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`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF CALIFORNIA
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`NUVASIVE, INC.,
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`v.
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`Plaintiff,
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`ALPHATEC HOLDINGS, INC., and
`ALPHATEC SPINE, INC.,
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`Defendants.
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`
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` Case No.: 18-CV-347-CAB-MDD
`
`ORDER RE MOTION TO DISMISS
`COUNTS VII AND VIII
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`
`[Doc. No. 20]
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`
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`Defendants Alphatec Holdings, Inc., and Alphatec Spine, Inc. (together, “Alphatec”)
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`have filed a motion to dismiss the seventh and eighth claims in the Plaintiff NuVasive,
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`Inc.’s complaint for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).
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`The motion as been fully briefed and the Court deems it suitable for submission without
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`oral argument. For the following reasons, the motion is granted.
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`I.
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`Allegations in the Complaint
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`NuVasive is a medical device company that invented and developed a spinal fusion
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`surgical procedure called eXtreme Lateral Interbody Fusion, or “XLIF.” [Doc. No. 1 at ¶
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`10.] XLIF was “the first spinal surgery using a lateral, transpsoas approach to the spine.”
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`[Id.] NuVasive invented both the XLIF procedure itself and the devices for performing
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`lateral spinal surgery. [Id. at ¶ 11.]
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`In 2016 or 2017, Alphatec launched the Battalion™ Lateral System, which, like
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`XLIF, is a lateral spinal fusion surgical procedure. [Id. at ¶¶ 42-43.] The 121-page
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`complaint alleges that the Battalion Lateral System copies the XLIF system and that
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`Alphatec is liable for willful infringement of six utility patents and two design patents
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`related to the XLIF procedure or the devices used to perform it. Alphatec moves to dismiss
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`only the two design patent infringement claims.
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`A. Claim VII – Infringement of Design Patent No. D750,252
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`NuVasive is the owner by assignment of all right, title, and interest in United States
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`Design Patent Number D750,252 (the “‘252 Patent”) for an “Intervertebral Implant.” [Doc.
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`No. 1 at ¶ 500.] NuVasive calls the implants it makes pursuant to this patent “CoRoent®”.
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`The CoRoent® line of implants are specially designed for lateral insertion spinal fusion
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`surgery. [Id. at ¶ 11.] These implants are “sized to span the entire width of the vertebral
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`body to provide maximum vertebral body support. In comparison, implants inserted
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`through non-lateral spinal fusion surgeries have a much smaller footprint and therefore
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`provide weaker intervertebral support.” [Id. at ¶ 21.]
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`The complaint alleges that Alphatec “directly infringes the ‘252 Patent by making,
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`using, selling, offering for sale, and/or importing into the United States products and
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`systems including, but not limited to the Battalion Lateral Spacer which is a component of
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`the Battalion Lateral System, without the permission of NuVasive.” [Id. at ¶ 505.] The
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`complaint includes the following comparison of the ‘252 Patent and the Battalion Lateral
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`Spacer:
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`Case 3:18-cv-00347-CAB-MDD Document 45 Filed 05/14/18 PageID.4794 Page 3 of 12
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`’252 Patent
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`Battalion™ Lateral Spacer
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`Ex. V at 1.
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`[Id. at page 116.] Notably, the broken lines in the ‘252 Patent illustrations “form[] no part
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`of the claimed design.” [Doc. No. 1-16 at 2.] Thus, the patent does not claim the ridges
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`on the top, the two apertures and connecting bridge, and the opening on the end reflected
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`in figure 7 above.
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`The complaint also includes a comparison of the CoRoent® XLIF implant and the
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`Battalion™ Lateral Spacer:
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`NuVasive’s
`CoRoent® XLIF Implant
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`Alphatec’s
`Battalion™ Lateral Spacer
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`
`Ex. B (XLIF Patient Education
`Brochure) at 6.
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`Ex. V (Alphatec’s webpage
`advertising the Battalion™ Lateral
`Spacer)
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`10
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`[Id. at ¶ 110.]
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`According to NuVasive:
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`An ordinary observer, familiar with the prior art, giving such attention as a
`purchaser usually gives, would be deceived by the resemblance and
`substantial similarity of the design of the Battalion™ Lateral Spacer and the
`claimed design in the ’252 patent, and would thus be induced to purchase one
`supposing it to be the other, taking into account that the scope of a design
`patent claim does not cover functional features, that broken lines form no part
`of the claimed design, and unclaimed features are irrelevant.
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`[Id. at ¶ 509.]
