Case 3:12-cv-02738-CAB-MDD Document 270 Filed 10/20/15 PageID.21781 Page 1 of 12
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
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` Case No.: 12-cv-2738-CAB (MDD)
`
`ORDER GRANTING
`COUNTERDEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OF
`NON-INFRINGEMENT OF U.S.
`DESIGN PATENT NO. 652,922
`
`Plaintiffs,
`
`WARSAW ORTHOPEDIC, INC.,
`MEDTRONIC SOFAMOR DANEK
`U.S.A., INC., MEDTRONIC PUERTO
`RICO OPERATIONS CO., and
`OSTEOTECH, INC.,
`
`v.
`NUVASIVE, INC.,
`
`Defendant.
`
`AND RELATED COUNTERCLAIMS.
`
`
`
`Before the Court is the motion for Summary Judgment of Non-Infringement of U.S.
`Design Patent No. 652,9221 (“the ‘922 patent”) brought by plaintiffs/counterdefendants,2
`collectively “Warsaw”. [Doc. No. 207, 246 (sealed).] The motion was opposed by
`defendant/counterclaimant NuVasive, Inc. [Doc. No. 248 (sealed).] Warsaw filed a reply.
`
`                                                                 
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`1 A copy of the patent is attached as Exhibit G to the Second Amended Counterclaim. [Doc. No. 85-7.]
`2 The Plaintiffs/Counterdefendants are Warsaw Orthopedic, Inc., Medtronic Sofamor Danek U.S.A.,
`Inc., Medtronic Puerto Rico Operations Co., Osteotech, Inc., Medtronic, Inc., Medtronic Sofamor Danek
`Deggendorf, Gmbh, Medtronic Logistics, LLC, Medtronic Xomed, Inc., and Spinalgraft Technologies,
`LLC.
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`[Doc. No. 251 (sealed).] The Court held a hearing on the motion and, having considered
`the submissions of the parties and the arguments of counsel, the motion is GRANTED.
`I.
`Background
`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). NuVasive is the assignee of the ‘922 patent for an ornamental design
`for a dilator. [Doc. No. 85-7, Claim.] The dilator is a tube used to gradually dilate tissue
`to create initial access into a patient for performing surgical procedures. NuVasive asserts
`that Warsaw’s 16mm NIM-Eclipse Direct Lateral Dilator infringes the ‘922 patent.
`The sole figure of the ‘922 patent is reproduced below:
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`The figure shows a perspective view of a dilator. The patent description explains
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`that:
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`The broken lines illustrate part of the distal portion that forms no part of the
`claimed design. The dilator is circular as seen from the end. The break line
`is shown at the wide end to indicate that only the distal portion of the dilator
`is illustrated. Only one view of the article is shown in the drawing or
`described in the specification. It is understood that the appearance of any part
`of the article not shown in the drawing or described in the specification forms
`no part of the claimed design.
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`[Id., Description.] The figure includes a cylindrical main body, a tapered section, and a
`rectangular surface indicium on the tapered section of the cylindrical main body at the
`distal edge. This indicium corresponds to the edges of an electrode that allows a user to
`detect and avoid nerves when employing the dilator in a surgical procedure. [Doc. No. 239,
`¶5.]
`On October 16, 2013, Warsaw filed a petition requesting inter partes review of the
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`‘922 patent, arguing the patent was invalid under 35 U.S.C. §§ 102 and 103. Warsaw
`challenged the patentability of the ‘922 patent, in part, on the basis that its features are
`purely functional. See Richardson, 597 F.3d at 1293-94 (if a patented design is primarily
`functional rather than ornamental, the patent is invalid). “When the design also contains
`ornamental aspects, it is entitled to a design patent whose scope is limited to those aspects
`alone and does not extend to any functional elements of the claimed article.” Id. at 1294.
`The Patent Trial and Appeal Board of the Patent and Trademark Office (“PTAB”)
`construed the claim of the ‘922 patent to separate its functional and ornamental aspects.
`See OddzOn Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396, 1405 (Fed. Cir 1997) (where a
`design contains both functional and non-functional elements, the scope of the claim must
`be construed in order to identify the non-functional aspects of the design as shown in the
`patent). The PTAB construed “the claim of the ‘922 patent to be the ornamental design of
`a dilator, including, as seen in the figure, a Cylindrical Main Body, a Tapered Section
`extending from the distal end of the Cylindrical Main Body, and Surface Indicia/Electrode
`on the Tapered Section in the shape of a rectangle, with one side of the rectangle being
`extensive with the distal edge of the Tapered Section.” [Doc. No. 174-6, at 8-9.]3
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`3 Page references are to the docketed CM/ECF assigned page numbers of a document.
