Nuvasive, Inc. v. Alphatec Holdings, Inc.

S.D. California

Nuvasive, Inc. v. Alphatec Holdings, Inc.

DecidedAugust 31, 2021

Docket3:18-cv-00347

StatusUnknown

This text of Nuvasive, Inc. v. Alphatec Holdings, Inc. (Nuvasive, Inc. v. Alphatec Holdings, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Nuvasive, Inc. v. Alphatec Holdings, Inc., (S.D. Cal. 2021).

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Opinion

1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 NUVASIVE, INC., Case No.: 3:18-CV-347-CAB-MDD

12 Plaintiff, ORDER ON MOTIONS FOR SUMMARY JUDGMENT 13 v. [Doc. Nos. 303, 304] 14 ALPHATEC HOLDINGS, INC. et al., 15 Defendants. 16 17 18 Before the Court are the parties’ motions for summary judgment of certain claims 19 and defenses relating to United States Patent Nos. 8,361,156 and 8,187,334. Plaintiff 20 NuVasive moves for judgment: (1) that Defendants Alphatec Holdings, Inc. and Alphatec 21 Spine, Inc.’s (jointly, “Alphatec”) accused devices – the Battalion Lateral Spacers, the 22 Transcend LIF PEEK Spacer, and the Titec Coated LLIF Implants – infringe the asserted 23 claims of the ‘156 patent and the ‘334 patent; (2) that these two patents are entitled to the 24 priority filing date of March 29, 2004 of a related U.S. provisional patent application, No. 25 60/557,536: and (3) for dismissal of Alphatec’s invalidity defense of indefiniteness. [Doc. 26 No. 303.] 27 Alphatec argues that the motions should be denied because there are disputed 28 material facts regarding both the alleged infringement of their accused devices and whether 1 NuVasive’s 2004 provisional application provides a sufficient description of later claimed 2 subject matter to reasonably convey that the inventor had possession of that subject matter 3 as of the 2004 filing date. Alphatec also filed its own motion requesting a judgment of 4 invalidity of both patents based on the indefiniteness of three claim terms. [Doc. No. 304.] 5 I. Legal Standard 6 The familiar standard for summary judgment applies to these motions. Where there 7 is no genuine issue as to any material fact and the movant is entitled to judgment as a matter 8 of law, summary judgment should be granted. Fed. R. Civ. P. 56(a). The nonmoving party 9 must come forward with specific facts showing there is a genuine issue for trial. Fed. R. 10 Civ. P. 56(e). “Where the record taken as a whole could not lead a rational trier of fact to 11 find for the non-moving party, there is no ‘genuine issue for trial.’” Matsushita Elec. Indus. 12 Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). It is not for the Court, however, to 13 weigh the evidence presented and determine the truth of the matter. Instead, the Court 14 must assess only whether there is sufficient evidence favoring the non-moving party, with 15 reasonable inferences drawn in the non-movant’s favor, such that a jury could return a 16 verdict for that party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).1 17 II. Infringement of the ‘156 Patent and ‘334 Patent 18 “Patent infringement, whether literal or by equivalence, is an issue of fact, which the 19 patentee must prove by a preponderance of the evidence.” Siemens Med. Sols. USA, Inc. 20 v. Saint-Gobain Ceramics & Plastics, Inc., 637 F.3d 1269, 1279 (Fed. Cir. 2011). To 21 establish literal infringement of an asserted claim, NuVasive must demonstrate that every 22 limitation recited in the claim is found in the accused devices.2 Akzo Nobel Coatings, Inc. 23 v. Dow Chemical Co., 811 F3d 1334, 1341 (Fed. Cir. 2016). NuVasive argues that there 24

