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 No. PGR2015-00019
`U.S. Patent No. 8,876,991 B2
`____________________
`
`
`PETITION FOR POST-GRANT 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
`
`

`
`TABLE OF CONTENTS
`
`
`Page
`
`
`I. 
`
`Mandatory Notices (37 C.F.R. § 42.8) ........................................................... 1 
`A. 
`Real Parties-in-Interest ......................................................................... 1 
`B. 
`Related Matters ..................................................................................... 1 
`C. 
`Counsel and Service Information ......................................................... 2 
`D. 
`Power of Attorney ................................................................................ 2 
`Payment of Fees (37 C.F.R. § 42.203) ........................................................... 2 
`II. 
`Summary of Reasons Why the Challenged Claims Are Unpatentable ......... 2 
`III. 
`IV.  Background and Summary of the ’991 Patent ................................................ 4 
`V. 
`Prosecution of the ’991 Patent ........................................................................ 6 
`VI.  Requirements for Post-Grant Review (37 C.F.R. § 42.204) ........................ 11 
`A.  Grounds for Standing (37 C.F.R. § 42.204(a)) .................................. 11 
`B. 
`Identification of Challenged Claims and Specific Statutory
`Grounds (37 C.F.R. § 42.204(b)(1)-(2)) ............................................ 11 
`Claim Construction (37 C.F.R. § 42.204(b)(3)) ................................. 13 
`1. 
`“heat-treating the entire shank” ............................................... 14 
`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” ..................................................................... 15 
`“permanent deformation” ......................................................... 21 
`3. 
`“diameter of 0.5 to 1.6 millimeters” ........................................ 22 
`4. 
`VII.  Effective Filing Date of the Challenged Claims and Eligibility for
`Post-Grant Review ........................................................................................ 22 
`A. 
`Prior Applications in the ’991 Patent Priority Chain Do Not
`Support Heat-Treating a Shank at the Claimed Temperature
`Range of 300°C to the Melting Point of the Alloy ............................ 23 
`Prior Applications in the ’991 Patent Priority Chain Do Not
`Support Heat-Treating a Shank at the Claimed Temperature
`Ranges to Produce the Recited Permanent Deformation ................... 24 
`
`C. 
`
`B. 
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`-i-
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`TABLE OF CONTENTS
`(continued)
`
`Page
`
`
`
`C. 
`
`D. 
`
`C. 
`
`Applications in the ’991 Patent Family Filed Prior to April 25,
`2012 Do Not Support Heat Treatment in a Reactive
`Atmosphere ........................................................................................ 27 
`Prior Applications in the ’991 Patent Priority Chain Do Not
`Satisfy the Written Description or Enablement Requirements of
`Section 112 for the Same Reasons as the ’991 Patent Itself .............. 31 
`VIII.  How the Claims Are Unpatentable Under 37 C.F.R. § 42.204(b) ............... 32 
`A. 
`Level of Skill in the Art ...................................................................... 32 
`B. 
`Ground 1: Lack of Enablement of Claims 12-16 Under § 112(a) ..... 33 
`1. 
`Legal Standard for Enablement ............................................... 33 
`2. 
`Lack of Enablement of the Challenged Claims ....................... 34 
`Ground 2: Lack of Written Description of Claims 12-16 Under
`§ 112(a) ............................................................................................... 45 
`1. 
`Legal Standard for Written Description ................................... 45 
`2. 
`Lack of Adequate Written Description for the Challenged
`Claims ...................................................................................... 46 
`D.  Ground 3: Anticipation of Claims 12-16 by Luebke 2008 ................ 48 
`E. 
`Ground 4: Obviousness of Claim 15 Over Luebke 2008 Either
`Alone or in View of Heath or ISO 3630-1 ......................................... 52 
`Ground 5: Anticipation of Claims 12-16 by Matsutani .................... 53 
`1. 
`Overview of Matsutani ............................................................ 54 
`2. 
`Anticipation of Claims 12-16 by Matsutani ............................ 54 
`G.  Ground 6: Anticipation of Claims 12-14 and 16 by Kuhn ................. 59 
`1. 
