UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`MAKO SURGICAL CORP.,
`Petitioner
`
`v.
`
`BLUE BELT TECHNOLOGIES, INC.,
`
`Named as Patent Owner
`
`_____________________
`
`IPR2015-00630
`
`U.S. Patent No. 6,205,411 B1
`
`_____________________
`
`RESPONSE ON BEHALF OF PARTY NAMED AS PATENT OWNER
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`Page
`
`Introduction ......................................................................................................... 1
`I.
`II. The Development of Computer-Assisted Orthopedic Surgery. .......................... 3
`A. The State of the Art in the late 1990s. .......................................................... 3
`B. Joint Venture between the Center for Orthopedic Research at
`Shadyside Hospital and Carnegie Mellon University .................................. 6
`1. DiGioia II. .............................................................................................. 7
`2. DiGioia .................................................................................................. 8
`3. U.S. Patent No. 5,880,976 ..................................................................... 9
`4. The ‘411 Patent .................................................................................... 14
`III. DiGioia does not render claims 1–17 of the ‘411 Patent Obvious. .................. 17
`A. DiGioia is not Prior Art to the ‘411 Patent Claims. ................................... 18
`1. DiGioia is not prior art under § 102(a) because it is not “by
`others.” ................................................................................................. 19
`2. Claims 1–17 of the ‘411 Patent are entitled to claim the benefit
`of the ‘976 Patent’s filing date, and thus DiGioia does not
`qualify as prior art under § 102(b). ...................................................... 21
`B. Even assuming DiGioia is prior art, Petitioner has not established
`that it renders claims 1–17 obvious. ........................................................... 28
`1. Petitioner has not established that “the pre-operative kinematic
`biomechanical simulator outputs a position for implantation of
`the artificial component,” as recited in independent claims 1
`and 10, would have been obvious in view of DiGioia. ....................... 28
`2. Petitioner has not established that DiGioia renders obvious a
`“pre-operative geometric planner” that “outputs at least one
`geometric model of the joint,” as recited by independent claims
`1 and 10. .............................................................................................. 35
`3. Petitioner has not established that DiGioia renders obvious a
`“creating a three dimensional component model of the artificial
`implant,” as recited in independent claim 17. ..................................... 37
`IV. Conclusion and Relief Requested ..................................................................... 39
`
`
`
`i
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`

`
`TABLE OF CONTENTS
`(continued)
`
`V. Named Patent Owner’s Exhibit List for Inter Partes Review of U.S. Pat.
`No. 6,205,411 .................................................................................................... 40
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`Page
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`ii
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`

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`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
`banc) ..................................................................................................................... 23
`Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996) ............................... 22
`Hynix Semiconductor, Inc. v. Rambus Inc., 645 F.3d 1336, 1352 (Fed. Cir. 2011) 23
`In re DeBaun, 687 F.2d 459 (CCPA 1982) ............................................................. 18
`In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ...................................................... 28
`In re Katz, 687 F.2d 450, 455 (Fed. Cir. 1982) ................................................ 18, 21
`InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1347 (Fed. Cir.
`2014) ..................................................................................................................... 28
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) ........................................ 28
`Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1354 (Fed. Cir. 2003)
` ....................................................................................................................... 17, 18
`
`Statutes
`35 U.S.C. § 101 ........................................................................................................ 14
`35 U.S.C. § 102 ................................................................................................. 17, 21
`35 U.S.C. § 103(a) .............................................................................................. 1, 16
`35 U.S.C. § 120 ........................................................................................................ 21
`
`Other Authorities
`M.P.E.P. § 211 ......................................................................................................... 21
`M.P.E.P. § 2132(III) ................................................................................................. 18
`
`iii
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`

