UNITED STATES PATENT AND TRADEMARKOFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`US ENDODONTICS, LLC,
`Petitioner
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner
`
`Case No. IPR2015-01476
`U.S. Patent No. 8,727,773 B2
`
`PETITION FOR INTER PARTES REVIEW
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`US Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Submitted Electronically via the Patent Review Processing System
`
`GOLD STANDARD EXHIBIT 2020
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`

`
`TABLE OF CONTENTS
`
`
`Page
`
`C. 
`
`
`I. 
`Introductory Statement ................................................................................... 1 
`II.  Mandatory Notices (37 C.F.R. § 42.8) ........................................................... 5 
`A. 
`Real Party-in-Interest ........................................................................... 5 
`B. 
`Related Matters ..................................................................................... 5 
`C. 
`Counsel and Service Information ......................................................... 6 
`D. 
`Power of Attorney ................................................................................ 6 
`Payment of Fees (37 C.F.R. § 42.103) ........................................................... 6 
`III. 
`IV.  Background and Summary of the ’773 Patent ................................................ 6 
`Requirements for Inter Partes Review (37 C.F.R. § 42.104) ........................ 8 
`V. 
`A.  Grounds for Standing (37 C.F.R. § 42.104(b)(1)) ............................... 8 
`B. 
`Identification of Challenged Claims and Specific Statutory
`Ground (37 C.F.R. § 42.104(b)(1)-(2)) ................................................ 9 
`Claim Construction (37 C.F.R. § 42.104(b)(3)) ................................... 9 
`1. 
`“heat-treating the entire shank”/ “entire instrument
`shank” ......................................................................................... 9 
`“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” .............................................................. 10 
`“permanent deformation” ......................................................... 17 
`3. 
`“diameter of 0.5 to 1.6 millimeters” ........................................ 17 
`4. 
`VI.  Effective Filing Date of the Challenged Claims........................................... 17 
`VII.  How the Claims Are Unpatentable Under 37 C.F.R. § 42.104(B) ............... 18 
`A. 
`Level of Skill in the Art ...................................................................... 18 
`B. 
`Ground 1: Obviousness of Claims 1, 4, 5, 9-10, and 12 over
`Endo in View of Tripi and McSpadden ............................................. 19 
`1. 
`Overview of Endo .................................................................... 19 
`2. 
`Overview of Tripi ..................................................................... 20 
`
`2. 
`
`
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`
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`-i-
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`

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`TABLE OF CONTENTS
`(continued)
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`Page
`
`
`
`C. 
`
`3. 
`Overview of McSpadden ......................................................... 20 
`Obviousness of claims 1, 4, 5, 8-10, and 12 ............................ 20 
`4. 
`Ground 2: Obviousness of Claim 8 over Endo in View of Tripi,
`McSpadden, and ISO 3630-1 ............................................................. 25 
`VIII.  Conclusion .................................................................................................... 26 
`
`
`
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`-ii-
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`
`
`Exhibit #
`1101
`
`1102
`
`1103
`
`1104
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`1111
`
`1112
`
`1113
`
`LISTING OF EXHIBITS
`
`
`Exhibit Description
`U.S. Patent No. 8,727,773 B2 (the “’773 patent”)
`
`Prosecution history of U.S. Patent No. 8,062,033
`
`PCT International Application Publication No. WO
`2005/122942 A2 (“2005 PCT application”)
`
`Declaration of A. Jon Goldberg
`
`Harmeet Walia et al., “An Initial Investigation of the Bending
`and Torsional Properties of Nitinol Root Canal Files,” 14 J.
