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`Exhibit 1007
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`Exhibit 1007
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`Mako Surgical Corp. Ex. 1007
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF FLORIDA
`MIAMI DIVISION
`
`CASE NO: 1:14-CV-61263-DPG/WCT
`
`
`MAKO SURGICAL CORP.,
`a Delaware corporation,
`ALL-OF-INNOVATION GMBH,
`a German corporation,
`
`
`Plaintiffs,
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`
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`vs.
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`BLUE BELT TECHNOLOGIES, INC.,
`a Pennsylvania corporation,
`
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`Defendant.
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` /
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`DEFENDANT BLUE BELT TECHNOLOGIES, INC.’S PRELIMINARY DISCLOSURE
`OF ASSERTED CLAIMS AND INFRINGEMENT CONTENTIONS
`FOR U.S. PATENT NO. 6,757,582
`
`Defendant Blue Belt Technologies, Inc. (“Blue Belt”), submits the following preliminary
`
`disclosure of asserted claims and infringement contentions to Plaintiffs Mako Surgical Corp.
`
`(“Mako”) and All-of-Innovation GmbH (“AOI”) (collectively, “Plaintiffs”).
`
`Blue Belt’s investigation into the extent of infringement by Mako is ongoing. Blue Belt
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`makes these contentions based on its current knowledge and such information regarding Mako’s
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`accused products as is publicly available. Since Mako has not yet produced documents, and
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`because not all information regarding Mako’s products is publicly known, Blue Belt explicitly
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`reserves the right to amend these disclosures as additional evidence comes to light during the
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`course of this litigation.
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`ASSERTED CLAIMS
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`Mako is liable under 35 U.S.C. §§ 271(a), (b), and (c) for infringement of claims 1, 3, 5-
`
`14, 16-30, 34-42, and 47-58 (“the Asserted Claims”) of U.S. Patent No. 6,757,582 issued to
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`Brisson et al. (“the ’582 patent”). Charts comparing the elements of the asserted claims to the
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`accused products are attached as Exhibit A.
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`ACCUSED INSTRUMENTALITY
`
`Mako’s Robotic Arm Interactive Orthopedic (RIO) System and/or Mako’s Tactile
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`Guidance System (TGS) (collectively referred to as “Mako’s RIO”), as well as the use of these
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`instrumentalities for, inter alia, MAKOplasty knee and hip procedures infringe the ’582 patent.
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`CLAIM CHARTS
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`Attached as Exhibit A is a claim chart identifying how the Accused Instrumentality (or its
`
`use) embodies each element of each asserted claim of the asserted patent.
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`As previously noted, this information is based on the publicly-available information
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`presently available to Blue Belt. Furthermore, the infringement evidence cited in these charts is
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`exemplary and not exhaustive. Based on information currently known to Blue Belt, Mako’s RIO
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`infringes the asserted claims of the ’582 patent in the manner disclosed in Exhibit A. Blue Belt’s
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`investigation is ongoing, and Blue Belt reserve the right to amend or supplement the claim charts
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`in Exhibit A based on continued investigation and discovery from Mako and others.
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`INDIRECT INFRINGEMENT
`
`Mako has contributed to the infringement of and/or actively induced infringement of the
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`’582 patent in violation of 35 U.S.C. §§ 271(b) and (c), and continues to do so with knowledge of
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`or willful blindness to the ’582 patent, with specific intent to contribute to the infringement of
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`and/or induce infringement, and with knowledge or willful blindness that the induced acts would
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`constitute patent infringement. At least Mako’s following activities constitute this infringement:
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`manufacturing, offering to sell, selling, and using Mako’s RIO in the United States, which is
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`especially made to be used in a fashion that infringes the asserted claims, is not a staple article or
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`commodity of commerce, and is not suitable for a substantial noninfringing use; offering
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`promotional, instructional, or demonstrative materials related to Mako’s RIO in order to market,
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`solicit, encourage, and enable infringing activity in the United States; and by providing a Mako
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`employee as an assistant during surgeries performed with the Accused Instrumentality in the
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`United States.
