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`WAR 01.2017 =
`
`411 East Wisconsin Avenue
`
`Suite 2400
`Milwaukee, Wisconsin 532024426
`414.277.5000
`
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`www.quarles.com
`
`.
`
`.
`
`Writer's Direct Dial: 414.277.5617
`E-Mail: joel.austin@quarles.com
`
`March 1, 2017
`
`Attomeys at Law in
`
`Chicago
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`Madison
`
`Milwaukee
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`Scottsdate
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`Washington,D.C.
`
`BY HAND DELIVERY
`
`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`Madison Building East, 10B20
`600 Dulany Street
`Alexandria, VA 22314-5793
`
`RE:
`
`US Endodontics, LLC v. Gold Standard Instruments, LLC
`Case No. PGR2015-00019
`U.S. Patent No. 8,876,991 B2
`
`Dear Sir or Madam:
`
`Enclosedplease find Patent Owner Gold Standard Instrument’s Notice of Appealin the
`above-referenced Post-Grant Review. The Notice of Appeal wasalso filed electronically with
`the Patent Trial and Appeal Board and with the Federal Circuit.
`
`Please stamp the enclosed extra copy of the Notice of Appeal indicating your receipt and
`return it to our courier.
`
`Please contact me should you have any questions.
`
`QB\44167698.1
`
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`

`

`Director of the United States Patent and Trademark Office
`March 1, 2017
`Page 2
`
`Very truly yours,
`
`QUARLES & BRADY LLP
`
`s/Joel A. Austin
`
`Joel A. Austin
`
`JAUSTIN:dh
`Enclosures
`
`cc:
`
`Counsel of Record (via e-mail)
`
`QB\44167698.1
`
`

`

`UNITED STATES PATENT AND TRADEMARKOFFICE
`
`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
`
`PATENT OWNER GOLD STANDARD INSTRUMENTS, LLC’S
`
`NOTICE OF APPEAL
`
`
`
`QB\44164847.2
`
`

`

`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`Madison Building East, 10B20
`600 Dulany Street
`Alexandria, VA 22314-5793
`
`Notice is hereby given, pursuant to 35 U.S.C. §§ 141 and 142, and 37 C.F.R.
`
`§§ 90.2(a), 90.3, and 104.2, that Patent Owner, Gold Standard Instruments, LLC
`
`(“GSI”), hereby appeals to the United States Court of Appeals for the Federal
`
`Circuit from the Final Written Decision entered on December 28, 2016 (Paper No.
`
`54) (attached hereto as Exhibit 1) by the Patent Trial and Appeal Board (“PTAB”),
`
`and from all underlying orders, decisions, rulings, and opinions.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), GSI indicates that the issue(s)
`
`on appealinclude, but are not limited to:
`
`1. Whether the PTAB erroredin its findings and determination that
`
`Claims 12-16 of GSI’s U.S. Patent No. 8,876,991 B2991 Patent”)
`
`/
`
`were eligible under Leahy-Smith America Invents Act, Pub. L. No.
`
`112-29, 125 State. 284 (2011) for Post-Grant Review under 42 C.F.R.
`
`§ 42.200 et seq.
`
`2. Whether the PTABerroredin its findings and determination that
`
`Claims 12-16 of the ’991 Patent are unpatentable under 35 U.S.C. §
`
`112(a) for lack of enablement.
`
`QB\44164847.2
`
`

`

`3. Whether the PTABerroredinits findings and determination that
`
`Claims 12-16 of the ’991 Patent are unpatentable under 35 U.S.C. §
`
`112(a) for lack of adequate written description.
`
`4. Whether the PTABerroredin its findings and determination that
`
`Claims 12-16 of the °991 Patent are unpatentable under 35 U.S.C. §
`
`102 as being anticipated by U.S. Patent Application Publication No.
`
`2008/0032260 Al to Luebke.
`
`5. Whether the PTABerroredin any ofits evidentiary findings and
`
`determinations adverse to GSI, including without limitation,
`
`excluding a portion of Exhibit 2034 as inadmissible hearsay and not
`excluding Exhibits 1006, 1020, and 1021.
`
`6. Any other finding or determination (legal or factual) adverse to GSI,
`
`including, without limitation, any claim construction rulings and
`
`errors in interpreting the disclosure of the ’991 Patent or any applied
`
`reference,all in view of the entire record and related evidence.
`
`GSIreservesthe right to challenge any other issues decided adversely to GSI
`
`in the Final Written Decision and/or any orders, decisions, or rulings underling the
`
`Final Written Decision.
`
`QB\44164847.2
`
`wo
`
`

