Nuvasive, Inc. v. Alphatec Holdings, Inc.

Opinion

1 2 3 4 5 6 7 10 11 NUVASIVE, INC., Case No.: 3:18-CV-347-CAB-MDD

12 Plaintiff, ORDER RE NUVASIVE’S MOTION 13 v. FOR PARTIAL SUMMARY JUDGMENT 14 ALPHATEC HOLDINGS, INC. et al.,

15 Defendants. [Doc. No. 250] 16 17 18 19 20 This is a patent infringement case in which NuVasive, Inc. (“NuVasive”) asserts that 21 Alphatec Holdings, Inc. (“Alphatec”) infringes seven of NuVasive’s United States 22 patents.1 Discovery has concluded, and NuVasive now moves for summary adjudication 23 of infringement of three of the asserted patents, U.S. Patent No. 8,439,832; U.S. Patent No. 24 8,355,780; and U.S. Patent 8,753,270.2 Additionally, NuVasive moves for summary 25 26 27 1 U.S. Patent No. 7,819,801; U.S. Patent No. 8,355,780; U.S. Patent No. 8,439,832; U.S. Patent No. 9,833,227; U.S. Patent No. 8,753,270; U.S. Patent No. 9,924,859; and U.S. Patent No. 9,974,531. 28 1 adjudication of the validity of all seven of the asserted patents. Finally, NuVasive moves 2 for summary adjudication of Alphatec’s inequitable conduct affirmative defense. [Doc. 3 No. 250.] Alphatec opposed. [Doc. No. 260.] NuVasive filed a reply. [Doc. No. 262.] 4 The Court held oral argument on March 13, 2020. Having considered the submissions of 5 the parties and the arguments of counsel, the motion is GRANTED IN PART and DENIED 7 The patents-at-issue generally claim a surgical access system including a tissue 8 distraction assembly and a tissue retraction assembly, both of which may be equipped with 9 one or more electrodes for use in detecting the existence of (and optimally the distance 10 and/or direction to) neural structures before, during, and after the establishment of an 11 operative corridor to a surgical target site.3 In particular, the systems are designed for use 12 in creating an operative corridor in a lateral, trans-psoas path to the lumbar spine. 13 NuVasive accuses Alphatec’s Battalion Lateral Lumbar Spacer System (“Battalion 14 System”) of infringing various claims of the patents at issue and moves for summary 15 judgment of infringement of claims 1, 3, 9 and 10 of the ‘832 patent, claims 21, 22, 24 and 16 27 of the ‘780 patent, and claims 1, 2, 3, 6 and 12 of the ‘270 patent. 17 I. Summary Judgment of Infringement 18 Pursuant of Fed. R. Civ. P. 56(a), summary judgment is appropriate when “there is 19 no genuine issue as to any material fact and the moving party is entitled to judgment as a 20 matter of law.” To prove direct infringement a patentee must establish, by a preponderance 21 of the evidence, that one or more claims of the patent read on the accused device literally 22 or under the doctrine of equivalence. See Adv. Cardiovascular Sys., Inc., v. Scimed Life 23 Sys., Inc. 261 F.3d 1329, 1336 (Fed Cir. 2001). Summary judgment for the plaintiff on the 24 issue of infringement is proper when no reasonable jury could not find that every limitation 25 recited in a properly construed claim is found in the accused device either literally or under 26 27 28 1 the doctrine of equivalents. See PC Connector Solutions LLC v. Smartdisk Corp., 406 F.3d 2 1359, 1364 (Fed. Cir. 2005). 3 Determining whether a claim has been infringed requires a two-step analysis. First 4 the claim must be properly construed to determine its scope and meaning. Second, the 5 claim as properly construed must be compared to the accused device. Id. at 1362. 6 A. The ‘832 Patent 7 The ‘832 patent is for a “Surgical Access System and Related Methods.” The system 8 is designed to establish an operative corridor through or near any of a variety of tissues 9 having neural structures which, if contacted or impinged, may result in neural impairment 10 for the patient. [Doc. No. 1-8, at Col. 2:65- Col. 3:3.] A specific intended use of the system 11 of the ‘832 patent, as set forth in claim 1, is to create an operative corridor in a lateral, 12 trans-psoas path to the lumbar spine. NuVasive alleges Alphatec’s Battalion System 13 literally infringes the following claims. 