Trials(@uspto.gov
`571-272-7822
`
`Paper 29
`Date: August 5, 2015
`
`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 IPR2015-00632
`Patent 8,727,773 B2
`
`Before JOSIAH C. COCKS, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`COCKS, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 CFR § 42.108
`
`GOLD STANDARD EXHIBIT 2012
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`
`571-272-7822
`
`Paper 29
`Date: August 5, 2015
`
`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 IPR2015-00632
`Patent 8,727,773 B2
`
`Before JOSIAH C. COCKS, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`COCKS, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 CFR § 42.108
`
`GOLD STANDARD EXHIBIT 2012
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`
`
`IPR2015-00632
`Patent 8,727,773 B2
`
`
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`I. INTRODUCTION
`Petitioner, US Endodontics, LLC (“US Endo” or “Petitioner”), filed a
`
`Petition (Paper 2, “Pet.”) requesting inter partes review of claims 1–17 of
`U.S. Patent 8,727,773 B2 (“the ’773 patent”). Patent Owner, Gold Standard
`Instruments, LLC (“GSI” or “Patent Owner”), filed a Preliminary Response
`(Paper 9, “Prelim. Resp.”) requesting that inter partes review of the above-
`noted claims not be instituted. We have jurisdiction under 35 U.S.C. § 314.
`To institute an inter partes review, we must determine that the
`
`information presented in the Petition shows “a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we
`conclude that the information presented in the Petition establishes a
`reasonable likelihood that Petitioner will prevail in showing that claims 1–17
`of the ’773 patent are unpatentable. Pursuant to 35 U.S.C. § 314, we hereby
`authorize an inter partes review to be instituted as to claims 1–17.
`
`Our factual findings and conclusions at this stage of the proceeding
`are based on the evidentiary record developed thus far (prior to Patent
`Owner’s Response). This is not a final decision as to patentability of claims
`for which inter partes review is instituted. Our final decision will be based
`on the record, as fully developed during trial.
`
`A. Related Matters
`The ’773 patent is stated to be the subject of a litigation styled
`
`Dentsply International, Inc. and Tulsa Dental Products LLC d/b/a Tulsa
`
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`Dental Specialties v. US Endodontics, LLC, Case No. 2:14-cv-00196-JRG-
`DHI (E.D. Tenn.). Paper 5, 21; see Paper 8, 1.
`
`
`
`B. The ’773 Patent (Ex. 1001)
`The ’773 patent is 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.” Id. at 2:56–57. In that respect, the ’773 patent explains
`that flexibility is a desirable attribute for endodontic devices such as “files,”
`but that, in the prior art, for files of larger sizes the “shank” portions of the
`files become “relatively inflexible,” which impedes the therapy of a root
`canal. Id. at 2:1–24.
`
`The ’773 patent also describes that it is known in the art that
`endodontic files may be formed of “superelastic alloys such as nickel-
`titanium that can withstand several times more strain than conventional
`materials without becoming plastically deformed.” Id. at 2:39–43. The ’773
`patent further explains that such “property is termed shape memory, which
`allows the superelastic alloy to revert back to a straight configuration even
`after clinical use, testing or fracture (separation).” Id. at 2:43–46.
`Nevertheless, the’773 patent represents that there is 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 2:47–52.
`
`Figures 1a and 1b, which are reproduced below, illustrate “a side
`elevational view of an endodontic instrument” (Fig. 1a), and “a partial
`
`1 GSI also identifies four patents, 8,562,341; 8,083,873; 8,062,033, and
`8,876,991 as “related matters” to this proceeding. Id. at 2–3.
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`detailed view of the shank of the endodontic instrument shown in FIG. 1a”
`(Fig. 1b). Id. at 3:21–24.
`
`
`
`
`
`The figures above depict an endodontic instrument according to the
`
`invention. With respect to those figures, the ’773 patent conveys the
`following:
`This embodiment of the invention is an endodontic
`
`instrument as shown in 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 and further
`includes a distal end 48. The shank 42 includes two continuous
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`helical flutes 51 as shown in FIG. 1b that extend along its lower
`portion. The flutes 51 define a cutting edge. A helical land 53
`is positioned between axially adjacent flutes as shown in FIG.
