Trials@uspto.gov
`§71-272-7822
`
`Paper 17
`Entered: January 29, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`V.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`Before JOSIAH C. COCKS, HYUN J. JUNG,and.
`TIMOTHY J. GOODSON,Administrative Patent Judges.
`
`GOODSON,Administrative Patent Judge.
`
`DECISION
`Institution of Post-Grant Review
`37 C.F-R. § 42.208
`
`
`§71-272-7822
`
`Paper 17
`Entered: January 29, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`V.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`Before JOSIAH C. COCKS, HYUN J. JUNG,and.
`TIMOTHY J. GOODSON,Administrative Patent Judges.
`
`GOODSON,Administrative Patent Judge.
`
`DECISION
`Institution of Post-Grant Review
`37 C.F-R. § 42.208
`
`
`
`PGR2015-00019
`Patent 8,876,991 B2
`
`I.
`
`INTRODUCTION
`
`US Endodontics, LLC (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
`
`requesting post-grant review of claims 12—16 of U.S. Patent No. 8,876,991
`
`B2 (“the 991 patent”). Gold Standard Instruments, LLC (“Patent Owner”)
`
`filed a Preliminary Response (Paper14, “Prelim. Resp.”) to the Petition.
`Wehavejurisdiction under 35 U.S.C. § 324(a), which provides that a
`post-grant review maybeinstituted only if “the information presented in the
`
`petition ... demonstrate[s] that it is more likely than notthat at least 1 of the
`
`claims challengedin the petition is unpatentable.” For the reasons explained
`
`below, upon consideration of the Petition and the Preliminary Response, we
`conclude that the information presented in the Petition demonstratesthatit is
`morelikely than notthat at least one ofthe challenged claimsis
`unpatentable. Accordingly, we authorize a post-grant review to be instituted
`
`as to claims 12-16 of the 991 patent.
`
`A. Related Matters
`
`Petitioner has filed two petitions for inter partes review challenging
`
`U.S. Patent No. 8,727,773 (“the ’773 patent”), whichis related to the ’991
`
`patent. Weinstituted review on several of the groundspresentedinthefirst
`
`petition. US Endodontics, LLC v. Gold Standard Instruments, LLC, Case
`
`IPR2015-00632 (PTAB Aug.5, 2015) (Paper 29). We deniedinstitution on
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`any of the grounds presented in the second petition. US Endodontics, LLC v.
`
`Gold Standard Instruments, LLC, Case IPR2015-01476 (PTAB Oct. 26,
`
`2015) (Paper 13).
`
`In addition, the ’773 patent and U.S. Patent No. 8,562,341, another
`
`patent related to the 991 patent, are being asserted against Petitioner in an
`ongoing lawsuit in the U.S. District Court for the Eastern District of
`Tennessee, Dentsply International, Inc. v. US Endodontics, LLC, Case No.
`
`2
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`
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`PGR2015-00019
`Patent 8,876,991 B2
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`2:14-cv-00196-JRG-DHI. Pet. 1; Paper 13, 3.
`
`B. The ’991 Patent
`
`The ’991 patentis titled “Dental and Medical Instruments Comprising
`
`Titanium.” Ex. 1001, Title. The invention is described as serving to
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`“overcome[] the problems encountered whencleaning and enlarging a
`
`curved root canal.” Jd. at 2:59-60. The ’991 patent explains that flexibility
`
`is a desirable attribute for endodontic devices such as “files,” but that in the
`priorart, the “shank”portionsof files of larger sizes are “relatively
`inflexible,” which impedesthe therapy of a root canal. Jd. at 2:4-26.
`
`The 7991 patent also describes that it is knownin theart that
`
`endodontic files may be formed of“superelastic alloys such as nickel-
`
`titanium that can withstand several times morestrain than conventional
`
`materials without becomingplastically deformed.” Jd. at 2:43-46. The ’991
`
`patent further explains that a property termed “shape memory.. . allows the
`
`superelastic alloy to revert back to a straight configuration even after clinical
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`use, testing or fracture (separation).” Jd. at 2:46—49. Accordingto the ’991
`
`patent, there remains a need for endodontic instruments that “have high
`
`flexibility, have high resistance to torsion breakage, maintain shape upon
`
`fracture, can withstand increased strain, and can hold sharp cutting edges.”
`
`Id. at 2:50-S5.
