Trials@uspto.gov
`571-272-7822
`
`Paper 54
`Entered: December 28, 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.
`
`FINAL WRITTEN DECISION
`35 US.C. § 328(a) and 37 CFR. § 42.208
`
`
`571-272-7822
`
`Paper 54
`Entered: December 28, 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.
`
`FINAL WRITTEN DECISION
`35 US.C. § 328(a) and 37 CFR. § 42.208
`
`
`
`PGR2015-00019
`Patent 8,876,991 B2
`
`I.
`
`INTRODUCTION
`
`US Endodontics, LLC (‘Petitioner’) filed a Petition (Paper1, “Pet.’’)
`
`requesting post-grant review of claims 12—16 of U.S. Patent No.
`
`8,876,991 B2 (Ex. 1001, “the ’991 patent”). Gold Standard Instruments,
`
`LLC (“Patent Owner”) filed a Preliminary Response (Paper 14, “Prelim.
`
`Resp.”) to the Petition. On January 29, 2016, weinstituted a post-grant
`
`review of claims 12—16 on certain grounds of unpatentability alleged in the
`
`Petition. See Paper 17 (“Dec. on Inst.”).
`
`After institution of trial, Patent Ownerfiled a Patent Owner Response
`
`(Paper 27, “PO Resp.”), and Petitioner filed a Reply (Paper 31, “Pet.
`
`Reply”). In addition, Patent Ownerfiled Observations on Cross
`
`Examination (Paper 37), to which Petitioner filed a Response (Paper 45).
`
`Both parties also filed motions to exclude evidence, and the briefing on
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`those motions included oppositions and replies. See Papers 36, 40, 43, 44,
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`46, 47. The parties presented oral argumentat a hearing held on October 19,
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`2016. Paper 53 (“Tr.”).
`
`For the reasons explained below, upon consideration of the evidence
`
`and arguments of both parties, we determine that Petitioner has shown by a
`
`preponderanceof the evidence that claims 12—16 of the ’991 patent are
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`unpatentable. See 35 U.S.C. § 326(e).
`
`A. Related Matters
`
`Petitioner has filed two petitions for inter partes review challenging
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`US. Patent No. 8,727,773 (‘the ’773 patent’), whichis related to the ’991
`
`patent. We instituted review on several of the grounds presentedin thefirst
`petition, and issued a Final Written Decision holding all ofthe challenged
`claims unpatentable. US Endodontics, LLC v. Gold Standard Instruments,
`
`LLC, Case IPR2015-00632 (PTAB Aug. 1, 2016) (Paper 78). We denied
`
`2
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`Patent 8,876,991 B2
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`institution on any of the grounds presented in the second petition. US
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`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
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`patent related to the °991 patent, are being asserted against Petitioner in an
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`ongoing lawsuit in the U.S. District Court for the Eastern District of
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`Tennessee, Dentsply International, Inc. v. US Endodontics, LLC, Case No.
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`2:14-cv-00196-JRG-DHI. Pet. 1; Paper 52, 3. The parties list a numberof
`
`pending patent applications owned by Patent Owner that maybeaffected by
`
`this proceeding. See Pet. 1; Paper 52, 3-4.
`
`B. The ’991 Patent
`
`The ’991 patentis titled “Dental and Medical Instruments Comprising
`
`Titanium.” Ex. 1001, Title. The invention is described as serving to
`
`“overcome[] the problems encountered when cleaning and enlarging a
`
`curved root canal.” Jd. at 2:59-60. The ’991 patent explainsthat flexibility
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`is a desirable attribute for endodontic files, but that in the prior art, the shank
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`portionsoffiles of larger sizes are relatively inflexible, which impedes the
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`therapy of a root canal. Jd. at 2:4—26.
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`The °991 patent also describes that it is known in theart that
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`endodontic files may be formed of “superelastic alloys such as nickel-
`titanium that can withstand several times more strain than conventional
`
`materials without becomingplastically deformed.” Jd. at 2:43-46. The ’991
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`patent further explains that a property termed “shape memory.. . allowsthe
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`superelastic alloy to revert back to a straight configuration even afterclinical
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`use, testing or fracture (separation).” Jd. at 2:46-49. Accordingto the ’991
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`patent, there remained a need for endodontic instruments that “have high
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`Patent 8,876,991 B2
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`flexibility, have high resistance to torsion breakage, maintain shape upon
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`fracture, can withstand increased strain, and can hold sharp cutting edges.”