`1b.
`Id. at 4:1–11.
`
`The ’773 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 instrument to “heat-treatment” so as to
`“relieve stress in the instrument to allow it to withstand more torque, rotate
`through a larger angle of deflection, change the handling properties, or
`visually exhibit a near failure of the instrument.” Id. at 5:64–6:1.
`
`By way of background, the Petition, through recourse to the
`declaration testimony of Dr. A. Jon Goldberg (Ex. 1002), and prior art of
`record (Exs. 1004 and 1005) provides the following explanation of the effect
`of heat-treatment on structures made of a superelastic material, such as
`Nickel-Titanium (“Ni-Ti”):
`
`The superelastic and shape memory properties result
`from the microscopic structure of Ni-Ti crystals, which can take
`on at least two relevant solid phases: austenite and martensite.
`In the austenite phase, the individual atoms in the crystal are
`arranged rigidly, whereas in the martensite phase, the atoms can
`shift within the lattice, making the material more flexible. The
`transformation between austenite and martensite depends
`principally on temperature, with martensite occurring at lower
`temperatures. Ex. 1002 at ¶ 28-29; see Ex. 1004 at 5-6;
`Ex. 1005 at 25.
`
`When Ni-Ti is in the martensite phase at ambient
`temperatures, it exhibits shape memory; when subjected to a
`bending force it will stay deformed, returning to its original
`shape when heated above a transformation temperature to form
`austenite. When ambient temperatures are higher than the
`transformation temperature, Ni-Ti is stable as austenite rather
`than martensite. However, a sufficient applied stress may
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`transform the austenite phase into a more flexible but meta-
`stable martensite phase despite being above its transformation
`temperature, allowing considerably more deformation. When
`the stress is released, Ni-Ti reverts quickly to the austenite
`phase, returning the object to its previous shape. This is
`superelasticity. Ex. 1002 at ¶¶ 30-31; Ex. 1004 at 5-6; Ex. 1005
`at 25.
`Pet. 3–4.
`
`
`
`C. Illustrative Claims
`Claims 1 and 13 are independent, and are reproduced below:
`
`1. 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 from 400˚ 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.
`
`13. 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 helical flutes
`defining a cutting edge extending from a distal end of the shank
`along an axial length of the shank, the instrument being in
`accordance with ISO Standard 3630-1, the shank consisting
`essentially of a superelastic nickel titanium alloy; and
`
`(b) after step (a), heat-treating the entire instrument shank
`at a temperature from 475˚ C. to 525˚ C.,
`
`
`
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`wherein the heat-treated shank has an angle greater than
`
`10 degrees of permanent deformation after torque at 45˚ of
`flexion tested in accordance with ISO Standard 3630-1.
`
`
`
`
`Ex. 1012
`Ex. 1014
`Ex. 1022
`Ex. 1023
`
`
`
`Ex. 1006
`
`
`Ex. 1016
`
`
`
`Ex. 1018
`
`
`
`Ex. 1019
`
`
`Ex. 1024
`
`
`
`D. References Relied Upon
`US Endo relies upon the following references:
`
`Luebke 2008
`US 2008/0032260 A1
`Feb. 7, 2008
`Gao
`US 2011/0271529 A1
`Nov. 10, 2011
`McSpadden
`US 2002/0137008 A1
`Sep. 26, 2002
`Matsutani
`US 7,713,815 B2
`Nov. 21, 2006
`
`Alan R. Pelton et al., Optimisation of Processing and Properties of
`Medical-Grade Nitinol Wire, 9 MINIMALLY INVASIVE THERAPIES &
`ALLIED TECHS. 107 (2000) (“Pelton”)
`
`International Standard ISO 3630-1, 1st ed. (1992) (“ISO 3630-1”)
`
`Salwa E. Khier et al., Bending properties of superelastic and
`nonsuperelastic nickel-titanium orthodontic wires, 99 AM. J.
`ORTHODONTICS & DENTOFACIAL ORTHOPEDICS 310 (1991)
`(“Khier”)
`
`Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical
`Properties of Nickel-Titanium Endodontic Instruments, 28 J.