`
`Figures 1a and 1b, which are reproducedbelow,illustrate “a side
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`elevational view of an endodontic instrument” (Fig. la), and “a partial
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`detailed view of the shank of the endodontic instrument shownin FIG. 1a”
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`(Fig. 1b). Id. at 3:26—29.
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`
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`PGR2015-00019
`
`Patent 8,876,991 B2
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`Fig. 1a
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`Fig. 4b
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`The figures above depict an endodonticinstrument according to the
`
`invention. With respect to those figures, the °991 patent conveys the
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`following:
`
`This embodimentofthe invention is an endodontic instrumentas
`shownin FIG. 1a that includes an elongate shank 42 mounted at
`its proximate end 47 to a handle 43. The shank 42 may be about
`30 millimeters long. The proximate end 47 may have a diameter
`of about 0.5 to about 1.6 millimeters. The shank 42 may include
`calibrated depth markings 45 andfurther includesa distal end 48.
`The shank 42 includes two continuoushelical flutes 51 as shown
`in FIG. 15 that extend along its lower portion. The flutes 51
`define a cutting edge. A helical land 53 is positioned between
`axially adjacent flutes as shownin FIG.15.
`
`Id. at 4:5-15.
`
`The ’991 patent also explains that fabricating a medical instrumentin
`
`accordance with the invention involves selecting a superelastic titanium
`
`alloy for the shank and subjecting the instrumentto “heat-treatment”so as to
`
`4
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`
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`PGR2015-00019
`Patent 8,876,991 B2
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`“relieve stress in the instrumentto allow it to withstand more torque, rotate
`throughalarger angle of deflection, change the handling properties, or
`visually exhibit a near failure of the instrument.” Jd. at 6:2—S.
`
`C. Illustrative Claim
`
`Claim 12 is independent, and is reproduced below:
`
`12. A method for manufacturing or modifying an
`endodontic instrument for use in performing root canal therapy
`on a tooth, the method comprising:
`(a) providing an elongate shank having a cutting edge
`extending from a distal end of the shank along an axial length of
`the shank, the shank comprising a superelastic nickel titanium
`alloy, and
`(b) after step (a), heat-treating the entire shank at a
`temperature above 25° C.up to but not equal to the melting point
`of the superelastic nickel titanium alloy,
`
`wherein the heat treated shank has an angle greater than
`10 degrees of permanent deformation after torque at 45 degrees
`of flexion whentested in accordance with ISO Standard 3630-1.
`
`D. References Relied Upon
`
`ThePetition relies on the following references:
`
`Luebke 2008
`Heath
`Matsutani
`McSpadden
`
`US 2008/0032260 Al Feb. 7, 2008
`US 5,628,674
`May13, 1997
`US 2006/0115786 Al
`June 1, 2006
`US 2002/0137008 Al Sept. 26, 2002
`
`Alan R.Pelton et al., Optimisation ofProcessing and Properties
`ofMedical-Grade Nitinol Wire, 9 MINIMALLY INVASIVE
`THERAPIES & ALLIED TECHS. 107 (2000) (“Pelton”)
`
`Ex. 1022
`Ex. 1024
`Ex. 1025
`Ex. 1031
`
`Ex. 1006
`
`International Standard ISO 3630-1, 15 ed. (1992) (“ISO 3630-1”)
`
`Ex. 1023
`
`Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical
`Properties ofNickel-Titanium Endodontic Instruments, 28 J.
`ENDODONTICS 716 (2002) (“Kuhn”)
`
`Ex. 1030
`
`
`
`unpatentable on the following grounds:
`
`ns aeaoe
`
`
`(none) § 112(a) (enablement)|12-16
`
`
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`PGR2015-00019
`Patent 8,876,991 B2
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`Teresa Roberta Tripiet al., Fabrication ofHard Coatings on NiTi
`Instruments, JOURNAL OF ENDODONTICS, Vol. 29, No. 2, 132-134 Ex. 1032
`(February 2003) (“Tripi’’)
`
`E. Alleged Grounds of Unpatentability
`
`Petitioner contends that claims 12—16 of the ’991 patent are
`
`a
`
`Ghallen:
`
`(none)
`
`§ 112 (a) (written
`description)
`
`12-16
`
`Luebke 2008
`
`Luebke 2008 aloneor in view of
`Heath or ISO 3630-1
`
`Matsutani
`
`Kuhn
`
`§ 102
`
`§ 103
`
`§ 102
`
`§ 102
`
`12-16
`
`15
`
`12-16
`
`12-14, 16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Kuhn alone or in view of Heath or|§ 103 15
`
`
`ISO 3630-1
`
`Kuhn alone or in view of Heath or|§ 103 12-16
`
`
`ISO 3630-1
`
`McSpadden, Pelton, and Kuhn
`
`McSpadden,Pelton, Kuhn, Heath
`and ISO 3630-1
`
`Tripi and McSpadden
`
`Tripi, McSpadden, and Heath or
`ISO 3630-1
`
`
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`12-14, 16
`
`15
`
`12-14, 16
`
`15
`
`
`
`
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`PGR2015-00019
`Patent 8,876,991 B2
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`A. Post-Grant Review Eligibility
`
`Ii.