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`
`
`I.
`
`Introduction
`
`As indicated in the Named Patent Owner’s Mandatory Notice Under 37
`
`C.F.R. § 42.8, Paper No. 5 (Feb. 18, 2015), Blue Belt was named by Petitioner as
`
`the Patent Owner in this proceeding, but does not own the ’411 Patent. Blue Belt
`
`is an exclusive licensee of the ’411 Patent. Therefore, this Petition should be
`
`dismissed or terminated. In the event that the Patent Trial and Appeal Board
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`(“Board”) does not dismiss or terminate this proceeding because the Patent Owner
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`Carnegie Mellon University (“Carnegie Mellon”) was not named as a party and
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`also finds claims 1–17 unpatentable, then the Patent Owner, Carnegie Mellon, has
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`authorized Blue Belt Technologies, Inc. (“Blue Belt”), the named Patent Owner, to
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`submit a response.
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`The Patent Trial and Appeal Board (“the Board”) instituted trial on the
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`following grounds: (1) for claims 1–15 and 17 of U.S. Patent No. 6,205,411 (“the
`
`‘411 Patent”) (Ex. 1001), 35 U.S.C. § 103(a) over DiGioia1 and (2) for claim 16,
`
`
` 1 A.M. DiGioia III et al. HipNav: Pre-Operative Planning and Intra-operative
`
`Navigational Guidance for Acetabular Implant Placement in Total Hip
`
`Replacement Surgery, Proceedings of the 2nd Computer Assisted Orthopedic
`
`Surgery Symposium (1996) (“DiGioia”) (Ex. 1005).
`
`
`
`1
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`

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`
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`§ 103(a) over DiGioia in view of DiGioia II.2 Institution Decision, Paper No. 6, at
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`11–12 (Aug. 4, 2015) (“Ins. Decision”). DiGioia cannot be the basis for an
`
`obviousness determination because it is not prior art. It discloses the inventors’
`
`own pioneering work published less than a year before the ‘411 Patent’s priority
`
`date. For that reason alone, the Board should find claims 1–15 and 17 patentable
`
`over DiGioia and should find claim 16 patentable over the proposed combination
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`of DiGioia and DiGioia II.
`
`Petitioner further fails to establish obviousness, even if DiGioia is found to
`
`be prior art, because its obviousness grounds lack the requisite “rational
`
`underpinning” needed to support an obviousness determination. Petitioner
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`consistently fails to even allege, let alone substantiate, the required motivation to
`
`modify DiGioia to supply admittedly missing elements. Equally problematic, Dr.
`
`Robert Howe’s declaration, on which Petitioner bases its obviousness arguments,
`
`merely repeats Petitioner’s allegations—typically verbatim. As a result, Dr.
`
`Howe’s declaration fails to provide evidentiary support, and Petitioner’s
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`allegations amount to nothing more than attorney argument. Accordingly, Blue
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` 2 A.M. DiGioia III et al., An Integrated Approach to Medical Robotics and
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`Computer Assisted Surgery in Orthopaedics, Proceedings of the 1st Int’l
`
`Symposium on Medical Robotics and Computer Assisted Surgery, 106–111
`
`(1995) (“DiGioia II”) (Ex. 1006).
`
`
`
`2
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`

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`
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`Belt Technologies, Inc. (“Blue Belt”) respectfully requests that claims 1–15 and 17
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`be found patentable over DiGioia and that claim 16 be found patentable over the
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`proposed combination of DiGioia and DiGioia II.
`
`II.
`
`The Development of Computer-Assisted Orthopedic Surgery.
`
`A.
`
`The State of the Art in the late 1990s.
`
`Hip replacement surgery is a traumatic procedure, often requiring long,
`
`painful recovery periods. In the late 1990s, surgeons replaced hips manually.
`
`Robert D. Howe & Yoky Matsuoka, Robotics for Surgery, Annu. Rev. Biomed
`
`Eng., 212–40, 220 (1999) (“Robotics for Surgery”) (Ex. 2001). After dislocating
`
`the hip joint and cutting off the head of the patient’s femur, a surgeon would force
`
`tools called broaches and reamers into the femur to create a cavity, and would
`
`place a prosthetic implant in the cavity. Id. The surgeon would also implant—
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`again, by hand—an acetabular cup into the patient’s hip joint. Id. at 222. As
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`shown in below (left), once the procedure is complete, the prosthetic head engages
`
`the acetabular cup. Id. at 221.
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`
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`3
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`

