Case 3:12-cv-02738-CAB-MDD Document 157 Filed 01/09/14 PageID.5581 Page 1 of 14
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`CASE NO. 12-cv-2738-CAB
`WARSAW ORTHOPEDIC, INC.,
`MEDTRONIC SOFAMOR DANEK
`SECOND CLAIM CONSTRUCTION
`USA, INC., MEDTRONIC PUERTO
`ORDER
`RICO OPERATIONS COMPANY,
`and OSTEOTECH, INC.,
`
`vs.
`NUVASIVE, INC.,
`
`Plaintiffs,
`
`Defendant.
`
`I.
`
`Introduction
`On November 7, 2013, the Court held a hearing to construe claims of four patents
`asserted by NuVasive, Inc., against Warsaw Orthopedic, Inc., Medtronic Sofamor
`Danek U.S.A., Inc., Medtronic Puerto Rico Operations Co., and Osteotech, Inc.
`(hereinafter collectively “Warsaw”) – U.S. Patent Nos. 8,005,535 (“the ‘535 patent”)
`and 8,000,782 (“the ‘782 patent”), which share a common specification; U.S. Patent No.
`8,016,767 (“the ‘767 patent”); and U.S. Patent No. 8,192,356 (“the ‘356 patent”). The
`parties filed briefs and claim construction charts in accordance with the local rules of
`this District. [Doc. Nos. 109, 121, 123, 124 and related exhibits.] Luke Dauchot, Esq.,
`Alexander MacKinnon, Esq., Nimalka Wickeramasekera, Esq., and Sharre Lotfollahi,
`Esq., appeared for Warsaw. Frank Scherkenbach, Esq., Michael Kane, Esq., and John
`Lamberson, Esq., appeared for NuVasive. Having considered the submissions of the
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`parties and the arguments of counsel, the Court construes the disputed terms addressed
`at argument1 as follows.
`II. Legal Standard
`The Court construes the claim language when the parties dispute what a person
`of skill in the art would understand the term to mean. Claims are not read in a vacuum
`but in the context of the entire patent including the specification. See Phillips v. AWH
`Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). The claims, the specification
`and the prosecution history are the most significant source of the legally operative
`meaning of disputed claims language. See SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331, 1338 (Fed Cir. 2005). The words of a claim are generally given the
`ordinary and customary meaning that a person of ordinary skill would have applied at
`the time of the invention. Phillips, 415 F.3d at 1313.
`III.
`The ‘535 and ‘782 Patents
`The ‘535 patent and ‘782 patent [Doc. Nos. 102-5 and 102-4, respectively] are
`directed at a method and system for performing surgical procedures involving the use
`of neurophysiology. [Doc. No. 102-5, Col. 1:22-26.] They share a common
`specification. The invention of the ‘535 patent claims methods for creating a working
`corridor through the patient’s psoas muscle to insert a spinal implant while monitoring
`the relationship between the surgical instruments and the patient’s nerves to avoid
`damaging nerves during the procedure. The fundamental method steps of the invention
`include: (a) stimulating one or more electrodes provided on a surgical accessory; (b)
`measuring the response of nerves innervated by the stimulation of step (a); (c)
`determining a relationship between the surgical accessory and the nerve based upon the
`response measured in step (b); and communicating this relationship to the surgeon in
`an easy-to-interpret fashion. [Id., Col. 3:27-34.] The invention of the ‘782 patent
`
`1 At the hearing counsel represented that the parties had reached agreement as to the
`construction of certain terms of these patents previously submitted as disputed. Any terms not
`addressed in this order are therefore deemed withdrawn from the Court’s consideration without
`prejudice to a request for construction upon a showing of good cause.
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`claims a surgical system for creating and using the corridor while monitoring the
`relationship between the instruments and the patient’s nerves. The system is capable
`of performing one or more of the following functions: (1) determination of nerve
`proximity and/or nerve direction relative to the sequential dilation access system during
`and following the creation of an operative corridor to surgical target site; (2) assessment
`of pedicle integrity after hole formation and/or after pedicle screw placement via the
`pedicle testing assembly; and/or (3) assessment of nerve pathology (health or status)
`before, during, and/or after a surgical procedure via the nerve root retraction assembly.
