Case 3:12-cv-02738-CAB-MDD Document 273-1 Filed 03/15/16 PageID.21816 Page 1 of 20
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`Luke L. Dauchot (S.B.N. 229829)
`luke.dauchot@kirkland.com
`Nimalka R. Wickramasekera (S.B.N. 268518)
`nimalka.wickramasekera@kirkland.com
`Sharre Lotfollahi (S.B.N. 258913)
`sharre.lotfollahi@kirkland.com
`Kirkland & Ellis LLP
`333 South Hope Street
`Los Angeles, California 90071
`Telephone: (213) 680-8400
`Facsimile: (213) 680-8500
`
`Attorneys for Plaintiffs/Counterclaim Defendants,
`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
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`
`CASE NO. 3:12-cv-02738-CAB (MDD)
`
`MEMORANDUM OF POINTS AND
`AUTHORITIES IN SUPPORT OF
`MOTION FOR CLARIFICATION
`AND RECONSIDERATION OF
`ORDER GRANTING DEFENDANT’S
`MOTION FOR SUMMARY
`JUDGMENT OF NON-
`INFRINGEMENT OF THE ’146
`PATENT
`
`April 12, 2016
`Date:
`Hon. Cathy Ann Bencivengo
`Judge:
`Courtroom: 4C
`
`PER CHAMBERS, NO ORAL
`ARGUMENT UNLESS ORDERED BY
`THE COURT
`
`)))))))))))))))))))
`
`WARSAW ORTHOPEDIC, INC.;
`MEDTRONIC SOFAMOR DANEK
`U.S.A., INC.; MEDTRONIC PUERTO
`RICO OPERATIONS CO.; and
`OSTEOTECH, INC.,
`Plaintiffs,
`
`vs.
`NUVASIVE, INC.,
`Defendant.
`
`AND RELATED COUNTERCLAIMS.
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`MEMO. ISO MOT. FOR CLARIFICATION AND RECONSIDERATION
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`TABLE OF CONTENTS
`INTRODUCTION .............................................................................................. 1
`I.
`LEGAL STANDARD ......................................................................................... 5
`II.
`III. STATEMENT OF FACTS ................................................................................ 5
`The Markman Order And Discovery ......................................................... 5
`A.
`B.
`The Reexamination Proceedings ................................................................ 6
`C.
`The Summary Judgment Order .................................................................. 9
`IV. ARGUMENT .................................................................................................... 10
`A.
`Reconsideration And Clarification Of The Summary Judgment
`Construction Is Warranted ....................................................................... 10
`Any Material Differences Between The Summary Judgment
`Construction And The POSITA Construction Warrant Reopening
`Discovery ................................................................................................. 14
`V. CONCLUSION ................................................................................................. 16
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`B.
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`TABLE OF AUTHORITIES
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`
`Cases
`Abbott Labs. v. Syntron Bioresearch Inc.,
`No. 89–cv–2359 H (POR), 2001 WL 34082554 (S.D. Cal. Mar. 7, 2001) ................. 5
`Avago Techs. Gen. IP PTE Ltd. v. Elan Microelectronics Corp.,
`No. C 04-05385 JW, 2009 WL 8612367 (N.D. Cal. Sept. 23, 2009) ....................... 15
`In re Armodafinil Patent Litig. Inc.,
`939 F. Supp. 2d 456 (D. Del. 2013) ...................................................................... 2, 12
`Johns Hopkins Univ. v. CellPro, Inc.,
`152 F.3d 1342 (Fed. Cir. 1998) ................................................................................. 14
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) ................................................................................. 13
`S.E.C. v. ABS Manager, LLC,
`No. 13–cv–319 GPC (BGS), 2014 WL 7272385 (S.D. Cal. Dec. 18, 2014) .............. 5
`Sch. Dist. No. 1J, Multnomah Cty., Or. v. AcandS, Inc.,
`5 F.3d 1255 (9th Cir. 1993) ......................................................................................... 5
`Smith v. Clark Cty. Sch. Dist.,
`727 F. 3d 950 (9th Cir. 2013) ...................................................................................... 5
`U.S. v. Martin,
`226 F.3d 1042 (9th Cir. 2000) ..................................................................................... 5
`United States v. U.S. Gypsum Co.,
`333 U.S. 364 (1948) ..................................................................................................... 5
`Verizon Servs. Corp. v. Cox Fibernet Virginia, Inc.,
`602 F.3d 1325 (Fed. Cir. 2010) ............................................................................. 2, 12
`Vita-Mix Corp. v. Basic Holding, Inc.,
`581 F.3d 1317 (Fed. Cir. 2009) ................................................................................. 15
`Rules
`FED. R. CIV. P. 54(b) ....................................................................................................... 5
`Fed. R. Civ. P. 59(e) ....................................................................................................... 5
`L.R. 7.1(i) ........................................................................................................................ 5
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`I.
