Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper7
`_Entered: August 10, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WRIGHT MEDICAL TECHNOLOGY,INC.,
`Petitioner,
`
`V.
`
`BIOMEDICAL ENTERPRISES, INC.,
`Patent Owner.
`
`Case IPR2015-00786
`Patent 8,584,853 B2
`
`Before MEREDITH C. PETRAVICK, JEREMY M. PLENZLER, and
`TIMOTHYJ. GOODSON,Administrative Patent Judges.
`
`PLENZLER,Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F-R. § 42.108
`
`
`Tel: 571-272-7822
`
`Paper7
`_Entered: August 10, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WRIGHT MEDICAL TECHNOLOGY,INC.,
`Petitioner,
`
`V.
`
`BIOMEDICAL ENTERPRISES, INC.,
`Patent Owner.
`
`Case IPR2015-00786
`Patent 8,584,853 B2
`
`Before MEREDITH C. PETRAVICK, JEREMY M. PLENZLER, and
`TIMOTHYJ. GOODSON,Administrative Patent Judges.
`
`PLENZLER,Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F-R. § 42.108
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`Wright Medical Technology,Inc. (“Petitioner”) filed a Petition to
`
`institute an inter partes review of claims 15—21 of U.S. Patent No. 8,584,853
`
`B2 (Ex. 1001, “the ’853 patent”). Paper 1 (“Pet.”). Biomedical Enterprises,
`
`Inc. (“Patent Owner’) filed a Preliminary Response. Paper 6 (“Prelim.
`
`Resp.”). We have jurisdiction under 35 U.S.C. § 314(a), which provides that
`
`an inter partes review maynotbeinstituted “unless .
`
`.
`
`. there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challenged in the petition.” For the reasons given below, weinstitute
`
`an inter partes review in this proceeding.
`
`B. Related Proceedings
`
`Petitioner and Patent Ownerindicate that the ’853 patentis the subject
`
`of the following federal district court case: Biomedical Enterprises, Inc. v.
`
`Solana Surgical, LLC, Case No. 1:14-cv-00095-LY (W.D. Tex.). Pet. 3;
`
`Paper5, 1.
`C. Asserted Grounds of Unpatentability and Evidence ofRecord
`Petitioner contends that the challenged claims are unpatentable under
`35 U.S.C. §§ 102 and 103 based on the following grounds (Pet. 6-9, 34-60).
`
`
`
`
`
`"U.S. Patent App. Pub. No. 2013/0030438 A1, pub. Jan. 31, 2013 (Ex.
`1009, “Fox”’).
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`
`
`
`
`
`
`
`
`
`Petitioner also provides testimony from Stephen H. Smith, M.D.
`
`Ex. 1002 (“the Smith Declaration’’).
`
`D. The ’853 Patent
`
`The ’853 patent is directed to “an orthopedic fixation system
`
`consisting of a sterile packaged implant kit and a sterile packaged instrument
`
`kit.” Ex. 1001, 1:7-9. The ’853 patentillustrates an exemplary sterile
`packaged implant kit in Figure 3A, reproduced below.
`
`? International Publication No. WO 2010/004330 A1, pub. Jan 14, 2010 (Ex.
`1010, “Bertazzoni”). The page numbersused herein correspond to those on
`the lowerright, included by Petitioner, for consistency with the citations in
`the Petition.
`> 4Fusion Shape Memory Quadripodal Implant, Product Information
`brochure by MemoMetal, Inc., marked “©2009” (Ex. 1008, “4Fusion’”).
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`245
`
`231
`
`230
`
`205,
`PX
`206
`
`m
`
`
`220
`
`go
`
`LP
`
`207
`
`Pa
`
`250
`
`Figure 3A
`
`Figure 3A is an exploded view ofsterile packaged implant kit 200. As seen
`
`in Figure 3A, implant kit 200 includes implant 205, insertion device 220,
`
`and drill guide 230. Jd. at 3:57-59. The ’853 patent notes that “‘[t]he entire
`
`assembly, consisting of implant 205 mounted to insertion device 220 and
`matching drill guide 230 are placed into an implant package 210 suitable to
`... maintain implant 205, insertion device 220, and matchingdrill guide 230
`
`sterile.” Jd. at 3:63—-4:1.