25 26 1 NuVasive’s objections to declarations Alphatec submitted in support of its opposition to NuVasive’s summary judgment motion [Doc. No. 331, at 8] are denied. 27 2 NuVasive’s motion does not make an infringement claim based on the doctrine of equivalents, so the Court considers the sufficiency of Alphatec’s evidence of a material dispute as to whether all the claim 28 1 are no material disputes that the accused Alphatec devices meet all the limitations of the 2 asserted claims.3 3 Alphatec asserts several factual disputes challenging whether the accused implants 4 meet all the limitations of the asserted claims. NuVasive argues that Alphatec’s positions 5 are factually incorrect. NuVasive may ultimately be right, but that is for a jury, not the 6 Court, to decide. NuVasive’s motion for summary judgment of infringement of the ‘154 7 patent and the ‘334 patent is therefore DENIED. 8 III. Priority Date 9 The ‘156 patent and ‘334 patent are continuations of U.S. Patent No. 7,918,891 with 10 a filing date of March 29, 2005. Alphatec asserts an affirmative defense of on-sale bar, 11 alleging commercial embodiments of the ‘891 patent were sold more than a year before the 12 filing date of the ‘891 patent. 35 U.S.C.§ 102(b) (pre-AIA). NuVasive challenges 13 Alphatec’s evidence of prior invalidating sales.4 NuVasive also seeks to establish a claim 14 of priority to an earlier provisional application, No. 60/557,536, filed on March 29, 2004. 15 NuVasive bears the burden of proving by a preponderance of the evidence that the 16 written description of the 2004 application supports and enables the claim limitations of 17 the ‘891 patent. See Speedfit LLC v. Woodway USA, Inc., 432 F. Supp. 3d 183, 208 18 (E.D.N.Y. 2020) (“[O]nce an accused infringer ‘has established a prima facie case of 19 invalidity and its burden is met,’ the patentee bears the burden of coming forward with 20 evidence to prove entitlement to claim priority to an earlier filing date.”) (quoting 21 22 23 3 Alphatec’s opposition to NuVasive’s motion for summary judgment of infringement contends in part that the motion must be denied because it broadly represents that all of Alphatec’s implants infringe the 24 asserted claims without distinguishing Alphatec’s devices that clearly do not meet certain dimensional 25 limitations of the claims. NuVasive however clarified its infringement assertion in its reply submission with a comprehensive list of the implants accused on a claim-by-claim basis. [Doc. No. 311-13.] 26 4 NuVasive’s Motion to Exclude the portion of Alphatec’s expert report regarding NuVasive’s sales that could constitute an on-sale bar [Doc. No. 302-1, at 5] was withdrawn at argument based on subsequently 27 considered evidence. [Doc. No. 332, Hrg. Transcript at 61.] The remainder of NuVasive’s motion to strike expert testimony [Doc. No. 302] was DENIED at the hearing for the reasons stated on the record. 28 1 PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008)). To satisfy 2 this burden, NuVasive must demonstrate that the 2004 application itself “describe[s] an 3 invention ... in sufficient detail that one skilled in the art can clearly conclude that the 4 inventor invented the claimed invention as of the filing date sought.” Trading Techs. Int'l, 5 Inc. v. eSpeed, Inc., 595 F.3d 1340, 1359 (Fed. Cir. 2010) (quoting Lockwood v. Am. 6 Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997)). “In other words, the specification of the 7 provisional [application] must ‘contain a written description of the invention and the 8 manner and process of making and using it, in such full, clear, concise, and exact terms,’ 9 35 U.S.C. § 112 ¶ 1, to enable an ordinarily skilled artisan to practice the invention claimed 10 in the non-provisional application.” Dynamic Drinkware, LLC v.

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1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 NUVASIVE, INC., Case No.: 3:18-CV-347-CAB-MDD

12 Plaintiff, ORDER ON MOTIONS FOR SUMMARY JUDGMENT 13 v. [Doc. Nos. 303, 304] 14 ALPHATEC HOLDINGS, INC. et al., 15 Defendants. 16 17 18 Before the Court are the parties’ motions for summary judgment of certain claims 19 and defenses relating to United States Patent Nos. 8,361,156 and 8,187,334. Plaintiff 20 NuVasive moves for judgment: (1) that Defendants Alphatec Holdings, Inc. and Alphatec 21 Spine, Inc.’s (jointly, “Alphatec”) accused devices – the Battalion Lateral Spacers, the 22 Transcend LIF PEEK Spacer, and the Titec Coated LLIF Implants – infringe the asserted 23 claims of the ‘156 patent and the ‘334 patent; (2) that these two patents are entitled to the 24 priority filing date of March 29, 2004 of a related U.S. provisional patent application, No. 25 60/557,536: and (3) for dismissal of Alphatec’s invalidity defense of indefiniteness. [Doc. 26 No. 303.] 27 Alphatec argues that the motions should be denied because there are disputed 28 material facts regarding both the alleged infringement of their accused devices and whether 1 NuVasive’s 2004 provisional application provides a sufficient description of later claimed 2 subject matter to reasonably convey that the inventor had possession of that subject matter 3 as of the 2004 filing date. Alphatec also filed its own motion requesting a judgment of 4 invalidity of both patents based on the indefiniteness of three claim terms. [Doc. No. 304.] 5 I. Legal Standard 6 The familiar standard for summary judgment applies to these motions. Where there 7 is no genuine issue as to any material fact and the movant is entitled to judgment as a matter 8 of law, summary judgment should be granted. Fed. R. Civ. P. 56(a). The nonmoving party 9 must come forward with specific facts showing there is a genuine issue for trial. Fed. R. 10 Civ. P. 56(e). “Where the record taken as a whole could not lead a rational trier of fact to 11 find for the non-moving party, there is no ‘genuine issue for trial.’” Matsushita Elec. Indus. 12 Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). It is not for the Court, however, to 13 weigh the evidence presented and determine the truth of the matter. Instead, the Court 14 must assess only whether there is sufficient evidence favoring the non-moving party, with 15 reasonable inferences drawn in the non-movant’s favor, such that a jury could return a 16 verdict for that party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).1 17 II. Infringement of the ‘156 Patent and ‘334 Patent 18 “Patent infringement, whether literal or by equivalence, is an issue of fact, which the 19 patentee must prove by a preponderance of the evidence.” Siemens Med. Sols. USA, Inc. 20 v. Saint-Gobain Ceramics & Plastics, Inc., 637 F.3d 1269, 1279 (Fed. Cir. 2011). To 21 establish literal infringement of an asserted claim, NuVasive must demonstrate that every 22 limitation recited in the claim is found in the accused devices.2 Akzo Nobel Coatings, Inc. 23 v. Dow Chemical Co., 811 F3d 1334, 1341 (Fed. Cir. 2016). NuVasive argues that there 24