`[Doc. No. 102-4, Col. 10:49-59.]
`A.
`The ‘535 Patent Constructions for Claim 1
`The terms and phrases of the ‘535 patent’s only independent claim, Claim 1, set
`forth in bold italics, are presented by the parties for construction. These constructions
`apply to the asserted dependent claims (Claims 3, 11 and 12), as well.
`
`Claim 1. A method of inserting a spinal implant through a trans-psoas
`operative corridor to an intervertebral disc, comprising:
`mounting a plurality of EMG electrodes proximate to selected leg
`muscles;
`activating a control unit operable to provide a stimulation signal and
`including a graphical user interface to receive user input and to display
`neuromuscular response information in response to signals from the EMG
`electrodes;
`inserting an initial dilator cannula in a trans-psoas path through
`bodily tissue toward a lateral aspect of a spine while an elongate
`stimulation instrument is disposed within an inner lumen of the initial
`dilator cannula;
`activating the elongate stimulation instrument to deliver the
`stimulation signal proximate to a distal end of the initial dilator cannula
`when the initial dilator cannula is inserted into the trans-psoas path
`toward the spine;
`monitoring the neuromuscular response information displayed by
`the control unit in response to delivery of the stimulation signal when the
`initial dilator cannula is inserted into the trans-psoas path toward the spine;
`advancing two or more sequential dilator cannulas of increasing
`diameter in the trans-psoas path toward the spine,
`advancing a working corridor instrument over the two or more
`sequential dilator cannulas in the trans-psoas path toward the spine;
`establishing a trans-psoas operative corridor to an intervertebral disc
`of the spine using the working corridor instrument; and
`delivering a spinal fusion implant through the trans-psoas operative
`corridor toward the spine.
`[Doc. No. 102-5, Col. 27:21-51.]
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`Case 3:12-cv-02738-CAB-MDD Document 157 Filed 01/09/14 PageID.5584 Page 4 of 14
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`1. initial dilator cannula
`Based on a plain reading of the claim language the initial dilator cannula is the
`first tube inserted to expand an opening or passage through bodily tissue. This is not
`disputed. Warsaw however contends that this claim element must be interpreted in
`conjunction with the later step of advancing two or more sequential dilator cannulas of
`increasing diameter, such that the initial dilator should be construed to be the first tube
`in a series that includes the later claimed sequential tubes of increasing diameter.
`The patent specification suggests the claimed invention encompasses a variety
`of systems for accomplishing the method steps, [Doc. No. 102-5, Col. 5:4-52], however
`the only method claimed is specific to the use of a sequential dilation access system that
`employs an initial dilator cannula, two or more sequential dilator cannulas and a
`working corridor instrument to accomplish the steps of establishing the trans-psoas
`operative corridor. [Id., Col. 27:21-51.]
`The specification identifies Figs. 16-19 as the illustration of “the sequential
`dilation access system 34 of the present invention in use creating an operative corridor.”
`[Id., Col. 19:62-67; Col. 18:52-57 (emphasis added)]. By referring to the disclosed
`system as the system of the present invention used to accomplish certain steps of the
`claimed method, and claiming and disclosing no other system to achieve these steps,
`Warsaw argues the patent is limited to the disclosed embodiment.
`In the specification, the initial dilator cannula 48 is shown as part of a series of
`cannulae of increasing diameter and the specification instructs that the cannulae of
`increasing diameter are guided over the previously installed cannula, illustrated in Fig.
`17. [Id., Col. 20:31-35.] Once the working cannula 50 is in place, the sequential
`cannulae may be removed to establish the working corridor. [Id., Col. 20:43-47.]
