IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`In re Patent of: Barry
`U.S. Patent No.: 7,670,358
`Issue Date:
`March 2, 2010
`Appl. Ser. No.: 11/027,026
`Filing Date:
`December 30, 2004
`Title:
`SYSTEM AND METHOD FOR ALIGNING VERTEBRAE IN
`THE AMELIORATION OF ABERRANT SPINAL COLUMN
`DEVIATION CONDITIONS
`
`Attorney Docket No.: 108136.00035
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`PETITION FOR INTER PARTES REVIEW OF UNITED STATES
`PATENT NO. 7,670,358 PURSUANT TO 35 U.S.C. §§ 311-319, 37 C.F.R. § 42
`
`
`
`
`
`
`

`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A.
`
`B.
`
`C.
`
`Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`
`D.
`
`Service Information
`
`II.
`
`PAYMENT OF FEES – 37 C.F.R. § 42.103
`
`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`B.
`
`C.
`
`Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`
`Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
`
`1.
`
`2.
`
`3.
`
`4.
`
`“spinal rod engagement means” (claims 1 and 3)
`
`“handle means” (claims 1 and 2)
`
`“mechanically linked” (claims 1 and 2)
`
`“a second group of multiple vertebrae” (claim 4)
`
`IV.
`
`SUMMARY OF THE ‘358 PATENT
`
`A. Overview of the ‘358 Patent
`
`B.
`
`C.
`
`Summary of the Prosecution History of the ‘156 Patent
`
`Legal Standard for Anticipation and Obviousness
`
`V.
`
`THE CHALLENGED CLAIMS ARE UNPATENTABLE
`
`1
`
`1
`
`1
`
`1
`
`1
`
`2
`
`2
`
`2
`
`2
`
`3
`
`4
`
`5
`
`5
`
`6
`
`6
`
`6
`
`7
`
`8
`
`9
`
`A. Ground 1 – Claims 1-5 are Invalid Under 35 U.S.C. § 102/103 in
`view of the ‘349 Patent
`10
`
`B. Ground 1 – Claim 1 are Invalid Under 35 U.S.C. § 102/103 in view
`of the ‘349 Patent
`21
`
`
`
`

`
`
`
`C. Ground 3 – Claims 1-5 are Obvious Under 35 U.S.C. § 103 Over the
`‘928 Appl. in view of the MTOS Chapter
`28
`
`D. Ground 4 – Claims 1-5 are Obvious Under 35 U.S.C. § 103 Over the
`‘928 Appl. in view of the Video and/or Slides
`37
`
`E. Ground 5 – Claims 1-5 are Obvious Under 35 U.S.C. § 103 Over the
`Video, the Slides, and/or the MTOS Chapter in view of the ‘928
`Appl.
`43
`
`F. Ground 6 – Claims 1-5 are Obvious Under 35 U.S.C. § 103 Over the
`Video, the Slides, and/or the MTOS chapter in view of the ‘328
`Appl.
`57
`
`VI. CONCLUSION
`
`
`60
`
`
`
`
`
`ii
`
`

`
`
`
`EXHIBITS
`
`MSD 1001 – Declaration of Lawrence G. Lenke, M.D. Regarding U.S. Patent No.
`7,670,358
`
`MSD 1002 – Thoracic Pedicle Screws for Idiopathic Scoliosis Video (2001)
`
`MSD 1003 – Free Hand Thoracic Screw Placement and Clinical Use in Scoliosis and
`Kyphosis Surgery slide presentation handout (2003)
`
`
`MSD 1004 – U.S. Patent Application Publication No. 2003/0065328
`
`MSD 1005 – U.S. Patent No. 5,219,349
`
`MSD 1006 – U.S. Patent Application Publication No. 2005/0245928
`
`MSD 1007 – [Reserved]
`
`MSD 1008 – Prosecution History of U.S. Patent No. 7,670,358
`
`MSD 1009 – Prosecution History of U.S. Patent No. 7,776,072
`
`MSD 1010 – [Reserved]
`
`MSD 1011 – Curriculum Vitae of Lawrence G. Lenke, M.D.
`
`MSD 1012 – Masters Techniques in Orthopaedic Surgery: The Spine, 2nd Edition,
`Chapter 17: “Posterior Spinal Instrumentation Techniques for Spinal
`Deformity”
`
`
`MSD 1013 – Krag et al., An Internal Fixator for Posterior Application to Short Segments of the
`Thoracic, Lumbar, or Lumbosacral Spine, CLINICAL ORTHOPAEDICS AND
`RELATED RESEARCH, 203: 75-98 (February 1986)
`
`
`MSD 1014 – W. Dick, The "fixateur interne" As a Versatile Implant for Spine Surgery, SPINE
`12:882-900, 1987;
`
`
`MSD 1015 – Olerud et al., Transpedicular Fixation of Thoracolumbar Vertebral Fractures,
`CLINICAL ORTHOPAEDICS AND RELATED RESEARCH 227:44-51, 1988
`
`
`
`
`
`iii
`
`