25 26 1 NuVasive’s objections to declarations Alphatec submitted in support of its opposition to NuVasive’s summary judgment motion [Doc. No. 331, at 8] are denied. 27 2 NuVasive’s motion does not make an infringement claim based on the doctrine of equivalents, so the Court considers the sufficiency of Alphatec’s evidence of a material dispute as to whether all the claim 28 1 are no material disputes that the accused Alphatec devices meet all the limitations of the 2 asserted claims.3 3 Alphatec asserts several factual disputes challenging whether the accused implants 4 meet all the limitations of the asserted claims. NuVasive argues that Alphatec’s positions 5 are factually incorrect. NuVasive may ultimately be right, but that is for a jury, not the 6 Court, to decide. NuVasive’s motion for summary judgment of infringement of the ‘154 7 patent and the ‘334 patent is therefore DENIED. 8 III. Priority Date 9 The ‘156 patent and ‘334 patent are continuations of U.S. Patent No. 7,918,891 with 10 a filing date of March 29, 2005. Alphatec asserts an affirmative defense of on-sale bar, 11 alleging commercial embodiments of the ‘891 patent were sold more than a year before the 12 filing date of the ‘891 patent. 35 U.S.C.§ 102(b) (pre-AIA). NuVasive challenges 13 Alphatec’s evidence of prior invalidating sales.4 NuVasive also seeks to establish a claim 14 of priority to an earlier provisional application, No. 60/557,536, filed on March 29, 2004. 15 NuVasive bears the burden of proving by a preponderance of the evidence that the 16 written description of the 2004 application supports and enables the claim limitations of 17 the ‘891 patent. See Speedfit LLC v. Woodway USA, Inc., 432 F. Supp. 3d 183, 208 18 (E.D.N.Y. 2020) (“[O]nce an accused infringer ‘has established a prima facie case of 19 invalidity and its burden is met,’ the patentee bears the burden of coming forward with 20 evidence to prove entitlement to claim priority to an earlier filing date.”) (quoting 21 22 23 3 Alphatec’s opposition to NuVasive’s motion for summary judgment of infringement contends in part that the motion must be denied because it broadly represents that all of Alphatec’s implants infringe the 24 asserted claims without distinguishing Alphatec’s devices that clearly do not meet certain dimensional 25 limitations of the claims. NuVasive however clarified its infringement assertion in its reply submission with a comprehensive list of the implants accused on a claim-by-claim basis. [Doc. No. 311-13.] 26 4 NuVasive’s Motion to Exclude the portion of Alphatec’s expert report regarding NuVasive’s sales that could constitute an on-sale bar [Doc. No. 302-1, at 5] was withdrawn at argument based on subsequently 27 considered evidence. [Doc. No. 332, Hrg. Transcript at 61.] The remainder of NuVasive’s motion to strike expert testimony [Doc. No. 302] was DENIED at the hearing for the reasons stated on the record. 28 1 PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008)). To satisfy 2 this burden, NuVasive must demonstrate that the 2004 application itself “describe[s] an 3 invention ... in sufficient detail that one skilled in the art can clearly conclude that the 4 inventor invented the claimed invention as of the filing date sought.” Trading Techs. Int'l, 5 Inc. v. eSpeed, Inc., 595 F.3d 1340, 1359 (Fed. Cir. 2010) (quoting Lockwood v. Am. 6 Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997)). “In other words, the specification of the 7 provisional [application] must ‘contain a written description of the invention and the 8 manner and process of making and using it, in such full, clear, concise, and exact terms,’ 9 35 U.S.C. § 112 ¶ 1, to enable an ordinarily skilled artisan to practice the invention claimed 10 in the non-provisional application.” Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 11 F.3d 1375, 1378 (Fed. Cir. 2015) (quoting New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 12 298 F.3d 1290, 1294 (Fed. Cir. 2002) (emphases in original)); see also Star Sci., Inc. v. 13 R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1371 (Fed. Cir. 2011) (“Consistent with 35 14 U.S.C. § 112 ¶ 1, the written description of the provisional application must enable one of 15 ordinary skill in the art to practice the invention claimed in the non-provisional 16 application.”). 17 Whether the 2004 application discloses all the limitations of the ‘891 patent (and 18 therefore the ‘156 patent and ‘334 patent) is contested by the experts. Further, NuVasive 19 offers nothing in its motion on this issue to explain the significance (or lack thereof) of the 20 addition of new material and multiple new figures to the application for the ‘891 patent, 21 that disclose and describe the later claimed radiopaque marker limitation. Again, the Court 22 will not weigh the competing opinions of the experts and determine which is more credible. 