Trials@uspto.gov
`571-272-7822
`
`Paper 13
`Date: October 26, 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 IPR2015-01476
`Patent 8,727,773 B2
`
`Before JOSIAH C. COCKS, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`COCKS, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 US. C.§ 325(d) and 37 CFR § 42.108
`
`GOLD STANDARD EXHIBIT 2022
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`

`

`IPR2015-01476
`Patent 8,727,773 B2
`
`
`
`
`
`I. INTRODUCTION
`Petitioner, US Endodontics, LLC (“US Endo” or “Petitioner”), filed a
`
`Petition (Paper 1, “Pet.”) requesting inter partes review of claims 1, 4, 5, 8–
`10, and 12 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 and 37 C.F.R. § 42.4(a).
`
`A. Related Matters
`The ’773 patent is stated to be the subject of a lawsuit styled Dentsply
`
`International, Inc. and Tulsa Dental Products LLC d/b/a Tulsa Dental
`Specialties v. US Endodontics, LLC, Case No. 2:14-cv-00196-JRG-DHI
`(E.D. Tenn.). Pet. 1, 5; Paper 4, 21.
`The ’773 patent also is the subject of an inter partes review trial
`
`currently pending before the Board, and involving the same parties, US
`Endodontics, LLC v. Gold Standard Instruments, LLC, Case IPR2015-00632
`(or “the ’632 IPR”). In that proceeding, we instituted review of claims 1–17
`on August 5, 2015 based on the following grounds of unpatentability:
`A. Claims 1, 2, and 9–12 are unpatentable under 35 U.S.C.
`§102(b) as anticipated by Kuhn[2];
`B. Claims 8, 13, 15, and 17 are unpatentable under 35 U.S.C.
`§103(a) over Kuhn and ISO 3630-1[3];
`
`1 GSI also identifies four patents (8,562,341; 8,083,873; 8,062,033; and
`8,876,991) and four patent applications (14/522,013; 14/722,309;
`14/722,390; 14/722,840) as “related matters” to this proceeding. Id. at 2–3.
`2 Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical Properties of
`Nickel-Titanium Endodontic Instruments, 28 J. ENDODONTICS 716 (2002).
`3 International Standard ISO 3630-1, 1st ed. (1992).
`2
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`IPR2015-01476
`Patent 8,727,773 B2
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`C. Claims 1–17 are unpatentable under 35 U.S.C. §103(a) over
`Kuhn, ISO 3630-1, McSpadden[4], and Pelton[5]; [and]
`D. Claims 1–17 are unpatentable under 35 U.S.C. §103(a) over
`Matsutani[6], Pelton, and ISO 3630-1[.]
`
`
`
`IPR2015-00632, Paper 29, 32.
`
`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
`
`
`4 US 2002/0137008 A1 issued September 26, 2002.
`5 Alan R. Pelton et al., Optimisation of Processing and Properties of
`Medical-Grade Nitinol Wire, 9 MINIMALLY INVASIVE THERAPIES & ALLIED
`TECHS. 107 (2000).
`6 US 7,713,815 B2 issued November 21, 2006.
`3
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`IPR2015-01476
`Patent 8,727,773 B2
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`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
`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:
`
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`Patent 8,727,773 B2
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`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
`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. 1104), and prior art of
`record (Ex. 1105) provides the following explanation of the effect of heat-
`treatment on structures made of a superelastic material, such as Nickel-
`Titanium (“Ni-Ti”):
`The Ni-Ti alloys described and claimed by the ’773 patent were
`first discovered in the 1960’s, and their use to make endodontic
`files was first disclosed as early as 1988 by Walia et al. See Ex.
`1105. When appropriately processed, Ni-Ti can exhibit both
`superelasticity (also known as pseudoelasticity) and shape
`memory. Superelasticity means that the material is relatively
`rigid until a threshold stress is applied to it; above that
`threshold, the material becomes considerably more flexible.
`When the stress is removed, the material reverts to its original
`shape. A shape memory material is flexible and does not revert
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`to its original shape immediately after it is deformed. However,
`when it is heated past a transformation temperature (austenite
`finish temperature, “Af”), it reverts to its pre-deformation
`shape. In other words, it “remembers” its original shape. Ex.