`ENDODONTICS 346 (1988) (“Walia”)
`
`Rejection dated March 15, 2015 in European Patent
`Application No. 05 756 629.1 - 1659
`
`Prosecution history of the ’773 patent
`
`Kazuhiko Endo et al., “Effects of Titanium Nitride Coatings
`on Surface and Corrosion Characteristics of Ni-Ti Alloy,” 13
`DENTAL MATERIALS J. 228 (1994) (“Endo”)
`
`E. Lugscheider et al., “Investigation of the Residual Stress
`and Mechanical Properties of (Cr,Al)N Arc PVD Coatings
`Used for Semi-solid Metal (SSM) Forming Dies,” 420-421
`THIN SOLID FILMS 318 (2002)
`
`Teresa Roberta Tripi et al., “Fabrication of Hard Coatings on
`NiTi Instruments,” 29 J. ENDODONTICS 132 (2003) (“Tripi”)
`
`U.S. Patent App. Pub. No. 2002/0137008 A1, McSpadden et
`al. (“McSpadden”)
`Orsure W. Stokes et al., “Corrosion in Stainless-Steel and
`Nickel-Titanium Files,” 25 J. ENDODONTICS 17 (1999)
`International Standard ISO 3630-1, 1st ed. (1992)
`
`
`
`
`
`
`
`-iii-
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`

`
`
`
`US Endodontics, LLC (“Petitioner”) petitions for Inter Partes Review
`
`(“IPR”) under 35 U.S.C. §§ 311-319 and 37 C.F.R., Part 42, of claims 1, 4, 5, 8-10,
`
`and 12 of U.S. Patent No. 8,727,773 (“the ’773 patent”), filed on April 25, 2012,
`
`issued on May 20, 2014, and currently assigned to Gold Standard Instruments,
`
`LLC (“GSI” or “Patent Owner”). There is a reasonable likelihood that Petitioner
`
`will prevail with respect to at least one claim challenged in this Petition.
`
`I. INTRODUCTORY STATEMENT
`
`This is US Endo’s second petition concerning the ’773 patent. The first
`
`petition—IPR2015-00632 (“the -632 Petition”)—explains that the claims of the
`
`’773 patent are not entitled to claim the benefit of any earlier filing date because, in
`
`their broadest sense,
`
`they cover heat-treating a nickel-titanium (“Ni-Ti”)
`
`endodontic file in any type of atmosphere, either reactive or unreactive with the
`
`Ni-Ti instrument, to achieve “permanent deformation.” IPR2015-00632, Paper 2,
`
`at pp. 16-19. In contrast to the claims of the ’773 patent, the disclosures in all
`
`applications in the claimed priority chain are limited to heat-treating in an
`
`unreactive atmosphere. Id. Every example in the specification of the ’773 patent
`
`(and the priority applications) describes heat-treating at 500°C for 75 minutes in
`
`argon, which Patent Owner acknowledges is unreactive with Ni-Ti. See IPR2015-
`
`00632, Paper 9, at p. 16; see also Ex. 1101 at 4:12-19.
`
`
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`- 1 -
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`

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`
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`Moreover, during prosecution of one of the priority applications, the
`
`inventor distinguished heat-treating the instruments in a reactive atmosphere from
`
`a non-reactive atmosphere in order to overcome a prior art rejection. IPR2015-
`
`00632, Paper 2, at pp. 16-19; Ex. 1102 at pp. 408-14. Specifically, during
`
`prosecution of U.S. App. No. 11/628,933 (“the ’933 app.”), the applicant relied
`
`upon a declaration from David Berzins, who compared files heat-treated in air with
`
`files heat-treated in an unreactive atmosphere according to the Luebke application,
`
`i.e., in argon. See Ex. 1102 at pp. 408-14. Berzins informed the PTO that heat-
`
`treatment in air produced shanks that remained superelastic at both room
`
`temperature and mouth temperature, contrary to the goals of the applicant’s
`
`invention. See id. at pp. 409-410. Berzins further declared that treatment in air,
`
`which is reactive with Ni-Ti, would result in a thick oxide layer that “may affect
`
`the surface integrity of the file as well as its properties and transformations.” Id. at
`
`p. 411.