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`MAKO’S LITERAL AND NONLITERAL INFRINGEMENT
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`Based on Blue Belt’s current investigation and understanding of the Accused
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`Instrumentality, each element of each asserted claim of the ’582 patent is literally present in the
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`Accused Instrumentality, unless explicitly indicated otherwise. To the extent that the Accused
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`Instrumentality is found to not literally embody any element of the asserted claims, Blue Belt
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`alleges, on information and belief, that any and all such elements are present under the doctrine of
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`equivalents in the Accused Instrumentality.
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`PRIORITY DATES
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`Each asserted claim of the ’582 patent is entitled to a priority date of at least as early as
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`May 3, 2002, and no later than April 30, 2003.
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`BLUE BELT’S PRACTICE OF THE ’582 PATENT
`
`Blue Belt’s NavioPFS® system and the use thereof embodies and/or practices every
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`element of the Asserted Claims of the ’582 patent.
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`WILLFUL INFRINGEMENT
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`Blue Belt alleges that Mako’s infringement of the ’582 patent is and has been
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`willful. Mako has known of the ’582 patent since well before Blue Belt’s counterclaim against
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`Mako for infringement. Despite this knowledge, Mako has chosen to practice the Asserted
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`Claims of the ’582 patent without a license or authorization. Mako has chosen to practice the
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`Asserted Claims despite an objectively high likelihood that its actions constituted infringement of
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`the ’582 patent, and with actual knowledge of this likelihood.
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`
`
`Dated: August 22, 2014
`
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`
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`By: /s/ Timothy P. Best
`
`Timothy P. Best
`
`FELDMAN GALE LLP
`James A. Gale
`Florida Bar No. 371726
`Email: jgale@feldmangale.com
`Richard Guerra
`Florida Bar No. 689521
`Email: rguerra@feldmangale.com
`One Biscayne Tower, Suite 3000
`Two South Biscayne Boulevard
`Miami, FL 33131
`Telephone No. (305) 358-5001
`Facsimile No. (305) 358-3309
`
`GIBSON, DUNN & CRUTCHER LLP
`Josh Krevitt (Admitted Pro Hac Vice)
`Email: jkrevitt@gibsondunn.com
`200 Park Avenue
`New York, NY 10166-0193
`Telephone No. (212) 351-4000
`Facsimile No. (212) 351-4035
`
`GIBSON, DUNN & CRUTCHER LLP
`Wayne M. Barsky (Admitted Pro Hac Vice)
`Email: wbarsky@gibsondunn.com
`Timothy P. Best (Admitted Pro Hac Vice)
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`Email: tbest@gibsondunn.com
`2029 Century Park East
`Los Angeles, CA 90067
`Telephone No. (310) 557-8500
`Facsimile No. (310) 552-7010
`
`
`GIBSON, DUNN & CRUTCHER LLP
`Stuart M. Rosenberg (Admitted Pro Hac Vice)
`Email: srosenberg@gibsondunn.com
`1881 Page Mill Road
`Palo Alto, CA 94304
`Telephone No. (650) 849-5300
`Facsimile No. (650) 849-5333
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`Counsel for Defendant Blue Belt Technologies, Inc.
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that on August 22, 2014, true and accurate copies of the within
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`document were served on the following counsel of record at the addresses and in the manner
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`indicated on the Service List.
`
`/s/ Timothy P. Best
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`SERVICE LIST
`Mako Surgical Corp., et al. v. Blue Belt Technologies, Inc.
`Case No.: 1:14-CV-61263-KMM/CMM
`United States District Court, Southern District of Florida
`
`
`SHOOK, HARDY & BACON L.L.P.
`Humberto H. Ocariz
`E-mail: hocariz@shb.com
`Miami Center, Suite 3200
`201 South Biscayne Blvd.