14 Claim 1. A system for forming an operating corridor to a lumber spine, comprising: 15 a distraction assembly to create a tissue distraction corridor in a lateral, trans- 16 psoas path to a lumbar spine, wherein said distraction assembly includes an 17 elongate inner element and a plurality of dilators, the plurality of dilators being configured to sequentially advance along the lateral, trans-psoas path to 18 the lumbar spine, the elongate inner element being positionable in a lumen of 19 an initial dilator of the plurality of dilators, wherein at least one instrument from the group consisting of said elongate inner element and said dilators 20 includes a stimulation electrode that outputs electrical stimulation for nerve 21 monitoring when the at least one instrument is positioned in the psoas muscle; 22 a three-bladed retractor tool slidable over an exterior of an outermost sequential dilator of the dilator system toward the targeted spinal disc along 23 the lateral, trans-psoas path, the three-bladed retractor assembly including: 24 a blade-holder assembly, and 25 a posterior-most retractor blade, a cephalad-most retractor blade, and a caudal-most retractor blade that extend from the blade-holder assembly, 26 wherein the posterior-most, cephalad-most, and caudal-most retractor blades 27 are slidably advanced over the exterior of the outermost sequential dilator while in a first position, wherein the blade-holder assembly is adjustable to 28 1 move the posterior-most, cephalad-most, and caudal-most retractor blades to a second position in which the cephalad-most and caudal-most retractor 2 blades are spaced apart from the posterior-most retractor blade to define an 3 operative corridor, 4 wherein three-bladed retractor tool is configured to define the operative corridor along the lateral, trans-psoas path to the lumbar spine in which a 5 space extending to the targeted spinal disc between the posterior-most, 6 cephalad-most, and caudal-most refractor [sic] blades is dimensioned so as to pass an implant through the operative corridor along the lateral, trans-psoas 7 path to the lumbar spine. 8 Claim 3. The system of claim 1, wherein the elongate inner member is 9 advanced along the lateral, trans-psoas path to the targeted spinal discs such that a distal tip portion of the elongate inner member penetrates into an 10 annulus of the targeted spinal disc. 11 Claim 9. The system of claim 1, further comprising a fourth retractor blade that couples with the blade-holder assembly only after the blade-holder 12 assembly moves the posterior-most, cephalad-most and caudal-most retractor 13 blades to the second position. 14 Claim 10. The system of claim 1, further comprising a fixation element to releasably engage with one of said retractor blades so that at least a portion of 15 the fixation element extends distally into the lumbar spine, wherein the 16 fixation element is configured to releasably engage with the posterior-most retractor blade after the posterior-most retractor blade is advanced along the 17 lateral, trans-psoas path to the lumbar spine. 18 [Doc. No. 1-8 at Col. 14:31- Col.15:45.] NuVasive contends that all the elements of claims 19 1, 3, 9 and 10 of the ‘832 patent are present in the Battalion System. 20 Alphatec’s Surgical Technique Guide describes the Battalion System as including: 21 (1) sequential dilators used to split and advance through the psoas muscle until flush to the 22 disc space; (2) the dilators having neuromonitoring capability; (3) a K-wire (i.e., an 23 elongate inner element) introduced through the dilators and inserted half-way into the 24 target disc; and (4) a three-blade retractor system introduced over the second dilator flush 25 with the disc space, the blades of which can be adjusted to define an operative corridor. 26 [Doc. No. 250-42.] The Squadron Retractor, as described in the surgical guide, includes 27 28 1 an intradiscal shim (i.e., fixation element) to stabilize the retractor and an optional fourth 2 blade. 3 1. Distraction Assembly Limitation 4 Alphatec contends that the Battalion System does not meet the limitations of claim 5 1 because it teaches a lateral, trans-psoas approach in which the surgeon is instructed to 6 first use blunt scissors and/or a finger to “dissect the subcutaneous tissue” to reach the 7 “retroperitoneal space” and then use a finger as a guide to insert an initial dilator to the 8 psoas muscle. [Doc. No. 250-42 at 5-7.] The initial dilator is then used to traverse the psoas 9 muscle to a position flush with the disc space. Alphatec argues that the “distraction 10 assembly” of the accused Battalion System therefore does not meet the distraction 11 assembly claim limitation as the system employs the use of scissors and/or the surgeon’s 12 finger to distract the tissues in the lateral path between the skin of the patient and the psoas 13 muscle, not just the use of sequential dilators. 