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`INTRODUCTION
`On February 17, 2016, the Court granted NuVasive’s Motion for Summary
`Judgment of Non-Infringement of the ’146 patent.1 (Doc. 271 (“Summary Judgment
`Order”).)2 In doing so, the Court revised its earlier Markman Order (Doc. 143)
`construction of claim terms because of arguments that Warsaw made during parallel
`’146 patent reexamination proceedings before the United States Patent and Trademark
`Office (“PTO”). Warsaw asks for reconsideration of the Court’s Summary Judgment
`Order in three respects:3 (1) reconsideration of the Court’s interpretation of Warsaw’s
`arguments to the PTO; (2) clarification of the Court’s revised claim construction; and
`(3) reopening of discovery to address material differences between the Court’s revised
`construction on summary judgment and its original Markman Order construction.
`Generally speaking, the ’146 patent captures the benefits of demineralized and
`mineralized allograft bone in an implant that both promotes bone growth and can
`serve as a marker after surgical implantation. Demineralized allograft bone promotes
`superior bone growth, but lacks structural support and does not appear in a radiograph
`because it is radiolucent; mineralized allograft bone was used in certain circumstances
`to provide structural support, but is not as effective as demineralized bone at
`promoting bone growth. In the prior art, mineralized allograft bone was typically
`placed into the surgical site, followed separately by the addition of demineralized
`allograft bone in the form of a glycerol gel that was injected into the site using a
`syringe. Dr. Scarborough, the ’146 patent inventor, recognized that although
`mineralized allograft bone was not as effective at promoting bone growth, it can be
`seen in a radiograph because it is radiopaque, and can thus act as a “marker.” By
`
`
`1
`U.S. Patent No. 5,676,146.
`2
`All citations to the record are based on original e-filing docket numbers.
`3 Warsaw takes issue with other aspects of the Court’s Summary Judgment
`Order, such as its consideration and treatment of facts, but does not address them on
`reconsideration. Of course, depending on any clarification of the Court’s claim
`construction, Warsaw may ask the Court to revisit its assessment of the discovery
`record.
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`claiming a combination of the two that is either “uniformly distributed” or a
`“substantially uniform admixture” (the “Uniformity Limitations”), the ’146 patent
`yields a mixture that promotes better bone growth and can serve as a marker for the
`implant as a whole.