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`Id. at 2:50-55.
`
`Figures la and 1b, reproduced below,illustrate “a side elevational
`
`view of an endodontic instrument” (Fig. la), and “a partial detailed view of
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`the shank of the endodontic instrument shownin FIG. la” (Fig. 1b). Jd. at
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`3:26—29.
`
`Fig. ta
`
`Fig. 1b
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`The ’991 patent describes that the “endodontic instrument .. . shown
`
`in FIG. la... includes an elongate shank 42 mountedat its proximate end
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`47 to ahandle 43.” Jd. at 4:5-8. The °991 patent also explains that
`
`fabricating a medical instrument in accordance with the invention involves
`
`selecting a superelastic titanium alloy for the shank and subjecting the
`
`instrumentto “heat-treatment”so as to “relieve stress in the instrumentto
`
`allow it to withstand more torque, rotate through a larger angle of deflection,
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`changethe handling properties, or visually exhibit a near failure of the
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`instrument.” Jd. at 6:2—5.
`
`
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`Patent 8,876,991 B2
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`C. Illustrative Claim
`
`Claim 12, reproduced below,is the only independent claim among the
`
`challenged claims:
`
`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 when tested in accordance with ISO Standard 3630-1.
`
`D. Instituted Grounds of Unpatentability
`
`Weinstituted trial as to claims 12—16 of the 991 on the following
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`grounds:
`
`1. Whether claims 12-16 are unpatentable under 35 U.S.C. § 112(a)
`
`for lack of enablement;
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`2. Whether claims 12-16 are unpatentable under 35 U.S.C. § 112(a)
`
`for lack of written description;
`
`3. Whether claims 12—16 are unpatentable under 35 U.S.C. § 102 as
`being anticipated by Luebke 2008;!
`
`'U.S. Patent App. Pub. No. 2008/0032260 A1, published Feb. 7, 2008 (Ex.
`1022).
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`5
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`PGR2015-00019
`Patent 8,876,991 B2
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`4, Whether claim 15 is unpatentable under 35 U.S.C. § 103 as
`obvious over Luebke 2008 alone or in view of Heath? or ISO
`
`3630-1;7
`5. Whether claims 12-14 and 16 are unpatentable under 35 U.S.C.
`§ 102 as being anticipated by Kuhn;‘ and
`
`6. Whether claim 15 is unpatentable under 35 U.S.C. § 103 as
`
`obvious over Kuhnaloneor in view of Heath or ISO 3630-1.
`
`See Dec. on Inst. 37.
`
`II.
`
`ANALYSIS
`
`A. Post-Grant Review Eligibility
`
`1. Legal Standards for Post-Grant Review Eligibility
`The post-grant review provisions set 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 madeby subsection (d)...
`
`shall apply only to patents described in section 3(n)(1).”). The first-
`
`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
`
`claimed invention that has an effective filing date on or after March 16,
`2013. See AIA § 3(n)(1). The relevant statute defines the “effectivefiling
`date” as:
`
`* U.S. Patent No. 5,628,674, issued May 13, 1997 (Ex. 1024).
`3 International Standard ISO 3630-1, 1% ed. (1992) (Ex. 1023).
`4 Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical
`Properties ofNickel-Titanium Endodontic Instruments, 28 J.
`ENDODONTICS 716 (2002) (Ex. 1030).
`> Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”).
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`6
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`(A) if subparagraph (B) does not apply, the actualfiling 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
`priority under section 119, 365(a), 365(b), 386(a), or 386(b) or
`to the benefit of an earlier filing date under section 120, 121,
`365(c), or 386(c).
`
`35 U.S.C. § 100(i)(1). Entitlement to the benefit of an earlier date under
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`§§ 119, 120, 121, and 365 is premised on disclosure of the claimed invention
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`“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), 120.6
`
`Applying these statutes to determine whethera patent is subject to the
`
`first-inventor-to-file provisions of the AIA, and therefore eligible for post-
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`grant review,is straightforward when the application from whichthe patent
`issued wasfiled before March 16, 2013, or when the application wasfiled on
`or after March 16, 2013 without any priority claim. The determinationis
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`more complex, however, for a patent that issues from a “transition
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`application,” which is an application filed on or after March 16, 2013 that
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`claims the benefit of an earlier filing date prior to March 16, 2013. See
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`MPEP§ 2159.04. As a consequenceofthe statutes discussed above, a
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`patent that issues from a transition application is available for post-grant
`
`review “if the patent contains .