`1104 ¶ 23.
`Pet. 7.
`
`
`
`
`
`C. Illustrative Claim
`Claim 1 is independent, and is 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.
`
`
`D. References Relied Upon
`US Endo relies upon the following references:
`
`Kazuhiko Endo et al., Effects of Titanium Nitride Coatings on
`Surface and Corrosion Characteristics of Ni-Ti Alloy, DENTAL
`MATERIALS JOURNAL 13(2): 228–239 (1994) (“Endo”).
`
`Teresa Roberta Tripi et al., Fabrication of Hard Coatings on NiTi
`Instruments, JOURNAL OF ENDODONTICS, Vol. 29, No. 2, 132–134
`(February 2003) (“Tripi”).
`
`McSpadden
`
`
`US 2002/0137008 A1
`
`Sep. 26, 2002
`
`
`Ex. 1108
`
`
`Ex. 1010
`
`Ex. 1111
`
`
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`IPR2015-01476
`Patent 8,727,773 B2
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`International Standard ISO 3630-1, 1st ed. (1992) (“ISO 3630-1”)
`E. The Proposed Grounds of Unpatentability
`US Endo contends that claims 1, 4, 5, 8–10, and 12 of the ’773 patent
`
`are unpatentable under 35 U.S.C. on the following grounds:
`Ground
`References
`Basis
`Claim(s) challenged
`
`
`Ex. 1113
`
`Endo, Tripi, and McSpadden
`Endo, Tripi, McSpadden, and
`ISO 3630-1
`
`§ 103
`§ 103
`
`1, 4, 5, 9, 10, and 12
`8
`
`1
`2
`
`
`
`II. ANALYSIS
`
`A. Statutory Discretion to Institute
`The authority to institute inter partes reviews is established by 35
`
`U.S.C. § 314, the relevant portions of which are reproduced below.
`§ 314. Institution of inter partes review
`
`(a) Threshold.—The Director may not authorize an inter
`partes review to be instituted unless the Director determines
`that the information presented in the petition filed under 311
`and any response filed under section 313 shows that there is a
`reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.
`
`As the Board has recognized, in stating that the Director “may not”
`
`institute review unless certain circumstances are met, Congress made
`institution of inter partes review discretionary. See Butamax Advanced
`Biofuels LLC, v. Geno, Inc., IPR2014-00581, slip op. at 6 (PTAB Oct. 14,
`2014) (Paper 8); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`Case IPR2013-00324, slip op. at 4 (PTAB Nov. 21, 2013) (Paper 19). The
`Director has delegated the decision to institute inter partes review to the
`
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`Board. See 37 C.F.R. § 42.4 (“[t]he Board institutes the trial on behalf of the
`Director.”).7 Thus, the Board, at its discretion, may determine whether to
`institute an inter partes review.
`Furthermore, in determining whether to institute an inter partes
`
`review, “the Board may authorize the review to proceed . . . on all or some
`of the grounds of unpatentability asserted for each claim.” 37 C.F.R.
`§ 42.108. 35 U.S.C. § 325(d) also provides that: “In determining whether to
`institute or order a proceeding under this chapter, chapter 30, or chapter 31,
`the Director may take into account whether, and reject the petition or request
`because the same or substantially the same prior art or arguments previously
`were presented to the Office.”
`Accordingly, whether to institute an inter partes review is at our
`
`discretion, and, in exercising that discretion, we may take into account
`whether “the same or substantially the same prior art or arguments” have
`been presented previously to the Board.
`
`B. Discussion
`As discussed above, this proceeding, IPR2015-01476, involves the
`
`same patent (i.e., the ’773 patent) and the same parties as IPR2015-00632, in
`which trial was instituted on August 5, 2015. Furthermore, all of the claims
`of the ’773 patent that US Endo seeks inter partes review in connection with
`IPR2015-01476 (i.e., claims 1, 4, 5, 8–10, and 12) are involved in the ’632
`IPR. In that respect, trial already is underway in the ’632 IPR based on
`grounds proposed by US Endo to each of claims 1, 4, 5, 8–10, and 12. More
`particularly, as set forth above, those proposed grounds include: (1) claims
`
`7 “The term trial includes . . . an inter partes review under Chapter 31 of title
`35, United States Code.” 37 C.F.R. § 42.2.