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`
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`After the surgery, patients are at increased risk for hip dislocation, i.e., the
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`prosthetic femoral head disengaging from the implanted acetabular cup as depicted
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`above (right). Id. at 220–21; ‘411 Patent, 1:37–40. Patients who experience hip
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`dislocation often must endure another hip replacement. See ‘411 Patent, 1:30–35.
`
`The most common cause of dislocation is “impingement of the femoral neck with
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`either the rim of an acetabular cup implant, or the soft tissue or bone surrounding
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`the implant.” Id. 1:45–47. Impingement, in turn, often occurs because the
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`acetabular cup was not positioned optimally in the first place. Id. 1:48–50.
`
`Optimal placement of the cup presents a two-part challenge: First, the surgeon
`
`must determine what is the “optimal” position for the patient, which varies from
`
`patient to patient based individual anatomies and the types of activities in which
`
`the patient normally engages. Robotics for Surgery at 223; ‘411 Patent, 2:56–67.
`
`Second, the surgeon must accurately place the implant in the predetermined
`
`
`
`4
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`

`
`
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`location during the surgery. See ‘411 Patent, 3:21–31 (describing technologies that
`
`help the surgeon intra-operatively place the implant).
`
`To try to address issues with optimal placement, a number of approaches had
`
`been developed by the late 1990s. For example, acetate templates allowed
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`surgeons to plan implant placement and size using an X-ray of the pelvis. Id.
`
`3:10–12. But the X-ray only provided a 2-D image of the pelvis, and thus often
`
`did not provide the degree of precision needed to correctly position the implant.
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`Id. 3:14–16. Research also began in the use of robots and other computer-based
`
`devices during surgery to properly align the implant with the patient with greater
`
`accuracy than was generally achievable using manual methods. Id. 3:19–15. These
`
`devices assumed that the patient’s pelvis and trunk were aligned in a known
`
`direction and could not take into account a person’s unique anatomy. Id. 3:25–33.
`
`Other similar systems improved on intra-operative placement, but did nothing to
`
`help in the pre-operative stage as they assumed that the proper position of the
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`implant would be provided as an input to the system, not generated by the system
`
`itself. Id. 4:32–38. Many of these systems had the added drawback that they
`
`required fiducial markers to be attached to the patient during imaging of the
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`patient’s joint and either remain attached until surgery was completed, or be
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`reattached at the precisely the same location during surgery so that the pre-
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`
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`5
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`

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`
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`operative image data could be used to guide the robot in the operating room. Id.
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`4:45–50.
`
`B.
`
`Joint Venture between the Center for Orthopedic Research at
`Shadyside Hospital and Carnegie Mellon University
`
`In 1994, Dr. Anthony DiGioia III, who was an orthopedic surgeon at
`
`Shadyside Hospital in Pittsburgh, PA, obtained funding to develop image-guided
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`systems for orthopedic surgery. Declaration of Dr. Branislav Jaramaz (filed
`
`herewith as Ex. 2002) (“Jaramaz Decl.”), ¶ 5. Dr. DiGioia hired Dr. Branislav
`
`Jaramaz as a researcher at Shadyside Hospital and invested funds into The
`
`Robotics Institute at Carnegie Mellon University (“CMU”) in coordination with
`
`Dr. Takeo Kanade. Id. At the time, Dr. Kanade was the Director of The Robotics
`
`Institute at CMU. Id.
`
`Together, Drs. DiGioia, Branislav, and Kanade applied for, and were
`
`awarded, a National Challenge Grant from the National Science Foundation. Id.
`
`¶ 6. They used funds from the National Challenge Grant to hire and provide
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`graduate funding for additional members of the research team. Id. ¶ 6. The
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`additional members included: Dr. David Simon, Dr. Robert O’Toole, Mr. Michael
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`Blackwell, Mr. Frederick Morgan, Mr. Bruce Colgan, and Mr. Eric Kischell. Id.
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`Dr. Simon was Dr. Kanade’s graduate student at the time. Id. Dr. O’Toole was a
`
`mechanical engineer also hired by Dr. DiGioia to be a researcher at Shadyside
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`
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`6
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`