`
`
`
`MSD 1016 – Guyer et al., The Wiltse Pedicle Screw Fixation System, ORTHOPAEDICS
`11:1455-1460, 1988.
`
`
`MSD 1017 – [Reserved]
`
`MSD 1018 – [Reserved]
`
`MSD 1019 – [Reserved]
`
`MSD 1020 – U.S. Patent No. 7,670,358
`
`MSD 1021 – U.S. Patent No. 7,776,072
`
`MSD 1022 – [Reserved]
`
`MSD 1023 – Declaration of David Poley
`
`MSD 1024 – Declaration of Ashley Owens
`
`MSD 1025 – Transcript of Thoracic Pedicle Screws for Idiopathic Scoliosis Video
`(2001)
`
`
`MSD 1026 – Declaration of Seth A. Kramer
`
`MSD 1027 – U.S. Patent Application Publication No. 2005/0085813
`
`
`
`iv
`
`

`
`
`
`
`
`Medtronic, Inc. (“Petitioner”) petitions for Inter Partes Review (“IPR”) under 35
`
`U.S.C. §§ 311-319 and 37 C.F.R. § 42 of claims 1-5 of U.S. Patent No. 7,670,358 (the
`
`“‘358 patent”) (Exhibit MSD 1020). As set forth below, Petitioner demonstrates
`
`there is a reasonable likelihood of prevailing in its challenge of at least one of claims
`
`1-5 identified in this petition as being unpatentable.
`
`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A.
`
`Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`Petitioner is the real party-in-interest for the instant petition.
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`Petitioner is not aware of any reexamination certificates or pending prosecution
`
`concerning the ‘358 patent. Petitioner is the named defendant in litigation concerning
`
`the ‘358 patent, Mark A Barry, MD v. Medtronic, Inc., filed in the Eastern District of
`
`Texas as Case No. 1:14-cv-00104-RC on February 18, 2014. The Petitioner was
`
`served with the complaint on February 20, 2014.
`
`C.
`
`Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`
`LEAD COUNSEL
`Jeff E. Schwartz, Reg. No. 39,019
`1030 15th Street, NW
`Washington, DC 20005
`
`
`D.
`
`Service Information
`
`BACK-UP COUNSEL
`Seth A. Kramer, Reg. No. 67,813
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103
`
`Please address all correspondence and service to both counsel listed above.
`
`Petitioner consents to service by email at jeschwartz@foxrothschild.com,
`
`
`
`

`
`
`
`skramer@foxrothschild.com, and ipdocket@foxrothschild.com (referencing Attorney
`
`Docket No. 108136.00035).
`
`II. PAYMENT OF FEES – 37 C.F.R. § 42.103
`
`Petitioner authorizes the PTO to charge Deposit Account No. 50-1943 for any
`
`fees due as a result of the filing of the present petition.
`
`III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`Petitioner certifies the ‘358 patent is eligible for IPR and Petitioner is not
`
`barred or estopped from requesting IPR. This petition is filed within one year of
`
`service of a complaint against Petitioner in district court litigation in which the ‘358
`
`patent was asserted.
`
`B.
`
`Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`
`Petitioner requests IPR of claims 1-5 of the ‘358 patent on the grounds set
`
`forth in the table below and requests that each of the claims be found unpatentable.
`
`A detailed explanation of the statutory grounds for the unpatentability of each claim is
`
`provided in the form of claim charts. Additional evidence supporting each ground is
`
`provided for in the Declaration of Lawrence G. Lenke, M.D. and its appendices.
`
`Ground Claims Basis for Rejection
`1
`1-5
`Invalid under § 102/103 by U.S. 5,219,349 (the “‘349 patent”)
`2
`1
`Invalid under § 102/103 by U.S. 2005/0245928 (the “‘928 Appl.”)
`3
`1-5
`Obvious under § 103 by the ‘928 Appl. in view of Masters
`Techniques in Orthopaedic Surgery: The Spine, 2nd Edition
`(“MTOS”), Ch. 17
`
`
`
`2
`
`