`After this suit was filed, the PTO reexamined the ’146 Patent at NuVasive’s
`request. NuVasive submitted prior art combinations of mineralized and demineralized
`bone it claimed invalidated the patent. Warsaw and its expert Dr. Barton Sachs
`differed. Warsaw pointed out that none of the prior art of record taught any mixing of
`mineralized and demineralized bone, or reasonably suggested combining the art in any
`manner that would achieve the claimed uniformity. They maintained that, even if the
`prior art taught mixing of mineralized and demineralized bone—and it did not—any
`teaching of mixing without an additional disclosure of mixing to the point of a
`uniform or substantially uniform mixture—or any indication of what the final result of
`the mixing would be—would not teach the Uniformity Limitations because mixing
`alone does not necessarily yield a uniform mixture.4 Expressly acknowledging that
`the ’146 claims are agnostic to how the Uniformity Limitations are created, the PTO
`agreed: “[t]he ’146 patent specification mentions a grid pattern for the uniform
`distribution; while this grid pattern is not claimed and the prior art is not required to
`disclose a grid or any other configuration, the term mixing alone does not achieve a
`uniformly distributed arrangement of one type of particle relative to the other type of
`particle.” (Doc. 229-6, Ex. 62 (PTO Notice of Intent to Issue Reexamination
`Certificate) at 239; see also Declaration of Nimalka Wickramasekera in Support of
`
`4
`Indeed, the law of invalidity provides that prior art does not inherently disclose
`a claimed feature unless that claimed feature is necessarily present: “[A] prior art
`reference may anticipate without disclosing a feature of the claimed invention if that
`missing characteristic is necessarily present, or inherent, in the single anticipating
`reference.” Verizon Servs. Corp. v. Cox Fibernet Virginia, Inc., 602 F.3d 1325, 1337
`(Fed. Cir. 2010) (citation omitted); see also In re Armodafinil Patent Litig. Inc., 939
`F. Supp. 2d 456, 465 (D. Del. 2013) (“A reference includes an inherent characteristic
`if that characteristic is the ‘natural result’ flowing from the reference’s explicitly
`explicated limitations. The mere fact that a certain thing may result from a given set
`of circumstances is not sufficient.”) (internal citations omitted).
`2
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`Plaintiffs’ Motion for Clarification and Reconsideration (“Wickramasekera Decl.”) at
`Ex. 1 Part 2, at 523.)
`In its Markman Order issued at the onset of discovery prior to the conclusion of
`the Reexamination, the Court, by agreement of the parties, ruled that the Uniformity
`Limitations were subject to the plain meaning accorded them by a POSITA (“POSITA
`Construction”). (Doc. 143 at 7–8; see also 2013-11-07 Markman Hr’g Tr. 12:16–23,
`55:11–15.) This was the construction applied by Warsaw and its experts for purposes
`of discovery and opposing summary judgment.
`On summary judgment after the close of discovery, the Court ordered a new
`construction of the Uniformity Limitations: “the component particles must be
`arranged consistently one type of particle relative to the other type of particle
`throughout the combination.” (Doc. 271 at 15 (emphasis added) (“Summary
`Judgment Construction”).) In so doing, the Court noted that it was adopting the
`PTO’s claim construction in the Reexamination. (Id. at 6–8.) In particular, the Court
`concluded that the ’146 Patent survived reexamination because Warsaw had argued
`that the Uniformity Limitations could not be met solely by mixing the mineralized and
`demineralized allograft bone. (Id. at 6–7, 15.) The Court granted NuVasive’s
`summary judgment motion of non-infringement at least in part because the opinions
`of Warsaw expert Dr. Julie Glowacki were based on a construction of the Uniformity
`Limitations that the Court deemed inconsistent with what Warsaw argued on
`Reexamination. (Id. at 15.)
`Warsaw respectfully differs with these conclusions as inconsistent with the
`Reexamination record. In fact, the Court’s Summary Judgment Construction is not
`one articulated by the PTO or Warsaw during Reexamination; nor did either maintain
`that the Uniformity Limitations must be accomplished through more than mixing.
`This aside, the Summary Judgment Order merits clarification.
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`First, the Summary Judgment Construction does not track the PTO language on
`which the former purports to be based. In addressing the prior art teachings, the PTO
`concluded that “the term mixing alone does not achieve a uniformly distributed
`arrangement of one type of particle relative to the other type of particle.” (Doc.