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`
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`Hospital (he would later study medicine at Harvard Medical School). Id. Mr.
`
`Blackwell was hired as a researcher at The Robotics Institute of CMU, and Mr.
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`Morgan was a graduate student in CMU’s Electrical Engineering department. Id.
`
`Mr. Colgan was a clinical support engineer at Shadyside Hospital. Id. Mr.
`
`Kischell was a programmer hired by The Robotics Institute of CMU. Id.
`
`1.
`
`DiGioia II.
`
`In 1995, the team published its first paper, DiGioia II, listing as authors Drs.
`
`DiGioia, Jaramaz, and O’Toole. DiGioia II at 106. DiGioia II provides a high-
`
`level overview of the goals of the research, particularly an “integrated approach”
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`that includes the following components: “1) biomechanics-based preoperative
`
`planning, 2) less traumatic surgical robotics, and 3) standardized postoperative
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`clinical tracking.” Id. With respect to the first component, the team was
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`“developing full three-dimensional models (of both the femur and acetabulum)
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`based upon CT scan data.” Id. at 110. For the second component, the team was
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`“investigating ‘frameless’ registration methods for surgical robotics in
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`orthopaeidics.” Id. The team sought to address the third component “through the
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`creation and use of a database we refer to as the ‘Total Joint Registry.’” Id. The
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`team explained that their work was ongoing: “It is our belief that the development
`
`of the described approach will represent a significant improvement for the field of
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`medical robotics. Our current work strives to make this goal a reality.” Id.
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`
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`7
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`
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`2.
`
`DiGioia
`
`The team described preliminary results of their work in DiGioia, which
`
`listed as authors Dr. DiGioia, Dr. Simon, Dr. Jaramaz, Mr. Blackwell, Mr. Morgan,
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`Dr. O’Toole, Mr. Colgan, and Mr. Kischell. DiGioia at 1.3 The authors submitted
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`this paper for review by the International Society for Computer Assisted
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`Orthopedic Surgery (CAOS) on February 22, 1996, and presented the paper at the
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`2nd CAOS Symposium on November 7, 1996. Jaramaz Decl., ¶ 8.
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`As shown in Figure 3 of DiGioia, the “Hip Navigation or HipNav system
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`includes three components[:] a pre-operative planner, a range of motion simulator,
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`and an intra-operative tracking and guidance system.” DiGioia at 1–2. The “pre-
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`operative planner” allows a surgeon to “manually specify the position of the
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`acetabular component within the pelvis based upon pre[-]operative CT images.”
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`Id. at 2. The “range of motion simulator” estimates “femoral range of motion
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`based upon the implant placement parameters provided by the pre-operative
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`planner.” Id. The “intra-operative tracking and guidance system” is used to
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`“accurately place the implant in the predetermined optimal position regardless of
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`the position of the patient on the operating room table.” Id.
`
` 3 DiGioia does not have page numbers aside from the page numbers added to
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`DiGioia by Petitioner. Accordingly, when referring to DiGioia, Blue Belt uses
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`the page numbers provided by Petitioner.
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`
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`8
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`
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`3.
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`U.S. Patent No. 5,880,976
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`
`
`U.S. Patent No. 5,880,976 (“the ‘976 Patent”) (filed herewith as Ex. 2003)
`
`issued from Application No. 08/803,993 (“the ‘993 Application”), which was filed
`
`on February 21, 1997. See ‘976 Patent File History (Ex. 1003) at 39. The ‘993
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`Application was allowed without an Office Action on the merits. See id. at 3 (‘976
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`Patent Transaction History).
`
`The ‘976 Patent describes apparatuses and methods that include “creating a
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`joint model of a patient’s joint into which an artificial component is to be
`
`implanted and creating a component model of the artificial component.” ‘976
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`Patent, 4:60–63. These models are used to “simulate movement of the patient’s
`
`joint with the artificial component in a test position” and to “calculate a range of
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`motion of the joint for at least one test position based on the simulated movement.”
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`Id. 4:63–5:1. “An implant position, including angular orientation, for the artificial
`
`
`
`9
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`

