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`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF CALIFORNIA
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`WARSAW ORTHOPEDIC, INC.,
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`Plaintiff,
`
`v.
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`NUVASIVE, INC.,
`
`
`
` Case No.: 12-CV-2738-CAB-MDD
`
`ORDER GRANTING MOTION FOR
`SUMMARY JUDGMENT
`
`
`Defendant.
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`[Doc. Nos. 207, 214, 218]
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`Before the Court is defendant NuVasive’s motion for summary judgment of non-
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`infringement of U.S. Patent No. 5,676,146 (“the ‘146 patent”). [Doc. Nos. 218, 247-1.]1
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`Plaintiffs (collectively “Warsaw”) opposed. [Doc. No. 236.] NuVasive submitted a reply
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`[Doc. No. 250-1], and the Court held oral argument. Having considered the submissions
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`of the parties and the arguments of counsel, the motion is GRANTED.2
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`
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`
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`1 All page references to docket entries correspond to the CM/ECF assigned page numbers for the docketed
`material.
`2 In light of the Court’s finding of non-infringement of the asserted claims, the Court declines to reach the
`defendant’s alternative arguments regarding improper claim broadening and invalidity, as well as its
`motion on damages. [Doc. No. 214.] These motions are deemed moot. In addition, the pending motions
`seeking to exclude the opinions of experts [Doc. Nos. 207, 214] are denied.
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`I.
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`The Patented Invention and the Accused Product
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`The invention of the ‘146 patent is directed to a surgical implant containing a
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`resorbable radiopaque marker and a method of locating the implant within a body. [Doc.
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`No. 1-2.] The implant, which can be used to repair skeletal defects and irregularities,
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`incorporates radiopaque material, e.g., nondemineralized or partially demineralized bone
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`particles, which is resorbable in its entirety and may contribute to the healing of bone
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`through natural processes. [Id., at Col. 1:30-40.] This radiopaque material is distributed in
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`radiolucent resorbable or non-resorbable material, during the manufacture of the implant
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`such that the radiopaque material serves as a marker, which can be visualized by x-ray or
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`other radiographic technique, facilitating the determination of the location and/or position
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`of the implant within a body. [Id., at Col. 1:44-48; Col. 3:4-10.]
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`NuVasive makes and sells a product called Osteocel Plus, an allograft bone matrix.
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`[Doc. No. 247-2.] Osteocel Plus is used for the repair, replacement or reconstruction of
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`musculoskeletal defects in a variety of surgical and implant applications. Warsaw accuses
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`this product of direct infringement, and also alleges that NuVasive’s sale and instruction
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`regarding the use of this product as a surgical implant constitutes indirect infringement.
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`The components of Osteocel Plus include cancellous bone chips, demineralized
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`bone, and mesenchymal stem cells and osteoprogenitor cells. NuVasive promotes this
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`product as a complete “cocktail” for various musculoskeletal applications to support fusion
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`due to its inclusion of these three components necessary for bone healing; cells (the
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`mesenchymal stem cells and osteoprogenitor cells), signals (the demineralized bone) and
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`scaffold (the cancellous bone chips). [Id., at 3.] Osteocel Plus is packaged by placing the
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`cancellous bone particles which include the cells in a jar, adding the demineralized bone to
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`the jar and then mixing them with a cryopreservation solution for frozen storage. [Doc.
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`No. 247-6.]
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`NuVasive contends that the evidence Warsaw relies upon to support its allegations
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`of infringement does not demonstrate that Osteocel Plus meets the limitations of the
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`asserted claims. NuVasive therefore moves for a judgment of non-infringement as a matter
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`of law.
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`II. Legal Standard
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`Under Federal Rule of Civil Procedure 56(a), “the court shall grant summary
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`judgment if the movant shows that there is no genuine dispute as to any material fact and
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`the movant is entitled to judgment as a matter of law.” The moving party has the burden
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`of establishing the absence of a genuine dispute of material fact. The court must view the
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`evidence in the light most favorable to the non-movant and draw all reasonable inferences
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`in the non-movant’s favor. Matsushita Elec. Inds. Co. Ltd., v. Zenith Radio Corp., 475
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`U.S. 574, 587 (1986). Where the record taken as a whole could not lead a rational trier of
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`fact to find for the nonmoving party, there is no genuine issue for trial. Id.
