Case 3:12-cv-02738-CAB-MDD Document 143 Filed 11/22/13 PageID.5414 Page 1 of 8
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`CASE NO. 12-cv-2738-CAB (MDD)
`WARSAW ORTHOPEDIC, INC.,
`MEDTRONIC SOFAMOR DANEK
`CLAIM CONSTRUCTION ORDER
`USA, INC., MEDTRONIC PUERTO
`AS TO THE ‘146 PATENT
`RICO OPERATIONS COMPANY,
`and OSTEOTECH, INC.,
`
`vs.
`
`NUVASIVE, INC.,
`
`Plaintiffs,
`
`Defendant.
`
`Introduction
`I.
`On November 7, 2013, the Court held a hearing to construe certain claims of
`United States Patent No. 5,676,146. The parties filed briefs and claim construction
`charts in accordance with the local rules of this District. [Doc. Nos. 109, 121, 123, 124
`and related exhibits.] Luke Dauchot, Esq., Alexander MacKinnon, Esq., Nimalka
`Wickeramasekera, Esq., and Sharre Lotfollahi, Esq., appeared for Warsaw Orthopedic,
`Inc., Medtronic Sofamor Danek U.S.A., Inc., Medtronic Puerto Rico Operations Co.,
`and Osteotech, Inc. (hereinafter collectively “Warsaw”). Frank Scherkenbach, Esq.,
`Michael Kane, Esq., and John Lamberson, Esq., appeared for NuVasive, Inc. Having
`considered the submissions of the parties and the arguments of counsel, the Court
`
`- 1 -
`
`12cv2738
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 143 Filed 11/22/13 PageID.5415 Page 2 of 8
`
`construes the disputed terms addressed at argument1 as follows.
`II.
`Legal Standard
`The Court construes the claim language when the parties dispute what a person
`of skill in the art would understand the term to mean. Claims are not read in a vacuum
`but in the context of the entire patent including the specification. See Phillips v. AWH
`Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005)(en banc). The claims, the specification
`and the prosecution history are the most significant source of the legally operative
`meaning of disputed claims language. See SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331, 1338 (Fed Cir. 2005). The words of a claim are generally given the
`ordinary and customary meaning that a person of ordinary skill would have applied at
`the time of the invention. Phillips, 415 F.3d at 1313.
`III. U.S. Patent No. 5,676,146
`Warsaw asserts that NuVasive infringes U.S. Patent No. 5,676,146 (“the ‘146
`patent”). The invention of the ‘146 patent is directed to a surgical implant containing
`a resorbable radiopaque marker and a method of locating the implant within a body.
`[Doc. No. 102-1.] The implant, which can be used to repair skeletal defects and
`irregularities, incorporates radiopaque material, e.g., nondemineralized or partially
`demineralized bone particles, which is resorbable in its entirety and may contribute to
`the healing of bone through natural processes. [Id., at Col. 1:30-40.] This radiopaque
`material is distributed in radiolucent resorbable or non-resorbable material during the
`manufacture of the implant such that the radiopaque material serves as a marker, which
`can be visualized by x-ray or other radiographic technique, facilitating the
`determination of the location and/or position of the implant within a body. [Id., at Col.
`1:44-48; Col. 3:4-10.]
`The terms and phrases of the following claim of the ‘146 patent, set forth in
`
`1 At the hearing counsel represented that the parties had reached agreement as to the
`construction of certain of the terms of the ‘146 patent previously submitted as disputed. Any terms
`not addressed in this order are therefore deemed withdrawn from the Court’s consideration without
`prejudice to a request for construction upon a showing of good cause.
`
`- 2 -
`
`12cv2738
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 143 Filed 11/22/13 PageID.5416 Page 3 of 8
`
`italics, are presented by the parties for construction. These terms are common to all the
`independent claims asserted in the litigation (Claims 13, 21, 25 and 26), and the
`construction applies to each of them.
`13. A method of determining the location and/or orientation of an
`osteogenic surgical implant within a body which comprises:
`a) surgically implanting within a body an osteogenic implant fabricated
`from a radiolucent material comprising allograft bone particles and a
`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
`b) post-surgically determining the location and/or orientation of the
`implant by a radiographic technique.
`
`An Osteogenic Surgical Implant
`A.
`The term osteogenic to describe the implant of the invention was added to certain
`claims of the patent during reexamination. None of the original claims of the patent
`included this term. Warsaw proposes that osteogenic has a plain and ordinary meaning
`to one of ordinary skill in the art and does not need to be construed. The inventor of the
`‘146 patent, Nelson Scarborough, however, testified that the definition of osteogenic
`is not unambiguous in the art. “I think a lot of people would probably have their own
`definitions of these terms [osteogenic], and I’m not sure – everybody doesn’t agree
`totally.” [Doc. No. 121-1, Ex. 7, at 124:18-125:16.] Consequently, the Court looks to
`the patent specification and the file history to determine the meaning of osteogenic in
`this invention.