`Warsaw contends that this description, identified as “the system of the present
`invention,” dictates that the initial dilator cannula be construed as part of the sequential
`dilation access system and further requires that in use, the two or more sequential
`dilator cannulas be advanced over the initial dilator cannula. This is the sequential
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`Case 3:12-cv-02738-CAB-MDD Document 157 Filed 01/09/14 PageID.5585 Page 5 of 14
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`dilation access system described in the specification as “the system of the present
`invention” and the language of Claim 1 is limited to the use of a sequential dilation
`access system.
`The Court agrees that the claim itself limits the method to the use of a sequential
`dilation access system, the specification discloses the sequential dilation access system
`of the invention, and in that disclosed system the two or more sequential dilator
`cannulas are advanced over the initial dilator cannula. No other sequential dilation
`access system is disclosed. The Court therefore construes the initial dilator cannula to
`be the first tube in a series of sequential tubes of increasing diameter.
`
`2.
`
`when the initial dilator cannula is inserted into the trans-psoas path
`toward the spine
`This phrase defines the method step of when the elongate stimulation instrument,
`disposed within the initial dilator cannula, is activated to deliver a stimulation signal.
`Based on the plain language of the claim, in the context of the entire claim and the
`specification, the Court construes this phrase as the continuous or selective delivery of
`the stimulation signal while the initial cannula is advanced from the point of insertion
`into the patient through the psoas muscle to the target spinal area. [Id., Col. 20:18-20
`(the electrode may be stimulated continuously or step-wise).]
`B.
`The ‘535 Patent Construction for Claim 11
`The following term of Claim 11, set forth in bold italics, was presented by the
`parties for construction.2
`
`Claim 11. A method of claim 10, wherein the numeric stimulation
`threshold current level, displayed by the control unit indicates an
`amplitude of the stimulation current pulses that evokes an EMG response
`having an amplitude value greater than a predetermined voltage value.
`[Id., Col. 28:39-43.]
`numeric stimulation threshold current level
`1.
`
`2 At the claim construction hearing the parties withdrew this term to allow them to further meet
`and confer on a joint construction. Supplemental briefs regarding the unresolved issues were
`submitted by each party on December 9, 2013 [Doc. Nos. 147 and 149] for the Court’s consideration.
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`This element of Claim 11 is introduced in Claim 10. Claim 10 recites, “The
`method of claim 8, wherein the stimulation signal delivered by the elongate stimulation
`instrument comprises stimulation current pulses, and the neuromuscular response
`information displayed by the control unit comprises a numeric stimulation threshold
`current level.” [Id., Col. 28:34-38 (emphasis added).] The specification identifies the
`threshold current stimulation as that current stimulation that evokes a significant EMG
`response, which is understood to be a voltage value determined by the user to be
`significant.
`
`A basic premise behind the neurophysiology employed in the present
`invention is that each nerve has a characteristic threshold current level (I
`thresh) at which it will depolarize. Below this threshold, current
`stimulation will not evoke a significant EMG response (V pp). Once the
`stimulation threshold (I thresh) is reached, the evoked response is
`reproducible and increases with increasing stimulation until saturation is
`reached.
`
`[Id., Col. 13:25-32.]
`The method claimed in the ‘535 patent includes a control unit that displays
`neuromuscular response information in response to signals from EMG electrodes
`mounted proximate to a patient’s selected leg muscles. The displayed neuromuscular
`response information is generated in response to the delivery of a stimulation signal
`from an elongate stimulation instrument that is inserted in the patient. [Id., Col. 27,
`Claim 1.] The neuromuscular response information indicates at least nerve proximity
`or direction relative to the elongate stimulation instrument. [Id., Col. 28, Claim 8.] The
`stimulation signal delivered by the elongate instrument comprises stimulation current
`pulses, and the displayed neuromuscular response information generated by the current
`pulses comprises a numeric stimulation threshold current value. [Id., Col. 28, Claim
`10.] The threshold value is the stimulation current level that evokes depolarization of
`the nerve such that it generates a significant EMG response from the leg muscles. The
`specification does not identify the threshold value as the minimum current level that
`evokes any EMG response, but rather that value that evokes a significant response.