`
`
`
`4
`
`5
`
`6
`
`7
`
`1-5
`
`2-5
`
`1-5
`
`1-5
`
`Obvious under § 103 by the ‘928 Appl. in view of the Thoracic
`Pedicle Screws for Idiopathic Scoliosis Video (the “Video”) and
`Free Hand Thoracic Screw Placement and Clinical Use in Scoliosis
`and Kyphosis Surgery slide handout (the “Slides”)
`Obvious under § 103 by the ‘928 Appl. in view of MTOS and the
`‘349 patent
`Obvious under § 103 by the Video, the Slides, and/or MTOS
`(alone or in combination) in view of the ‘928 Appl.
`Obvious under § 103 by the Video, the Slides, and/or MTOS
`(alone or in combination) in view of U.S. 2003/0065328 (the “‘328
`Appl.”)
`
`
`
`The Video, the Slides, the MTOS chapter published in November 2003 (see
`
`Declaration of Seth Kramer (MSD 1026) at ¶¶ 2,3), the ‘349 patent, and the ‘328
`
`Appl. each qualify as prior art under §102(b) because they were published more than
`
`one year prior to December 30, 2004. The ‘928 Appl. qualifies as prior art under
`
`§102(e) because it was filed prior to December 30, 2004. None of these references
`
`were cited in a rejection during prosecution of the ‘358 patent. The ‘928 Appl. was
`
`cited during prosecution of a related patent, U.S. 7,776,072 (MSD 1021). The
`
`USPTO, however, did not take in to account alternative ways that one skilled in the
`
`art would understand the disclosure of the ‘928 Appl. in view of the knowledge
`
`generally available to one of ordinary skill in the art to read on these claims.
`
`C.
`
`Claim Construction under 37 C.F.R. §§ 42.104(b)(3)
`
`With these constructions, Petitioner does not concede that the scope of the
`
`terms construed or other terms in the claims are reasonably certain to one of ordinary
`
`skill in the art. See generally Nautilus, Inc. v. Bioig Instruments, Inc., 2014 WL 2440536, __
`
`
`
`3
`
`

`
`
`
`U.S. __ (June 2, 2014). To the contrary, Petitioner believes that many of the terms are
`
`indefinite and reserves all rights to argue indefiniteness in the related litigation.
`
`In an IPR, the claim terms are given their “broadest reasonable construction in
`
`light of the specification.” 37 C.F.R. § 42.100(b). The claims terms are understood by
`
`their plain and ordinary meanings except where construed otherwise in the
`
`specification. Means-plus-function elements, as defined by 35 U.S.C. § 112, ¶ 6, are
`
`interpreted as being the structure disclosed to accomplish the described function, and
`
`all equivalents to this structure. Consistent with this standard, a proposed
`
`interpretation for certain claim terms is provided below. Petitioner does not concede
`
`that these terms should be construed the same way in a district court proceeding.
`
`1.
`
`“spinal rod engagement means” (claims 1 and 3)
`
`Under the broadest reasonable construction, the plain meaning
`
`of this term is “a structure for contacting or interfacing with a spinal
`
`rod.” Patent Owner has contended in co-pending litigation that this
`
`element is in means-plus-function form. Petitioner disagrees that the
`
`broadest reasonable interpretation is so limited. However, if the
`
`Board decides that this term is a means-plus-function element, without agreeing to
`
`this position or waiving any arguments and solely for purposes of this IPR the
`
`following alternative construction is submitted. The broadest reasonable construction
`
`of the claimed function is securing a screw to a spinal rod. The corresponding
`
`structure for this function is a structure forming at least a portion of a passageway for
`
`
`
`4
`
`