`ENDODONTICS 716 (2002) (“Kuhn”)
`
`S. Miyazaki et al., Characteristics of Deformation and
`Transformation Pseudoelasticity in Ti-Ti Alloys, 53 J. PHYSIQUE
`COLLOQUES C4-255 (1982) (“Miyazaki”)
`
`
`
`E. The Proposed Grounds of Unpatentability
`US Endo contends that claims 1–17 of the ’632 patent are
`
`unpatentable under 35 U.S.C. on the following grounds:
`
`
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`Ground
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`
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`References
`
`1
`2
`3
`4
`5
`6
`7
`
`8
`9
`
`10
`
`11
`
`12
`
`
`
`Luebke 2008
`Gao
`Gao and ISO 3630-1
`Gao, ISO 3630-1, and Khier
`Kuhn
`Kuhn and ISO 3630-1
`Kuhn, ISO 3630-1,
`McSpadden, and Pelton
`Kuhn, ISO 3630-1, and Khier
`Kuhn, ISO 3630-1,
`McSpadden, Pelton, and Khier
`
`McSpadden, Miyazaki, and ISO
`3630-1
`Matsutani, Pelton, and ISO
`3630-1
`Matsutani, Pelton, ISO 3630-1,
`and Khier
`
`II. ANALYSIS
`
`Basis
`
`§ 102
`§ 102
`§ 103
`§ 103
`§ 102
`§ 103
`§ 103
`
`§ 103
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`
`
`Claim(s)
`challenged
`1–17
`1–7 and 9–12
`8 and 13–17
`1–17
`1, 2, and 9–12
`8, 13, 15, and 17
`1–17
`
`1–17
`1–17
`
`
`1–17
`
`1–17
`
`1–17
`
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable construction in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b); In re Cuozzo Speed
`Techs., LLC, No. 2014–1301, ___ F.3d ___, 2015 WL 4097949, at *5–*8
`(Fed. Cir. July 8, 2015). Under the broadest reasonable construction
`
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`standard, claim terms usually are 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). However, a “claim term will not receive its ordinary
`meaning if the patentee acted as his own lexicographer” and clearly set forth
`a definition of the claim term in the specification. CCS Fitness, Inc. v.
`Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002).
`Neither party contends that the ’773 patent sets forth any
`lexicographic definition for any claim term. For purposes of this Decision,
`we have given all claim terms their ordinary and customary meaning as
`would be understood by a skilled artisan in light of the Specification of the
`’773 patent. Nevertheless, we address expressly the meaning of the
`following claim terms/phrases: (1) “heat treating”; and (2) “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.”
`
`1. “heat treating”
`Each of claims 1 and 13 is drawn to a method of manufacturing or
`
`modifying an endodontic instrument and includes a step of providing an
`elongate shank. Each claim also includes a step of “heat treating” that
`shank. US Endo contends that, in the context of an inter partes review
`proceeding, the claimed act of heat-treating the shank “should be construed
`to include heat treatment in any environment.” Pet. 7. GSI expresses
`agreement with US Endo’s construction. Prelim. Resp. 10.
`
`Although the Specification of the ’773 patent describes heat treating
`of an endodontic instrument’s shank only in connection with an atmosphere
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`that is “unreactive with the shank” (see, e.g., Ex. 1001, 2:62–65), we observe
`that neither claim 1 nor claim 13 makes explicit any requirement as to the
`characteristics of the atmosphere in which the claimed heat-treating occurs.
`Furthermore, other claims that depend from claim 1 or claim 13 make clear
`that the act of heat-treating may be performed in “any atmosphere” (claim 4)
`or in an atmosphere that is “unreactive, ambient, or any other acceptable
`heat treatment process” (claims 5, 6, and 16). Accordingly, for purposes of
`this Decision, we construe claims 1 and 13 as permitting the step of heat-
`treating the shank in any atmosphere or environment.
