NuVasive, Inc. v. Alphatec Holdings, Inc.

Decision Date31 August 2021
Docket NumberCase No.: 3:18-CV-347-CAB-MDD
Citation557 F.Supp.3d 1069
Parties NUVASIVE, INC., Plaintiff, v. ALPHATEC HOLDINGS, INC. et al., Defendants.
CourtU.S. District Court — Southern District of California

Andrew Ross Graben, Pro Hac Vice, Hilgers Graben PLLC, Dallas, TX, James Bub Windle, Pro Hac Vice, Michael T. Hilgers, Pro Hac Vice, Trenton D. Tanner, Pro Hac Vice, Hilgers Graben PLLC, Lincoln, NE, Morris Fodeman, Pro Hac Vice, Wilson Sonsini Goodrich & Rosati, New York, NY, Paul D. Tripodi, Akin Gump Strauss Hauer & Feld LLP, Irvine, CA, Christiana Garrett, Christina Elizabeth Dashe, Natalie Jordana Morgan, Rhyea Malik, Wendy Lynn Devine, Wilson Sonsini Goodrich & Rosati, P.C., San Diego, CA, Erik Carlson, Wilson Sonsini Goodrich & Rosati, Los Angeles, CA, Sara L. Tolbert, Wilson Sonsin Goodrich and Rosati, Palo Alto, CA, for Plaintiff.

Brian J. Nisbet, Pro Hac Vice, Saranya Raghavan, Pro Hac Vice, Winston & Strawn LLP, George C. Lombardi, Pro Hac Vice, Winston & Strawn/Chicago, Chicago, IL, Corinne Stone Hockman, Pro Hac Vice, Winston & Strawn/Chicago, Houston, TX, David P. Dalke, Nimalka R. Wickramasekera, William M. Wardlaw, Shilpa Ananth Coorg, Lev Tsukerman, Winston & Strawn LLP, Los Angeles, CA, for Defendants Alphatec Holdings, Inc., Alphatec Spine, Inc.

ORDER ON MOTIONS FOR SUMMARY JUDGMENT

Cathy Ann Bencivengo, United States District Judge

Before the Court are the partiesmotions for summary judgment of certain claims and defenses relating to United States Patent Nos. 8,361,156 and 8,187,334. Plaintiff NuVasive moves for judgment: (1) that Defendants Alphatec Holdings, Inc. and Alphatec Spine, Inc.’s (jointly, "Alphatec") accused devices – the Battalion Lateral Spacers, the Transcend LIF PEEK Spacer, and the Titec Coated LLIF Implants – infringe the asserted claims of the ‘156 patent and the ‘334 patent ; (2) that these two patents are entitled to the priority filing date of March 29, 2004 of a related U.S. provisional patent application, No. 60/557,536: and (3) for dismissal of Alphatec's invalidity defense of indefiniteness. [Doc. No. 303.]

Alphatec argues that the motions should be denied because there are disputed material facts regarding both the alleged infringement of their accused devices and whether NuVasive's 2004 provisional application provides a sufficient description of later claimed subject matter to reasonably convey that the inventor had possession of that subject matter as of the 2004 filing date. Alphatec also filed its own motion requesting a judgment of invalidity of both patents based on the indefiniteness of three claim terms. [Doc. No. 304.]

I. Legal Standard

The familiar standard for summary judgment applies to these motions. Where there is no genuine issue as to any material fact and the movant is entitled to judgment as a matter of law, summary judgment should be granted. Fed. R. Civ. P. 56(a). The nonmoving party must come forward with specific facts showing there is a genuine issue for trial. Fed. R. Civ. P. 56(e). "Where the record taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no ‘genuine issue for trial.’ " Matsushita Elec. Indus. Co. v. Zenith Radio Corp. , 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). It is not for the Court, however, to weigh the evidence presented and determine the truth of the matter. Instead, the Court must assess only whether there is sufficient evidence favoring the non-moving party, with reasonable inferences drawn in the non-movant's favor, such that a jury could return a verdict for that party. Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 249, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).1

II. Infringement of the ‘156 Patent and ‘334 Patent

"Patent infringement, whether literal or by equivalence, is an issue of fact, which the patentee must prove by a preponderance of the evidence." Siemens Med. Sols. USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc. , 637 F.3d 1269, 1279 (Fed. Cir. 2011). To establish literal infringement of an asserted claim, NuVasive must demonstrate that every limitation recited in the claim is found in the accused devices.2 Akzo Nobel Coatings, Inc. v. Dow Chemical Co. , 811 F.3d 1334, 1341 (Fed. Cir. 2016). NuVasive argues that there are no material disputes that the accused Alphatec devices meet all the limitations of the asserted claims.3

Alphatec asserts several factual disputes challenging whether the accused implants meet all the limitations of the asserted claims. NuVasive argues that Alphatec's positions are factually incorrect. NuVasive may ultimately be right, but that is for a jury, not the Court, to decide. NuVasive's motion for summary judgment of infringement of the '154 patent and the ‘334 patent is therefore DENIED .