`
`
`
`receiving a rod for performing the claimed function. See, e.g., ‘358 patent at 4:1-4;
`
`4:47-59; Figs. 3 and 4. The term, in this alternative, encompasses this structure and
`
`equivalents pursuant to 35 U.S.C. § 112, ¶ 6.
`
`2.
`
`“handle means” (claims 1 and 2)
`
`Under the broadest reasonable construction, the term “handle means” means
`
`“a part that is designed especially to be grasped by the hand or that may be grasped by
`
`the hand.” WEBSTER’S THIRD NEW INT’L DICT. 1027 (1993) (“WEBSTER’S”). Patent
`
`Owner has contended in co-pending litigation that this element is in means plus
`
`function form. Petitioner disagrees that the broadest reasonable interpretation is so
`
`limited. However, if the Board decides that it is a means plus function element,
`
`without agreeing to this position or waiving any arguments and solely for purposes of
`
`this IPR the following construction is proposed. The claimed function is facilitating
`
`simultaneous application of manipulative forces to a first/second group of pedicle
`
`screw engagement members, and simultaneously moving each associated pedicle
`
`screw engagement member. The corresponding structure for performing the claimed
`
`function is a handle from which shafts extend or linked handles. See, e.g., ‘358 patent
`
`at 3:48-63; 5:1-35; Figs. 1, 3 and 5. The term encompasses these structures, and
`
`equivalents pursuant to 35 U.S.C. § 112, ¶ 6.
`
`3.
`
`“mechanically linked” (claims 1 and 2)
`
`Under the broadest reasonable construction, the term “mechanically linked”
`
`means “joined by a physical connection or physically joined.” This proposed
`
`
`
`5
`
`

`
`
`
`construction is supported by Figure 1, showing the handles 34 joined to their
`
`respective shafts 36 by way of a physical connection; and by the dictionary definitions
`
`of “mechanical” (“caused by, resulting from, or relating to a process that involves a
`
`purely physical as opposed to a chemical change”) and “link” (“to couple or connect
`
`by or as if by a connecting element”). WEBSTER’S 1317 and 1400-01 (1993).
`
`4.
`
`“a second group of multiple vertebrae” (claim 4)
`
`Under the broadest reasonable construction, the term “a second group of
`
`vertebrae” means “multiple vertebrae located at least in part at a different location on
`
`the spine than the first group of vertebrae.” See, e.g, ‘358 patent at Fig. 1.
`
`IV. SUMMARY OF THE ‘358 PATENT
`
`A. Overview of the ‘358 Patent
`
`The ‘358 patent is directed to methods for the amelioration of aberrant spinal
`
`column deviations. See, e.g., ‘358 patent, 3:11-17. As described and claimed, the
`
`method of the ‘358 patent generally sets out steps for the selection and implantation
`
`of multiple pedicle screws, the engagement of these pedicle screws by pedicle screw
`
`engagement members, and the application of force from a handle means attached to
`
`the engagement members such that the force is transmitted to the pedicle screws
`
`engagement members to rotate the vertebrae.
`
`The method also calls for the use of a pedicle screw and rod system, as was
`
`well known at the time of invention. The claims provide that this method may be
`
`
`
`6
`
`

`
`
`
`performed on a second set of pedicle screws by an identical apparatus, either
`
`sequentially or simultaneously.
`
`B.
`
`Summary of the Prosecution History of the ‘156 Patent
`
`The application that issued as the ‘358 patent was filed on December 30, 2004.
`
`The prosecution history of the ‘358 patent, as obtained from PAIR, is submitted
`
`herewith as Exhibit MSD 1008.
`
`
`
`During prosecution of the ‘358 patent, the claims were rejected numerous
`
`times by the USPTO. In a non-final office action dated January 23, 2008, the USPTO
`
`rejected all of the pending claims over U.S. Patent No. 6,090,113 (the “‘113 patent”).
`
`Notably, in rejecting these claims, the USPTO asserted that the ‘113 patent’s
`
`disclosure of “two systems intended to be fixed, for example, to the same vertebrae of
`
`the column, one on each side of the median axis of the spinal column” as anticipating
`
`the claimed first and second sets of pedicle screws being implanted in a first and
`
`second group of vertebrae, and the presence of a first and a second pedicle screw
`
`cluster derotation tool. See MSD 1008 at 166.
`
`In a reply filed on September 11, 2008, the applicant first noted that that the
`
`disclosure of the ‘113 patent regarding the connection of pedicle screws by spinal rods
`
`was inapplicable to the patentability of the claims and was “nothing new, as pedicle
`
`screws are connected together in any number of prior art references.” See MSD 1008
`
`at 109. In an attempt to distinguish the claims from the ‘113 patent, the applicant
`
`asserted that the claims were patentable because the ‘113 patent failed to disclose a
`
`
`
`7
`
`