`
`.
`
`. at least one claim that was not disclosed in
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`compliance with the written description and enablement requirements of
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`§ 112(a) in the earlier application for which the benefit of an earlier filing
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`date prior to March 16, 2013 was sought.” Jnguran, LLC v. Premium
`
`6 Section 386 is irrelevant here becauseit concernstherightof priority for
`international design applications. See 35 U.S.C. §§ 381-390.
`7
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`Genetics (UK) Ltd., Case PGR2015-00017, slip op. at 11 (PTAB Dec. 22,
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`2015) (Paper8).
`
`Separate from the requirementthat the patent is subject to the AJA’s
`_ lirst-inventor-to-file provisions, an additional requirement for post-grant
`review eligibility is that “[a] petition for a post-grant review may only be
`
`filed not later than the date that is 9 monthsafter 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 monthfiling
`
`deadline.’ See Pet. 11. Nor does Patent Ownerdispute Petitioner’s
`
`representation that it is not barred or estopped from requesting post-grant
`
`review of the ’991 Patent. Seeid.
`
`Patent Ownerdoes contend, however, that the °991 patentis ineligible
`
`for post-grant review becauseits claims are entitled to an effective filing
`
`date of June 7, 2005. See PO Resp. 40. Thus, with respect to post-grant
`
`review eligibility, the only dispute is whether the ’991 patent is subject to
`
`the first-inventor-to-file provisions of the AIA.
`
`2. Facts Relevant to Post-Grant Review Eligibility
`
`The application that issued as the ’991 patent wasfiled on January 29,
`2014, and was assigned Application No. 14/167, 311 (“the ’311
`application”). Ex. 1001, at [21], [22]. The ’991 patent claimspriority to a
`
`series of continuation and divisional applications reaching back to June7,
`
`2005, as well as a provisional application filed on June 8, 2004. Jd, at [60].
`Consistent with the characterization of the earlier applications in the ’991
`patent’s priority claim, Petitioner agrees that “[t]he descriptions in the
`
`7 The ’991 patent issued on November4, 2014. Ex. 1001, at [45]. The
`Petition was filed on August 3, 2015. See Paper3, 1.
`8
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`priority applications are substantively the same except for their claims; the
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`entire family comprises continuation and divisional applications (but not
`
`continuation-in-part applications).” Pet. 32. Thus,it is undisputed that the
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`Specification of the °991 patent is substantively identical to the
`
`specifications of the applications to whichit claims priority. See Prelim.
`
`Resp. 25; PO Resp. 40. It is also undisputed that the claims in the 7311
`
`application, as filed on January 29, 2014, are identical to the claims as issued
`
`in the 991 patent. See Pet. 6; Ex. 1003, 23-25.
`
`3. Burden ofProofon Post-Grant Review Eligibility
`
`In this case, eligibility hinges on whether the °991 patent is subject to
`
`the first-inventor-to-file provisions of the AIA. That analysis, in turn,
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`depends on whetherthe patent contains any claims having an effective filing
`
`date on or after March 16, 2013. In the Petition, Petitioner argued that
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`“Patent Ownerbears the ultimate burden of demonstrating entitlement to an
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`earlier application’s filing date.” Pet. 22 (citing In re NTP, Inc., 654 F.3d
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`1268, 1276-77 (Fed. Cir. 2011)). Petitioner argued that the ’991 patentis
`
`eligible for post-grant review because “Patent Owner will not be able to
`meetits burden of proving that the claimsatissue are entitled to a filing date
`earlier than the... January 29, 2014 filing date.” Jd. at 23. In our Decision
`
`on Institution, we determinedthatit is Petitioner, not Patent Owner, that
`
`bears the burden to prove that the °991 patent is subject to the first-inventor-
`
`to-file provisions of the AIA and,therefore, eligible for post-grant review.
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`Dec. on Inst. 9-12 (citing Research Corp. Technologies, Inc. v. Microsoft
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`Corp., 627 F.3d 859, 870-71 (Fed. Cir. 2010); Tech. Licensing Corp.v.
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`Videotek, Inc., 545 F.3d 1316, 1327-29 (Fed. Cir. 2008); PowerOasis, Inc.