`
`ANALYSIS
`
`1. Legal Standards for Post-Grant Review Eligibility
`The post-grant review provisionsset forth in Section 6(d) of the AIA!
`
`apply only to patents subject to the first-inventor-to-file provisions of the
`
`AIA. See AIA § 6(f)(2)(A) (“The amendments made by subsection (d) .. .
`
`shall apply only to patents described in section 3(n)(1).””). Thefirst-
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`inventor-to-file provisions apply to any application for patent, and to any
`
`patent issuing thereon, that contains or contained at any time a claim to a
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`claimed invention that has an effective filing date on or after March 16,
`
`2013. See AIA § 3(n)(1). The definition of “effective filing date”
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`referenced in § 3(n)(1) providesthat:
`
`(A) if subparagraph (B) does not apply, the actual filing date of
`the patent or the application for the patent containing a claim to
`the invention; or
`
`(B) the filing date of the earliest application for which the patent
`or application is entitled, as to such invention, to a right of
`
`' Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”).
`* The full text of Section 3(n)(1) of the AIA providesas follows:
`Except as otherwise provided in this section, the amendments
`made bythis section shall take effect upon the expiration of the
`18-month period beginning on the date of the enactmentofthis
`Act, and shall apply to any application for patent, and to any
`patent issuing thereon, that contains or contained at any time—
`(A) aclaim to a claimed inventionthat has an effective filing date
`as defined in section 100(i) oftitle 35, United States Code, that
`is on orafter the effective date described in this paragraph; or
`(B) a specific reference under section 120, 121, or 365(c)oftitle
`35, United States Code, to any patent or application that contains
`or contained at any time such a claim.
`AIA § 3(n)(1).
`
`7
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`PGR2015-00019
`Patent 8,876,991 B2
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`priority under section 119, 365(a), or 365(b) or to the benefit of
`an earlier filing date under section 120, 121, or 365(c).
`35 U.S.C. § 100(i)(1). Entitlement to the benefit of an earlier date under
`
`§§ 119, 120, 121, and 365 is premised on disclosure of the claimed invention
`
`“in the mannerprovided by § 112(a)(other than the requirementto disclose
`the best mode)” in the earlier application. See 35 U.S.C. §§ 119(e), 120.
`As a consequenceofthese statutes, a patent that issues from an
`
`application filed after March 16, 2013, that claims priority to an application
`filed before March 16, 2013, is available for post-grant review “if the patent
`
`contains .. . at least one claim that was not disclosed in compliance with the
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`written description and enablement requirements of § 112(a) in the earlier
`application for which the benefit of an earlier filing date prior to March16,
`2013 was sought.” Inguran, LLC v. Premium Genetics (UK) Ltd., Case
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`PGR2015-00017, slip op. 11 (PTAB Dec. 22, 2015) (Paper8).
`
`Separate from the requirementthat the patent is subject to the AIA’s
`first-inventor-to-file provisions, an additional requirement for post-grant
`
`review eligibility is that “[a] petition for a post-grant review may only be
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`filed not later than the date that is 9 months after the date of the grant of the
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`patent.” 35 U.S.C. § 321(c); see 37 C.F.R..§ 42.202(a). Here, Patent Owner
`
`does not dispute that the Petition was filed within the nine month filing
`
`deadline.* See Pet. 11. Nor does Patent Ownerdispute Petitioner’s
`
`3 Patent applicationsfiled on or after March 16, 2013 that claim the benefit
`of an earlier filing date prior to March 16, 2013 are sometimesreferred to as
`“transition applications.” See MPEP § 2159.04.
`+ The °991 patent issued on November4, 2014. Ex. 1001, (45). The Petition
`wasfiled on August 3, 2015. See Paper3, 1.