`229-6 at 239 (PTO Notice of Intent to Issue Reexamination Certificate) (emphasis
`added) (“PTO Phraseology”).) As Dr. Julie Glowacki explains in her attached
`declaration, the PTO Phraseology is consistent with her understanding of the
`Uniformity Limitations as gained from the perspective of a person of ordinary skill in
`the art. (See Wickramasekera Decl. at Ex. 2 (Declaration of Dr. Julie Glowacki in
`Support of Plaintiffs’ Motion for Clarification and Reconsideration (“Glowacki
`Decl.”)) ¶¶ 5–11.) At least in verbiage, the Court’s construction of the Uniformity
`Limitations differs from the PTO Phraseology: “‘the component particles must be
`arranged consistently one type of particle relative to the other type of particle
`throughout the combination.’” (Doc. 271 at 15 (emphasis added).) Warsaw
`respectfully asks for clarification as to any substantive difference between the
`Summary Judgment Construction and the PTO Phraseology. Second, Warsaw asks
`for clarification as to whether the Summary Judgment Construction imposes on the
`claimed mixture a process beyond mixing.
`Warsaw also seeks reconsideration to reopen discovery. The discovery record
`on which the Court decided summary judgment was predicated on its earlier Markman
`Order that the Uniformity Limitations were understood to have plain meaning to a
`POSITA. The Summary Judgment Order was predicated on a new, post-discovery,
`construction. Accordingly, Warsaw asks that the Court reopen discovery for the
`limited purpose of addressing any material differences between the POSITA
`Construction applied by Dr. Glowacki and the Summary Judgment Construction, as
`clarified by the Court.
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`II. LEGAL STANDARD
`District courts have the discretion to reconsider interlocutory rulings before a
`final judgment is entered. See FED. R. CIV. P. 54(b); U.S. v. Martin, 226 F.3d 1042,
`1048–49 (9th Cir. 2000). Under Federal Rule of Civil Procedure 59(e), the Court may
`properly reconsider an interlocutory decision “if the district court (1) is presented with
`newly discovered evidence; (2) clear error or the initial decision was manifestly
`unjust, or (3) if there is an intervening change in controlling law.” S.E.C. v. ABS
`Manager, LLC, No. 13–cv–319 GPC (BGS), 2014 WL 7272385, at *2 (S.D. Cal. Dec.
`18, 2014) (citing Sch. Dist. No. 1J, Multnomah Cty., Or. v. AcandS, Inc., 5 F.3d 1255,
`1263 (9th Cir. 1993)); see also United States v. U.S. Gypsum Co., 333 U.S. 364, 395
`(1948); Smith v. Clark Cty. Sch. Dist., 727 F. 3d 950 (9th Cir. 2013); L.R. 7.1(i). A
`motion for reconsideration may concurrently seek clarification of a claim construction
`where the construction is unclear and its proper application should have created a
`triable issue of fact that precludes summary judgment. See Abbott Labs. v. Syntron
`Bioresearch Inc., No. 89–cv–2359 H (POR), 2001 WL 34082554, *3–4 (S.D. Cal.
`Mar. 7, 2001).
`III. STATEMENT OF FACTS
`A. The Markman Order And Discovery
`On August 17, 2012, Warsaw filed its complaint alleging that NuVasive
`infringed the claims of the ’146 patent. On November 7, 2013, this Court held a
`Markman hearing regarding the disputed terms of the ’146 patent. Although the
`parties initially disputed the meaning of the Uniformity Limitations, NuVasive
`ultimately agreed that the terms had plain meaning. (2013-11-07 Markman Hr’g Tr.
`12:16–23.) On November 22, 2013, the Court issued its claim construction order
`regarding the ’146 patent. The Court concluded that the terms had plain meaning to
`persons of ordinary skill in the art. (Doc. 143 at 7–8 (“POSITA Construction”); see
`also Markman Hr’g Tr. 12:16–23, 55:11–15.) After the Court issued its Markman
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`Order, fact and expert discovery proceeded. Based on the Court’s Markman Order,
`the parties conducted discovery under the POSITA Construction, which Dr. Glowacki
`understood as requiring “homogeneity of the components and their arrangement
`throughout the implant.” (Glowacki Decl. ¶ 6; see also Doc. 236 (Plaintiffs’
`Opposition to NuVasive’s Motion for Summary Judgment of Non-Infringement) at
`16.)
`
`B.