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`v. T-Mobile USA, Inc., 522 F.3d 1299, 1305-06 (Fed. Cir. 2008)). In the
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`briefing following our Decision on Institution, neither party has contested
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`this assignment of the burden of proofon eligibility for post-grant review.
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`Accordingly, for the same reasons explained in our Decision on Institution,
`
`we maintain our determination that Petitioner bears the burden to show that
`
`the ’991 patentis eligible for post-grant review.
`
`4. Analysis ofPost-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
`
`satisfy the written description and enablement requirements of 35 U.S.C.
`
`§ 112 for claims 12-16. See Pet. 31-45. Becausethe disclosure of the
`
`priority applications is the sameas that of the 991 patent’s Specification,
`
`Petitioner argues, the priority applications also fail to provide adequate
`
`support for the subject matter of claims 12-16. Jd. at 31-32. Thus,
`
`accordingto Petitioner, claims 12—16 are notentitled to an effectivefiling
`
`date earlier than January 29, 2014. Id.
`
`As we noted in our Decision onInstitution, 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 lack support in earlier applications to which priority is
`
`claimed. See Dec. on Inst. 12. Instead, Petitioner’s contention is that neither
`
`the ’311 application nor anyofthe earlier applications adequately supports
`
`claims 12-16, and therefore, the effective filing date for those claimsis the
`
`actualfiling date. See Pet. 31-32.
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`10
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`Petitioner’s argument accords with the definition of “effective filing
`
`date” set forth above, which provides in subparagraph (B)that the effective
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`filing date is the filing date of the earliest application to which the patentis
`
`entitled to priority or to the benefit of an earlier filing date. 35 U.S.C.
`
`§ 100(i)(1)(B). Subparagraph (A) provides that “if subparagraph (B) does
`
`not apply,” the effective filing date is the actualfiling 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) doesnot apply andthe effective filing date is the
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`actual filing date of the application under subparagraph (A), regardless of
`
`whetherthe disclosure in the application is sufficient to support the claim.
`Consequently, we agree with Petitioner that if claims 12-16 are shown to
`lack adequate § 112 support in the ’311 application andall of the earlier
`
`applications to whichpriority is claimed, the effective filing date for those
`claims is the actualfiling date of the ’311 application.®
`
`Our analysis of Petitioner’s enablement and written description
`
`challengesis set forth in Sections JJ.D.1. and II.D.2., respectively. For the
`
`reasons explained therein, we determine that Petitioner has shownthat
`
`claims 12-16 are not adequately supported by the disclosure ofthe *311
`
`application. Becauseit is undisputed that the ’311 application has the same
`
`disclosure as the earlier applications to which the ’991 patent claimspriority,
`
`see Pet. 32; Prelim. Resp. 25; PO Resp. 40, we also determine that Petitioner
`
`has shownthat claims 12-16 are not entitled to an effective filing date
`
`8 We came to the same conclusion in our Decision onInstitution. See Dec.
`on Inst. 13. The parties’ briefing after that Decision does not contest that
`determination.
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`11
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`earlier than January 29, 2014. Therefore, Petitioner has met its burden to
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`show that the ’991 patentis eligible for post-grant review.
`
`B. Claim Construction
`
`Claims of an unexpired patent are interpreted using the broadest
`
`reasonable interpretation in light of the specification. 37 C.F.R. § 42.200(b);
`
`see Cuozzo Speed Techs. LLC v. Lee, 136 8S. Ct. 2131, 2144-46 (2016)
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`(upholding the use of the broadest reasonable interpretation standard).
`
`Underthe broadest reasonable interpretation claim construction standard,
`
`claim terms are generally given their ordinary and customary meaning,as
`
`would be understood by one ofordinary skill in the art in the context of the
`
`entire disclosure. Jn re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
`
`Cir. 2007).
`
`.
`
`In our Decision on Institution, for the purposes of that decision, we
`
`adopted the parties’ agreed-upon construction that the phrase “heat-treating
`
`the entire shank” in claim 12 includes heat treatment in any environment.
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`Dec. on Inst. 22. We also construed the clause in claim 12 that recites
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`“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.” We disagreed with Petitioner’s
`
`argumentthat this “wherein” clause should not be considered limiting. See
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`id. at 22. Instead, we construed the “wherein” clause as a limitation that lays
`
`out a metric for determining if a heat treatment processfalls within the scope
`
`of the claim. See id. at 22-24.