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`Claim 11 specifically requires that the amplitude of the current pulses evoking the EMG
`response be greater than a predetermined voltage value.
`The threshold value of the stimulation current is that which evokes a significant
`voltage value (EMG response). For Claim 11, that voltage value is predetermined and
`the stimulation current has an amplitude greater than the predetermined voltage value.
`The Court construes numeric stimulation threshold current level as a numeric value
`indicating the stimulation current required to elicit a significant EMG response, which
`is further defined in Claim 11 to be a value greater than a predetermined voltage value.
`C.
`The ‘782 Patent Constructions
`The terms and phrases of the independent claims of the ‘782 patent [Doc. No.
`102-4], set forth in bold italics, are presented by the parties for construction. These
`constructions apply to the asserted dependent claims as well.
`Claim 1. A surgical system for neural monitoring while forming an
`operative corridor in a trans-psoas approach to a spine, comprising:
`a sequential dilation access system comprising a plurality of dilating
`cannulas to form a trans-psoas corridor between a skin surface and a
`targeted spine site, the plurality of dilating cannulas comprising an outer
`dilating cannula fitting over another of the dilating cannulas when
`advanced in a trans-psoas path toward the targeted spine site,
`wherein a stimulation electrode is positioned on at least one of the
`dilating cannulas to deliver a stimulation signal for nerve monitoring
`proximate to a distal end of the dilating cannula when advanced in the
`trans-psoas path, the stimulation electrode being arranged in a fixed
`position relative to a longitudinal axis of the at least one dilating cannula
`such that the stimulation electrode rotates with the at least one dilating
`cannula when the at least one dilating cannula is rotated about the
`longitudinal axis;
`a working corridor instrument that is slidable over the outer dilating
`cannula to form a trans-psoas operative corridor to the targeted spine
`site.
`* * *
`Claim 9. A system for forming a path to a spinal target site via a trans-
`psoas approach, comprising:
`a dilating cannula having longitudinal axis, a distal end, a proximal
`end, and a length such that said proximal end extends beyond a skin
`surface when said distal end is positioned adjacent to said spinal target
`site via a trans-psoas approach to said spinal target site, said dilator
`being insulated along the entire length with the exception of at least one
`exposed electrical contact at said proximal end and an exposed stimulation
`electrode at said distal end, said stimulation electrode being exposed along
`only a radial portion of said distal end, said dilating cannula further
`including a reference mark viewable when said distal end of said dilating
`cannula is located between said skin surface and said spinal target site and
`indicative of the radial position of said exposed stimulating electrode;
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`a stimulation clip having a first end attachable to said proximal end
`of said dilating cannula and a cable for establishing electrical
`communication between said stimulation clip and an electrical stimulator,
`said first end establishing electrical communication between said at least
`one electrical contact of said dilating cannula and said stimulation clip
`when said stimulation clip is attached to said dilating cannula.
`* * *
`Claim 20. The surgical system of claim 18, wherein the neuromuscular
`response data displayed comprises a numeric stimulation threshold
`current level that indicates an amplitude of the stimulation current pulses
`required to evoke a neuromuscular response having an amplitude value
`greater than a predetermined value.
`[Id., Col. 27:25-Co1. 30:3.]
`
`1.
`
`to form a trans-psoas corridor between a skin surface and a
`targeted spine site: when advanced in a trans-psoas path toward
`the targeted spine site: when advanced in the trans-psoas path: to
`form a trans-psoas operative corridor to the targeted spine site;
`when said distal end is positioned adjacent to said spinal target site
`via a trans-psoas approach to said spinal target site.
