UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
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`
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`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
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`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.
`
`
`_______________
`
`
`PATENT OWNER GOLD STANDARD INSTRUMENTS, LLC’S NOTICE
`OF APPEAL
`
`
`
`
`
`
`
`
`
`_______________
`
`
`
`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.
`
`
`_______________
`
`
`PATENT OWNER GOLD STANDARD INSTRUMENTS, LLC’S NOTICE
`OF APPEAL
`
`
`
`
`
`
`
`
`
`Case IPR2015-00632
`Patent 8,727,773 B2
`
`
`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 37 C.F.R. § 90.2(a), 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
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`on August 1, 2016 (Paper No. 78) (attached hereto as Exhibit 1), and all underlying
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`orders, decisions, rulings, and opinions.
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`
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), GSI indicates that the issues
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`on appeal include, but are not limited to:
`
`1.
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`The Patent Trial and Appeal Board’s determination of unpatentability
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`of claims 1-17 of GSI’s U.S. Patent No. 8,727,773, under 35 U.S.C. § 103,
`
`including any finding, claim interpretation, or determination supporting or related
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`to this issue, and all other issues decided adversely to GSI in any orders, decisions,
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`rulings and opinions.
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`
`
`Simultaneously with this submission, a copy of this Notice of Appeal is
`
`being filed with the Patent Trial and Appeal Board. In addition, a copy of this
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`Notice of Appeal, along with the required docketing fees, is being filed with the
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`Clerk's Office for the United States Court of Appeals for the Federal Circuit.
`
`
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`1
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`Respectfully submitted,
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`
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`
`
`/ Joseph A. Hynds /
`By:
`
`Date: August 31, 2016
`Joseph A. Hynds, Reg. No. 34,627
`
`
`
`
`
`Steven Lieberman (admitted pro hac vice)
`
`
`
`
`
`C. Nichole Gifford, Reg. No. 44,122
`
`
`
`
`
`Derek F. Dahlgren (admitted pro hac vice)
`
`
`
`
`
`Jason M. Nolan, Reg. No. 72,427
`
`
`
`
`
`ROTHWELL, FIGG, ERNST &
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`
`
`
`
`
` MANBECK, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040
`Facsimile: 202-783-6031
`
`Counsel for Patent Owner
`Gold Standard Instruments, LLC
`
`2
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`EXHIBIT 1
`
`EXHIBIT 1
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`
`
`Paper 78
`Date: August 1, 2016
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`
`
`
`
`
`
`
`Trials@uspto.gov
`571-272-7822
`
`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.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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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”). We issued a Decision to
`institute an inter partes review (Paper 29, “Inst. Dec.”) of the ’773 patent on
`the following proposed grounds of unpatentability: (1) claims 1, 2, and 9–12
`under 35 U.S.C. §102(b) as anticipated by Kuhn;1 (2) claims 8, 13, 15, and
`17 under 35 U.S.C. §103(a) as obvious over Kuhn and ISO 3630-1;2 (3)
`claims 1–17 under 35 U.S.C. §103(a) as obvious over Kuhn, ISO 3630-1,
`McSpadden,3 and Pelton;4 and (4) claims 1–17 under 35 U.S.C. §103(a) as
`obvious over Matsutani,5 Pelton, and ISO 3630-1. Inst. Dec. 31–32.
`After institution of trial, Patent Owner, Gold Standard Instruments,
`LLC (“GSI” or “Patent Owner”), filed a Patent Owner’s Response (Paper
`44, “PO Resp.”), to which US Endo replied (Paper 57, “Pet. Reply”). Oral
`argument was conducted on April 5, 2016. A transcript of that argument has
`been made of record in this proceeding. Paper 77 (“Tr”). Both parties have
`filed Motions to Exclude. Papers 62, 63.
`
`
`1 Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical Properties of
`Nickel-Titanium Endodontic Instruments, 28 J. ENDODONTICS 716 (2002)
`(Ex. 1019).