`
`Theparties’ briefing after institution does not contest those
`
`constructions, nor do the parties propose that any other term should be
`
`construed. At the hearing, Petitioner confirmed that it does not challenge the
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`12
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`construction of the “wherein” clause that we adopted in the Decision on
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`Institution. See Tr. 7:18-23. Patent Owneragrees that our construction of
`
`the “wherein” clause wascorrect, but argues that the analysis in our
`
`Decision on Institution did not faithfully apply the construction that we
`
`adopted. See id. at 34:3-16. Patent Owner’s argument concerning the
`
`relevance of the “wherein” clause to the enablementanalysis is discussed
`
`below. Accordingly, we maintain the constructions set forth in our Decision
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`on Institution.
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`C. Level ofOrdinary Skill in the Art
`
`In determining the level of ordinary skill in the art, relevant factors
`
`include the type of problems encounteredin theart, the prior art solutions to
`
`those problems, the rapidity with which innovations are made, the
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`sophistication of the technology, and the educational level of active workers
`
`in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d
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`955, 962 (Fed. Cir. 1986).
`
`Petitioner argues, with support from the testimony of Dr. Goldberg,
`
`that a person of ordinary skill in the art at the time of the invention ofthe
`
`°991 patent would have:
`
`(i) a bachelor’s degree or master’s degree in materials science,
`metallurgy, or a related field and at least two years of experience
`so as to understand the structural, chemical, and mechanical
`properties that can be manipulated in Ni-Ti alloy materials used
`in dental applications, or (ii) a Ph.D. or equivalent degree in
`materials science, metallurgy, or a related field and at least one
`year of experience so as to understand the structural, chemical,
`and mechanical properties that can be manipulated in Ni-Ti alloy
`materials used in dental applications.
`Pet. 32-33 (citing Ex. 1002 § 75). Patent Owner did not contest this
`
`proposal or present a competing definition in its briefing, and stated at the
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`13
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`hearing that it does not object to Petitioner’s proposed definition of the level
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`of ordinary skill in the art. Tr. 34:18-35:3. We adopt the parties’ agreed-
`
`upon definition of the level of ordinary skill in the art.
`
`D. Asserted Grounds of Unpatentability
`
`1, Enablement
`
`a. Legal Principles
`
`“Section 112 requires that the patent specification enable those skilled
`in the art to make andusethe full scope of the claimed invention without
`
`undue experimentation.” Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d
`
`1052, 1070-71 (Fed. Cir. 2005). The Federal Circuit has explained that an
`
`enabling disclosure is “part of the guid pro quo ofthe patent bargain.” AK
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`Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1244 (Fed. Cir. 2003).
`
`Specifically, the enablement requirement under § 112
`
`ensures that the public knowledge is enriched by the patent
`specification to a degree at least commensurate with the scope of
`the claims. The scope of the claims must be less than or equalto
`the scope of the enablement. The scope of enablement,in turn,
`is that which is disclosed in the specification plus the scope of
`what would be knownto one ofordinary skill without undue
`experimentation.
`National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d
`1190, 1195-96 (Fed Cir. 1999), “Whether undue experimentation is needed
`is not a single, simple factual determination, but rather is a conclusion
`
`reached by weighing manyfactual considerations.” Jn re Wands, 858 F.2d
`
`731, 737 (Fed. Cir. 1988). Factors to be considered include
`
`(1) the quantity of experimentation necessary, (2) the amount of
`direction or guidance presented, (3) the presence or absence of
`working examples, (4) the nature of the invention, (5) the state
`of the prior art, (6) the relative skill of those in the art, (7) the
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`predictability or unpredictability of the art, and (8) the breadth of
`the claims.
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`Td.
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`b. Summary ofthe Parties’ Contentions Regarding Enablement
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`Petitioner’s enablement arguments focus on the range of temperatures
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`at which the claimed heat treatment occurs. Claim 12 recites
`
`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 when tested in accordance with ISO
`Standard 3630-1.
`
`Ex. 1001, 10:42-48 (emphasis added). Dependent claim 14 narrows the
`
`tempcrature range somewhat, reciting that “the temperature is from 300° C.
`
`up to but not equal to the melting point of the superelastic nickel titanium
`
`alloy.” Jd. at 10:53-54.