`
`
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`component is determined based on a predetermined range of motion and the
`
`calculated range of motion.” Id. 5:1–4.
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`Figure 1 of the ‘976 Patent, provided below, shows an apparatus 10 that
`
`includes a geometric pre-operative planner 12, a pre-operative kinematic
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`biomechanical simulator 14, and intra-operative navigational software 16. Id.
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`5:63–6:8. Geometric pre-operative planner 12 is used to create “geometric models
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`of the joint and the components to be implanted based on geometric data received
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`from skeletal structure data source 13.” Id. 6:18–20. Pre-operative biomechanical
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`simulator 14 simulates the “movement of the joint using the geometric models.”
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`Id. 6:22–23. The simulation results are used to “determin[e] implant positions,
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`including angular orientations, for the components.” Id. 6:23–24. The “implant
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`positions are used in conjunction with the geometric models in intra-operative
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`navigational software 16 to guide a medical practitioner in the placement of the
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`implant components at the implant positions.” Id. 6:25–28.
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`
`
`10
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`

`
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`
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`“The pre-operative geometric planner 12, the pre-operative kinematic
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`biomechanical simulator 14 and the intra-operative navigational software [16]” can
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`be implemented with “a computer system 20 having at least one display monitor
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`22,” as shown in Figure 3 of the ‘976 Patent, which is provided below. Id. 6:29–
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`34. To track the location of the patient, a camera 32 can be positioned to detect
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`light emitted by a “number of special light emitting diodes, or targets 34.” Id.
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`6:56–62.
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`
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`11
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`

`
`
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`
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`Figure 2 of the ‘976 Patent, provided below, shows a flowchart that
`
`illustrates the operation of apparatus 10. Id. 7:3–4. The flowchart of Figure 2
`
`includes steps 40–48 which represent a pre-operative procedure 50, and steps 52–
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`56, which represent a “procedure 60 which enables a surgeon to realize the desired
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`implant position in the surgical theater.” Id. 8:17–23. In step 40, the skeletal
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`structure of the joint is determined using tomographic or computed tomographic
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`data, e.g., computed tomography (CT), magnetic resonance imaging (MRI),
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`positron emission tomographic (PET), or ultrasound scanning. Id. 7:4–12. In step
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`42, a surface model of the joint is created from the skeletal structure of the joint,
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`
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`12
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`

`
`
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`and geometric models of the artificial components are created. Id. 7:22–38. In
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`step 44, the geometric models of the joint and artificial components are used to
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`simulate movement of the joint containing the implanted artificial components. Id.
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`7:40–43.
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`In the example of a total hip replacement (THR) surgery, the skeletal
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`structure of the patient’s femur and pelvic regions can be obtained via CT scans
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`and used to create geometric surface models of the patient’s pelvis and femur. Id.
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`9:57–65. Simulations can be conducted with the acetabular cup and the femoral
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`implant positioned at various test locations using various parameters related to the
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`implants and the patient’s hip joint. Id. 10:20–29.
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`In step 46, the simulated range of motion is used to calculate a range of
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`motion, and in step 48 the calculated ranges of motion are compared to the
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`predetermined range of motion to select an implant position for the artificial
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`components. Id. 7:66–8:3. The selection of an implant position can be automated
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`such that a position is automatically output or manual control can be provided over
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`the selection of implants and/or implant locations. Id. 7:55–65. In the example of
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`THR surgery, the implant location can be determined by comparing the calculated
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`range of motion with the predetermined range of motion. Id. 11:1–5.
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`In step 52, the implant positions are identified in the geometric model of the
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`joint. Id. 8:24–27. In step 54, the joint model generated in the pre-operative stage
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`
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`13
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`