`8
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`PGR2015-00019
`Patent 8,876,991 B2
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`representationthat it is not barred or estopped from requesting post-grant
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`review of the 991 Patent. Seeid.
`Patent Ownerdoes contend, however,that the °991 patent is ineligible
`for post-grant review becauseits claimsareentitled to an effective filing
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`date of June 7, 2005. See Prelim. Resp. 31. Thus, with respect to post-grant
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`review eligibility, the only dispute is whether the ’991 Patent is subject to
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`the first-inventor-to-file provisions of the AIA.
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`2. Facts Relevant to Post-Grant Review Eligibility
`
`The application that issued as the ’991 patent was filed on January 29,
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`2014, and was assigned Application No. 14/167, 311 (‘the 7311
`application”). Ex. 1001, (22). The "991 patent claimspriority to a series of
`continuation and divisional applications reaching back to June 7, 2005, as
`
`well as a provisional application filed on June 8, 2004. Jd. at (60).
`
`Consistent with the characterization in the ’991 patent’s priority claim of the
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`earlier applications, Petitioner agrees that “[t]he descriptions in the priority
`
`applications are substantively the same except for their claims; the entire
`
`family comprises continuation and divisional applications (but not
`continuation-in-part applications).” Pet. 32. Thus,it is undisputed that the
`Specification of the ’991 patent is substantively identical to the
`
`- specifications of the applications to which it claimspriority. See Prelim.
`Resp. 25. It is also undisputed that the claimsin the ’311 application, as
`
`filed on January 29, 2014, are identical to the claimsas issued in the ’991
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`patent. See Pet. 6; Ex. 1003, 23-25.
`
`3. Burden ofProofon Post-Grant Review Eligibility
`
`Wefirst consider who carries the burden to establish that the °991
`
`patent is eligible for post-grant review. In this case, as noted above,
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`
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`PGR2015-00019
`Patent 8,876,991 B2
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`eligibility hinges on whether the 991 Patent is subject to the first-inventor-
`
`to-file provisions of the AIA. That analysis, in turn, depends on whether the
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`patent contains any claims havinganeffective filing date on or after March
`
`16, 2013. Petitioner contends that “Patent Ownerbears the ultimate burden
`
`of demonstrating entitlement to an earlier application’s filing date.” Pet. 22
`
`(citing In re NTP, Inc., 654 F.3d 1268, 1276-77 (Fed. Cir. 2011)).
`
`Petitioner argues that the 991 patent is eligible for post-grant review
`
`because “Patent Ownerwill not be able to meet its burden of proving that
`
`.
`
`the claims at issue are entitled to a filing date earlier than the .
`
`.
`
`. January 29,
`
`2014 filing date.” Jd. at 23. The Preliminary Response does notspecifically
`
`address who carries the burden on post-grant review eligibility.
`
`Petitioner’s argument that Patent Ownercarries the burden on this
`
`issue misapplies N7P’s holding. Although the patentee carried the burden to
`
`show entitlement to a claimed priority date in the circumstances of N7P,that
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`case does not signify that a patentee alwayscarries that burden. As
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`explained in other Federal Circuit decisions, the patentee carries the burden
`
`to show entitlement to a priority date when the patenteerelies on that
`
`priority date to overcomean anticipation or obviousness argument. See
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`Research Corp. Technologies, Inc. v. Microsoft Corp., 627 F.3d 859, 870-71
`
`(Fed. Cir. 2010); Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316,
`
`1327-29 (Fed. Cir. 2008); PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d
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`1299, 1305—06 (Fed. Cir. 2008). The reason for this allocation of the burden
`
`is that the party asserting invalidity has carried its burden of going forward
`
`with invalidating prior art, hence the “patentee then has the burden of going
`
`forward with evidenceto the contrary,i.e., the patentee must showthat the
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`prior art does not actually invalidate the patent or that it is not priorart
`
`10
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`PGR2015-00019
`Patent 8,876,991 B2
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`becausethe asserted claim is entitled to the benefit of an earlier filing date.”
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`Research Corp. Technologies, 627 F.3d at 870 (citing Tech. Licensing, 545
`
`F.3d at 1329).
`
`Here,the issue of entitlement to a claimed priority date arises in the
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`context of post-grant review eligibility, not in rebuttal to an obviousness or
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`anticipation argument. Specifically, Petitioner’s argument for post-grant
`
`review eligibility is based on the 991 patent containing claims with an
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`effective filing date of January 29, 2014, rather than any of the earlier
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`claimedpriority dates. See Pet. 23.