`
`Petitioner arguesthat “‘heat-treating’ a superelastic, nickel-titanium
`
`endodontic instrumentat as low as 25°C, or at mouth temperature (37°C),
`
`will not result in a file that exhibits the recited level of permanent
`
`deformation.” Pet. 36 (citing Ex. 1002 Ff 101-102). 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
`
`that would satisfy it, one must processthe alloy so as to changeits
`
`transformation temperatures.” Ex. 1002 4101. 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-treatment at
`25-37°C does not provide this energy.
`Significantly higher
`
`15
`
`
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`PGR2015-00019
`Patent 8,876,991 B2
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`temperatures are required: one paper explained that, with respect
`to one Ni-Tialloy, the transformation temperature did not change
`significantly with a treatment temperature of 300°C.
`
`Id. § 102 (citing Ex. 1006, 113).
`
`To show that the method of the ’991 patent is inoperative within the
`
`claimed temperature ranges, Petitioner describes testing in which the shanks
`
`of ten ProFile brand Ni-Ti endodontic files were heat-treated at 25°C for
`
`durations between 75 minutes and twelve hours. Pet. 36—37 (citing Ex. 1015
`
`{{ 4-5). The heat-treated shanks were then subjected to flexion testing in
`
`accordance with ISO Standard 3630-1, and their permanent deformation was
`
`measured to be between 0.04 and 2.19 degrees, averaging 0.87 degrees.
`
`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
`
`permanent deformation in the 300°C-treated shanks between 0.07 and 2.73
`
`degrees, averaging 1.17 degrees. Pet. 39 (citing Ex. 1015 4 3-5; Ex. 1018,
`
`10; Ex. 1002 § 107). Thus, none of the 25°C-treated shanksor the 300°C-
`
`treated shanks exhibited permanent deformation of greater than 10 degrees
`
`as required by the “wherein”clause of claim 12. Pet. 39.
`
`Petitioner further argues that claims 12—16 are not enabled because
`
`undue experimentation would be required to practice the full scope of the
`
`claimed invention. Pet. 40-45. Petitioner asserts, with reference to Dr.
`
`Goldberg’s testimony, that “the results of heat treatment depend on several
`
`variables, including temperature, time, alloy composition andalloy treatment
`
`history.” Pet. 41 (citing Ex. 1002 7111). Petitioner argues that the
`
`Specification provides insufficient guidance regarding how to achieve the
`
`claimed permanent deformationresult using the claimed heat treatment
`
`parameters. Pet. 45. Example 4 in the 991 patent is the only description
`
`16
`
`
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`PGR2015-00019
`Patent 8,876,991 B2
`
`provided in the Specification for achieving the claimed permanent
`
`deformation. Jd. at 41; see also Ex. 1001, 8:35-62 (describing heat-
`
`treatment at 500°C for 75 minutes offiles comprising 54-57 weight percent
`
`nickel and 43-46 weight percent titanium). According to Petitioner, “the
`
`specification does not provide any guidanceas 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 combinations of these variables. Jd. at 44-45 (citing Ex. 1002
`
`q 125). In particular, the claims do not specify a duration for heat-treating,
`
`encompassternperature 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—
`
`15) or include a range of 54-57 weight percent nickel (claim 16). See Ex.
`
`1001, 10:35-60.
`
`Patent Ownerpresents several arguments in rebuttal. See PO Resp.
`
`17-33. Patent Owner arguesthat Petitioner’s testing does not show
`
`inoperative embodiments because “the ‘wherein’ clause limits the heat
`
`treatments encompassed by claims 12—16 to only thosethat result in a NiTi
`
`file that is capable of exhibiting the claimed degree of permanent
`
`deformation.” Jd. at 17. Because noneofPetitioner’s tests produced the
`
`deformation characteristic recited in the “wherein” clause, Patent Owner
`
`asserts that those tested files were outside the scope of claims 12-16. Jd. at
`18-19. Further, Patent Ownerarguesthat Petitioner’s showing of
`
`inoperative embodiments is insufficient because Petitioner tested at only two
`
`temperatures, and “[i]t is not necessary that every permutation within a
`
`17
`
`
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`PGR2015-00019
`Patent 8,876,991 B2
`
`generally operable invention be effective in order for an inventorto obtain a
`
`generic claim, providedthat the effect is sufficiently demonstrated to
`
`characterize a generic invention.” Jd. at 20 (quoting Capon v. Eshhar, 418
`
`F.3d 1349, 1359 (Fed. Cir. 2005)).
