`SOUTHERN DISTRICT OF CALIFORNIA
`
`NUVASIVE, INC.,
`
`Case No.: 18-CV-347-CAB-MDD
`
`Plaintiff,
`
`v.
`ALPHATEC HOLDINGS, INC., and
`ALPHATEC SPINE, INC.,
`
`Defendants.
`
`ORDER RE MOTION TO DISMISS
`COUNTS VII AND VIII
`
`[Doc. No. 32]
`
`Defendants Alphatec Holdings, Inc., and Alphatec Spine, Inc. (together, “Alphatec”)
`have filed a motion to dismiss the seventh and eighth claims in the Plaintiff NuVasive,
`Inc.’s complaint for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).
`The motion as been fully briefed and the Court deems it suitable for submission without
`oral argument. For the following reasons, the motion is granted.
`I.
`Allegations in the Complaint
`NuVasive is a medical device company that invented and developed a spinal fusion
`surgical procedure called extreme Lateral Interbody Fusion, or “XLIF.” [Doc. No. 1 at f
`10.] XLIF was “the first spinal surgery using a lateral, transpsoas approach to the spine.”
`
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 1 of 12
`
`
`
`[Id.] NuVasive invented both the XLIF procedure itself and the devices for performing
`lateral spinal surgery. [Id. at f 1L]
`In 2016 or 2017, Alphatec launched the Battalion™ Lateral System, which, like
`XLIF, is a lateral spinal fusion surgical procedure. [Id. at || 42-43.] The 121-page
`complaint alleges that the Battalion Lateral System copies the XLIF system and that
`Alphatec is liable for willful infringement of six utility patents and two design patents
`related to the XLIF procedure or the devices used to perform it. Alphatec moves to dismiss
`only the two design patent infringement claims.
`A. Claim VII - Infringement of Design Patent No. D750,252
`NuVasive is the owner by assignment of all right, title, and interest in United States
`Design Patent Number D750,252 (the ‘“252 Patent”) for an “Intervertebral Implant.” [Doc.
`No. 1 at 1500.] NuVasive calls the implants it makes pursuant to this patent “CoRoent®”.
`The CoRoent® line of implants are specially designed for lateral insertion spinal fusion
`surgery. [Id. at 111.] These implants are “sized to span the entire width of the vertebral
`body to provide maximum vertebral body support. In comparison, implants inserted
`through non-lateral spinal fusion surgeries have a much smaller footprint and therefore
`provide weaker intervertebral support.” [Id. at 121.]
`The complaint alleges that Alphatec “directly infringes the ‘252 Patent by making,
`using, selling, offering for sale, and/or importing into the United States products and
`systems including, but not limited to the Battalion Lateral Spacer which is a component of
`the Battalion Lateral System, without the permission of NuVasive.” [Id. at | 505.] The
`complaint includes the following comparison of the ‘252 Patent and the Battalion Lateral
`Spacer:
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 2 of 12
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`’252 Patent
`
`Battalion™ Lateral Spacer
`
`Ex. V at 1.
`
`FIG. 5
`
`fig. r
`
`[Id. at page 116.] Notably, the broken lines in the ‘252 Patent illustrations “form[] no part
`of the claimed design.” [Doc. No. 1-16 at 2.] Thus, the patent does not claim the ridges
`on the top, the two apertures and connecting bridge, and the opening on the end reflected
`in figure 7 above.
`The complaint also includes a comparison of the CoRoent® XLIF implant and the
`Battalion™ Lateral Spacer:
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 3 of 12
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`NuVasive’s
`CoRoent® XLIF Implant
`
`Alphatec’s
`Battalion™ Lateral Spacer
`
`h
`
`Ex. B (XLIF Patient Education
`Brochure) at 6.
`
`Ex. V (Alphatec’s webpage
`advertising the Battalion™ Lateral
`Spacer)
`
`[Id. at |110.]
`
`According to NuVasive:
`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.
`
`[Id. at |509.]