`
`
`
`pedicle screw cluster derotation tool that could simultaneously engage “multiple
`
`pedicle screws in clusters of selected vertebrae to effect en masse manipulation of that
`
`cluster is only possible through the essential system components” namely the joining
`
`of the pedicle screw wrenches of the pedicle screw cluster derotation tool. See id.
`
`Unpersuaded, the USPTO issued a final office action on February 11, 2009,
`
`again rejecting all claims over the ‘113 patent. The USPTO noted that the claims did
`
`not require “en masse spinal column scoliotic correction” but instead only required
`
`“that the spinal column is corrected in the form of ‘clusters’ meaning, more than
`
`one,” which was satisfied by the ‘113 patent disclosing the correction of more than
`
`one vertebrae of the spinal column at a time. See MSD 1008 at 87.
`
`In a reply filed on July 13, 2009, the applicant amended the claims such that
`
`they required, inter alia, “in a single motion simultaneously rotating said vertebrae.”
`
`See MSD 1008 at 62-63 (amendment shown by underline). The applicant then argued
`
`that the ‘113 patent does not disclose such single motion to rotate the vertebrae, but
`
`instead required multiple actions. See id. at 70. The ‘358 patent subsequently issued
`
`on March 2, 2010.
`
`C.
`
`Legal Standard for Anticipation and Obviousness
`
`A claim is invalid as anticipated when “each and every element as set forth in
`
`the claim is found, either expressly or inherently described, in a single prior art
`
`reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d
`
`1051, 1053 (Fed. Cir. 1987).
`
`
`
`8
`
`

`
`
`
`A claim is obvious, and therefore invalid, under 35 U.S.C. § 103(a) if, at the
`
`time the invention was made, “the combined teachings of the prior art, taken as a
`
`whole, would have rendered the claimed invention obvious to one of ordinary skill in
`
`the art.” In re Napier, 55 F. 3d 610, 613 (Fed. Cir. 1995). “The combination of
`
`familiar elements according to known methods is likely to be obvious when it does no
`
`more than yield predictable results.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416,
`
`127 S. Ct. 1727, 1739, 167 L. Ed. 2d 705 (2007). There is no requirement to find
`
`precise teachings directed to specific subject matter of a claim; common sense,
`
`inferences, and creative steps that a person of ordinary skill in the art would employ
`
`should be considered. Id. at 1741. The Board should apply common sense,
`
`recognizing that “familiar items may have obvious uses beyond their primary
`
`purposes, and in many cases a person of ordinary skill will be able to fit the teachings
`
`of multiple patents together like pieces of a puzzle.” Id. at 1742. If “a patent ‘simply
`
`arranges old elements with each performing the function it had been known to
`
`perform’ and yields no more than one would expect from such an arrangement, the
`
`combination is obvious.” Id. at 1740.
`
`V.
`
`THE CHALLENGED CLAIMS ARE UNPATENTABLE
`
`The challenged claims recite systems and methods for spinal column derotation
`
`having features that were well known prior to the filing date of the ‘358 patent. See
`
`e.g., Declaration of Lawrence G. Lenke, M.D. Regarding U.S. Patent No. 7,670,358
`
`(hereinafter, the “Lenke Decl.”), attached hereto as Exhibit MSD 1001, at ¶ 61. As
`
`
`
`9
`
`

