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9 UNITED STATES DISTRICT COURT
10 SOUTHERN DISTRICT OF CALIFORNIA
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12 NUVASIVE, INC., Case No.: 18-CV-347-CAB-MDD
13 Plaintiff,
ORDER RE MOTION TO DISMISS
14 v. COUNTS VII AND VIII
15 ALPHATEC HOLDINGS, INC., and
ALPHATEC SPINE, INC., [Doc. No. 20]
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Defendants.
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19 Defendants Alphatec Holdings, Inc., and Alphatec Spine, Inc. (together, “Alphatec”)
20 have filed a motion to dismiss the seventh and eighth claims in the Plaintiff NuVasive,
21 Inc.’s complaint for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).
22 The motion as been fully briefed and the Court deems it suitable for submission without
23 oral argument. For the following reasons, the motion is granted.
24 I. Allegations in the Complaint
25 NuVasive is a medical device company that invented and developed a spinal fusion
26 surgical procedure called eXtreme Lateral Interbody Fusion, or “XLIF.” [Doc. No. 1 at ¶
27 10.] XLIF was “the first spinal surgery using a lateral, transpsoas approach to the spine.”
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1 [Id.] NuVasive invented both the XLIF procedure itself and the devices for performing
2 lateral spinal surgery. [Id. at ¶ 11.]
3 In 2016 or 2017, Alphatec launched the Battalion™ Lateral System, which, like
4 XLIF, is a lateral spinal fusion surgical procedure. [Id. at ¶¶ 42-43.] The 121-page
5 complaint alleges that the Battalion Lateral System copies the XLIF system and that
6 Alphatec is liable for willful infringement of six utility patents and two design patents
7 related to the XLIF procedure or the devices used to perform it. Alphatec moves to dismiss
8 only the two design patent infringement claims.
9 A. Claim VII – Infringement of Design Patent No. D750,252
10 NuVasive is the owner by assignment of all right, title, and interest in United States
11 Design Patent Number D750,252 (the “‘252 Patent”) for an “Intervertebral Implant.” [Doc.
12 No. 1 at ¶ 500.] NuVasive calls the implants it makes pursuant to this patent “CoRoent®”.
13 The CoRoent® line of implants are specially designed for lateral insertion spinal fusion
14 surgery. [Id. at ¶ 11.] These implants are “sized to span the entire width of the vertebral
15 body to provide maximum vertebral body support. In comparison, implants inserted
16 through non-lateral spinal fusion surgeries have a much smaller footprint and therefore
17 provide weaker intervertebral support.” [Id. at ¶ 21.]
18 The complaint alleges that Alphatec “directly infringes the ‘252 Patent by making,
19 using, selling, offering for sale, and/or importing into the United States products and
20 systems including, but not limited to the Battalion Lateral Spacer which is a component of
21 the Battalion Lateral System, without the permission of NuVasive.” [Id. at ¶ 505.] The
22 complaint includes the following comparison of the ‘252 Patent and the Battalion Lateral
23 Spacer:
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’252 Patent Battalion™ Lateral Spacer
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8 Ex. V at 1.
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15 [Id. at page 116.] Notably, the broken lines in the ‘252 Patent illustrations “form[] no part

16 of the claimed design.” [Doc. No. 1-16 at 2.] Thus, the patent does not claim the ridges

17 on the top, the two apertures and connecting bridge, and the opening on the end reflected

18 in figure 7 above.

19 The complaint also includes a comparison of the CoRoent® XLIF implant and the

20 Battalion™ Lateral Spacer:

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NuVasive’s Alphatec’s
2 CoRoent® XLIF Implant Battalion™ Lateral Spacer
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Ex. B (XLIF Patient Education Ex. V (Alphatec’s webpage
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Brochure) at 6. advertising the Battalion™ Lateral
9 Spacer)
10 [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
13 purchaser usually gives, would be deceived by the resemblance and
substantial similarity of the design of the Battalion™ Lateral Spacer and the
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claimed design in the ’252 patent, and would thus be induced to purchase one
15 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
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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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1 Battalion™ Lateral System (the ‘Battalion™ Initial Dilator’), without the permission of
2 NuVasive.” [Id. at ¶ 527.] The complaint includes the following comparison of the ‘519
3 Patent and the Battalion™ Initial Dilator:
4 ’519 Patent Battalion™ Initial Dilator
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Ex. U (Alphatec Surgical Guide) at 5.
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17 [Id. at page 116.] As with the ‘252 Patent, the “broken lines . . . form[] no part of the
18 claimed design.” [Doc. No. 1-17 at 2.]
19 According to NuVasive:
20 An ordinary observer, familiar with the prior art, giving such attention as a
purchaser usually gives, would be deceived by the resemblance and
21 substantial similarity of the design of the Battalion™ Initial Dilator and the
22 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
23 patent claim does not cover functional features, that broken lines form no part
24 of the claimed design, and unclaimed features are irrelevant.
25 [Id. at ¶ 531.]
26 II. Legal Standard on Motions to Dismiss
27 To survive a motion to dismiss under Rule 12(b)(6), “a complaint must contain
28 sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its