`2 International Standard ISO 3630-1, 1st ed. (1992) (Ex. 1016).
`3 US 2002/0137008 A1 issued Sep. 26, 2002 (Ex. 1022).
`4 Alan R. Pelton et al., Optimisation of Processing and Properties of
`Medical-Grade Nitinol Wire, 9 MINIMALLY INVASIVE THERAPIES & ALLIED
`TECHS. 107 (2000) (Ex. 1006).
`5 US 7,137,815 B2 issued Nov. 21, 2006 (Ex. 1023).
`2
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`We have jurisdiction under 35 U.S.C. § 318(a). We have considered
`the evidence and arguments of both parties, and, for the reasons set forth
`below, we determine that US Endo has met its burden of showing, by a
`preponderance of the evidence, that claims 1–17 of the ’773 patent are
`unpatentable.
`
`
`
`A. 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 2:39–43.6 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
`
`
`6 “Nickel-titanium” is also referenced in this Decision as “Ni-Ti” or “NiTi.”
`3
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`breakage, maintain shape upon fracture, can withstand increased strain, and
`can hold sharp cutting edges.” Id. at 2:47–52.
`
`Figures 1a and 1b are reproduced below:
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`
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`Figures 1a and 1b above illustrate “a side elevational view of an
`
`endodontic instrument” (Fig. 1a), and “a partial detailed view of the shank of
`the endodontic instrument shown in FIG. 1a” (Fig. 1b). Id. at 3:21–24.
`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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`4
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`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. Thus,
`according to the ’773 patent, after undergoing such heat treatment, the
`resulting shank has “high flexibility, high resistance to torsion breakage,
`maintains shape upon fracture, can withstand increased strain, and can hold
`sharp cutting edges.” Id. at 2:65–3:1.
`
`
`
`B. 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.
`
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`5
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`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.,
`
`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.
`
`
`II. ANALYSIS
`
`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); see Cuozzo Speed
`Techs. LLC v. Lee, No. 15–446, 2016 WL 3369425, at *12 (U.S. June 20,
`2016). Under the broadest reasonable construction 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). Nevertheless, 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).
`For purposes of our Decision instituting trial in this inter partes
`review, we determined that no terms of the ’773 patent acquired any special
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`meaning. Thus, we gave all terms their broadest reasonable meaning as
`would be understood by a person of ordinary skill in the art in light of the
`Specification. Inst. Dec. 9. We discussed the meaning of certain
`terms/phrases appearing in claims 1 and 13: (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.” Id. at 9–12. Our expressed
`constructions of those terms/phrases is set forth below.
`
`Claim Term/Phrase
`“heat-treating”
`
`The “wherein” clause
`
`Construction
`“[W]e construe claims 1 and 13 as permitting the
`step of heat-treating the shank in any atmosphere
`or environment.” Id. at 10.
`
`“[W]e regard the “wherein” clause in each of
`claims 1 and 13 as a limitation of the claims and
`lays out a metric for determining if a heat
`treatment process falls within the scope of the
`claims.” Id. at 12.
`
`
`
`Neither party disputes that all claim terms of the ’773 patent should be given
`their ordinary meaning. Nor does either party offer any alternative
`constructions for the terms/phrases noted above. We do not discern that the
`record developed during trial gives reason to alter the constructions
`expressed above. Accordingly, for the reasons set forth in the Decision
`instituting trial, and in the absence of any challenge from the parties, we
`maintain the constructions set forth above.
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`B. The Ground of Unpatentability
`Based on Anticipation
`Anticipation is established only when a single prior art reference
`discloses all elements of the claimed invention. In re Spada, 911 F.2d 705,
`708 (Fed. Cir. 1990). US Endo contends that claims 1, 2, and 9–12 are
`anticipated by Kuhn.
`
`
`
`1. 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 716.7 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,
`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.