`

`Simultaneously with this submission, a copy of this Notice of Appeal is
`
`being filed with the PTAB. In addition, a copy of this Notice of Appeal, along
`
`with the required docketing fees, is being filed with the Clerk’s Office for the
`
`United States Court of Appeals for the Federal Circuit.
`
`Date: March 1, 2017
`
`Respectfully submitted,
`
`/Joseph A. Hynds/
`Joseph A. Hynds, Reg. No. 34,627
`
`ROTHWELL, FIGG, ERNST &
`MANBECK,P.C. —
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040
`Facsimile: 202-783-603 1
`
`Counselfor Patent Owner Gold Standard
`Instruments, LLC
`
`QB\44164847.2
`
`

`

`UNITED STATES PATENT AND TRADEMARKOFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`Vv.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`
`
`
`Case PGR2015-00019
`Patent 8,876,991 B2
`
`
`CERTIFICATE OF FILING AND SERVICE
`
`Filed Electronically via PTAB E2E
`
`The undersigned herebycertifies that the foregoing PATENT OWNER
`
`GOLD STANDARD INSTRUMENTS, LLC’S NOTICE OF APPEAL andthe
`
`Final Written Decision, was filed with the Patent Trial and Appeal Board on March
`
`1, 2017, using the PTAB E2E System pursuant to 37 C.F.R. § 42.6(b)(1).
`
`/Erik van Leeuwen/
`Erik van Leeuwen
`Litigation Operations Coordinator
`Rothwell, Figg, Ernst & Manbeck, P.C.
`
`QB\44164847.2
`
`

`

`The undersignedcertifies that on March 1, 2017, a copy of the foregoing
`
`PATENT OWNER GOLD STANDARD INSTRUMENTS,LLC’S NOTICE OF
`
`APPEALandthe Final Written Decision (along with the fee set forth in Federal
`
`Circuit Rule 52), were electronically filed with the Federal Circuit using the
`
`Court’s CM/ECFSystem.
`
`The undersignedfurther certifies that on March 1, 2017, a copy of the
`
`foregoing PATENT OWNER GOLD STANDARD INSTRUMENTS, LLC’S
`
`NOTICE OF APPEALandthe Final Written Decision werefiled by hand delivery
`
`with the Director of the United States Patent and Trademark Office, at the
`
`following address:
`
`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`Madison Building East, 10B20
`600 Dulany Street
`Alexandria, VA 22314-5793
`
`The undersigned furthercertifies that on March 1, 2017, a copy of the
`
`foregoing PATENT OWNER GOLD STANDARD INSTRUMENTS,LLC’S
`
`NOTICE OF APPEALandthe Final Written Decision wasserved via electronic
`
`mail on lead and backup counsel for Petitioner US Endodontics, LLC, with a
`
`courtesy copyviafirst-class mail, postage paid:
`
`Jeffrey S. Ginsberg, Esq.
`Abhishek Bapna, Esq.
`
`QB\44164847.2
`
`

`

`Patterson Belknap Webb & Tyler LLP
`1133 Avenue of the Americas
`New York, NY 10036-6710
`
`Emails:
`jginsberg@pbwt.com
`abapna@pbwt.com
`
`/Joel A. Austin/
`Joel A. Austin
`Reg. No. 59,712
`Appellate Counselfor Patent Owner
`Gold Standard Instruments, LLC
`
`QB\44 164847.2
`
`2*
`
`