`
`Implant 205 is described as being “made from a shape-memory or
`
`superelastic material such as nitinol” and “ha[ving] two legs, 206 and 207,
`
`that are designed to swing inward.” Jd. at 3:43-47. The ’853 patent
`
`explains that “[i]mplant 205 is mounted on disposable insertion device 220,”
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`which “holds the implant 205 such that implant[] legs 206 and 207 are held
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`mechanically in a parallel position for easier insertion into bone.” /d. at
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`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`3:47-50. After implant 205 is inserted into adjacent bones,insertion device
`220 can be twisted off implant 205 to release implant 205, which then
`squeezes the adjacent bones together. Jd. at 3:52—54.
`
`E. Illustrative Claim
`
`Asnoted above, Petitioner challenges claims 15—21. Claim 15 is the
`
`only independent claim challenged, and is reproduced below:
`
`15. An orthopedic fixation system, comprising:
`a sterile packaged implant kit, comprising:
`at
`least one surgical
`implant, comprising legs movable
`between a first convergent position and a second
`substantially parallel position, wherein movement of the
`legs from the first convergent position to the second
`substantially parallel position stores a compressive force
`in the implant, further wherein movement of the legs
`from the second substantially parallel position to the first
`convergentposition releases the compressive force stored
`in the implant,
`
`an insertion device adapted to engage the implant with the
`legs
`in their
`second substantially parallel position,
`wherein the insertion device maintains the legs in their
`second substantially parallel position such that
`the
`implant stores the compressive force, and
`an implant package adapted to receive therein the at least
`one surgical
`implant mounted on the insertion device
`such that the insertion device maintains the legs in their
`second substantially parallel position, whereby the
`implant package maintains the at
`least one surgical
`implant and the insertion device sterile after sterilization
`of the sterile packaged implant kit.
`
`Ex. 1001, 7:19-8:4.
`
`
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`IPR2015-00786
`Patent 8,584,853 B2
`
`Il.
`
`ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable interpretation in light of the specification in which
`
`they appear and the understanding of others skilled in the relevantart.
`
`37 C.F.R. § 42.100(b); see also In re Cuozzo Speed Techs., LLC, No. 2014-
`1301, 2015 WL 4097949, at *7-8 (Fed. Cir. July 8, 2015). Applying that
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`standard, we interpret the claim termsof the ’853 patent accordingto their
`
`“ordinary and customary meaning”in the context of the patent’s written
`
`description. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007) (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005)
`
`(en banc)).
`
`Petitioner contends that no term requires an explicit construction, “as
`
`the plain and ordinary meaningis the broadest reasonable interpretation and
`
`is sufficiently clear.” Pet. 27. Petitioner, however, proposes constructions
`
`for several terms to rebut potential constructions that Petitioner expected
`
`Patent Owner would offer.
`
`/d. at 27—33. In the Preliminary Response,
`
`Patent Owner doesnot offer a proposed construction for any specific term.
`
`At this stage of the proceeding, no particular term requires an express
`
`construction in order to conduct properly our analysis ofthe prior art.
`
`B. Anticipation by Fox
`
`Petitioner contendsthat claims 15—19 and 21 are anticipated by Fox.
`
`Pet. 35-43. For the reasons discussed below, we are persuaded that
`
`Petitioner has demonstrated a reasonable likelihood ofprevailing at trial on
`
`its challenge to these claims.
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`Fox is directed to “staples used for fixation of bone andsoft tissue of
`
`the musculoskeletal system .
`
`.
`
`. that are caused to change shape throughtheir
`
`metallurgic properties and their interaction with mechanical instruments to
`
`pull together and compress bone.” Ex. 1009 § 1.. Petitioner identifies
`
`disclosures in Fox corresponding to each limitation of claims 15—19 and 21
`
`(Pet. 35-43). Patent Owner doesnot dispute Petitioner’s contentions
`regarding the disclosures of Fox in its Preliminary Response.’ We have
`
`reviewed and are persuadedbyPetitioner’s contentions regarding these
`claims.
