Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 38
`Entered: May4, 2016
`
`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
`TIMOTHY J. GOODSON,Administrative Patent Judges.
`
`PLENZLER, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 CFR. § 42.73
`
`
`Tel: 571-272-7822
`
`Paper 38
`Entered: May4, 2016
`
`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
`TIMOTHY J. GOODSON,Administrative Patent Judges.
`
`PLENZLER, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 CFR. § 42.73
`
`
`
`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 US. Patent No. 8,584,853
`
`B2 (Ex. 1001, “the ’853 patent”). Paper 1 (“Pet.”). In our Decision on
`
`Institution (Paper 7, “Decision to Institute” or “Dec.”), we instituteda trial to
`review the patentability of claims 15~21 based on the following grounds:
`
`
`Basis|Claim(s) Challenged
`
`| References
`
`
`§ 102
`15-19 and 21
`
`
`
`
`Dec. 11. Petitioner also provided testimony from Stephen H. Smith, M.D.
`Ex. 1002 (“the Smith Declaration”).
`Subsequentto institution, Biomedical Enterpriscs, Inc. (“Patent
`Owner”) tiled a Patent Owner Response. Paper 11 (“PO Resp.”). Petitioner
`filed a Reply to the Patent Owner Response. Paper 18 (‘‘Pet. Reply”). After
`receiving our authorization (Paper 22), Patent Ownerfiled a Sur-Reply,
`limited to addressing claim construction issuesraised in Petitioner’s Reply.
`
`Paper 27 (“PO Sur-Reply”).
`
`An oral hearing was held on February 17, 2016, and a transcript of the
`
`hearing is included in the record. Paper 30 (“Tr.”).
`
`'U.S. Patent App. Pub. No. 2013/0030438 A1, pub. Jan. 31, 2013 (Ex.
`1009, “Fox”).
`? International Publication No. WO 2010/004330 Al, pub. Jan 14, 2010 (Ex.
`1010, “Bertazzoni”). The page numbers used herein correspondto those on
`the lowerright, included by Petitioner, for consistency with the citations in
`the Petition.
`,
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`We havejurisdiction under 35 U.S.C. § 6(c). This Final Written
`
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`For the reasons that follow, we determinethat Petitioner has failed to
`
`show by a preponderanceofthe evidence that claims 15-21 of the ’853
`
`patent are unpatentable.
`
`B. Related Proceedings
`
`Petitioner and Patent Ownerindicate that the ’853 patent is 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. The ’853 Patent
`
`The °853 patent is directed to “an orthopedic fixation system
`
`consisting ofa sterile packaged implant kit and a sterile packaged instrument
`
`kit.” Ex. 10U1, 1:7-9.
`
`‘I'he ’853 patentillustrates an exemplary sterile
`
`packaged implant kit in Figure 3A, reproduced below.
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`
`
`———
`a “
`
`Figure 3A is an exploded viewofsterile packaged implant kit 200. As seen
`
`in Figure 3A, implant kit 200 includes implant 205, insertion device 220,
`
`and drill guide 230. Id. at3:57-59. The ’853 patent notes that “[t]he entire
`
`assembly, consisting of implant 205 mountedto insertion device 220 and
`
`matchingdrill guide 230 are placed into an implant package 210 suitable to
`
`.. maintain implant 205, insertion device 220, and matching drill 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 3:44-47. The ’853 patent
`
`explains that “[i]mplant 205 is mounted on disposable insertion device 220,”
`
`which “holds the implant 205 such that implant[] legs 206 and 207 are held
`
`mechanically in a parallel position for easier insertion into bone.” Jd. at
`
`
`
`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.
`
`/d. at 3:52-54.
`
`D. Illustrative Claim
`
`As noted 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 movementofthe legs from
`the second substantially parallel position to the first
`convergent position 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 adaptedto 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 maintainstheat least one surgical implant and the
`insertion device sterile after sterilization of the sterile
`packagedimplantkit.
`
`Ex. 1001, 7:19-8:4.
`
`
`
`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 ofothers skilled in the relevant art.