`The matter raised with regard to these limitations of Claim 1 and Claim 9: “to
`form a trans-psoas corridor;” “when advanced in a trans-psoas path;” and “when said
`distal end is positioned,” is not a question of ambiguity as to the meaning that requires
`construction, but whether these limitations should be construed as method steps
`incorporated in a system claim. Warsaw contends these claims are indefinite because
`these limitations require a user of the system to perform certain acts. A single patent
`claim covering both apparatus and method of using that apparatus is invalid for
`indefiniteness. 35 U.S.C. §112(2). IPXL Holdings, LLC v. Amazon.com, Inc., 430 F.3d
`1377, 1384 (Fed. Cir. 2005). In IPXL Holdings, the court found a dependent claim of
`the patent invalid as indefinite because it recited the claimed system and included the
`limitation of “the user uses the input means” of the claimed system. The court held it
`was therefore “unclear whether infringement of claim 25 occurs when one creates a
`system ... or whether infringement occurs when the user actually uses the input
`means....” Id.
`In this case, the claim limitations Warsaw contends are method steps are
`functional limitations of the claimed systems. The disclosed systems have a very
`specific function and the phrases Warsaw challenges define and limit the claimed
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`function, but the claim language does not include the steps of a user forming, advancing
`or positioning the apparatus. The phrases highlighted by Warsaw cannot be
`distinguished from other phrases that limit the scope of the claimed apparatus, such as
`in Claim 1, “when the at least one dilating cannula is rotated about the longitudinal
`axis,” or in Claim 9, “when said distal end of said dilating cannula is located between
`said skin surface and said spinal target site,” or “when said stimulation clip is attached
`to said dilating cannula.” Warsaw does not contend these functional limitations are
`method steps. These limitations are not discernible from the limitations Warsaw argues
`require a user to perform certain actions. The Court finds that Warsaw has not
`demonstrated that these claims should be invalidated as indefinite.
`a radial portion of said distal end
`2.
`Claim 9 includes the limitation of an exposed stimulation electrode located at the
`distal end of a dilating cannula, exposed along only a radial portion of said distal end.
`The parties dispute the meaning of a radial portion of the distal end of the dilating
`cannula. Warsaw seeks to limit this phrase to the structure disclosed in the patent at
`figure 16, which depicts a dilating cannula with a tapered distal end and the electrode
`positioned at an angle relative to the longitudinal axis of the cannula. Dependent Claim
`10, however, describes this limitation and would be rendered superfluous if Claim 9 is
`interpreted to require a cannula structure that is tapered with the electrode located on
`the angle portion.
`The plain language of Claim 9 does not limit the dilating cannula to the figure
`disclosed in the patent. Unlike Claim 1, which is limited to a system employing “a
`sequential dilation access system” and therefore similar to Claim 1 of the ‘535 patent,
`discussed above, Claim 9 is not so narrow. Claim 9 only requires a dilating cannula
`with an exposed stimulation electrode at the distal end. There is no limitation in the
`claim as to the shape of the distal end of the cannula and in the context of the patent, the
`radial portion is interpreted to be a segment of the circumference at the distal end of the
`cannula.
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` a numeric stimulation threshold current level
`3.
`For the reasons set forth above in the discussion of the ‘535 patent, the Court
`construes numeric stimulation threshold current level as a numeric value indicating the
`stimulation current required to elicit a significant EMG response. In the context of
`Claim 20, this value is further limited to a value greater than a predetermined value.
`IV. The ‘767 Patent
`The ‘767 patent [Doc. No. 102-6] is directed at a method of accessing a surgical
`target site using tissue distraction and retraction assemblies and detecting the existence
`of neural structures before, during and after the establishment of an operating corridor.
`[Id., Col. 2:64-Col. 3:15.] Although the specification indicates the invention relates
`generally to systems and methods for performing any number of surgical procedures
`[Id., Col. 1:34-37; Col. 2:4-9], the patent claims only a method of accessing the lumbar
`spine along a lateral, trans-psoas path to insert an implant in the lumbar spine. The
`terms and phrases of the ‘767 patent’s only independent claim, Claim 1, set forth in
`bold italics, are presented by the parties for construction.