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`After an adequate time for discovery, a motion for summary judgment is appropriate
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`against a party who fails to make a showing sufficient to establish the existence of an
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`element essential to that party’s case, and on which that party will bear the burden of proof
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`at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986) (holding that the moving
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`party is entitled to a judgment as a matter of law if the nonmoving party fails to make a
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`sufficient showing on an essential element of its case with respect to which it has the burden
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`of proof).
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`Determining whether a patent claim is infringed requires a two-step inquiry: first,
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`the claim must be properly construed to determine its scope and meaning; second, the claim
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`as properly construed must be compared to the accused device or method. See Wolverine
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`World Wide, Inc., v. Nike, Inc., 38 F.3d 1192, 1196 (Fed. Cir. 1994). The party alleging
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`infringement bears the burden of proving by a preponderance of evidence that every
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`limitation set forth in the asserted claim is found in accused product or process, either
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`literally or by substantial equivalent. Id.3
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`III. The Asserted Claims
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`
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`Warsaw alleges NuVasive’s Osteocel Plus product infringes the following claims of
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`the ‘146 patent [Doc. No. 1-2.].
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`13. A method of determining the location and/or orientation of an osteogenic
`surgical implant within a body which comprises:
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`a) surgically implanting within a body an osteogenic implant fabricated
`from a radiolucent material comprising allograft bone particles and an
`radiopaque material comprising particles of nondemineralized or partially
`nondemineralized allograft bone, the radiopaque material being uniformly
`distributed within the radiolucent material, wherein the radiopaque
`material is provided in sufficient quantity for use as a marker; and
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`b) post-surgically determining the location and/or orientation of the
`implant by a radiographic technique.
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`15. The method of claim 13 wherein the radiographic technique is x-ray
`imaging.
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`21. An osteogenic surgical implant for surgical implantation in the body, the
`implant comprising particles of a
`radiolucent material
`including
`demineralized allograft bone particles in substantially uniform admixture with
`a radiopaque material including particles of nondemineralized or partially
`demineralized allograft bone, wherein the radiopaque material is provided in
`sufficient quantity for use as a marker.
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`25. An osteogenic surgical implant for surgical implantation in the body
`comprising nondemineralized or partially demineralized allograft bone
`particles and demineralized allograft bone particles uniformly distributed in
`an inert carrier, the nondemineralized or partially demineralized allograft
`bone particles being provided in sufficient quantities for use as a marker, the
`surgical implant being stored in a package for subsequent implantation.
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`
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`3 In its opposition to NuVasive’s motion, Warsaw withdrew its allegations of infringement by the doctrine
`of equivalence [Doc. No. 236, at 13], so the analysis herein is limited to sufficiency of Warsaw’s evidence
`of literal infringement of the claims at issue.
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`26. An osteogenic surgical implant for surgical implantation in the body, the
`implant comprising particles of a radiolucent material in substantially uniform
`admixture with particles of nondemineralized or partially demineralized bone,
`wherein the particles of nondemineralized or partially demineralized bone are
`provided in sufficient quantities for use as a radiopaque marker, the surgical
`implant being stored in a package for subsequent implantation.
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`Each of the asserted independent claims is directed at a surgical implant that includes
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`in its composition radiopaque material (nondemineralized or partially nondemineralized
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`allograft bone) which is uniformly distributed throughout or in a substantially uniform
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`admixture with radiolucent material, in sufficient quantity for the radiopaque material to
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`act as a marker for the determination of the location and/or orientation of the implant after
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`surgical implantation in the body.
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`IV. Claim Construction and Reexamination Proceedings
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`The parties submitted certain terms and phrases for claim construction, including the
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`phrase uniformly distributed within. However, they withdrew their request for construction
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`of uniformly distributed, sought only the construction of the word within. Although the
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`plain meaning of within would ordinarily be “inside,” in the context of the patent disclosure
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`the Court found such a construction to be nonsensical. It is clear from the specification
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`that the radiopaque material is uniformly distributed throughout the radiolucent material
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`comprising the implant. The patent does not teach putting the radiopaque material inside
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`the radiolucent material; such a construction would be illogical. Consequently, to the
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`extent the word within results in any ambiguity the Court construed it to mean in this
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`context, throughout. [Doc. No. 143.]