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1 face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v.
2 Twombly, 550 U.S. 544, 570 (2007)). Thus, the Court “accept[s] factual allegations in the
3 complaint as true and construe[s] the pleadings in the light most favorable to the
4 nonmoving party.” Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031
5 (9th Cir. 2008). On the other hand, the Court is “not bound to accept as true a legal
6 conclusion couched as a factual allegation.” Iqbal, 556 U.S. at 678 (quoting Twombly, 550
7 U.S. at 555). Nor is the Court “required to accept as true allegations that contradict exhibits
8 attached to the Complaint or . . . allegations that are merely conclusory, unwarranted
9 deductions of fact, or unreasonable inferences.” Daniels-Hall v. Nat’l Educ. Ass’n, 629
10 F.3d 992, 998 (9th Cir. 2010). “In sum, for a complaint to survive a motion to dismiss, the
11 non-conclusory factual content, and reasonable inferences from that content, must be
12 plausibly suggestive of a claim entitling the plaintiff to relief.” Moss v. U.S. Secret Serv.,
13 572 F.3d 962, 969 (9th Cir. 2009) (quotation marks omitted).
14 III. Discussion
15 Design patents protect new, original, and ornamental designs for an article of
16 manufacture. 35 U.S.C. § 171; Richardson v. Stanley Works, Inc., 597 F.3d 1288, 1293
17 (Fed. Cir. 2010) (“[A] design patent, unlike a utility patent, limits protection to the
18 ornamental design of the article.”). A design patent protects the ornamental features the
19 patentee chooses, not every conceivable shape of the basic design. Sofpool LLC v. Kmart
20 Corp., No. CIV. S-10-3333 LKK/JFM, 2013 WL 2384331, at *5 (E.D. Cal. May 30, 2013).
21 A design patent is infringed “[i]f, in the eye of an ordinary observer, giving such attention
22 as a purchaser usually gives, two designs are substantially the same, if the resemblance is
23 such as to deceive such an observer, inducing him to purchase one supposing it to be the
24 other.” Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665, 670 (Fed. Cir. 2008) (citing
25 Gorham Co. v. White, 81 U.S. 511, 528 (1871)); Crocs, Inc. v. Int’l Trade Comm’n, 598
26 F.3d 1294, 1303 (Fed. Cir. 2010) (“To show infringement under the proper test, an ordinary
27 observer, familiar with the prior art designs, would be deceived into believing that the
28 accused product is the same as the patented design.”).

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1 “Where the claimed and accused designs are ‘sufficiently distinct’ and ‘plainly
2 dissimilar,’ the patentee fails to meet its burden of proving infringement as a matter of
3 law.” Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d 1312, 1335 (Fed. Cir. 2015)
4 (citing Egyptian Goddess, 543 F.3d at 678). “Differences, however, must be evaluated in
5 the context of the claimed design as a whole, and not in the context of separate elements in
6 isolation. Where, as here, the claimed design includes several elements, the fact finder must
7 apply the ordinary observer test by comparing similarities in overall designs, not
8 similarities of ornamental features in isolation.” Id. at 1335; see also Richardson, 597 F.3d
9 at 1295 (“In evaluating infringement, we determine whether the deception that arises is a
10 result of the similarities in the overall design, not of similarities in ornamental features in
11 isolation.”) (citation omitted). “There can be no infringement based on the similarity of
12 specific features if the overall appearance of the designs are dissimilar.” OddzOn Prods.,
13 Inc. v. Just Toys, Inc., 122 F.3d 1396, 1405 (Fed. Cir. 1997). “In some instances, the
14 claimed and the accused design will be sufficiently distinct that it will be clear without
15 more that the patentee has not met its burden of proving the two designs would appear
16 ‘substantially the same’ to the ordinary observer. . . .” Egyptian Goddess, 573 F.3d at 678.
17 This case presents two such instances.
18 A. ‘252 Patent
19 In its motion, Alphatec identifies several distinct differences between the ‘252 Patent
20 and the Battalion Lateral Spacer that, according to NuVasive, infringes that patent:
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14 For its part, NuVasive fails, both in the complaint and in its opposition, to explain what
15 ornamental features claimed in the ‘252 Patent are infringed by the Battalion Lateral
16 Spacer, let alone argue that an ordinary observer would be deceived into thinking the
17 accused product is the patented design. Instead, NuVasive merely points to the various
18 similarities between the patent and the accused design, almost all of which are not even
19 part of the claimed design. [Doc. No. 32 at 15.] Ultimately, however, the differences
20 between the two designs as evident from the illustrations and photographs in the complaint,
21 make NuVasive’s infringement claim implausible.
22 As specified in the above comparison copied from Alphatec’s brief, the Battalion
23 Lateral Spacer has an indentation and cutouts on its trailing end that do not appear in the
24 patent. The Battalion Lateral Spacer is also flatter than the claimed design on its trailing
25 end. On the whole, these distinctions make the overall appearance of the Battalion Lateral
26 Spacer substantially different from the claimed design. Indeed, “[t]he claimed and accused
27 designs are plainly dissimilar even to one less discerning than the ordinary observer; these
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1 entity or a surgeon.” Ethicon Endo-Surgery, 796 F.3d at 1337.