`Miami, FL 33131
`Telephone: (305) 358-5171
`Facsimile: (305) 358-7470
`Via E-Mail
`
`Morrison & Foerster LLP
`Wendy J. Ray
`E-mail: wray@mofo.com
`707 Wilshire Blvd.
`Los Angeles, CA 90017-3543
`Telephone: (213) 892-5200
`Facsimile: (213) 892-5454
`Via E-Mail & U.S. Mail
`
`Morrison & Foerster LLP
`Wesley E. Overson
`E-mail: woverson@mofo.com
`Danielle Coleman
`E-mail: dcoleman@mofo.com
`Elizabeth A. Patterson
`E-mail: epatterson@mofo.com
`425 Market Street
`San Francisco, CA 94105
`Telephone: (415) 268-7000
`Facsimile: (415) 268-7522
`Via E-Mail
`
`Counsel for Plaintiffs
`Mako Surgical Corp. and All-of-Innovation GmbH
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`101761739
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Asserted Claim 1:
`
`Asserted claim 1 is entitled to a priority date of at least as early as May 3, 2002, based on U.S. Provisional Patent Application No.
`60/377,695, and no later than April 3, 2003, based on U.S. Application No. 10/427,093. Mako’s Robotic Arm Interactive Orthopedic
`(RIO) System, Mako’s Tactile Guidance System (TGS), and their use in knee and hip procedures, including but not limited to
`“MAKOplasty” (collectively referred to below as “Mako’s RIO”) infringe claim 1. Each of the limitations of claim 1 is literally
`embodied by Mako’s RIO, or is present under the doctrine of equivalents.
`
`
`Brisson ’582 Patent Asserted Claim
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`
`1. A system, comprising:
`
`A cutting tool;
`
`Mako’s RIO is a system:
`“The centerpiece of MAKOplasty is the RIO system, our proprietary robotic arm,
`interactive, orthopedic system, that provides both pre-operative and intra-operative
`guidance to the orthopedic surgeon, enabling tissue sparing bone removal and accurate
`implant insertion and alignment. The RIO system consists of two elements: a tactile
`robotic arm utilizing an integrated bone cutting instrument and a patient specific
`visualization component.”
`[Mako Surgical Corp., 2012 Form 10-K at 15]
`
`Mako’s RIO includes a bone cutting tool:
`“The RIO system consists of two elements: a tactile robotic arm utilizing an integrated
`bone cutting instrument and a patient specific visualization component.”
`[Mako Surgical Corp., 2012 Form 10-K at 15]
`“Bone Cutting Instruments — The bone cutting instrument is integrated into the
`tactile robotic arm at the end effector. For MAKOplasty PKA procedures, this
`instrument is composed of a high speed motor and a component that houses a variety of
`single use bone cutting tips. . . . The cutting tip is the disposable end tip of the bone
`cutting instrument that makes contact with the joint and actually removes the bone for
`placement of the knee implant in accordance with the pre-operative surgical plan. . . .
`For MAKOplasty THA procedures, the bone cutting instrument is a reamer
`(similar to a drill) that allows hemispherical cutting baskets to be attached to the
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`1
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Brisson ’582 Patent Asserted Claim
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`
`reamer.”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
`“…the high speed burr attached to the robotic arm.”
`[Conditt, M. & Van Vorhis, P., “Mind the Gap – Achieving a Naturally Balanced and
`Aligned Knee Following UKA with the MAKOplasty® Procedure,” (Sept. 2009), at 1]
`“The system consists of a high-speed 75,000 rpm electric burr (eMax2 from the
`Anspach Effort, Palm Beach Gardens, Fla), which is operated via a foot pedal. Power is
`controlled and ensured via linkage with the robotic system.”
`[Pearle, A.D. et al., “Robot-Assisted Unicompartmental Knee Arthroplasty,” J.
`Arthroplasty 25(2):230-237 (2010), at 233.]