23 These are factual disputes for a jury to decide. 24 NuVasive’s motion for summary judgment of the 2004 priority filing date for the 25 ‘154 patent and the ‘334 patent is therefore DENIED. 26 IV. Affirmative Defense of Indefiniteness 27 A patent is presumed valid and the burden of establishing the invalidity of a patent 28 or any claim thereof is on the party asserting such invalidity by clear and convincing 1 evidence. 35 U.S.C. § 282; Microsoft Corp. v. I4I Ltd. P’ship, 564 U.S. 91, 97 (2011) 2 (holding that invalidity defenses must be proved by clear and convincing evidence). The 3 patent’s specification shall conclude with one or more claims particularly pointing out and 4 distinctly claiming the subject matter which the applicant regards as his invention. 35 5 U.S.C. §112. Section 112, ¶ 2 requires that “a patent’s claim language, viewed in light of 6 the specification and prosecution history, inform those skilled in the art about the scope of 7 the invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 8 U.S. 898, 134 S. Ct. 2120, 2129 (2014). 9 The parties agree with the Patent Trial and Appeal Board that a person of ordinary 10 skill in the art regarding these patents is someone with a medical degree with two or three 11 years of experience performing procedures using interbody spinal fusion implants. 12 NuVasive represents that its designated expert, Dr. Jim Youssef, is a person of ordinary 13 skill in the art regarding the ‘156 patent and the ‘334 patent. [Doc. No. 332, Hrg. Transcript 14 at 9, 14.] 15 Based on the intrinsic evidence and the testimony of Dr. Youssef as a person of 16 ordinary skill, Alphatec argues that the asserted claims of the ‘156 patent and the ‘334 17 patent fail to meet the statutory requirement of definiteness. 18 A. The Scope of “Proximate to Said Medial Plane” is Not Reasonably 19 Certain. 20 The ‘156 patent is directed at a spinal fusion implant with certain features, including 21 radiopaque markers positioned in the implant to be readily observable under X-ray or 22 fluoroscopy such that a surgeon may track the progress of the implant during implantation 23 and/or determine the placement of the implant after implantation. [Doc. No. 110-38, at 24 Col. 6:49-56.] The location of certain of these radiopaque markers is set forth in the claims. 25 Claim 1 of the ‘156 patent claims: 26 A spinal fusion implant of non-bone construction positionable within an interbody space between a first vertebra and a second vertebra, said implant 27 comprising: 28 1 an upper surface including anti-migration elements to contact said first vertebra when said implant is positioned within the interbody space, a lower 2 surface including anti-migration elements to contact said second vertebra 3 when said implant is positioned within the interbody space, a distal wall, a proximal wall, a first sidewall, and a second sidewall generally opposite from 4 the first sidewall, wherein said distal wall, proximal wall, first sidewall, and 5 second sidewall comprise a radiolucent material; wherein said implant has a longitudinal length extending from a proximal 6 end of said proximal wall to a distal end of said distal wall, said implant has a 7 maximum lateral width extending from said first sidewall to said second sidewall along a medial plane that is generally perpendicular to said 8 longitudinal length, and said longitudinal length is greater than said maximum 9 lateral width; at least a first fusion aperture extending through said upper surface and 10 lower surface and configured to permit bone growth between the first vertebra 11 and the second vertebra when said implant is positioned within the interbody space, said first fusion aperture having: a longitudinal aperture length 12 extending generally parallel to the longitudinal length of said implant, and a 13 lateral aperture width extending between said first sidewall to said second sidewall, wherein the longitudinal aperture length is greater than the lateral 14 aperture width; and 15 at least first and second radiopaque markers oriented generally parallel to a height of the implant, where said first radiopaque marker extends into said 16 first sidewall at a position proximate to said medial plane, and second 17 radiopaque marker extends into said second sidewall at a position proximate to said medial plane. 18