`Warsaw contends that if construction is needed the term should be limited to “a
`surgical implant that includes live cells,” and therefore promotes bone growth by a
`biological mechanism known as osteogenesis. NuVasive opposes the limited
`construction advanced by Warsaw and argues for a broader construction of osteogenic
`as a “surgical implant that participates in the process of new bone growth,” and
`therefore promotes bone growth by any of three biological mechanisms – osteogenesis,
`osteoconduction and osteoinduction.
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`- 3 -
`
`12cv2738
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 143 Filed 11/22/13 PageID.5417 Page 4 of 8
`
`The word “osteogenic” only appears once in the ‘146 patent’s specification in an
`illustrative example of the claimed implant:
`EXAMPLE 1
`A sheet fabricated from demineralized elongated bone particles is
`manufactured according to the method described in U.S. Pat. No.
`5,507,813. While the sheet is being wet-laid nondemineralized bone
`particles that have been classified to a predetermined range are added
`thereto. The mineralized particles are uniformly distributed within the wet
`sheet which is then subjected to the remaining manufacturing operations
`described in the aforesaid patent. The resultant flexible sheets are then cut
`into implant-sized pieces.
`. . .
`EXAMPLE 4
`The nondemineralized particles of Example 1 can be distributed in
`a flowable osteogenic composition which is comprised of demineralized
`bone particles and an inert carrier such as glycerol.
`[Doc. No. 102-1, Col. 3:34-43; Col. 4:4-8 (emphasis added).]
`A flowable osteogenic composition comprised of demineralized bone particles
`and glycerol is disclosed in U.S. Patent No. 5,507,813 (“the ‘813 patent”) [Doc. No. 98-
`10], the content of which is incorporated by reference in the specification of the ‘146
`patent. [Doc. No. 102-1, Col. 1:49-52.] The ‘813 patent defines “osteogenic” as the
`ability of the material fabricated by the method disclosed in that patent to “participate
`in the process of new bone growth regardless of the mechanism(s) involved,” e.g.
`osteogenesis, osteoconduction and/or osteoinduction. [Doc. No. 98-10, Col. 2:1-13.]
`The ‘146 patent adopts this definition of osteogenic through its incorporation of the
`‘813 patent; nothing in the specification or file history suggests the inventor of the ‘146
`patent rejected or narrowed the ‘813 patent’s definition of osteogenic. This is further
`evidenced by the ‘146 patent’s teaching that the implant of the ‘146 patent invention
`when fabricated from demineralized bone leads to new bone growth by one or more
`biological mechanisms such as osteogenesis, osteoconduction and/or osteoinduction.
`[Doc. No. 102-1, Col. 2:62–3:1.] The patent specification does not limit its disclosed
`implant to promoting bone growth by osteogenesis and provides no language that
`modifies or limits the construction of an osteogenic implant to only an implant with live
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`- 4 -
`
`12cv2738
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 143 Filed 11/22/13 PageID.5418 Page 5 of 8
`
`cells. The term is used to describe materials that promote bone growth by all three of
`the biological mechanisms.
`During the reexamination, the term osteogenic was applied broadly by both the
`examiner and the patentee to describe materials disclosed in prior art that were not
`limited to promoting bone growth by osteogenesis. The Prewett reference ( “U.S.
`Patent No. 5,510,396”) discloses a process for producing a flowable osteogenic
`composition using demineralized bone particles and glycerol to promote bone growth
`by one or more mechanisms such as osteogenesis, osteoconduction and/or
`osteoinduction. [Doc. No. 102-13, Col. 2:21-26.] The Frenkel reference2 is described
`as disclosing the use of osteogenic materials to enhance bone fusion. [Doc. No. 98-11,
`at 13 of 66.] The text of that reference discloses a demineralized bone matrix gel acting
`as an osteoconductive/osteoinductive material to enhance bone fusion. The Dowd
`reference (the ‘813 patent), discussed above, teaches that osteogenic materials are those
`that perform any of the three biological mechanisms to promote bone growth.
`Throughout the reexamination the examiner and the patentee refer to osteogenic
`compositions in the broad sense of the term as descriptive of a material that performs
`any of the three biological mechanisms to promote bone growth.
`The file history shows that the patentee introduced the word osteogenic to certain
`claims during the final amendments filed in the reexamination proceeding. Claim 13
`was amended adding the term osteogenic to describe the surgical implant of the
`invention to distinguish it from the Kensey reference (U.S. Patent No. 5,441,517),
`which is directed toward a device for vascular closure. The Kensey reference, the
`patentee argued, has no discussion or application to the use of bone particles and is
`directed to substantially different subject matter. [Doc. No. 98-11, at 64-66.] The
`addition of osteogenic to traverse Kensey does not support an inference that the
`patentee intended by this amendment to narrow the scope of osteogenic to cover only
`
`2Frenkel et al., Use of Demineralized Bone Matrix Gel to Enhance Spine Fusion. 19th Annual
`Meeting of the Society of Biomaterials, April 28-May 2, 1993, Birmingham, AL. p. 162.