`Use of rotating cutting burr.
`[Mako Surgical Corp. video, “MAKOplasty Robotic Arm Partial Knee Resurfacing, Left
`Medial Unicompartmental,” available at
`https://www.youtube.com/watch?v=xsoyy07Uoh0, at, e.g., 00:36:15–00:38:00; 00:38:35–
`00:48:45.]
`
`Mako’s RIO is especially made to remove bone tissue in a target shape in a workpiece,
`where the target shape matches the shape of a surgical orthopaedic implant:
`“The planned positions of the femoral and tibial components can then be fine-tuned such
`that the joint articular surfaces are placed to fill the gap left by the disease process
`throughout the flexion arc. . . . This final planned position then defines the volume of
`bone to be resected by the high speed burr attached to the robotic arm.”
`[Conditt, M. & Van Vorhis, P., (Sept. 2009), at 2]
`“This patient specific visualization of our implant overlaid onto an image of the
`patient’s actual joint helps the surgeon to plan the procedure pre-operatively, by
`providing information that enables the surgeon to determine the optimal placement,
`alignment and sizing of the implant. The final planned placement of the implant
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`A workpiece that includes a target
`shape;
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Brisson ’582 Patent Asserted Claim
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`establishes the boundaries of the tactile “safety zone” for surgery. During surgery,
`each monitor projects an active 3-D computer graphics visualization of the patient’s
`joint, showing the areas of the bone that are actually removed as the procedure
`progresses”
`[Mako Surgical Corp., 2012 Form 10-K at 17]
`“The acetabulum is reamed with robotic guided navigation with the reamer constrained
`by a virtual haptic tunnel which prevents the surgeon from going off-line or too
`deep…. The cup is connected to the robot and directed to the correct inclination and
`anteversion through a virtual haptic tunnel created by the robot.”
`[Tarwala, R. & Dorr, L.D., “Robotic Assisted Total Hip Arthroplasty Using the MAKO
`Platform,” Curr. Rev. Musculoskelet. Med. 4:151,156 (2011) at 152, Fig. 1 (caption)]
`“Medical devices can be marketed only for the indications for which they are cleared or
`approved. . . . Certain of our currently marketed products, such as our RIO system, are
`class II devices marketed pursuant to 510(k) marketing clearances.”
`[Mako Surgical Corp., 2012 Form 10-K at 29]
`[Mako’s RIO system has FDA approval only for a total hip arthroplasty application and
`for partial knee replacement applications. See, e.g., FDA Medical Device 510(k)
`Approvals Database, available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
`cfPMN/pmn.cfm.]
`Target shape depends on implant plan and C-T data for patient’s joint.
`[Mako Surgical Corp. video, “MAKOplasty Robotic Arm Partial Knee Resurfacing, Left
`Medial Unicompartmental,” available at
`https://www.youtube.com/watch?v=xsoyy07Uoh0, at, e.g., 00:00:00–00:05:20.]
`
`
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`a tracker to provide tracking data
`
`Mako’s RIO possesses an infrared camera tracking system that obtains tracking data from
`
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Brisson ’582 Patent Asserted Claim
`associated with the cutting tool and the
`workpiece, where the tracker includes
`at least one of:
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`infrared-reflective markers attached to the workpiece and the robotic arm:
`“The camera system captures the positions of the femur and the tibia during
`manipulation of the knee through a range of motion.”
`[Conditt, M. & Van Vorhis, P., (Sept. 2009), at 2]
`“Stereo Tracking System Camera and Instruments — During a MAKOplasty
`procedure, the location of the tactile “safety zone” is updated continuously based on
`bone tracking data supplied to the computer system by an infrared stereo tracking
`system, which consists of a special camera that is directed toward a series of tracking
`arrays attached to the patient’s anatomy by bone pins. The tracking system assists the
`robotic arm system in locating and physically tracking the patient’s anatomy and
`coordinating its real time position with the cutting instrument of the robotic arm. It has
`a sufficient refresh rate to provide the robotic arm system with an adequate flow of
`information regarding movements of both the patient and the robotic arm to ensure
`optimal cutting and placement.”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
`Cutting tool image updates in real time based on tracker data.