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`B. Claim VIII – Infringement of Design Patent No. D652,519
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`NuVasive is also the owner by assignment of all right, title, and interest in and to
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`United States Design Patent Number D652,519 (the “‘519 Patent”) for a “Dilator.” [Id. at
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`¶¶ 515, 516.] The XLIF surgical procedure uses sequential dilators, “which are a series of
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`successively larger dilators used to create and then incrementally widen an opening to the
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`spine.” [Id. at ¶ 19.] “The sequential dilators include directional electrodes at their distal
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`ends which electrically stimulate nerves in the psoas muscle.” [Id.]
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`The complaint alleges that “Alphatec directly infringes the ‘519 Patent, by making
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`using, selling, offering for sale, and/or importing into the United States products and
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`systems including, but not limited to, the Initial Dilator which is a component of the
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`Battalion™ Lateral System (the ‘Battalion™ Initial Dilator’), without the permission of
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`NuVasive.” [Id. at ¶ 527.] The complaint includes the following comparison of the ‘519
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`Patent and the Battalion™ Initial Dilator:
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`’519 Patent
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`Battalion™ Initial Dilator
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`Ex. U (Alphatec Surgical Guide) at 5.
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`[Id. at page 116.] As with the ‘252 Patent, the “broken lines . . . form[] no part of the
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`claimed design.” [Doc. No. 1-17 at 2.]
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`According to NuVasive:
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`An ordinary observer, familiar with the prior art, giving such attention as a
`purchaser usually gives, would be deceived by the resemblance and
`substantial similarity of the design of the Battalion™ Initial Dilator and the
`claimed design in the ’519 patent, and would thus be induced to purchase one
`supposing it to be the other, taking into account that the scope of a design
`patent claim does not cover functional features, that broken lines form no part
`of the claimed design, and unclaimed features are irrelevant.
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`[Id. at ¶ 531.]
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`II. Legal Standard on Motions to Dismiss
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`To survive a motion to dismiss under Rule 12(b)(6), “a complaint must contain
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`sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its
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`face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v.
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`Twombly, 550 U.S. 544, 570 (2007)). Thus, the Court “accept[s] factual allegations in the
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`complaint as true and construe[s] the pleadings in the light most favorable to the
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`nonmoving party.” Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031
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`(9th Cir. 2008). On the other hand, the Court is “not bound to accept as true a legal
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`conclusion couched as a factual allegation.” Iqbal, 556 U.S. at 678 (quoting Twombly, 550
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`U.S. at 555). Nor is the Court “required to accept as true allegations that contradict exhibits
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`attached to the Complaint or . . . allegations that are merely conclusory, unwarranted
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`deductions of fact, or unreasonable inferences.” Daniels-Hall v. Nat’l Educ. Ass’n, 629
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`F.3d 992, 998 (9th Cir. 2010). “In sum, for a complaint to survive a motion to dismiss, the
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`non-conclusory factual content, and reasonable inferences from that content, must be
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`plausibly suggestive of a claim entitling the plaintiff to relief.” Moss v. U.S. Secret Serv.,
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`572 F.3d 962, 969 (9th Cir. 2009) (quotation marks omitted).
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`III. Discussion
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`Design patents protect new, original, and ornamental designs for an article of
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`manufacture. 35 U.S.C. § 171; Richardson v. Stanley Works, Inc., 597 F.3d 1288, 1293
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`(Fed. Cir. 2010) (“[A] design patent, unlike a utility patent, limits protection to the
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`ornamental design of the article.”). A design patent protects the ornamental features the
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`patentee chooses, not every conceivable shape of the basic design. Sofpool LLC v. Kmart
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`Corp., No. CIV. S-10-3333 LKK/JFM, 2013 WL 2384331, at *5 (E.D. Cal. May 30, 2013).
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`A design patent is infringed “[i]f, in the eye of an ordinary observer, giving such attention
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`as a purchaser usually gives, two designs are substantially the same, if the resemblance is
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`such as to deceive such an observer, inducing him to purchase one supposing it to be the
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`other.” Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665, 670 (Fed. Cir. 2008) (citing
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`Gorham Co. v. White, 81 U.S. 511, 528 (1871)); Crocs, Inc. v. Int’l Trade Comm’n, 598
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`F.3d 1294, 1303 (Fed. Cir. 2010) (“To show infringement under the proper test, an ordinary
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`observer, familiar with the prior art designs, would be deceived into believing that the
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`accused product is the same as the patented design.”).