`
`In AIA proceedings, the generalruleis that “[t]he moving party has
`
`the burden of proof to establish that it is entitled to the requestedrelief.” 37
`
`C.F.R. § 42.20(c); see also 35 U.S.C. § 326(e) (“In a post-grant review
`instituted underthis chapter, the petitioner shall have the burden of proving a
`proposition of unpatentability by a preponderance of the evidence.”). In its
`Petition, Petitioner is requesting post-grant review of claims 12-16 ofthe
`991 patent. Pet. 1. As part of showingthatit is entitled to that request,
`Petitioner must showthat the ’991 patentis eligible for post-grant review.
`See 37 C.F.R. § 42.204(a) (requiring, as part of the contentofpetition, that
`
`“petitioner must certify that the patent for which review is soughtis
`available for post-grant review”); see also Inguran, LLC v. Premium
`Genetics (UK) Ltd., Case PGR2015-00017, slip op. 7 (PTAB Dec. 22, 2015)
`
`(Paper 8) (“[T]he petitioner bears the burden ofsetting forth grounds for
`standing for post-grant review.”). Amongthe requirements for post-grant
`revieweligibility is that the patent is subjectto the first-inventor-to-file
`provisions of the AIA. See AIA §§ 3(n)(1), 6(f)(2)(A). Thus, as part of
`
`showingthatit is entitled to the requested relief of post-grant review, the
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`11
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`PGR2015-00019
`Patent 8,876,991 B2
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`petitioner has the burden to show that the patent is subject to the first-
`inventor-to-file provisions of the AIA.
`|
`Having determinedthat a petitioner seeking post-grant review carries
`
`the burden to showthat the patent is subject to the first-inventor-to-file
`
`provisions of the AIA and,therefore, eligible for post-grant review, we now
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`turn to the analysis of whether Petitioner carried that burden in this case.
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`4. Sufficiency ofPetitioner’s Showing on Post-Grant Review
`
`Eligibility
`
`Petitioner presents several arguments for why the ’991 patent includes
`claims with an effective filing date of January 29, 2014, whichis the actual -
`filing date of the ’311 application. See Pet. 23-32. Among these arguments
`
`is Petitioner’s contention that the disclosure of the °991 patent does not
`
`enable a skilled artisan to perform the methodrecited in claims 12-16. See
`
`Pet. 31-45. Because the disclosureof the priority applications is the same as
`that of the ’991 patent’s Specification, the priority applicationsalso fail to
`
`provide an enabling disclosure for the subject matter of claims 12-16. Jd. at
`31-32. Thus, according to Petitioner, claims 12-16 are notentitled to an
`effective filing date earlier than January 29, 2014. Id.
`
`Wepausehereto note that Petitioner’s contention that January 29,
`
`2014,is the effective filing date for claims 12—16 is not based on an
`
`argumentthat those claims are adequately supported in the ’311 application
`
`but not in earlier applications to whichpriority is claimed. Instead,
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`Petitioner’s contention is that neither the 7311 application nor any of the
`
`earlier applications provides an enabling disclosure for claims 12—16, and
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`therefore, the effective filing date for those claimsis the actualfiling date.
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`See Pet. 31-32. Petitioner’s argument is consistent with the definition of
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`12
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`“effective filing date” set forth above, which provides in subparagraph (B)
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`that the effective filing date is the filing date of the earliest application to
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`whichthe patent is entitled to priority or to the benefit of an earlier filing
`
`date. 35 U.S.C. § 100(i)(1)(B). Subparagraph (A) providesthat “if
`
`subparagraph (B) doesnot apply,” the effective filing date is the actual filing
`
`date of the patent containing a claim to the invention. 35 U.S.C.
`
`§ 100(i)(1)(A). Underthis definition, if a claim in a patent application is not
`
`entitled to an earlier filing date, then subparagraph (B) does not apply and
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`the effective filing date is the actual filing date of the application under
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`subparagraph (A), regardless of whether the disclosure in the applicationis
`
`sufficient to support the claim. Accordingly, we agree with Petitionerthatif
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`claims 12—16 are shownto lack support in the ’311 application and all of the
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`earlier applications to which priority is claimed, the effective filing date for
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`.
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`those claimsis the actual filing date of the ’311 application.
`
`Turning back to Petitioner’s enablement argument, Petitioner focuses
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`on the range of temperatures at which the claimed heat treatment occurs.