`
`2. Discussion—Anticipation
`In its Petition, US Endo urges that Kuhn discloses all the features
`
`required by claims 1, 2, and 9–12. Pet. 29–33. GSI does not agree. PO
`
`
`7 Kuhn is paginated as 716–720 in volume 28, number 20 of the Journal of
`Endodontics. That pagination scheme is referenced in this Decision.
`8
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`Resp. 19–34.8 In particular, GSI urges that that Kuhn lacks certain features
`required by those claims. Namely, GSI focuses our attention on the
`requirements of claim 1 pertaining to: (1) heat-treating the “entire” shank;
`and (2) obtaining a “greater than 10 degrees of permanent deformation” after
`bend testing.
`
`
`
`a. Heat-treating the “entire” shank
`We instituted trial in this inter partes review proceeding on the
`
`ground that Kuhn anticipates claim 1. In that regard, we determined, at that
`time, that US Endo had shown a reasonable likelihood of success in showing
`that Kuhn disclosed all the features of claim 1, including that Kuhn accounts
`for heat treatment of the “entire” shank. In making that determination we
`credited the testimony of US Endo’s declarant, Dr. A. Jon Goldberg (Ex.
`1002). Inst. Dec. 16–17. GSI maintains that Kuhn’s disclosure is
`insufficient to convey the practice of heat-treating the entirety of a shank. In
`
`
`8 We are cognizant that in its Reply submitted in response to GSI’s Patent
`Owner’s Response, US Endo now contends the following:
`
`In light of the Board’s finding that the “wherein” clause is
`a limitation, and for the purposes of this Reply only, Petitioner
`acknowledges that the reasons provided in Ground 5 of the
`Petition do not support a finding that claims 2 and 11 are
`anticipated by Kuhn, and that the reasons provided in Ground 6
`do not support a finding that claims 13, 15, and 17 are obvious
`over Kuhn and ISO 3630-1.
`Pet. Reply 11 n.6.
`
`More to that contention, at oral argument, US Endo represented to the
`panel that it did not believe that a preponderance of the evidence supported a
`determination that claims 2, 11, 13, 15, and 17 were unpatentable over Kuhn
`or Kuhn taken with ISO 3630-1. See Tr. 31–32.
`
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`taking that position, GSI points to specific disclosure in Kuhn as to the
`extent of heat treatment that it contemplates and also to the testimony of its
`own declarant, Dr. Robert Sinclair (Ex. 2006). PO Resp. 17–20. With the
`benefit of the record now before us that has been developed during trial, we
`revisit the question of whether Kuhn, itself, contemplates heat-treating the
`entire shank of an endodontic instrument.
`
`There is no dispute that Kuhn discloses heat-treating at least some
`portion of the shank of an endodontic instrument, such as a file. For
`instance, in describing “Thermal Treatments,” Kuhn clearly provides that
`“heat treatments” are applied in some fashion to the file specimens that it
`discloses. Ex. 1019, 717. Before discussing those treatments, however,
`Kuhn describes that the specimens were “cut” to separate “active” parts from
`“inactive” parts of the file. Id. We do observe that, in connection with a
`discussion of “bending tests,” Kuhn proposes that “instruments that have
`been heat-treated” are subjected to those tests. Id. Yet, Kuhn provides no
`additional qualifier as to what extent of the “instruments” were heat-treated.
`
`Dr. Goldberg testifies that “Kuhn says nothing about treating only
`portions of the instruments,” and concludes that “[b]ecause Kuhn is silent on
`the subject, one of ordinary skill in the art would have understood that the
`‘entire shank’ was treated.” Ex. 1002 ¶ 132. Dr. Goldberg also infers that
`the entire shank is heat-treated based on Kuhn’s mention of bending an
`instrument “near the handle” as a part of a bending test. Id. In view of that
`testimony, US Endo concludes that Kuhn discloses heat treatment of the
`entire shank. Pet. 30. Both GSI and Dr. Sinclair, however, contend that
`such conclusion is unwarranted. PO Resp. 18–20; Ex. 2026 ¶¶ 65–71. In
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`that respect, GSI and Dr. Sinclair urge that Kuhn only contemplates heat-
`treating portions of a file that are less than the entirety of a shank of the file.