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`The PTAB rejected Warsaw’s contention that the design was primarily functional
`and found that the tapered section and the surface indicia/electrode are not purely
`functional elements of the claimed design. The PTAB determined that the function of the
`tapered section, to aid in tissue penetration of the surgical dilator, could be accomplished
`by tapering shapes having different ornamental appearances. The Administrative Patent
`Judge (“APJ”), by way of example, found that the “more rounded shape of tapering” used
`in a prior art dilator tube depicted in U.S. Patent No. 5,171,279, Fig. 4B, “differs noticeably
`from the frustoconical tapered section of the dilator claimed in the ‘922 patent.” [Doc.
`No. 174-6, at 7.]
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`Similarly, with regard to the nerve detection function of an electrode on the tapered
`section of the dilator, the PTAB determined that that function could be accomplished using
`electrodes that have substantially different shapes and orientations, and therefore
`substantially different ornamental appearances. [Id.] Again by way of example, the APJ
`compared the triangular-shaped electrode employed on NuVasive’s currently available
`dilator with the rectangular-shaped electrode of the design. [Id., at 6-7.] The PTAB
`declined to institute inter partes review.
`Following the PTAB decision, the parties briefed the issue of claim construction for
`this Court’s consideration. The Court adopted the PTAB’s construction for the purpose of
`identifying the non-functional aspects of the design as shown in the patent. [Doc. No. 183,
`Transcript of Hr’g., at 66-69.] Warsaw now moves for summary judgment of non-
`infringement on the basis that the design features of the accused dilator and the ‘922 patent
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`are sufficiently distinct and plainly dissimilar, such that NuVasive cannot prove
`infringement as a matter of law.
`II. Legal Framework
`Pursuant to Fed. R. Civ. P. 56(a), summary judgment is appropriate when “there is
`no genuine issue as to any material fact and the moving party is entitled to judgment as a
`matter of law.” Material facts are those that may affect the outcome of the case. See
`Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A dispute as to a material fact
`is genuine if there is sufficient evidence for a reasonable jury to return a verdict for the
`non-moving party.
`The moving party bears the burden to show that no genuine issue of material fact
`exists. See Celotex Corp. v. Caltrett, 477 U.S. 317, 323-24 (1986). If this burden is met,
`the burden shifts to the non-moving party to set forth affirmative evidence from which a
`jury might return a verdict in its favor. All evidence must be viewed in the light most
`favorable to the non-moving party. At this stage, a court does not assess the credibility or
`weigh the evidence, but simply determines whether there is a genuine factual issue for trial.
`Anderson, 477 U.S. at 249.
`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). The patentee must
`prove by a preponderance of the evidence that 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. Richardson, 597 F.3d at 1295.
`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.
`Egyptian Goddess, 543 F.3d at 678. If the claimed and accused designs are not plainly
`dissimilar, the inquiry may benefit from comparing the claimed and accused designs with
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`prior art to identify differences that are not noticeable in the abstract but would be
`significant to the hypothetical ordinary observer familiar with the prior art. Id.
`When the claimed design includes several elements, the ordinary observer test must
`be applied by comparing similarities in overall designs, not similarities of ornamental
`features in isolation. Richardson, 597 F.3d at 1295. Similarity at a conceptual level,
`however, is not sufficient to demonstrate infringement of the claimed designs. See OddzOn,
`122 F.3d at 1405 (claim must be limited to the overall ornamental visual impression, rather
`than to the broader general design concept).
`The claimed design does not cover the universe of designs that remotely resemble
`the basic design. The patent protects the ornamental features the patentee chooses and
`leaves other ornamental design features to the imagination of other designers. See Sofpool
`LLC v. Kmart Corp., 2013 WL 2384331, *1, 5 (E.D. Ca., May 30, 2013) (the patent protects
`the shapes and proportions the patentee chooses, not every conceivable shape and
`proportion that could arise from its basic design.)
`III. Discussion
`The design claimed in the ‘922 patent and the accused design of Warsaw’s 16mm
`NIM-Eclipse Direct Lateral Dilator are reproduced below.