`
`
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`is registered with the intra-operative position of the patient’s joint. Id. 8:33–37.
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`Registration can involve locating coordinates of points on the bony surface, and
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`fitting those points can be with the joint model. Id. 8:38–43. In the example of
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`THR surgery, positional data from discrete locations on the patient’s pelvis and
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`femur can be used as inputs to the registration process. Id. 11:20–23.
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`In step 56, the positions of the joint and of the implant components are
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`tracked and compared in near real time to the implant position identified in the
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`joint model. Id. 9:26–28. Intra-navigational software 16 can be used to determine
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`the relative position of the artificial component and the implant position. Id. 9:31–
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`35. For example, intra-navigational software 16 can display on a monitor the near
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`real time relative position of the acetabular cup and the pre-operatively specified
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`implant position. Id. 11:50–54.
`
`4.
`
`The ‘411 Patent
`
`The ‘411 Patent issued from Application No. 09/189,914 (“the ‘914
`
`Application”), which was filed on November 12, 1998. See ‘411 Patent File
`
`History (Ex. 1002) at 2. The ‘914 Application was filed as a continuation-in-part
`
`application of the ‘993 Application. Id. at 32. As such, the ‘411 Patent includes
`
`much of the same description as the ‘976 Patent. For example, Figures 1–3 of the
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`‘411 Patent are identical to Figures 1–3 of the ‘976 Patent.
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`
`
`14
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`

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`
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`The PTO issued one Office Action during the prosecution of the ‘914
`
`Application. Id. at 3. In the Office Action, the Examiner rejected then-pending
`
`claims 1–29 of the ‘914 Application under obviousness-type double patenting over
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`claims 1–24 of the ‘976 Patent. Id. at 265. The Examiner also rejected then-
`
`pending claims 1 and 10 as not being directed to patent-eligible subject matter
`
`under 35 U.S.C. § 101, and rejected then-pending claims 17–28 under § 101 as
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`being directed to the same invention as claims 16–27 of U.S. Patent No. 6,002,859
`
`(“the ‘859 Patent”) (filed herewith as Ex. 2005). Id. at 266–70. The Applicant
`
`filed a Response to the Office Action that included (1) a terminal disclaimer over
`
`the ‘976 Patent, id. at 281, (2) amendments to then-pending claims 1 and 10, id. at
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`279–80, and (3) cancellation of then-pending claims 17–28, id. at 282. The
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`Examiner allowed the ‘914 Application after the Applicant’s Response. Id. at 286.
`
`Then-pending claims 1–16 and 29 of the ‘914 Application issued as claims
`
`1–17 of the ‘411 Patent, including independent claims 1, 10, and 17, which are
`
`provided below.
`
`1. An apparatus for facilitating the implantation of an artificial
`component in one of a hip joint, a knee joint, a hand and wrist joint,
`an elbow joint, a shoulder joint, and a foot and ankle joint,
`comprising:
`
`a pre-operative geometric planner; and
`
`a pre-operative kinematic biomechanical simulator in
`communication with said pre-operative geometric planner wherein
`
`
`
`15
`
`