`

`EXHIBIT 1
`
`

`

`Trials@uspto.gov
`571-272-7822
`
`Paper 54
`Entered: December28, 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 U.S.C. § 328(a) and 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 (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, we instituted 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 Owner filed Observations on Cross
`Examination (Paper 37), to which Petitioner filed a Response (Paper45).
`Both parties also filed motions to exclude evidence,and the briefing on
`those motions included oppositions and replies. See Papers 36, 40, 43, 44,
`46, 47. Theparties presented oral argumentat a hearing held on October 19,
`
`.
`2016. Paper 53 (“Tr.”).
`Forthe reasons explained below, upon consideration of the evidence
`and arguments of both parties, we determinethat Petitioner has shown by a
`preponderance ofthe evidence that claims 12-16 of the ’991 patentare
`unpatentable. See 35 U.S.C. § 326(e).
`|
`A. Related Matters
`
`Petitioner hasfiled two petitions for inter partes review challenging
`U.S. Patent No. 8,727,773 (“the ’773 patent”), which is related to the °991
`patent. Weinstituted review on severalofthe grounds presentedin thefirst
`petition, and issued a Final Written Decision holding all of the challenged
`claims unpatentable. US Endodontics, LLC v. Gold Standard Instruments,
`LLC, Case IPR2015-00632 (PTAB Aug.1, 2016) (Paper 78). We denied
`
`2
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`institution on any of the groundspresented 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.
`2:14-cv-00196-JRG-DHI. Pet. 1; Paper 52,3. The parties list a number of
`pendingpatent applications owned by Patent Owner that may be affected by
`
`this proceeding. See Pet. 1; Paper 52, 3-4.
`__-B. The ’991 Patent
`The 991 patentis titled “Dental and MedicalInstruments 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 explainsthatflexibility
`
`is a desirable attribute for endodonticfiles, but that in the priorart, the shank
`
`portionsoffiles of larger sizes are relatively inflexible, which impedesthe
`
`therapy of a root canal. Jd. at 2:4-26.
`The ’991 patent also describesthatit is known in the art that
`endodontic files may be formedof “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
`patent further explainsthat a property termed “shape memory.. . allows the
`superelastic alloy to revert back to a straight configuration evenafter clinical
`use, testing or fracture (separation).” Id. at 2:46-49. According to the 991
`patent, there remained a need for endodontic instrumentsthat “have high
`
`3
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`flexibility, have high resistance to torsion breakage, maintain shape upon
`fracture, can withstand increasedstrain, and can hold sharp cutting edges.”
`
`Id. at 2:50-55.
`Figures la and 1b, reproduced below,illustrate “a side elevational
`view ofan endodontic instramen ” (Fig. 1a), and “a partial detailed view of
`the shank of the endodontic instrument shown in FIG.1a” (Fig. 1b). Jd. at
`
`3:26-29.
`
`Fig. 1a
`
`Fig. 1b
`
`The 991 patent describesthat the “endodontic instrument.. . shown
`in FIG. la... includes an elongate shank 42 mounted atits proximate end
`47 to a handle 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,
`changethe handling properties, or visually exhibit a near failure of the
`instrument.” Jd. at 6:2—5.
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`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 ofthe shank along an axial length of
`the shank, the shank comprising a superelastic nickel titantum
`alloy, and
`(b) after step (a), heat-treating the entire shank at a
`temperature above 25° C.upto but not equalto 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
`
`grounds:
`1. Whether claims 12-16 are unpatentable under 35 U.S.C. § 112(a)
`
`for lack of enablement;
`
`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;!
`
`1 U.S. Patent App. Pub. No. 2008/0032260 A1, published Feb. 7, 2008 (Ex.
`1022).
`
`5
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`4. Whether claim 15 is unpatentable under 35 U.S.C. § 103 as
`obvious over Luebke 2008 alone orin 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 Kuhn aloneorin 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 provisionsset forth in Section 6(d) ofthe AJA?