`The involved ground, here, is one premised on anticipation. The
`“hallmark of anticipation is prior invention” which means that to anticipate,
`a prior art reference must disclose all elements of the claim “within the four
`corners of the document” and “arranged as in the claim.” Net MoneyIn, Inc.
`v. VeriSign Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). In this case, that
`means that Kuhn, itself, must disclose heat-treating the entirety of a file’s
`shank. It is not enough that a skilled artisan, based on the knowledge of the
`art they carry with them, may have “understood” that the entire shank is
`available for heat treatment. Indeed, that one of ordinary skill in the art
`might have selected between a limited number of heat treatment options
`based on their knowledge in the art is not the proper inquiry when
`considering anticipation.
`We do not discern that Kuhn’s description of providing heat treatment
`to its file specimens is of suitable specificity to glean from that description
`that it is the entirety of the shank portion of a file that is subjected to heat
`treatment. It also is unclear what portions of a shank Kuhn contemplates for
`heat treatment in its disclosure that portions “near the handle” are deformed
`when subjected to a bending test. See Ex. 1019, 718. Although Dr.
`Goldberg points to that disclosure as “confirm[ing] that the ‘entire shank’ is
`treated,” he does not explain adequately why that is so. See Ex. 1002 ¶ 132.
`
`b. Conclusion—Anticipation
`Having considered the record as has now been developed during trial,
`
`we conclude that Kuhn does not disclose that the entire shank of an
`endodontic instrument is subjected to heat treatment. That is a requirement
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`of claim 1, and, thus, is also a requirement of claims 2 and 9–12, which
`ultimately depend from claim 1. Accordingly, we are not persuaded that a
`preponderance of the evidence demonstrates that claims 1, 2, and 9–12 are
`anticipated by Kuhn.
`
`
`
`C. The Grounds of Unpatentability
`Based on Obviousness
`A claim is unpatentable for obviousness under § 103(a) if the
`
`differences between the claimed subject matter and the prior art are such that
`the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations, including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of skill in the art; and (4) where in evidence, so-called
`secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17–
`18 (1966). We also recognize that prior art references must be “considered
`together with the knowledge of one of ordinary skill in the pertinent art.” In
`re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (citing In re Samour, 571
`F.2d 559, 562 (CCPA 1978)).
`
`Trial was instituted on the following grounds premised on
`obviousness: (1) claims 8, 13, 15, and 17 as obvious over Kuhn and ISO
`3630-1; (2) claims 1–17 as obvious over Kuhn, ISO 3630-1, McSpadden,
`and Pelton; and (3) Claims 1–17 as obvious over Matsutani, Pelton, and ISO
`3630-1.
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`1. Level of Ordinary Skill in the Art
`In determining the level of skill in the art, various factors may be
`considered, including the “type of problems encountered in the art; prior art
`solutions to those problems; rapidity with which innovations are made;
`sophistication of the technology; and educational level of active workers in
`the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing
`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962
`(Fed. Cir. 1986)). Here, the parties are in general agreement as to the level
`of ordinary skill in the art. In that respect, declarants for both parties opine
`that one of ordinary skill in the art would have an underlying educational
`background in “materials science, metallurgy, or a related field,” and would
`have an understanding of the structural and mechanical properties of NiTi
`endodontic instruments. See Ex. 1002 ¶ 63; see Ex. 2026 ¶ 22. We adopt
`the above-noted contention of the parties as to the level of ordinary skill.
`Furthermore, we observe that the prior art of record in this proceeding also is
`indicative of the level of ordinary skill in the art. See Okajima v. Bourdeau,
`261 F.3d 1350, 1355 (Fed. Cir. 2001); GPAC, 57 F.3d at 1579; In re
`Oelrich, 579 F.2d 86, 91 (CCPA 1978).