`B. Claim VIII - Infringement of Design Patent No. D652,519
`NuVasive is also the owner by assignment of all right, title, and interest in and to
`United States Design Patent Number D652,519 (the ‘“519 Patent”) for a “Dilator.” [Id. at
`|| 515, 516.] The XLIF surgical procedure uses sequential dilators, “which are a series of
`successively larger dilators used to create and then incrementally widen an opening to the
`spine.” [Id. at 119.] “The sequential dilators include directional electrodes at their distal
`ends which electrically stimulate nerves in the psoas muscle.” [Id.]
`The complaint alleges that “Alphatec directly infringes the ‘519 Patent, by making
`using, selling, offering for sale, and/or importing into the United States products and
`systems including, but not limited to, the Initial Dilator which is a component of the
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 4 of 12
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`Battalion™ Lateral System (the ‘Battalion™ Initial Dilator’), without the permission of
`NuVasive ” [Id. at | 527.] The complaint includes the following comparison of the ‘519
`Patent and the Battalion™ Initial Dilator:
`
`’519 Patent
`
`Battalion™ Initial Dilator
`
`<D39
`5=
`
`30
`
`VI'M /
`Ex. U (Alphatec Surgical Guide) at 5,
`
`[Id. at page 116.] As with the ‘252 Patent, the “broken lines . . . form[] no part of the
`claimed design.” [Doc. No. 1-17 at 2.]
`According to NuVasive:
`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.
`
`[Id. at 1531.]
`II.
`Legal Standard on Motions to Dismiss
`To survive a motion to dismiss under Rule 12(b)(6), “a complaint must contain
`sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 5 of 12
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`face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v.
`Twombly, 550 U.S. 544, 570 (2007)). Thus, the Court “accept[s] factual allegations in the
`complaint as true and construe[s] the pleadings in the light most favorable to the
`nonmoving party.” Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031
`(9th Cir. 2008). On the other hand, the Court is “not bound to accept as true a legal
`conclusion couched as a factual allegation.” Iqbal, 556 U.S. at 678 (quoting Twombly, 550
`U.S. at 555). Nor is the Court “required to accept as true allegations that contradict exhibits
`attached to the Complaint or . . . allegations that are merely conclusory, unwarranted
`deductions of fact, or unreasonable inferences.” Daniels-Hall v. Nat 7 Educ. Ass’n, 629
`F.3d 992, 998 (9th Cir. 2010). “In sum, for a complaint to survive a motion to dismiss, the
`non-conclusory factual content, and reasonable inferences from that content, must be
`plausibly suggestive of a claim entitling the plaintiff to relief.” Moss v. U.S. Secret Serv.,
`572 F.3d 962, 969 (9th Cir. 2009) (quotation marks omitted).
`III. Discussion
`Design patents protect new, original, and ornamental designs for an article of
`manufacture. 35 U.S.C. § 171; Richardson v. Stanley Works, Inc., 597 F.3d 1288, 1293
`(Fed. Cir. 2010) (“[A] design patent, unlike a utility patent, limits protection to the
`ornamental design of the article.”). A design patent protects the ornamental features the
`patentee chooses, not every conceivable shape of the basic design. Sofpool LLC v. Kmart
`Corp., No. CIV. S-10-3333 LKK/JFM, 2013 WL 2384331, at *5 (E.D. Cal. May 30,2013).
`A design patent is infringed “[i]f, in the eye of an ordinary observer, giving such attention
`as a purchaser usually gives, two designs are substantially the same, if the resemblance is
`such as to deceive such an observer, inducing him to purchase one supposing it to be the
`other.” Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665, 670 (Fed. Cir. 2008) (citing
`Gorham Co. v. White, 81 U.S. 511, 528 (1871)); Crocs, Inc. v. Int’l Trade Comm’n, 598
`F.3d 1294,1303 (Fed. Cir. 2010) (“To show infringement under the proper test, an ordinary
`observer, familiar with the prior art designs, would be deceived into believing that the
`accused product is the same as the patented design.”).