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`The invention of this patent is directed at fabricating an otherwise radiolucent
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`surgical implant with sufficient radiopaque material distributed throughout it, such that the
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`implant can be readily visualized by x-ray or other radiographic technique following
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`implantation in the body. The Court also found that individuals of skill in the art will
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`understand that the limitation that the particles of nondemineralized or partially
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`demineralized bone be provided in sufficient quantity for use as a marker means the
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`quantity of radiopaque material used in the implant must be adequate to allow for the ready
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`visualization by x-ray or other radiographic technique of the implant after implantation. Id.
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`Following the issuance of the Court’s claim construction order, NuVasive filed a
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`request for ex parte reexamination by the Patent Office of the ‘146 patent. [Doc. No. 229-
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`6, at 2-17.]4 All the asserted claims were subject to NuVasive’s request for reexamination
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`contending the claims were unpatentable under 35 U.S.C. §103. The examiner instituted
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`the reexamination and initially rejected the asserted claims in light of the prior art submitted
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`by NuVasive. [Id. at 62.]
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`In response to the prior art presented in the reexamination, Warsaw submitted
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`argument and declarations from experts with regard to the meaning and scope of the claim
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`terms uniformly distributed and substantially uniform admixture and the claim limitation
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`that the particles of nondemineralized or partially demineralized bone be provided in
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`sufficient quantity for use as a marker. Specifically, Dr. Barton Sachs stated, on behalf of
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`the patent owner, that to distinguish over prior art references, art that disclosed making a
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`composite graft of demineralized and non-demineralized bone and the taking of post-
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`surgical x-rays is not sufficient to demonstrate that the radiopaque material functioned as
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`a marker as required by the claims. “[T]here are several variables that are required for the
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`cancellous tissue to have been able to function as a marker, including the distribution and
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`positioning of the radiopaque material, the ratio and volumes of radiopaque and radiolucent
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`material, the components selected, and the size and processing of component. The
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`processing of product is key.” [Id., at 79-80.]
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`Dr. Sachs explained that it is difficult to evenly mix particles of different sizes and
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`densities to achieve the substantially uniform admixture or a uniform distribution as
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`described in the patent, and particularly impractical in an operating room environment. [Id.
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`at 76, 93-94.] According to Dr. Sachs, “[a] uniform composite graft instead would need to
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`4 The Court denied NuVasive’s request to stay this litigation while the claims were in reexamination, so
`the Patent Office proceeding and the District Court litigation continued as parallel proceedings for a while.
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`be created in a tissue processing lab using measured quantities of materials, which are
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`consistent, following a reproducible, predictable processing procedure.” [Id. at 76.]
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`Dr. Sachs further represented that there is a fundamental distinction between having
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`an individual component that is radiopaque and having the radiopaque portion function as
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`a marker for the entire graft. The reason, he explained, that the asserted claims required a
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`uniform distribution of the radiopaque material in the graft or that the graft be a
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`substantially uniform admixture is to ensure that the graft as a whole is readily visible in a
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`radiograph. [Id. at 186.] “Unless the radiopaque material is properly mixed and there is a
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`sufficient quantity of the material, the material itself could be radiopaque, but would not
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`serve as a marker for the implant as a whole. … The radiopaque material must be uniformly
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`distributed and/or be a substantially uniform admixture.…” [Id. at 185.] If, for example,
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`the radiopaque material is concentrated to one side it would be difficult to locate or orient
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`the implant post-implantation. He emphasized to the patent examiner that prior art did not
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`disclose the proper volume and size of the radiopaque material, the correct ratio to the
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`radiolucent material, and the uniform distribution of the radiopaque material throughout
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`the whole of the composite graft, all of which are needed for the radiopaque material to act
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`as a marker for the determination of the location and/or orientation of the surgical implant.
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`[Id. at 186.]
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`Based on the patent owner arguments, including Dr. Sachs’ declaration, the patent
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`examiner reversed his earlier rejection of the claims. [Id. at 236-241.] Confirming the
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`asserted claims over the prior art, the examiner concluded that the prior art did not teach
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`radiopaque material being uniformly distributed within or in substantially uniform
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`admixture with the radiolucent materials. The examiner adopted the patent owner’s
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`explanation that to function as a marker, as claimed in the patent, a sufficient quantity of
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`radiopaque material must be uniformly distributed, one type of particle relative to the other
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`type of particle, in an arrangement throughout the implant. Disclosures that taught mixing
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`alone of the particles did not sufficiently disclose this limitation. [Id. at 239-240.]