`[Mako Surgical Corp. video, “MAKOplasty Robotic Arm Partial Knee Resurfacing, Left
`Medial Unicompartmental,” available at
`https://www.youtube.com/watch?v=xsoyy07Uoh0, at, e.g., 00:36:30–00:38:00; 00:39:10–
`00:41:45.]
`Workpiece image updates in real time based on tracker data.
`[Mako Surgical Corp. video, “MAKOplasty Robotic Arm Partial Knee Resurfacing, Left
`Medial Unicompartmental,” available at
`https://www.youtube.com/watch?v=xsoyy07Uoh0, at, e.g., 00:22:05–00:24:28;00:48:50–
`00:49:35.]
`
`at least one first marker associated Mako’s RIO uses infrared-reflective navigation markers that are anchored to pins inserted
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Brisson ’582 Patent Asserted Claim
`with the workpiece, and
`
`at least one second marker
`associated with the cutting tool; and
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`into the patient’s femur and tibia:
`“During the surgical procedure, standard navigation markers are placed in the
`femur and the tibia and are also mounted on a robotic arm.”
`[Conditt, M. & Van Vorhis, P., (Sept. 2009), at 1]
`“This system uses optical motion capture technology to dynamically track marker
`arrays fixed to the robotic arm, femur, and tibia, allowing the surgeon to freely
`adjust limb position and orientation during tactile-guided bone cutting.”
`[Roche, M., “Robotic-Assisted Unicompartmental Knee Arthroplasty: The MAKO
`Experience,” Clinical Sports Medicine 33:123-132 (2014), at 126.]
`“Pelvic array placement .... After the pins have been inserted, the pelvic attachment
`device is inserted onto the pins…. This base is used for attachment of the pelvic array.
`… Femoral registration requires insertion of two screws; one large screw for holding
`the femoral array and a smaller screw to be used to verify accuracy of registration
`(check point).”
`[Tarwala, R. & Dorr, L.D., “Robotic Assisted Total Hip Arthroplasty Using the MAKO
`Platform,” Curr. Rev. Musculoskelet. Med. 4:151,156 (2011) at 154]
`Insertion of tibial and femoral marker arrays.
`[Mako Surgical Corp. video, “MAKOplasty Robotic Arm Partial Knee Resurfacing, Left
`Medial Unicompartmental,” available at
`https://www.youtube.com/watch?v=xsoyy07Uoh0, at, e.g., 00:11:40–00:14:30.]
`
`Mako’s RIO uses infrared-reflective navigation markers that are anchored to the robotic
`arm, to which is attached the bone cutting tool:
`“During the surgical procedure, standard navigation markers are placed in the
`femur and the tibia and are also mounted on a robotic arm.”
`[Conditt, M. & Van Vorhis, P., (Sept. 2009), at 1]
`
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Brisson ’582 Patent Asserted Claim
`
`a controller to control the cutting tool
`based on the tracking data associated
`with the cutting tool and the tracking
`data associated with the workpiece.
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`“This system uses optical motion capture technology to dynamically track marker
`arrays fixed to the robotic arm, femur, and tibia, allowing the surgeon to freely adjust
`limb position and orientation during tactile-guided bone cutting.”
`[Roche, M., “Robotic-Assisted Unicompartmental Knee Arthroplasty: The MAKO
`Experience,” Clinical Sports Medicine 33:123-132 (2014), at 126.]
`Marker arrays are associated with the RIO arm and at its end effector.
`[Mako Surgical Corp. video, “MAKOplasty Robotic Arm Partial Knee Resurfacing, Left
`Medial Unicompartmental,” available at
`https://www.youtube.com/watch?v=xsoyy07Uoh0, at, e.g., 00:32:50–00:33:45.]