`
`2. The “wherein” clause
`Each of claims 1 and 13 includes a concluding “wherein” clause that
`
`specifies that a shank, once heat-treated, will exhibit a particular level of
`permanent deformation (i.e. “an angle greater than 10 degrees”) after being
`subjected to a particular level of torque (i.e., “45 degrees of flexion”) upon
`being “tested in accordance with ISO Standard 3630-1.” US Endo contends
`the following with respect to the “wherein” clauses of claims 1 and 13:
`Petitioner submits that, for the purpose of patentability under 35
`U.S.C. §§ 102–103, this clause should not be considered a
`limitation because it only states the intended result of
`performing the claimed heat treatment process. However, if the
`“wherein” clause is determined to be a limitation, then, based
`on
`the applicant’s representations and arguments during
`prosecution, it is met by a prior art reference disclosing “some
`degree of permanent deformation” and/or by a heat-treated file
`with an austenite finish temperature about mouth temperature.
`Pet. 7–8.
`
`GSI responds that the noted “wherein” clauses may not be discounted
`and, instead, “constitute material limitations of the claimed methods,”
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`(Prelim. Resp. 11). According to GSI, that is so because the clauses
`establish the means for determining whether a heat treatment process is
`encompassed by the claims. In that respect, GSI submits that a given heat
`treatment process is outside the scope of the claims if it does not transform a
`superelastic nickel titanium material into one that exhibits greater than 10
`degrees of permanent deformation after the application of 45 degrees of
`torque upon testing in the ISO Standard 3630-1 bend test. Id.
`
`On this record, we do not agree with US Endo that the pertinent
`“wherein” clause should be disregarded as a limiting aspect of claims 1 and
`13. We recognize that the Federal Circuit has declined to give weight to
`phrases in “whereby” clauses of method claims that simply expressed the
`intended result of a process step that has been positively recited. See, e.g.,
`Minton v. Nat’l Ass’n of Sec. Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir.
`2003) (holding that the district court was correct in not giving weight to the
`phrase “traded efficiently” because the term “efficiently” did not inform the
`mechanics of how the trade is executed and was instead a laudatory term
`characterizing the result of the executing step). The inquiry, however, in
`that regard is fact-specific and determined on a case-by-case basis. Here, the
`noted “wherein” clauses provide a means of assessing the efficacy of the act
`of heat-treating a shank to determine if the resulting physical transformation
`of the shank places the heat treating process within the confines of the
`claims. In circumstances such as those present here, the “wherein” clause
`sets forth a necessary purpose of a claim step, and should, therefore, be
`regarded as a material limitation of the claim. See Griffin v. Bertina, 285
`F.3d 1029, 1034 (Fed. Cir. 2002) (determining that “wherein” clauses of a
`claim were limiting because they “provide the necessary purpose for the
`
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`steps” of a method.) Further, unlike the merely laudatory term to which the
`court declined to give weight in Minton, the “wherein” clause in this case
`sets forth a specific, quantitative test.
`
`We are cognizant that US Endo proposes an alternative approach that,
`should the “wherein” clauses of claims 1 and 13 be considered limiting, then
`“some” degree of permanent deformation should suffice for the expression
`“greater than 10 degrees” of permanent deformation that now appears in
`those claims. US Endo, however, provides no meaningful explanation as to
`why that should be the case. To that end, US Endo does not articulate a
`reason why “some degree” of deformation somehow forms a meaning or
`construction of “greater than 10 degrees.” We decline, on this record, to so
`construe that aspect of the wherein clauses in the proffered manner.
`
`At this time, we regard the “wherein” clause in each of claims 1 and
`13 as a limitation of the claims that lays out a metric for determining if a
`heat treatment process falls within the scope of the claims.
`
`B. Discussion
`US Endo, in its Petition, advances twelve grounds that it contends
`
`establish the unpatentability of the claims of the ’773 patent. Of those
`grounds, four are premised on the assertion that the claims of the ’773 patent
`are entitled only to a filing date of April 25, 2012, which is the actual filing
`date of the application that became the ’773 patent. GSI, on the other hand,
`contends that the effective filing date of the claims of the ’773 patent are
`June 7, 2005, which is the filing date of PCT application
`PCT/US2005/019947 (“the PCT application”), to which the ’773 patent
`claims priority. Prelim Resp. 15; see Ex. 1001.