14 To meet the limitations of claim 1, the distraction assembly must include sequential 15 dilators, an elongate element, and the retractor in accordance with the claim limitations. 16 “Includes” is the equivalent of “comprising” and is therefore not limiting. See Lucent 17 Technologies, Inc. v. Gateway, Inc., 525 F.3d 1200, 1214 (Fed. Cir. 2008) (“including” and 18 “comprising” have the same meaning namely, that the listed elements are essential but 19 other elements may be added). The distraction assembly of claim 1 does not preclude the 20 addition of a scissor or finger to assist in the creation of the distraction corridor, provided 21 the distraction assembly also utilizes the elongate inner element and the plurality of 22 dilators. It is undisputed that the Battalion System includes the essential elements. It is 23 also undisputed that these elements of the accused system are capable of creating a 24 distraction corridor in a lateral, trans-psoas path to the patient’s spinal target, with or 25 without the addition of the scissors or a finger to dissect the subcutaneous tissue. 26 Accordingly, the Court finds that the Battalion System meets the distraction assembly 27 limitation. 28 1 2. Electrodes That Output Electrical Stimulation Limitation 2 Alphatec also argues that the Battalion System does not meet the claim limitation of 3 “electrodes that output electrical stimulation for nerve monitoring when [. . .] positioned in 4 the psoas muscle.” [Doc. No. 1-8 at Col. 14:42-45.] Because the Battalion System does 5 not include a source of electrical stimulation, Alphatec contends the electrodes on its 6 dilators of the system do not “output electrical stimulation” as required by the claim. 7 The question, however, is whether “all of the elements of the claim are present in 8 the accused system.” Omega Patents, LLC v. CalAmp Corp., 920 F.3d 1337, 1345 (Fed. 9 Cir. 2019). “To infringe a claim that recites capability and not actual operation, an accused 10 device need only be capable of operating in the described mode.” Finjan Inc. v. Secure 11 Computing Corp., 626 F.3d 1197, 1204 (Fed. Cir. 2010). Here, claim 1 requires only that 12 the elongate inner element or at least one of the dilators have a stimulation electrode 13 capable of outputting electrical stimulation for nerve monitoring when positioned in the 14 psoas muscle. Claim 1 does not recite as an element a source for generating the electrical 15 stimulation to the electrodes. There is no dispute that the electrodes on the dilators of the 16 Battalion System are capable of outputting electrical stimulation when positioned in the 17 psoas muscle if the electrodes are connected to the “appropriate neuromonitoring 18 platform.” [Doc. No. 250-42 at 6.] Thus, the Batallion System’s lack of a neuromonitoring 19 platform does not render it non-infringing because a source of electrical stimulation is not 20 an element of Claim 1. 21 In light of the foregoing, and because Alphatec did not raise any other disputed facts, 22 NuVasive’s motion for summary judgment of infringement of ‘832 patent by the Battalion 23 System is GRANTED. 24 B. The ‘780 Patent 25 The ‘780 patent is also for a “Surgical Access System and Related Methods.” The 26 system is designed to establish an operative corridor through or near any of a variety of 27 tissues having neural structures which, if contacted or impinged, may result in neural 28 impairment for the patient. [Doc. No. 1-6, at Col. 2:65- Col. 3:4.] A specific intended use 1 of the system of the ‘780 patent, as set forth in claim 21, is to create an operative corridor 2 in a lateral, trans-psoas path to the lumbar spine. NuVasive alleges Alphatec’s Battalion 3 System literally infringes the following claims. 