`Claim 1. A method of accessing a surgical target site, comprising:
`forming an initial distraction corridor using an elongate stimulation
`instrument that is delivered to a lateral aspect of a targeted spinal disc
`along a lateral, trans-psoas path to the lumbar spine while a stimulation
`electrode of the elongate stimulation instrument outputs an electrical
`stimulation signal from a distal tip portion for nerve monitoring during
`delivery of the elongate stimulation instrument along the lateral, trans-
`psoas path to the lumbar spine;
`activating a nerve monitoring system that controls the electrical
`stimulation signal output from the stimulation electrode of the elongate
`stimulation instrument during delivery of the elongate stimulation
`instrument along the lateral, trans-psoas path to the lumbar spine, the
`nerve monitoring system detecting electromyographic (EMG) activity via
`a set of EMG sensor electrodes in communication with muscle myotomes
`associated with nerves in the vicinity of the targeted spinal disc;
`receiving nerve monitoring information from a video display device
`of the nerve monitoring system that contemporaneously displays: a
`numeric stimulation threshold required to obtain the EMG activity in at
`least one of said leg muscle myotomes, and a graphical representation of
`a patient, wherein the video display device is operable to alert a user of at
`least one of a presence and absence of a nerve near the elongate
`stimulation instrument;
`positioning an inner wire member in a disc annulus at the lateral
`aspect of the targeted spinal disc, the inner wire member being slidably
`disposed within a tubular distraction member of the elongate stimulation
`instrument such that a distal tip of the inner wire member is inserted along
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`Case 3:12-cv-02738-CAB-MDD Document 157 Filed 01/09/14 PageID.5591 Page 11 of 14
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`the lateral, trans-psoas path and penetrates into the disc annulus at the
`lateral aspect of the targeted spinal disc;
`after forming the initial distraction corridor using the elongate
`stimulation instrument, advancing a plurality of sequential dilators to
`further dilate tissue along the lateral, trans-psoas path to the lumbar spine
`while the inner wire member remains engaged with the disc annulus at the
`lateral aspect of the targeted spinal disc;
`slidably advancing a plurality of retractor blades of a retractor
`assembly simultaneously over an outer dilator of the plurality of sequential
`dilators and toward the targeted spinal disc along the lateral, trans-psoas
`path to the lumbar spine, the retractor assembly including the plurality of
`retractor blades and a handle assembly having pivotable arm portions that
`extend generally perpendicularly relative to the plurality of retractor
`blades, wherein the plurality of retractor blades are simultaneously
`advanced over the outer dilator while in a closed position, wherein the
`retractor blades are operable to adjust to an open position by rotation of a
`rotatable knob element of the handle assembly that mates with teeth of a
`rack member so as to move a first retractor blade relative to a second
`retractor blade of the plurality of retractor blades, wherein each of the
`pivotable arm portions is arranged between the plurality of retractor blades
`and the rotatable knob element and is pivotable so as to reposition one arm
`portion relative to another;
`removing the plurality of sequential dilators away from the retractor
`assembly so that the plurality of retractor blades form a lateral operative
`corridor to the lateral aspect of the targeted spinal disc along the lateral,
`trans-psoas path to the lumber spine, and
`removably engaging a fixation element with the first retractor blade
`of the plurality of retractor blades so that a distal portion of the fixation
`element extends from a distal end of the first retractor blade and secures
`into a portion of the lumbar spine; and
`inserting an implant through the lateral operative corridor formed
`by the plurality of retractor blades along the lateral, trans-psoas path to the
`lumber spine.
`[Doc. No. 102-6, Col. 12:63-Col. 14:3.]
`
`A.
`
`during delivery of the elongate stimulation instrument along the lateral,
`trans-psoas path to the lumbar spine
`This phrase defines the method step of when the elongate stimulation instrument
`outputs an electrical stimulation signal from the distal tip portion for nerve monitoring.