`
`For example, Fox disclosesa staple that is operable to store
`
`mechanical energy whenits legs are parallel and release the stored
`
`mechanical energy when returned to a non-parallel configuration (Ex. 1009
`
`4] 36, 234), which Petitioner contends corresponds to the “surgical implant”
`
`recited in claim 15 (Pet. 38-39). Fox further discloses “[d]isposable staple
`
`extrusion instrument 120 with integrated cartridge 92” (Ex. 1009
`
`181, Fig.
`
`8) with “[t]he bone staple [] held in a parallel shape understrain by the
`
`cartridge”(id. § 136), which Petitioner contends discloses the “insertion
`
`device” recited in claim 15 (Pet. 40).
`
`Asfor the “sterile packaged implant kit” and the “implant package
`
`maintain[ing] the at least one surgical implant and the insertion devicesterile
`after sterilization ofthe sterile packaged implant kit” requirements ofclaim
`15, Petitioner cites Fox’s discussion ofthe disclosed product being part of a
`pre-sterilized procedure kit. Pet. 38, 41 (citing Ex. 1009 {J 31, 254, 260,
`
`264, 271). The cited portions of Fox support Petitioner’s contentions. For
`
`* Patent Owner’s arguments are directed to alleged redundancy amongthe
`challenges. Prelim. Resp. 3-9.
`
`
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`IPR2015-00786
`Patent 8,584,853 B2
`
`example, Fox explains that “disposable staple instrument 120 combined with
`
`an integral S-shaped staple cartridge 92, as shown in FIG. 8... can be
`
`delivered to the hospital in a quality controlled sterile package.” Ex. 1009
`
`q 264.
`
`Based on the record before us, we are persuaded that Petitioner has
`
`demonstrated a reasonable likelihood ofprevailing at trial on its challenge to
`
`claims 15-19 and 21 as being anticipated by Fox.
`
`C. Obviousness over Fox and Bertazzoni
`
`Claim 20 ultimately depends from claim 15 and recites additional
`39 66
`
`componentsof the implant kit including “an implanttray,”
`“an implant outer
`cover,” and “an implant seal.” Petitioner acknowledges that “Fox does not
`expressly describe the structuresof tray, outer cover and seal.” Pet. 44.
`
`Petitioner cites Bertazzoni as teaching these limitations, and reasonsthatit
`
`would have been obviousto a person skilled in the art to include these
`
`features in Fox’s implant kit. Jd. at 44-45.
`
`For example, Bertazzoni describes a container, a lid, and a double
`
`bagged arrangement (Ex. 1010, 9), which Petitioner contends correspond to
`39 66s
`“implant outer cover,” and “implantseal,”
`
`the claimed “implant tray,”
`
`respectively (Pet. 44-45). Petitioner contends that it would have been
`
`obvious to include these features in Fox’s implant kit because Bertazzoni
`
`and Foxare “directed to similar devices, i.e. orthopedic implants, and
`
`[Bertazzoni] notes that ‘[a]ny surgical procedure typically requires a number
`
`of instruments’ and seeks ‘to simplify inventory and procedurein the
`
`operating room,’ while maintaining a sterile environment and reduction of
`
`contamination risk.” Pet. 45 (quoting Ex. 1010, 2). Petitioner additionally
`
`notes Fox’s discussion that “the orthopedic instrument, cartridge and implant
`
`—
`
`
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`IPR2015-00786
`Patent 8,584,853 B2
`
`can be an ‘integral disposable extrusion instrument’ to allow the ‘product to
`
`be part of... a pre-sterilized fully disposable procedure specific kit’” and
`
`that the “‘pre-sterilized combination instrument, cartridge and implant can be
`
`packaged with a drill and drill guide so that the medical procedure kit fully
`
`supports the surgical technique.” Pet. 44 (quoting Ex. 1009 § 260).
`
`Based on the record before us, we are persuaded byPetitioner’s
`contentions, which Patent Owner doesnotrebut at this time. Accordingly,
`Petitioner has established a reasonable likelihood of prevailing onits
`
`challenge to claim 20 based on obviousness over Fox and Bertazzoni.