`
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`1. The effective filing date of the ’773 patent
`US Endo contends that all the applications on which the ’773 patent
`
`claims priority lack support under 35 U.S.C. § 112 for heat treatment in a
`“reactive” atmosphere. Pet. 15–16. According to US Endo, because the
`claims of the ’773 patent encompass within their scope the act of heat-
`treating a shank in any atmosphere, including one that is reactive to the
`shank, the claims of the ’773 patent are not entitled to the benefit of the
`filing date of any of the earlier applications. To that end, US Endo is of the
`view that, with respect to the application that became the ’773 patent, “it
`cannot be said that applicant possessed an invention comprising conducting
`the heat treatment step in atmospheres that are both reactive and unreactive
`with Ni-Ti prior to the April 25, 2012 filing date.” Id. at 18–19.
`
`GSI does not agree. In disputing US Endo’s assertions, GSI maintains
`that the PCT application describes at least two embodiments of the
`invention, including one in which “superelastic nickel titanium files [] were
`coated by heat-treatment at 500 ºC in a non-inert, or reactive, atmosphere—
`nitrogen gas and titanium” citing the PCT application (Ex. 2003) at
`paragraphs 35–42 and Figures 3–7. Prelim. Resp. 16. We observe that US
`Endo seemingly recognizes that the PCT application describes a heat
`treatment process performed in an environment that is reactive, but discounts
`that description as being applied only to “coated instruments.” Pet. 16
`(emphasis omitted). US Endo, however, does not articulate why the
`“coated” aspect of the instruments has significance with respect to the type
`of atmosphere employed, i.e., in this case, one that is reactive to the
`instrument.
`
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`To satisfy 35 U.S.C. § 112, the written description must convey with
`
`reasonable clarity to those skilled in the art that the inventor was in
`possession of the claimed invention. See Vas-Cath Inc. v. Mahurkar, 935
`F.2d 1555, 1563–64 (Fed. Cir. 1991). One shows “possession” of the
`invention by describing the invention using such descriptive means as
`words, structures, figures, diagrams, formulas, etc. that fully set forth the
`claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572
`(Fed. Cir. 1997). Here, US Endo does not explain adequately why the
`above-noted heat treatment procedure involving a “nitrogen gas and
`titanium” atmosphere described in the PCT application is insufficient to
`convey the use of a reactive atmosphere.2 On this record, we are not
`persuaded that the inventors of the ’773 patent did not demonstrate that they
`possessed the use of a heat treatment process employing a reactive
`atmosphere at the time of the filing of the PCT application.
`
`Therefore, at this time, we are persuaded that the ’773 patent is
`entitled to an effective filing date that is the filing date of the PCT
`application.
`
`2. Proposed Grounds 1–4
`Each of the grounds designated 1–4 in the Petition and in this
`
`Decision includes either Luebke 2008 or Gao. US Endo’s position that those
`references are available as “prior art” in the context of the ’773 patent is
`predicated on a determination that the claims of the ’773 patent are entitled
`only to the filing date of April 25, 2012. For the reasons discussed above,
`
`
`2 We understand that description in the PCT application to carry forward
`through all applications intervening the PCT application and the ’773 patent
`to which the ’773 patent claims priority.
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`we do not discern that the claims of the ’773 patent find inadequate support
`in the PCT application so as to deprive those claims of the effective filing
`date of that PCT application, i.e., June 7, 2005.
`
`Accordingly, we conclude that, in light of the record before us,
`Luebke 2008 and Gao are not considered properly as prior art to the ’773
`patent. We are not persuaded, therefore, that US Endo has shown a
`reasonable likelihood of prevailing in its challenge to any of the claims in
`connection with proposed grounds 1–4.
`
`3. Proposed Grounds 5, 6, and 7
`Each of proposed grounds 5, 6, and 7 is based on Kuhn. In particular,
`
`ground 5 applies Kuhn as anticipating claims 1, 2, and 9–12, ground 6
`applies Kuhn and ISO 3630-1 as rendering obvious claims 8, 13, 15, and 17,
`and ground 7 applies Kuhn, ISO 3630-1, McSpadden, and Pelton as
`rendering obvious claims 1–17.
`
`a. Overview of Kuhn
`Kuhn is an article in the Journal of Endodontics titled “Fatigue and
`
`Mechanical Properties of Nickle-Titanium Endodontic Instruments.”