`Overview of Kuhn .................................................................... 59 
`2. 
`Anticipation of Claims 12-14, and 16 ...................................... 59 
`H.  Ground 7: Obviousness of Claim 15 Over Kuhn Either Alone or
`in View of Heath or ISO 3630-1 ........................................................ 63 
`Ground 8: Obviousness of Claims 12-16 over Kuhn Either
`Alone or in View of Heath or ISO 3630-1 ......................................... 64 
`
`F. 
`
`I. 
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`-ii-
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`TABLE OF CONTENTS
`(continued)
`
`Page
`
`
`
`J. 
`
`Ground 9: Obviousness of Claims 12-14 and 16 Over
`McSpadden and Pelton in View of Kuhn ........................................... 65 
`1. 
`Overview of Pelton .................................................................. 65 
`2. 
`Overview of McSpadden ......................................................... 66 
`3. 
`Obviousness of Claims 12-14 and 16 ...................................... 66 
`K.  Ground 10: Obviousness of Claim 15 Over McSpadden and
`Pelton in View of Kuhn and in Further View of Heath or ISO
`3630-1 ................................................................................................. 72 
`Ground 11: Obviousness of Claims 12-14 and 16 Over Tripi in
`View of McSpadden ........................................................................... 73 
`1. 
`Overview of Tripi ..................................................................... 73 
`2. 
`Obviousness of Claims 12-14 and 16 ...................................... 74 
`M.  Ground 12: Obviousness of Claim 15 Over Tripi in View of
`McSpadden and in Further View of Heath or ISO 3630-1 ................ 77 
`IX.  The Grounds in the Petition are Not Redundant .......................................... 77 
`X. 
`Conclusion .................................................................................................... 80 
`
`
`L. 
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`-iii-
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`

`
`LISTING OF EXHIBITS
`
`Exhibit Description
`U.S. Patent No. 8,876,991
`
`Declaration of A. Jon Goldberg
`
`Prosecution history of U.S. Patent No. 8,876,991
`Fujio Miura et al., The super-elastic property of the Japanese NiTi
`alloy wire for use in orthodontics, 90 AM. J. ORTHODONTICS &
`DENTOFACIAL ORTHOPEDICS 1 (1986)
`
`Satish B. Alapati, “An investigation of phase transformation
`mechanisms for nickel-titanium rotary endodontic instruments,” PhD
`thesis, 2006
`Alan R. Pelton et al., Optimisation of Processing and Properties of
`Medical-Grade Nitinol Wire, MINIMALLY INVASIVE THERAPIES &
`ALLIED TECHS. 107 (2000)
`
`U.S. Patent No. 5,697,906 to Ariola et al.
`
`Prosecution history of U.S. Patent No. 8,727,773
`
`Prosecution history of U.S. Patent No. 8,083,873
`
`Prosecution history of U.S. Patent No. 8,062,033
`
`U.S. Patent No. 8,727,773
`
`Prosecution history of European Patent Application No. 05756629.1
`Transcript of Motion Hearing, Nov. 25, 2014, Dentsply International,
`Inc. v. US Endodontics, LLC, Docket No. CV-2-14-196 (E.D. Tenn.)
`(excerpts)
`International Standard ISO 3630-1, 2nd ed. (2008)
`Declaration of Walter Zanes
`
`
`Exhibit #
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`
`
`
`
`-iv-
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`

`
`
`Exhibit #
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`LISTING OF EXHIBITS
`(continued)
`
`Exhibit Description
`Edgar Schäfer et al., Bending Properties of Rotary Nickel-Titanium
`Instruments, 96 ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY
`757 (2003)
`Luca Testarelli et al., Bending Properties of a New Nickel-Titanium
`Alloy with a Lower Percent by Weight of Nickel, 37 J. ENDODONTICS
`1293 (2011)
`
`Declaration of Adam Kozak
`Excerpts of Expert Report of Robert Sinclair, Ph.D., Dentsply
`International, Inc. v. US Endodontics, LLC, Docket No. CV-2-14-196
`(E.D. Tenn.)