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`Prosecution history is an important part of the intrinsic record relevant to claim
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`construction. Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). Statements
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`made by Warsaw in the reexamination proceeding are relevant to the interpretation of key
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`terms. See e.g., Evolutionary Intelligence, LLC v. Sprint Nextel Corp., No. C-13-03587,
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`2014 WL 4802426, at *4 (N.D. Cal. Sept. 26, 2014) (“Statements made by [the patent
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`holder] during the IPR could disclaim claim scope, aid the court in understanding the
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`meaning of the terms, or otherwise affect the interpretation of key terms.”). In light of the
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`patent holder’s representations, made and adopted in the reexamination proceeding to
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`distinguish over prior art, this Court construes the claim limitation that the radiopaque
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`material be uniformly distributed within or in substantially uniform admixture with the
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`radiolucent material as requiring more than the two components being mixed together. To
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`be uniformly distributed within or in substantially uniform admixture, the component
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`particles must be arranged consistently one type of particle relative to the other type of
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`particle throughout the combination.
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`The patent owner further represented that this uniformity of distribution of the
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`radiopaque material relative to the radiolucent material in the implant is important to
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`establish the marker limitation. While some quantity of radiopaque material in the implant
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`may provide visualization by x-ray or other radiographic technique after implantation,
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`visualization alone does not necessarily meet the marker limitation. To act as a marker,
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`i.e., provide for the determination of the location and/or orientation of the surgical implant,
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`the radiopaque material must also be uniformly distributed throughout the entire implant
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`to provide for visualization of the whole implant, not just a portion of it. The phrase
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`provided in sufficient quantity for use as a marker is therefore further defined to mean the
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`quantity of radiopaque material used in the implant must be adequate to allow for the ready
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`visualization by x-ray or other radiographic technique of the implant as a whole after
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`implantation.
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`V.
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`Infringement Analysis
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`With fact and expert discovery now closed, Warsaw must demonstrate that the
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`accused product meets the uniform distribution or substantially uniform admixture claim
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`limitation. To that end, the evidentiary support for Warsaw’s contention that NuVasive’s
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`Osteocel Plus product infringes the claims of the ‘146 patent is set forth in the expert report
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`of Julie Glowacki, Ph.D. [Doc. No. 247-10.] Dr. Glowacki opines that the radiopaque
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`component in Osteocel Plus is uniformly distributed or in substantially uniform admixture
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`with the radiolucent component based on her review of Osteocel Plus marketing materials
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`and its processing protocol. [Id. ¶¶76-81.] Dr. Glowacki’s conclusion is based on the
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`following evidence identified in her report [Id. ¶¶76-82]:
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`1) Osteocel Plus is marketed as a “complete ‘cocktail’” with viable stem cells
`“well integrated within the matrix.” [Doc. No. 247-2, at 3; Doc. No. 247-23,
`at 44.] Further, a NuVasive witness testified that surgeons are instructed to
`use the whole product as both components in the product, the demineralized
`material and cancellous material, are important. [Doc. No. 247-7, at 35.]
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`2) During processing the product is “shake[n] vigorously to mix.” [Doc. No.
`247-4, at 15.] Further NuVasive represented its development team was
`“working towards packing and formulation improvements which may help
`ensure a consistent, homogenous product.” [Doc. No. 247-24, at 3.]
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`3) Surgeons are informed that “once thawed Osteocel Plus will settle to the
`bottom of the container.” They are instructed when filling an implant cage
`with the product or packing a disc space, to deliver Osteocel Plus using a
`spatula and to “scoop product from the jar rather than pick up individual
`pieces to assure delivery of homogenous mixture.” [Doc. No. 247-2, at 3.]
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`After reviewing this evidence, the Court finds that none of it actually supports Dr.
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`Glowacki’s conclusion.
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`A. The Description of Osteocel Plus as a Complete Solution Does Not
`Support the Conclusion the Product Meets the Claim Limitation.
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`It is undisputed that the Osteocel Plus matrix is comprised of demineralized bone
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`matrix (“DBM”) and cancellous bone chips (non-demineralized bone particles) which
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`contain human stem cells. NuVasive markets this combination as a “complete cocktail”
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`because it provides all three components necessary for bone repair. [Doc. No. 247-2, at 3.]