4 Claim 21. A system for forming an operating corridor to a lumber spine, comprising: 5 a dilator system to create a distraction corridor along a lateral, trans-psoas path 6 to a lumbar spine, wherein said dilator system comprises at least two dilators 7 of sequentially larger widths deliverable to a spinal disc along the lateral, trans-psoas path to the lumbar spine, a second dilator of said at least two 8 dilators being slidably engageable with an exterior of the first of said at least 9 two dilators, at least one of the first and second dilators including a stimulation electrode to deliver electrical stimulation for nerve monitoring when the 10 stimulation electrode is positioned along the lateral, trans-psoas path to the 11 lumbar spine; 12 a three-bladed retractor assembly slidable over the dilator system toward the spinal disc along the lateral, trans-psoas path, the three-bladed retractor 13 assembly including: 14 a blade holder assembly and first, second and third retractor blades that extend generally perpendicularly relative to arm members of the blade holder 15 assembly, 16 wherein the three-bladed retractor assembly is adjustable from a first position 17 in which the first, second and third retractor blades are adjacent to one another and slidable over the dilator system to a second position in which the second 18 and third retractor blades are moved away from the first retractor blade to 19 enlarge the distraction corridor and thereby form an operative corridor along the lateral, trans-psoas path to the lumbar spine, 20 wherein the first retractor blade is linearly movable relative to the second 21 and third retractor blades in response to rotation of a knob element on the 22 blade holder assembly, 23 wherein the second refractor [sic] blade is movable relative to the first blade in response to pivoting movement of the first pivotable arm member of said 24 arm members which is coupled to the second retractor blade, and wherein the 25 third retractor blade is movable relative to the first blade in response to pivoting movement of the second pivotable arm member of said arm members 26 which is coupled to the third retractor blade; and 27 wherein when the three-bladed retractor assembly is adjusted to the second position to form the operative corridor along the lateral, trans-psoas path to 28 1 the lumbar spine, the first retractor blade is a posterior-most retractor blade of the first, second, and third retractor blades and the operative corridor is 2 dimensioned so as to pass an implant through the operative corridor and into 3 the lumbar spine. 4 Claim 22. The system of claim 21, wherein when the three-bladed retractor assembly is adjusted to the second position to form the operative corridor, the 5 first retractor blade is the posterior-most retractor blade, the second blade is a 6 cephalad-most retractor blade, and the third blade is a caudal-most retractor blade. 7 Claim 24. The system of claim 21, wherein said arm members of the blade 8 holder assembly further comprise a translating arm member coupled to the 9 first retractor blade, wherein the rotation of the knob element of the blade holder assembly causes the translating arm member to linearly adjust a 10 position of the first retractor blade relative to the second and third retractor 11 blades. Claim 27. The system of claim 21, further comprising an elongate member 12 deliverable to a spinal disc along a lateral, trans-psoas path to the lumbar spine 13 such that a distal tip region of the elongate member is configured to penetrate into an annulus of the spinal disc, said first dilator being configured to slidably 14 engage an exterior of the elongate member. 15 [Doc. No. 1-6, at Col. 15:3- Col.16:36.] 16 As discussed supra, the Battalion System includes: (1) sequential dilators used to 17 split and advance through the psoas muscle until flush to the disc space; (2) the dilators 18 having neuromonitoring capability; (3) a K-wire introduced through the dilators and 19 inserted half-way into the target disc; and (4) a three-blade retractor system introduced over 20 the second dilator flush with the disc space, the blades of which can be adjusted to define 21 an operative corridor. NuVasive contends that all the elements of claims 21, 22, 24 and 27 22 are present in the Battalion System. 