`Alan R. Pelton et al., The Physical Metallurgy of Nitinol for Medical
`Applications, 55 J. METALS 33-37 (May 2003)
`S. Miyazaki et al., Characteristics of Deformation and Transformation
`Pseudoelasticity in Ti-Ti Alloys, 43 J. PHYSIQUE COLLOQUES C4-255
`(1982)
`
`U.S. Patent App. Pub. No. 2008/0032260 A1 to Luebke
`
`International Standard ISO 3630-1, 1st ed. (1992)
`
`U.S. Patent No. 5,628,674 to Heath et al.
`
`U.S. Patent Application Publication No. US 2006/0115786 A1 to
`Matsutani et al.
`
`Japanese Unexamined Patent Application Publication Number
`2006-149675 to Matsutani et al.
`
`English translation of Japanese Unexamined Patent Application
`Publication Number 2006-149675 to Matsutani et al.
`
`Transmittal from prosecution history of U.S. Patent Application Serial
`No. 11/287,771, enclosing Japanese Patent Application No. 2004-
`344717 to Matsutani et al.
`
`
`
`
`
`-v-
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`

`
`
`Exhibit #
`1029
`
`1030
`
`LISTING OF EXHIBITS
`(continued)
`
`Exhibit Description
`Transmittal from prosecution history of U.S. Patent Application Serial
`No. 11/287,771, with English translation of enclosed Japanese Patent
`Application No. 2004-344717 to Matsutani et al.
`Grégoire Kuhn & Laurence Jordan, Fatigue and Mechanical
`Properties of Nickel-Titanium Endodontic Instruments, 28 J.
`ENDODONTICS 716 (2002)
`
`1031
`
`U.S. Patent App. Pub. No. 2002/0137008 A1, McSpadden et al.
`
`1032
`
`1033
`
`Teresa Roberta Tripi et al., “Fabrication of Hard Coatings on NiTi
`Instruments,” 29 J. ENDODONTICS 132 (2003)
`Harmeet Walia et al., An Initial Investigation of the Bending and
`Torsional Properties of Nitinol Root Canal Files, 14 J. ENDODONTICS
`346 (1988)
`1034 M. G. A. Bahia, Fatigue Behaviour of Nickel–Titanium Superelastic
`Wires and Endodontic Instruments, FATIGUE & FRACTURE OF ENG’G
`MATS. & STRUCTURES 29, 518–523 (2006)
`
`1035
`
`Printout of the webpage:
`http://www.tulsadentalspecialties.com/default/endodontics/RotaryFiles
`/ProFileISO.aspx, accessed on July 22, 2015, and Safety Data Sheet
`for Nickel Titanium Wire: NITINOL 55, linked on that webpage.
`1036 Masao J. Drexel et al., The Effects of Cold Work and Heat Treatment
`on the Properties of Nitinol Wire, Proc. Int’l Conference on Shape
`Memory & Superelastic Techs., SMST-2006, pp. 447-454 (2008)
`
`1037
`
`Prosecution history of U.S. Patent No. 8,562,341
`
`1038 W.A. Brantley et al., Differential Scanning Calorimetric Studies of
`Nickel Titanium Rotary Endodontic Instruments, 28 J. ENDODONTICS
`567 (2002)
`
`-vi-
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`

`
`LISTING OF EXHIBITS
`(continued)
`
`Prosecution history exhibits are cited in this Petition using page numbers
`
`
`
`added by Petitioner. Other exhibits are cited by their original page or paragraph
`
`numbers.
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`-vii-
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`
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`US Endodontics, LLC (“Petitioner”) petitions for post-grant review (“PGR”)
`
`under 35 U.S.C. §§ 321-329 and 37 C.F.R., Part 42, of claims 12-16 of U.S. Patent
`
`No. 8,876,991 (“the ’991 patent”). The ’991 patent issued on November 4, 2014
`
`from U.S. Patent Application No. 14/167,311, filed on January 29, 2014, and is
`
`currently assigned to Gold Standard Instruments, LLC (“Patent Owner”).