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`Both dilators have a cylindrical main body, with a tapered section extending from
`the distal end of the cylindrical main body, and an electrode on the tapered section
`extensive with the distal edge of the tapered section. NuVasive argues that there is an
`overall appearance of sameness between the accused dilator and the patented design, or at
`least there is a factual dispute as to the sameness precluding the grant of summary
`judgment. NuVasive’s assessment of sameness, however, as discussed below, is based on
`the general design concept and functionality of the devices. It disregards the actual overall
`visual differences in the ornamental aspects of the design and the accused dilator.
`The patentee must show that the perceived similarity is based on the ornamental
`features of the design. “The patentee must establish that an ordinary person would be
`deceived by reason of the common features in the claimed and accused designs which are
`ornamental.” OddzOn, 122 F.3d at 1405.
`NuVasive provides the opinion of Dr. Hansen Yuan, a surgeon familiar with the
`selection and use of dilators in surgery, and identifies him as an ordinary observer. Dr.
`Yuan contends that the ordinary observer is a surgeon who would not notice the ornamental
`differences between the accused dilator and the patented design and would consider the
`devices interchangeable. [Doc. No. 246-5 (sealed), Infringement Report of Dr. Yuan, ¶34.]
`In his report, Dr. Yuan describes how a surgeon selects a dilator during surgery.
`According to him, a representative of a medical device company, such as Warsaw or
`NuVasive, is present during surgery with kits containing devices such as the accused dilator
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`that may be needed during the surgical procedure. The representative would typically
`know what devices are used in the procedure and would have the devices available and
`ready at the start of surgery. When the surgeon requests a stimulated dilator, the medical
`device representative provides the instrument from his or her company’s kit. [Doc. No.
`246-5, ¶¶31-32.]
`In this context, Dr. Yuan’s analysis then focuses on the functional similarities
`between the accused dilator and the dilator design. He concludes that as long as the design
`differences do not impact the functionality of the dilator, the surgeon simply would not be
`looking for them and would not notice or appreciate them. [Id., ¶34; Doc. No. 248, at 11.]
`In his opinion, even fairly dramatic changes in the size, shape, or location of the electrode,
`or the degree of the taper of the tip, are not meaningful as long as they do not impact
`functionality. [Id., at 6.]
`It is NuVasive’s contention that these features, the actual design choices that the
`patent protects, such as the shape of the electrode, the precise location of the electrode, or
`the degree of taper, are “minor differences” that do not defeat the substantial similarity
`between the two dilators, because they ultimately do not impact the functionality of the
`dilator. As long as the functionality of the two dilators is interchangeable, differences in
`design are irrelevant and the structural overall visual impression is sufficiently similar
`because one dilator could be used as well as the other. [Doc. No. 246-5, ¶40; Doc. No.
`248, at 11.]
`The Court finds that Dr. Yuan’s infringement opinion that the accused dilator and
`the design are functionally interchangeable does not assist in the analysis of the similarity
`of the ornamental aspects of the accused dilator and the patented design. Dr. Yuan
`concludes that he would not notice or care about the design differences, despite
`acknowledging that there are visible differences, because he considers the patented design
`and the accused dilator functionally interchangeable. It is however the very features that
`he disregards as minor that the patent protects.
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`Dr. Yuan recognizes that the electrode on the accused dilator is “skinnier and longer
`than the surface marking shown in the NuVasive design patent” and that it “extends slightly
`above the shoulder of the taper, rather than terminating slightly below it,” but he concludes
`that a typical surgeon would not notice or appreciate these variations.4 A typical surgeon,
`he states, “might notice whether or not an electrode is present, and perhaps its general shape
`(such as rectangular or triangular). But beyond that, variations in the dimensions of the
`electrode are not something that a typical surgeon would notice or appreciate at the time of
`purchase or use of the dilator (i.e., right before or during surgery.)” [Id., ¶40.]
`However, as the PTAB stated, the shape and orientation of the electrodes are the
`design elements covered by the patent, not simply the presence or absence of an electrode
`on the tapered section. [Doc. No. 174-6, at 8 (the surface indicia/electrode is not purely
`functional as its function can be accomplished by different shapes and orientations).] A
`design patent protects the ornamental features the patentee chooses, not every conceivable
`shape of the basic design. See Sofpool, 2013 WL 2384331, *5. In this case, the designer
`of the ‘922 patent selected the shape of a rectangle for the electrode that is oriented
`extensive to the distal edge of the tapered section and terminates short of the cylindrical
`main body. In contrast, the accused device utilizes a narrow strip with a curved end for the
`shape of the electrode that is oriented extensive to the distal edge of the tapered section but
`terminates past the tapered section on the cylindrical main body.