`
`2. Ground Based on Kuhn, ISO 3630-1, McSpadden, and Pelton
`US Endo explains in detail where it believes all of the features of
`claims 1–17 are found in Kuhn, ISO 3630-1, McSpadden and Pelton, and
`why a person of ordinary skill in the art would have combined the teachings
`of those references. See Pet. 34–43.
`
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`a. Overview of ISO 3630-1
`As a part of its “Introduction,” ISO 3630-1 describes its content as
`follows:
`This International Standard covers significant features of hand-
`and power-operated dental root canal instruments which are used
`by the dentist for the mechanical preparation of roots canals for
`treatment. In dentistry these instruments are also referred to as
`endodontic instruments.
`Part 1, in addition to the specific instruments indicated, includes
`general specifications, requirements and test methods which are
`applicable to all types of root-canal instruments.
`
`Ex. 1016, 5.9
`
`b. Overview of McSpadden
`McSpadden is titled “Endodontic Instrument.” Ex. 1022, Title. The
`reference is directed generally to “nickel-titanium endodontic instruments
`used for performing root canal therapy.” Id. ¶ 3. McSpadden describes the
`following in connection with the use of nickel-titanium for such instruments:
`Nickel-titanium has several peculiar properties that make
`it very useful in endodontic applications. In particular, the alloy
`has the unusual ability to reversibly change its crystalline
`structure from a hard, high-modular “austentitic” crystalline
`form to a soft, ductile “martensitic” crystalline form upon
`application of pressured and/or by cooling. This results in a
`highly elastic material having a very pronounced pseudo-elastic
`strain characteristic.
` This pseudo-elastic elastic strain
`characteristic is often described as “superelasticity.”
`Id. ¶ 8. McSpadden also summarizes its invention as follows:
`
`It is therefore an object of the present invention to provide
`an improved class of superelastic alloy materials particularly
`
`9 In this Decision, the referenced pagination of ISO 3630-1 is that appearing
`at the lower center of each page of the document.
`14
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`adapted for use in endodontic files. It is another object of the
`invention to provide an endodontic instruments having improved
`manipulation control, sharp cutting edges, and a reduced
`tendency to break during use.
`Id. ¶ 14.
`
`In further describing the formation of an endodontic instruments from
`a NiTi alloy, McSpadden explains the following:
`[T]he drawn NiTi wire is first heat treated and fully annealed to
`relieve most if not all of the latent stress and crystalline
`deformation in the material and to set a permanent straightened
`shape to the wire prior to machining. Such heat treatment and
`annealing is typically required to optimize the material’s
`super[e]lasticity and other desired properties.
`Id. ¶ 51.
`
`c. Overview of Pelton
`Pelton is titled “Optimisation of processing and properties of medical
`grade Nitinol wire.” Ex. 1006, Title. Pelton summarizes its content as
`follows:
`The purpose of this paper is to review the current processing and
`resultant properties of standard Nitinol wire for guide-wire
`applications. Optimised Ti-50.8at%Ni wire was manufactured
`according to industry standards by precise control of the
`composition, cold work and continuous strain-age annealing.
`Mechanical properties of this wire are reported from –100°C to
`200°C to demonstrate the effects of test temperature. Within the
`‘superelastic window’ the plateau stresses are linearly related to
`test temperature. Additional ageing treatments can be used as a
`tool to fine-tune transformation temperatures and mechanical
`properties.
` A
`review of
`the
`fatigue properties of
`thermomechanically-treated Nitinol wire shows that they are
`affected by test temperature, stress and strain.
`
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`Id. at 107.10
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`The following is a reproduction of Pelton’s Figures 9 and 10:
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`Figures 9 and 10 above depict the effect of ageing temperature and
`
`time on the transformation temperature of Nitinol wire (i.e., a wire made of
`nickel and titanium). Id. at 114. As evident from the figures, and as
`
`
`10 Pelton is paginated 107 to 118 of the Minimally Invasive Therapies &
`Allied Techs. Journal. That pagination sequence is referenced in this
`Decision.