`
`37 C.F.R. § 42.100(b). Applying that standard, we interpret the claim terms
`
`of 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)).
`
`The dispute between the parties focuses mainly on the scope of claim
`
`15. The dispute is with respect to the following two limitationsrecited in
`
`claim 15: “movementof the legs from the first convergent position to the
`
`second substantially parallel position stores a compressive force in the
`
`implant” and “the insertion device maintains the legs in their second
`
`substantially parallel position such that the implant stores the compressive
`
`force.” Specifically, the dispute focuses on whether the scope of the claim
`
`includes an implant kit having a surgical implant that stores a compressive
`
`force whenits legs are displaced from a converged to a parallel position in
`the austenite phase, but that is loaded on an insertion device whenthat
`implant is in a martensitic phase(i.e., plastic deformation rather than elastic
`deformation during loading)’. See Pet. Reply 2-4; PO Sur-Reply1.
`
`3 Petitioner acknowledgesthat these properties arise in nitinol. See Pet.
`Reply 6-15. There is no dispute that the claims cover a surgical implant
`madefrom nitinol, or that nitinol is the material used for the surgical
`implants in Patent Owner’s antedating evidence.
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`Petitioner contends that the claim recites the process used to impart
`
`the compressive force into the implant. Pet. Reply 3. Petitioner’s
`
`interpretation relies on the antecedent basis for “compressive force” recited
`
`in the limitation requiring that “the insertion device maintains the legs in
`
`their second substantially parallel position such that the implantstores the
`
`compressive force”(i.e., that it requires “the compressive force”to be “a
`
`compressive force” resulting from the “movementofthe legs from thefirst
`
`convergent position to the second substantially parallel position” recited
`
`earlier in the claim). Pet. Reply 4; Tr. 11:11-18. Petitioner cites the
`
`prosecution history of the ’853 patent as supportingits position. Pet. Reply
`
`5-6 (citing Ex. 1007, 2, 5, 7-9).
`
`Patent Ownerdisagrees, arguing that the claim doesnotrecite a
`
`process of loading the implant on the insertion device. PO Sur-Reply 1-3.
`
`Rather, Patent Owner contendsthat the “movementof the legs from thefirst
`
`convergent position to the second substantially parallel position stores a
`
`compressive force in the implant” limitation recited in claim 15 defines only
`
`the characteristics of the surgical implantitself, and not a limitation on how
`
`the implant is loaded on the insertion device. /d. at 1. We agree with Patent
`
`Owner.
`
`Weread the “movementofthe legs from the first convergent position
`
`to the second substantially parallel position stores a compressive force in the
`implant” recited in claim 15 as defining the characteristics ofthe implant,
`and specifying the type of force that is stored by the implant(1.e., a
`
`compressive force that biases the legs of the implant inward toward the
`
`convergedposition). The subsequentlimitation that the insertion device
`
`“maintains the legs in their second substantially parallel position such that
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`the implant stores the compressive force” defines the structure of the
`
`insertion device as one that maintains the legs of the implant in the parallel
`
`position, regardless of how the implant wasplaced ontheinsertion device.
`
`The “maintains”limitation does not specify any particular manner in which
`
`the implant is loaded onthe insertion device.
`
`Ourinterpretation follows the plain and ordinary meaning ofthe claim
`
`language. It is also consistent with the specification, whichis silent as to
`
`how the surgical implant is loaded on the implant device. Petitioner does
`
`not dispute that the specification fails to provide any guidance onthis issue,
`
`noting that “[n]o explanation or limitation is provided with respectto the
`
`mannerin which a force can be stored in an implant, or of the specific
`
`mannerin which movementofthe legs is operable to ‘store[] a compressive
`
`force in the implant’”in the ’853 patent specification. Pet. Reply 27.