`
`I. MANDATORY NOTICES (37 C.F.R. § 42.8)
`
`A. Real Parties-in-Interest
`
`Petitioner US Endodontics, LLC; Petitioner’s two owners, Charles Goodis
`
`and Bobby Bennett; and Edge Endo, LLC and Guidance Endodontics, LLC, both
`
`owned by Charles Goodis, are the real parties-in-interest.
`
`B. Related Matters
`
`Petitioner has filed two petitions for inter partes review of related U.S.
`
`Patent No. 8,727,773 (“the ’773 patent”). See IPR2015-00632 and IPR2015-01476.
`
`The ’773 patent and related U.S. Patent No. 8,562,341 are currently being asserted
`
`against Petitioner by Patent Owner’s licensee Dentsply International, Inc. and
`
`Tulsa Dental Products LLC 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).
`
`Additionally, Patent Owner has patent applications pending that might be affected
`
`by this proceeding: Ser. Nos. 14/522,013, 14/722,309, 14/722,390, and 14/722,840.
`
`Petitioner is not aware of any other pending administrative matter or litigation that
`
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`- 1 -
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`
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`would affect, or be affected by, a decision in this proceeding.
`
`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).
`
`II.
`
`PAYMENT OF FEES (37 C.F.R. § 42.203)
`
`The required fee of $30,000 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).
`
`III. SUMMARY OF REASONS WHY THE CHALLENGED CLAIMS ARE
`UNPATENTABLE
`
`
`
`Issuance of the ’991 patent was a mistake; it appears that the examiner
`
`reviewed the wrong claim set when issuing the Notice of Allowance and
`
`erroneously believed that the claims were limited to heat-treating a nickel titanium
`
`(“Ni-Ti”) endodontic instrument at above 400°C. The applicant was actually
`
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`- 2 -
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`
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`claiming a much broader temperature range (as low as 25°C), which is not enabled,
`
`lacks written description and is otherwise unpatentable as anticipated by and
`
`obvious over the prior art.
`
`The specification of the ’991 patent is directed generally to “heat-treating” a
`
`Ni-Ti endodontic file (used for root canal procedures) to alter its physical
`
`properties. The specification states that certain heat-treating conditions will remove
`
`superelasticity from the file and make it permanently deformable (i.e., after heat-
`
`treating, a sufficient stress applied to the file will cause it to bend and retain the
`
`bent shape after the stress is removed, whereas a superelastic file will return to its
`
`original shape). Each of the examples in the ’991 patent describes heat-treating at
`
`500°C. The claims of the ’991 patent, however, recite a method of heat-treating at
`
`temperatures as low as 25°C—essentially room temperature—in order to obtain
`
`permanent deformation. The specification does not describe or enable how to
`
`change the physical properties of nickel titanium by “heat-treating” at room
`
`temperature.
`
`The examiner initially recognized this, rejecting the claims for, inter alia,
`
`lack of enablement, stating that “not all superelastic nickel titanium alloys
`
`subjected to a heat treatment at these low of temperatures would appear to result in
`
`that degree of deformation.” Ex. 1003 at 82-83. After a response from the applicant
`
`in which the claims were not amended, the examiner issued a Notice of Allowance,
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`- 3 -
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`

`
`
`
`stating that “[a] method of . . . heat-treating the entire instrument or device at 400
`
`C or above . . . was neither taught nor suggested by the prior art as a whole.” Id. at
`
`153 (emphasis added). In other words, the examiner allowed the claims based on
`
`the mistaken understanding that they required heat-treating at 400°C or above, and
`
`not the 25°C (or 300ºC) actually claimed.