19 [Id., at Col. 12:32-67.] 20 All the asserted claims of the ‘156 patent include the limitation that the first and 21 second radiopaque markers extend into the sidewalls of the implant “at a position 22 proximate to [the] medial plane.” [Id., at Col. 12:63-67.] The parties agree that the medial 23 plane is the midline of the implant and proximate is understood to mean “near.” The 24 question presented, therefore, is what a person of ordinary skill in the art would understand 25 to be the objective boundary of “near the midline.” 26 27 28 1 The specification makes no reference to “markers.” In the description of the anti- 2 || migration features of the implant, the specification discloses the option to include “spike 3 ||elements” that may be disposed in the implant in its proximal, distal and central regions.° 4 || [Id., at Col. 6:27-35.] The exemplary depictions in the patent’s figures show these spike 5 elements positioned at each end and at the midline of the implant. [See e.g., id., Fig. 3 (7), 6 and (9). | 7 id 34 7 2 \ 8 -2 £ □□ 8 8 a cr \ mn ‘sy cemengee ymnpgemapyse ) ‘y 9 NLRC REE EAE GOL FIR DR dh

Fo | hii po i □ qa bw i A en Po Ye 12 a | foe P| f cial LG PPerPrerPerperpg Vie PPEPPEPPEPPeTTeT Tey GS) | Nome UN SAA Ae / 14 j see att att tice antec bene a ES 22 ‘ eA 15 4 58 ot we | RE 16 FUG. 3 16 17 ~ 18 The specification teaches that when these anti-migration spike elements are made of 19 || radiodense materials and the implant is manufactured from a radiolucent material, the spike 20 elements will be readily observable under X-ray or fluoroscopy such that a surgeon can use 21 ||them to track the progress of the implant during implantation and/or determine the 22 placement of the implant after implantation. [/d., at Col. 2:53-Col. 3:10; 6:49-56; Col. 23 || 11:4-Col.12:11; Figs 2, 3, 20 and 21.] The limitation in claim 1 of a “radiopaque marker” 24 ||therefore corresponds to the specification’s disclosure of providing spike elements of 25 26 > The specification identifies the proximal end of the implant (22) with spike element 7 described as in 27 |! the “proximal region.” It also identifies the distal end of the implant (16) with spike element 8 described ag in the “distal region.” Spike element 9 is identified as in the implant’s “central region.” This is the extent of the discussion of “regions” of the implant in the specification. [/d., at Col. 6:27-35.] TF

1 radiodense materials incorporated into a radiolucent implant for purposes of enhancing 2 visualization of the implant by the surgeon during or after implantation. [Id., at Col. 2:53- 3 62.] Nothing further is disclosed to explain the significance or benefit of positioning the 4 spike elements at any particular location within a “region” of the implant. There is nothing 5 disclosed identifying what portion of the implant is considered to be proximate to the 6 midline. 7 Alphatec does not dispute that spike element (9) in Figs. 2, 3, 20 and 21, illustrates 8 a radiopaque marker “proximate to the medial plane,” as it appears to be at the midline of 9 the implant. However, in the absence of any intrinsic evidence in the specification and 10 prosecution history as to what area constitutes proximate to the midline, Alphatec argues 11 that the disclosure does not provide any way for a person of ordinary skill to objectively 12 determine whether a marker is proximate to, or near, the medial plane if a marker is located 13 farther away from the midline than depicted in the specification. Specifically, the patent 14 does not teach how far a marker can be moved from the midline and still be within the 15 scope of the claim. 16 Alphatec acknowledges that mathematical precision is not required, but the patent 17 must inform those skilled in the art with reasonable certainty of the scope of the claim. 18 Nautilus, Inc., 134 S.Ct. at 2129 (“The definiteness requirement mandates clarity, while 19 recognizing absolute precision is unattainable.”). It must be precise enough to afford clear 20 notice of what is claimed, thereby apprising the public of what is still open to them. Id. 21 Otherwise, there would be a “zone of uncertainty which enterprise and experimentation 22 may enter only at the risk of infringement claims.” Id. (citing Union Carbon Co. v. Binney 23 & Smith Co., 317 U.S. 228, 236 (1942)). The claims must provide objective boundaries 24 for those of skill in the art. Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370-71 25 (Fed. Cir. 2014). In this case, the specification and prosecution history provide no notice 26 of the distance at which a marker could be placed away from the midline and still be 27 proximate to the midline. 28 1 Definiteness is evaluated from the perspective of someone skilled in the relevant art. 2 Nautilus, Inc., 134 S.Ct. at 2128. Alphatec argues that the testimony of Dr. Youssef, 3 NuVasive’s expert witness, as a person of skill in this art, establishes that the patent does 4 not disclose an objective boundary for one to determine whether a marker is near the middle 5 or not. 6 Dr. Youssef testified that the practical application for the markers described in Claim 7 1 is to assist a surgeon in visualizing the location of the implant after insertion. [Doc. No. 8 304-23, at 57:1-10.] NuVasive argues that a marker positioned “proximate to the medial 9 plane” is intended to provide the surgeon with a visual mark at or near the center of the 10 implant. Dr. Youssef testified that such a marker should be “close” to the midline. 11 However, when asked how to determine what constitutes “close,” he testified that he could 12 only offer an opinion for himself. Despite being designated as a person of ordinary skill, 13 he did not feel he could comment for other surgeons as to whether a marker was close to 14 the medial plane. [Doc. No. 304-22, at 88:5-23.] 15 When asked if there is an objective standard to determine whether a marker is at a 16 position proximate to the medial plane, Dr. Youssef replied that “it’s a subjective analysis 17 using the claim language, the understanding of the claim language, the agreed-upon terms, 18 and for those terms that don’t have a construed definition, using the ordinary meaning of 19 those terms.” [Id., at 105:11-19.] He testified that he did not think that there is an objective 20 boundary. [Id., at 102:3-12.] 21 22 23 24 25 26 27 28 1 At his deposition, Dr. Youssef was shown a series of annotated images of Figure 3 2 || of the ‘156 patent. 3 4 «a

6 | L We HIM | [ “a! 7 8 “IMAGE 1 | “IMAGE □ 9 Ex. 16 (Dep. Ex. 7) Ex. 17 (Dep. Ex. 8)

10 1] 12 . tel Ta 13 | | □□ ss , 14 15 “IMAGE "IMAGE 16 Ex. 18 (Dep. Ex. 9) Ex. 19 (Dep. Ex. 10)

