the prior art and, in fact, would have been
`inoperable.” Pet. Reply 5; Smith & Nephew, 721 F.3d at 1381. In that case,
`the Federal Circuit stated that such an argument “naturally raises the
`question of how [the patent owner] managed to make such a combination
`work.” Smith & Nephew, 721 F.3d at 1381. The Federal Circuit further
`explained that the problem with this argument “is that it is contending that a
`standard non-locking screw would be inoperative to obtain compression in a
`threaded hole, while at the same time claiming that it managed to achieve
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`exactly that objective, all through the deus ex machina of a ‘specialized
`screw.’” Id. “But an unclaimed and undisclosed feature such as the
`‘specialized screw’ cannot be the basis for finding [the] patent to be non-
`obvious over the prior art.” Id.
`We agree with Petitioner that claim 66 does not require steps of co-
`registering the claimed first image data set and x-ray image data. First, we
`consider the claim language. Claim 66 does not require that the “first image
`data set” and the “x-ray image data” be co-registered, or combined, in any
`manner. Ex. 1001, 122:9–24. We recognize Patent Owner’s argument that
`the two types of image data must be reflected in the surgical tool made by
`the claimed method; however, this does not require co-registration.
`Tr. 20:17–21:12. The claim simply requires a method of creating a surgical
`instrument that is based in part on first image data and x-ray image data,
`wherein the instrument includes a patient-specific surface derived from the
`first image data, and includes a guide that is oriented relative to the patient-
`specific surface of the instrument based on information derived from the x-
`ray image data. Ex. 1001, 122:9–24. The claim does not prescribe the
`manner in which these steps occur; in other words, the claim does not
`require that the first image data set and the x-ray image data be co-
`registered, in order to create the instrument or orient the guide.5
`For example, Petitioner relies upon Dr. Mabrey’s testimony and
`contends that “it would have been obvious to a POSITA . . . to identify the
`
`5 We agree with Petitioner that many antecedent steps are required in order
`to perform the steps recited in the claims. “For example, the MRI machine
`may need to be plugged in in order to obtain the first image data from the
`MRI machine.” Tr. 48:21–22. We also agree “[t]hat does not make
`plugging in the MRI machine a claim limitation.” Id. at 48:22–23.
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`mechanical axis on a standing x-ray, calculate the angle between the
`transcondylar axis and the mechanical axis, and manually transfer the
`mechanical axis to the [first] image,” e.g., an MRI or CT image, for use in
`creating a tool. Pet. Reply 17 (citing Ex. 1202 ¶¶ 7–9, 40; Ex. 1211 ¶ 21;
`Ex. 1210, 37:11–41:19). More specifically, Dr. Mabre
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