`
`
`
`
`
`said pre-operative geometric planner outputs at least one geometric
`model of the joint and the pre-operative kinematic biomechanical
`simulator outputs a position for implantation of the artificial
`component.
`
`10. A system for facilitating an implant position for at least one
`artificial component in one of a hip joint, a knee joint, a hand and
`wrist joint, an elbow joint, a shoulder joint, and a foot and ankle joint,
`comprising:
`
`a computer system including;
`
`a pre-operative geometric planner; and
`
`a pre-operative kinematic biomechanical simulator in
`communication with said pre-operative geometric planner wherein
`pre-operative geometric planner outputs at least one geometric model
`of the joint and the pre-operative kinematic biomechanical simulator
`outputs a position for implantation of the artificial component; and
`a tracking device in communication with said computer system.
`
`17. A computerized method of facilitating the implantation of an
`artificial implant in one of a hip joint, a knee joint, a hand and wrist
`joint, an elbow joint, a shoulder joint, and a foot and ankle joint,
`comprising:
`
`creating a three dimensional bone model based on skeletal
`geometric data of a bone and a bony cavity into which the artificial
`implant is to be implanted;
`
`creating a three dimensional component model of the artificial
`implant;
`
`16
`
`

`
`
`
`simulating movement of the joint with the artificial implant in a
`
`test position;
`
`calculating a range of motion of the artificial implant and the
`bones comprising the joint for the test position based on the simulated
`movement;
`
`determining an implant position based on a predetermined
`range of motion and the calculated range of motion;
`
`identifying the implant position in the bone model;
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`aligning the bone model with the patient’s bone and placing the
`implant based on positional tracking data providing the position of the
`implant and the bone; and
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`tracking the implant and the bone to maintain alignment of the
`bone model and to determine the position of the implant relative to the
`bone.
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`III. DiGioia does not render claims 1–17 of the ‘411 Patent Obvious.
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`The Board should find claims 1–15 and 17 patentable over DiGioia and
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`claim 16 patentable over the proposed combination of DiGioia in view of DiGioia
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`II for two independent reasons. First, being the inventors’ own work published
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`less than one year before the ‘411 Patent’s priority date, DiGioia is not prior art,
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`and thus cannot serve as the basis for an obviousness conclusion under § 103(a).
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`Second, even assuming that DiGioia were prior art, Petitioner fails to establish the
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`“rational underpinning” needed to support an obviousness determination.
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`
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`17
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`

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`
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`A.
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`DiGioia is not Prior Art to the ‘411 Patent Claims.
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`DiGioia cannot serve as a basis for obviousness under § 103(a) unless it
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`qualifies as prior art under at least one subsection of 35 U.S.C. § 102.4 See
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`Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1355 (Fed. Cir. 2003)
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`(explaining that “prior art” is subject matter admitted by the patent owner as prior
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`art or subject matter listed in 35 U.S.C. § 102). As explained below, DiGioia does
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`not qualify as prior art under the only subsections of § 102 that could be relevant
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`here, i.e., subsections (a) and (b).5
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` 4 Because the ’411 Patent’s filing date is before the effective date of the America
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`Invents Act (“AIA”), Blue Belt refers herein to pre-AIA versions of § 102.
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` 5 None of the remaining subsections of § 102 are relevant because none of the
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`remaining subsections covers a non-patent publication such as DiGioia.
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`Subsection (c) refers to “abandon[ment] of the invention”; subsection (d) refers
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`to the invention being “first patented . . . in a foreign country prior to the date of
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`the application for patent in this country”; subsection (e)(1) refers to
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`“application for patent”; subsection (e)(2) refers to “a patent granted on an
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`application”; subsection (f) refers to an inventor not “himself invent[ing] the
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`subject matter sought to be patented”; and subsections (g)(1)–(2) refer to “an
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`interference.”
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`
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`18
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`