`
`Citing the Berzins declaration, and distinguishing the prior art, the applicant,
`
`Neill Luebke, argued that “heat-treating the instrument in an atmosphere consisting
`
`essentially of a gas unreactive with the shank … yields a shape memory file;” that
`
`is one that will stay bent (deformed) when subjected to a bending force after the
`
`force is removed. Id. at 406. See, also, id. at 494 (examiner accepting applicant’s
`
`
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`- 2 -
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`
`
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`representation, noting that the temperature range and unreactive atmosphere, were
`
`critical in distinguishing over the prior art).
`
`Because the ’773 patent is not entitled to claim priority to an earlier filing
`
`date, the -632 Petition asserts that the claims of the ’773 patent are unpatentable
`
`over references—including the named inventor’s own prior publication—that were
`
`published between the filing date of the ’773 patent and the filing date of the
`
`earliest application in the claimed priority chain. See IPR2015-00632, Paper 2, at
`
`pp. 21-28.
`
`In its preliminary response to the -632 Petition, the Patent Owner disputes
`
`Petitioner’s priority date position. The Patent Owner asserts that the ’773 patent is
`
`entitled to claim the benefit of a 2005 PCT application because that application
`
`discloses applying a titanium nitride coating to the endodontic instruments by way
`
`of physical vapor deposition (“PVD”). IPR2015-00632, Paper 9, at pp. 16-19.
`
`According to the Patent Owner, this PVD process involves inherent heat-treating in
`
`a reactive atmosphere, and provides support for claims of the ’773 patent. Id.
`
`The Patent Owner’s assertions regarding the 2005 PCT application and its
`
`PVD disclosure lacks merit. As an initial matter, the Patent Owner wrongly asserts
`
`that the 2005 PCT application discloses the atmospheric and temperature
`
`conditions of the “inherent heat-treatment” associated with the PVD coating
`
`process. Patent Owner’s Preliminary Response, IPR2015-00632, Paper 9, at p. 16-
`
`
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`- 3 -
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`

`
`
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`17. The 2005 PCT application contains no such disclosure. Ex. 1103, ¶¶ 35-42,
`
`Figs. 3-7.
`
`The 2005 PCT application (and all other applications in the priority chain)
`
`discloses coating by PVD as a prior art coating process that can be performed
`
`separately from “heat-treating” according to the “inventive” parameters (i.e., heat-
`
`treating in an argon atmosphere at 500°C), in order to produce sharper cutting
`
`edges and improved resistance to heat-degradation. Ex. 1103 at ¶¶ 30-33. The
`
`specification of the 2005 PCT application compares PVD to the “inventive”
`
`process of heat-treating in argon (a non-reactive atmosphere) at 500°C and
`
`concludes that the “inventive” process was superior in terms of attributes such as
`
`flexibility, fatigue life and torsional resistance. Ex. 1103 at ¶¶ 37, 39-41.
`
`There is no disclosure in the 2005 PCT application of applying a coating to a
`
`Ni-Ti endodontic file by PVD at a temperature within the claimed range. Indeed,
`
`there is no disclosure of any of the “inherent heat-treatment” parameters (e.g.,
`
`atmosphere, time or temperature) at which application of a coating by PVD to a
`
`Ni-Ti endodontic file would occur to achieve the claimed result (i.e., permanent
`
`deformation), or even how the PVD coating was applied in the disclosed
`
`examples.
`
`Nonetheless, and to the extent that PVD coated files, as disclosed in the
`
`priority applications, can provide written description support for the broad scope of
`
`
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`- 4 -
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`
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`the claims of the ’773 patent, as Patent Owner asserts, then those claims are
`
`unpatentable over references disclosing the prior art process of coating Ni-Ti
`
`endodontic files by way of PVD. The specific grounds of proposed rejection based
`
`on PVD prior art references are set forth below.
`
`II. MANDATORY NOTICES (37 C.F.R. § 42.8)
`
`A. Real Party-in-Interest
`
`Petitioner US Endodontics, LLC, Edge Endo, LLC, Guidance Endo, LLC,
`
`Charles Goodis, and Bobby Bennett, are the real parties-in-interest.