`
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`explained, Pelton contemplates heat treatment of various Nitinol wires
`ranging from 300°C to 550°C for durations between 0 and 200 minutes. Id.
`Pelton also contemplates that its disclosed Nitinol wire is used in medical
`applications such as for endodontic instruments. Id. at 107.
`
`
`
`d. Discussion—Kuhn, ISO 3630-1, McSpadden, and Pelton
`As was the case in the context of the anticipation ground based on
`Kuhn, the dispute between the parties primarily centers on two features
`required by the claims: (1) heat-treating the “entire” shank; and (2) obtaining
`a “greater than 10 degrees of permanent deformation” after bend testing.
`
`i. Heat-treating the “entire” shank
`Although, as discussed above, it is not apparent that Kuhn discloses
`the act of heat-treating the entire shank of a file, that does not end the
`inquiry into whether a person of ordinary skill in the art would have
`recognized that such practice was an available option. The record is replete
`with description of heat-treating medical tools, including endodontic
`instruments. Indeed, that is a practice described, for instance, in each of
`Kuhn, McSpadden, and Pelton.
`We agree with US Endo (Pet. Reply 4–5) that there are a finite and
`predictable number of options for heat-treating the extent of an endodontic
`instrument, i.e., heat-treating a portion of the shank or heat-treating the
`entire shank. In such scenarios, a skilled artisan has good reason to pursue
`known options within their technical grasp. See KSR, 550 U.S. at 421
`(2007). We are mindful of GSI’s arguments (PO Resp. 17–20) and Dr.
`Sinclair’s testimony (Ex. 2026 ¶¶ 63–71) urging that Kuhn, itself, does not
`disclose heat-treating the entirety of a shank. Indeed, as discussed above, we
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`agree there is some question in that regard. Here, however, we do not
`discern that GSI or Dr. Sinclair consider appropriately what a person of
`ordinary skill and creativity in the art would have understood from the
`teachings of the prior art beyond simply Kuhn’s disclosure. We conclude
`that a skilled artisan practicing the teachings of the prior art in connection
`with heat-treating a nickel-titanium instrument would have had the
`background knowledge, creativity, and common sense to heat-treat the
`entirety of a shank, as opposed to some partial portion, if so desired. See
`Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir.
`2009). In that respect, we observe that none of Kuhn, McSpadden, and
`Pelton suggests a prohibition to any particular heat treatment approach, and
`we do not discern that a skilled artisan would have viewed heat-treating the
`entire shank of a file as unknown or unworkable. Indeed, it simply is not
`evident why a person of ordinary skill in the art practicing the heat treatment
`of an endodontic instrument based on the teachings of the prior art would
`have viewed heat treatment of the entire shank of such an instrument as
`some type of barrier. In reaching that conclusion, we also credit Dr.
`Goldberg’s testimony that a skilled artisan would have known that heat-
`treating the entire shank would “avoid the difficulties and added expense
`associated with partial heat treatment.” Ex. 1002 ¶ 201.
`Accordingly, we determine that, on the record at hand, a person of
`ordinary skill in the art would have known heat-treating the “entire shank”
`of an endodontic instrument as required by the claims of the ’773 patent was
`an available option, and that selecting such an option would have been
`obvious.
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`ii. “greater than 10 degrees of permanent deformation”
`Each of claims 1 and 13 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 the
`prior art 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 teachings of Pelton and McSpadden concerning the materials of
`the instruments and wires they disclose; (3) the declaration testimony of Dr.
`Goldberg at paragraphs 135–137; and (4) representations made by the
`applicants during the prosecution of the patent application that became the
`’773 patent. Id. at 30–31, 34–38.
`
`According to Dr. Goldberg, the curve shown in Figure 6A that
`corresponds to a file heat-treated at 400 ºC indicates th
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