`
`
`
`detailed in the claim charts below, prior art references anticipate and/or render
`
`obvious the challenged claims of the ‘358 patent.
`
`A. Ground 1 – Claims 1-5 are Invalid Under 35 U.S.C. § 102/103 in
`view of the ‘349 Patent
`
`As shown in the claim charts below, claims 1-5 are anticipated and/or rendered
`
`obvious by the ‘349 patent.
`
`With respect to claim 1, the ‘349 patent discloses a system and method for
`
`aligning vertebrae in the amelioration of aberrant spinal column deviation conditions,
`
`and incorporates into its disclosure the use of spinal fixation devices that utilize
`
`pedicle rod and screw systems. See ‘349 patent at 6:41-57 (incorporating by reference:
`
`Krag et al., An Internal Fixator for Posterior Application to Short Segments of the Thoracic,
`
`Lumbar, or Lumbosacral Spine, CLINICAL ORTHOPAEDICS AND RELATED RESEARCH,
`
`203: 75-98 (February 1986) (MSD 1013); W. Dick, The "fixateur interne" As a Versatile
`
`Implant for Spine Surgery, SPINE 12:882-900 (1987) (MSD 1014); Olerud et al.,
`
`Transpedicular Fixation of Thoracolumbar Vertebral Fractures, CLINICAL ORTHOPAEDICS
`
`AND RELATED RESEARCH 227:44-51 (1988) (MSD 1015); and Guyer et al., The Wiltse
`
`Pedicle Screw Fixation System, ORTHOPAEDICS 11:1455-1460 (1988) (MSD 1016). As
`
`such, the ‘349 patent discloses a first set of pedicle screws 12 each having a threaded
`
`shank segment and a head segment. The pedicle screws each have a spinal rod
`
`conduit (clamp 18) that is formed substantially transverse to the length of each screw,
`
`and is sized and shaped to receive a spinal rod member 22. The pedicle screws also
`
`
`
`10
`
`

`
`
`
`include a spinal rod engagement means (clamp bolt 20) that secures the spinal rod
`
`member to the pedicle screw in a substantially fixed relative position and orientation.
`
`The ‘349 patent discloses that each pedicle screw is implanted in a pedicle region of
`
`each of a first group of multiple vertebrae of a spinal column.
`
`The ‘349 patent also discloses a first pedicle screw cluster derotation tool. This
`
`tool includes a first handle means in the form of hinged extensions 136, portions of
`
`laterally extending arms 112, the lower portions of dorsally extending legs 110, and
`
`threaded rod 210 that connects the portions of dorsally extending legs 110. The tool
`
`also includes a first group of pedicle screw engagement members in the form of shafts
`
`14. These shafts 14 are mechanically linked to the above-described handle means by
`
`shaft clamps 122. The ‘349 patent discloses that the shafts each engage with the head
`
`segments of each pedicle screw. Because of the rigid mechanical link between the
`
`handle means and the pedicle screw shafts 14, any force placed on the handle means
`
`would necessarily be transferred to the shafts, and subsequently transmitted to the
`
`head segment of each pedicle screw that is engaged with the respective shaft.
`
`The ‘349 patent provides that the disclosed tool allows the surgeon to “execute
`
`any of the common movements of the spine (flexion, extension, distraction,
`
`compression or anterior/posterior shear) with a high degree of mechanical control.”
`
`‘349 patent at 5:68 to 6:3. As anterior or posterior shear is a rotational movement, the
`
`‘349 patent explicitly discloses that the application of force to the handle means
`
`simultaneously rotates the vertebrae in which the pedicle screws are implanted to
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`11
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`
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`achieve an amelioration of an aberrant spinal column deviation condition.
`
`Alternatively, the ‘349 patent inherently discloses such simultaneous rotation of the
`
`vertebrae as it would be readily apparent to one of ordinary skill in the art to provide
`
`such simultaneous rotation by placing a downward, i.e., in the ventral direction, force
`
`on either of the laterally extending arm 112 portions of the first handle means. See
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`Lenke Decl., at ¶ 72. Due to the rigid connection between the laterally extending
`
`arms provided by the threaded rod 210, such force would necessarily be transmitted
`
`to both shafts 14 and subsequently to the screws, thereby simultaneously pushing
`
`down the one side of vertebrae to which the screws are attached to effect rotational
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`vertebral movement. See ‘349 patent at 5:8-12 (providing that T-handles 100, which
`
`include laterally extending arm 112, may be used by surgeon as handles to manually
`
`manipulate spine). Alternatively, to the extent that such disclosure is not inherent, it
`
`would have been obvious to one of ordinary skill in the art to use the device disclosed
`
`in the ‘349 patent to simultaneously derotate the vertebrae. See Lenke Decl. at ¶ 72.
`
`The ‘349 patent discloses that a spinal rod member 22 is extended through the
`
`spinal rod conduits, clamps 18, of one or more of the pedicle screws of the first set of
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`pedicle screws, and after the application of manipulative force is completed, spinal rod
`
`engagement means in the form of clamp bolts 20 are actuated to lock the spinal rod
`
`member in place to maintain the desired arrangement of the vertebrae.
`
`Claim 1[A]: A
`method for aligning
`vertebrae in the
`
`The ‘349 patent discloses a method for treating and correcting
`deformities and injuries of the spine. See ‘349 patent at 2:36-40
`(“It is therefore an object of the present invention to provide a
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`
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`12
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`
`
`
`amelioration of
`aberrant spinal
`column deviation
`conditions
`comprising the
`steps of:
`
`Claim 1[B]: selecting
`a first set of pedicle
`screws, said pedicle
`screws each having
`a threaded shank
`segment and a head
`segment;
`
`device for producing realignment of vertebrae affected by
`various spinal disorders, including fractures and dislocations,
`which device employs a significant mechanical advantage.”);
`2:49-52 (“It is also an object of the present invention to
`provide a device for alignment of a spine which distributes the
`applied force evenly across the screws and pedicles to which it
`attaches.”).
`
`The ‘349 patent discloses the
`selection of a first set of pedicle
`screws. See ‘349 patent at 4:36-39
`(“The shaft clamps provide a
`positive linkage between the T-
`handles 100 and the shaft handles
`14 attached to the pedicle screws
`12.”).
`
`Threaded Shank
`Segment
`
`Head
`Segment
`
`First Set of Pedicle Screws
`The ‘349 patent discloses that
`the pedicle screws have a
`threaded shank segment and a
`head segment. See ’349 patent
`at FIG. 1.
`
`The ‘349 patent
`discloses a first
`pedicle screw
`cluster derotation
`tool having first
`handle means
`and a first group
`of pedicle screw
`engagement
`members which
`are mechanically
`linked with said
`first handle
`means. See ‘349
`patent at FIGS. 2
`and 3.
`
`
`Claim 1[C]: selecting
`a first pedicle screw
`cluster derotation
`tool, said first
`pedicle screw cluster
`derotation tool
`having a first handle
`means and a first
`group of pedicle
`screw engagement
`members which are
`mechanically linked
`with said first
`handle means, each
`pedicle screw
`engagement
`member being
`configured for
`engaging with, and
`
`
`
`(First Handle
`Means is
`indicated in
`red)
`
`First
`Pedicle
`Screw
`Cluster
`Derotation
`Tool
`
`Pedicle Screw
`Engagement Members
`
`13
`
`