`
`Mako’s RIO employs a computerized controller unit to provide the control signals that
`limit the surgeon from cutting outside of the “safety zone,” including shutting off the burr
`if it has cut too deeply. These constraints are defined and effected with reference to the
`data obtained from the tracking system.
`“Controller — The controller is the electronic hardware and firmware component of our
`computing system which interfaces with our proprietary surgical planning and execution
`software to allow the surgeon to safely guide the tactile robotic arm. The controller
`governs the basic, low-level functions of the tactile robotic arm, such as the tactile
`constraints and the safety circuit.”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
`“The system consists of a high-speed 75,000 rpm electric burr (eMax2 from the
`Anspach Effort, Palm Beach Gardens, Fla), which is operated via a foot pedal. Power is
`controlled and ensured via linkage with the robotic system.”
`[Pearle, A.D. et al., “Robot-Assisted Unicompartmental Knee Arthroplasty,” J.
`Arthroplasty 25(2):230-237 (2010), at 233.]
`“If penetration occurs beyond 0.5 mm, the burr tip shuts off.”
`[Roche, M., “Robotic-Assisted Unicompartmental Knee Arthroplasty: The MAKO
`
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`6
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Brisson ’582 Patent Asserted Claim
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`Experience,” Clinical Sports Medicine 33:123-132 (2014), at 128-29.]
`“In addition, excessive pressure against the limits of the 3-D cutting volume or rapid
`movement of the patient’s anatomy immediately stops the cutting instrument,
`preventing unintentional resection outside the implant area from occurring.”
`[Pearle, A.D. et al., “Robot-Assisted Unicompartmental Knee Arthroplasty,” J.
`Arthroplasty 25(2):230-237 (2010), at 233.]
`The system as controls the cutting tool by not allowing cutting to occur beyond a
`warning zone. “When this happens, the motor that operates the burr will completely
`stop.”
`[Mako Surgical Corp. video, “MAKOplasty Medial Unicompartmental Partial Knee
`Resurfacing,” available at https://www.youtube.com/watch?v=uGv75UDqAFA, at, e.g.,
`00:15:51-15:59.]
`Stereo Tracking System Camera and Instruments — During a MAKOplasty procedure,
`the location of the tactile “safety zone” is updated continuously based on bone
`tracking data supplied to the computer system by an infrared stereo tracking system,
`which consists of a special camera that is directed toward a series of tracking arrays
`attached to the patient’s anatomy by bone pins. The tracking system assists the robotic
`arm system in locating and physically tracking the patient’s anatomy and coordinating
`its real time position with the cutting instrument of the robotic arm. It has a sufficient
`refresh rate to provide the robotic arm system with an adequate flow of information
`regarding movements of both the patient and the robotic arm to ensure optimal
`cutting and placement. Using the system, the surgeon can freely move the robotic arm
`within the defined space, but encounters tactile resistance as the boundaries of such
`space are reached.”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Asserted Claim 3:
`
`Asserted claim 3 is entitled to a priority date of at least as early as May 3, 2002, based on U.S. Provisional Patent Application No.
`60/377,695, and no later than April 3, 2003, based on U.S. Application No. 10/427,093. Mako’s Robotic Arm Interactive Orthopedic
`(RIO) System, Mako’s Tactile Guidance System (TGS), and their use in knee and hip procedures, including but not limited to
`“MAKOplasty” (collectively referred to below as “Mako’s RIO”) infringe claim 3. Each of the limitations of claim 3 is literally
`embodied by Mako’s RIO, or is present under the doctrine of equivalents.
`
`
`Brisson ’582 Patent Asserted Claim
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`
`3. A system according to claim 1,
`wherein the cutting tool includes at
`least one cutting element, and where
`the cutting element comprises at least
`one of: at least one blade, at least one
`rotatable blade, at least one retractable
`blade, at least one water jet, at least one
`particulate jet, at least one lithotriptor,
`and at least one ultrasonic lithotriptor.