`
`- 5 -
`
`12cv2738
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 143 Filed 11/22/13 PageID.5419 Page 6 of 8
`
`materials with live cells that promote bone growth by osteogenesis. It does not
`constitute an express disclaimer of the broader definition of osteogenic incorporated in
`the patent and applied by the patentee and the examiner throughout the examination.
`The amendment simply reflects that the implant of the ‘146 invention promotes bone
`growth by one or more of the biological mechanisms of osteogenesis, osteoconduction
`and/or osteoinduction, which Kensey does not address.
`In the final amendments, other claims of the patent were also amended to include
`the term osteogenic to describe the implant of the invention to traverse the Campbell
`reference (U.S. Patent No. 4,627,853). To distinguish over Campbell the patentee
`argued Campbell discloses tanning a bone piece to be implanted with glutaraldehyde
`which renders the bone non-antigenic. The patentee concludes the implant disclosed
`in Campbell is therefore non-osteogenic and “teaches against an osteogenic surgical
`[implant].” [Doc. No. 98-11, at 55 of 66.] The patentee therefore amended to include
`the osteogenic character of implant of the invention to distinguish over Campbell.
`The implant exposed to the tanning process disclosed in Campbell is noted to
`promote bone growth by osteoconduction. [Doc. No. 109-3, Col. 4:40-48.]
`Consequently, Warsaw argues this amendment to traverse Campbell demonstrates that
`when the patentee argued Campbell teaches against an osteogenic implant he was
`necessarily narrowing the definition of osteogenic in the ‘146 patent to only materials
`with live cells that promote bone growth by osteogenesis. NuVasive countered that
`Campbell does not disclose bone growth by osteoinduction, so it is not clear without
`further discussion that the amendment adding osteogenic to describe the implant of the
`‘146 patent necessarily and expressly limited the patent’s surgical insert to materials
`with live cells. See Toshiba Corp. v. Imation Corp. 681 F.3d 1358, 1370 (Fed. Cir.
`2012) (a statement in the prosecution history can only amount to disclaimer if the
`applicant “clearly and unambiguously” disavowed claim scope.)
`The record does not create a compelling argument that in distinguishing over
`Campbell, by amending to highlight the osteogenic nature of the implant of the
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`- 6 -
`
`12cv2738
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 143 Filed 11/22/13 PageID.5420 Page 7 of 8
`
`invention, the patentee was expressly redefining and/or narrowing the definition of
`osteogenic to only materials that include live cells. The amendment includes no
`discussion about the biological mechanism of the claimed implant. In the reasons for
`allowance the patent examiner makes no specific reference to the implant now having
`the limitation of requiring the use of materials with live cells. [Doc. No. 102-10, at 54-
`57 of 60.] The distinction that Campbell allows bone growth by osteoconduction but
`not osteogenesis or osteoinduction is not addressed. The patentee never represents that
`his invention requires the presence of live cells in the implant materials. Without more,
`it is unclear whether the patentee simply overlooked the osteoconductive capability of
`the Campbell disclosure or truly intended to and effectively limited the scope of his
`invention. It is not clear that this representation in the prosecution history effectively
`narrowed the meaning of osteogenic material in this patent to only material with live
`cells and therefore expressly disclaimed the broader definition of the term as set forth
`in the ‘813 patent which it appears the patentee and the examiner operated under
`throughout the reexamination.
`Having considered the claims, the specification and the file history, the Court
`concludes that, in the context of this patent, an osteogenic surgical implant is an implant
`capable of promoting new bone growth by the biological mechanism of osteogenesis,
`osteoconduction and/or osteoinduction.
`Uniformly Distributed Within
`B.
`The parties withdrew their request for construction of uniformly distributed,
`however still sought construction of the word within. NuVasive argued that within
`should be construed to mean “inside,” which ordinarily would be its plain meaning. In
`the context of the patent disclosure, however, such a construction would be nonsensical.
`It is clear from the specification that the radiopaque material is uniformly distributed
`throughout the radiolucent material comprising the implant. The patent does not teach
`putting the radiopaque material inside the radiolucent material; such a construction
`would be illogical. Consequently, to the extent the word within results in any
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`- 7 -
`
`12cv2738
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 143 Filed 11/22/13 PageID.5421 Page 8 of 8
`
`ambiguity, the Court construes it to mean in this context, throughout.
`Provided in Sufficient Quantity for Use as a Marker
`C.
`The invention of this patent is directed at fabricating an otherwise radiolucent
`surgical implant with sufficient radiopaque material distributed throughout it, such that
`the implant can be readily visualized by x-ray or other radiographic technique following
`implantation in the body. The Court agrees with Warsaw that individuals of skill in the
`art will understand that this limitation, provided in sufficient quantity for use as a
`marker, means the quantity of radiopaque material used in the implant must be adequate
`to allow for the ready visualization by x-ray or other radiographic technique of the
`implant after implantation. No further construction is needed.
`IT IS SO ORDERED.
`
`DATED: November 22, 2013
`
`CATHY ANN BENCIVENGO
`United States District Judge
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`- 8 -
`
`12cv2738
`
`