`
`
`
`transmitting
`manipulative forces
`applied to said first
`handle means to
`said head segment
`of each pedicle
`screw of said first
`set of pedicle
`screws,
`Claim 1[D]:
`implanting a [sic]
`each pedicle screw
`in a pedicle region
`of each of a first
`group of multiple
`vertebrae of a spinal
`column which
`exhibits an aberrant
`spinal column
`deviation condition;
`
`Claim 1 [E]:
`engaging each
`pedicle screw
`engagement
`member
`respectively with
`said head segment
`of each pedicle
`screw of said first
`set of pedicle
`screws; and
`
`Claim 1 [F]:
`
`
`
`The ‘349 patent discloses the
`implantation of each pedicle screw in a
`pedicle region of each of a first group
`of multiple vertebrae of a spinal
`column that exhibits an aberrant spinal
`column deviation condition;. See ‘349
`patent at 1:25-30 (“…holes are drilled in the appropriate
`vertebrae through the pedicle on either side of each vertebrae.
`After the holes are drilled, pedicle screws 12 are screwed into
`place using a shaft handle 14 which is attached to flats 16
`provided on the top of each screw 12.”); FIG. 1; § V.A., Claim
`1[A], supra (incorporated here).
`The ‘349 patent shows the engaging of each pedicle
`engagement member with the head
`segment of a respective pedicle screw.
`See ‘349 patent at 1:25-40 (“After the
`holes are drilled, pedicle screws 12 are
`screwed into place using a shaft handle
`14 which is attached to flats 16 provided
`on the top of each screw 12. The shaft
`handles 14 are best seen in FIG. 2. Once
`the pedicle screws 12 are in place, each
`one has an articulating clamp 18 attached
`to it by means of a clamp bolt 20. Clamp
`bolt 20 is placed through clamp 18 and loosely threaded into
`the head of pedicle screw 12. The clamp bolts 20 are left loose
`until realignment of the vertebrae by the reduction frame has
`been completed. Shaft handles 14 remain attached to the tops
`of the pedicle screws 12. The shaft handles may be provided
`with removable grips which are not shown in FIG. 2”).
`The ‘349 patent discloses applying manipulative force to the
`
`Engagement of
`head segments
`
`14
`
`

