Nuvasive, Inc. v. Alphatec Holdings, Inc.

District Court, S.D. California·Decided April 24, 2020·No. 3:18-cv-00347·Unknown

Opinion

NUVASIVE, INC., Case No.: 3:18-CV-347-CAB-MDD

Plaintiff, ORDER RE ALPHATEC’S MOTION v. FOR SUMMARY JUDGMENT

ALPHATEC HOLDINGS, INC. et al., [Doc. No. 252, 256] Defendants. This is a patent infringement case in which NuVasive asserts that Alphatec infringes seven of its United States patents.1 Discovery has concluded and Alphatec now moves for summary judgment of non-infringement of all the asserted patents, for summary judgment of the allegations of indirect infringement, for summary judgment of its invalidity defense as to the ‘832 patent and for the adjudication of NuVasive’s assignor estoppel claim. Finally, Alphatec moves for summary adjudication of NuVasive’s claim of lost profits damages. [Doc. No. 256.] NuVasive opposed. [Doc. No. 261.] Alphatec filed a reply. [Doc. No. 264.] The Court held oral argument on March 13, 2020. Having considered the

1 U.S. Patent No. 7,819,801 [Doc. No. 1-4]; U.S. Patent No. 8,355,780 [Doc. No. 1-6]; U.S. Patent No. 8,439,832 [Doc. No. 1-8]; U.S. Patent No. 9,833,227 [Doc. No. 1-10]; U.S. Patent No. 8,753,270 [Doc. No. 1-12]; U.S. Patent No. 9,924,859 [Doc. No. 110-44]; and U.S. Patent No. 9,974,531 [Doc. No. 110- submissions of the parties and the arguments of counsel, the motion is GRANTED IN PART and DENIED IN PART. The patents-at-issue generally claim a surgical access system including a tissue distraction assembly and a tissue retraction assembly, both of which may be equipped with one or more electrodes for use in detecting the existence of (and optimally the distance and/or direction to) neural structures before, during and after the establishment of an operative corridor to a surgical target site.2 In particular the systems are designed for use in creating an operative corridor in a lateral, trans-psoas path to the lumbar spine. NuVasive accuses Alphatec’s Battalion Lateral Lumbar Spacer System (“Battalion System”) of infringing various claims of the patents-at-issue. Alphatec moves for summary judgment of non-infringement of all the asserted claims. I. Summary Judgment of Non-Infringement Pursuant of Fed. R. Civ. P. 56(a), summary judgment is appropriate when “there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law.” The court must construe all facts in a light most favorable to the non- moving party and draw reasonable inferences in that party’s favor, but it should grant summary judgment where a claim is factually unsupported, or where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party. Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). To prove direct infringement a patentee must establish, by a preponderance of the evidence, that one or more claims of the patent read on the accused device literally or under the doctrine of equivalence. See Advanced Cardiovascular Sys., Inc., v. Scimed Life Sys., Inc. 261 F.3d 1329, 1336 (Fed Cir. 2001). When an accused infringer seeks summary judgment of non-infringement, “nothing more is required than the filing of a motion stating that the patentee has no evidence of infringement and pointing to the specific ways in which the accused [products do] not meet the claim limitations.” Exigent Tech. v. Atrana Solutions, Inc., 442 F.3d 1301, 1309 (Fed. Cir. 2006). Alphatec contends that its accused Battalion System does not meet all the limitations of any of the patents-at-issue. A. Dilator System/Distraction Assembly Limitation. NuVasive contends that the Battalion System infringes the system claims of four of its patents, the ‘801 patent, the ‘832 patent, the ‘780 patent, and the ‘531 patent and the method claims of the ‘832 patent and ‘227 patent. Each of these patents are for a “Surgical Access System and Related Methods.” They are directed at systems and methods designed to establish an operative corridor through or near any of a variety of tissues having neural structures which, if contacted or impinged, may result in neural impairment for the patient. [See generally Doc. No. 1-4, at Col. 2:51-54.] Each of the surgical access systems claimed in the patents-at-issue includes the claim limitation of a dilator system [Id., at Col. 13:32-34; Doc. No. 1-6, at Col. 15:5-6; and Doc. No. 110-46, at Col. 13:36-37] or a tissue distraction assembly comprising dilators [Doc. No. 1-8, at Col. 14:33-36] to create a tissue distraction corridor along a lateral trans-psoas path to the lumbar spine. The claimed dilator systems and tissue distraction assembly of each asserted patent are comprised of a plurality of sequential dilators used in the creation of the tissue distraction corridor. In the context of these patents, the use of these dilators, preferably with nerve monitoring electrodes, is disclosed as critical to traverse nerve-rich tissues, such as the psoas muscle, and avoid neural impairment. The accused system is described in Alphatec’s Surgical Technique Guide. [Doc. No. 250-42.] The system includes sequential dilators used to split and advance through the psoas muscle until flush to the disc space. Implementation of the Battalion System also instructs the surgeon to first use blunt scissors and/or a finger to “dissect the subcutaneous tissue” to reach the “retroperitoneal space” and then use a finger as a guide to insert an initial dilator to the psoas muscle. [Doc. No. 250-42, at 5-7.] The initial dilator is then used to traverse the psoas muscle to a position flush with the disc space to complete the distraction corridor to the targeted disc space. Alphatec argues that the accused Battalion System does not meet the distraction assembly or dilator system claim limitation as its system employs the use of scissors and/or the surgeon’s finger to distract the tissues in the lateral path between the skin of the patient and the psoas muscle, not just the use of sequential dilators to form the corridor. The asserted claims require a dilator system or distraction assembly that includes or comprises sequential dilators used to create the distraction corridor. “Includes” and “comprising” are equivalent, and not limiting. See Lucent Tech., Inc. v. Gateway, Inc., 525 F.3d 1200, 1214 (Fed. Cir. 2008) (“including” and “comprising” have the same meaning namely, that the listed elements are essential but other elements may be added.) The asserted claims do not preclude the addition of a scissor or finger to assist in the creation of the distraction corridor, provided the distraction assembly or dilator system also utilizes a plurality of dilators to create the corridor to the target surgical site, particularly in accordance with the patents’ disclosures to traverse nerve-rich tissue such as the psoas muscle to reach the target site. It is undisputed that the Battalion System includes the essential elements—the sequential dilators. It is also undisputed that these elements of the accused system are capable of creating a distraction corridor in a lateral trans-psoas path to the patient’s spinal target with or without the addition of the scissors or a finger to dissect the subcutaneous tissue. “It is fundamental that one cannot avoid infringement merely by adding elements if each element recited in the claim is found in the accused device.” A.D. Dick Co. v. Burrough Corp., 713 F.2d 700, 703 (Fed. Cir. 1983). Alphatec’s motion for summary judgment of non-infringement of the system claims of ‘801 patent, the ‘780 patent, the ‘832 p

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Nuvasive, Inc. v. Alphatec Holdings, Inc., (S.D. Cal. 2020).

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