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 6 of 12
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`“Where the claimed and accused designs are ‘sufficiently distinct’ and ‘plainly
`dissimilar,’ the patentee fails to meet its burden of proving infringement as a matter of
`law.” Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d 1312, 1335 (Fed. Cir. 2015)
`(citing Egyptian Goddess, 543 F.3d at 678). “Differences, however, must be evaluated in
`the context of the claimed design as a whole, and not in the context of separate elements in
`isolation. Where, as here, the claimed design includes several elements, the fact finder must
`apply the ordinary observer test by comparing similarities in overall designs, not
`similarities of ornamental features in isolation.” Id. at 1335; see also Richardson, 597 F.3d
`at 1295 (“In evaluating infringement, we determine whether the deception that arises is a
`result of the similarities in the overall design, not of similarities in ornamental features in
`isolation.”) (citation omitted). “There can be no infringement based on the similarity of
`specific features if the overall appearance of the designs are dissimilar.” OddzOn Prods.,
`Inc. v. Just Toys, Inc., 122 F.3d 1396, 1405 (Fed. Cir. 1997). “In some instances, the
`claimed and the accused design will be sufficiently distinct that it will be clear without
`more that the patentee has not met its burden of proving the two designs would appear
`‘substantially the same’ to the ordinary observer....” Egyptian Goddess, 573 F.3d at 678.
`This case presents two such instances.
`A. ‘252 Patent
`In its motion, Alphatec identifies several distinct differences between the ‘252 Patent
`and the Battalion Lateral Spacer that, according to NuVasive, infringes that patent:
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 7 of 12
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`No cutouts on
`trailing end
`
`Curvature at
`trailing end
`
`No cutouts on
`trailing end
`
`No indentation
`on trailing end
`
`’252 Patent
`
`No cutouts on
`trailing end
`
`Battalion™ Lateral Spacer
`
`Indentation
`on trailing
`end
`
`No curvature
`at trailing enc
`
`Indentation
`on trailing
`end
`
`Cutouts on trailing end
`
`No cutouts on
`trailing end
`
`For its part, NuVasive fails, both in the complaint and in its opposition, to explain what
`ornamental features claimed in the ‘252 Patent are infringed by the Battalion Lateral
`Spacer, let alone argue that an ordinary observer would be deceived into thinking the
`accused product is the patented design. Instead, NuVasive merely points to the various
`similarities between the patent and the accused design, almost all of which are not even
`part of the claimed design. [Doc. No. 32 at 15.] Ultimately, however, the differences
`between the two designs as evident from the illustrations and photographs in the complaint,
`make NuVasive’s infringement claim implausible.
`As specified in the above comparison copied from Alphatec’s brief, the Battalion
`Lateral Spacer has an indentation and cutouts on its trailing end that do not appear in the
`patent. The Battalion Lateral Spacer is also flatter than the claimed design on its trailing
`end. On the whole, these distinctions make the overall appearance of the Battalion Lateral
`Spacer substantially different from the claimed design. Indeed, “[t]he claimed and accused
`designs are plainly dissimilar even to one less discerning than the ordinary observer; these
`distinctions would only be more evident to a sophisticated observer, whether a purchasing
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 8 of 12
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`entity or a surgeon.” Ethicon Endo-Surgery, 796 F.3d at 1337.
`NuVasive would have the Court ignore the obvious differences between the claimed
`and accused products and deny the motion to dismiss simply because the complaint
`contains the conclusory allegation, contradicted by the comparison of the illustrations and
`photographs in the complaint, that an ordinary observer would be deceived into thinking
`that the accused product was actually the patented design. For this argument, NuVasive
`relies on Hall v. Bed Bath & Beyond, Inc., 705 F.3d 1357, 1362 (Fed. Cir. 2013), where
`the Federal Circuit held that a patent infringement complaint need only “(i) allege
`ownership of the patent, (ii) name each defendant, (iii) cite the patent that is allegedly
`infringed, (iv) state the means by which the defendant allegedly infringes, and (v) point to
`the sections of the patent law invoked.” Id. (citing Phonometrics, Inc. v. Hospitality
`Franchise Systems, Inc., 203 F.3d 790, 794 (Fed. Cir. 2000). In Hall, the Federal Circuit
`stated that “this is ‘enough detail to allow the defendants to answer’ and that ‘Rule 12(b)(6)
`requires no more.” Id. (quoting Phonometrics, 203 F.3d at 794). Here, the Court does not
`need to decide whether these requirements differ from the Iqbal/Twombly pleading
`requirements and therefore require denial of Alphatec’s motion.1 Due to the obvious
`differences between the claimed design and the Battalion Lateral Spacer reflected in the
`complaint itself and attachments thereto, NuVasive does not satisfy the fourth element
`because it does not state the means by which Alphatec infringes the ‘252 Patent (or the
`
`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 plaintiffs reliance on
`Phonometrics was misplaced because that case predates the abrogation of Form 18); e.Digital Corp. v.