`Dr. Yuan also recognizes that the accused dilator has numbered depth markings
`along the main body of the dilator and that the claimed design has no such markings. He
`discounts this difference on the basis that the depth markings on the accused dilator are
`almost entirely functional, not ornamental, and therefore need not be considered. “Any
`ornamental aspect of these particular markings is minimal, and thus of minor importance
`in the ultimate infringement analysis.” [Doc. No. 246-5, ¶41.] He also asserts that the depth
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`4 The electrode on the accused dilator is also not rectangular in shape, but has a curved fourth side. Dr.
`Yuan’s opinion does not address this.
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`markings on the accused dilator, which he describes as an intermediate dilator, are not
`generally used by a surgeon and would be ignored. He therefore simply disregards this
`plainly visible dissimilarity. [Id., ¶42.]
`Although such markings have a functional purpose, they can also have an
`ornamental aspect. As Warsaw demonstrated in its reply brief, different fonts, sizes, styles,
`and locations can be selected by the designer of a dilator to implement the functional aspect
`of depth markings. [Doc. No. 251, at 16.]
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` These choices are no less design choices than the selection of the size, shape and
`orientation of the electrode, or the shape and slope of the tapered tip of the dilator. Each
`aspect of the dilator has a functional purpose but can be expressed by a particular design
`selection. In the case of the patented design, the designer opted for no markings on the
`main body of the dilator. The difference between the accused device and the patented
`design is not an insubstantial difference between font selections. 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.
`Dr. Yuan makes no reference in his opinion to the visual difference between the
`shape of the tapered section of the accused dilator and the patented design. The PTAB, in
`its assessment of the patentability of the ‘922 design, specifically noted that there is a
`design aspect regarding the implementation of the functional purpose of the tapered end
`that makes the design patentable. To demonstrate that design aspect, the APJ described as
`noticeably different the more rounded shape of tapering used in a prior art dilator tube
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`compared to the frustoconical tapered section of the dilator claimed in the ‘922 patent.
`[Doc. No. 174-6, at 7.]
`The Court recognizes that the tapered portion of the accused dilator resembles that
`prior art design described as noticeably different than the ‘922 design.
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`Egyptian Goddess, 543 F.3d at 681 (“An ordinary observer, comparing the claimed and
`accused designs in light of the prior art, will attach importance to differences between the
`claimed design and the prior art depending on the overall effect of those differences on the
`design.”)
`Observing the overall ornamental aspects of the ‘922 design patent in comparison to
`the accused device, they are plainly dissimilar. NuVasive offered no evidence that an
`ordinary observer aware of the prior art would find the overall ornamental aspects of the
`design and the accused device to be substantially similar. See Richardson, 597 F.3d at
`1295 (from the perspective of an ordinary observer familiar with the prior art, there must
`be substantial similarity in the overall visual effect of the accused device and the patented
`design).
` Dr. Yuan’s opinion that the design dissimilarities are minor because they do not
`impact the functionality of the dilator does not create a material dispute. His opinion as to
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`the similarity of the design and the accused device is not based on the protected ornamental
`features, which he asserts he would not notice, but on the similarity of the broader general
`design concept that he concludes makes the dilators functionally interchangeable.5
`Functional interchangeability is not the proper test, and a jury cannot find infringement
`based on Dr. Yuan’s opinion of functional similarity. NuVasive has not met its burden to
`demonstrate a substantial similarity of the protected ornamental features.
`IV. Conclusion
`The overall ornamental aspects of the 16mm NIM-Eclipse Direct Lateral Dilator are
`not substantially similar to those of the ‘922 patent design. The Court finds that NuVasive
`cannot establish by a preponderance of the evidence that an ordinary observer would be
`deceived into thinking that the accused device is the same as the patented design. Warsaw’s
`motion for summary judgment of non-infringement is GRANTED.
`IT IS SO ORDERED.
`
`Dated: October 20, 2015
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`                                                                 
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`5 As part of its motion for summary judgment, Warsaw also moved to exclude Dr. Yuan’s opinion as
`legally erroneous. [Doc. No. 246, at 22-27.] The Court considered Dr. Yuan’s opinion and found it did
`not inform the analysis. Warsaw’s request to exclude is deemed moot.
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