17 18 Image | is of Fig. 3 as shown in the specification highlighting in red the first and second radiopaque markers (9) at the midline. In the subsequent images, those markers were moved gradually away from the midline. Dr. Youssef opined that the markers depicted in Image 2 fell within the scope of the claim and the markers depicted in Image 3 22 were “pretty close” to the medial plane and therefore, in his opinion, were still proximate to the medial plane. [/d., 91:12-16; 102:18-103:25.] As to the markers depicted in Image 4, he concluded that they did not come within the scope of the claim. [/d., at 104:25-106:5.] When asked why he concluded the markers in Image 3 were within the scope of the claim but those in Image 4 were not, he testified that he came to that conclusion “because one is further from the medial plane than the other.” [/d., at 106:6-14.] In response to the follow-

1 up question, “Is there some position between the two that might be the boundary?”, he 2 replied, “I think it's subjective.” [Id., at 106:15-18.] 3 While some modicum of uncertainty is allowed, a patent must be precise enough to 4 afford clear notice of what is claimed, thereby apprising the public of what is still open to 5 them. Nautilus, 134 S.Ct. at 2128-29. Claims cannot rely on the “unpredictable vagaries of 6 any one person’s opinion.” Interval Licensing LLC, 766 F.3d at 1376. 7 When a word of degree is used, the specification must provide some standard for 8 measuring that degree that one of ordinary skill would understand. The lone example in 9 the specification depicts the markers at the midline and therefore provides no guidance as 10 to what constitutes near or close to the midline. Dr. Youssef provided no functional 11 explanation or other objective guidance to support his determination of when the distance 12 from the midline no longer constitutes near or close, just his subjective opinion. While 13 absolute precision is not required, such ambiguity and subjectivity does not provide the 14 clarity needed to inform the public as to the scope of this claim. 15 Accordingly, based on the specification and prosecution history, and as 16 acknowledged by Dr. Youssef, a person of ordinary skill in the art, the claim limitation 17 “proximate to the medial plane” is a subjective limitation that fails to inform those skilled 18 in the art about the scope of the invention with reasonable certainty. 19 Alphatec’s motion for summary judgment of invalidity of the ‘156 patent for failure 20 to meet the statutory requirement of definiteness is therefore GRANTED. 21 B. The Scope of a Central Region Positioned Generally Centrally 22 between the Proximal and Distal Walls is Disputed. 23 The ‘334 patent, which has the same specification as the ‘156 patent, is also directed 24 at a spinal fusion implant with certain features including radiopaque markers positioned in 25 the implant to be readily observable under X-ray or fluoroscopy such that a surgeon may 26 track the progress of the implant during implantation and/or determine the placement of 27 the implant after implantation. [Doc. No. 110-48, at Col. 6:49-56.] The location of certain 28 of these radiopaque markers is set forth in the claims. 1 Claim 1 of the ‘334 patent claims: 2 A spinal fusion implant of non-bone construction positionable within an interbody space between a first vertebra and a second vertebra, said implant 3 comprising: 4 an upper surface including anti-migration elements to contact said first vertebra when said implant is positioned within the interbody space, a lower 5 surface including anti-migration elements to contact said second vertebra 6 when said implant is positioned within the interbody space, a distal wall, a proximal wall, a first sidewall, and a second sidewall, said distal wall, 7 proximal wall, first sidewall, and second sidewall comprise a radiolucent 8 material; wherein said implant has a longitudinal length greater than 40 mm 9 extending from a proximal end of said proximal wall to a distal end of said 10 distal wall; wherein a central region of said implant includes portions of the first 11 and second sidewalls positioned generally centrally between the proximal 12 wall and the distal wall, at least a portion of the central region defining a maximum lateral width of said implant extending from said first sidewall 13 to said second sidewall, where said longitudinal length is at least two and 14 half times greater than said maximum lateral width; at least a first fusion aperture extending through said upper surface and 15 lower surface and configured to permit bone growth between the first vertebra 16 and the second vertebra when said implant is positioned within the interbody space, said first fusion aperture having: a longitudinal aperture length 17 extending generally parallel to the longitudinal length of said implant, and a 18 lateral aperture width extending between said first sidewall to said second sidewall, wherein the longitudinal aperture length is greater than the lateral 19 aperture width; and 20 at least three radiopaque markers; wherein a first of the at least three radiopaque markers is at least partially positioned in said distal wall, a second 21 of said at least three radiopaque markers is at least partially positioned in said 22 proximal wall, and a third of said at least three radiopaque markers is at least partially positioned in said central region. 23