`
` As set forth below, claims 12-16 of the ’991 patent are invalid under 35
`
`U.S.C. § 112; heat-treating at from “above 25°C,” which is recited as a lower
`
`bound in claims 12-13 and 15-16, or “from 300°C,” which is recited as a lower
`
`bound in claim 14, to obtain permanent deformation is neither enabled nor
`
`operable. Further, there is no disclosure of heat-treating at as low as 25°C (or
`
`300°C) to obtain permanent deformation in the chain of priority applications.
`
`Accordingly, the claims are not entitled to an effective filing date earlier than the
`
`’991 patent’s January 29, 2014 filing date and are invalid over the prior art,
`
`including applicant’s own prior published patent application. Even if entitled to an
`
`earlier effective filing date, the claims are invalid as anticipated by and obvious
`
`over prior art disclosing heat-treating of nickel titanium within the claimed range.
`
`The specific bases of invalidity are set forth in further detail below.
`
`IV. BACKGROUND AND SUMMARY OF THE ’991 PATENT
`
`The ’991 patent describes a method of modifying a Ni-Ti endodontic
`
`instrument for use in root canal therapy. A thin file is used to remove diseased
`
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`- 4 -
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`
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`tissue from a tooth’s root(s). As described, the instrument includes a shank,
`
`comprised of a Ni-Ti alloy, and a handle. The shank includes cutting edge(s)
`
`necessary to remove tissue from the root canal. Ex. 1001 at 3:6-10, 4:3-8, Fig. 1a.
`
`When appropriately processed, Ni-Ti can exhibit both superelasticity (also
`
`known as pseudoelasticity) and shape memory. Ex. 1002 ¶ 23. Superelasticity
`
`means that the material is relatively rigid until a threshold stress is applied, above
`
`which the material becomes more flexible. Id. When the stress is removed, the
`
`material reverts to its original shape. Id. A shape memory material is flexible and
`
`does not revert to its original shape immediately after it is deformed. Id. However,
`
`when the material is heated past a transformation temperature, it reverts to its pre-
`
`deformation shape. Id.
`
`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. Id. ¶ 26. In the austenite phase, the material is rigid,
`
`whereas in the martensite phase, the material is more flexible. Id. The
`
`transformation between austenite and martensite depends principally on
`
`temperature. Martensite occurs at lower temperatures. Id.; see Ex. 1004 at 5-6; Ex.
`
`1005 at 25.
`
`When Ni-Ti is in the martensite phase, it exhibits shape memory; when
`
`subjected to a bending force it will stay deformed (bent), returning to its original
`
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`- 5 -
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`
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`shape when heated above a transformation temperature (austenite finish (Af)
`
`temperature) to form austenite. Ex. 1002 ¶¶ 27-28. When ambient temperatures are
`
`higher than the transformation temperature, Ni-Ti is stable as austenite rather than
`
`martensite. Id. ¶ 29. However, a sufficient applied stress may transform the
`
`austenite phase into a more flexible but meta-stable martensite phase, allowing
`
`considerably more deformation. Id. When the stress is released, Ni-Ti reverts to the
`
`austenite phase, returning the object to its previous shape: This is superelasticity.
`
`Id.; see also Ex. 1004 at 5-6; see Ex. 1005 at 25.
`
`By 2004, it was well known that heat treatment of a Ni-Ti alloy could
`
`change its transformation temperature. Ex. 1002 ¶ 30; see, e.g., Ex. 1006 at 112-
`
`15; Ex. 1007 at 3:12-30. The alleged invention of the ’991 patent is to increase the
`
`transformation temperature so that a Ni-Ti endodontic file, under conditions of use
`
`(i.e., at mouth temperature), is in the martensite phase rather than the austenite
`
`phase so that the file can be permanently deformed when subjected to bending
`
`forces. See, e.g., Ex. 1003 at 129; see also Ex. 1008 at 144-60; Ex. 1002 ¶¶ 31-34.
`
`V.
`
`PROSECUTION OF THE ’991 PATENT
`
`U.S. Patent Application No. 14/167,311 (“the ’311 application”) was filed
`
`by applicant Neill Luebke on January 29, 2014. The application claims are
`
`identical to the claims that ultimately issued with the ’991 patent.