`The Reexamination Proceedings
`On January 24, 2014, NuVasive, relying on a declaration from Dr. Sandhu—its
`non-infringement and invalidity expert in this case—requested ex parte reexamination
`of the ’146 patent. (Doc. 229-6 at 2, 4–5.) NuVasive sought reexamination in light of
`Cook, et al., “In Vivo Evaluation of Demineralized Bone Matrix as a Bone Graft
`Substitute for Posterior Spinal Fusion,” SPINE, vol. 20, no. 8, pp. 877-886 (1995)
`(“Cook”) plus Prewett, et al., U.S. 5,314,476 (“Prewett”) and Dowd, et al., U.S.
`5,507,813 (“Dowd”). (Id. at 63.) The PTO instituted the third reexamination
`proceedings of the ’146 patent on these grounds and rejected the considered claims on
`June 25, 2014. (Id. at 62.) Neither NuVasive’s expert declaration to the PTO nor its
`reexamination request offered any construction for the Uniformity Limitations. (See
`id. at 13.)
`Responding to the June 25, 2014 office action, Warsaw enumerated many
`limitations that were neither disclosed nor taught by the cited references. (Id. at 66–
`83.) With respect to the Uniformity Limitations, Warsaw argued that “Cook does not
`disclose uniformly distributing the allograft cubes and the demineralized bone particle
`gel. Instead, the cancellous cubes were ‘placed’ into the defect site separately from
`the DBM, which was then administered with a syringe . . . . DBM injected over
`cancellous cubes would not be a uniform mixture (much like peanut butter spread on
`toast would not be a uniform mixture.” (Id. at 72–73.) In his declaration to the PTO,
`Dr. Sachs explained that Cook did not disclose these limitations for several reasons:
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`First, the reference never discusses how the composite graft was mixed.
`Based on how composite grafts were created in the operating room, a
`person of ordinary skill in the art would recognize that composite grafts
`are not mixed to the point of uniformity. In light of this, the Cook
`reference does not suggest or provide a reason for creating a graft with a
`uniform distribution; unless the reference indicates that the composite
`graft was mixed to uniformity, which would be a unique protocol, a
`person of ordinary skill would know that the graft did not have
`uniformity. Second, that some of the demineralized bone gel was
`incorporated into the pores of the cancellous cubes does not indicate that
`the mixture was a substantially uniform admixture or had a uniform
`distribution. Third, the postoperative CT scans taken at 6 weeks and 12
`weeks indicate that the only graft that is visible is the autograft implant.
`In light of this fact, it is clear that the composite graft was not a uniform
`mixture or a substantially uniform admixture and that the radiopaque
`material used was not uniformly distributed with the demineralized bone
`gel. If it had been, one would have expected to have seen the composite
`graft in the CT scans.
`(Id. at 73 (internal citation omitted).)
`In sum, Dr. Sachs concluded that even if the prior art references mixing, that
`statement alone does not teach the Uniformity Limitations because mixing does not
`necessarily achieve them. He noted that the absence of a reference teaching mixing to
`the point of achieving the Uniformity Limitations was particularly relevant given that
`the relevant particles being mixed were not easily mixed to uniformity or even
`substantial uniformity. (Doc. 271 at 7.) But Dr. Sachs did not say that achieving the
`Uniformity Limitations was impossible through mixing alone. Indeed, he explained
`precisely the opposite: “unless the reference indicates that the composite graft was
`mixed to uniformity, which would be a unique protocol, a person of ordinary skill
`would know that the graft did not have uniformity.” (Doc. 229-6 at 184 (Sachs Decl.),
`¶ 17 (emphases added).) In other words, Dr. Sachs explained that because the prior
`art references did not teach mixing to achieve the unique result of a homogenous
`mixture of mineralized and demineralized bone, they did not disclose the Uniformity
`Limitations. This, of course, stands in distinct contrast to NuVasive’s statements to its
`physicians that the accused Osteocel product is a “homogenous mixture.” (Doc. 212,
`Ex. 12 (Expert Report of Julie Glowacki Regarding U.S. Patent No. 5,676,146 C2)
`¶ 51.)