`
`B. Related Matters
`
`The ’773 patent is currently being asserted against Petitioner by licensee
`
`Dentsply International, Inc. and its wholly-owned subsidiary Tulsa Dental Products
`
`LLC (d/b/a Tulsa Dental Specialties) in pending litigation filed on June 24, 2014 in
`
`the U.S. District Court for the Eastern District of Tennessee, No. 14-CIV-196
`
`(JRG). US Endo has filed a petition for inter partes review of the ’773 patent,
`
`IPR2015-00632, which is pending. Additionally, GSI has patent applications
`
`pending that might be affected by this proceeding: serial nos. 14/522,013,
`
`14/722,309, 14/722,390, and 14/722,840. Petitioner is not aware of any pending
`
`administrative matter that would affect, or be affected by, a decision in this
`
`proceeding.
`
`
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`- 5 -
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`
`
`C. Counsel and Service Information
`
`Lead Counsel:
`
`Jeffrey S. Ginsberg (Reg. No. 36,148)
`
`Back-up Counsel: Matthew G. Berkowitz (Reg. No. 57,215)
`
`
`
`
`
`
`
`Eric T. Schreiber (Reg. No. 58,771)
`
`Electronic Service:
`
`jginsberg@kenyon.com; mberkowitz@kenyon.com; and
`
`eschreiber@kenyon.com
`
`Post and Delivery: Kenyon & Kenyon LLP, One Broadway, New York, NY 10004
`
`Telephone: 212-425-7200
`
`Facsimile: 212-425-5288
`
`D. Power of Attorney
`
`A power of attorney is filed herewith according to 37 C.F.R. § 42.10(b).
`
`III. PAYMENT OF FEES (37 C.F.R. § 42.103)
`
`The required fee of $23,000 is being paid through the Patent Review
`
`Processing System. The USPTO is authorized to charge any fee deficiency, or
`
`credit any overpayment, to Deposit Account 11-0600 (Kenyon & Kenyon LLP).
`
`IV. BACKGROUND AND SUMMARY OF THE ’773 PATENT
`
`The ’773 patent describes a method of modifying a Ni-Ti endodontic
`
`instrument for use in root canal therapy, which involves drilling through the hard
`
`outer portion of a tooth and removing diseased tissue (pulp) from the inside. A thin
`
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`- 6 -
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`
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`file is needed to remove the tissue from the tooth’s root(s). This thin file is the
`
`endodontic instrument to which the ’773 patent pertains. See Ex. 1104 at ¶ 19.
`
`As claimed, the file (or other endodontic instrument) includes a component
`
`made from a superelastic Ni-Ti alloy. The file is subjected to heat treatment at a
`
`temperature of from at least 400°C up to the melting point of the Ni-Ti alloy. As a
`
`result of the heat treatment, the instruments allegedly “exhibit higher resistance to
`
`torsion breakage, can withstand increased strain, have higher flexibility, have
`
`increased fatigue life and maintain any acquired shape upon fracture better.” Ex.
`
`1101 at 9:19-23.
`
`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 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 at ¶ 23.
`
`
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`- 7 -
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`

`
`
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`As is relevant to this petition, the specification of the ’773 patent describes
`
`the results of a flexion test, measuring the angle of permanent deformation after
`
`bending (“ADP”), of 3 different groups of endodontic files: (1) an untreated
`
`control group; (2) a group heat-treated in a furnace in an argon atmosphere at
`
`500°C for 75 minutes and then slowly cooled; and (3) a group coated with titanium
`
`nitride using PVD with an inherent heat-treatment. Ex. 1101 at 8:34-59. The
`
`specification does not disclose the “inherent heat-treatment” parameters of the
`
`PVD process that was applied to the group of coated files; for example there is no
`
`disclosure of the temperature at which the titanium-nitride coating was applied by
`
`PVD. The specification does explain that the “ten files that were heat-treated in a
`
`furnace in an argon atmosphere at 500°C. for 75 minutes showed the highest ADP
`
`of the 3 groups tested. Thus, the heat-treated files maintain the acquired (test
`
`deformed) shape rather than the shape memory exhibited in the untreated control
`
`(nickel-titanium instruments).” Ex. 1101 at 8:54-59.