`Ex. 1019, Title. Kuhn sets forth that the “aim” of its disclosure is “to show
`fatigue characteristics of superelastic NiTi, and subsequently, the effect of
`the process history on fracture life.” Id. at 716.3 Kuhn describes the study
`of “files” measuring 25 mm in length and a taper ranging between 0.04 and
`0.06 mm per mm length. Id. at 717. Kuhn explains that the files were
`subjected to heat treatments that consist of “anneals at 350 ºC, 400 ºC,
`
`3 Kuhn is paginated as pages 716–720 in volume 28, number 20 of the
`Journal of Endodontics. That pagination scheme is referenced in this
`Decision.
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`450 ºC, 510 ºC, 600 ºC and 700 ºC in salt baths for 10 min and at 600 ºC and
`700 ºC for 15 min.” Id. Kuhn also explains that “bending tests” were
`performed on “[n]ew instruments, instruments used in the clinic, and
`instruments that have been heat-treated” to obtain “information about the
`elastic behavior (flexibility) of the files.” Id.
`
`b. Anticipation of claims 1, 2, and 9–12 by Kuhn
`US Endo contends that Kuhn discloses all the features required by
`
`claims 1, 2, and 9–12, such that the reference anticipates those claims.
`Pet. 29–33. GSI challenges US Endo’s contention on the theory that Kuhn
`lacks three features required by those claims. In particular, according to
`GSI, Kuhn does not disclose: (1) heat treating the “entire” shank as set forth
`in claim 1 (Prelim. Resp. 28); (2) a “greater than 10 degrees of permanent
`deformation” after bend testing (id. at 28–31); and (3) the composition
`limitation of claim 12 pertaining to a make-up of 54–57% nickel and 43–
`46% titanium for the material of the shank (id. at 30).
`
`i. Heat-treating the “entire” shank
`US Endo contends that Kuhn’s disclosure accounts for the
`
`requirement that an entire shank is heat-treated. In that respect, US Endo
`proposes that Kuhn does not limit its heat treatment disclosures to only a
`portion of the instruments, and maintains that “Kuhn performed bend-testing
`on the entire shank, confirming that the entire shank was treated,” citing to
`Kuhn at page 718. Pet. 30. US Endo also relies on the testimony of Dr.
`Goldberg, who testifies, based on the content of Kuhn, it is his opinion that
`Kuhn contemplates heat-treating the entirety of a shank. Ex. 1002 ¶ 132.
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`GSI disputes that Kuhn contemplates the step of heat-treating the
`
`entirety of a shank. Instead, GSI urges that Kuhn discloses applying heat
`treatments only to portions of a file, specifically the “working or active part
`of the file,” and, thus, does not disclose heat-treating the entire shank of an
`endodontic instrument. Prelim. Resp. 29 (citing Ex. 1019 (Kuhn), 717).
`
`The portion of Kuhn at page 717 that is referenced by GSI does
`disclose that an exemplary tested file is one measuring 25 mm in length, but
`is “cut to separate [the] working or active part of the file from the inactive
`part.” Ex. 1019, 717, first column. In further describing the methodologies
`of a thermal treatment process, Kuhn sets forth that the file is cut into
`segments measuring 5 mm in length. Id. In later explaining the nature of
`“bending tests,” however, Kuhn describes that “bending of files” occurs and
`that those files constitute “[n]ew instruments, instruments used in the clinic,
`and instruments that have been heat-treated.” Id. at 717, second column.
`Kuhn also sets forth that the bending tests involve bending the “tip of the
`instrument” (id. at 718, second column), and that aspects of the bending tests
`involve bending the instruments by as much as 8 mm (see id. at 719,
`Fig. 6A).
`
`Although Kuhn does set forth that heat treatment may be performed
`on portions of a file that have been cut, we observe that Kuhn also seemingly
`contemplates that bend testing is performed on instruments as a whole that
`have been subjected to heat treatment (e.g., bending the “tip of the
`instrument” (id. at 718, second column)). We also are mindful that, in
`bending or deforming files by as much as 8 mm as a part of the bending tests
`(e.g. as shown in Fig. 6A), Kuhn clearly contemplates that some samples
`undergoing those tests must be larger in length than the samples that were
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`“cut” so as to be 5 mm in length. In considering the record before us, and
`for purposes of this Decision, we are persuaded that Kuhn conveys that the
`entirety of an instrument file or shank may be heat-treated.