`
`Although Petitioner contendsthat the prosecution history supportsits
`
`narrowerinterpretation ofthe claim, we disagree. As Patent Owner
`
`contends, “there is no support in... the file history to deviate from the plain
`
`meaning and impart a manufacturing requirement”into the claim. PO Sur-
`
`Reply 2. The portions of the prosecution history identified by Petitioner
`
`explain that the claimed arrangementallowsfor sterilization of the kit at the
`production site. Ex. 1007, 8-9. We are not persuadedthat this places the
`
`limitation asserted by Petitioner regarding how the kit is assembledat the
`
`productionsite.
`
`For purposesof this Decision, we determine that claim 15 does not
`
`recite a particular process for assembly ofthe recited kit. Accordingly, for
`
`purposesofthis Decision(i.e., patentability), we determinethat a kit having
`
`the structural limitations required by the claims meets the claim limitations
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`discussed above, even if, for example, the legs of the implant device are
`
`displaced and loaded on the insertion device when the implantis in a fully
`
`martensitic phase.
`
`B. Whether Fox is Prior Art
`
`Each ofthe challenges in this trial are based, at least in part, on Fox.
`
`Fox wasfiled on July 27, 2011 and published on January 31, 2013. Ex.
`
`1009, (22), (43). The 853 patentlists February 16, 2012 asits filing date,
`
`andit does notclaim priority to an earlier date. Ex. 1001, (22). Petitioner
`
`asserts that Fox “qualifies as prior are under pre-AIA 35 U.S.C. § 102(c).”
`
`Pet. 6. Patent Owner respondsthat the challenged claims were conceived
`
`and reducedto practice before Fox’s filing date, and thus Fox wasnotfiled
`
`“before the invention by the applicant” as required by § 102(e). PO Resp.2.
`
`In support of this argument, Patent Owner presents evidence to antedate Fox.
`
`See id. at 4-32. For example, Patent Owneroffers evidencethatits “second
`generation kit” was reducedto practice by May 19, 2011, which pre-dates
`the July 27, 2011 filing date of Fox. Jd. at 25-32.
`
`There is no dispute that the “second generation kit” includes each
`
`structural elementrecited in claims 15-21. See Pet. Reply 3-21. Rather,
`
`Petitioner contends that Patent Owner’s evidence regarding the “second
`
`generation kit” fails to provide sufficient evidence of prior invention because
`
`that kit is allegedly assembled by a process wherethe legs of the surgical
`implant (staple) are displaced and loaded on the insertion device when the
`
`surgical implantis in a fully martensitic phase, which Petitioner defines as
`“Method1,” Id at 11-13, 18-21.
`Other than arguing that the challenged claims preclude loading the
`surgical implant on the insertion device in the claims using “Method 1,”
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`Petitioner offers no explanation or evidence rebutting Patent Owner’s
`
`evidence ofprior invention. As explained abovein our discussion of claim
`
`construction, we do notread the claimsasreciting a particular process for
`loading the surgical implant on the insertion device. More specifically, we
`
`do not read the challenged claims as precluding loading the surgical implant
`
`on the insertion device using “Method 1.” Accordingly, Patent Owner’s
`
`evidence of antedating based on the “second generation kit”is effectively
`
`unrebutted.
`
`Moreover,at oral hearing, Petitioner conceded that if we interpret the
`claims in the manner explained in our claim construction discussion above
`(i.e., not precluding loading the surgical implant on the insertion device
`
`using “Method 1”), then the evidence set forth by Patent Owner regarding
`
`the “second generation kit” successfully antedates Fox. See Tr. 8:3—7 (“If
`
`the Board holdsthat the plain and ordinary meaning of the ‘wherein’ clause
`
`includes within that scope the method we’ve identified as Method 1, we
`
`would agree with you, then their swear-behind evidence would be
`
`sufficient.”).
`
`“(TJhere are two distinct burdens of proof: a burden of persuasion and
`
`a burden of production.” Dynamic Drinkware, LLCv. Nat’! Graphics, Inc.,
`
`800 F.3d 1375, 1378 (Fed. Cir. 2015) (citing Tech. Licensing Corp.v.