`
`V. REQUIREMENTS FOR INTER PARTES REVIEW (37 C.F.R. § 42.104)
`
`A. Grounds for Standing (37 C.F.R. § 42.104(b)(1))
`
`Petitioner certifies that the ’773 patent is available for IPR. This Petition has
`
`been filed within one year after the date on which US Endo was served with a
`
`complaint alleging infringement of the ’773 patent. No real parties-in-interest or
`
`
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`- 8 -
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`
`
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`privies of Petitioner were served with any such complaint. Petitioner is not barred
`
`or estopped from requesting IPR.
`
`B. Identification of Challenged Claims and Specific Statutory Ground (37
`C.F.R. § 42.104(b)(1)-(2))
`
`Petitioner challenges claims 1, 4, 5, 8-10, and 12 of the ’773 patent (“the
`
`Challenged Claims”) under 35 U.S.C. §103, as set forth below. Cancellation of
`
`these claims is requested. Petitioner requests that claims 1, 4, 5, 8-10, and 12 be
`
`cancelled on the following ground:
`
`Ground 1: Obviousness Under 35 U.S.C. § 103 of Claims 1, 4, 5, 9-10, and 12
`
`Over Endo in View of Tripi, and in Further View of McSpadden
`
`Ground 2: Obviousness Under 35 U.S.C. § 103 of Claim 8 Over Endo in View of
`
`Tripi and in Further View of McSpadden and ISO 3630-1
`
`C. Claim Construction (37 C.F.R. § 42.104(b)(3))
`
`A claim subject to IPR is given its “broadest reasonable construction in light
`
`of the specification of the patent in which it appears.” 37 C.F.R. § 42.100(b).
`
`Petitioner submits, for the purposes of this IPR petition only, the following claim
`
`constructions.
`
`1. “heat-treating the entire shank”/ “entire instrument shank”
`
`This limitation appears in each of the two independent claims, 1 and 13. In
`
`the concurrent district court litigation, Petitioner has asserted that this limitation
`
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`- 9 -
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`
`
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`should be construed to require “heat-treating the entire shank/entire instrument
`
`shank in an atmosphere consisting essentially of a gas unreactive with nickel
`
`titanium” since, among other reasons, the patent text uniformly states that the
`
`atmosphere is one that consists essentially of a gas does not react with the shank
`
`component of the instrument. See Ex. 1101 at Abstract, 2:62-65, 4:12-15, 4:17-20,
`
`7:40-43, 7:67-8:2, 8:20-21, 8:47-49, 9:6-9. In IPR2015-00632, Petitioner stated
`
`that the broadest reasonable interpretation of this limitation does not require a
`
`particular atmosphere for heat treatment. Patent Owner agreed. Petitioner takes
`
`the same position in this Petition in light of the applicability of the broadest
`
`reasonable interpretation standard in IPR proceedings.
`
`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”
`
`The “wherein” clause appears in independent claims 1 and 13. As Petitioner
`
`explained in the -632 Petition, for the purpose of patentability under 35 U.S.C.
`
`§§ 102 and 103, this clause should not be considered a limitation because it only
`
`states the intended result of performing the claimed heat treatment process.
`
`A clause in a method claim adds no patentable weight to the claim if it
`
`merely states the intended result of a positively recited method step. See Minton v.
`
`Nat’l Assoc. of Sec. Dealers, 336 F.3d 1373, 1381 (Fed. Cir. 2003); Baxter
`
`Healthcare Corp. v. Millennium Biologix, LLC, IPR2013-00590, Paper 9, at pp. 8-
`
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`- 10 -
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`

`
`
`
`9 (PTAB Mar. 21, 2014) (finding “wherein” clause not limiting insofar as it
`
`described intended result); M.P.E.P. § 2111.04.