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`“Where the claimed and accused designs are ‘sufficiently distinct’ and ‘plainly
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`dissimilar,’ the patentee fails to meet its burden of proving infringement as a matter of
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`law.” Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d 1312, 1335 (Fed. Cir. 2015)
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`(citing Egyptian Goddess, 543 F.3d at 678). “Differences, however, must be evaluated in
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`the context of the claimed design as a whole, and not in the context of separate elements in
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`isolation. Where, as here, the claimed design includes several elements, the fact finder must
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`apply the ordinary observer test by comparing similarities in overall designs, not
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`similarities of ornamental features in isolation.” Id. at 1335; see also Richardson, 597 F.3d
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`at 1295 (“In evaluating infringement, we determine whether the deception that arises is a
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`result of the similarities in the overall design, not of similarities in ornamental features in
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`isolation.”) (citation omitted). “There can be no infringement based on the similarity of
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`specific features if the overall appearance of the designs are dissimilar.” OddzOn Prods.,
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`Inc. v. Just Toys, Inc., 122 F.3d 1396, 1405 (Fed. Cir. 1997). “In some instances, the
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`claimed and the accused design will be sufficiently distinct that it will be clear without
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`more that the patentee has not met its burden of proving the two designs would appear
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`‘substantially the same’ to the ordinary observer. . . .” Egyptian Goddess, 573 F.3d at 678.
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`This case presents two such instances.
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`A.
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`‘252 Patent
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`In its motion, Alphatec identifies several distinct differences between the ‘252 Patent
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`and the Battalion Lateral Spacer that, according to NuVasive, infringes that patent:
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`For its part, NuVasive fails, both in the complaint and in its opposition, to explain what
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`ornamental features claimed in the ‘252 Patent are infringed by the Battalion Lateral
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`Spacer, let alone argue that an ordinary observer would be deceived into thinking the
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`accused product is the patented design. Instead, NuVasive merely points to the various
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`similarities between the patent and the accused design, almost all of which are not even
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`part of the claimed design. [Doc. No. 32 at 15.] Ultimately, however, the differences
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`between the two designs as evident from the illustrations and photographs in the complaint,
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`make NuVasive’s infringement claim implausible.
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`As specified in the above comparison copied from Alphatec’s brief, the Battalion
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`Lateral Spacer has an indentation and cutouts on its trailing end that do not appear in the
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`patent. The Battalion Lateral Spacer is also flatter than the claimed design on its trailing
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`end. On the whole, these distinctions make the overall appearance of the Battalion Lateral
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`Spacer substantially different from the claimed design. Indeed, “[t]he claimed and accused
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`designs are plainly dissimilar even to one less discerning than the ordinary observer; these
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`distinctions would only be more evident to a sophisticated observer, whether a purchasing
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`entity or a surgeon.” Ethicon Endo-Surgery, 796 F.3d at 1337.
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`NuVasive would have the Court ignore the obvious differences between the claimed
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`and accused products and deny the motion to dismiss simply because the complaint
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`contains the conclusory allegation, contradicted by the comparison of the illustrations and
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`photographs in the complaint, that an ordinary observer would be deceived into thinking
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`that the accused product was actually the patented design. For this argument, NuVasive
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`relies on Hall v. Bed Bath & Beyond, Inc., 705 F.3d 1357, 1362 (Fed. Cir. 2013), where
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`the Federal Circuit held that a patent infringement complaint need only “(i) allege
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`ownership of the patent, (ii) name each defendant, (iii) cite the patent that is allegedly
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`infringed, (iv) state the means by which the defendant allegedly infringes, and (v) point to
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`the sections of the patent law invoked.” Id. (citing Phonometrics, Inc. v. Hospitality
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`Franchise Systems, Inc., 203 F.3d 790, 794 (Fed. Cir. 2000). In Hall, the Federal Circuit
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`stated that “this is ‘enough detail to allow the defendants to answer’ and that ‘Rule 12(b)(6)
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`requires no more.” Id. (quoting Phonometrics, 203 F.3d at 794). Here, the Court does not
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`need to decide whether these requirements differ from the Iqbal/Twombly pleading
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`requirements and therefore require denial of Alphatec’s motion.1 Due to the obvious
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`differences between the claimed design and the Battalion Lateral Spacer reflected in the
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`complaint itself and attachments thereto, NuVasive does not satisfy the fourth element
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`because it does not state the means by which Alphatec infringes the ‘252 Patent (or the
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`1 Hall was issued before Form 18 of the Appendix to the Federal Rules of Civil Procedure (“Form 18”)
`was abrogated by the Supreme Court. “Form 18 effectively immunized a claimant from attack regarding
`the sufficiency of the pleading.” See Lifetime Indus., Inc. v. Trim-Lok, Inc., 869 F.3d 1372, 1376-77 (Fed.