`
`_D. Obviousness over 4Fusion
`
`Petitioner contends that claims 15-19 and 21 would have been
`
`obvious over 4Fusion. Pet. 45—58. Initially, we note that Patent Owner
`
`questions the publication date to be accorded to 4Fusion. Prelim. Resp. 5
`
`(characterizing 4Fusion as “ha[ving] no clear publication date.”). Petitioner
`
`alleges that 4Fusion was published in 2009, but offers no further explanation
`
`in the Petition to support this allegation. Pet. 6. The only date information
`
`provided in Petition for 4Fusion is “©2009,” indicating a copyright date of
`2009, provided in the Petition’s description of exhibits.” Id. at v. Petitioner
`
`relies on 4Fusion beinga priorart printed publication under 35 U.S.C.
`
`§ 102(b). Jd. at 6. We are not persuaded that Petitioner has provided
`
`sufficient evidence to establish that 4Fusion qualifies as a prior art printed
`
`publication.
`
`> Upon inspection of 4Fusion, we note that the documentadditionally
`includes a date of “11/23/09” on the top of each page. Ex. 1008, 1-2. The
`significance of this date is unclear, however, and Petitionerfails to allege
`that is of any significance for establishing the document asa printed
`publication.
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
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`As noted above, Petitioner offers no explanation as to why 4Fusion
`
`qualifies as a prior art printed publication that was “published in 2009” as
`
`alleged, and appearsto rely solely on the copyright marking “©2009.” Even
`
`registration of a copyright, without more, does not demonstrate sufficient
`
`accessibility to establish that the reference is a printed publication. Jn re
`Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009). Here, Petitioner has not even
`
`provided evidence that 4Fusion was registered with the U.S. Copyright
`
`Office. Furthermore, assuming the document was created and marked with a
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`“©” in 2009, the copyright date indicated on 4Fusion does not demonstrate
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`sufficient accessibility to the public interested in the art at any timeprior to
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`the critical date of the ’853 patent.
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`Accordingly, Petitioner has failed to establish a reasonable likelihood
`
`of success on this challenge to claims 15—19 and 21.
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`E. Obviousness over 4Fusion and Bertazzoni
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`Claim 20 ultimately depends from claim 15, and Petitioner contends
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`that claim 15 would have been obvious over the combination of 4Fusion and
`
`Bertazzoni. Pet. 58-60. Because, as noted above, Petitioner has failed to
`
`establish that 4Fusionis a prior art printed publication, Petitioner has also
`failedto establish a reasonablelikelihood of success on this challenge to
`claim 20.
`
`Il.
`
`CONCLUSION
`
`For the foregoing reasons, we determinethat the information
`
`presented in the Petition establishes a reasonable likelihoodthat, for
`
`purposes of this Decision, Petitioner would prevail in establishing the
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`unpatentability of claims 15~—21 of the ’853 patent.
`
`10
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`The Board has not madea final determination on the patentability of
`
`any challenged claims.
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`IV. ORDER
`
`For the reasonsgiven,it is
`
`ORDEREDthatan inter partes review is instituted asto:
`
`A.
`
`B.
`
`Claims 15-19 and 21 as anticipated by Fox; and
`
`Claim 20 as obvious over Fox and Bertazzoni;
`
`FURTHER ORDEREDthat, pursuant to 35 U.S.C. § 314(a), inter
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`partes review of the °853 patent is hereby instituted commencing on the
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`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`
`§ 42.4, notice is hereby given ofthe institution ofatrial; and
`
`FURTHER ORDEREDthatthetrial is limited to the grounds
`
`identified above. No other groundsare authorized.
`
`PETITIONER:
`
`PatrickD. McPherson
`Samuel W.Apicelli
`DUANE MORRIS LLP
`PDMcPherson@duanemorris.com
`swapicelli@duanemorris.com
`
`PATENT OWNER:
`
`David M. Hoffman
`FISH & RICHARDSONP.C.
`IPR22484-0004IP 1 @fr.com
`
`11
`
`
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