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`
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`1.
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`DiGioia is not prior art under § 102(a) because it is not “by
`others.”
`
`To qualify as prior art under § 102(a), a publication must be “by others.”
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`That is, the inventive entity of the publication must be different from the inventive
`
`entity of the claimed subject matter. M.P.E.P. § 2132(III); In re Katz, 687 F.2d
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`450, 455 (Fed. Cir. 1982). A publication’s listing of authors does not determine, or
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`even establish a presumption, as to its inventive entity. Katz, 687 F.2d at 455.
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`Rather, the question is “whether the portions of the reference relied on as prior art,
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`and the subject matter of the claims in question, represent the work of a common
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`inventive entity.” Riverwood Int’l Corp., 324 F.3d at 1356 (citing In re DeBaun,
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`687 F.2d 459 (CCPA 1982)).
`
`DiGioia lists two authors who are not inventors of the ‘411 Patent, Bruce
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`Colgan and Eric Kischell, and the ‘411 Patent lists one inventor who is not listed as
`
`an author on DiGioia, Dr. Takeo Kanade. Compare DiGioia at 1, with ‘411 Patent,
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`cover page (Ex. 1001 at 1). Nevertheless, Dr. Branislav Jaramaz, listed both as an
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`inventor on the ‘411 Patent and as an author on DiGioia, explains that the inventive
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`entity for the work described in DiGioia and for the challenged claims of the ‘411
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`Patent is identical. Jaramaz Decl. ¶¶ 13–17. As Dr. Jaramaz explains, the team’s
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`goal in listing the authorship of DiGioia was to not limit the authors to the
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`individuals who had contributed to DiGioia’s content, but rather to list everyone
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`who had been recently involved in the day-to-day operations developing the
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`
`19
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`

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`
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`HipNav system. Id. ¶ 11. Among the listed authors, the contributions of Dr.
`
`Jaramaz, Dr. Simon, Mr. Blackwell, Mr. Morgan, and Dr. O’Toole were reflected
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`in DiGioia. Id. ¶¶ 13–15 (explaining their contributions). Although Mr. Colgan
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`and Mr. Kischell were listed as authors on DiGioia, their work was not in fact
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`reflected in DiGioia, and instead pertained to different aspects of the system not
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`discussed in DiGioia. Id. ¶ 16. Mr. Colgan was a clinical support engineer who
`
`focused on facilitating operation in an operating room, e.g., ensuring sterilization
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`of the equipment and ensuring that that the system would function well alongside a
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`surgeon. Id. Mr. Kischell’s responsibility was to develop software code for pre-
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`processing of CT scan images based on algorithms developed by Mr. Blackwell,
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`Dr. Simon, Mr. Morgan, and Dr. O’Toole. Id. Mr. Kischell also developed a user
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`interface to the system. Id. None of these subjects are described in DiGioia. Nor
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`were Mr. Kischell’s or Mr. Colgan’s contributions reflected in claims 1–17 of the
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`‘411 Patent. Id. ¶ 17.
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`As Dr. Jaramaz further explains, Dr. Kanade worked with his graduate
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`student at the time, Dr. Simon (who is listed as an author of DiGioia and as an
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`inventor on the ‘411 Patent), on developing 3-D registration algorithms described
`
`on page 5 of DiGioia. Id. ¶ 15. The reason Dr. Kanade was not listed as an author
`
`on DiGioia was that, by the time DiGioia was published, Dr. Kanade had assumed
`
`an advisory role, and thus was less involved in the day-to-day development of the
`
`
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`20
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`

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`
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`system. Id. But this does not diminish Dr. Kanade’s original contributions. Id.
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`Indeed, Petitioner’s expert, Dr. Robert Howe, acknowledged during his deposition
`
`that, having spoken to Dr. Kanade at the time and known about the HipNav system
`
`described in DiGioia, it was his understanding that Dr. Kanade contributed to the
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`registration subject matter described on page 5 of DiGioia. Deposition Transcript
`
`of Dr. Robert Howe (filed herewith as Ex. 2006) (“Howe Depo.”) at 52:10–53:19
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`(noting that he knew of the HipNav system and had talked to Dr. Kanade about Dr.
`
`Kanade’s contributions), 86:7–10 (confirming that Dr. Kanade’s contribution is
`
`reflected on page 5 of DiGioia).
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`Thus, the inventorship of the ‘411 Patent is identical to the i