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`The cancellous bone chips are processed to retain viable stem cells within the chips, the
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`stem cells thereby being well integrated within the matrix. [Doc. No. 247-23, at 44; 247-3,
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`at 9-11.] These representations by NuVasive, that Osteocel Plus is a medically complete
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`solution, however do not support Dr. Glowacki’s conclusion that the combination of these
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`components in the mixture necessarily meets the limitation of uniform distribution or
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`substantially uniform admixture to provide a marker.
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`Warsaw itself has argued the contrary conclusion with regard to prior art practices.
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`According to Warsaw’s expert Dr. Sachs, creating composite implant that maximizes
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`biological activity is in “contra-distinction” to creating a composite implant that meets the
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`limitation of uniform distribution or substantially uniform admixture needed for the
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`cancellous material to act as a marker for the entire implant. [Doc. 229-6, ¶20.] Dr. Sachs
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`states that a matrix that includes the elements necessary for bone repair does not necessarily
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`have the desired level of uniformity required by the patent. “To achieve the maximum
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`benefits associated with each of the components of the composite graft, having a
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`substantially uniform admixture or a uniform distribution of the materials is not necessary.
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`. . . [T]he materials must simply be brought together, ensuring that all of the DBM, for
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`example, is not in a single place. . . . [H]aving a substantially uniform admixture or a
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`uniform distribution of the materials in the graft, generally, is not medically beneficial.”
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`[Doc. No. 247-11, at 20-21.]
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`NuVasive’s marketing statements regarding the medical benefits of the accused
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`composite product are not sufficient evidence from which one can conclude that Osteocel
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`Plus meets the claim limitation of uniform distribution or substantially uniform admixture.
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`The fact the components are present in combination, as Dr. Sachs notes, does not
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`demonstrate that they are necessarily present in uniform distribution throughout the
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`implant. Nor do the materials Dr. Glowacki relies upon, which speak to the medical
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`benefits of the combined components, make any mention that the cancellous material is or
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`should be distributed uniformly relative to the DBM throughout the whole implant so it
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`can act as marker to determine the location and/or placement of the implant.
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`B. The Packaging Protocol for Osteocel Plus Does Not Support the
`Conclusion the Product Meets the Claim Limitation.
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` The protocol for the packaging of Osteocel Plus instructs that the nondemineralized
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`cancellous bone is measured and placed in a jar, the DBM is measured and placed on top,
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`and then a cryoprotectant solution is added to cover both bone products. The jar is covered
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`and vigorously shaken to mix, and visually inspected to ensure that all bone product is
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`submerged in the cryoprotectant solution. [Doc. No. 247-4, at 8-16.] Based on this
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`protocol, Dr. Glowacki concludes that this processing step results in a product that meets
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`the limitation of uniform distribution or substantially uniform admixture.
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`Dr. Glowacki contends that this shaking step is performed to ensure “proper mixing”
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`of all the components.” [Doc. No. 427-10, ¶78.] By “proper mixing,” she infers that the
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`shaking step is intended to and results in a uniform distribution or substantially uniform
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`admixture of the bone products within the jar. The protocol however makes no reference
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`to achieving a proper mix of the two bone components in a consistent particle to particle
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`arrangement in the jar. Nor does it disclose any inspection or testing steps to confirm such
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`a result.
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` This processing step of “vigorous shaking” is performed after the cryoprotectant
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`solution is added. The jar is capped and shaken to ensure all the bone product is submerged
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`in the solution before freezing. [Doc. No. 247-4, at 15-16.] Frank Vizesi, Ph.D.,
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`NuVasive’s Manager of Research and Development for Biologics, testified that “the
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`vigorous shaking step is to ensure the cryoprotectant is fully engaged with the particles,
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`with the -- with the cancellous bone and the DBM.” [Doc. No. 247-7, at 35.]
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`What constitutes “vigorous” and how long the technician should shake the jar is not
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`set forth in the processing protocol. The specific implementation of this mixing step is left
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`to the discretion of the individual technician governed only by the visual assessment that
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`the bone products are fully submerged in the cryoprotectant solution as a result. The step
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`set forth in the protocol does not comport with Dr. Sachs’s requirement that the processing
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`procedure be a reproducible, predicable processing protocol because it is “key” to
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`achieving the uniform composite graft claimed in the invention. [Doc. No. 229-6, at 76,
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`79-80 (a uniform composite graft needs to be created in a tissue processing lab using
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`measured quantities of materials, which are consistent, following a reproducible,
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`predictable processing procedure).]