24 [Id., at Col. 12:32-Col. 13:4.] 25 All the asserted claims of the ‘334 patent include the limitation that a third 26 radiopaque marker be “at least partially positioned in [the] central region” of the implant.” 27 [Id., at Col. 13:2-4.] The claim itself describes the “central region” as the portion of the 28 implant “generally centrally” between the proximal and distal walls that includes the width 1 || of the implant at its maximum width from side wall to side wall. Alphatec argues that this 2 ||claim language read in light of the specification fails to inform a person of ordinary skill 3 to an objective boundary of what area of the implant is “generally centrally” between 4 || the proximal and distal walls. 5 NuVasive disagrees, arguing that the specification teaches that a purpose of the 6 || radiopaque markers is to enhance a surgeon’s ability to visualize the position of an implant 7 || within the interbody space. In that context, NuVasive contends that a person of ordinary 8 || skill would understand that the portion of the implant that is “generally centrally” between 9 proximal and distal walls comprises that area of the implant in which the positioning 10 || of the third marker would assist the surgeon’s visualization. According to NuVasive, while 11 |/not mathematically precise, the objective boundaries of the central region are ascertainable 12 || with reasonable certainty based on the functional purpose. See Biosig Instruments, Inc. v. 13 || Nautilus, Inc., 783 F.3d 1374, 1382 (Fed. Cir. 2015) (“The degree of precision necessary 14 || for adequate claims is a function of the nature of the subject matter.”) 15 As noted supra, the patent specification identifies the proximal wall (22), distal wall 16 || (16) and sidewalls (14) of the implant. In his expert report, Dr. Youssef illustrated on an 17 ||accused device, markers that are positioned in the central region of an implant in 18 accordance with the claim language. His blue circle encompasses the markers and the 19 ||maximum lateral width of the implant and a region “‘positioned generally centrally 20 21 22 | Maximum Lateral Wickh | 23 if li aoa “aa > oe 25 fe ad 26 a 27 | Central Region | 28

1 between the proximal and distal wall’–so that’s generally center, between those two walls 2 somewhere in the center.” [Doc. No. 304-23, at 50:19-51:6; 54:4-7.] 3 In response to an inquiry at his deposition as to whether a marker placed outside this 4 blue circle would not meet the claim limitation, Dr. Youssef responded that his circle was 5 a general example. He testified that “for a marker to fall outside [the central] region, it 6 would be necessary for them to be closer to the proximal or distal walls.” [Id., at 52:5-8.] 7 [M]y blue circle is just a depiction in static. It could be moved and adjusted to still meet the limitations of the claim and still account for the central region. 8 So really to get a marker outside the boundary of the central region as defined 9 by [the claim] would be pretty tough. I think you’d have to put them closer to the proximal and distal walls to get them there. 10

11 [Id., at 54:18-25.] 12 Dr. Youssef testified that the central region, as long as it includes the maximum 13 lateral width, could be expanded to include the area to the left or the right up to either the 14 distal or proximal wall. [Id., 51:19-53:12.] The claim language allows that “the boundary 15 could be fairly substantial.” [Id., at 53:12-14.] However, he also clarified that although 16 the general central region has “a lot of real estate,” he did not consider the central region 17 to be everything between the proximal and distal walls. [Id., at 64:16-23.] 18 Dr. Youssef explained that a person of ordinary skill in the art would understand the 19 scope or breadth of the claimed central region in the context of the usefulness of the 20 placement of a third radiopaque marker. [Id., at 74-77.] In his opinion, the third marker 21 described in the claim is intended to provide a third reference point for the surgeon 22 evaluating the placement of the implant. The breadth of the central region would therefore 23 be understood in part by the positional purpose of the third marker. In other words, the 24 third marker is no longer in the central region when it is positioned too close to the first or 25 second marker of the claim limitation (which are positioned at least partially in the 26 proximal or distal walls) to be of practical usefulness as a third reference point. 27 When asked how close to the proximal and distal walls a marker would need to be 28 placed to be out of the central region, he responded, “Well, it’s hard to know. . . . I don’t 1 an answer for you. I don’t know exactly how far out but much closer to the proximal 2 || distal wall than the circle that’s shown [in his drawing].” [/d., at 55:11-14.] 3 To establish an objective boundary for the central region, that portion of the implant 4 ||“‘generally centrally” between the proximal and distal walls, Dr. Youssef was shown Figure 5 ||3 from the specification with locations marked in red for placement of the third marker. 6

a Nei pet al 10 FIG, 3 14 FIG. 3 10 FIG. 1 IMAGE 1 IMAGE 2 IMAGE 3 Ex. 16 (Dep. Ex. 7) Ex. 17 (Dep. Ex. 8) Ex. 18 (Dep. Ex. 9) 12 Ps : '

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15 os bh ~ 16 FIG. FIG. 3 FIG. IMAGE 4 IMAGE 5 IMAGE 6 17 Ex. 19 (Dep. Ex. 10) Ex. 20 (Dep. Ex. 11) Ex. 21 (Dep. Ex. 12) 18 = 19 | 20 UNA 21 22 IMAGE 7 Ex. 22 (Dep. Ex. 13) 23 24 He testified that the markers depicted in Images 1-6 were positioned within his 25 understanding of the central region — far enough from the proximal markers (7) to provide 26 a useful third reference point. [/d., at 67-78.] The markers depicted in Image 7, he testified, 27 were not within his understanding of the central region because they were too close to the 28