23 1. Distraction Assembly and Electrode Stimulation Limitations 24 In its opposition Alphatec raises the some of the same arguments for non- 25 infringement of this patent that it made with respect to the ‘832 patent: (1) the Battalion 26 System does not create a distraction corridor with only the use of dilators and therefore 27 does not meet the claim’s dilator system limitation; and (2) it does not include a source of 28 1 electrical stimulation so it does not “deliver electrical stimulation for nerve monitoring 2 when the stimulation electrode is positioned along the lateral, trans-psoas path to the 3 lumbar spine.” For the reasons discussed supra regarding the ‘832 patent, these arguments 4 do not preclude a finding of infringement of the ‘780 patent. 5 2. Slidably Engageable Limitation 6 Alphatec additionally contends that NuVasive has not demonstrated that the 7 Battalion System meets the ‘780 patent’s claim limitation of “a second dilator of said at 8 least two dilators being slidably engageable with an exterior of the first of said at least two 9 dilators.” The Court previously construed “slideably engageable” as “slides to contact.” 10 [Doc. No. 167.] In the Battalion System a secondary dilator is advanced over an initial 11 dilator’s exterior in a clockwise, counter-clockwise motion. [Doc No. 250-42 at 9.] 12 Although Alphatec does not dispute that the secondary dilator of the Alphatec 13 system is advanced by sliding it over the initial dilator, Alphatec contends that the dilators 14 do not contact one another. Alphatec asserts that the dilators are designed to have a gap or 15 clearance such that they are easily slideable and that NuVasive has not demonstrated that 16 the secondary dilator sufficiently contacts the exterior of the initial dilator to meet the claim 17 limitation. Although the Court finds Alphatec’s argument weak, it is for a jury to resolve 18 the factual dispute as to whether the circumferential differences between the sequential 19 dilators of the Battalion System result in contact between the interior of the secondary 20 dilator and the exterior of the initial dilator as the secondary dilator is slidably advanced 21 over the initial dilator. 22 3. Pivoting Movement Limitation 23 Alphatec also challenges NuVasive’s assertion that the Squadron Retractor of the 24 Battalion System meets the claim limitation requiring that the arm members of the retractor 25 assembly move in a pivoting manner – the retractor blade “is movable… in response to 26 pivoting movement of the… pivotable arm member.” [Doc. No. 1-6 at Col. 15:37-39.] 27 The Squadron Retractor has three arm members to which the retractor blades are attached. 28 The retractor blades are positioned to slide over the dilator and then the arm members are 1 adjusted to move two of the blades away from the third to form the operative corridor. 2 [Doc. No. 250-42 at 16.] Alphatec contends that although the arm members of the 3 Squadron Retractor move away from each other, the movement is not a “pivoting 4 movement.” 5 The Court was not asked to construe “pivoting movement” at the claim construction 6 hearing. “Pivoting movement,” although used in claim 21, does not appear in the body of 7 the specification of the ‘780 patent. NuVasive contends it has a plain and ordinary meaning 8 and requires no further explanation. Alphatec references PCT application WO 9 2006/042241, related to the ‘780 patent, which describes in the summary of the invention 10 that the cephalad-most and/or caudal-most blade may pivot or “rotate outward from a 11 central axis of insertion” such that the operative corridor may be further expanded. [Doc. 12 No. 260-11 at 9.] This definition of “pivoting movement”—to rotate outward or turn away 13 from a central axis of insertion—is adopted by the Court. 14 The evidence presented, including a demonstration at the oral argument of the 15 operation of the Squadron Retractor, establishes that the retractor arms to which the blades 16 are affixed, once the blades are inserted into the distraction corridor, are operable to move 17 outward from that insertion point to expand the distraction corridor into an operative 18 corridor. The parties dispute whether the movement of the retractor arms of the accused 19 device meets the pivot limitation, i.e., whether they a rotate or turn away from the central 20 axis of insertion. This material factual dispute must be resolved by a jury. 21 In light of the foregoing, NuVasive’s motion for summary adjudication of 22 infringement of claim 21 is DENIED. Because claims 22, 24 and 27 depend from claim 23 21, summary adjudication of infringement of those claims is also DENIED. 