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`Dr. Glowacki provides no factual support for her conclusion that this processing step
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`-- vigorous shaking, for an unspecified amount of time -- actually results in the DBM and
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`cancellous bone mixing into a uniform distribution or substantially uniform admixture
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`throughout the jar. She has not replicated the process, performed any tests, or referred to
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`any publications or other authority that this protocol results in a mixture sufficient to meet
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`the claim limitation, requiring a consistent particle to particle arrangement throughout the
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`composition. Thus, the ultimate conclusion in her report does not create a genuine factual
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`dispute sufficient to defeat summary judgment. Applied Companies v. U.S., 144 F.3d 1470,
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`1475 (Fed. Cir. 1998) (an affidavit alone in the absence of evidentiary support, is
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`insufficient to create a genuine issue of material fact).
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`Moreover, Dr. Sachs on behalf of Warsaw, when discussing prior art, contends that
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`mixing by hand generally does not satisfy this limitation. Although the component parts
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`will combine by this shaking step, the two component particles of different size and density
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`are “difficult to mix evenly,” into a substantially uniform admixture or uniform
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`distribution, according to Dr. Sachs. [Doc. No. 247-11, ¶58.] For example, he notes that
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`“demineralized bone powder commonly sticks to itself and clumps when it comes in
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`contact with fluid.” [Id. ¶84.]
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`A substantially uniform admixture or uniform distribution, according to Dr. Sachs
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`and consistent with Warsaw’s representations in the reexamination proceeding, means that
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`“the components are positioned in a certain manner within the composite, relative to one
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`another, in a uniform spacing.” He opined that even a product described as a “very, very,
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`very well mixed” composition does not specify the relative position of the components to
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`each other in the mixture. [Doc. No. 247-13, at 40-42.] Dr. Sachs analogizes it to a salad
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`with slices of grilled chicken that is shaken up or mixed in a bowl. The whole composite
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`is combined, while the slices of grilled chicken may not be uniformly distributed within
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`the salad. [Id. ¶65.]
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`With regard to the protocol in this case, the shaking distributes the cryoprotectant
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`solution (the salad dressing, to continue the analogy) among the component bone particles,
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`but it is an assumption without foundation that the DBM, initially layered above the
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`cancellous bone component in the jar, and the cancellous bone will end up distributed
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`evenly and consistently relative to each other throughout the jar after fluid is added and the
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`jar is shaken. The NuVasive documentation, referenced by Dr. Glowacki, indicating that
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`NuVasive continues to work toward packing and formulation improvements which may
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`help ensure a consistent, homogenous product, further supports a conclusion that the
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`protocol does not, in fact, result in a consistent, uniform distribution. [Doc. No. 247-24, at
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`3 (emphasis added).]
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`C. The Implant Preparation Guide for Osteocel Plus Does Not Support
`the Conclusion the Product Meets the Claim Limitation
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`The processing protocol evidences that the cancellous bone particles with stem cells
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`and the DBM are present in combination submerged in the cryoprotectant solution when
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`Osteocel Plus is frozen. There is no evidence that this composition in the cryoprotectant
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`solution is in uniform distribution, or a substantially uniform admixture. Nor is there any
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`evidence that this composition would remain in uniform distribution suspended in this
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`liquid composite prior to freezing, even if the shaking step momentarily achieved such a
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` To prepare for use as an implant, the surgical user is directed to thaw the jar
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`containing the product in a warm sterile bath “until the material in the vial flows freely
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`upon inversion.” [Doc. No. 247-6, at 2.] The guide states that once thawed “Osteocel Plus
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`will settle to the bottom of the container.” Using a screen to retain the graft material in the
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`jar, the user is instructed to decant the cryopreservation solution from the jar, and then
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`cover the material with warm sterile saline until the user is ready to pack the implant cage
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`or disc space. The sterile saline is then decanted. Using a spatula, the user is directed to
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`“scoop product from the jar rather than pick up individual pieces to assure delivery of
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`homogenous mixture.” [Id., at 2-3.]
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`Dr. Glowacki c