`
`Mako’s RIO system embodies all the elements of claim 1 by virtue of the reasoning and
`evidence previously discussed. Additionally, Mako’s RIO includes a rotatable blade or
`reamer bone cutting tool:
`“Bone Cutting Instruments — The bone cutting instrument is integrated into the
`tactile robotic arm at the end effector. For MAKOplasty PKA procedures, this
`instrument is composed of a high speed motor and a component that houses a variety of
`single use bone cutting tips. . . . The cutting tip is the disposable end tip of the bone
`cutting instrument that makes contact with the joint and actually removes the bone for
`placement of the knee implant in accordance with the pre-operative surgical plan. . . .
`For MAKOplasty THA procedures, the bone cutting instrument is a reamer
`(similar to a drill) that allows hemispherical cutting baskets to be attached to the
`reamer.”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
`“…the high speed burr attached to the robotic arm.”
`[Conditt, M. & Van Vorhis, P., “Mind the Gap – Achieving a Naturally Balanced and
`Aligned Knee Following UKA with the MAKOplasty® Procedure,” (Sept. 2009), at 1]
`Use of rotating cutting burr.
`[Mako Surgical Corp. video, “MAKOplasty Robotic Arm Partial Knee Resurfacing, Left
`Medial Unicompartmental,” available at
`https://www.youtube.com/watch?v=xsoyy07Uoh0, at, e.g., 00:36:15–00:48:45.]
`
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`
`
`Asserted Claim 5:
`
`Asserted claim 5 is entitled to a priority date of at least as early as May 3, 2002, based on U.S. Provisional Patent Application No.
`60/377,695, and no later than April 3, 2003, based on U.S. Application No. 10/427,093. Mako’s Robotic Arm Interactive Orthopedic
`(RIO) System, Mako’s Tactile Guidance System (TGS), and their use in knee and hip procedures, including but not limited to
`“MAKOplasty” (collectively referred to below as “Mako’s RIO”) infringe claim 5. Each of the limitations of claim 5 is literally
`embodied by Mako’s RIO, or is present under the doctrine of equivalents.
`
`
`Brisson ’582 Patent Asserted Claim
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`
`5. A system according to claim 1,
`where the controller transmits a control
`signal to the cutting tool, where the
`control signal includes at least one of:
`an analog signal, a digital signal, and
`no signal.
`
`Mako’s RIO system embodies all the elements of claim 1 by virtue of the reasoning and
`evidence previously discussed. Additionally, Mako’s RIO system employs an electronic
`controller that governs the robotic arm by providing a flow of digital and/or analog
`information based on continuously-updated tracking data:
`“Controller — The controller is the electronic hardware and firmware component of our
`computing system which interfaces with our proprietary surgical planning and execution
`software to allow the surgeon to safely guide the tactile robotic arm. The controller
`governs the basic, low-level functions of the tactile robotic arm, such as the tactile
`constraints and the safety circuit.”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
`“The system consists of a high-speed 75,000 rpm electric burr (eMax2 from the
`Anspach Effort, Palm Beach Gardens, Fla), which is operated via a foot pedal. Power is
`controlled and ensured via linkage with the robotic system.”
`[Pearle, A.D. et al., “Robot-Assisted Unicompartmental Knee Arthroplasty,” J.
`Arthroplasty 25(2):230-237 (2010), at 233.]
`“If penetration occurs beyond 0.5 mm, the burr tip shuts off.”
`[Roche, M., “Robotic-Assisted Unicompartmental Knee Arthroplasty: The MAKO
`Experience,” Clinical Sports Medicine 33:123-132 (2014), at 128-29.]
`
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`Mako Surgical Corp. Ex. 1007
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Brisson ’582 Patent Asserted Claim
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`“In addition, excessive pressure against the limits of the 3-D cutting volume or rapid
`movement of the patient’s anatomy immediately stops the cutting instrument,
`preventing unintentional resection outside the implant area from occurring.”