24 C. The ‘270 Patent 25 The ‘270 patent is also for a “Surgical Access System and Related Methods.” The 26 system is designed to establish an operative corridor through or near any of a variety of 27 tissues having neural structures which, if contacted or impinged, may result in neural 28 impairment for the patient. [Doc. No. 1-12 at Col. 3:1-6.] The claims of the ‘270 patent 1 are specifically directed at a shim device designed to augment the structural stability of the 2 retractor blades. [Id. at Col. 4:56-62.] NuVasive alleges the Battalion System’s intradiscal 3 shim literally infringes the following claims. 4 Claim 1. A spinal shim device configured to releasably attach to spinal access retractor blade and to penetrate into a spinal disc space for anchoring the 5 spinal access retractor blade to the disc space, the shim device comprising: 6 a proximal portion configured to releasably attach to a spinal access 7 refractor [sic] blade, a distal extension configured to extend distally of the spinal access retractor blade and penetrate into a disc space between two 8 adjacent vertebrae, and a maximum longitudinal length extending from a 9 proximal-most end of the proximal portion to a distal-most end of the distal extension and extending parallel to a longitudinal axis of the shim device, 10 wherein the maximum longitudinal length of shim device is less than a 11 maximum longitudinal length of the spinal access retractor blade to which the proximal portion is configured to releasably attach; 12 the distal extension including: a tapered tip region, and a maximum lateral 13 width of the distal extension located proximally away from the distal-most 14 end; the proximal portion having a proximal lateral width that is greater than the 15 maximum lateral width of the distal extension, the proximal portion defining 16 a forward surface portion, and the proximal portion including a rearwardly extending ridge structure to releasably engage with a corresponding groove 17 along an interior face of the spinal access refractor [sic] blade when the 18 proximal portion releasably attaches to the spinal access retractor blade, the ridge structure having a length extending parallel to the longitudinal axis of 19 the shim device and being bisected by a longitudinal plane passing through 20 the longitudinal axis of the shim device. 21 Claim 2. The spinal shim device of claim 1, wherein the proximal lateral width of the proximal portion is defined between opposing lateral sides of the 22 proximal portion, the rearwardly extending ridge structure being centered 23 between the opposing lateral sides of the proximal portion. 24 Claim 3. The spinal shim device of claim 2, wherein the length of the rearwardly extending ridge structure is greater than a lateral width of the ridge 25 structure and greater than a rearwardly extending thickness of the ridge 26 structure. 27 Claim 6. The spinal shim device of claim 1, wherein the distal extension includes a distal lateral width that is generally consistent along a portion of 28 1 the distal extension that is adjacent to the tapered tip region, the distal lateral width being the maximum lateral width of the distal extension. Claim 12. The spinal shim device of claim 1, wherein a maximum lateral 3 width of the proximal portion extends in a lateral plane that extends 4 perpendicularly to the longitudinal axis and passes through the ridge structure. 5 ||[Doc. No. 1-12, at Col. 14:30 — Col. 16:21.] 6 The intradiscal shim of the Battalion System has a rearward extending structure that 7 ||releasably engages with a corresponding groove on the interior face of a retractor blade. g || [Doc. No. 250-42 at 20; Doc. No. 253-7 at 2.] The parties dispute whether that structure g ||meets the claim limitation of a rearwardly extending ridge structure having “a length 10 extending parallel to the longitudinal axis of the shim device.” [Doc. No. 1-12 at 14:57- 11 12 NuVasive contends that claim 1 does not require the rearward extending ridge 13 || Structure to have a specific length of parallel extension along the longitudinal axis, and that 14 || therefore the structure identified by Alphatec meets the limitation. Moreover, NuVasive 15 |}contends that the rearward extending structure of the Alphatec shim is not limited, as 16 || Alphatec asserts, to the portion that engages into the retractor blade groove. As highlighted 17 yellow below, NuVasive contends that the rearward extending ridge structure of the 18 Alphatec shim includes the entire portion of the shim that extends rearward from the 19 || Surface portion, thereby having a length extending parallel to the longitudinal axis of the 29 || Shim device. [Doc. No. 253-7 at 2, highlighting added. | 21 09 (4) 209 73 Ze EDEL LBL OT 7 Pp =a 5 24 |, ro GY sa(e) 25 15/4 26.8520.05¢ 5 ) 26 SECTION A-A 27 28