`
`Videotek, Inc., 545 F.3d 1316, 1326-27 (Fed. Cir. 2008)). “The burden of
`
`persuasion ‘is the ultimate burden assigned to a party who must prove
`
`something to a specified degree of certainty.”’ Jd. (quoting Tech. Licensing,
`
`545 F.3d at 1326). “A quite different burden is that of going forward with
`
`evidence--sometimesreferred to as the burden of production--a shifting
`
`burden the allocation of which depends on wherein the processoftrial the
`
`10
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`issue arises.” Tech. Licensing, 545 F.3d at 1327 (citations omitted). The
`burden ofproduction may shift between the parties and may involve
`“producing additional evidence and presenting persuasive argument based
`
`on new evidenceor evidence already of record.” Dynamic Drinkware, 800
`
`F.3d at 1379 (quoting Tech. Licensing, 545 F.3d at 1327). Here, Petitioner
`
`has the ultimate burden of persuasion to establish that Fox is prior art and
`
`Patent Ownerhas the burdenof production or the burden of going forward
`
`with the evidence to show invention prior to Fox. Against this background,
`
`we consider Patent Owner’s argument regardingprior invention.
`
`Applying ourinterpretation of the challenged claims, Patent Owner’s
`
`evidence regarding the “second generation kit” is sufficientto carry its
`
`burden to show prior invention for the challenged claims under our
`
`interpretation of those claims, as conceded bythe Petitioner. Accordingly,
`
`1]
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`we determine that Fox is notprior art to the ’853 patent.*° Thus, Petitioner
`
`has failed to demonstrate unpatentability of claims 15-21 by a
`
`preponderanceofthe evidence, as Fox is relied on in each ofthe challenges
`
`involvedin this trial.
`
`I.
`
`CONCLUSION
`
`For the foregoing reasons, we determine that Petitioner has failed to
`
`establish by a preponderanceofthe evidence that claims 15-21 of the ’853
`
`patent are unpatentable.
`
`* Our decision with respect to Patent Owner’s evidence of antedating would
`not changeif the claimsrecited the specific process alleged by Petitioner.
`Evenif the claims recited the process of loading the surgical implant whenit
`is in at least a partially austenitic phase, as Petitioner contends, that would be
`a product-by-process limitation and Petitioner concedesthat the product
`created by that process does not result in any change to the structure or
`function of the surgical implant (or any otherstructure recited in the claims).
`See Tr. 16:13—-15 (“[T]here is no difference in the actual staple itself. There
`is a difference in how theforceis stored in that staple.”). The patentability
`of a product does not depend onits method of production. Jn re Thorpe, 777
`F.2d 695, 697 (Fed. Cir. 1985) (citing In re Pilkington, 411 F.2d 1345, 1348
`(CCPA 1969)). If the product in a product-by-process claim is the same as
`or obvious from a productofthe prior art, the claim is unpatentable even
`though the prior product was madebya different process. Jd. (citing In re
`Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983)); Johnson & Johnson v. W.L.
`Gore, 436 F. Supp. 704, 726 (D. Del. 1977); see also In re Fessmann, 489
`F.2d 742, 744 (CCPA 1974).
`> Because Petitioner hasfailed to establish that Fox is prior art in view of the
`evidence provided by Patent Ownerregarding the “second generation kit,”
`we need not address Patent Owner’s additional contentions regarding
`antedating basedonits “first generation kit” or whether Fox qualifies as
`being “by another” under 35 U.S.C. § 102(c).
`
`12
`
`
`
`IPR2015-00786
`Patent 8,584,853 B2
`
`IV. ORDER
`
`Forthe reasons given,it is
`
`ORDEREDthatclaims 15-21 of the ’853 patent have not been shown
`
`to be unpatentable; and
`
`FURTHER ORDEREDthatparties to the proceeding seeking judicial
`
`review ofthis Final Written Decision must comply with the notice and
`
`service requirements of 37 C.F.R. § 90.2.
`
`PETITIONER:
`
`Patrick D. McPherson
`PDMcPherson@duanemorris.com
`
`Samuel W.Apicelli
`SWApivelli(gduauemorris.coll
`
`PATENT OWNER:
`
`David M. Hoffman
`TPR22484-0004IP 1@fr.com
`
`13
`
`
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