`[Pearle, A.D. et al., “Robot-Assisted Unicompartmental Knee Arthroplasty,” J.
`Arthroplasty 25(2):230-237 (2010), at 233.]
`The system as controls the cutting tool by not allowing cutting to occur beyond a
`warning zone. “When this happens, the motor that operates the burr will completely
`stop.”
`[Mako Surgical Corp. video, “MAKOplasty Medial Unicompartmental Partial Knee
`Resurfacing,” available at https://www.youtube.com/watch?v=uGv75UDqAFA, at, e.g.,
`00:15:51-15:59.]
`Stereo Tracking System Camera and Instruments — During a MAKOplasty procedure,
`the location of the tactile “safety zone” is updated continuously based on bone
`tracking data supplied to the computer system by an infrared stereo tracking system,
`which consists of a special camera that is directed toward a series of tracking arrays
`attached to the patient’s anatomy by bone pins. The tracking system assists the robotic
`arm system in locating and physically tracking the patient’s anatomy and coordinating
`its real time position with the cutting instrument of the robotic arm. It has a sufficient
`refresh rate to provide the robotic arm system with an adequate flow of information
`regarding movements of both the patient and the robotic arm to ensure optimal
`cutting and placement. Using the system, the surgeon can freely move the robotic arm
`within the defined space, but encounters tactile resistance as the boundaries of such
`space are reached.”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Asserted Claim 6:
`
`Asserted claim 6 is entitled to a priority date of at least as early as May 3, 2002, based on U.S. Provisional Patent Application No.
`60/377,695, and no later than April 3, 2003, based on U.S. Application No. 10/427,093. Mako’s Robotic Arm Interactive Orthopedic
`(RIO) System, Mako’s Tactile Guidance System (TGS), and their use in knee and hip procedures, including but not limited to
`“MAKOplasty” (collectively referred to below as “Mako’s RIO”) infringe claim 6. Each of the limitations of claim 6 is literally
`embodied by Mako’s RIO, or is present under the doctrine of equivalents.
`
`
`Brisson ’582 Patent Asserted Claim
`
`Infringement under 35 U.S.C. § 271(a), (b), and (c)
`
`6. A system according to claim 1,
`where the tracker includes tracking data
`based on at least three positions and at
`least three angles.
`
`Mako’s RIO system embodies all the elements of claim 1 by virtue of the reasoning and
`evidence previously discussed. Additionally, Mako’s RIO system employs a Northern
`Digital Inc. camera to detect the position and orientation of navigation markers placed, for
`example, on the robotic arm, the patient’s femur, and the patient’s tibia:
`“. . . Northern Digital Inc., or NDI, the supplier of our camera systems . . . .”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
`“Polaris Optical Tracking Systems Track the 3D position and orientation of active or
`passive markers . . . .”
`[Northern Digital website, http://www.ndigital.com/medical/products/polaris-family/.]
`“Stereo Tracking System Camera and Instruments — During a MAKOplasty procedure,
`the location of the tactile “safety zone” is updated continuously based on bone tracking
`data supplied to the computer system by an infrared stereo tracking system, which
`consists of a special camera that is directed toward a series of tracking arrays attached
`to the patient’s anatomy by bone pins. The tracking system assists the robotic arm
`system in locating and physically tracking the patient’s anatomy and coordinating its
`real time position with the cutting instrument of the robotic arm.”
`[Mako Surgical Corp., 2012 Form 10-K at 16]
`“During the surgical procedure, standard navigation markers are placed in the femur and
`the tibia and are also mounted on a robotic arm.”
`
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`BLUE BELT’S PRELIMINARY INFRINGEMENT CONTENTIONS AGAINST MAKO’S RIO
`U.S. PATENT NO. 6,757,582
`
`Brisson ’582 Patent Asserted Cla