`
`The “wherein” clause at issue merely states the intended result of heat
`
`treating the instrument: It describes a property of “the heat treated shank,” i.e., the
`
`shank after it has undergone step (b). There are no further steps to be performed on
`
`or with the heat-treated shank. Rather, the claims merely state that if a particular
`
`test is performed on the shank after the claimed method is performed, a certain
`
`range of results will be achieved. The “wherein” clause does not alter the first two
`
`steps or require the performance of any additional step(s). It is just the intended
`
`result.
`
`Step (a) of the claims involves the provision of a known instrument, and step
`
`(b) involves the application of a ubiquitous metallurgical technique to that
`
`instrument. The “wherein” clause merely recites the result of a known or obvious
`
`process—and this is not patentable. See Bristol Myers-Squibb Co. v. Ben Venue
`
`Labs., 246 F.3d 1368, 1375-77 (Fed. Cir. 2001); accord King Pharms. v. Eon Labs,
`
`616 F.3d 1267, 1274-76 (Fed. Cir. 2010). In fact, the substance of the result was
`
`already known, and the inventor merely selected an unorthodox way of measuring
`
`it. Neither the intended result nor the particular method of measuring it should be
`
`treated as a limitation of the claimed method.
`
`Petitioner’s position is consistent with the European Patent Office’s
`
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`- 11 -
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`
`
`
`conclusion set forth in its rejection of Patent Owner’s foreign counterpart
`
`application: “In the previous communication under point 5.3, the examining
`
`division objected to claim 11 as being merely directed to a result being achieved.
`
`. . . [C]laim 1, which [recites ‘characterized … in that the 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’], still refers to a result to be
`
`achieved.” Ex. 1106 at p. 4 (emphasis in original).
`
`Petitioner’s position is also consistent with the examiner’s apparent
`
`understanding of this clause during prosecution of the application leading to the
`
`’773 patent. Original claim 1 included a shank made of a “titanium alloy,” not
`
`limited to nickel-titanium, and a “wherein” clause similar to that in the issued
`
`claims, requiring the heat-treated shank to have “an angle greater than 10 degrees
`
`of permanent deformation after torque at 45 degrees of flexion.” Ex. 1107 at p. 16.
`
`The examiner rejected the claim, and its dependent claims, for lack of enablement
`
`because “not all titanium alloys subjected to this treatment would result in that
`
`degree of deformation” and “[t]he dependent claims do not provide further steps
`
`that would always result in this degree of permanent deformation.” Id. at p. 73
`
`(emphasis supplied). In response, the applicant amended the claim to recite a
`
`nickel and titanium alloy in a particular ratio, id. at p. 100, without asserting any
`
`error in the examiner’s reasoning. See id. at p. 103. Thereafter, the examiner
`
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`- 12 -
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`
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`withdrew the enablement rejection. See id. at pp. 125-31. When he eventually
`
`allowed the claims (after further prosecution), the examiner reasoned that “while a
`
`titanium alloy will not always result in the above [claimed] properties, a shape
`
`memory nickel titanium alloy will result from the claimed method distinguished
`
`from the superelastic properties of the prior art.” Id. at pp. 227-28 (emphasis
`
`supplied). In other words, the examiner did not treat the “wherein” clause as a
`
`limitation on the method, but as a stated goal of the positively recited steps. The
`
`examiner evidently believed that the method steps were sufficient to produce a
`
`shape-memory alloy without superelasticity, which in turn would meet the
`
`“wherein” clause of claim 1.