`Claim 12 recites
`|
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`heat-treating the entire shank at a temperature above 25° C. up
`to but not equal to the melting point of the superelastic nickel
`titanium alloy, wherein the heat treated shank has an angle
`greater than 10 degrees of permanent deformation after torqueat
`45 degrees of flexion when tested in accordance with ISO
`Standard 3630-1.
`
`Ex. 1001, 10:42-48 (emphasis added). Dependent claim 14 narrows the
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`temperature range somewhat,reciting that “the temperature is from 300° C.
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`up to but not equal to the melting point of the superelastic nickel titantum
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`alloy.” Id. at 10:53—54.
`
`13
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`PGR2015-00019
`Patent 8,876,991 B2
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`Petitioner argues that ““‘heat-treating’ a superelastic, nickel-titanium
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`endodontic instrument at as low as 25°C, or at mouth temperature (37°C),
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`will not result in a file that exhibits the recited level of permanent
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`deformation.” Pet. 36 (citing Ex. 1002 J 101-02). Petitioner’s declarant,
`
`Dr. Goldberg,testifies that “[i]n order to transform a Ni-Ti endodontic
`
`instrument from one which would notsatisfy the ‘wherein’ clause into one
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`that would satisfy it, one must processthe alloy so as to changeits
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`transformation temperatures.” Ex. 1002 § 101. Yet, according to Dr.
`
`Goldberg:
`
`[SJubjecting a Ni-Ti instrument to 25—37°C will not alter its
`transformation temperatures. Effective heat-treatment requires
`enough thermal energy for the individual atoms to move to
`different positions within the solid material. Heat-treatmentat
`25-37°C does not provide this energy.
`Significantly higher
`temperatures are required: one paper explained that, with respect
`to one Ni-Ti alloy, the transformation temperature did not change
`significantly with a treatment temperature of 300°C.
`Id. § 102 (citing Ex. 1006, 113).
`
`To showthat the method of the ’991 patent is inoperative within the
`
`claimed temperature ranges, Petitioner describes testing in which the shanks
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`of ten ProFile brand Ni-Ti endodontic files were heat-treated at 25°C for
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`durations between 75 minutes and twelve hours. Pet. 36-37 (citing Ex. 1015
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`{7 4-5). The heat-treated shanks were then subjected to flexion testing in
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`accordance with ISO Standard 3630-1, and their permanent deformation was
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`measured to be between 0.04 and 2.19 degrees, averaging 0.87 degrees.
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`Pet. 37 (citing Ex. 1018, 10; Ex. 1002 § 105). Similar testing was conducted
`with a heat-treatment at 300°C,andthe results of that testing showed
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`permanent deformation in the 300°C-treated shanks between 0.07 and 2.73
`
`degrees, averaging 1.17 degrees. Pet. 39 (citing Ex. 1015 9] 3-5; Ex. 1018,
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`14
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`Patent 8,876,991 B2
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`10; Ex. 1002 ¢ 107). Thus, none of the 25°C-treated shanks or the 300°C-
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`treated shanks exhibited permanent deformation of greater than 10 degrees
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`as required by the “wherein” clause of claim 12. Pet. 39.
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`Petitioner further argues that claims 12—16 are not enabled because
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`undue experimentation would be required to practice the full scope of the
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`claimed invention. Pet. 40-45. Petitioner asserts, with reference to Dr.
`
`Goldberg’s testimony,that “the results of heat treatment depend on several
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`variables, including temperature, time, alloy composition andalloy treatment
`
`history.” Pet. 41 (citing Ex. 1002 § 111). Petitioner argues that the
`
`Specification provides insufficient guidance regarding how to achieve the
`
`claimed permanent deformation result using the claimed heat treatment
`
`parameters. Pet. 45. Example 4 in the ’991 patentis the only description
`
`providedin the Specification for achieving the claimed permanent
`
`deformation. Id. at 41; see also Ex. 1001, 8:35—62 (describing heat-
`
`treatment at 500°C for 75 minutes of files comprising 54—57 weight percent
`
`nickel and 43-46 weight percent titanium). According to Petitioner,“the
`
`specification does not provide any guidance as to how variations in time and
`
`temperature, or alloy composition, may affect the results one way or
`another.” Pet. 45. Thus, the example disclosed in the Specification is
`insufficient to enable claims 12—16, which encompassa broad range of
`
`possible combinationsof these variables. Jd. at 4445 (citing Ex. 1002
`
`q 125). In particular, the claims do not specify a duration for heat-treating,
`
`encompasstemperature ranges from above 25°C (claims 12, 13, 15, 16) or
`
`300°C (claim 14) up to but not equal to the melting point of the alloy, and
`
`either do not specify a composition for the nickel titanium alloy (claims 12—
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`PGR2015-00019
`Patent 8,876,991 B2
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`15) or include a range of 54-57 weight percent nickel (claim 16). See Ex.