`
`
`
`applying
`manipulative force
`to said first handle
`means in a manner
`for simultaneously
`engaging said first
`group of pedicle
`screw engagement
`members and first
`set of pedicle screws
`and thereby in a
`single motion
`simultaneously
`rotating said
`vertebrae of said
`first group of
`multiple vertebrae
`in which said
`pedicle screws are
`implanted to
`achieve an
`amelioration of an
`aberrant spinal
`column deviation
`condition;
`
`Application of
`force on handle
`
`Direction of
`rotation of
`vertebrae
`
`first handle means in a manner for simultaneously engaging
`said first group of pedicle screw engagement members and first
`set of pedicle screws and thereby in a single motion
`simultaneously rotating said vertebrae of said first group of
`multiple vertebrae in
`which said pedicle
`screws are implanted to
`achieve an amelioration
`of an aberrant spinal
`column deviation
`condition. See ‘349
`patent at 2:62-66 (“A
`further object of the
`present invention is to
`provide a device for
`alignment of a spine
`which includes a mechanical means for producing the motions
`of flexion/extension, distraction/compression, and
`anterior/posterior shear.”); 5:4-12 (“The T-handles 100 of the
`present invention provide a positive linkage between the two
`pedicles to which it is attached. The linkage ensures that force
`applied is evenly distributed to the two pedicles, thereby
`decreasing the likelihood of damage to any one pedicle. Once
`the T-handles 100 have been installed as described above, they
`may be used by the surgeon simply as handles for manual
`manipulation of the spine without assembling further
`components of the present invention.”) (emphasis added); 5:55
`to 6:4 (“The arrangement of lower-rod assembly 200 effectively
`provides for rigid connection between T-handles 100 and
`lower-rod assembly 200, while providing five degrees of
`freedom for adjustment: two rotational degrees of freedom
`provided by clamping collars 117 around sleeves 116 and
`around their taper fit joints with clamping collars 220, 224; one
`rotational degree of freedom provided by male clamping collar
`220 and sleeve 214; and two translational degrees of freedom
`provided by the movement of T-handle sleeves 116 or threaded
`leg 110 and lower-rod sleeves 214 and 215 on threaded rod
`210. With the lower-rod assembly 200 installed on the T-
`handles 100, the surgeon may execute any of the common
`movements of the spine (flexion, extension, distraction,
`compression or anterior/posterior shear) with a high degree of
`
`
`
`15
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`

`
`
`
`Claim 1 [G]:
`selecting a first
`length of a spinal
`rod member;
`wherein one or
`more of said pedicle
`screws of said first
`set of pedicle screws
`each includes: a
`spinal rod conduit
`formed substantially
`transverse of the
`length of said
`pedicle screw and
`sized and shaped
`for receiving
`passage of said
`spinal rod member
`therethrough; and
`spinal rod
`engagement means
`for securing said
`pedicle screw and
`said spinal rod
`member, when
`extending through
`said spinal rod
`conduit, in a
`substantially fixed
`relative position and
`orientation;
`
`Claim 1 [H]:
`extending said first
`length of said spinal
`rod member
`through said spinal
`rod conduits of one
`or more of said
`
`
`
`Spinal Rod
`Engagement
`Means
`
`Spinal
`Rod
`Conduit
`
`mechanical control.”).
`The ‘349 patent discloses that the described device is used with
`a fixator device (10) implanted in vertebrae on either/both
`sides of the multiple vertebrae to be rigidly fixed in a corrected
`position, including by threading a permanent fixation rod (22)
`through a conduit (clamp 18) on the top of the pedicle screws.
`See ‘349 patent at 6:41-57 (“The invention has been described
`above with reference to the Vermont Spinal Fixator device
`shown in FIG. 1. However, with only minor modifications
`depending on the particular
`device, the invention may be
`utilized with any spinal fixation
`device which employs at least
`four points of attachment to the
`spine, similar to the Vermont
`Spinal Fixator. Such
`modifications are well within the
`ability of a person of ordinary
`skill in the art based on the
`disclosure contained herein.
`Illustrative examples of such devices are contained in the
`following publications: W. Dick, The "fixateur interne" As a
`Versatile Implant for Spine Surgery, Spine 12:882-900, 1987;
`Olerud et al., Transpedicular Fixation of Thoracolumbar
`Vertebral Fractures, Clinical Ort