2 NuVasive would have the Court ignore the obvious differences between the claimed
3 and accused products and deny the motion to dismiss simply because the complaint
4 contains the conclusory allegation, contradicted by the comparison of the illustrations and
5 photographs in the complaint, that an ordinary observer would be deceived into thinking
6 that the accused product was actually the patented design. For this argument, NuVasive
7 relies on Hall v. Bed Bath & Beyond, Inc., 705 F.3d 1357, 1362 (Fed. Cir. 2013), where
8 the Federal Circuit held that a patent infringement complaint need only “(i) allege
9 ownership of the patent, (ii) name each defendant, (iii) cite the patent that is allegedly
10 infringed, (iv) state the means by which the defendant allegedly infringes, and (v) point to
11 the sections of the patent law invoked.” Id. (citing Phonometrics, Inc. v. Hospitality
12 Franchise Systems, Inc., 203 F.3d 790, 794 (Fed. Cir. 2000). In Hall, the Federal Circuit
13 stated that “this is ‘enough detail to allow the defendants to answer’ and that ‘Rule 12(b)(6)
14 requires no more.” Id. (quoting Phonometrics, 203 F.3d at 794). Here, the Court does not
15 need to decide whether these requirements differ from the Iqbal/Twombly pleading
16 requirements and therefore require denial of Alphatec’s motion.1 Due to the obvious
17 differences between the claimed design and the Battalion Lateral Spacer reflected in the
18 complaint itself and attachments thereto, NuVasive does not satisfy the fourth element
19 because it does not state the means by which Alphatec infringes the ‘252 Patent (or the
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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
23 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
24 Form 18 and Iqbal/Twombly); see also Scripps Research Inst. v. Illumina, Inc., No. 16-CV-661 JLS
25 (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.
26 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
27 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
28 established by Twombly and Iqbal, requiring plaintiffs to demonstrate a ‘plausible claim for relief.’”).

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1 ‘519 Patent).
2 In sum, the claimed and accused designs, as represented by the illustrations in the
3 patent and pictures of the accused device in the complaint or attached thereto, are so plainly
4 dissimilar that no ordinary observer would be deceived into thinking the Battalion Lateral
5 Spacer is the same as the design claimed in the ‘252 Patent. No discovery into prior art or
6 construction of the ornamental features of the claimed design would make NuVasive’s
7 claim plausible. Accepting as true the factual allegations in the complaint, including the
8 illustrations and photographs depicted therein, the Battalion Lateral Spacer is sufficiently
9 distinct from the claimed design that the complaint does not state a plausible claim for
10 infringement.2 Accordingly, the motion to dismiss this claim is granted, and because the
11 plain distinctions between the two designs would render amendment futile, the dismissal
12 is with prejudice.
13 B. ‘519 Patent
14 The result is the same for NuVasive’s claim of infringement of the ‘519 Patent. Once
15 again, Alphatec identifies numerous differences with this comparison of the claimed design
16 and accused product pasted from Alphatec’s motion:
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Because “an illustration depicts a design better than it could be by any description and a description
27 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
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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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1 dissimilarities between the claimed design and accused product, the dismissal is with
2 prejudice.
3 IV. Conclusion
4 In light of the foregoing, it is hereby ORDERED that Alphatec’s motion to dismiss
5 is GRANTED. Further, because amendment would be futile, Claims VII and VIII are
6 therefore DISMISSED WITH PREJUDICE. Alphatec shall file and serve its answer to
7 the remaining claims in the complaint on or before May 21, 2018.
8 It is SO ORDERED.
9 Dated: May 14, 2018
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