`
`In another rejection, the examiner explicitly rebutted arguments based on the
`
`flexion test in the “wherein clause”:
`
`Applicant argues with respect to the flexion test and Patel having a
`final superelastic property. First, it is noted that the claims do not
`currently recite the flexion test actually being performed as part of the
`method. The test is only referred to inferentially to establish physical
`properties of the shank, so the prior art references do not currently
`need to show the conducting of this test (however, Heath has been
`included to show this being a standard test to make the rejection more
`complete). Secondly, the test is referred to as being conducted on the
`heat treated shank, which Patel’s wire after annealing (heat treatment)
`would have the same properties as the claimed invention (same
`material/manufacture steps). It is only after Patel’s wire is cold
`- 13 -
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`

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`
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`worked that it returns to the superelastic state. The flexion test is
`currently claimed specific to the heat treated shank rather than a cold
`worked shank.
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`Ex. 1107 at p. 129 (underline emphasis supplied). Thus, in addition to noting that
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`the prior art need not show the flexion test, the examiner concluded that because
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`the prior art showed the “same material/manufacture steps” as the claimed
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`invention, it also “would have the same properties.” Id. Following this rejection,
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`the applicant requested an interview with the examiner, agreeing with the
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`examiner’s reasoning that the flexion test “is only referred to inferentially” but
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`disagreeing with his conclusion that Patel’s heat-treated wire would have the same
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`properties. See id. at p. 145. The applicant submitted sixteen pages of notes
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`distinguishing Patel (U.S. Pat. App. Pub. No. 2005/0090844) as “evidence that the
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`Patel device is superelastic and that the subject matter of claim 1 does not have this
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`property.” See id. at pp. 145-60. The applicant, Neill Luebke, argued that, unlike
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`the prior art, the instrument resulting from his method had a high enough
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`transformation temperature that, during clinical use at body temperature (37°C),
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`the instrument would be in the martensitic phase. See id.
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`Following the interview, the examiner expressed his understanding of the
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`applicant’s invention to be heat treatment of a superelastic instrument that results
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`in “non-superelastic properties that allows for some degree of permanent
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`deformation,” in contrast to the prior art in which heat treatment was used “to
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`arrive at a superelastic device.” Id. at p. 163. Despite the fact that the pending
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`claim
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`included a “wherein” clause
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`requiring post-treatment permanent
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`deformation, the examiner suggested that the applicant amend the claim to
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`distinguish the prior art. Id. In other words, the examiner declined to give any
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`weight to the “wherein” clause; if he had considered the “wherein” clause to be a
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`limitation, then the applicant’s argument that Patel did not disclose a permanently
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`deformable device (which the Examiner accepted) would have itself been enough.
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`Instead, and in response to the examiner’s suggestion, the applicant amended the
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`claim to add the requirement that the starting material, prior to the heat-treatment
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`step, be a “superelastic nickel titanium alloy.” Id. at pp. 168-70.
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`In sum, the “wherein” clause describes the intended result; it does not alter
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`the method itself in any way. It therefore does not confer patentable weight and is
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`not limiting for the purpose of determining patentability over the prior art.1
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`1
`Petitioner notes that in Griffin v. Bertina, 285 F.3d 1029, 1032-34 (Fed. Cir.
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`2002), “wherein” clauses in an interference count were held to be limiting because
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`they gave “meaning and purpose to the manipulative steps.” There, the issue was
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`whether a party had shown reduction to practice, which “does not occur until the
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`inventor has determined that the invention will work for its intended purpose.” Id.
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`(citation omitted). Furthermore, the claims in Griffin included the step of
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`“assaying for the presence of a point mutation,” and the “wherein” clauses at issue
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`In the -632 Petition, Petitioner explained that, if the Board disagrees with
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`Petitioner’s position that the “wherein” clauses at issue are not limiting, the Board
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`should nevertheless find that the prior art sufficiently satisfies those limitations if it
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`discloses a method of making a heat-treated instrument that “allows for some
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`degree of permanent deformation” (to quote the examiner’s understanding of the
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`invention). IPR2015-00632, Paper 2, at pp. 12-13. Petitioner further explained
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`that, if the Board finds that the “wherein” phrase is limiting, it should also find that
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`it is met by the prior art disclosure of a heat-treated file with an austenite finish
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`temperature (or transition temperature) of 37°C or greater. Id. at pp. 13-14.