`
`On April 11, 2014, the examiner issued an office action rejecting all claims
`
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`- 6 -
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`
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`of the ’311 application for lack of enablement. Ex. 1003 at 82-84. The claims
`
`recited subjecting a superelastic, Ni-Ti dental (or endodontic) instrument to heat
`
`treatment at a temperature range of from either 25°C or 300°C up to the melting
`
`point of Ni-Ti, with the result that the heat-treated instrument would have “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” (or substantially
`
`identical language). See id. at 23-25. The examiner’s rejection reasoned that “not
`
`all superelastic nickel titanium alloys subjected to a heat treatment at these low of
`
`temperatures would appear to result in that degree of deformation.” Id. at 82-83.
`
`The examiner “further noted that 25 C is less than the temperature of the mouth” so
`
`that the claimed method would “be broad enough to encompass placing a
`
`superelastic nickel titanium archwire in a patient’s mouth.” Id. at 83-84.
`
`The examiner’s rejection also relied on the applicant’s own arguments
`
`during prosecution of an earlier related application, Ser. No. 12/977,625 (“the ’625
`
`application”), wherein the applicant asserted that the temperature range he was
`
`now trying to claim was ineffective for creating a permanently deformable file.
`
`Specifically, the examiner noted that during prosecution of the ’625 application,
`
`the applicant sought to traverse a prior art rejection over a reference disclosing heat
`
`treatment at 350°C based on “the criticality of the temperature being over 400 C.”
`
`Ex. 1003 at 83. The examiner quoted the applicant’s prior arguments, which
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`
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`referenced an inventor declaration submitted therewith (“the 2008 declaration”):
`
`The Inventor’s Declaration explains that the angular deflection was
`significantly larger for the files heat-treated at 500°C, that the cyclic
`fatigue data demonstrate the remarkable property of passive flexibility
`in the files heat-treated at 500°C compared to the files heat-treated at
`375°C, that the torque data indicates that the heat did not degrade the
`metal in the files heat-treated at 500°C, and that the bend test data
`shows that the files heat-treated at 500°C have improved flexibility
`compared to the files heat-treated at 375°C. This, heat treatment
`within the claimed range was critical to improving the beneficial
`properties of the endodontic instruments.
`
`Id. (quoting the 8/26/2011 amendment in the ’625 application) (emphasis added);
`
`see also Ex. 1010 at 105-06 (applicant making same argument during prosecution
`
`of an earlier priority application).
`
`The examiner noted that, “[i]t is unclear how these temperatures [in the ’311
`
`application] are now sufficient when they had previously been established outside
`
`the critical range.” Ex. 1003 at 83.
`
`On July 9, 2014, applicant submitted a response to the outstanding office
`
`action in the ’311 application, which included a new declaration (“the 2014
`
`declaration”). Applicant argued that the 2008 declaration and accompanying
`
`amendment outlining the “criticality” of 400°C was not relevant to the then-
`
`pending independent claims of the ’625 application since they did not include the
`
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`- 8 -
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`
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`“angle of permanent deformation” clause, as required by the pending claims of the
`
`’311 application. Id. at 117. Applicant failed to mention that the dependent claims
`
`of the ’625 application pending at the time of the 2008 declaration did include such
`
`a “permanent deformation” clause. See Ex. 1009 at 82. The examiner of the ’625
`
`application relied on applicant’s representations in ultimately allowing the claims
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`of that application, stating that the claimed temperature range of 400°C and above
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`was “critical in providing distinguishing shape memory qualities.” Id. at 130
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`(Statement of Reasons for Allowance) (emphasis added).
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`Applicant Luebke’s 2014 declaration references a new study that he
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`allegedly conducted to demonstrate that 375°C was a sufficient heat treatment
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`temperature to create an instrument with a Ni-Ti shank in the martensitic phase,
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`which applicant argued indicates that such instrument will have “an angle greater
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`than 10 degrees of permanent deformation after torque at 45º of flexion when
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`tested in accordance with ISO Standard 3630-1.” Ex. 1003 at 126-27 (¶¶ 4-5). The
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`2014 declaration does not mention subjecting any of the files to actual testing in
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`accordance with ISO Standard 3630-1 (as claimed) to determine whether
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`permanent deformation is achieved; rather, applicant represented that since the
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`heat-treated files were in the martensitic phase, they satisfied the claims. See id.