`apply only to patents subjectto the first-inventor-to-file provisionsof 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 toa
`claimed invention that has an effective filing date on or after March 16,
`
`2013. See AIA § 3(n)(1). The relevant statute defines the “effective filing
`
`date”as:
`
`2U.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”).
`
`6
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`(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 nght 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. § 100G)(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 manner provided by § 112(a) (other than the requirementto disclose
`the best mode)”in the earlier application. See 35 U.S.C. §§ 119(e), 120.°
`
`Applying these statutes to determine whethera patent is subject to the
`
`first-inventor-to-file provisions of the AIA, and therefore eligible for post-
`
`grant review,is straightforward when the application from which the patent
`
`issued wasfiled before March 16, 2013, or when the application wasfiled on
`
`or after March 16, 2013 without any priority claim. The determinationis
`
`more complex, however, for a patent that issues from a “transition
`
`application,” whichis an application filed on or after March 16, 2013 that
`
`claims the benefit of an earlier filing date prior to March 16, 2013. See
`
`MPEP § 2159.04. As aconsequence ofthe statutes discussed above,a
`
`patent that issues from a transition application is available for post-grant
`
`review “if the patent contains .. . at least one claim that wasnot disclosed in
`
`compliance with the written description and enablement requirements of
`§ 112(a) in the earlier application for which the benefit of an earlier filing
`date prior to March 16, 2013 was sought.” Inguran, LLC v. Premium
`
`® Section 386 is irrelevant here becauseit concernsthe rightof priority for
`international design applications. See 35 U.S.C. §§ 381-390.
`7
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`Genetics (UK) Ltd., Case PGR2015-00017,slip op. at 11 (PTAB Dec.22,
`
`2015) (Paper8).
`Separate from the requirementthatthe patent is subject to the AIA’s
`first-inventor-to-file provisions, an additional requirementfor 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
`
`patent.” 35 U.S.C. § 321(c); see 37 C.F.R. § 42.202(a). Here, Patent Owner
`does notdispute that the Petition wasfiled within the nine month filing
`deadline.’ See Pet. 11. Nor does Patent Ownerdispute Petitioner’s
`
`representationthat it is not barred or estopped from requesting post-grant
`
`review of the ’991 Patent. See id.
`
`Patent Ownerdoes contend, however, that the ’991 patent is ineligible
`
`for post-grant review becauseits claims are entitled to an effectivefiling
`
`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 was filed 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 June 7,
`
`2005, as well as a provisional application filed on June 8, 2004. Id. at [60].
`
`Consistent with the characterization of the earlier applications in the °991
`
`patent’s priority claim,Petitioner agreesthat “[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 Paper 3, 1.
`8
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`priority applications are substantively the same exceptfor 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 whichit claims priority. See Prelim.
`Resp. 25; PO Resp.40. It is also undisputed that the claimsin the *311
`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,
`
`depends on whetherthe patent contains any claims having an effective filing
`
`date on or after March 16, 2013. In the Petition, Petitioner argued 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 argued that the ’991 patentis
`
`eligible for post-grant review because “Patent Ownerwill not be able to
`
`meet its 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 determined that it is Petitioner, not Patent Owner, that
`
`bears the burden to provethat the ’991 patent is subject to the first-inventor-
`to-file provisions of the AIA and, therefore, eligible for post-grant review.
`Dec. on Inst. 9-12 (citing Research Corp. T.echnologies, 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 1299, 1305-06 (Fed. Cir. 2008)). In the
`
`