`8
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`IPR2015-01476
`Patent 8,727,773 B2
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`1, 2, and 9–12 are anticipated by Kuhn; (2) claims 8, 13, 15, and 17 are
`unpatentable over Kuhn and ISO 3630-1; (3) claims 1–17 are unpatentable
`over Kuhn, ISO 3630-1, McSpadden, and Pelton; and (4) claims 1–17 are
`unpatentable under 35 U.S.C. §103(a) over Matsutani, Pelton, and ISO
`3630-1.
`
`Here, US Endo proposes two additional grounds of unpatentability
`that involve two additional references, namely Endo and Tripi.8 US Endo,
`however, does not explain why those additional grounds are better than any
`of the prior art involved in the ’632 IPR. In that regard, US Endo does not
`present Endo and Tripi as constituting prior art that somehow more closely
`or more effectively accounts for limitations of the pertinent claims of the
`’773 patent beyond, for instance, any of Kuhn, Pelton, or Matsutani. To that
`end, US Endo does not explain why the grounds based on Endo and Tripi are
`not understood reasonably as being based on “substantially the same prior
`art or arguments” that were presented in the ’632 IPR. Indeed, like each of
`Kuhn, Pelton, and Matustani, Endo and Tripi discuss various types of heat
`treatment techniques for tools or instruments made of a Ni-Ti shape memory
`alloy.
`
`US Endo also does not articulate a reason why it could not have
`offered the proposed grounds based on Endo and Tripi earlier as a part of its
`Petition in the ’632 IPR. To the extent that the grounds are offered in some
`capacity to respond to arguments made by GSI in its Preliminary Response
`in the ’632 IPR, we observe that generally a petitioner is not permitted to
`respond to arguments presented by a patent owner in a preliminary response
`
`
`8 The proposed grounds also involve McSpadden and ISO 3630-1 which, as
`noted above, already are of record in the ’632 IPR.
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`until after a trial has been instituted. See 77 Fed. Reg. 48702, Response to
`Comment 54 (Aug. 14, 2012). (“The statutes provide for only a petition and
`a patent owner preliminary response prior to institution. Allowing a reply as
`a matter of right would negatively impact the ability of the Office to meet
`the time requirements of 35 U.S.C. 314(b), as amended, and 35 U.S.C.
`324(c).”)
`
`On the record before us, we conclude that the two proposed grounds
`based on Endo and Tripi amount simply to additional, parallel challenges of
`the claims of the ’773 patent, without explanation as to why such challenges
`are improvements upon grounds for which inter partes review already has
`been instituted. GSI requests that we deny institution on those two grounds
`because they are “redundant,” and so as to “secure a just, speedy, and
`inexpensive resolution of the proceedings” citing to 37 C.F.R. § 42.1.
`Prelim. Resp. 33. We exercise our discretion and deny institution of inter
`partes review on any of the grounds proposed by US Endo in connection
`with IPR2015-01476.
`
`III. CONCLUSION
`For the foregoing reasons, we deny institution based on any of the
`
`grounds presented in conjunction with US Endo’s Petition in IPR2015-
`01476 pursuant to our authority arising under 35 U.S.C. §§ 314 and 325(d),
`and 37 C.F.R. §§ 42.4 and 42.108.
`
`
`
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`IPR2015-01476
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`IV. ORDER
`
`
`
`It is
`
`ORDERED that institution of inter partes review is denied with
`
`respect to all grounds of unpatentability presented in US Endo’s
`Petition in IPR2015-01476.
`
`
`
`
`
`For PETITIONER:
`
`Jeffrey S. Ginsberg
`jginsberg@pbwt.com
`PATTERSON BELKNAP WEBB & TYLER LLP
`
`
`For PATENT OWNER:
`
`Joseph A. Hynds
`jhynds@rfem.com
`
`Randy Brenner-Leifer
`ebrenner@rothwellfigg.com
`
`Jason M. Nolan
`jnolan@rothwellfigg.com
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`
`11
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