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`The 2014 declaration also cites to a graph included in a reference that
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`applicant stated “published after the filing date of his application.” Per the
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`applicant, the graph allegedly demonstrated that instruments heat-treated between
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`300-400°C “will have a phase such that an angle greater than 10 degrees of
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`permanent deformation … will be achieved.” See id. at 127-28, ¶6.1
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`The examiner ultimately allowed the claims of the ’311 application, stating
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`that “a shape memory nickel-titanium alloy will result from the claimed method
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`distinguished from the superelastic properties of the prior art.” Ex. 1003 at 153-54.
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`The claimed method, per the examiner, included “heat-treating the entire
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`instrument or device at 400 C or above but not [above] the melting temperature.”
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`Id. (emphasis added). However, none of the claims of the ’311 application recites
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`400°C or above. The examiner’s reasons for allowance did not address the
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`applicant’s actual claims (with temperature ranges as low as from above 25°C) or
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`the clear inconsistencies between the applicant’s 2008 and 2014 declarations.2
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`While the applicant submitted comments to the allowance statement, the applicant
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`merely asserted that the examiner’s recitation of 400ºC was “underinclusive” given
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`1
`As further explained in sections VIII.B.2(c) and VIII.J.3, at footnote 28,
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`infra, the cited graph actually originated from a 2000 (prior art) publication to
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`Pelton (Ex. 1006 at 114 (Fig. 10)), which applicant failed to mention.
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`2
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`The same assistant examiner handled the examination of the ’773 patent,
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`which issued just 6 months earlier and did include claims with a 400°C
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`temperature threshold. Ex. 1011; Ex. 1008 at 209-11, 227-28.
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`
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`the actual claimed temperature ranges. Id. at 197-98. The discrepancy was never
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`addressed by the USPTO.
`
`VI. REQUIREMENTS FOR POST-GRANT REVIEW (37 C.F.R. § 42.204)
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`A. Grounds for Standing (37 C.F.R. § 42.204(a))
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`Petitioner certifies that the ’991 patent is available for PGR. The ’991 patent
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`issued on November 4, 2014 from an application filed on January 29, 2014. For the
`
`reasons discussed below (section VII), at least one claim of the ’991 patent has an
`
`effective filing date on or after March 16, 2013 such that PGR is available. See
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`Leahy-Smith America Invents Act, Pub. L. No. 112-29, sec. 3(n)(1)(A), 6(f)(2),
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`125 Stat. 284, 293, 311 (2011). This Petition is filed less than nine months after the
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`issuance of the ’991 patent. See 35 U.S.C. § 321(c). Petitioner is not barred or
`
`estopped from requesting PGR.
`
`B.
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`Identification of Challenged Claims and Specific Statutory
`Grounds (37 C.F.R. § 42.204(b)(1)-(2))
`
`Petitioner challenges claims 12-16 of the ’991 patent (“the Challenged
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`Claims”) under 35 U.S.C. §§ 102, 103, and 112.3 Claim 12 reads:
`
`12. A method for manufacturing or modifying an endodontic
`instrument for use in performing root canal therapy on a tooth,
`the method comprising:
`(a) providing an elongate shank having a cutting edge
`
`
`3
`Citations are to the current, post-AIA version of the Patent Act.
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`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 above 25° C. up to but not equal to the melting
`point of the superelastic nickel titanium alloy,
`wherein the heat treated shank has an angle greater than
`10 degrees of permanent deformation after torque at 45 degrees
`of flexion when tested in accordance with ISO Standard 3630-
`1.