`
`Patent Owneralso criticizes Petitioner’s testing on the basis thatit did
`
`not take into account whatan ordinarily skilled artisan would have gleaned
`
`from the ’991 patent’s teaching that the time period selected for heat
`
`exposure was dependent on the temperature.
`
`/d. at 21-22 (citing Ex. 1001,
`
`4:16-29). “Despite the express teaching that other temperatures and times
`
`are suitable, Petitioner either intentionally did not test longer periods of time
`
`at 300°C (or other temperatures), or tested them and did not provide the
`
`results of that data.” Jd. at 22. Finally, concerning the testing, Patent Owner
`
`points to the cross-examination testimony of Messrs. Zanes and Kozak,
`
`employeesat the laboratories that carried out Petitioner’s testing, that the
`
`tested files had an initial bend before bend testing was conducted, andthat
`
`the bend testing was carried out in the samedirection as the initial bend.
`
`/d.
`
`at 22 (citing Ex. 2040, 45-48; Ex. 2041, 61-66). According to Patent
`
`Owner, conducting bend testing in the same direction as the initial bend
`
`minimized the amountof resulting deformation, which calls into question
`
`the accuracy of the data gathered. Jd. at 22-23.
`
`Next, Patent Ownerchallenges Petitioner’s showing that any
`
`experimentation would be undue. Patent Ownerarguesthat Petitioner’s
`
`undue experimentation analysis is premised on an incorrect interpretation of
`
`the “wherein” clause. PO Resp. 24-25. With respect to the Wands factors,
`
`Patent Ownercontendsthat Petitioner failed to address the quantity of
`
`experimentation that would be neededto practice the claimed invention. Jd.
`
`18
`
`
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`PGR2015-00019
`Patent 8,876,991 B2
`
`at 26-27. Patent Ownerargues that Dr. Goldberg’s cross examination
`
`testimony showsthat he was unsure whether the volume oftesting would be
`
`undue.
`
`/d. at 27 (citing Ex. 2039, 182-83). Patent Ownerasserts that
`
`“Petitioner has never stated that the experimentation would involve overly
`
`complex testing, testing beyondthe skill of one in theart at the time of Dr.
`
`Luebke’s invention, or more testing than a person of skill in the art would be
`
`capable of performing.” /d. at 28. Patent Ownerfurther arguesthat
`
`Petitioner does not address the guidance in the ’991 patent concerning
`
`examples for heat-treatment temperatures and durations. Jd. at 29-31.
`
`‘While Petitioner did make reference to Dr. Luebke’s Example 4,Petitioner
`
`did not analyze what a personofskill in the art would have gleaned from
`
`those heat treatment processes based on their knowledge ofthe art.” /d. at
`
`31. Patent Owneralso asserts that Petitioner did not address the nature of
`
`the invention, the state of the priorart, or the relative skill of those in theart.
`
`Id. at 31-32. Finally, regarding the Wands factors, Patent Owner challenges
`
`the sufficiency of Petitioner’s analysis of the unpredictability of the art and
`
`the breadth of the claims. Jd. at 32-33.
`
`In Reply, Petitioner submitted evidence of additionaltesting it carried
`
`out to address Patent Owner’s criticisms of the testing it had conducted
`
`previously. See Reply 5-8. Petitioner summarizesthis additional testing
`and the results as follows:
`.
`
`testing comprised the following heat
`supplemental
`This
`treatment cycles: 40°C for each of 75 minutes, 2 hours, 4 hours,
`8 hours, 12 hours, 24 hours, and 28 hours; and 300°C for 24 and
`28 hours.
`
`The samplesheat treated at 40°C showed between 0.56 and 1.50
`degrees of deformation, averaging 1.00 degrees, far below the 10
`degrees required by the claims of the ’991 patent. Ex. 1041, p.
`
`19
`
`
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`PGR2015-00019
`Patent 8,876,991 B2
`
`13. The samples heat treated at 300°C showed between 1.36 and
`2.59 degrees of deformation, averaging 1.81 degrees, also far
`below the claimed 10 degrees.
`/d. at 13.
`
`Id. at 6. In response to Patent Owner’s criticism regarding bendingin the
`
`same direction as the initial bend, Petiti
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