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`1001, 10:35-60.
`
`Patent Owner counters that the testing discussed in the Petition does
`
`not show lack of enablement because“[i]t is not necessary that every
`
`permutation within a generally operable invention be effective in order for
`
`an inventor to obtain a generic claim, provided that the effect is sufficiently
`
`demonstrated to characterize a generic invention.” Prelim. Resp. 17-18
`(quoting Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005)). Patent
`Ownerfurther argues that the testing in which heat-treatment was conducted
`
`at 25°C establishes nothing because that temperature is outside the
`
`temperature range of claim 12, which recites heat-treating the shank at a
`
`temperature “above 25° C.” Prelim. Resp. 18. Patent Owneralso discounts
`
`the testing in which heat-treatment was conducted at 300°C on the grounds
`
`that the °991 patent teaches that the temperature is dependent on the time
`
`period selected, but Petitioner did not establish that selecting the time period
`was beyondroutine skill in the art. /d. at 18-19 (citing Ex. 1001, 4:16-19).
`With respect to Petitioner’s argument that undue experimentation
`
`would be required to practice the full scope of claims 12—16, Patent Owner
`
`asserts that Petitioner has not addressed manyof the Wandsfactors that are
`
`relevant to the determination of whether experimentation is undue. See
`
`Prelim. Resp. 19-23 (citing In re Wands, 858 F.2d 731, 737 (Fed. Cir.
`
`1988)). Patent Owneralso arguesthat Petitioner’s argument of undue
`
`’ experimentation is premised on Dr. Goldberg’s testimony, but that Dr.
`
`Goldberg’s deposition testimony in a district court case establishes that he is
`
`not knowledgeable about common methodsofheat-treating Ni-Ti. Prelim.
`
`Resp. 24 (citing Ex. 2014, 146:6—11). Finally, Patent Ownerargues that
`
`16
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`Patent 8,876,991 B2
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`Petitioner’s undue experimentation argument“is premised on an incorrect
`
`interpretation of claims 12-16” because Petitioner erroneously asserts that
`
`the “wherein”clause of claim 12 “is satisfied by a file that merely exhibits
`
`‘some’ degree of deformation or which has an Ar greater than 37°C.”
`
`Prelim. Resp. 24.
`
`On the current record, we find Petitioner’s arguments concerning lack
`
`of enablementfor claims 12—16 to be persuasive. We do agree with Patent
`
`Ownerthat the testing involving heat-treating at 25°C is outside of the
`
`temperature range of claim 12, and,therefore, is insufficient by itself to
`
`prove the inoperability of claims 12-16. Nevertheless, the results of that
`
`25°C testing tend to support Dr. Goldberg’s testimony that temperaturesin
`
`the range of 25—37°C simply do not provide sufficient thermal energy to
`
`cause the changein transformation temperature that is necessary to satisfy
`
`the “wherein”clause. Ex. 1002 § 102. The maximum permanent
`
`deformation after flexion testing of the 25°C heat-treated shanks was 2.19
`
`degrees, and the average was 0.87 degrees. See Pet. 37; Ex. 1018, 10.
`
`Theseresults are significantly lower than the claimed permanent
`
`deformation of greater than 10 degrees. See Ex. 1001, 10:45-46. Moreover,
`the results from the 25°C heat-treatmentare similar to the results ofthe
`
`300°C heat-treatmentin that the 300°C-treated shanks showed an average of
`
`1.17 degrees of permanent deformation with a maximum of 2.73 degrees.
`
`See Pet. 39; Ex. 1018, 10. The similarity of these results suggests that
`
`increasing the temperature of the heat-treatment from 25°C to 300°C had
`
`only a very minor effect on permanent deformation after the flexion test, and
`
`therefore shanks heat-treated at temperatures within the range from 25°C to
`
`17
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`Patent 8,876,991 B2
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`300°C for durations from 75 minutes to twelve hours would likewise fail to
`
`satisfy the “wherein” clause of claim 12.