`Ex. 1001 at 10:35-48. Each of claims 13 through 16 depends from claim 12. Claim
`
`13 recites that step (b) occur in certain atmospheres, including any “acceptable heat
`
`treatment process.” Id. at 10:49-51. Claim 14 specifies that the heat-treatment
`
`temperature in step (b) is “from 300° C” up to the melting point of the alloy. Id. at
`
`10:52-54. Claim 15 provides that the shank has a diameter of 0.5 to 1.6
`
`millimeters. Id.at 10:55-57. Finally, claim 16 recites that the alloy is 54-57 percent
`
`nickel by weight. Id. at 10:58-60.
`
`Petitioner requests cancellation of claims 12-16 on the following grounds:4
`
`Ground 1: Lack of Enablement of Claims 12-16 Under 35 U.S.C. § 112(a)
`
`Ground 2: Lack of Written Description of Claims 12-16 Under § 112(a)
`
`
`4 With respect to § 103 obviousness grounds, Petitioner also relies on the
`
`knowledge of one of ordinary skill, as explained in further detail in section VIII.
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`Ground 3: Anticipation of Claims 12-16 by Luebke 2008 Under § 102(a)
`
`Ground 4: Obviousness of Claim 15 Over Luebke 2008 Either Alone or in View
`
`of Heath or ISO 3630-1 Under § 103
`
`Ground 5: Anticipation of Claims 12-16 by Matsutani Under § 102(a)
`
`Ground 6: Anticipation of Claims 12-14 and 16 by Kuhn Under § 102(a)
`
`Ground 7: Obviousness of Claim 15 Over Kuhn Either Alone or in View of
`
`Heath or ISO 3630-1 Under § 103
`
`Ground 8: Obviousness of Claims 12-16 Over Kuhn Either Alone or in View of
`
`Heath or ISO 3630-1 Under § 103
`
`Ground 9: Obviousness of Claims 12-14 and 16 Over McSpadden and Pelton in
`
`View of Kuhn Under § 103
`
`Ground 10: Obviousness of Claim 15 Over McSpadden and Pelton in View of
`
`Kuhn and in Further View of Heath and ISO 3630-1 Under § 103
`
`Ground 11: Obviousness of Claims 12-14 and 16 Over Tripi in View of
`
`McSpadden Under § 103
`
`Ground 12: Obviousness of Claim 15 Over Tripi in View of McSpadden and in
`
`Further View of Heath or ISO 3630-1 Under § 103
`
`C. Claim Construction (37 C.F.R. § 42.204(b)(3))
`
`A claim subject to PGR is given its “broadest reasonable construction in
`
`light of the specification of the patent in which it appears.” 37 C.F.R. § 42.200(b).
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`Petitioner submits, for the purposes of this PGR only, the following claim
`
`constructions.
`
`1.
`
`“heat-treating the entire shank”
`
`This limitation appears in independent claim 12 of the ’991 patent. In the
`
`pending district court litigation involving the ’991 patent’s parent (the ’773 patent),
`
`Petitioner has asserted that the same limitation should be construed to require
`
`“heat-treating the entire shank in an atmosphere consisting essentially of a gas
`
`unreactive with nickel titanium” since the specification uniformly states that the
`
`atmosphere is one that consists essentially of a gas not reactive with the shank
`
`component of the instrument. See Ex. 1011 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; see also Ex. 1001 at 2:65-3:1, 4:16-19,
`
`4:21-24, 7:44-47, 8:4-6, 8:23-24, 9:10-12. Also, during prosecution of an earlier,
`
`related application, the applicant made clear that the unreactive atmosphere was an
`
`essential part of the invention (see infra section VII.C, regarding priority date).
`
`The contrary position is that (i) the ’991 patent claim language does not
`
`expressly limit heat treatment to an unreactive atmosphere, and (ii) dependent
`
`claim 13 of the ’991 patent purports to cover treatment in “unreactive, ambient or
`
`any other acceptable heat treatment process.”5 For the purposes of this proceeding,
`
`5
` Claims 4-6 and 16 of the ’773 patent are the first disclosure, in any of the
`
`applications to which the ’991 patent claims priority, of heat treatment in anything
`
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