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`In addition, Warsaw argued that neither Prewett nor Dowd taught these
`limitations. With respect to Prewett, Warsaw argued that the passages of the reference
`relied upon by the PTO related to a mixture of demineralized bone particles and a
`glycerol carrier. (Doc. 229-6 at 73–75.) “Prewett discloses nothing about creating a
`composite graft containing demineralized and nondemineralized bone uniformly
`distributed in a carrier.” (Id. at 74 (emphasis added).) Similarly, Dowd disclosed “a
`sheet made up of elongated demineralized bone fibers” not a mixture of demineralized
`and nondemineralized bone. (Id. at 82.) As Dr. Sachs explained, it was not known to
`make mixtures that satisfy the Uniformity Limitations at the time of the invention of
`the ’146 patent:
`For a surgeon to evenly mix particles that are of different sizes and
`densities in an operating room environment would have been difficult
`and impractical. Operating room time is an important (and expensive)
`commodity. . . . Surgeons did not have sufficient time to spend mixing
`components into a substantially uniform admixture or a uniform
`distribution, as described in the ’146 patent. . . . The variability in the
`nature and amount of materials that would be mixed in an operating room
`makes the creation of a composite graft that is a substantially uniform
`admixture or has a uniform distribution during surgery difficult.”
`(Id. at 76 (emphasis added).) “Instead, ‘[a] uniform composite graft instead would
`need to be created in a tissue processing lab using measured quantities of materials,
`which are consistent, following a reproducible, predictable processing procedure.’”
`(Id.)
`
`The PTO agreed with Warsaw’s arguments regarding the scope and content of
`the prior art, and confirmed the patentability of the claims under consideration. (Doc.
`229-6 at 237.) The PTO summarized Warsaw’s arguments with respect to Cook:
`“patent owner argues that the allograft material (radiopaque material) is only disclosed
`as being placed and no disclosure of any mixing of the composite graft is included.”
`(Id. at 238 (emphasis added).) And Prewett “only teaches modification of the carrier
`to prevent separation of the glycerol from the bone particles themselves.” (Id.)
`Importantly, in using the term “achieve,” the Examiner did not suggest that the act of
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`mixing could not achieve the Uniformity Limitations. The Examiner repeatedly noted
`that the “term” mixing alone did not achieve—i.e., disclose—the Uniformity
`Limitations. (E.g., id. at 239.)
`The PTO concluded that “Cook does not explicitly disclose mixing of DBM
`and Allograft cubes.” (Id.) Moreover, the PTO concluded that, even assuming that
`Cook disclosed mixing (and it did not), “[t]he ’146 patent specification mentions a
`grid pattern for the uniform distribution; while this grid pattern is not claimed and the
`prior art is not required to disclose a grid or any other configuration, the term mixing
`alone does not achieve a uniformly distributed arrangement of one type of particle
`relative to the other type of particle.” (Id.) Similarly, Prewett “teaches uniformly
`distributed bone particles within the carrier, this teaching does not achieve a uniformly
`distributed arrangement of the radiopaque particles with the radiolucent material.”
`(Id.) The PTO also concluded that Cook did not disclose the radiopaque material
`being provided in sufficient quantity for use as a marker. (Id. at 240.) In reaching
`these conclusions, the PTO did not adopt a construction for the Uniformity
`Limitations that differed from Dr. Glowacki’s POSITA Construction (based upon the
`Markman Order) on which she predicated her opinions in this case. (See Glowacki
`Decl. ¶¶ 5–11.)
`C. The Summary Judgment Order
`At the close of discovery, NuVasive filed a motion for summary judgment of
`non-infringement of the ’146 patent. In its motion, NuVasive argued that it was
`entitled to judgment as a matter of law that Osteocel Plus does not infringe the
`asserted claims of the ’146 patent because Warsaw could not sustain its burden to
`prove that Osteocel Plus meets the Uniformity Limitations. (Doc. 211 at 11–13.)