III. Priority Date

The ‘156 patent and ‘334 patent are continuations of U.S. Patent No. 7,918,891 with a filing date of March 29, 2005. Alphatec asserts an affirmative defense of on-sale bar, alleging commercial embodiments of the ‘891 patent were sold more than a year before the filing date of the ‘891 patent. 35 U.S.C.§ 102(b) (pre-AIA). NuVasive challenges Alphatec's evidence of prior invalidating sales.4 NuVasive also seeks to establish a claim of priority to an earlier provisional application, No. 60/557,536, filed on March 29, 2004.

NuVasive bears the burden of proving by a preponderance of the evidence that the written description of the 2004 application supports and enables the claim limitations of the ‘891 patent. See Speedfit LLC v. Woodway USA, Inc. , 432 F. Supp. 3d 183, 208 (E.D.N.Y. 2020) ("[O]nce an accused infringer ‘has established a prima facie case of invalidity and its burden is met,’ the patentee bears the burden of coming forward with evidence to prove entitlement to claim priority to an earlier filing date.") (quoting PowerOasis, Inc. v. T-Mobile USA, Inc. , 522 F.3d 1299, 1305 (Fed. Cir. 2008) ). To satisfy this burden, NuVasive must demonstrate that the 2004 application itself "describe[s] an invention ... in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought." Trading Techs. Int'l, Inc. v. eSpeed, Inc. , 595 F.3d 1340, 1359 (Fed. Cir. 2010) (quoting Lockwood v. Am. Airlines , 107 F.3d 1565, 1572 (Fed. Cir. 1997) ). "In other words, the specification of the provisional [application] must ‘contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms,’ 35 U.S.C. § 112 ¶ 1, to enable an ordinarily skilled artisan to practice the invention claimed in the non-provisional application." Dynamic Drinkware, LLC v. Nat'l Graphics, Inc. , 800 F.3d 1375, 1378 (Fed. Cir. 2015) (quoting New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co. , 298 F.3d 1290, 1294 (Fed. Cir. 2002) (emphases in original)); see also Star Sci., Inc. v. R.J. Reynolds Tobacco Co. , 655 F.3d 1364, 1371 (Fed. Cir. 2011) ("Consistent with 35 U.S.C. § 112 ¶ 1, the written description of the provisional application must enable one of ordinary skill in the art to practice the invention claimed in the non-provisional application.").

Whether the 2004 application discloses all the limitations of the ‘891 patent (and therefore the ‘156 patent and ‘334 patent ) is contested by the experts. Further, NuVasive offers nothing in its motion on this issue to explain the significance (or lack thereof) of the addition of new material and multiple new figures to the application for the ‘891 patent, that disclose and describe the later claimed radiopaque marker limitation. Again, the Court will not weigh the competing opinions of the experts and determine which is more credible. These are factual disputes for a jury to decide.

NuVasive's motion for summary judgment of the 2004 priority filing date for the '154 patent and the ‘334 patent is therefore DENIED .

IV. Affirmative Defense of Indefiniteness

A patent is presumed valid and the burden of establishing the invalidity of a patent or any claim thereof is on the party asserting such invalidity by clear and convincing evidence. 35 U.S.C. § 282 ; Microsoft Corp. v. I4I Ltd. P'ship , 564 U.S. 91, 97, 131 S.Ct. 2238, 180 L.Ed.2d 131 (2011) (holding that invalidity defenses must be proved by clear and convincing evidence). The patent's specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 35 U.S.C. § 112. Section 112, ¶ 2 requires that "a patent's claim language, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty." Nautilus, Inc. v. Biosig Instruments, Inc. , 572 U.S. 898, 134 S. Ct. 2120, 2129, 189 L.Ed.2d 37 (2014).

The parties agree with the Patent Trial and Appeal Board that a person of ordinary skill in the art regarding these patents is someone with a medical degree with two or three years of experience performing procedures using interbody spinal fusion

implants. NuVasive represents that its designated expert, Dr. Jim Youssef, is a person of ordinary skill in the art regarding the ‘156 patent and the ‘334 patent. [Doc. No. 332, Hrg. Transcript at 9, 14.]

Based on the intrinsic evidence and the testimony of Dr. Youssef as a person of ordinary skill, Alphatec argues that the asserted claims of the ‘156 patent and the ‘334 patent fail to meet the statutory requirement of definiteness.

A. The Scope of "Proximate to Said Medial Plane" is Not Reasonably Certain.

The ‘156 patent is directed at a spinal fusion

implant with certain features, including radiopaque markers positioned in the implant to be readily observable under X-ray or fluoroscopy such that a surgeon may track the progress of the implant during implantation and/or determine the placement of the implant after implantation. [Doc. No. 110-38, at Col. 6:49-56.] The location of certain of these...

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