`Based on the plain language of the claim, in the context of the entire claim and the
`specification, the Court construes this phrase as the selective emission of the stimulation
`signal while the elongate stimulation instrument is advanced from the point of insertion
`into the patient through the psoas muscle to the lumbar spine. [Id., Col. 6:31-35 (by
`applying a stimulation signal to such instruments and monitoring the evoked EMG
`signals from the myotomes associated with the nerves being passed by the distraction
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`Case 3:12-cv-02738-CAB-MDD Document 157 Filed 01/09/14 PageID.5592 Page 12 of 14
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`and retraction systems of the present invention); Col. 10:3-6 (a stimulation signal is
`emitted from the stimulation electrodes as the various components are advanced
`towards or maintained at or near the surgical target site); Col. 10:41-42 (selectively
`providing a stimulation signal); Col. 10:53-54 (the user may selectively initiate a
`stimulation signal).]
`B.
`a numeric stimulation threshold
`The specification makes only one reference to the stimulation threshold current
`[Id., Col. 11:67] as information displayed on the nerve monitoring system. The parties
`have agreed it is a numeric value, and in the instance of this claim it is defined as that
`numeric value required to obtain EMG activity in at least one of a patient’s leg muscle
`myotomes. No further construction is needed.
`in a closed position
`C.
`The claimed retractor assembly has a plurality of blades that are advanced over
`the sequential dilators to the targeted spinal disc to form the lateral operative corridor.
`These plurality of blades are in a closed position, i.e., not retracting tissue, while they
`are moved into position. Claim 1 does not require that the closed position of the blades
`be in any particular structure, only that the blades are inserted in a non-retracting
`formation. Warsaw contends the closed position should be construed as “with the
`retractor blades in generally abutting relation to one another.” This particular formation
`of the closed position, however, is claimed in dependent Claim 13.
`Claim 13. The method of claim 11, wherein the plurality of retractor
`blades are simultaneously advanced over the outer dilator while in a closed
`position, each of the plurality of retractor blades is in abutting relation
`with a respective adjacent retractor blade of the plurality of retractor
`blades.
`Requiring the closed position in Claim 1 to be limited to a position in which the blades
`are in abutting relation to one another would render Claim 13 superfluous. Claim 1 is
`therefore not construed so narrowly and the phrase in a closed position is construed as
`in a non-retracting formation.
`V. The ‘356 Patent
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`The ‘356 patent [Doc. No. 102-7] is directed at a system for accessing a surgical
`target site using tissue distraction and retraction assemblies and detecting the existence
`of neural structures before, during and after the establishment of an operating corridor.
`[Id., Col. 1:32-25; Col. 2:62- Col.3:6.] As with the ‘767 patent, although the
`specification indicates the invention relates generally to systems and methods for
`performing any number of surgical procedures, the patent claims only a system for
`accessing the lumbar spine along a lateral, trans-psoas path to deliver an implant to the
`lumbar spine. The terms and phrases of the ‘356 patent, set forth in bold italics, are
`presented by the parties for construction.
`Claim 21. A system for accessing a spinal disc of a lumbar spine through
`an operative corridor, comprising:
`a distraction assembly to create a tissue distraction corridor to a
`lumbar spine, wherein said distraction assembly comprises: an elongate
`penetration member deliverable to a spinal disc along a lateral, trans-psoas
`path to the lumbar spine such that a distal tip region of the elongate
`penetration member penetrates into an annulus of a spinal disc in the
`lumbar spine, and at least two dilators of sequentially larger diameter
`deliverable to the spinal disc along the lateral, trans-psoas path to the
`lumbar spine, a first dilator of the at least two dilators having a lumen
`configured to slidably receive the elongate penetration member, at least
`one of said at least two dilators including a stimulation electrode to deliver
`electrical stimulation for nerve monitoring when said stimulation
`electrode is positioned in the lateral, trans-psoas path to the lumbar
`spine, and
`a retraction assembly comprising a plurality of retractor blades that
`enlarge the tissue distraction