`
`
`
`ii. “greater than 10 degrees of permanent deformation”
`Claim 1 culminates in a recitation that “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.”
`US Endo contends that the bending tests described in Kuhn satisfy the
`above-noted requirement, including that, at least in one example, a shank
`that underwent heat treating, and subsequently subjected to a bending test,
`displayed the required 10 degrees of permanent deformation. Pet. 30–31. In
`support of that contention, US Endo points to: (1) results of bend tests of a
`400ºC-treated file depicted in Kuhn’s Figures 6A; (2) the declaration
`testimony of Dr. Goldberg at paragraphs 135–137; and (3) and
`representations made by the applicants during the prosecution of the patent
`application that became the ’773 patent. Id.
`
`According to Dr. Goldberg, the curve shown in Figure 6A that
`corresponds to a file heat treated at 400 ºC indicates that the file exhibited
`permanent deformation of “about 1.8 millimeters” after undergoing 8
`millimeters of deflection. Ex. 1002 ¶ 135. Although characterized as a
`“rough estimate,” Dr. Goldberg testifies that such disclosure relays “10.125
`degrees” of deformation for the treated file. Id. Dr. Goldberg further
`provides the following testimony:
`Kuhn also discusses the effect of treatment on the material’s
`transformation temperature. The 400°C treatment, per Kuhn,
`raised the instrument’s transformation temperature from 35°C
`to 40°C, which is above mouth temperature. Ex. 1019 (Kuhn)
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`at 719. Thus, it was no longer superelastic by Kuhn’s
`definition; this increase in the transformation temperature
`confirms
`that
`the
`treated
`instrument would satisfy
`the
`“wherein” clause. See supra section V; see also supra section
`VI-B; Ex. 1008 (’773 patent prosecution history) at 147, 151-
`52, 159. Kuhn discloses this very property with respect to the
`400°C-treated instrument, which per Kuhn gave “good results.”
`As such, in my opinion, Kuhn not only discloses the feature that
`Dr. Luebke used to distinguish his invention, but also teaches it
`to be a desirable one.
`Id. ¶ 137. Thus, Dr. Goldberg testifies that, as determined from the bending
`test applied to the file treated at 400 ºC, the transformation temperature, i.e.,
`the temperature at which the file transitions between martensite and
`austenite, was increased from 35 ºC to 40 ºC. Dr. Goldberg also testifies
`that such an increase in the transformation temperature was a desired result
`of the invention of the ’773 patent, as represented by Dr. Luebke during
`prosecution of the application that became the ’773 patent.
`
`GSI generally discounts Kuhn’s teachings as satisfying the
`requirement of claim 1’s “wherein” clause. Prelim. Resp. 30–31. On this
`record, however, GSI does not explain why Dr. Goldberg’s above-noted
`testimony should be discredited. GSI also generally argues that Kuhn does
`not convey that its bending test is the ISO Standard 3630-1 bend test;
`however, we do not discern that claim 1 requires that the ISO Standard
`3630-1 bend test must be employed. Rather, the claim simply requires
`particular resulting deformation properties of a treated shank, and specifies
`that the ISO Standard 3630-1 bend test is a way to ascertain that the shank
`has the desired characteristics. On this record, GSI does not explain why we
`should disregard Dr. Goldberg’s testimony that the bend test used in Kuhn
`conveys that the disclosed heat treatment of a file at 400 ºC also establishes a
`
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`file with the required deformation, or point to evidence serving to undermine
`Dr. Goldberg’s testimony. We are mindful, however, that, at this stage of
`the proceeding, GSI has not yet had opportunity to submit any new
`testimony evidence to countervail that testimony. See 37 C.F.R. § 41.107(c).
`
` Accordingly, at this time, we are persuaded that US Endo has
`demonstrated for purposes of the institution of trial that Kuhn discloses the
`requirement of the pertinent “wherein” clause of claim 1.
`
`iii. The composition limitations of claim 12
`Claim 12 depends from claim 1 and provides that “the superelastic
`
`nickel titanium alloy comprises 54–57 weight percent nickel and 43–46
`weight percent titanium.” In accounting for th
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