`iBabyLabs, 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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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 9 of 12
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`‘519 Patent).
`In sum, the claimed and accused designs, as represented by the illustrations in the
`patent and pictures of the accused device in the complaint or attached thereto, are so plainly
`dissimilar that no ordinary observer would be deceived into thinking the Battalion Lateral
`Spacer is the same as the design claimed in the ‘252 Patent. No discoveiy into prior art or
`construction of the ornamental features of the claimed design would make NuVasive’s
`claim plausible. Accepting as true the factual allegations in the complaint, including the
`illustrations and photographs depicted therein, the Battalion Lateral Spacer is sufficiently
`distinct from the claimed design that the complaint does not state a plausible claim for
`infringement.2 Accordingly, the motion to dismiss this claim is granted, and because the
`plain distinctions between the two designs would render amendment futile, the dismissal
`is with prejudice.
`B. ‘519 Patent
`The result is the same for NuVasive’s claim of infringement of the ‘519 Patent. Once
`again, Alphatec identifies numerous differences with this comparison of the claimed design
`and accused product pasted from Alphatec’s motion:
`
`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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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 10 of 12
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`No depth
`markings
`
`Wide & short taper
`
`Trapezoidal
`electrode
`
`Electrode situated
`centrally to taper &
`occupies large portion
`of taper
`
`Depth markings
`
`Skinny & long taper
`
`Electrode situated near
`end of taper &
`occupies small portion
`of taper
`
`Triangular electrode
`
`If anything, the distinctions are even more obvious than they are with respect to the
`‘252 Patent infringement claim. The accused product, like the claimed design, is
`cylindrical and tapers at one end, but no ordinary observer would be deceived into thinking
`they are substantially similar. The depth marking on the accused product alone are enough
`to preclude any infringement claim as it “is a visually distinct dissimilarity between the
`dilators, the accused dilator with markings on the main body and the design of the main
`cylinder chosen by the patentee, without markings or any measurement indicia.” Warsaw
`Orthopedic, Inc. v. NuVasive, Inc., No. 12-cv-2738-CAB (MDD), 2015 WL 11234133, at
`*5 (S.D. Cal. Oct. 20, 2015). Further, as Alphatec points out, the degree of taper at the end
`is different, the shape, size, and location of the electrode is different. On the claimed
`design, the electrode vertically extends over the majority of the tapered portion; on the
`accused product, the electrode vertically extends over only the bottom quarter or third of
`the tapered portion.
`In sum, the design of the Battalion Lateral Dilator is substantially different from the
`design claimed in the ‘519 Patent. The illustrations and photographs in the complaint and
`attachments thereto demonstrate that no ordinary observer would be deceived into thinking
`that the accused device is the same as the patented design. As a result, the complaint does
`not state a plausible claim for infringement, and Alphatec’s motion to dismiss is granted as
`to this claim as well. Further, because any amendment would be futile in light of the plain
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 11 of 12
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`dissimilarities between the claimed design and accused product, the dismissal is with
`prejudice.
`IV. Conclusion
`In light of the foregoing, it is hereby ORDERED that Alphatec’s motion to dismiss
`is GRANTED. Further, because amendment would be futile, Claims VII and VIII are
`therefore DISMISSED WITH PREJUDICE. Alphatec shall file and serve its answer to
`the remaining claims in the complaint on or before May 21, 2018.
`It is SO ORDERED
`Dated: May 14,2018
`
`Hon. Cathy Ann Bencivengo
`United States District Judge
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1062, p. 12 of 12
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