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`Petitioner stands by both of those positions.
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`
`
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`described the properties of the “point mutation” that was to be “assay[ed] for.” See
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`id. at 1031. The “wherein” clauses did not describe an intended result of the
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`“assaying” step but rather provided information as to how that step must be
`
`performed—in particular, what kind of “point mutation” to test for.
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`By contrast, the “wherein” clauses in the ’773 patent merely state the
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`intended result of the “heat-treating” step, which cannot patentably distinguish the
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`claims over the prior art, even if stated in the claims themselves. See Minton, 336
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`F.3d at 1381.
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`3. “permanent deformation”
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`Claims 1 and 13 recite this term within the “wherein” clause discussed
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`above. If the Board concludes that the “wherein” clause is a limitation, Petitioner
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`submits that “permanent deformation” means “deformation remaining after force is
`
`removed.” Permanent deformation need not be “permanent” in the sense that the
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`instrument never returns to its original shape. See, e.g., Ex. 1107 at p. 110
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`(applicant explaining that “martensitic Ni-Ti” exhibited permanent deformation).
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`Martensitic Ni-Ti will stay deformed when bent. See Ex. 1104 at ¶ 26; supra
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`section IV.
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`4. “diameter of 0.5 to 1.6 millimeters”
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`Claim 8 recites that “the instrument shank has a diameter of 0.5 to 1.6
`
`millimeters.” The diameters of tapered endodontic files are usually measured at the
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`tip, but the specification makes clear that claim 8 refers to the proximate end, i.e.,
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`the end that is connected to the handle. Ex. 1101 at 4:1-6; Fig. 1a. Therefore,
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`Petitioner submits that this term means “diameter of 0.5 to 1.6 millimeters at the
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`proximate end.”
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`VI. EFFECTIVE FILING DATE OF THE CHALLENGED CLAIMS
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`In the -632 Petition, Petitioner argued that the claims should not be entitled
`
`to a priority date earlier than April 25, 2012 (the filing date of the ’773 patent), for
`
`several reasons. Petitioner stands by those arguments; however, the references
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`relied upon in this Petition are prior art to the ’773 patent regardless of the
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`Challenged Claims’ effective filing date, since the prior art references were
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`published more than one year before June 8, 2004, the earliest priority date claimed
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`on the face of the ’773 patent.2
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`VII. HOW THE CLAIMS ARE UNPATENTABLE UNDER 37 C.F.R. § 42.104(B)
`
`A. Level of Skill in the Art
`
`A person of ordinary skill in the art at the time the invention was made
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`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 nickel titanium alloy materials used in dental applications, or (ii) a
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`Ph.D. or equivalent degree in materials science, metallurgy, or a related field and at
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`least one year of experience so as to understand the structural, chemical, and
`
`mechanical properties that can be manipulated in nickel titanium alloy materials
`
`used in dental applications. Ex. 1104 at ¶ 28. This level of education and
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`
`2
`Patent Owner concedes that the claims are not entitled to the 2004 priority
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`date and instead asserts that the correct priority date is June 7, 2005. IPR2015-
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`00632, Paper 9, at p. 15.
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`experience applies whether the invention is deemed to have been made in 2004,
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`2012, or any time in between. Id.
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`B. Ground 1: Obviousness of Claims 1, 4, 5, 9-10, and 12 over Endo in
`View of Tripi and McSpadden
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`Endo published in 1994, Tripi published in February 2003, and McSpadden
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`published in 2002. All three references are prior art under § 102(b) (pre-AIA) even
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`if the claims are determined to be entitled to a priority date of June 8, 2004, the
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`earliest priority date claimed by the ’773 patent. In view of these references, claims
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`1, 4, 5, 8-10, and 12 would have been obvious under 35 U.S.C. §103.
`
`1. Overview of Endo
`