`

`PGR2015-00019
`~ Patent 8,876,991 B2
`
`briefing following our Decision onInstitution, neither party has contested
`this assignmentof the burden ofproofon eligibility for post-grant review.
`Accordingly, for the same reasonsexplained in our DecisiononInstitution,
`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 ofthe 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 requirementsof 35 U.S.C.
`§ 112 for claims 12-16. See Pet. 31-45. Becausethe disclosure ofthe
`priority applications is the sameasthat 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. Id. at 31-32. Thus,
`accordingto Petitioner, claims 12-16 are not entitled to an effective filing
`date earlier than January 29, 2014. Jd.
`
`Aswenoted in our Decision on Institution, 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 supportedin 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 any oftheearlier applications adequately supports
`claims 12-16, and therefore, the effectivefiling date for those claims is the
`
`actualfiling date. See Pet. 31-32.
`
`10
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`Petitioner’s argument accords with the definition of “effective filing
`
`date” set forth above, which provides in subparagraph (B)that the effective
`
`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 actual filing date of the patent
`containing a claim to the invention. 35 U.S.C. § 100@)(1)(A). Underthis
`
`definition, if a claim in a patent applicationis not entitled to an earlierfiling
`
`date, then subparagraph (B) does not apply andtheeffective filing date is the
`actual filing date of the application under subparagraph (A), regardless of
`whether the 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
`claimsis the actualfiling date of the ’311 application.®
`
`Our analysis of Petitioner’s enablement and written description
`challenges is set forth in Sections II.D.1. and II.D.2., respectively. For the
`reasons explained therein, we determine that Petitioner has shown that
`claims 12-16 are not adequately supported by the disclosure of the °311
`application. Becauseit is undisputed that the °311 application has the same
`disclosure as the earlier applications to which the 991 patent claims priority,
`see Pet. 32; Prelim. Resp. 25; PO Resp. 40, we also determine that Petitioner
`
`has shown that claims 12~16 are not entitled to an effectivefiling date
`
`8 We cameto the same conclusion in our Decision on Institution. See Dec.
`on Inst. 13. The parties’ briefing after that Decision does not contestthat
`determination.
`
`11
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`earlier than January 29, 2014. Therefore, Petitioner has met its burden to
`show that the ’991 patent is eligible forpost-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 S. Ct. 2131, 214446 (2016)
`(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 of ordinary skill in the art in the context of the
`
`entire disclosure. In 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.
`
`Dec. on Inst. 22. Wealso construed the clause in claim 12 that recites
`
`“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
`id. at 22. Instead, we construed the “wherein”clauseasa 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. Atthe hearing, Petitioner confirmedthat it does not challenge the
`
`12
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`construction of the “wherein” clause that we adopted in the Decision on
`
`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 constructionsset forth in our Decision
`
`on Institution.
`
`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
`
`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
`
`955, 962 (Fed. Cir. 1986).
`
`Petitioner argues, with support from the testimony of Dr. Goldberg,
`
`that a person of ordinary skill in theart at the time of the invention of the
`
`°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 475). Patent Owner did not contest this
`
`proposal or present a competing definitionin its briefing, and stated at the
`
`13
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`hearing that it does not object to Petitioner’s proposed definition of the level
`
`of ordinary skill in the art. Tr. 34:18-35:3. We adoptthe 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 explainedthat an
`
`enabling disclosureis “part of the quid pro quo of the patent bargain.” AK
`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 equal to
`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 known to one of ordinary 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 many factual considerations.” In 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
`
`14
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`predictability or unpredictability ofthe art, and (8) the breadth of
`the claims.
`
`Id.
`
`b. Summary ofthe Parties’ Contentions Regarding Enablement
`
`Petitioner’s enablement arguments focus on the range of temperatures
`
`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 torqueat
`45 degrees of flexion when tested in accordance with ISO
`Standard 3630-1.
`
`Ex. 1001, 10:42-48 (emphasis added). Dependent claim 14 narrowsthe
`temperature range somewhat,reciting that “the temperature is from 300° C.
`up to but not equal to the melting point of the superelastic nickel titantum
`
`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 4] 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:
`
`[S]ubjecting 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
`
`15
`
`

`

`PGR2015-00019
`Patent 8,876,991 B2
`
`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. 4 102 (citing Ex. 1006, 113).
`
`To show that the methodofthe ’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
`
`{7 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,andtheresults 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 J 3-5; Ex. 1018,
`10; Ex. 1002 4 107). Thus, none of the 25°C-treated shanks or 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

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