1 markers in the proximal wall (7) and would therefore have no practical application. [Id., at 2 79.] 3 Alphatec argues that Dr. Youssef’s opinion regarding the area of the implant that 4 constitutes the central region is subjective and lacks sufficient clarity to establish an 5 objective boundary thereby rendering the claim indefinite. NuVasive argues that a skilled 6 artisan could determine with reasonable certainty the inherent parameters of the central 7 region based the claim language and the disclosed functional purpose for the placement of 8 the third radiopaque marker. 9 There was no intrinsic evidence in the specification to aid in the determination of the 10 scope of ‘156 patent’s claim term “proximate to the medial plane.” The only extrinsic 11 evidence defining the scope was Dr. Youssef’s subjective opinion. In contrast, the claim 12 language of the ‘334 patent describes parameters for the scope of the claim term “central 13 region” and Dr. Youssef’s interpretation of those parameters is tied to the functional 14 teachings disclosed in the specification. Whether he is correct that one of ordinary skill 15 could determine with reasonable certainty the inherent parameters of the invention based 16 on these disclosures is a factual dispute. The cross-motions for summary judgment on this 17 invalidity defense for the ‘334 patent are therefore DENIED. 18 C. The Scope of Approximately 18 mm is Reasonably Certain. 19 The asserted claims of the ‘334 patent include limitations regarding the dimensions 20 of the claimed spinal fusion implant. In accordance with Claim 1, the implant must have 21 a longitudinal length greater than 40 mm from the proximal end of the proximal wall to the 22 distal end of the distal wall. Further, that longitudinal length must be at least two and half 23 times greater than the maximum lateral width. [Id., at Col. 44-46, 52-54.] 24 Dependent Claim 18 of the ‘334 patent requires: 25 The spinal fusion implant of claim 1, wherein said maximum lateral width of said implant is approximately 18 mm. 26

27 [Id., at Col. 14:11-13.] 28 1 Alphatec argues that a person of ordinary skill could not determine with reasonable 2 certainty what is encompassed by the claim limitation that the maximum lateral width of 3 the implant be approximately 18 mm. This contention was raised primarily due to Dr. 4 Youssef’s opinion that an implant with a maximum lateral width in a range of 16 mm to 5 22 mm “could fall in the scope” of approximately 18 mm as required by Claim 18. [Doc. 6 No. 304-24, at 45:18-25.] 7 The use of a term of degree in the context of this claim does not render the claim 8 indefinite. A person of ordinary skill would find “approximately” in this context of this 9 claim to encompass a modest deviation from 18 mm. The specification describes an 10 implant intended for use in lumbar fusion with dimensions ranging between 9 and 18 mm 11 in width, 8 and 16 mm in height and a length ranging between 25 and 45 mm. [Doc. No. 12 110-48, at Col. 2:17-21; Col. 5:15-19; Col. 11:58-63.] A person of ordinary skill in the art 13 would be able to reasonably ascertain from the examples in the specification that an implant 14 with a maximum width of “approximately 18 mm,” which correspondingly requires at least 15 a 45 mm length in accordance with Claim 1, is described in the specification. Allowing 16 for some modest deviation in either direction from 18 mm does not make the claim 17 indefinite. 18 The Court rejects Dr. Youssef’s assessment that the scope of “approximately 18 19 mm” includes a width up to 22 mm. His expansive inclusion of a width more than 22% 20 greater than the claim’s stated numerical width is more than a modest deviation and is 21 without any support in the specification. Finding Dr. Youssef’s opinion unsupported does 22 not require the Court to find the claim indefinite.6 23 24 25 26 27 6 The Court notes that NuVasive is not seeking to apply Dr. Youssef’s expansive interpretation of Claim 18 and has conceded that Alphatec’s accused devices that are wider than 18 mm do not come within the 28 1 NuVasive’s motion for dismissal of Alphatec’s affirmative defense of invalidity of 2 Claim 18 of the ‘334 patent for failure to meet the statutory requirement of definiteness is 3 therefore GRANTED. 4 V. Disposition 5 In light of the foregoing, it is hereby ORDERED as follows: 6 1. NuVasive’s motion for partial summary judgment is 7 a. DENIED as to the infringement of Alphatec’s Accused Devices; 8 b. DENIED as to establishing the 2004 priority filing date for the ‘154 patent 9 and the ‘334 patent; 10 c. DENIED as to dismissal of Alphatec’s affirmative defense of invalidity of 11 the ‘156 Patent; 12 d. DENIED as to dismissal of Alphatec’s affirmative defense of invalidity of 13 Claim 1 of the ‘334 Patent; 14 e. GRANTED as to dismissal of Alphatec’s affirmative defense of invalidity 15 of Claim 18 of the ‘334 Patent; 16 2. Alphatec’s motion for summary judgment is 17 a. GRANTED as to its affirmative defense of invalidity of the ‘156 Patent; 18 b. DENIED as its affirmative defense of invalidity of Claim 1 of the ‘334 19 Patent; 20 c. DENIED as to its affirmative defense of invalidity of Claim 18 of the ‘334 21 Patent. 22 23 24 25 26 27 28 1 3. A telephonic status conference will be held on September 7, 2021, at 10:00 a.m. 2 using the Court’s AT&T Teleconference connection at (888)398-2342, access 3 code: 1749358. 4 It is SO ORDERED. 5 ||Dated: August 31, 2021 € □ 6 Hon. Cathy Ann Bencivengo 7 United States District Judge 8 9 10 1] 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

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