`
`Regarding Patent Owner’s argumentthat Petitioner’s 300°C testing is
`
`not probative because the ’991 patent teaches that the heat-treatment
`
`temperature is dependent on the time period selected (see Prelim. Resp. 18—
`
`19), this criticism is unpersuasive becausePetitioner’s 300°C testing did
`
`vary the time period of the heat-treatment. See Ex. 1015 44. Specifically,
`
`the shanks were heat-treated for 75 minutes, two hours, four hours, eight
`
`hours, and twelve hours. Jd.
`
`In Example 4 of the ’991 patent, the files were
`
`heat-treated at 500°C for 75 minutes. Ex. 1001, 8:50-52. In a more general
`
`description, the °991 patent teaches that“the shank is heat-treated for
`
`approximately 1 to 2 hours.” Jd. at 4:24—25. The time periods used in
`
`Petitioner’s 300°C testing include the disclosed time periods and also
`
`significantly longer time periods. Yet none of the 300°C-treated shanks
`
`showed a permanent deformationafter flexion testing greater than 2.73
`degrees. Ex. 1002 7 107. Further, the maximumpermanent deformation
`was exhibited by the shanks heat-treated for two hours, not those heat-
`treated for twelve hours. Id.
`
`Thus, on the current record, considering the testing results as a whole
`
`and in conjunction with Dr. Goldberg’s testimony,Petitioner has shown that
`the methodsrecited in claims 12—16 fail to achieve the claimed permanent
`
`deformation characteristic for all temperatures within the claimed ranges.
`
`Wealso agree with Petitioner that the inclusion within the scope of claims
`
`12-16 of temperatures that do not provide the permanent deformation
`
`recited in the “wherein” clause tends to support a determination that the
`
`claims are not enabled. See Pet. 34 (“[W]hen a rangeis claimed, there must
`
`18
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`PGR2015-00019
`Patent 8,876,991 B2
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`be reasonable enablement of the scope of the range.”) (quoting AK Steel
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`Corp. v. Sollac & Ugine, 344 F.3d 1234, 1244 (Fed. Cir. 2003)); see also
`Durel Corp. v. Osram Sylvania Inc., 256 F.3d 1298, 1306-07 (Fed. Cir.
`
`2001) (“If Sylvania had shownthata significant percentage of oxide
`
`coatings within the scope of the claims were not enabled, that might have
`
`been sufficient to prove invalidity.”). Patent Owner correctly notes that “[i]t
`
`is not necessary that every permutation within a generally operable invention
`
`be effective in order for an inventor to obtain a generic claim, provided that
`
`the effect is sufficiently demonstrated to characterize a generic invention.”
`
`Prelim. Resp. 17-18 (quoting Capon, 418 F.3d at 1359). But, on the current
`
`record, we are not convinced that the invention recited in claims 12—16
`
`should be considered “a generally operable invention”or that the effect of
`
`the claimed methodhas been “sufficiently demonstrated to characterize a
`
`generic invention.” Capon, 418 F.3d at 1359.
`
`Patent Owner’s challenges to Petitioner’s undue experimentation
`analysis are also unpersuasive. The Preliminary Response arguesthat the
`
`Petition ignores several of the Wands factors, but the Wands factors “are
`
`illustrative, not mandatory.” Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d
`
`1200, 1213 (Fed. Cir. 1991). Moreover, with respect to someofthe
`purportedly untreated Wands factors, the Preliminary Response simply fails
`to address the relevant portions of the Petition. For example, Patent Owner
`asserts that the Petitioner “does not analyze the breadth ofthe claimsas part
`of a Wandsanalysis.” Prelim. Resp. 23. Yet, as summarized above,
`
`Petitioner’s undue experimentation analysis argues that the Specification
`
`does not provide an enabling disclosure for the broad range of temperatures,
`
`heat-treatment durations, and alloy compositions within the scope of claims
`
`19
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`PGR2015-00019
`Patent 8,876,991 B2
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`12-16. See Pet. 44-45. As another example, Patent Ownerasserts that
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`“Petitioner has not identified . .. what a person ofskill in the art would glean
`
`from the working examples disclosed in the ’991 patent.” Prelim. Resp. 21.
`
`This assertion is also inaccurate. See, e.g., Pet. 41 (“An appropriate starting
`
`point for this [undue experimentation] analysis is the single example
`
`provided by applicant Luebke for achieving permanent deformati
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