`Warsaw opposed, arguing that with all reasonable inferences properly drawn in its
`favor, the evidence it relied upon could “support a finding by the jury that Osteocel
`Plus meets these limitations.” (Doc. 236 at 13.) Warsaw also argued that, contrary to
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`NuVasive’s contention, it consistently applied the POSITA Construction for purposes
`of infringement in this case and validity before the PTO, and thus a revised claim
`construction as requested by NuVasive at this late stage was not warranted. (Id. at
`16.)
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`On February 17, 2016, the Court granted NuVasive’s motion for summary
`judgment. Therein the Court determined that “the sole evidence Warsaw offers to
`support its infringement claims is an expert report that is based on a construction of
`the claims that is inconsistent with the construction argued by Warsaw through Dr.
`Sachs and adopted by the PTO in the reexamination proceedings to overcome the
`prior art.” (Doc. 271 at 15 (emphasis added).) In its order, the Court adopted a new
`construction for the Uniformity Limitations based upon one the Court believed had
`been adopted by Warsaw and the PTO during reexamination: “the component
`particles must be arranged consistently one type of particle relative to the other type of
`particle throughout the combination.” (Id.) Under the Summary Judgment
`Construction, the Court concluded that “no reasonable jury can conclude on the
`evidence presented by Warsaw . . . that Ostecoel Plus meets the claims
`limitation[s] . . . .” (Id.)
`IV. ARGUMENT
`A. Reconsideration And Clarification Of The Summary Judgment
`Construction Is Warranted
`The Court should grant reconsideration and clarification of the order granting
`summary judgment of non-infringement of the asserted claims of the ’146 patent. In
`the Summary Judgment Order, the Court states as follows:
`“To be uniformly distributed within or
`in substantially uniform
`admixture, the component particles must be arranged consistently one
`type of particle relative to the other type of particle throughout the
`combination.”
`(Id.) The Court indicated that its construction was based upon “the construction
`argued by Warsaw through Dr. Sachs and adopted by the Patent Office in the
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`reexamination proceedings to overcome prior art.” (Id.) But in articulating the scope
`of the prior art, the PTO addressed whether it disclosed a “uniformly distributed
`arrangement of one type of particle relative to the other type of particle.” (Dkt 229-6
`at 239.) As explained by Dr. Glowacki in the attached declaration, the PTO
`Phraseology is consistent with the POSITA Construction underlying her opinions.
`(Glowacki Decl. ¶¶ 5–11.) However, it is unclear whether the Court intends there to
`be a difference between the PTO Phraseology and the POSITA Construction.
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`The scope of the Court’s construction is also unclear given language in the
`Summary Judgment Order that the requisite level of uniformity must be achieved
`through more than mixing. (Doc. 271 at 12.) Yet, there is no basis for such a
`limitation: the ’146 patent does not claim a novel process to achieve a uniform or
`substantially uniform distribution of mineralized and demineralized bone; the claims
`simply require a mixture that meets the Uniformity Limitations. In any event,
`Warsaw did not advocate—and the PTO did not adopt—a position that mixing can
`never achieve the Uniformity Limitations.
`Rather, the more modest observation offered by Warsaw’s expert during the
`Reexamination was that the mere fact of mixing (and there was no such disclosure in
`the prior art) was not necessarily sufficient to achieve the Uniformity Limitations.
`Indeed, Warsaw did not distinguish the prior art on the basis that mixing cannot
`achieve the Uniformity Limitations. In fact, none of the cited references disclosed any
`mixture of both demineralized and nondemineralized bone. (Doc. 229-6 at 74, 82.)
`Cook—the only reference that disclosed an implant containing both mineralized bone
`and demineralized bone—did not disclose an implant that was mixed at all, rather
`allograft material was placed in the defect site and DBM gel added with a syringe.
`(Id. at 72.) Because none of the prior art being considered during the reexamination
`disclosed “mixing,” Dr. Sachs did not, as suggested by the Court, “distinguish[]” the
`prior art by arguing “that mixing alone does not meet this limitation . . . .” (Doc. 271
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`MEMO. ISO MO