`Cir. 2017) (citation omitted) (noting that the Federal Circuit has never recognized any distinction between
`Form 18 and Iqbal/Twombly); see also Scripps Research Inst. v. Illumina, Inc., No. 16-CV-661 JLS
`(BGS), 2016 WL 6834024, at *5 n.4 (S.D. Cal. Nov. 21, 2016) (noting that the plaintiff’s reliance on
`Phonometrics was misplaced because that case predates the abrogation of Form 18); e.Digital Corp. v.
`iBaby Labs, Inc., No. 15-CV-05790-JST, 2016 WL 4427209, at *3 (N.D. Cal. Aug. 22, 2016) (“Absent
`Form 18 itself, there is simply no support in the Federal Rules of Civil Procedure for a different pleading
`standard for direct patent infringement claims. As a result, the Court concludes that former Form 18 no
`longer controls and that allegations of direct infringement are now subject to the pleading standards
`established by Twombly and Iqbal, requiring plaintiffs to demonstrate a ‘plausible claim for relief.’”).
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`‘519 Patent).
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`In sum, the claimed and accused designs, as represented by the illustrations in the
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`patent and pictures of the accused device in the complaint or attached thereto, are so plainly
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`dissimilar that no ordinary observer would be deceived into thinking the Battalion Lateral
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`Spacer is the same as the design claimed in the ‘252 Patent. No discovery into prior art or
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`construction of the ornamental features of the claimed design would make NuVasive’s
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`claim plausible. Accepting as true the factual allegations in the complaint, including the
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`illustrations and photographs depicted therein, the Battalion Lateral Spacer is sufficiently
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`distinct from the claimed design that the complaint does not state a plausible claim for
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`infringement.2 Accordingly, the motion to dismiss this claim is granted, and because the
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`plain distinctions between the two designs would render amendment futile, the dismissal
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`is with prejudice.
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`B.
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`‘519 Patent
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`The result is the same for NuVasive’s claim of infringement of the ‘519 Patent. Once
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`again, Alphatec identifies numerous differences with this comparison of the claimed design
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`and accused product pasted from Alphatec’s motion:
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`2 Because “an illustration depicts a design better than it could be by any description and a description
`would probably not be intelligible without the illustration,” Crocs, Inc., 598 F.3d at 1302–03, no further
`verbal allegations could overcome the distinctions apparent from the illustrations and photographs in the
`complaint and attached patent.
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`If anything, the distinctions are even more obvious than they are with respect to the
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`‘252 Patent infringement claim. The accused product, like the claimed design, is
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`cylindrical and tapers at one end, but no ordinary observer would be deceived into thinking
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`they are substantially similar. The depth marking on the accused product alone are enough
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`to preclude any infringement claim as it “is a visually distinct dissimilarity between the
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`dilators, the accused dilator with markings on the main body and the design of the main
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`cylinder chosen by the patentee, without markings or any measurement indicia.” Warsaw
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`Orthopedic, Inc. v. NuVasive, Inc., No. 12-cv-2738-CAB (MDD), 2015 WL 11234133, at
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`*5 (S.D. Cal. Oct. 20, 2015). Further, as Alphatec points out, the degree of taper at the end
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`is different, the shape, size, and location of the electrode is different. On the claimed
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`design, the electrode vertically extends over the majority of the tapered portion; on the
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`accused product, the electrode vertically extends over only the bottom quarter or third of
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`the tapered portion.
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`In sum, the design of the Battalion Lateral Dilator is substantially different from the
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`design claimed in the ‘519 Patent. The illustrations and photographs in the complaint and
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`attachments thereto demonstrate that no ordinary observer would be deceived into thinking
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`that the accused device is the same as the patented design. As a result, the complaint does
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`not state a plausible claim for infringement, and Alphatec’s motion to dismiss is granted as
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`to this claim as well. Further, because any amendment would be futile in light of the plain
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`18-CV-347-CAB-MDD
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`Case 3:18-cv-00347-CAB-MDD Document 45 Filed 05/14/18 PageID.4803 Page 12 of 12
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`dissimilarities between the claimed design and accused product, the dismissal is with
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`prejudice.
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`IV. Conclusion
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`In light of the foregoing, it is hereby ORDERED that Alphatec’s motion to dismiss
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`is GRANTED. Further, because amendment would be futile, Claims VII and VIII are
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`therefore DISMISSED WITH PREJUDICE. Alphatec shall file and serve its answer to
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`the remaining claims in the complaint on or before May 21, 2018.
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`It is SO ORDERED.
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`Dated: May 14, 2018
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