1 Alphatec contends that the structure of its shim that engages with a corresponding 2 || groove in the retractor is not a parallel extension from the shim device. The releasable 3 ||structure of the shim is only that portion that extends perpendicularly from the surface 4 || portion as highlighted in yellow below. [Id., highlighting added. ] 5 _— of 7 ees A OP AD fe MI! PF penne anon? foe

SECTION A-A

12 || Therefore, according to Alphatec, the intradiscal shim of the Battalion System does not 13 || meet the claim limitation. 14 The Court finds a material factual dispute at to whether the accused device meets all 15 || the limitations of claim 1. NuVasive’s motion for summary adjudication of infringement 16 of claim 1 and its dependent claims 2, 3, 6 and 12 is DENIED. 7 II. Summary Adjudication of Invalidity Defenses 18 Each claim of a patent is presumed valid. 35 U.S.C. § 282. The party challenging 19 ||the validity of a patent claim must prove invalidity by clear and convincing evidence. 0 Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 108-09 (2011). A patent claim is invalid 91 obvious if the differences between the claimed invention and the prior art are such that 02 the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed 94 vention pertains. 35 U.S.C. § 103. 5 NuVasive moves for summary adjudication that Alphatec’s invalidity challenges 6 against all seven patents at issue fail as a matter of law to establish invalidity based on 97 || obviousness by clear and convincing evidence. To prevail on its motion, NuVasive must 28 establish that Alphatec, “who bears the burden of proof at trial, failed to produce clear and

1 convincing evidence on an essential element of a defense upon which a reasonable jury 2 could invalidate the patent.” Eli Lilly & Co. v. Barr Labs, Inc., 251 F.3d 955, 962-63 (Fed. 3 Cir 2001). 4 As to each asserted patent, NuVasive contends that Alphatec’s evidence of 5 obviousness, provided by Dr. Charles Branch, is insufficient and relies only upon his 6 conclusory and unsupported opinions that a person of skill in the art would be motivated 7 to combine the various prior art references he puts forth. Alphatec’s opposition however 8 is persuasive that its evidence challenging the validity of the patent claims at issue is 9 sufficient for a reasonable jury to conclude the patents are obvious. NuVasive has not 10 demonstrated that Alphatec’s invalidity defenses fail as a matter of law. The motion for 11 summary adjudication of the validity of the patents at issue, or more accurately an 12 adjudication dismissing Alphatec’s affirmative defenses of invalidity as to each patent, is 14 III. Summary Adjudication of the Inequitable Conduct Defense 15 NuVasive moves for summary adjudication of Alphatec’s affirmative defense of 16 inequitable conduct during the prosecution of the ‘227, ‘531, ‘832 and ’859 patents. The 17 Court finds many material facts in dispute regarding this defense. Further, because it is an 18 equitable defense for the Court’s determination, it will be bifurcated from the jury trial and 19 heard separately as a bench trial at the conclusion of the jury case. The motion is therefore 21 IV. Conclusion 22 For the reasons stated above and on the record at the hearing on this motion, 23 NuVasive’s motion for summary adjudication is: 24 1. GRANTED as to infringement of the ‘832 Patent; 25 2. DENIED as to infringement of the ‘780 Patent; 26 3. DENIED as to infringement of the ‘270 Patent; 27 4. DENIED as to Alphatec’s invalidity defenses; and 28 1 5. DENIED as to Alphatec’s inequitable conduct defense. 2 It is SO ORDERED. 3 ||Dated: April 10, 2020 € Z 4 Hon. Cathy Ann Bencivengo 5 United States District Judge 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28